Titles of Regulations: 1VAC30-45. Certification for Noncommercial Environmental Laboratories.

1VAC30-46. Accreditation for Commercial Environmental.

Statutory Authority: §2.2-1105 of the Code of Virginia.

Publication of final regulations: 24:25 VA.R. 3449-3523 August 18, 2008.

Suspension of final stage: The final stage of the regulatory process was suspended on Wednesday, September 17, 2008, pursuant to § 2.2-4007.06 of the Code of Virginia. The reason for the suspension is that at least 25 persons requested additional public comment.

Delay of effective date: The effective date of this regulatory action will be delayed.

Additional public comment: The Division of Consolidated Laboratory Services of the Department of General Services (DGS-DCLS) will hold a 30-day public comment period on the issues raised by those who requested additional public comment. A summary of these issues is provided below. DGS-DCLS will only take comments on the issues that were raised and the specific regulatory provisions set out below.

DGS-DCLS will receive public comments until 5 p.m. on November 12, 2008. DGS-DCLS will not hold a public hearing. Comments may be sent by email or letter to the contact listed below. Any comment sent by email must include the name, address, and phone number of the person sending the comment.

Contact person: Nancy S. Saylor, Consultant to the Division of Consolidated Laboratory Services, Department of General Services, 600 North 5^th Street, Richmond, VA, 23219, telephone (804) 231-7980, email nssaylor@verizon.net.

Summary of issues raised by those persons requesting additional public comment: Citizen water quality monitoring groups have two main concerns. First, fees charged under the environmental laboratory certification program will severely affect the ability of citizen monitoring groups to continue operation. Citizen monitoring groups are funded through grants from the Department of Environmental Quality (DEQ). Grant money is limited. If citizen monitoring groups are charged fees, this grant money will be diverted to DCLS and not used for its intended purpose, to fund the operation of these groups. Second, the final regulations do not take into account the recent changes DEQ has made to its citizen water quality monitoring program. This leads to a conflict between the certification program and the citizen monitoring program. Since 2004, DEQ has developed a three-tiered system to define how the agency will use citizen monitoring data. DEQ has assigned quality assurance and quality control (QA/QC) requirements for each of the tiers. DEQ has approved many QA/QC plans developed by citizen monitoring groups during this time.

Environmental research laboratories at Virginia’s institutions of higher education also raised concerns. First, the impacts of the regulations on research conducted by these laboratories are unclear because the regulations do not specifically address whether these laboratories would be commercial or noncommercial. One commenter from a university laboratory stated that the laboratory performs both research and permit monitoring analysis. Second, these laboratories are concerned about the fees and other costs of the certification program. These costs could have an adverse impact on the operation of the laboratories. Third, providing research analysis to DEQ is different than submitting data for the purpose of complying with a permit. Laboratories providing research analysis should not be subject to the same requirements as those submitting compliance data.

Background: The regulations establish the certification program required by § 2.2-1105 of the Code of Virginia for environmental laboratories submitting data to the Department of Environmental Quality under the state’s air, water and waste laws. There are two regulations, one for noncommercial environmental laboratories (1VAC30-45) and one for commercial environmental laboratories (1VAC30-46). Each regulation is organized into two parts. Part I of each regulation contains the provisions pertaining to the administration of the program. This part describes the process that owners of environmental laboratories must use to be certified and to maintain certification under the program. Part II of each regulation contains the quality assurance and quality control standards that environmental laboratories must meet to be certified under the program. The standards in Part II of Chapter 45 have been developed for Virginia noncommercial environmental laboratories. The standards in Part II of Chapter 46 are the 2003 National Environmental Laboratory Accreditation Conference standards, which are incorporated by reference into the regulation.

The regulations were first proposed in February 2004. DGS-DCLS took written comments for 60 days. DGS-DCLS also held public hearings statewide to hear public comments. At the end of the 60-day public comment period, DGS-DCLS reviewed the public comments and revised the regulations. Because some of the revisions were significant, DGS-DCLS announced an additional 30-day public comment period in September 2004. Following this public comment period, DGS-DCLS made additional changes to the regulations. One of these changes was the elimination from the definition of environmental analysis and from the program requirements of taxonomic identification of samples for which there is no national accreditation standard such as algae or benthic macroinvertebrates. This change was made in response to comments from citizen monitoring groups who commented during the second public comment period, for the first time. DGS-DCLS sent the draft final regulation package for review to the Department of Planning and Budget, the Secretary of Administration, and the Governor’s Policy Office, in March 2005. This executive review was ongoing until July 10, 2008, when the Governor’s Office approved the final regulations to be promulgated in the Virginia Register.

Provisions to be added to 1VAC30-45-30: DGS-DCLS and DEQ have been working together to draft regulatory provisions that address the issues raised by both citizen monitoring groups and laboratories at institutions of higher education. These proposed new provisions are set out below. DGS-DCLS requests comments on the specific language of 1VAC30-45-30 C and D. 1VAC30-45-30 is provided in its entirety. Please comment only on the proposed additional language, which is underlined.

The citizen water quality monitoring program at DEQ has grown since 2004, when DEQ and DGS-DCLS last discussed how the certification program would affect citizen monitoring groups. At that time, seven laboratories were affected and only three of these laboratories would incur significant fees. The program to use citizen monitors was at the beginning of its development. Since 2004, Virginia’s General Assembly and the Environmental Protection Agency (EPA) have encouraged DEQ to increase its use of citizen monitors of the state’s waters. Since 2004, DEQ has created a program that provides separate tiers for different levels of citizen monitoring data usage. As the significance of the data use increases, the requirements for quality assurance and quality control increase. For Tier III, the highest tier, where data are used to list or delist waters on the 303(d) impaired water list, to assess waters for the 305(b) report to EPA, or to use with DEQ data for TMDL development, DEQ requires a quality assurance project plan, laboratory audit, and the submittal of calibration and quality control associated information to DEQ when submitting data. DGS-DCLS and DEQ are proposing (see 1VAC30-45-30 C) to allow citizen monitoring groups and certain affiliated environmental laboratories to meet DEQ’s quality assurance and quality control requirements in lieu of the requirements of the certification program. DGS-DCLS sees no need to override the working quality assurance program that DEQ has developed for citizen monitoring groups. In addition, these groups have limited funds. Any increase in costs would hamper their ability to provide data to DEQ.

DEQ works with many environmental laboratories at institutions of higher education on various research projects that provide information on the environmental health of the state’s waters. Some examples are fish health studies that analyze blood chemistry and organ condition; water quality studies focusing on storm-event patterns to assess metals, pesticides, and organics; benthic biomonitoring; and an assessment of chemistry from fish kill vs. nonfish kill areas. Most of these laboratories only perform research analyses. Some of the laboratories eventually provide analyses that support water standards development or that may be associated with permitting. DEQ proposes to identify and require these laboratories to be certified (see 1VAC30-45-30 D).

DEQ believes that analyses performed by laboratories at institutions of higher education that are used by DEQ and are directly associated with DEQ regulations, permits, compliance and/or enforcement activities must be certified by DGS-DCLS. Analyses performed by laboratories at institutions of higher education and used by DEQ as environmental research do not require certification.

DGS-DCLS and DEQ will treat environmental laboratories at institutions of higher education that perform environmental analysis required by permits or compliance orders for themselves or for others just as they would laboratories owned commercially or by local governments or authorities. If the laboratory does work for other persons, the laboratory would be deemed a commercial laboratory under 1VAC30-46. If the laboratory does work for the institution of higher education of which it is a part, the laboratory would be deemed a noncommercial laboratory and be subject to 1VAC30-45. If the laboratory is a state institution of higher education and works for another state agency, the laboratory would be deemed noncommercial.

Regulatory provisions for review:

1VAC30-45-30. Applicability.

A. This chapter applies to any owner of a noncommercial environmental laboratory.

B. Any environmental laboratory owned by an agency of the federal government may be certified as follows:

1. By DGS-DCLS to the standards set out in this chapter, or

2. By a federal primary accrediting authority to the standards established by the National Environmental Laboratory Accreditation Conference.

C. Citizen monitoring groups. Section 62.1-44.19:11 of the Code of Virginia both establishes a citizen water quality monitoring program for Virginia and encourages the growth of the program. The Department of Environmental Quality (DEQ) has a separate program of quality assurance and quality control (QA/QC) standards for citizen monitoring groups and their laboratories to follow. The following laboratories shall meet the DEQ QA/QC requirements developed for the purposes of citizen monitoring of water quality in lieu of the requirements of 1VAC30, Chapter 45 or 1VAC30, Chapter 46:

1. Laboratories owned by citizen monitoring groups.

2. Laboratories at institutions of higher education affiliated with citizen monitoring groups for the purposes of analyzing samples for the groups.

D. Environmental research performed by environmental laboratories owned by institutions of higher education. Environmental laboratories owned by institutions of higher education located in Virginia that perform analyses for the purpose of providing environmental research data to DEQ at DEQ’s request shall meet the QA/QC requirements specified by DEQ. An environmental laboratory owned by an institution of higher education located in Virginia that performs environmental research for DEQ shall not be subject to the requirements of either 1VAC30, Chapter 45 or 1VAC30, Chapter 46 unless DEQ requires the laboratory to do so.

Titles of Regulations: 1VAC30-45. Certification for Noncommercial Environmental Laboratories.

1VAC30-46. Accreditation for Commercial Environmental.

Statutory Authority: §2.2-1105 of the Code of Virginia.

Publication of final regulations: 24:25 VA.R. 3449-3523 August 18, 2008.

Suspension of final stage: The final stage of the regulatory process was suspended on Wednesday, September 17, 2008, pursuant to § 2.2-4007.06 of the Code of Virginia. The reason for the suspension is that at least 25 persons requested additional public comment.

Delay of effective date: The effective date of this regulatory action will be delayed.

Additional public comment: The Division of Consolidated Laboratory Services of the Department of General Services (DGS-DCLS) will hold a 30-day public comment period on the issues raised by those who requested additional public comment. A summary of these issues is provided below. DGS-DCLS will only take comments on the issues that were raised and the specific regulatory provisions set out below.

DGS-DCLS will receive public comments until 5 p.m. on November 12, 2008. DGS-DCLS will not hold a public hearing. Comments may be sent by email or letter to the contact listed below. Any comment sent by email must include the name, address, and phone number of the person sending the comment.

Contact person: Nancy S. Saylor, Consultant to the Division of Consolidated Laboratory Services, Department of General Services, 600 North 5^th Street, Richmond, VA, 23219, telephone (804) 231-7980, email nssaylor@verizon.net.

Summary of issues raised by those persons requesting additional public comment: Citizen water quality monitoring groups have two main concerns. First, fees charged under the environmental laboratory certification program will severely affect the ability of citizen monitoring groups to continue operation. Citizen monitoring groups are funded through grants from the Department of Environmental Quality (DEQ). Grant money is limited. If citizen monitoring groups are charged fees, this grant money will be diverted to DCLS and not used for its intended purpose, to fund the operation of these groups. Second, the final regulations do not take into account the recent changes DEQ has made to its citizen water quality monitoring program. This leads to a conflict between the certification program and the citizen monitoring program. Since 2004, DEQ has developed a three-tiered system to define how the agency will use citizen monitoring data. DEQ has assigned quality assurance and quality control (QA/QC) requirements for each of the tiers. DEQ has approved many QA/QC plans developed by citizen monitoring groups during this time.

Environmental research laboratories at Virginia’s institutions of higher education also raised concerns. First, the impacts of the regulations on research conducted by these laboratories are unclear because the regulations do not specifically address whether these laboratories would be commercial or noncommercial. One commenter from a university laboratory stated that the laboratory performs both research and permit monitoring analysis. Second, these laboratories are concerned about the fees and other costs of the certification program. These costs could have an adverse impact on the operation of the laboratories. Third, providing research analysis to DEQ is different than submitting data for the purpose of complying with a permit. Laboratories providing research analysis should not be subject to the same requirements as those submitting compliance data.

Background: The regulations establish the certification program required by § 2.2-1105 of the Code of Virginia for environmental laboratories submitting data to the Department of Environmental Quality under the state’s air, water and waste laws. There are two regulations, one for noncommercial environmental laboratories (1VAC30-45) and one for commercial environmental laboratories (1VAC30-46). Each regulation is organized into two parts. Part I of each regulation contains the provisions pertaining to the administration of the program. This part describes the process that owners of environmental laboratories must use to be certified and to maintain certification under the program. Part II of each regulation contains the quality assurance and quality control standards that environmental laboratories must meet to be certified under the program. The standards in Part II of Chapter 45 have been developed for Virginia noncommercial environmental laboratories. The standards in Part II of Chapter 46 are the 2003 National Environmental Laboratory Accreditation Conference standards, which are incorporated by reference into the regulation.

The regulations were first proposed in February 2004. DGS-DCLS took written comments for 60 days. DGS-DCLS also held public hearings statewide to hear public comments. At the end of the 60-day public comment period, DGS-DCLS reviewed the public comments and revised the regulations. Because some of the revisions were significant, DGS-DCLS announced an additional 30-day public comment period in September 2004. Following this public comment period, DGS-DCLS made additional changes to the regulations. One of these changes was the elimination from the definition of environmental analysis and from the program requirements of taxonomic identification of samples for which there is no national accreditation standard such as algae or benthic macroinvertebrates. This change was made in response to comments from citizen monitoring groups who commented during the second public comment period, for the first time. DGS-DCLS sent the draft final regulation package for review to the Department of Planning and Budget, the Secretary of Administration, and the Governor’s Policy Office, in March 2005. This executive review was ongoing until July 10, 2008, when the Governor’s Office approved the final regulations to be promulgated in the Virginia Register.

Provisions to be added to 1VAC30-45-30: DGS-DCLS and DEQ have been working together to draft regulatory provisions that address the issues raised by both citizen monitoring groups and laboratories at institutions of higher education. These proposed new provisions are set out below. DGS-DCLS requests comments on the specific language of 1VAC30-45-30 C and D. 1VAC30-45-30 is provided in its entirety. Please comment only on the proposed additional language, which is underlined.

The citizen water quality monitoring program at DEQ has grown since 2004, when DEQ and DGS-DCLS last discussed how the certification program would affect citizen monitoring groups. At that time, seven laboratories were affected and only three of these laboratories would incur significant fees. The program to use citizen monitors was at the beginning of its development. Since 2004, Virginia’s General Assembly and the Environmental Protection Agency (EPA) have encouraged DEQ to increase its use of citizen monitors of the state’s waters. Since 2004, DEQ has created a program that provides separate tiers for different levels of citizen monitoring data usage. As the significance of the data use increases, the requirements for quality assurance and quality control increase. For Tier III, the highest tier, where data are used to list or delist waters on the 303(d) impaired water list, to assess waters for the 305(b) report to EPA, or to use with DEQ data for TMDL development, DEQ requires a quality assurance project plan, laboratory audit, and the submittal of calibration and quality control associated information to DEQ when submitting data. DGS-DCLS and DEQ are proposing (see 1VAC30-45-30 C) to allow citizen monitoring groups and certain affiliated environmental laboratories to meet DEQ’s quality assurance and quality control requirements in lieu of the requirements of the certification program. DGS-DCLS sees no need to override the working quality assurance program that DEQ has developed for citizen monitoring groups. In addition, these groups have limited funds. Any increase in costs would hamper their ability to provide data to DEQ.

DEQ works with many environmental laboratories at institutions of higher education on various research projects that provide information on the environmental health of the state’s waters. Some examples are fish health studies that analyze blood chemistry and organ condition; water quality studies focusing on storm-event patterns to assess metals, pesticides, and organics; benthic biomonitoring; and an assessment of chemistry from fish kill vs. nonfish kill areas. Most of these laboratories only perform research analyses. Some of the laboratories eventually provide analyses that support water standards development or that may be associated with permitting. DEQ proposes to identify and require these laboratories to be certified (see 1VAC30-45-30 D).

DEQ believes that analyses performed by laboratories at institutions of higher education that are used by DEQ and are directly associated with DEQ regulations, permits, compliance and/or enforcement activities must be certified by DGS-DCLS. Analyses performed by laboratories at institutions of higher education and used by DEQ as environmental research do not require certification.

DGS-DCLS and DEQ will treat environmental laboratories at institutions of higher education that perform environmental analysis required by permits or compliance orders for themselves or for others just as they would laboratories owned commercially or by local governments or authorities. If the laboratory does work for other persons, the laboratory would be deemed a commercial laboratory under 1VAC30-46. If the laboratory does work for the institution of higher education of which it is a part, the laboratory would be deemed a noncommercial laboratory and be subject to 1VAC30-45. If the laboratory is a state institution of higher education and works for another state agency, the laboratory would be deemed noncommercial.

Regulatory provisions for review:

1VAC30-45-30. Applicability.

A. This chapter applies to any owner of a noncommercial environmental laboratory.

B. Any environmental laboratory owned by an agency of the federal government may be certified as follows:

1. By DGS-DCLS to the standards set out in this chapter, or

2. By a federal primary accrediting authority to the standards established by the National Environmental Laboratory Accreditation Conference.

C. Citizen monitoring groups. Section 62.1-44.19:11 of the Code of Virginia both establishes a citizen water quality monitoring program for Virginia and encourages the growth of the program. The Department of Environmental Quality (DEQ) has a separate program of quality assurance and quality control (QA/QC) standards for citizen monitoring groups and their laboratories to follow. The following laboratories shall meet the DEQ QA/QC requirements developed for the purposes of citizen monitoring of water quality in lieu of the requirements of 1VAC30, Chapter 45 or 1VAC30, Chapter 46:

1. Laboratories owned by citizen monitoring groups.

2. Laboratories at institutions of higher education affiliated with citizen monitoring groups for the purposes of analyzing samples for the groups.

D. Environmental research performed by environmental laboratories owned by institutions of higher education. Environmental laboratories owned by institutions of higher education located in Virginia that perform analyses for the purpose of providing environmental research data to DEQ at DEQ’s request shall meet the QA/QC requirements specified by DEQ. An environmental laboratory owned by an institution of higher education located in Virginia that performs environmental research for DEQ shall not be subject to the requirements of either 1VAC30, Chapter 45 or 1VAC30, Chapter 46 unless DEQ requires the laboratory to do so.

Titles of Regulations: 2VAC5-10. Public Participation Guidelines (repealing 2VAC5-10-10 through 2VAC5-10-70).

2VAC5-11. Public Participation Guidelines (adding 2VAC5-11-10 through 2VAC5-11-110).

Statutory Authority: §§ 2.2-4007.02 and 3.2-109 of the Code of Virginia.

Effective Date: November 12, 2008.

Agency Contact: Roy E. Seward, Jr., Regulatory Coordinator, Department of Agriculture and Consumer Services, Oliver W. Hill, Sr., Building, 102 Governor Street, Richmond, VA 23219, telephone (804) 786-3535, FAX (804) 371-7679, or email roy.seward@vdacs.virginia.gov.

Summary:

The regulations comply with the legislative mandate (Chapter 321, 2008 Acts of Assembly) that agencies adopt model public participation guidelines issued by the Department of Planning and Budget by December 1, 2008. Public participation guidelines exist to promote public involvement in the development, amendment, or repeal of an agency's regulations.

This regulatory action repeals the current public participation guidelines and promulgates new public participation guidelines as required by Chapter 321 of the 2008 Acts of Assembly. Highlights of the public participation guidelines include (i) providing for the establishment and maintenance of notification lists of interested persons and specifying the information to be sent to such persons; (ii) providing for public comments on regulatory action; (iii) establishing the time period during which public comments shall be accepted; (iv) providing that the plan to hold a public meeting shall be indicated in any notice of intended regulatory action; (v) providing for the appointment, when necessary, of regulatory advisory panels to provide professional specialization or technical assistance and negotiated rulemaking panels if a regulatory action is expected to be controversial; and (vi) providing for the periodic review of regulations.

CHAPTER 11
PUBLIC PARTICIPATION GUIDELINES

Part I
Purpose and Definitions

2VAC5-11-10. Purpose.

The purpose of this chapter is to promote public involvement in the development, amendment or repeal of the regulations of the Board of Agriculture and Consumer Services or the Department of Agriculture and Consumer Services. This chapter does not apply to regulations, guidelines, or other documents exempted or excluded from the provisions of the Administrative Process Act (§2.2-4000 et seq. of the Code of Virginia).

2VAC5-11-20. Definitions.

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Administrative Process Act" means Chapter 40 (§2.2-4000 et seq.) of Title 2.2 of the Code of Virginia.

"Agency" means the Board of Agriculture and Consumer Services or the Department of Agriculture and Consumer Services, which is the unit of state government empowered by the agency's basic law to make regulations or decide cases. Actions specified in this chapter may be fulfilled by state employees as delegated by the agency.

"Basic law" means provisions in the Code of Virginia that delineate the basic authority and responsibilities of an agency.

"Commonwealth Calendar" means the electronic calendar for official government meetings open to the public as required by § 2.2-3707 C of the Freedom of Information Act.

''Negotiated rulemaking panel'' or ''NRP'' means an ad hoc advisory panel of interested parties established by an agency to consider issues that are controversial with the assistance of a facilitator or mediator, for the purpose of reaching a consensus in the development of a proposed regulatory action.

"Notification list" means a list used to notify persons pursuant to this chapter. Such a list may include an electronic list maintained through the Virginia Regulatory Town Hall or other list maintained by the agency.

"Open meeting" means any scheduled gathering of a unit of state government empowered by an agency's basic law to make regulations or decide cases, which is related to promulgating, amending or repealing a regulation.

"Person" means any individual, corporation, partnership, association, cooperative, limited liability company, trust, joint venture, government, political subdivision, or any other legal or commercial entity and any successor, representative, agent, agency, or instrumentality thereof.

"Public hearing" means a scheduled time at which members or staff of the agency will meet for the purpose of receiving public comment on a regulatory action.

"Regulation" means any statement of general application having the force of law, affecting the rights or conduct of any person, adopted by the agency in accordance with the authority conferred on it by applicable laws.

"Regulatory action" means the promulgation, amendment, or repeal of a regulation by the agency.

"Regulatory advisory panel" or "RAP" means a standing or ad hoc advisory panel of interested parties established by the agency for the purpose of assisting in regulatory actions.

"Town Hall" means the Virginia Regulatory Town Hall, the website operated by the Virginia Department of Planning and Budget at www.townhall.virginia.gov, which has online public comment forums and displays information about regulatory meetings and regulatory actions under consideration in Virginia and sends this information to registered public users.

"Virginia Register" means the Virginia Register of Regulations, the publication that provides official legal notice of new, amended and repealed regulations of state agencies, which is published under the provisions of Article 6 (§2.2-4031 et seq.) of the Administrative Process Act.

Part II
Notification of Interested Persons

2VAC5-11-30. Notification list.

A. The agency shall maintain a list of persons who have requested to be notified of regulatory actions being pursued by the agency.

B. Any person may request to be placed on a notification list by registering as a public user on the Town Hall or by making a request to the agency. Any person who requests to be placed on a notification list shall elect to be notified either by electronic means or through a postal carrier.

C. The agency may maintain additional lists for persons who have requested to be informed of specific regulatory issues, proposals, or actions.

D. When electronic mail is returned as undeliverable on multiple occasions at least 24 hours apart, that person may be deleted from the list. A single undeliverable message is insufficient cause to delete the person from the list.

E. When mail delivered by a postal carrier is returned as undeliverable on multiple occasions, that person may be deleted from the list.

F. The agency may periodically request those persons on the notification list to indicate their desire to either continue to be notified electronically, receive documents through a postal carrier, or be deleted from the list.

2VAC5-11-40. Information to be sent to persons on the notification list.

A. To persons electing to receive electronic notification or notification through a postal carrier as described in 2VAC5-11-30, the agency shall send the following information:

1. A notice of intended regulatory action (NOIRA).

2. A notice of the comment period on a proposed, a reproposed, or a fast-track regulation and hyperlinks to, or instructions on how to obtain, a copy of the regulation and any supporting documents.

3. A notice soliciting comment on a final regulation when the regulatory process has been extended pursuant to § 2.2-4007.06 or 2.2-4013 C of the Code of Virginia.

B. The failure of any person to receive any notice or copies of any documents shall not affect the validity of any regulation or regulatory action.

Part III
Public Participation Procedures

2VAC5-11-50. Public comment.

A. In considering any nonemergency, nonexempt regulatory action, the agency shall afford interested persons an opportunity to submit data, views, and arguments, either orally or in writing, to the agency. Such opportunity to comment shall include an online public comment forum on the Town Hall.

1. To any requesting person, the agency shall provide copies of the statement of basis, purpose, substance, and issues; the economic impact analysis of the proposed or fast-track regulatory action; and the agency's response to public comments received.

2. The agency may begin crafting a regulatory action prior to or during any opportunities it provides to the public to submit comments.

B. The agency shall accept public comments in writing after the publication of a regulatory action in the Virginia Register as follows:

1. For a minimum of 30 calendar days following the publication of the notice of intended regulatory action (NOIRA).

2. For a minimum of 60 calendar days following the publication of a proposed regulation.

3. For a minimum of 30 calendar days following the publication of a reproposed regulation.

4. For a minimum of 30 calendar days following the publication of a final adopted regulation.

5. For a minimum of 30 calendar days following the publication of a fast-track regulation.

6. For a minimum of 21 calendar days following the publication of a notice of periodic review.

7. Not later than 21 calendar days following the publication of a petition for rulemaking.

C. The agency may determine if any of the comment periods listed in subsection B of this section shall be extended.

D. If the Governor finds that one or more changes with substantial impact have been made to a proposed regulation, he may require the agency to provide an additional 30 calendar days to solicit additional public comment on the changes in accordance with § 2.2-4013 C of the Code of Virginia.

E. The agency shall send a draft of the agency's summary description of public comment to all public commenters on the proposed regulation at least five days before final adoption of the regulation pursuant to § 2.2-4012 E of the Code of Virginia.

2VAC5-11-60. Petition for rulemaking.

A. As provided in § 2.2-4007 of the Code of Virginia, any person may petition the agency to consider a regulatory action.

B. A petition shall include but is not limited to the following information:

1. The petitioner's name and contact information;

2. The substance and purpose of the rulemaking that is requested, including reference to any applicable Virginia Administrative Code sections; and

3. Reference to the legal authority of the agency to take the action requested.

C. The agency shall receive, consider and respond to a petition pursuant to § 2.2-4007 and shall have the sole authority to dispose of the petition.

D. The petition shall be posted on the Town Hall and published in the Virginia Register.

E. Nothing in this chapter shall prohibit the agency from receiving information or from proceeding on its own motion for rulemaking.

2VAC5-11-70. Appointment of regulatory advisory panel.

A. The agency may appoint a regulatory advisory panel (RAP) to provide professional specialization or technical assistance when the agency determines that such expertise is necessary to address a specific regulatory issue or action or when individuals indicate an interest in working with the agency on a specific regulatory issue or action.

B. Any person may request the appointment of a RAP and request to participate in its activities. The agency shall determine when a RAP shall be appointed and the composition of the RAP.

C. A RAP may be dissolved by the agency if:

1. The proposed text of the regulation is posted on the Town Hall, published in the Virginia Register, or such other time as the agency determines is appropriate; or

2. The agency determines that the regulatory action is either exempt or excluded from the requirements of the Administrative Process Act.

2VAC5-11-80. Appointment of negotiated rulemaking panel.

A. The agency may appoint a negotiated rulemaking panel (NRP) if a regulatory action is expected to be controversial.

B. An NRP that has been appointed by the agency may be dissolved by the agency when:

1. There is no longer controversy associated with the development of the regulation;

2. The agency determines that the regulatory action is either exempt or excluded from the requirements of the Administrative Process Act; or

3. The agency determines that resolution of a controversy is unlikely.

2VAC5-11-90. Meetings.

Notice of any open meeting, including meetings of a RAP or NRP, shall be posted on the Virginia Regulatory Town Hall and Commonwealth Calendar at least seven working days prior to the date of the meeting. The exception to this requirement is any meeting held in accordance with § 2.2-3707 D of the Code of Virginia allowing for contemporaneous notice to be provided to participants and the public.

2VAC5-11-100. Public hearings on regulations.

A. The agency shall indicate in its notice of intended regulatory action whether it plans to hold a public hearing following the publication of the proposed stage of the regulatory action.

B. The agency may conduct one or more public hearings during the comment period following the publication of a proposed regulatory action.

C. An agency is required to hold a public hearing following the publication of the proposed regulatory action when:

1. The agency's basic law requires the agency to hold a public hearing;

2. The Governor directs the agency to hold a public hearing; or

3. The agency receives requests for a public hearing from at least 25 persons during the public comment period following the publication of the notice of intended regulatory action.

D. Notice of any public hearing shall be posted on the Town Hall and Commonwealth Calendar at least seven working days prior to the date of the hearing. The agency shall also notify those persons who requested a hearing under subdivision C 3 of this section.

2VAC5-11-110. Periodic review of regulations.

A. The agency shall conduct a periodic review of its regulations consistent with:

1. An executive order issued by the Governor pursuant to § 2.2-4017 of the Administrative Process Act to receive comment on all existing regulations as to their effectiveness, efficiency, necessity, clarity, and cost of compliance; and

2. The requirements in § 2.2-4007.1 of the Administrative Process Act regarding regulatory flexibility for small businesses.

B. A periodic review may be conducted separately or in conjunction with other regulatory actions.

C. Notice of a periodic review shall be posted on the Town Hall and published in the Virginia Register.

Titles of Regulations: 2VAC5-10. Public Participation Guidelines (repealing 2VAC5-10-10 through 2VAC5-10-70).

2VAC5-11. Public Participation Guidelines (adding 2VAC5-11-10 through 2VAC5-11-110).

Statutory Authority: §§ 2.2-4007.02 and 3.2-109 of the Code of Virginia.

Effective Date: November 12, 2008.

Agency Contact: Roy E. Seward, Jr., Regulatory Coordinator, Department of Agriculture and Consumer Services, Oliver W. Hill, Sr., Building, 102 Governor Street, Richmond, VA 23219, telephone (804) 786-3535, FAX (804) 371-7679, or email roy.seward@vdacs.virginia.gov.

Summary:

The regulations comply with the legislative mandate (Chapter 321, 2008 Acts of Assembly) that agencies adopt model public participation guidelines issued by the Department of Planning and Budget by December 1, 2008. Public participation guidelines exist to promote public involvement in the development, amendment, or repeal of an agency's regulations.

This regulatory action repeals the current public participation guidelines and promulgates new public participation guidelines as required by Chapter 321 of the 2008 Acts of Assembly. Highlights of the public participation guidelines include (i) providing for the establishment and maintenance of notification lists of interested persons and specifying the information to be sent to such persons; (ii) providing for public comments on regulatory action; (iii) establishing the time period during which public comments shall be accepted; (iv) providing that the plan to hold a public meeting shall be indicated in any notice of intended regulatory action; (v) providing for the appointment, when necessary, of regulatory advisory panels to provide professional specialization or technical assistance and negotiated rulemaking panels if a regulatory action is expected to be controversial; and (vi) providing for the periodic review of regulations.

CHAPTER 11
PUBLIC PARTICIPATION GUIDELINES

Part I
Purpose and Definitions

2VAC5-11-10. Purpose.

The purpose of this chapter is to promote public involvement in the development, amendment or repeal of the regulations of the Board of Agriculture and Consumer Services or the Department of Agriculture and Consumer Services. This chapter does not apply to regulations, guidelines, or other documents exempted or excluded from the provisions of the Administrative Process Act (§2.2-4000 et seq. of the Code of Virginia).

2VAC5-11-20. Definitions.

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Administrative Process Act" means Chapter 40 (§2.2-4000 et seq.) of Title 2.2 of the Code of Virginia.

"Agency" means the Board of Agriculture and Consumer Services or the Department of Agriculture and Consumer Services, which is the unit of state government empowered by the agency's basic law to make regulations or decide cases. Actions specified in this chapter may be fulfilled by state employees as delegated by the agency.

"Basic law" means provisions in the Code of Virginia that delineate the basic authority and responsibilities of an agency.

"Commonwealth Calendar" means the electronic calendar for official government meetings open to the public as required by § 2.2-3707 C of the Freedom of Information Act.

''Negotiated rulemaking panel'' or ''NRP'' means an ad hoc advisory panel of interested parties established by an agency to consider issues that are controversial with the assistance of a facilitator or mediator, for the purpose of reaching a consensus in the development of a proposed regulatory action.

"Notification list" means a list used to notify persons pursuant to this chapter. Such a list may include an electronic list maintained through the Virginia Regulatory Town Hall or other list maintained by the agency.

"Open meeting" means any scheduled gathering of a unit of state government empowered by an agency's basic law to make regulations or decide cases, which is related to promulgating, amending or repealing a regulation.

"Person" means any individual, corporation, partnership, association, cooperative, limited liability company, trust, joint venture, government, political subdivision, or any other legal or commercial entity and any successor, representative, agent, agency, or instrumentality thereof.

"Public hearing" means a scheduled time at which members or staff of the agency will meet for the purpose of receiving public comment on a regulatory action.

"Regulation" means any statement of general application having the force of law, affecting the rights or conduct of any person, adopted by the agency in accordance with the authority conferred on it by applicable laws.

"Regulatory action" means the promulgation, amendment, or repeal of a regulation by the agency.

"Regulatory advisory panel" or "RAP" means a standing or ad hoc advisory panel of interested parties established by the agency for the purpose of assisting in regulatory actions.

"Town Hall" means the Virginia Regulatory Town Hall, the website operated by the Virginia Department of Planning and Budget at www.townhall.virginia.gov, which has online public comment forums and displays information about regulatory meetings and regulatory actions under consideration in Virginia and sends this information to registered public users.

"Virginia Register" means the Virginia Register of Regulations, the publication that provides official legal notice of new, amended and repealed regulations of state agencies, which is published under the provisions of Article 6 (§2.2-4031 et seq.) of the Administrative Process Act.

Part II
Notification of Interested Persons

2VAC5-11-30. Notification list.

A. The agency shall maintain a list of persons who have requested to be notified of regulatory actions being pursued by the agency.

B. Any person may request to be placed on a notification list by registering as a public user on the Town Hall or by making a request to the agency. Any person who requests to be placed on a notification list shall elect to be notified either by electronic means or through a postal carrier.

C. The agency may maintain additional lists for persons who have requested to be informed of specific regulatory issues, proposals, or actions.

D. When electronic mail is returned as undeliverable on multiple occasions at least 24 hours apart, that person may be deleted from the list. A single undeliverable message is insufficient cause to delete the person from the list.

E. When mail delivered by a postal carrier is returned as undeliverable on multiple occasions, that person may be deleted from the list.

F. The agency may periodically request those persons on the notification list to indicate their desire to either continue to be notified electronically, receive documents through a postal carrier, or be deleted from the list.

2VAC5-11-40. Information to be sent to persons on the notification list.

A. To persons electing to receive electronic notification or notification through a postal carrier as described in 2VAC5-11-30, the agency shall send the following information:

1. A notice of intended regulatory action (NOIRA).

2. A notice of the comment period on a proposed, a reproposed, or a fast-track regulation and hyperlinks to, or instructions on how to obtain, a copy of the regulation and any supporting documents.

3. A notice soliciting comment on a final regulation when the regulatory process has been extended pursuant to § 2.2-4007.06 or 2.2-4013 C of the Code of Virginia.

B. The failure of any person to receive any notice or copies of any documents shall not affect the validity of any regulation or regulatory action.

Part III
Public Participation Procedures

2VAC5-11-50. Public comment.

A. In considering any nonemergency, nonexempt regulatory action, the agency shall afford interested persons an opportunity to submit data, views, and arguments, either orally or in writing, to the agency. Such opportunity to comment shall include an online public comment forum on the Town Hall.

1. To any requesting person, the agency shall provide copies of the statement of basis, purpose, substance, and issues; the economic impact analysis of the proposed or fast-track regulatory action; and the agency's response to public comments received.

2. The agency may begin crafting a regulatory action prior to or during any opportunities it provides to the public to submit comments.

B. The agency shall accept public comments in writing after the publication of a regulatory action in the Virginia Register as follows:

1. For a minimum of 30 calendar days following the publication of the notice of intended regulatory action (NOIRA).

2. For a minimum of 60 calendar days following the publication of a proposed regulation.

3. For a minimum of 30 calendar days following the publication of a reproposed regulation.

4. For a minimum of 30 calendar days following the publication of a final adopted regulation.

5. For a minimum of 30 calendar days following the publication of a fast-track regulation.

6. For a minimum of 21 calendar days following the publication of a notice of periodic review.

7. Not later than 21 calendar days following the publication of a petition for rulemaking.

C. The agency may determine if any of the comment periods listed in subsection B of this section shall be extended.

D. If the Governor finds that one or more changes with substantial impact have been made to a proposed regulation, he may require the agency to provide an additional 30 calendar days to solicit additional public comment on the changes in accordance with § 2.2-4013 C of the Code of Virginia.

E. The agency shall send a draft of the agency's summary description of public comment to all public commenters on the proposed regulation at least five days before final adoption of the regulation pursuant to § 2.2-4012 E of the Code of Virginia.

2VAC5-11-60. Petition for rulemaking.

A. As provided in § 2.2-4007 of the Code of Virginia, any person may petition the agency to consider a regulatory action.

B. A petition shall include but is not limited to the following information:

1. The petitioner's name and contact information;

2. The substance and purpose of the rulemaking that is requested, including reference to any applicable Virginia Administrative Code sections; and

3. Reference to the legal authority of the agency to take the action requested.

C. The agency shall receive, consider and respond to a petition pursuant to § 2.2-4007 and shall have the sole authority to dispose of the petition.

D. The petition shall be posted on the Town Hall and published in the Virginia Register.

E. Nothing in this chapter shall prohibit the agency from receiving information or from proceeding on its own motion for rulemaking.

2VAC5-11-70. Appointment of regulatory advisory panel.

A. The agency may appoint a regulatory advisory panel (RAP) to provide professional specialization or technical assistance when the agency determines that such expertise is necessary to address a specific regulatory issue or action or when individuals indicate an interest in working with the agency on a specific regulatory issue or action.

B. Any person may request the appointment of a RAP and request to participate in its activities. The agency shall determine when a RAP shall be appointed and the composition of the RAP.

C. A RAP may be dissolved by the agency if:

1. The proposed text of the regulation is posted on the Town Hall, published in the Virginia Register, or such other time as the agency determines is appropriate; or

2. The agency determines that the regulatory action is either exempt or excluded from the requirements of the Administrative Process Act.

2VAC5-11-80. Appointment of negotiated rulemaking panel.

A. The agency may appoint a negotiated rulemaking panel (NRP) if a regulatory action is expected to be controversial.

B. An NRP that has been appointed by the agency may be dissolved by the agency when:

1. There is no longer controversy associated with the development of the regulation;

2. The agency determines that the regulatory action is either exempt or excluded from the requirements of the Administrative Process Act; or

3. The agency determines that resolution of a controversy is unlikely.

2VAC5-11-90. Meetings.

Notice of any open meeting, including meetings of a RAP or NRP, shall be posted on the Virginia Regulatory Town Hall and Commonwealth Calendar at least seven working days prior to the date of the meeting. The exception to this requirement is any meeting held in accordance with § 2.2-3707 D of the Code of Virginia allowing for contemporaneous notice to be provided to participants and the public.

2VAC5-11-100. Public hearings on regulations.

A. The agency shall indicate in its notice of intended regulatory action whether it plans to hold a public hearing following the publication of the proposed stage of the regulatory action.

B. The agency may conduct one or more public hearings during the comment period following the publication of a proposed regulatory action.

C. An agency is required to hold a public hearing following the publication of the proposed regulatory action when:

1. The agency's basic law requires the agency to hold a public hearing;

2. The Governor directs the agency to hold a public hearing; or

3. The agency receives requests for a public hearing from at least 25 persons during the public comment period following the publication of the notice of intended regulatory action.

D. Notice of any public hearing shall be posted on the Town Hall and Commonwealth Calendar at least seven working days prior to the date of the hearing. The agency shall also notify those persons who requested a hearing under subdivision C 3 of this section.

2VAC5-11-110. Periodic review of regulations.

A. The agency shall conduct a periodic review of its regulations consistent with:

1. An executive order issued by the Governor pursuant to § 2.2-4017 of the Administrative Process Act to receive comment on all existing regulations as to their effectiveness, efficiency, necessity, clarity, and cost of compliance; and

2. The requirements in § 2.2-4007.1 of the Administrative Process Act regarding regulatory flexibility for small businesses.

B. A periodic review may be conducted separately or in conjunction with other regulatory actions.

C. Notice of a periodic review shall be posted on the Town Hall and published in the Virginia Register.

Title of Regulation: 2VAC20-51. Regulations Governing Pesticide Applicator Certification Under Authority of Virginia Pesticide Control Act (amending 2VAC20-51-10 through 2VAC20-51-210).

Statutory Authority: §3.2-3906 of the Code of Virginia.

Effective Date: December 1, 2008.

Agency Contact: Liza Fleeson, Program Manager, Department of Agriculture and Consumer Services, P. O. Box 1163, Richmond, VA 23218, telephone (804) 371-6559, FAX (804) 786-9149, TTY (800) 828-1120, or email liza.fleeson@vdacs.virginia.gov.

Summary:

The amendments (i) add new definitions to clarify who must be certified and keep pesticide application records; (ii) add new definitions to clarify the required supervision standard for people training to become applicators; (iii) add categories and subcategories of pesticide applicators; (iv) establish minimum standards for on-the-job training for registered technicians when working in different categories or subcategories; (v) establish a time frame within which a person would have to finish training and take the registered technician examination; (vi) eliminate the provision allowing businesses or agencies to proctor the registered technician examination to their own employees; and (vii) require applicators not for hire to keep records of all pesticides applied, not just those that are restricted use.

Changes from the proposed regulation include additional language that requires that if an applicant fails the registered technician examination, he must reapply and retake the exam within 30 days. If the exam is failed again, or not taken within 30 days, the individual may not apply pesticides commercially until the exam is passed.

Summary of Public Comments and Agency's Response: A summary of comments made by the public and the agency's response may be obtained from the promulgating agency or viewed at the office of the Registrar of Regulations.

2VAC20-51-10. Definitions.

The following words and terms when used in this chapter shall have the following meanings, unless the context clearly indicates otherwise. An asterisk or double asterisk following a definition indicates that the definition has been taken from the Virginia Pesticide Control Act, Article 1 ([ §3.1-249.27 (§3.2-3900 ] et seq.) or Article 4 ([ §3.1-249.59 (§3.2-3935 ] et seq.), respectively, of Chapter [ 14.1 39 ] of Title [ 3.1 3.2 ] of the Code of Virginia.

"Accident" means an unexpected, undesirable event, involving the use or presence of a pesticide, that adversely affects man or the environment.

"Act" means the Virginia Pesticide Control Act ([ §3.1-249.27 (§3.2-3900 ] et seq. of the Code of Virginia).

"Adjuvant" means any substance added to a pesticide formulation to enhance the effect of the active ingredient.

"Agricultural commodity" means any plant or part thereof, or animal, or animal product, produced by a person, including farmers, ranchers, vineyardists, plant propagators, Christmas tree growers, aquaculturists, floriculturists, orchardists, foresters, nurserymen, wood treaters not for hire, or other comparable persons, primarily for sale, consumption, propagation, or other use by man or animals.*

"Board" means the Pesticide Control Board.*

"Board-approved training" means a course which includes, at a minimum, study and review of all the material contained in an edition used in Virginia of (i) a basic pesticide applicator certification training core manual and (ii) a certification training manual for each specific category pertaining to the type of pesticide application to be done.

"Certificate" means the document issued to a certified applicator or registered technician who has completed all the requirements of Article 3 ([ §3.1-249.51 (§3.2-3929 ] et seq.) of Chapter [ 14.1 39 ] of Title [ 3.1 3.2 ] of the Code of Virginia.

"Certification" or "certified" means the recognition granted by the Pesticide Control Board to an applicator upon satisfactory completion of board-approved requirements.*

"Chemigation" means the application of any pesticide through an irrigation system.

"Commercial applicator" means any applicator who has completed the requirements as determined by the board, including appropriate training and time in service, to apply for a certification, and who uses or supervises the use of any pesticide for any purpose or on any property, other than as provided in the definition of private applicator.*

"Commercial applicator not for hire" means any commercial applicator who uses or supervises the use of pesticides as part of his job duties only on property owned or leased by him or his employer. This definition shall It also apply applies to governmental employees who use or supervise the use of pesticides, whether on property owned or leased by them or their employers or not, in the performance of their official duties.

"Commissioner" means the Commissioner of Agriculture and Consumer Services.*

"Competent person" means a person having the demonstrated ability to perform the task to which he is assigned.

"Department" means the Department of Agriculture and Consumer Services.*

"Drift" means the physical movement of pesticide through the air at the time of pesticide application or soon thereafter from the target site to any nontarget or off-target site. Pesticide drift will not include movement of pesticides to nontarget or off-target sites caused by erosion, migration, volatility, or windblown soil particles that occurs after application unless specifically addressed on the pesticide product label with respect to drift control requirements.

"EPA" means the United States Environmental Protection Agency.

"Fumigant" means any substance which by itself or in combination with any other substance emits or liberates a gas or gases, fumes or vapors, which gas or gases, fumes or vapors, when liberated and used, that will destroy vermin, rodents, insects, and other pests, and are usually lethal, poisonous, noxious, or dangerous to human life.

"Fungicide" means any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any fungi or plant disease.*

"Herbicide" means any substance or mixture of substances intended for preventing, destroying, repelling or mitigating any weed.*

"Incident" means a definite and separate occurrence or event, involving the use or presence of a pesticide, that adversely affects man or the environment.

"Insecticide" means any substance or mixture of substances intended for preventing, destroying, repelling or mitigating any insects which may be present in any environment whatsoever.*

"Knowledge" means the possession and comprehension of pertinent facts, together with the ability to use them in dealing with specific problems and situations within the pesticide context.

"Label" means the written, printed, or graphic matter on, or attached to, the pesticide or device, or the immediate container thereof, and the outside container or wrapper of the retail package, if any, of the pesticide or device.*

"Labeling" means all labels and other written, printed, or graphic matter (i) upon the pesticide or device or any of its containers or wrappers, (ii) accompanying the pesticide or device at any time, or (iii) to which reference is made on the label or in literature accompanying the pesticide or device, except when accurate, nonmisleading reference is made to current official publications of the agricultural experiment station, the Virginia Polytechnic Institute and State University, the Department of Agriculture and Consumer Services, the State Board of Health, or similar federal institutions or other official agencies of the Commonwealth or other states when such states are authorized by law to conduct research in the field of pesticides.*

"Licensed" or "licensee" means those businesses which, when meeting the requirements established by the Pesticide Control Board, are issued a license to engage in the sale, storage, distribution, recommend the use, or application of pesticides in Virginia in exchange for compensation.*

"Marine antifoulant paint" means any compound, coating, paint or treatment applied or used for the purpose of controlling freshwater or marine fouling organisms on vessels.**

"Nontarget organism" means any living organism, including but not limited to animals, insects, and plants, other than the one against which the pesticide is intended to be applied.

"Pesticide" means (i) any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any insects, rodents, fungi, bacteria, weeds, or other forms of plant or animal life or viruses, except viruses on or in living man or other animals, which the commissioner shall declare to be a pest; (ii) any substance or mixture of substances intended for use as a plant regulator, defoliant, or desiccant; and (iii) any substance which is intended to become an active ingredient thereof.*

"Pesticide business" means any person engaged in the business of: distributing, applying or recommending the use of a product; or storing, selling, or offering for sale pesticides directly to the user. The term "pesticide business" does not include (i) wood treaters not for hire; (ii) seed treaters not for hire; (iii) operations which produce agricultural products unless the owners or operators of such operations described in clauses (i), (ii), and (iii) are engaged in the business of selling or offering for sale pesticides, or distributing pesticides to persons outside of that agricultural producing operation in connection with commercial transactions; or (iv) businesses exempted by regulations adopted by the board.*

"Private applicator" means an applicator who uses or supervises the use of any pesticide which is classified for restricted use for purposes of producing any agricultural commodity on property owned or rented by him or his employer or, if applied without compensation other than trading of personal services between producers of agricultural commodities, on the property of another person.*

"Reentry interval" as noted on the pesticide label, means the amount of time which must elapse between the time of a pesticide application and the time when it is safe for a person to enter the treated area without label-required personal protective equipment.

"Registered technician" means an individual who renders services similar to those of a certified commercial applicator, but who has not completed all the training or time in service requirements to be eligible for examination for certification as a commercial applicator and is limited to application of general use pesticides. However, if he applies restricted use pesticides he shall do so only under the direct supervision of a certified commercial applicator.*

"Registered technician not for hire" means any registered technician who uses or supervises the use of pesticides as part of his job duties only on property owned or leased by him or his employer. It also applies to governmental employees who use or supervise the use of pesticides, whether on property owned or leased by them or their employers or not, in the performance of their official duties.

"Repeat violation" means another violation following the first violation of the same provision of the Virginia Pesticide Control Act or the federal Insecticide, Fungicide, and Rodenticide Act (7 USC §136 et seq.), or regulations adopted pursuant thereto, committed within a three-year period commencing with the date of official notification of the first violation of the provision.

"Restricted entry interval" means the time after the end of a pesticide application during which entry into the treated area is restricted.

"Restricted use pesticide" or "pesticide classified for restricted use" means any pesticide classified for restricted use by the administrator of the EPA under the provisions of 1947 (7 USC §3(d)(1)(c)) of the federal Insecticide, Fungicide, and Rodenticide Act (as amended).

"Rodenticide" means any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating rodents or any other vertebrate animal which the commissioner shall declare to be a pest.*

"Synergism" means the interaction of two or more active ingredients in a pesticide formulation which produce a total pesticidal effect that is greater than the sum of the ingredients.

"Tributyltin compounds" means any compound having three normal butyl groups attached to a tin atom and with or without an anion such as chloride, fluoride, or oxide.**

"Under the direct supervision of" means the act or process whereby the application of a pesticide is made by a competent person acting under the instructions and control of a certified applicator who is responsible for the actions of that person.*

"Under the direct on-site supervision of" means the act or process whereby the application of a pesticide is made by a competent person acting under the instructions and control of a certified applicator who is responsible for the actions of that person and is physically present on the property upon which the pesticides are pesticide is being applied, and is in constant visual contact with the person applying the pesticide.

"Unreasonable adverse effects on the environment" means any unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of any pesticide.*

"Use" means the employment of a pesticide for the purposes of (i) preventing, destroying, repelling, or mitigating any pest or (ii) regulating plant growth, causing defoliation or desiccation of plants. The term "use" shall include application or mixing, and shall include handling or transfer of a pesticide after the manufacturer's original seal is broken. The term "use" shall also include any act with respect to a particular pesticide which is consistent with the label directions for that particular pesticide.*

"Vessel" means every description of watercraft, other than a seaplane, used or capable of being used as a means of transportation on the water, whether self-propelled or otherwise, and includes barges and tugs.**

Part II
Certification of Pesticide Applicators

2VAC20-51-20. General requirements for certification.

A. The following persons must be certified as pesticide applicators:

1. Commercial applicators;

2. Registered technicians; and

3. Private applicators.

B. Commercial applicators not for hire must be certified only when using any pesticide in the following areas except as noted in subsection C of this section:

1. Areas open to the general public at daycare facilities, educational institutions, health care facilities, and convalescent facilities;

2. Areas where open food is stored, processed, or sold; and

3. Recreational lands over five acres in size.

C. Employees of local, state, and federal governmental agencies who use or supervise the use of any pesticides pesticide on any area in the performance of their official duties must be certified as either commercial applicators not for hire or registered technicians, but they are exempt from any certification fees.

D. All persons desiring certification as pesticide applicators must:

1. Complete board-approved training appropriate for the desired classification; and

2. Submit a completed application to the commissioner; and

2. 3. Pass required examination(s).

a. Applicants who do not pass the examination on their first attempt are eligible to be reexamined for the same category 10 days from the date of the first examination.

b. Applicants who fail on the second or subsequent attempts must wait 30 days from the date of the last examination before being reexamined in the same category.

c. Applicants requesting reexamination must resubmit a completed application to the commissioner or his duly authorized agent and pay the nonrefundable applicator certification fee again as determined by 2VAC20-30, Rules and Regulations Governing the Pesticide Fees Charged by the Department of Agriculture and Consumer Services Under the Virginia Pesticide Control Act.

E. Persons with a history of repeat violations of federal or state pesticide laws or whose certification or pesticide business license has been revoked within the two-year period immediately prior to application are not eligible for certification. Persons Such persons may appear before the board to show why they should be granted certification as outlined under provisions of [ §3.1-249.63 D § 3.2-3940 E ] of the Code of Virginia.

F. Applicants for certification cannot engage in the activity for which they are requesting certification, unless participating in supervised direct on-site training, until certification has been issued by the commissioner. Commercial applicators may not apply pesticides in any category or subcategory activity until they have passed the category-specific examination and obtained the appropriate certification.

G. A commercial or private applicator or registered technician may request a duplicate of the certification card if the applicator's or technician's card has been lost, stolen, mutilated or destroyed. The department shall issue a duplicate card to the applicator or technician upon payment of the costs of duplication.

2VAC20-51-30. Specific certification requirements for commercial applicators.

A. In addition to the general requirements listed in 2VAC20-51-20, applicants for commercial applicator certification shall meet the following requirements:

1. Certification as a registered technician, as well as employment as a registered technician for at least a year; or

2. One year of education, training, or experience in a pesticide related field which provides the equivalent practical knowledge of proper pesticide use required of a registered technician.

B. The application process for commercial applicators is as follows:

1. The application must be in writing to the commissioner; and

2. The application must contain:

a. Name;

b. Principal business address in the Commonwealth and elsewhere;

c. Qualifications and proposed operations; and

d. Classification(s) desired.

Individuals seeking certification as commercial applicators must pay a fee as determined by regulations promulgated by the Pesticide Control Board 2VAC20‑30, Rules and Regulations Governing the Pesticide Fees Charged by the Department of Agriculture and Consumer Services Under the Virginia Pesticide Control Act.

C. Applicants shall, within 90 days after submitting the application and paying the fee, report to an authorized testing location and take the required examinations.

D. Aerial pesticide application applicants must meet the requirements of the Federal Aviation Agency, the Department of Aviation of the Commonwealth, and any other applicable federal or state laws or regulations to operate aerial equipment.

2VAC20-51-40. Specific certification requirements for private applicators.

A. Each applicant for a private applicator's certificate shall apply to the commissioner and then report to an authorized testing location within 90 days and take an examination for each certification category, specified in 2VAC20-51-80, applicable to his operation. The application shall contain the applicant's name, address and classification desired for certification.

B. Persons who cannot read or understand labels will shall not be certified as private applicators unless they demonstrate competence to apply restricted use pesticides on their own properties. After consulting the appropriate Virginia Cooperative Extension Service agent, a department pesticide investigator may recommend that the board grant a waiver of the literacy requirement. Persons certified under this waiver shall obtain certification in the categories of limited certificate or single product certification as described in 2VAC20-51-80. Recommendations shall be based upon personal knowledge of the individuals' competence to apply restricted use pesticides on their own properties.

2VAC20-51-50. Certification procedures for registered technicians.

A. In addition to the general requirements listed in 2VAC20-51-20, individuals seeking certification as registered technicians must:

1. Receive on-the-job training in the proper application of pesticides under the direct on-site supervision of a certified commercial applicator for at least 20 hours during the six-month period prior to applying for certification;

2. Complete at least 20 hours of board-approved training;

3. Submit an application form with the fee established by regulations of the Pesticide Control Board; and

4. Pass Take the examination within 90 days after submitting the application and paying the fee an individual is hired or transferred into a position where duties and functions involve the commercial use of pesticides. Individuals not passing the examination [ must follow the procedures outlined in 2VAC20-51-20 D 3 on the first attempt must reapply, following the procedures outlined in 2VAC20-51-20 D 3, and retake the examination within 30 days after the first attempt. Individuals failing to take and pass the exam within 30 days of the initial exam may not apply pesticides commercially, even under direct on-site supervision, until they pass the examination ] .

B. Certified commercial applicators may apply to the commissioner, or his duly authorized agent, in writing, for authorization to proctor the registered technician exam. Authorized proctors may administer and grade the examinations, and shall notify the commissioner, or his duly authorized agent, of the grade received by the applicant. Failure to safeguard examination materials or follow testing procedures shall result in revocation of authority to proctor the registered technician examination. Before registered technicians begin working in any application category or subcategory that is different from the category in which they received their original training, they shall receive additional training from a commercial applicator in the following aspects of pesticide application as it relates to the proposed category or subcategory of work:

1. Pesticides to be used, including reading and understanding the label;

2. Application equipment and techniques;

3. Pests to be controlled;

4. Personal protective equipment and clothing; and

5. Environmental concerns, including storage and disposal of pesticides applied.

The commercial applicator providing training to a registered technician shall be certified in the category or subcategory for which he is providing the training and shall provide proof to the department of such training on forms provided by the department. Such forms must be received by the department within 10 calendar days of the completion of such training.

2VAC20-51-70. Categories for commercial applicator certification.

A. Commercial applicators must be certified in one or more of the following commercial applicator categories or subcategories:

1. Agricultural pest control.

a. Agricultural plant pest control. This subcategory is for commercial applicators who will be using or supervising the use of pesticides in production of agricultural crops, or on grasslands, or noncrop agricultural lands.

b. Agricultural animal pest control. This subcategory is for commercial applicators who will be using or supervising the use of pesticides on agriculturally related animals.

c. Fumigation of soil and agricultural products. This subcategory is for commercial applicators who will be using or supervising the use of pesticides for soil fumigation in production of an agricultural commodity and the application of pesticides for fumigation of agricultural products. Certification in this subcategory requires concurrent certification in the agricultural plant pest control category.

d. Chemigation. This subcategory is for commercial applicators who will be using or supervising the use of pesticides through an irrigation system. Certification in this subcategory requires concurrent certification in the agricultural plant pest control category.

2. Forest pest control. This category is for commercial applicators who will be using or supervising the use of pesticides in forests, forest nurseries, and seed orchards.

3. Ornamental and turf pest control.

a. Ornamental pest control. This subcategory is for commercial applicators who will be using or supervising the use of pesticides in the maintenance and production of ornamental trees, shrubs, and flowers in and out-of-doors.

b. Turf pest control. This subcategory is for commercial applicators who will be using or supervising the use of pesticides in the production and maintenance of turf, including, but not limited to, turf in golf courses, residential lawns, parks, and cemeteries.

4. Seed treatment (excluding fumigation). This category is for commercial applicators who will be using or supervising the use of pesticides on seeds.

5. Aquatic pest control.

a. Aquatic pest control - general. This subcategory is for commercial applicators who will be using or supervising the use of pesticides in or on standing or running water, for the express purpose of controlling pests. This excludes applicators engaged in public health related activities included in subdivision 8 of this subsection, public health pest control.

b. Marine antifoulant paints. This subcategory is for commercial applicators who will be using or supervising the use of marine antifoulant paints containing tributyltin or other restricted use pesticides.

6. Right-of-way pest control. This category is for commercial applicators who will be using or supervising the use of pesticides in the maintenance of public rights-of-way and in the maintenance of fence lines, structural perimeters or other similar areas.

7. Industrial, institutional, structural, and health-related pest control.

a. General pest control (excluding fumigation). This subcategory is for commercial applicators who will be using or supervising the use of pesticides to control household type pests, pests that inhabit or infest structures, stored products, and residential food preparation areas, and pests capable of infesting or contaminating foods and foodstuffs at any stage of processing facilities.

b. Wood-destroying pest control (excluding fumigation). This subcategory is for commercial applicators who will be using or supervising the use of pesticides to control organisms that destroy structures made of wood.

c. Fumigation. This subcategory is for commercial applicators who will be using or supervising the use of fumigant-type pesticides.

d. Vertebrate pest control (excluding structural invaders). This subcategory is for commercial applicators who will be using or supervising the use of pesticides to control vertebrate pest animals.

e. Sewer root pest control. This subcategory is for commercial applicators who use pesticides for sewer line root control.

8. Public health pest control. This category is for commercial applicators who will be using or supervising the use of pesticides for the management and control of pests having medical and public health significance.

9. Regulatory pest control. This category is for federal, state, and local governmental employee applicators who will be using or supervising the use of pesticides in the control of regulated pests.

10. Demonstration and research pest control. This category is for commercial applicators who will be demonstrating the proper use and techniques of application of pesticides (including classroom demonstration), or who will be supervising such demonstration. It also includes applicators who will be conducting pesticide research on greenhouse or field plots.

11. Aerial pesticide application. This category is for commercial applicators who will be using or supervising the use of any pesticide applied by fixed- or rotary-wing aircraft.

12. Wood preservation and wood product treatment. This category is for commercial applicators who will be using or supervising the use of pesticides at treating plants and sawmills for preservative treatment of wood and wood products.

13. Miscellaneous. This category is to be used to designate categories or subcategories of commercial applicators using specific pesticides or uses for which the U.S. EPA may mandate certification in order to allow for the pesticide or use.

B. A commercial applicator certified in one category and seeking initial certification in one or more additional categories shall meet the certification requirements of each of the new categories in which he desires certification.

2VAC20-51-90. Determination of general knowledge and qualifications for private and commercial applicators and registered technicians.

A. Applicants shall be tested on their knowledge and qualifications concerning the use and handling of pesticides. The examination will test the applicants' general knowledge required for all categories, and the additional knowledge specifically required for each category or subcategory in which an applicator desires to be certified.

B. All applicants for certification as private or commercial applicators or registered technicians shall demonstrate practical knowledge of the principles and practices of pest control and the safe use of pesticides, as contained in a basic pesticide applicator certification training core manual. Testing will be based on problems and situations in the following areas:

1. Federal and Commonwealth of Virginia pesticide laws and regulations;

2. Understanding and interpreting pesticide labels;

3. Handling of accidents and incidents;

4. Proper methods of storing, mixing/loading, transporting, handling, applying, and disposing of pesticides;

5. Safety and health, including proper use of personal protective equipment;

6. Potential adverse effects caused by the application of pesticides under various climatic or environmental conditions, such as drift from the target area, pesticide run-off, ground water and drinking water contamination, and hazard to endangered species; and

7. Recognizing common pests and general pest biology.

2VAC20-51-100. Specific knowledge required for the categories of commercial applicators.

Applicants for commercial applicator certification shall possess the skills and knowledge associated with the chosen category(s) as they pertain to those items listed in 2VAC20-51-90 B 1 through 6, including recognizing category specific pests and their biology as contained in a the appropriate Virginia category specific training manual(s).

2VAC20-51-160. Revocation of certificate by the board.

A. Any of the violative acts listed under §3.1-249.63 C of the Code of Virginia shall constitute grounds for revocation by the board of a certificate. The board may, after opportunity for a hearing, deny, suspend, revoke or modify a certificate upon any violation of any act set out in [ §3.1-249.63 C §3.2-3940 B ] of the Code of Virginia.

B. The board shall suspend the license or certificate of an individual if a civil penalty issued to the person is not paid within 60 days of issuance unless the business or person challenges such civil penalty pursuant to §3.1-249.70 F of the Code of Virginia. If the board imposes a civil penalty upon a person and such civil penalty is not paid within 60 days thereof, the certificate of such person shall automatically be suspended until payment in full is made. If the person appeals the board’s order imposing the civil penalty, then the person may forward the proposed amount of the civil penalty to the commissioner’s office for placement in an interest-bearing trust account in the State Treasurer’s office. Upon such an amount being held, the suspension shall not be imposed or shall be lifted, as the case may be. This provision relates only to a suspension caused by a failure to pay the civil penalty and does not affect any suspension or revocation of a certificate for any other reason.

Part VII
Reporting of Pesticide Accidents, Incidents, or Loss

2VAC20-51-170. Reporting of pesticide accidents and incidents.

A. Commercial or private applicators or registered technicians shall report any pesticide accident or incident in which they are involved that constitutes a threat to any person, to public health or safety, or to the environment, as a result of the use or presence of any pesticide. The accident or incident shall be reported whether or not a restricted use pesticide is involved.

B. The applicator shall make the initial notification to the department's Office of Pesticide Services by telephone within a reasonable time, not to exceed 48 hours after the accident or incident occurrence, should circumstances prevent immediate notification. The applicator shall prepare and submit a full written report of the accident or incident to the Office of Pesticide Services within 10 days after the initial notification.

C. B. When the accident or incident involves a discharge or spillage of a pesticide, the applicator shall contact the department for guidance to determine whether the discharged or spilled amount is a reportable quantity.

D. C. The applicator shall make the initial notification to the department's Office of Pesticide Services by telephone within a reasonable time, not to exceed 48 hours after the accident or incident occurrence, should circumstances prevent immediate notification. The applicator shall prepare and submit a written report of the accident or incident to the Office of Pesticide Services within 10 working days after the initial notification. The report shall include the following:

1. Name of individuals involved in accident or incident;

2. Name of pesticide involved;

3. Quantity of pesticide spilled, and containment procedures;

4. Time, date, and location of accident or incident;

5. Mitigating actions taken; and

6. Bodies Name (or description if unnamed) and location of bodies of water nearby where contamination of such bodies of water could reasonably be expected to occur due to natural or manmade actions.

2VAC20-51-200. General recordkeeping requirements for commercial applicators not for hire and registered technicians not for hire.

A. Commercial applicators not for hire and registered technicians not for hire, being exempt from the pesticide business license requirement of the board and the recordkeeping requirements under this license, are required to maintain pesticide application records as prescribed in this chapter. These records shall be maintained by the commercial applicator not for hire and the registered technician not for hire for a period of two years.

B. Records governed by this regulation shall be made available for inspection by the commissioner, or his duly authorized agent, during normal business hours upon written request. Records not readily available shall be submitted to the commissioner within 72 hours, if so requested in writing.

C. Persons possessing records governed by this part shall fully comply with the requirements contained in 7 USC §136f and regulations adopted pursuant thereto.

2VAC20-51-210. Specific recordkeeping requirements for commercial applicators not for hire and registered technicians not for hire.

Commercial applicators not for hire and registered technicians not for hire shall maintain a record of each restricted use pesticide applied, containing the following:

1. Name of property owner, address or location, and, as applicable, phone number of the site of application;

2. Name and certification number (or certification number of the supervising certified applicator) of the person making the application;

3. Day, month, and year of application;

4. Type of plants, crops, animals, or sites treated and principle principal pests to be controlled;

5. Acreage, area, or number of plants or animals treated;

6. Brand name or common product name of pesticide used;

7. EPA registration number;

8. Amounts of pesticide concentrate and amount of diluent used, by weight or volume, in mixture applied; and

9. Type of application equipment used.

FORMS

Record of Required Additional Registered Technician Training [ (proposed) (eff. 12/08) ].

Commercial Pesticide Applicator Certification Application - A, Form VDACS-07211 (eff. 11/98 11/01).

Pesticide Registered Technician Application [ , ] Form VDACS-07212 (eff. 11/98 11/01).

Private Pesticide Applicator Request for Authorization to Take Pesticide Applicator Examination at Department of Motor Vehicles Customer Service Center (eff. 12/98).

Application for Reciprocal Pesticide Applicator Certificate, Form VDACS-07210 (eff. 7/95 7/00).

Power of Attorney (not dated).

Commercial Pesticide Applicator Request for Authorization to Take Pesticide Applicator Examination - B, Form VDACS-07218 (eff. 11/98 11/01).

Commercial Pesticide Applicator Certification Exam, Form VDACS-07216 (not dated) bubble answer sheet, 2003.

Private Pesticide Applicator Certification Exam bubble answer sheet, 2003.

Virginia Registered Technician Certification Examination Answer Sheet (eff. 2/98).

Not-For-Hire Virginia Registered Technician Certification Examination Answer Sheet (eff. 2/98).

Title of Regulation: 4VAC20-260. Pertaining to Designation of Seed Areas and Clean Cull Areas (amending 4VAC20-260-35, 4VAC20-260-40).

Statutory Authority: §§28.2-201, 28.2-210 and 28.2-507 of the Code of Virginia.

Effective Date: October 1, 2008, through October 31, 2008.

Agency Contact: Jane Warren, Agency Regulatory Coordinator, Marine Resources Commission, 2600 Washington Avenue, 3rd Floor, Newport News, VA 23607, telephone (757) 247-2248, FAX (757) 247-2002, or email betty.warren@mrc.virginia.gov.

Preamble:

The amendments establish a maximum cull size of 4-1/4 inches for harvested oysters, culling tolerances for undersized and oversized oysters, and stricter penalties for the Lower Rappahannock River, Rotation Areas 1 through 3, in the 2008-2009 public oyster harvest season.

4VAC20-260-35. Maximum cull size in the Rappahannock River.

In order to protect potentially disease tolerant oysters in the Lower Rappahannock River, maximum size limits are hereby established. In the Lower Rappahannock River, Rotation Areas 1 through 6 3, oysters larger than the maximum size limit shall either be collected by the Marine Resources Commission or returned immediately to the natural beds, rocks, or shoals when taken. Allowance for oversized oysters and shells incidentally retained during culling are described in 4VAC20-260-40.

Oysters taken for direct human consumption from Rotation Areas 1 through 6 3 in the Lower Rappahannock River shall not have shells greater than 4-1/4 inches in length.

4VAC20-260-40. Culling tolerances or standards.

A. In the clean cull areas, except the Lower Rappahannock River, Rotation Areas 1 through 6 3, if more than one four-quart measure of undersized oysters or shells is found per bushel inspected, it shall constitute a violation of this emergency chapter.

B. In the Lower Rappahannock River, Rotation Areas 1 through 6 3, if more than one four-quart measure of undersized or oversized oysters or shells is found per bushel inspected, it shall constitute a violation of this emergency chapter.

C. In the James River seed areas, if more than one six-quart measure of shells is found per bushel of seed oysters inspected, it shall constitute a violation of this chapter.

D. In the James River seed areas, if more than one four-quart measure of undersized oysters or shells are found per bushel of clean cull oysters inspected, it shall constitute a violation of this chapter.

E. On the seaside of Eastern Shore seed areas, if more than one four-quart measure of undersized (less than three inches) oysters and shell is found per bushel of oysters to be marketed for direct consumption, it shall constitute a violation of this chapter.

Title of Regulation: 4VAC20-620. Pertaining to Summer Flounder (amending 4VAC20-620-20, 4VAC20-620-30, 4VAC20-620-40).

Statutory Authority: §§28.2-201 and 28.2-204 of the Code of Virginia.

Effective Date: October 1, 2008.

Agency Contact: Jane Warren, Agency Regulatory Coordinator, Marine Resources Commission, 2600 Washington Avenue, 3rd Floor, Newport News, VA 23607, telephone (757) 247-2248, FAX (757) 247-2002, or email betty.warren@mrc.virginia.gov.

Summary:

The amendments (i) delay opening of the fall-directed commercial flounder fishery until the first Monday in December; (ii) delay opening the winter-directed commercial flounder fishery until the last Monday in February; (iii) extend the 10-day landing period to a 12-day landing period in the winter directed commercial flounder fishery; (iv) redefine “land” or “landing” as to offload; (v) establish the quota as a total of allowable landings; (vi) modify the possession limit from 12,500 pounds to 25,000 pounds for the last Monday in February through the day preceding the first Monday in December; (vii) modify the possession limit from 10,000 pounds to 20,000 pounds from the first Monday in December through December 31 of each year; (viii) establish that upon request by a marine police officer, the seafood buyer or processor shall offload and accurately determine the total weight of all Summer Flounder aboard any vessel landing Summer Flounder in Virginia; and (ix) establish that when contacting the VMRC operations station the buyer shall provide an estimate of the landings weight.

These amendments make it unlawful to (i) land in Virginia any amount of Summer Flounder more than once in any consecutive five-day period and (ii) possess aboard any vessel in Virginia any amount of Summer Founder in excess of 10% by weight of all other landed species on board the vessel once it has been projected and announced that 85% of the allowable landings has been taken. The Marine Resources Commission will give timely notice of any changes in possession limits.

4VAC20-620-20. Definitions.

The following words and terms when used in this chapter shall have the following meanings unless the context indicates otherwise:

"Chesapeake Bay and its tributaries" means all tidal waters of Virginia, including the Potomac River tributaries but excluding the coastal area as defined in this section.

"Coastal area" means the area that includes Virginia's portion of the Territorial Sea and all of the creeks, bays, inlets, and tributaries on the seaside of Accomack County, Northampton County, including areas east of the causeway from Fisherman Island to the mainland and the City of Virginia Beach, including federal areas and state parks fronting on the Atlantic Ocean and east and south of the point where the shoreward boundary of the Territorial Sea joins the mainland at Cape Henry.

"Land" or "landing" means to enter port with finfish, shellfish, crustaceans or other marine seafood on board any boat or vessel, to begin offloading offload or attempt to offload finfish, shellfish, crustaceans or other marine seafood, or to offload finfish, shellfish, crustaceans, or other marine seafood.

"Potomac River tributaries" means all the tributaries of the Potomac River that are within Virginia's jurisdiction beginning with, and including, Flag Pond, thence upstream to the District of Columbia boundary.

"Safe harbor" means that a vessel has been authorized by the commissioner to enter Virginia waters from federal waters solely to either dock temporarily at a Virginia seafood buyer's place of business or traverse the Intracoastal Waterway from Virginia to North Carolina.

4VAC20-620-30. Commercial harvest quotas quota and allowable landings.

A. During each calendar year, allowable commercial landings of Summer Flounder shall be limited to the a quota in total pounds calculated pursuant to the joint Mid-Atlantic Fishery Management Council/Atlantic States Marine Fisheries Commission Summer Flounder Fishery Management Plan, as approved by the National Marine Fisheries Service on August 6, 1992 (50 CFR Part 625); and shall be distributed as described in subsections B through G of this section.

B. The commercial harvest of Summer Flounder from Virginia tidal waters for each calendar year shall be limited to 300,000 pounds of the annual quota described in subsection A of this section. Out of Of this amount, 142,114 pounds shall be set aside for a Chesapeake Bay-wide harvest quota.

C. From the first Monday in January through the day preceding the last first Monday in October of each calendar year, December allowable landings of Summer Flounder harvested outside of Virginia shall be limited to an amount of pounds equal to 70.7% of the total quota described in subsection A of this section after deducting the amount specified in subsection B of this section.

D. From the last first Monday in October December through December 31 of each calendar year, allowable landings of Summer Flounder harvested outside of Virginia shall be limited to an amount of pounds equal to 29.3% of the total quota, as described in subsection A of this section, after deducting the amount specified in subsection B of this section, and as may be further modified by subsection E.

E. During the period set forth in subsection C of this section, should Should landings from the first Monday in January through the day preceding the first Monday in December exceed or fall short of the quota specified for that period 70.7% of the quota described in subsection A of this section, any such excess shall be deducted from allowable landings described in subsection D of this section, and any such shortage shall be added to, the quota for the period set forth the allowable landings as described in subsection D of this section. Should landings the commercial harvest specified in subsection B of this section be projected to fall short of the quota specified for that period as less than 300,000 pounds, any such shortage shall be added to the quota for the period set forth allowable landings described in subsection D of this section.

F. For each of the time periods and quotas set forth in subsections C and D of this section, the The Marine Resources Commission will give timely notice to the industry of the calculated poundages and any adjustments thereto to any allowable landings described in subsections C and D of this section. It shall be unlawful for any person to harvest or to land Summer Flounder for commercial purposes after the commercial harvest or landing quota any allowable landings as described in this section has have been attained and announced as such. If a any person lands Summer Flounder after the commercial harvest or landing quota has any allowable landing have been attained and announced as such, the entire amount of Summer Flounder in that person's possession shall be confiscated.

G. It shall be unlawful for any buyer of seafood to receive any Summer Flounder after any commercial harvest or landing quota as described in this section has been attained and announced as such.

4VAC20-620-40. Commercial vessel possession and landing limitations.

A. From January 1 through the day preceding the first last Monday in February, it shall be unlawful for any person harvesting Summer Flounder outside of Virginia's waters to possess aboard any vessel in Virginia any amount of Summer Flounder in excess of 10% by weight of all other landed species on board the vessel.

B. From the first last Monday in February through the day preceding the last first Monday in October December, it shall be unlawful for any person harvesting Summer Flounder outside of Virginia waters to do any of the following:

1. Possess aboard any vessel in Virginia waters an any amount of Summer Flounder in excess of 12,500 25,000 pounds.

2. Land Summer Flounder in Virginia for commercial purposes more than twice within during each consecutive 10-day 12-day period, with the first 10-day 12-day period beginning on the the first last Monday in February.

3. Land in Virginia more than a total of 12,500 pounds of Summer Flounder during each consecutive 10-day 12-day period, with the first 10-day 12-day period beginning on the first last Monday in February.

4. Land in Virginia any amount of Summer Flounder more than once in any consecutive five-day period.

5. Possess aboard any vessel in Virginia any amount of Summer Flounder in excess of 10% by weight of all other landed species on board the vessel once it has been projected and announced that 85% of the allowable landings have been taken. The Marine Resources Commission will give timely notice of any changes in possession limits.

C. When it is projected and announced that 85% of the quota, for the period from the first Monday in January through the day preceding the last Monday in October has been taken, it shall be unlawful for any person harvesting Summer Flounder outside of Virginia's waters to possess aboard any vessel, in Virginia, any amount of Summer Flounder, in excess of 10%, by weight, of all other landed species on board the vessel.

D. C. From the last first Monday in October December through December 31 of each year, it shall be unlawful for any person harvesting Summer Flounder outside of Virginia waters to do any of the following:

1. Possess aboard any vessel in Virginia waters an any amount of Summer Flounder in excess of 10,000 20,000 pounds.

2. Land Summer Flounder in Virginia for commercial purposes more than twice within during each consecutive 10-day 12-day period, with the first 10-day 12-day period beginning on the last first Monday in October December.

3. Land in Virginia more than a total of 10,000 pounds of Summer Flounder during each consecutive 10-day 12-day period, with the first 10-day 12-day period beginning on the last first Monday in October December.

4. Land in Virginia any amount of Summer Flounder more than once in any consecutive five-day period.

4. 5. Possess aboard any vessel in Virginia any amount of Summer Flounder in excess of 10% by weight of all other landed species on board the vessel once it has been projected and announced that 85% of the quota has allowable landings described in 4VAC20-620-30 D have been taken, except as described in subdivision 5 6 of this subsection. The Marine Resources Commission will give timely notice of any changes in possession limits.

5. 6. Possess aboard any vessel in Virginia any amount of Summer Flounder once it has projected and announced that 100% of the quota described in 4VAC20-620-30 A has been taken.

E. For each of the time periods set forth in subsections A, B, C and D of this section, the Marine Resources Commission will give timely notice of any changes in possession limits.

D. Upon request by a marine police officer, the seafood buyer or processor shall offload and accurately determine the total weight of all Summer Flounder aboard any vessel landing Summer Flounder in Virginia.

F. Each E. Any possession limit described in subsections A, B, C and D of this section shall be determined by the net weight in pounds of Summer Flounder as customarily packed, boxed and weighed by the seafood buyer or processor. The net weight of any Summer Flounder in pounds found in excess of this any possession limit described in subsections A, B, C and D of this section shall be prima facie evidence of violation of this chapter. Persons in possession of Summer Flounder, aboard any vessel, in excess of the possession limit shall be in violation of this chapter, unless that vessel has requested and been granted safe harbor. Any buyer or processor offloading or accepting any quantity of Summer Flounder from any vessel in excess of the possession limit shall be in violation of this chapter, except as described by subsection I H of this section. A buyer or processor may accept or buy Summer Flounder from a vessel that has secured safe harbor, provided that vessel has satisfied the requirements described in subsection I H of this section.

G. F. If a person violates the possession limits described in this section, the entire amount of Summer Flounder in that person's possession shall be confiscated. Any confiscated Summer Flounder shall be considered as a removal from the appropriate commercial harvest or landings quota. Upon confiscation, the marine patrol police officer shall inventory the confiscated Summer Flounder and, at a minimum, secure two bids for purchase of the confiscated Summer Flounder from approved and licensed seafood buyers. The confiscated fish will be sold to the highest bidder and all funds derived from such sale shall be deposited for the Commonwealth pending court resolution of the charge of violating the possession limits established by this chapter. All of the collected funds will be returned to the accused upon a finding of innocence or forfeited to the Commonwealth upon a finding of guilty.

H.. G. It shall be unlawful for a licensed seafood buyer or federally permitted seafood buyer to fail to contact the Marine Resources Commission Operation Station prior to a vessel offloading Summer Flounder harvested outside of Virginia. The buyer shall provide to the Marine Resources Commission the name of the vessel, and its captain, an estimate of the amount in pounds of Summer Flounder on board that vessel, and the anticipated or approximate offloading time. Once offloading of any vessel is complete and the weight of the landed Summer Flounder has been determined, the buyer shall contact the Marine Resources Commission Operations Station and report the vessel name and corresponding weight of Summer Flounder landed. It shall be unlawful for any person to offload from a boat or vessel for commercial purposes any Summer Flounder during the period of 10 6 p.m. to 7 a.m.

I. H. Any boat or vessel that has entered Virginia waters for safe harbor shall only offload Summer Flounder when the state that licenses that vessel requests to transfer quota to Virginia, in the amount that corresponds to that vessel's possession limit, and the commissioner agrees to accept that transfer of quota.

J. I. After any commercial harvest or landing quota as described in 4VAC20-620-30 has been attained and announced as such, any boat or vessel possessing Summer Flounder on board may enter Virginia waters for safe harbor but shall contact the Marine Resources Commission Operation Center in advance of such entry into Virginia waters.

Title of Regulation: 4VAC20-720. Pertaining to Restrictions on Oyster Harvest (amending 4VAC20-720-20, 4VAC20-720-40, 4VAC20-720-50, 4VAC20-720-60, 4VAC20-720-70, 4VAC20-720-75, 4VAC20-720-80, 4VAC20-720-95, 4VAC20-720-100, 4VAC20-720-106).

Statutory Authority: §§28.2-201, 28.2-507 and 28.2-518 of the Code of Virginia.

Effective Date: October 1, 2008.

Agency Contact: Jane Warren, Agency Regulatory Coordinator, Marine Resources Commission, 2600 Washington Avenue, 3rd Floor, Newport News, VA 23607, telephone (757) 247-2248, FAX (757) 247-2002, or email betty.warren@mrc.virginia.gov.

Summary:

These amendments establish open harvest seasons in the James River Seed Area, October 1, 2008, through April 30, 2009; James River Hand Scrape Area and Thomas Rock Hand Scrape Area, November 1, 2008, through January 31, 2009; Rappahannock River Rotation Area 2, December 1, 2008, through January 31, 2008, and Rappahannock River Rotation Area 4, October 1, 2008, through November 30, 2008; and February 1, 2009, through March 31, 2009; Great Wicomico River, Chesapeake Bay (Blackberry Hangs and Deep Rock), York River, Rappahannock River Area 9, and Mobjack Bay, December 1, 2008, through February 28, 2009; Tangier - Pocomoke Sounds, Rotation Area 2, December 1, 2008, through February 28, 2009; and the seaside of the Eastern Shore, November 1, 2008, through February 28, 2009. The commission will consider alternate season dates. These amendments also define the Mobjack Bay hand scrape area.

4VAC20-720-20. Definitions.

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Coan River Area" means that area of the Coan River to the Virginia-Maryland state line (PRV1A to PRV1B), except for that area above a line from Walnut Point (Survey Station Walnut) to Stephens Point (Survey Station Arthur).

"Deep Rock Patent Tong Area (Lower Chesapeake Bay)" means the area described as follows: starting at Cherry Point, Gwynns Island, thence northeast to G"1P" along the south side of the channel to Piankatank River; thence east-southeast to G"1R"; thence southwest to Sandy Point, Gwynns Island, North of Hole-in the-Wall.

"Deep Water Shoal State Replenishment Seed Area (DWS)" in the James River (574.66 Acres) means the areas beginning at a point approximately 530 feet west of Deep Water Shoal Light, said point being Corner 1 as located by Virginia State Plane Coordinates, South Zone, NAD 1927, north 302,280.00, east 2,542,360.00; thence north azimuth 30°49'59", 4,506.99 feet to Corner 2, north 306,150.00, east 2,544,670.00; thence north azimuth 135°08'57", 5,430.60 feet to Corner 3, north 302,300.00, east 2,548,500.00; thence north azimuth 212°13'54", 3,487.42 feet to Corner 4, north 299,350.00, east 2,546,640.00; thence north azimuth 269°10'16", 2,765.29 feet to Corner 5, north 299,310.00, east 2,543,875.00; thence north azimuth 332°58'26", 3,334.09 feet to Corner 1, being the point of beginning.

"Great Wicomico River Hand Scrape Area" means that area east of a line drawn from Sandy Point to Cockrell Point.

"Hand scrape" means any device or instrument with a catching bar having an inside measurement of no more than 22 inches, which is used or usable for the purpose of extracting or removing shellfish from a water bottom or the bed of a body of water.

"James River Hand Scrape Area" means those public oyster grounds of the James River west of the Monitor and Merrimac Bridge Tunnel and northeast of the Mills E. Godwin/Nansemond River Bridge (Route 17) to the James River Bridge (Route 17).

"Lower Machodoc Area" means that area of the Lower Machodoc River to the Virginia-Maryland state line (PRV5A to PRV5C).

"Mobjack Bay Hand Scrape Area" shall consist of all of Public Ground No. 25, Gloucester County (Towe Stake) within these coordinates: 37° 20.59', N., 76° 23.24', W.; 37° 20.38', N., 76° 22.72', W.; 37° 19.86', N., 76° 23.59', W.; 37° 20.03', N. 76° 23.77', W.; and 37° 20.39', N., 76° 23.58', W. and that portion of Public Ground No. 2, Mathews County (Pultz Bar), within these coordinates: 37° 21.25', N., 76° 21.37', W.; 37° 21.27', N., 76° 20.96', W.; 37° 21.02', N., 76° 20.94', W.; and 37° 21.05', N., 76° 21.33', W.

"Nomini River Hand Scrape Area" means that area of the Nomini River inside of Public Ground #1 No.1 to the Virginia-Maryland state line (PRV6A to PRV6B) (Kingscopsico), Public Ground 26 (Deans) and Public Ground 28 (Cut).

"Oyster Patent Tong" means any patent tong not exceeding 100 pounds in gross weight, including any attachment other than rope and with the teeth not to exceed four inches in length.

"Pocomoke and Tangier Sounds Management Area (PTSMA)" means the area as defined in § 28.2-524 of the Code of Virginia.

"Public oyster ground" means all those grounds defined in § 28.2-551 of the Code of Virginia, all ground set aside as public oyster ground by court order, and all ground set aside as public oyster ground by order of the Marine Resources Commission.

"Rappahannock River Rotation Area 1" shall consist of all public grounds in the Rappahannock River with a boundary defined as beginning at the MLW west of Broad Creek (37° 33.952', N., 76° 19.309', W.); thence north to a VMRC buoy on the Baylor line (37° 34.539', N., 76° 19.022', W.) to VMRC buoy (37° 34.683', N., 76° 19.100' W.); thence, northeasterly to VMRC Buoy (37° 35.017', N., 76° 19.450', W.); thence, northeasterly to Sturgeon Bar Light (7R) (37° 35.150', N., 76° 19.733', W.); thence, continuing northwest to Mosquito Point Light (8R) (37° 36.100', N., 76° 21.300', W.); thence to the house on Mosquito Point (37° 36.523, N., 76° 21.595', W.) bounded on the east by a line from Windmill Point (37° 35.793', N., 76° 14.180', W.); thence, southeast to Windmill Point Light (37° 35.793', N., 76° 14.180', W.); thence southwesterly to Stingray Point Light (37° 33.673', N., 76° 16.362', W.); thence, westerly to Stingray Point (37° 33.692', N., 76° 17.986', W.)

"Rappahannock River Rotation Area 2" shall consist of all public grounds in the Rappahannock River with a boundary on the east side defined as beginning at the house at Mosquito Point (37° 36.523', N., 76° 21.595', W.); thence, southeast to Mosquito Point Light "8R" (37° 36.100', N., 76° 21.300', W.); thence, continuing southeasterly to Sturgeon Bar Beacon "7R" (37° 35.150', N., 76° 19.733', W.); thence, southwesterly to VMRC buoy (37° 34.933', N., 76° 21.050', W.); thence, southwesterly to VMRC buoy (37° 34.883', N., 76° 21.100', W.); thence, to a pier west of Hunting Creek at Grinels (37° 34.436', N., 76° 26.288', W.). Rappahannock River Rotation Area 2 is bordered on the west by a line beginning at Mill Creek channel marker "4" (37° 35.083', N., 76° 26.950', W.); thence, northeasterly to Mill Creek channel marker "2" (37° 35.483', N., 76° 24.567', W.); thence, northeasterly to the house at Mosquito Point (37° 36.523', N., 76° 21.595', W.).

"Rappahannock River Rotation Area 3" shall consist of all public grounds in the Rappahannock River with a boundary defined as beginning from the north channel fender at the Norris Bridge (37° 37.483', N., 76° 25.035', W.); thence, southeast to the house on Mosquito Point (37° 36.523', N., 76° 21.595', W.); thence southwest to Mill Creek channel marker "2" (37° 35.483', N., 76° 24.567', W.); thence southwesterly to Mill Creek channel marker "4" (37° 35.083', N., 76° 24.950', W.); thence northeasterly to Parrotts Creek channel marker "1" (37° 36.033', N., 76° 25.417', W.); thence northerly to VMRC buoy (37° 36.333', N., 76° 25.200', W.); thence returning northerly to the Norris Bridge north channel fender.

"Rappahannock River Rotation Area 4" shall consist of all public grounds in the Rappahannock River with the boundary defined as beginning at the White Stone end of the Norris Bridge (37° 38.129', N., 76° 24.722', W.); thence, along the Norris Bridge to the north channel fender (37° 37.483', N., 76° 25.035 25.345', W.); thence westerly to the VMRC buoy 5-4 (36° 38.005', N., 76° 30.028', W.); thence, north to Old House Point (37° 39.139', N., 76° 29.685', W.); thence, northerly to Ball Point (37° 41.660', N., 76° 28.632', W.); thence, continuing northerly to Bar Point (37° 41.666', N., 76° 28.866', W.); thence easterly to Black Stump Point (37° 41.737', N., 76° 28.111', W.); thence, southeasterly to the western headland of Taylor Creek (37° 40.983', N., 76° 27.602', W.); thence, southwesterly to VMRC Buoy at Ferry Bar north (37° 40.300', N., 76° 28.500', W.); thence, southeasterly to VMRC Buoy at Ferry Bar South (37° 40.167', N., 76° 28.583, W.); thence, southwesterly to Corrotoman Point Duck Blind (37° 39.945 39.876', N., 76° 28.467 28.420', W.); thence, southerly to VMRC Buoy 543 (37° 39.267', N., 76° 27.850', W.); thence, southerly to VMRC Buoy at Drumming West (37° 38.833 38.883', N., 76° 27.683', W.); thence, southerly to VMRC buoy at Drumming East (37° 38.833', N., 76° 27.567', W.); thence, northeasterly to Orchard Point (37° 38.924', N., 76° 27.126', W.).

"Rappahannock River Rotation Area 5" shall consist of public grounds in the Rappahannock River with a boundary defined as beginning east of a line from the east headland of Whiting Creek (37° 36.658', N., 76° 30.312', W.); thence, north to Towlest Pt. Towles Point buoy "6" (37° 38.033', N., 76° 30.283', W.); thence, easterly to VMRC buoy 5-4 (37° 38.005', N., 76° 30.028', W.) continuing easterly to the Norris Bridge north channel fender (37° 37.483', N., 76° 25.035 25.345', W.); thence, along the Norris Bridge southwest to Grey's Point (37° 36.833', N., 76° 25.999', W.).

"Rappahannock River Rotation Area 6" shall consist of all public grounds in the Rappahannock River with a boundary defined as beginning from Balls Point (37° 39.355', N., 76° 34.444', W.); thence, northeast to the flashing red buoy "8" off Rogue Pt. (37° 40.158', N., 76° 32.939', W.); thence, southeasterly to VMRC Towles Point Area buoy (37° 38.833', N., 76° 31.536', W.); thence, southwesterly to VMRC White House Sanctuary buoy (37° 38.150', N., 76° 30.533', W.); thence, southeasterly to red buoy "6" (37° 38.033', N., 76° 30.283', W.); thence, southerly to the eastern headland of the mouth of Whiting Creek (37° 36.658', N., 76° 30.312', W.).

"Rappahannock River Area 7" shall consist of all public grounds in the Rappahannock River with a boundary defined as beginning south of a line from Punchbowl Point (37° 44.675', N., 76° 37.325', W.) to Monaskon Point (37° 44.063', N., 76° 34.108', W.) to a line from Rogue's Point (37° 40.040', N., 76° 32.253', W.); thence, northwest to flashing red buoy "8" (37° 40.158', N., 76° 32.939', W.) continuing southwest to Balls Point (37° 39.355', N., 76° 34.444', W.).

"Rappahannock River Area 8" shall consist of all public grounds in the Rappahannock River with a boundary defined as beginning east and south of a line from Jones Point (37° 46.786', N., 76° 40.835', W.) to Sharps Point (37° 49.364', N., 76° 42.087', W.) to a line from Punchbowl Point (37° 44.675', N., 76° 37.325', W.) to Monaskon Point (37° 44.063', N., 76° 34.108', W.).

"Rappahannock River Area 9" shall consist of all public grounds in the Rappahannock River with a boundary defined as beginning west of the line drawn from Sharps Pt. (37° 49.364', N., 76° 42.087', W.) to Jones Pt (37° 46.786', N., 76° 40.835', W.) to the Route 360 (Drumming (Downing Bridge).

"Standard oyster dredge" means any device or instrument having a maximum weight of 150 pounds with attachments, maximum width of 50 inches and maximum tooth length of four inches.

"Tangier-Pocomoke Sounds Rotation Area 1" shall include all public and unassigned grounds within the PTSMA, in Tangier Sound, that are west and south of a line beginning at the Maryland-Virginia Line (37° 54.61360', N., 75° 53.97396', W.) continuing south on Great Fox Island (37° 53.69465', N., 75° 53.88988', W.); thence continuing west to point "Area 2-NW" (37° 53.36335', N., 75° 56.55896', W.); thence south to a point "Area 2-SW" (37° 48.44291', N., 75° 56.48836', W.); thence continuing east to the north end of Watts Island (37° 48.77578', N., 75° 53.59941', W.). Area 1 shall also include all of the public and unassigned grounds in the PTSMA in Pocomoke Sound south and west of a line beginning at the house on Great Fox Island (37° 53.69465', N., 75° 53.88988', W.); thence east southeast to Red Channel Marker # 8 (37° 52.45833', N., 75° 49.40000', W.); thence south southeast to Green Channel Marker "C – 1" (37° 52.10000', N., 75° 47.80833', W.) thence southeast to Flashing Red "2+1" (37° 50.95333', N., 75° 46.64167', W.); thence south to the northernmost tip of Russell Island (37° 48.38796', N., 75° 47.02241', W.).

"Tangier-Pocomoke Sounds Rotation Area 2" shall include all public and unassigned grounds in the PTSMA with a boundary defined as beginning at the house on Great Fox Island (37° 53.69465', N., 75° 53.88988', W.); thence south to the north end of Watts Island (37° 48.77578', N., 75° 53.59941', W.); thence west to a point "Area 2-SW" (37° 48.44291', N., 75° 56.48836', W.); thence north to point "Area 2-NW" (37° 53.36335', N., 75° 56.55896', W.); thence back east to the house on Great Fox Island. This area includes Public Ground # No. 7, known as "Thoroughfare Rock" and Public Ground # No. 8, known as "California Rock" in Tangier Sound. Area 2 shall also include all public and unassigned grounds in the PTSMA in Pocomoke Sound northeast of a line beginning at the house on Great Fox Island (37° 53.69465', N., 75° 53.88988', W.); thence east southeast to Red Channel Marker # 8 (37° 52.45833', N., 75° 49.40000', W.); thence south southeast to Green Channel Marker "C – 1" (37° 52.10000', N., 75° 47.80833', W.); thence southeast to Flashing Red "2+1" (37° 50.95333', N., 75° 46.64167', W.); thence south to the northernmost tip of Russell Island (37° 48.38796', N., 75° 47.02241', W.).

"Tangier Sound Hand Tong Area" means that area in the PTSMA south and west of a line from Fishbone Island thence southeast to bell buoy #5, thence south southwest to buoy #3 (such area to include all of Public Ground 3 and Flat Rock) and shall be a hand tong area only and Cod Harbor (approximately 1,124 acres) beginning at a point of East Point Marsh, said point having the Virginia state coordinates, south section, coordinates of north 555,414.89, east 2,730,388.85; thence south 79°59', east 2,260 feet to a line designating the western extent of the PTSMA as described in § 28.2-524 of the Code of Virginia; thence south 10°16', west 2,800 feet; thence south 28°46', west 8,500 feet to a point on Sand Spit, position north 545,131.78, east, 2,728,014.94; thence along the mean low water line of Cod Harbor in a west, north and northeast direction crossing Canton Creek and Mailboat Harbor from headland to headland to the point of beginning.

"Thomas Rock Hand Scrape Area" means an area in the James River with an eastern boundary being the James River, Route 17 bridge and a western boundary being a line drawn from the south side of the river at Rainbow Farm Point; thence to the channel buoy green #5; and thence to Blunt Point on the north side of the river.

"Unassigned ground" means all grounds other than public oyster ground as defined by this chapter and which have not been set aside or assigned by lease, permit, or easement by the Marine Resources Commission.

"Upper Chesapeake Bay (Blackberry Hangs Hand Scrape Area)" means the area in Public Ground Number 118, south from the Smith Point Light to the Great Wicomico Light.

"Yeocomico River Area" means that area of the Yeocomico River inside Public Grounds 102, 104, 107, 112 and 113.

"York River Hand Scrape Area" means an area above the Route 17 or Coleman Bridge in Public Ground No. 30, along the north side of the river, to just above Aberdeen Creek.

4VAC20-720-40. Open season and areas.

The lawful seasons and areas for the harvest of oysters from the public oyster grounds and unassigned grounds are as follows:

1. James River Seed Area, including the Deep Water Shoal State Replenishment Seed Area: October 1, 2007 2008, through April 30, 2008 2009.

2. Seaside of Eastern Shore: for clean cull oysters only, October 1, 2007 November 1, 2008, through January 31, 2008 February 28, 2009.

3. The following areas shall be opened from October 1, 2007 December 1, 2008, through December 31, 2007 February 28, 2009: the Rappahannock River Areas 8 and Area 9; the Nomini Great Wicomico River Hand Scrape Area; the Upper Chesapeake Bay (Blackberry Hangs Hand Scrape Area); the York River and Mobjack Bay Hand Scrape Area Areas; and Deep Rock Patent Tong Area (Lower Chesapeake Bay).

4. The Rappahannock River Rotation Areas 1 and 6 Area 4: October 1, 2007 2008, through November 30, 2007 2008, and February 1, 2009, through March 31, 2009. Rappahannock River Rotation Area 2: December 1, 2008, through January 31, 2009.

5. Tangier - Pocomoke Sounds Rotation Area 1 2: December 1, 2007 2008, through February 29, 2008 28, 2009.

6. The James River Hand Scrape Area and the Thomas Rock Hand Scrape Area (James River): October November 1, 2007 2008, through December 31, 2007, and February 1, 2008, through March 31, 2008 January 31, 2009.

4VAC20-720-50. Closed harvest season and areas.

It shall be unlawful for any person to harvest oysters from the following areas during the specified periods:

1. All public oyster grounds and unassigned grounds in the Chesapeake Bay and its tributaries, including the tributaries of the Potomac River, except those areas listed in 4VAC20-720-40, are closed: October 1, 2007 2008, through September 30, 2008 2009.

2. James River Seed Area, including the Deep Water Shoal State Replenishment Seed Area: May 1, 2008 2009, through September 30, 2008 2009.

3. All public oyster grounds and unassigned grounds on the Seaside of Eastern Shore: for clean cull oysters, October 1, 2008, through October 31, 2008, and February March 1, 2008 2009, through September 30, 2008 2009, and for seed oysters, all year.

4. The following areas shall be closed from January 1, 2008, October 1, 2008, through November 30, 2008, and March 1, 2009, through September 30, 2008 2009: Rappahannock River Areas 8 and Area 9; the Nomini River Hand Scrape Area Great Wicomico River (Hand Scrape Area); Deep Rock Patent Tong Area (Lower Chesapeake Bay); the Upper Chesapeake Bay (Blackberry Hangs Hand Scrape Area); and the York River and Mobjack Bay Hand Scrape Area Areas.

5. The Rappahannock River Rotation Areas 1 and 6 Area 2: December 1, 2007 October 1, 2008, through November 30, 2008, and February 1, 2009, through September 30, 2008 2009. Rotation Area 4: December 1, 2008, through January 31, 2009, and April 1, 2009, through September 30, 2009.

6. Tangier - Pocomoke Sounds Rotation Area 1 2: October 1, 2007 2008, through November 30, 2007 2008, and March 1, 2008 2009, through September 30, 2008 2009.

7. The James River Hand Scrape Area and the Thomas Rock Hand Scrape Area (James River): January 1, 2008, through January 31, 2008, and April 1, 2008, October 1, 2008, through October 31, 2008, and February 1, 2009, through September 30, 2008 2009.

4VAC20-720-60. Day and time limit.

A. It shall be unlawful to take, catch or possess oysters on Saturday and Sunday from the public oyster grounds or unassigned grounds in the waters of the Commonwealth of Virginia, except that this provision shall not apply to any person harvesting no more than one bushel per day by hand or ordinary tong for household use only during the season when the public oyster grounds or unassigned grounds are legally open for harvest. The presence of any gear normally associated with the harvesting of oysters on board the boat or other vehicle used during any harvesting under this exception shall be prima facie evidence of violation of this chapter.

B. It shall be unlawful for any person to harvest or attempt to harvest oysters prior to sunrise or after 2 p.m. from the areas described in subdivisions 1, 3, 5, and 6 of 4VAC20-720-40, except as described in 4VAC20-720-106. In addition, it shall be unlawful for any boat with an oyster dredge aboard to leave the dock until one hour before sunrise or return to the dock after sunset, and it shall be unlawful for any boat with a hand scrape aboard to leave the dock until one-half hour before sunrise or return to the dock after sunset.

C. It shall be unlawful for any person to harvest or attempt to harvest oysters in the Rappahannock River Rotation Areas 1 and 6 2 and 4 prior to 7 a.m. and after 1 p.m.

D. It shall be unlawful for a boat with an oyster dredge aboard to leave the dock until one hour before sunrise or return to the dock after sunset.

E. It shall be unlawful for a boat with a hand scrape aboard to leave the dock until one-half hour before sunrise or return to the dock after sunset.

4VAC20-720-70. Gear restrictions.

A. It shall be unlawful for any person to harvest oysters in the James River Seed Areas, including the Deep Water Shoal State Replenishment Seed Area , and the Rappahannock River Area 9, except by hand or ordinary tong. It shall be unlawful for any person to have a hand scrape on board a boat that is harvesting or attempting to harvest oysters from public grounds by hand tong.

B. It shall be unlawful to harvest oysters from the seaside of the Eastern Shore, except by hand.

C. It shall be unlawful to harvest oysters in the Rappahannock River Rotation Area 1 or 6 Areas 2 and 4, Rappahannock River Area 8; James River Hand Scrape Area, Thomas Rock Hand Scrape Area, Nomini River Hand Scrape Area, Upper Chesapeake Bay (Blackberry Hangs Hand Scrape Area), and York River, Great Wicomico and Mobjack Bay Hand Scrape Area Areas, except by hand scrape.

D. It shall be unlawful for any person to have more than one hand scrape on board any boat that is harvesting oysters or attempting to harvest oysters from public grounds. It shall be unlawful for any person to have a hand tong on board a boat that is harvesting or attempting to harvest oysters from public grounds by hand scrape.

E. It shall be unlawful to harvest oysters from the Tangier – Pocomoke Rotation Area 1 2, except by a standard oyster dredge.

F. It shall be unlawful to harvest oysters from the Deep Rock Patent Tong Area, except by a standard oyster patent tong.

4VAC20-720-75. Gear license.

A. It shall be unlawful for any person to harvest shellfish, from the hand scrape areas in the Rappahannock River, James River, Upper Chesapeake Bay, York River, Mobjack Bay and Nomini River Area Great Wicomico River, unless that person has first obtained a current hand scrape license.

B. It shall be unlawful for any person to harvest shellfish, with a dredge from the public oyster grounds in the Tangier – Pocomoke Sounds Rotation Area 1 2, unless that person has first obtained a current dredge license.

C. It shall be unlawful for any person to harvest shellfish, with a patent tong from the public oyster grounds in the Deep Rock Patent Tong Area unless that person has first obtained a current patent tong license.

4VAC20-720-80. Quotas and harvest limits.

A. In the James River Seed Area, including the Deep Water Shoal State Replenishment Seed Area, there shall be an oyster harvest quota of 80,000 bushels of seed oysters. It shall be unlawful for any person to harvest seed oysters from the James River Seed Area after the 80,000 bushel quota has been reached. In the James River Seed Area, including the Deep Water Shoal State Replenishment Seed Area, there shall be an oyster harvest quota of 15,000 bushels of clean cull oysters. It shall be unlawful for any person to harvest clean cull oysters from the James River Seed Area, including the Deep Water Shoal State Replenishment Seed Area, after the 15,000 bushel quota has been reached.

B. The lawful daily limit of clean cull oysters harvested from the areas as described in subdivisions 3, 4, and 6 of 4VAC20-720-40 shall be determined by the number of registered commercial fishermen licensees on board the vessel multiplied by eight bushels. It shall be unlawful to possess on board any vessel or to land more than the daily limit of clean cull oysters.

C. In the Tangier - Pocomoke Sounds Rotation Area 1 2, where harvesting is allowed by dredge, there shall be a harvest limit of eight bushels per registered commercial fisherman licensee on board the vessel. It shall be unlawful for any registered commercial fisherman licensee to possess more than eight bushels per day. No blue crab bycatch is allowed. It shall be unlawful to possess on board any vessel more than 250 hard clams.

D. Harvesters who export the oysters to an out-of-state market or do not sell the oysters to a licensed and Department of Health certified Virginia buyer but sell the oysters directly to the public for human consumption shall report oysters harvested on a daily basis and pay oyster taxes weekly.

4VAC20-720-95. Harvesting permit required for the Rappahannock River Rotation Areas 1 through 6.

A harvesting permit is required for the Rappahannock River rotation areas Rotation Areas 1 through 6. Included with this permit will be a map of the two rotation areas that are open for harvesting in any given year and a culling stick specific to management provisions for these areas. It shall be unlawful for any person to harvest or attempt to harvest oysters from the Rappahannock River Rotation Areas 1 through 6 without first obtaining and having on board a harvest permit, with a map of lower Rappahannock Rotation Areas 1 through 6, and culling stick specific to these areas that are open for harvesting in any given year.

4VAC20-720-100. Seed oyster planting procedures.

A. The marine police officer at the point of seed harvest may require that an officer be present during the seed planting. When this is required, it will be specified on the seed transfer permit. If an officer is required to be present at planting, the planter shall notify the law-enforcement marine police officer in the area prior to planting. It shall be unlawful for the permittee or planter to plant the oysters without a marine police officer being present.

B. The planting of seed oysters shall consist of spreading the oysters loosely on the bottom of the planting area. It shall be unlawful to plant seed oysters in any manner except by spreading the oysters loosely on the bottom.

C. Seed oysters shall be placed on a designated and marked area of the private ground from which said oysters are not to be removed until after March 31. It shall be unlawful to reharvest these seed oysters prior to April 1.

4VAC20-720-106. Public health and warm water harvest restrictions.

A. It shall be unlawful for any person to have any cat, dog, or other animal on board a vessel during the harvest of oysters.

B. From May 1 through September 30, any vessel used for the harvest of oysters for human consumption from either public or private grounds shall have shading over the area that serves as storage for the oysters (except as described in subsection C of this section), and all oysters in the vessel shall be offloaded every day.

C. From May 1 through September 30, any vessel used for the harvest of oysters for human consumption that are placed in an aquaculture container completely covered by a lid or top, shall not be required to have shading over that container.

D. From May 1 June 15 through September 30 August 31, it shall be unlawful for any person, or person aboard a vessel, to leave the dock or shore prior to one hour before sunrise to harvest or attempt to harvest oysters from public or private grounds.

E. From May 1 through June 14, it shall be unlawful to harvest oysters for human consumption from public or private grounds after 11 a.m., and oysters harvested before 11 a.m. shall be refrigerated by 11 a.m. that same day.

E. F. From May 1 June 15 through September 30 August 31, it shall be unlawful to harvest oysters for human consumption from public or private grounds after 10 a.m., and oysters harvested before 10 a.m. shall be refrigerated by 10 a.m. that same day, except as described below:.

G. From September 1 through September 30, it shall be unlawful to harvest oysters for human consumption from public or private grounds after 12 p.m., and oysters harvested before 12 p.m. shall be refrigerated by 12 p.m. that same day.

1. This H. Subsections E, F, and G of this section shall not apply to the harvest of seed oysters or the customary husbandry processes associated with aquaculture of oysters.

2. I. Oysters may be harvested after 10 a.m. the end of the designated harvesting time in subsections E, F, and G of this section provided there is a Virginia Department of Health, Division of Shellfish Sanitation-approved refrigeration system or ice storage area for the oysters on board the harvest vessel that is in use for cooling oysters at all times after 10 a.m or the total time expended on harvesting those oysters does not exceed two hours from start of harvest to refrigeration of those oysters, and there is verifiable documentation, such as a log book or GPS trip log that corresponds to that harvesting event.

3. The total time expended on harvesting those oysters does not exceed two hours from start of harvest to refrigeration of those oysters, and there is verifiable documentation, such as a log book or GPS trip log that corresponds to that harvesting event.

Title of Regulation: 4VAC20-751. Pertaining to the Setting and Mesh Size of Gill Nets (amending 4VAC20-751-10, 4VAC20-751-15, 4VAC20-751-20).

Statutory Authority: §§28.2-201 and 28.2-210 of the Code of Virginia.

Effective Date: September 29, 2008, through October 28, 2008.

Agency Contact: Jane Warren, Agency Regulatory Coordinator, Marine Resources Commission, 2600 Washington Avenue, 3rd Floor, Newport News, VA 23607, telephone (757) 247-2248, FAX (757) 247-2002, or email betty.warren@mrc.virginia.gov.

Preamble:

The amendment makes it unlawful for any person to place any unattended gill net within 500 yards of the mean high-water mark, on the ocean side of Northampton and Accomack counties, north of a line, beginning at the southern most point of Smith Island and thence extending due east to the three-mile limit line.

4VAC20-751-10. Purpose.

The purpose of this emergency chapter is to reduce the out-of-season by-catch of American shad and to preclude the harvest of coastal migratory striped bass, thereby reducing injuries and mortalities to these two species. This emergency chapter is also intended to reduce the strandings and mortalities of threatened and endangered sea turtles.

4VAC20-751-15. Definitions.

The following words and terms when used in this emergency chapter shall have the following meaning unless the context clearly indicates otherwise:

"Unattended gill net" means any gill net set in Virginia tidal waters, described in 4VAC20-751-20 E, that is located more than one mile from the licensee of that gill net.

4VAC20-751-20. Gill net mesh sizes, restricted areas, and season.

A. From January 1 through March 25 of each year, it shall be unlawful for any person to place, set, or fish any gill net with a stretched mesh size between 3-3/4 inches and six inches within the restricted areas as set forth below, except that during the month of February any legally licensed fisherman may place, set, or fish any gill net with a stretched mesh size from five inches to six inches within the restricted areas described in this subsection. From March 26 through June 15 of each year, it shall be unlawful for any person to place, set, or fish any gill net with a stretched mesh size greater than six inches within the restricted areas set forth below, except as described in 4VAC20-252-135:

1. In James River, those tidal waters upstream of a line connecting Willoughby Spit and Old Point Comfort;

2. In Back River, those tidal waters upstream of a line connecting Factory Point and Plumtree Point;

3. In Poquoson River, those tidal waters upstream of a line connecting Marsh Point and Tue Point;

4. In York River, those tidal waters upstream of a line connecting Tue Point and Guinea Marshes;

5. In Mobjack Bay, those tidal waters upstream of a line connecting Guinea Marshes and New Point Comfort;

6. In Milford Haven, those tidal waters upstream of a line connecting Rigby Island and Sandy Point;

7. In Piankatank River, those tidal waters upstream of a line connecting Cherry Point and Stingray Point; and

8. In Rappahannock River, those tidal waters upstream of a line connecting Stingray Point to Windmill Point.

B. During the period May 1 through June 30, it shall be unlawful for any person to have aboard any vessel or to place, set, or fish more than 8,400 feet of gill net.

C. During the period May 1 through June 30, it shall be unlawful for any person to have aboard any vessel or to place, set, or fish any gill net in the Chesapeake Bay or in Virginia's portion of the Territorial Sea, that is made, set or fished in a tied-down manner, by connecting the net's head rope and foot rope with lines, which cause the net to form a pocket of webbing.

D. During the period June 1 through June 30, it shall be unlawful for any person to have aboard any vessel or to place, set, or fish any gill net with a stretched mesh greater than six inches in the Virginia portion of the Territorial Sea, south of a line connecting Smith Island Light and the three-mile limit line.

E. From June 1 through October 15, it shall be unlawful for any person to place any anchored, weighted, or unattended gill net, within 500 yards of the mean high-water mark, on the ocean side of Northampton and Accomack counties, north of a line, beginning at the southern most point of Smith Island and thence extending due east to the three-mile limit line.

Titles of Regulations: 6VAC15-10. Public Participation Guidelines (repealing 6VAC15-10-10 through 6VAC15-10-100).

6VAC15-11. Public Participation Guidelines (adding 6VAC15-11-10 through 6VAC15-11-110).

Statutory Authority: §§2.2-4007.02 and 53.1-5 of the Code of Virginia.

Effective Date: November 15, 2008.

Agency Contact: Janice Dow, Agency Regulatory Coordinator, Department of Corrections, 6900 Atmore Drive, Richmond, VA 23235, telephone (804) 674-3303 ext: 1128, FAX (804) 674-3017, or email janice.dow@vadoc.virginia.gov.

Summary:

The regulations comply with the legislative mandate (Chapter 321, 2008 Acts of Assembly) that agencies adopt model public participation guidelines issued by the Department of Planning and Budget by December 1, 2008. Public participation guidelines exist to promote public involvement in the development, amendment, or repeal of an agency's regulations.

This regulatory action repeals the current public participation guidelines and promulgates new public participation guidelines as required by Chapter 321 of the 2008 Acts of Assembly. Highlights of the public participation guidelines include (i) providing for the establishment and maintenance of notification lists of interested persons and specifying the information to be sent to such persons; (ii) providing for public comments on regulatory action; (iii) establishing the time period during which public comments shall be accepted; (iv) providing that the plan to hold a public meeting shall be indicated in any notice of intended regulatory action; (v) providing for the appointment, when necessary, of regulatory advisory panels to provide professional specialization or technical assistance and negotiated rulemaking panels if a regulatory action is expected to be controversial; and (vi) providing for the periodic review of regulations.

CHAPTER 11
PUBLIC PARTICIPATION GUIDELINES

Part I
Purpose and Definitions

6VAC15-11-10. Purpose.

The purpose of this chapter is to promote public involvement in the development, amendment or repeal of the regulations of the Department of Corrections. This chapter does not apply to regulations, guidelines, or other documents exempted or excluded from the provisions of the Administrative Process Act (§2.2-4000 et seq. of the Code of Virginia).

6VAC15-11-20. Definitions.

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Administrative Process Act" means Chapter 40 (§2.2-4000 et seq.) of Title 2.2 of the Code of Virginia.

"Agency" means the Department of Corrections, which is the unit of state government empowered by the agency's basic law to make regulations or decide cases. Actions specified in this chapter may be fulfilled by state employees as delegated by the agency.

"Basic law" means provisions in the Code of Virginia that delineate the basic authority and responsibilities of an agency.

"Commonwealth Calendar" means the electronic calendar for official government meetings open to the public as required by § 2.2-3707 C of the Freedom of Information Act.

''Negotiated rulemaking panel'' or ''NRP'' means an ad hoc advisory panel of interested parties established by an agency to consider issues that are controversial with the assistance of a facilitator or mediator, for the purpose of reaching a consensus in the development of a proposed regulatory action.

"Notification list" means a list used to notify persons pursuant to this chapter. Such a list may include an electronic list maintained through the Virginia Regulatory Town Hall or other list maintained by the agency.

"Open meeting" means any scheduled gathering of a unit of state government empowered by an agency's basic law to make regulations or decide cases, which is related to promulgating, amending or repealing a regulation.

"Person" means any individual, corporation, partnership, association, cooperative, limited liability company, trust, joint venture, government, political subdivision, or any other legal or commercial entity and any successor, representative, agent, agency, or instrumentality thereof.

"Public hearing" means a scheduled time at which members or staff of the agency will meet for the purpose of receiving public comment on a regulatory action.

"Regulation" means any statement of general application having the force of law, affecting the rights or conduct of any person, adopted by the agency in accordance with the authority conferred on it by applicable laws.

"Regulatory action" means the promulgation, amendment, or repeal of a regulation by the agency.

"Regulatory advisory panel" or "RAP" means a standing or ad hoc advisory panel of interested parties established by the agency for the purpose of assisting in regulatory actions.

"Town Hall" means the Virginia Regulatory Town Hall, the website operated by the Virginia Department of Planning and Budget at www.townhall.virginia.gov, which has online public comment forums and displays information about regulatory meetings and regulatory actions under consideration in Virginia and sends this information to registered public users.

"Virginia Register" means the Virginia Register of Regulations, the publication that provides official legal notice of new, amended and repealed regulations of state agencies, which is published under the provisions of Article 6 (§2.2-4031 et seq.) of the Administrative Process Act.

Part II
Notification of Interested Persons

6VAC15-11-30. Notification list.

A. The agency shall maintain a list of persons who have requested to be notified of regulatory actions being pursued by the agency.

B. Any person may request to be placed on a notification list by registering as a public user on the Town Hall or by making a request to the agency. Any person who requests to be placed on a notification list shall elect to be notified either by electronic means or through a postal carrier.

C. The agency may maintain additional lists for persons who have requested to be informed of specific regulatory issues, proposals, or actions.

D. When electronic mail is returned as undeliverable on multiple occasions at least 24 hours apart, that person may be deleted from the list. A single undeliverable message is insufficient cause to delete the person from the list.

E. When mail delivered by a postal carrier is returned as undeliverable on multiple occasions, that person may be deleted from the list.

F. The agency may periodically request those persons on the notification list to indicate their desire to either continue to be notified electronically, receive documents through a postal carrier, or be deleted from the list.

6VAC15-11-40. Information to be sent to persons on the notification list.

A. To persons electing to receive electronic notification or notification through a postal carrier as described in 6VAC15-11-30, the agency shall send the following information:

1. A notice of intended regulatory action (NOIRA).

2. A notice of the comment period on a proposed, a reproposed, or a fast-track regulation and hyperlinks to, or instructions on how to obtain, a copy of the regulation and any supporting documents.

3. A notice soliciting comment on a final regulation when the regulatory process has been extended pursuant to § 2.2-4007.06 or 2.2-4013 C of the Code of Virginia.

B. The failure of any person to receive any notice or copies of any documents shall not affect the validity of any regulation or regulatory action.

Part III
Public Participation Procedures

6VAC15-11-50. Public comment.

A. In considering any nonemergency, nonexempt regulatory action, the agency shall afford interested persons an opportunity to submit data, views, and arguments, either orally or in writing, to the agency. Such opportunity to comment shall include an online public comment forum on the Town Hall.

1. To any requesting person, the agency shall provide copies of the statement of basis, purpose, substance, and issues; the economic impact analysis of the proposed or fast-track regulatory action; and the agency's response to public comments received.

2. The agency may begin crafting a regulatory action prior to or during any opportunities it provides to the public to submit comments.

B. The agency shall accept public comments in writing after the publication of a regulatory action in the Virginia Register as follows:

1. For a minimum of 30 calendar days following the publication of the notice of intended regulatory action (NOIRA).

2. For a minimum of 60 calendar days following the publication of a proposed regulation.

3. For a minimum of 30 calendar days following the publication of a reproposed regulation.

4. For a minimum of 30 calendar days following the publication of a final adopted regulation.

5. For a minimum of 30 calendar days following the publication of a fast-track regulation.

6. For a minimum of 21 calendar days following the publication of a notice of periodic review.

7. Not later than 21 calendar days following the publication of a petition for rulemaking.

C. The agency may determine if any of the comment periods listed in subsection B of this section shall be extended.

D. If the Governor finds that one or more changes with substantial impact have been made to a proposed regulation, he may require the agency to provide an additional 30 calendar days to solicit additional public comment on the changes in accordance with § 2.2-4013 C of the Code of Virginia.

E. The agency shall send a draft of the agency's summary description of public comment to all public commenters on the proposed regulation at least five days before final adoption of the regulation pursuant to § 2.2-4012 E of the Code of Virginia.

6VAC15-11-60. Petition for rulemaking.

A. As provided in § 2.2-4007 of the Code of Virginia, any person may petition the agency to consider a regulatory action.

B. A petition shall include but is not limited to the following information:

1. The petitioner's name and contact information;

2. The substance and purpose of the rulemaking that is requested, including reference to any applicable Virginia Administrative Code sections; and

3. Reference to the legal authority of the agency to take the action requested.

C. The agency shall receive, consider and respond to a petition pursuant to § 2.2-4007 and shall have the sole authority to dispose of the petition.

D. The petition shall be posted on the Town Hall and published in the Virginia Register.

E. Nothing in this chapter shall prohibit the agency from receiving information or from proceeding on its own motion for rulemaking.

6VAC15-11-70. Appointment of regulatory advisory panel.

A. The agency may appoint a regulatory advisory panel (RAP) to provide professional specialization or technical assistance when the agency determines that such expertise is necessary to address a specific regulatory issue or action or when individuals indicate an interest in working with the agency on a specific regulatory issue or action.

B. Any person may request the appointment of a RAP and request to participate in its activities. The agency shall determine when a RAP shall be appointed and the composition of the RAP.

C. A RAP may be dissolved by the agency if:

1. The proposed text of the regulation is posted on the Town Hall, published in the Virginia Register, or such other time as the agency determines is appropriate; or

2. The agency determines that the regulatory action is either exempt or excluded from the requirements of the Administrative Process Act.

6VAC15-11-80. Appointment of negotiated rulemaking panel.

A. The agency may appoint a negotiated rulemaking panel (NRP) if a regulatory action is expected to be controversial.

B. An NRP that has been appointed by the agency may be dissolved by the agency when:

1. There is no longer controversy associated with the development of the regulation;

2. The agency determines that the regulatory action is either exempt or excluded from the requirements of the Administrative Process Act; or

3. The agency determines that resolution of a controversy is unlikely.

6VAC15-11-90. Meetings.

Notice of any open meeting, including meetings of a RAP or NRP, shall be posted on the Virginia Regulatory Town Hall and Commonwealth Calendar at least seven working days prior to the date of the meeting. The exception to this requirement is any meeting held in accordance with § 2.2-3707 D of the Code of Virginia allowing for contemporaneous notice to be provided to participants and the public.

6VAC15-11-100. Public hearings on regulations.

A. The agency shall indicate in its notice of intended regulatory action whether it plans to hold a public hearing following the publication of the proposed stage of the regulatory action.

B. The agency may conduct one or more public hearings during the comment period following the publication of a proposed regulatory action.

C. An agency is required to hold a public hearing following the publication of the proposed regulatory action when:

1. The agency's basic law requires the agency to hold a public hearing;

2. The Governor directs the agency to hold a public hearing; or

3. The agency receives requests for a public hearing from at least 25 persons during the public comment period following the publication of the notice of intended regulatory action.

D. Notice of any public hearing shall be posted on the Town Hall and Commonwealth Calendar at least seven working days prior to the date of the hearing. The agency shall also notify those persons who requested a hearing under subdivision C 3 of this section.

6VAC15-11-110. Periodic review of regulations.

A. The agency shall conduct a periodic review of its regulations consistent with:

1. An executive order issued by the Governor pursuant to § 2.2-4017 of the Administrative Process Act to receive comment on all existing regulations as to their effectiveness, efficiency, necessity, clarity, and cost of compliance; and

2. The requirements in § 2.2-4007.1 of the Administrative Process Act regarding regulatory flexibility for small businesses.

B. A periodic review may be conducted separately or in conjunction with other regulatory actions.

C. Notice of a periodic review shall be posted on the Town Hall and published in the Virginia Register.

Titles of Regulations: 6VAC15-10. Public Participation Guidelines (repealing 6VAC15-10-10 through 6VAC15-10-100).

6VAC15-11. Public Participation Guidelines (adding 6VAC15-11-10 through 6VAC15-11-110).

Statutory Authority: §§2.2-4007.02 and 53.1-5 of the Code of Virginia.

Effective Date: November 15, 2008.

Agency Contact: Janice Dow, Agency Regulatory Coordinator, Department of Corrections, 6900 Atmore Drive, Richmond, VA 23235, telephone (804) 674-3303 ext: 1128, FAX (804) 674-3017, or email janice.dow@vadoc.virginia.gov.

Summary:

The regulations comply with the legislative mandate (Chapter 321, 2008 Acts of Assembly) that agencies adopt model public participation guidelines issued by the Department of Planning and Budget by December 1, 2008. Public participation guidelines exist to promote public involvement in the development, amendment, or repeal of an agency's regulations.

This regulatory action repeals the current public participation guidelines and promulgates new public participation guidelines as required by Chapter 321 of the 2008 Acts of Assembly. Highlights of the public participation guidelines include (i) providing for the establishment and maintenance of notification lists of interested persons and specifying the information to be sent to such persons; (ii) providing for public comments on regulatory action; (iii) establishing the time period during which public comments shall be accepted; (iv) providing that the plan to hold a public meeting shall be indicated in any notice of intended regulatory action; (v) providing for the appointment, when necessary, of regulatory advisory panels to provide professional specialization or technical assistance and negotiated rulemaking panels if a regulatory action is expected to be controversial; and (vi) providing for the periodic review of regulations.

CHAPTER 11
PUBLIC PARTICIPATION GUIDELINES

Part I
Purpose and Definitions

6VAC15-11-10. Purpose.

The purpose of this chapter is to promote public involvement in the development, amendment or repeal of the regulations of the Department of Corrections. This chapter does not apply to regulations, guidelines, or other documents exempted or excluded from the provisions of the Administrative Process Act (§2.2-4000 et seq. of the Code of Virginia).

6VAC15-11-20. Definitions.

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Administrative Process Act" means Chapter 40 (§2.2-4000 et seq.) of Title 2.2 of the Code of Virginia.

"Agency" means the Department of Corrections, which is the unit of state government empowered by the agency's basic law to make regulations or decide cases. Actions specified in this chapter may be fulfilled by state employees as delegated by the agency.

"Basic law" means provisions in the Code of Virginia that delineate the basic authority and responsibilities of an agency.

"Commonwealth Calendar" means the electronic calendar for official government meetings open to the public as required by § 2.2-3707 C of the Freedom of Information Act.

''Negotiated rulemaking panel'' or ''NRP'' means an ad hoc advisory panel of interested parties established by an agency to consider issues that are controversial with the assistance of a facilitator or mediator, for the purpose of reaching a consensus in the development of a proposed regulatory action.

"Notification list" means a list used to notify persons pursuant to this chapter. Such a list may include an electronic list maintained through the Virginia Regulatory Town Hall or other list maintained by the agency.

"Open meeting" means any scheduled gathering of a unit of state government empowered by an agency's basic law to make regulations or decide cases, which is related to promulgating, amending or repealing a regulation.

"Person" means any individual, corporation, partnership, association, cooperative, limited liability company, trust, joint venture, government, political subdivision, or any other legal or commercial entity and any successor, representative, agent, agency, or instrumentality thereof.

"Public hearing" means a scheduled time at which members or staff of the agency will meet for the purpose of receiving public comment on a regulatory action.

"Regulation" means any statement of general application having the force of law, affecting the rights or conduct of any person, adopted by the agency in accordance with the authority conferred on it by applicable laws.

"Regulatory action" means the promulgation, amendment, or repeal of a regulation by the agency.

"Regulatory advisory panel" or "RAP" means a standing or ad hoc advisory panel of interested parties established by the agency for the purpose of assisting in regulatory actions.

"Town Hall" means the Virginia Regulatory Town Hall, the website operated by the Virginia Department of Planning and Budget at www.townhall.virginia.gov, which has online public comment forums and displays information about regulatory meetings and regulatory actions under consideration in Virginia and sends this information to registered public users.

"Virginia Register" means the Virginia Register of Regulations, the publication that provides official legal notice of new, amended and repealed regulations of state agencies, which is published under the provisions of Article 6 (§2.2-4031 et seq.) of the Administrative Process Act.

Part II
Notification of Interested Persons

6VAC15-11-30. Notification list.

A. The agency shall maintain a list of persons who have requested to be notified of regulatory actions being pursued by the agency.

B. Any person may request to be placed on a notification list by registering as a public user on the Town Hall or by making a request to the agency. Any person who requests to be placed on a notification list shall elect to be notified either by electronic means or through a postal carrier.

C. The agency may maintain additional lists for persons who have requested to be informed of specific regulatory issues, proposals, or actions.

D. When electronic mail is returned as undeliverable on multiple occasions at least 24 hours apart, that person may be deleted from the list. A single undeliverable message is insufficient cause to delete the person from the list.

E. When mail delivered by a postal carrier is returned as undeliverable on multiple occasions, that person may be deleted from the list.

F. The agency may periodically request those persons on the notification list to indicate their desire to either continue to be notified electronically, receive documents through a postal carrier, or be deleted from the list.

6VAC15-11-40. Information to be sent to persons on the notification list.

A. To persons electing to receive electronic notification or notification through a postal carrier as described in 6VAC15-11-30, the agency shall send the following information:

1. A notice of intended regulatory action (NOIRA).

2. A notice of the comment period on a proposed, a reproposed, or a fast-track regulation and hyperlinks to, or instructions on how to obtain, a copy of the regulation and any supporting documents.

3. A notice soliciting comment on a final regulation when the regulatory process has been extended pursuant to § 2.2-4007.06 or 2.2-4013 C of the Code of Virginia.

B. The failure of any person to receive any notice or copies of any documents shall not affect the validity of any regulation or regulatory action.

Part III
Public Participation Procedures

6VAC15-11-50. Public comment.

A. In considering any nonemergency, nonexempt regulatory action, the agency shall afford interested persons an opportunity to submit data, views, and arguments, either orally or in writing, to the agency. Such opportunity to comment shall include an online public comment forum on the Town Hall.

1. To any requesting person, the agency shall provide copies of the statement of basis, purpose, substance, and issues; the economic impact analysis of the proposed or fast-track regulatory action; and the agency's response to public comments received.

2. The agency may begin crafting a regulatory action prior to or during any opportunities it provides to the public to submit comments.

B. The agency shall accept public comments in writing after the publication of a regulatory action in the Virginia Register as follows:

1. For a minimum of 30 calendar days following the publication of the notice of intended regulatory action (NOIRA).

2. For a minimum of 60 calendar days following the publication of a proposed regulation.

3. For a minimum of 30 calendar days following the publication of a reproposed regulation.

4. For a minimum of 30 calendar days following the publication of a final adopted regulation.

5. For a minimum of 30 calendar days following the publication of a fast-track regulation.

6. For a minimum of 21 calendar days following the publication of a notice of periodic review.

7. Not later than 21 calendar days following the publication of a petition for rulemaking.

C. The agency may determine if any of the comment periods listed in subsection B of this section shall be extended.

D. If the Governor finds that one or more changes with substantial impact have been made to a proposed regulation, he may require the agency to provide an additional 30 calendar days to solicit additional public comment on the changes in accordance with § 2.2-4013 C of the Code of Virginia.

E. The agency shall send a draft of the agency's summary description of public comment to all public commenters on the proposed regulation at least five days before final adoption of the regulation pursuant to § 2.2-4012 E of the Code of Virginia.

6VAC15-11-60. Petition for rulemaking.

A. As provided in § 2.2-4007 of the Code of Virginia, any person may petition the agency to consider a regulatory action.

B. A petition shall include but is not limited to the following information:

1. The petitioner's name and contact information;

2. The substance and purpose of the rulemaking that is requested, including reference to any applicable Virginia Administrative Code sections; and

3. Reference to the legal authority of the agency to take the action requested.

C. The agency shall receive, consider and respond to a petition pursuant to § 2.2-4007 and shall have the sole authority to dispose of the petition.

D. The petition shall be posted on the Town Hall and published in the Virginia Register.

E. Nothing in this chapter shall prohibit the agency from receiving information or from proceeding on its own motion for rulemaking.

6VAC15-11-70. Appointment of regulatory advisory panel.

A. The agency may appoint a regulatory advisory panel (RAP) to provide professional specialization or technical assistance when the agency determines that such expertise is necessary to address a specific regulatory issue or action or when individuals indicate an interest in working with the agency on a specific regulatory issue or action.

B. Any person may request the appointment of a RAP and request to participate in its activities. The agency shall determine when a RAP shall be appointed and the composition of the RAP.

C. A RAP may be dissolved by the agency if:

1. The proposed text of the regulation is posted on the Town Hall, published in the Virginia Register, or such other time as the agency determines is appropriate; or

2. The agency determines that the regulatory action is either exempt or excluded from the requirements of the Administrative Process Act.

6VAC15-11-80. Appointment of negotiated rulemaking panel.

A. The agency may appoint a negotiated rulemaking panel (NRP) if a regulatory action is expected to be controversial.

B. An NRP that has been appointed by the agency may be dissolved by the agency when:

1. There is no longer controversy associated with the development of the regulation;

2. The agency determines that the regulatory action is either exempt or excluded from the requirements of the Administrative Process Act; or

3. The agency determines that resolution of a controversy is unlikely.

6VAC15-11-90. Meetings.

Notice of any open meeting, including meetings of a RAP or NRP, shall be posted on the Virginia Regulatory Town Hall and Commonwealth Calendar at least seven working days prior to the date of the meeting. The exception to this requirement is any meeting held in accordance with § 2.2-3707 D of the Code of Virginia allowing for contemporaneous notice to be provided to participants and the public.

6VAC15-11-100. Public hearings on regulations.

A. The agency shall indicate in its notice of intended regulatory action whether it plans to hold a public hearing following the publication of the proposed stage of the regulatory action.

B. The agency may conduct one or more public hearings during the comment period following the publication of a proposed regulatory action.

C. An agency is required to hold a public hearing following the publication of the proposed regulatory action when:

1. The agency's basic law requires the agency to hold a public hearing;

2. The Governor directs the agency to hold a public hearing; or

3. The agency receives requests for a public hearing from at least 25 persons during the public comment period following the publication of the notice of intended regulatory action.

D. Notice of any public hearing shall be posted on the Town Hall and Commonwealth Calendar at least seven working days prior to the date of the hearing. The agency shall also notify those persons who requested a hearing under subdivision C 3 of this section.

6VAC15-11-110. Periodic review of regulations.

A. The agency shall conduct a periodic review of its regulations consistent with:

1. An executive order issued by the Governor pursuant to § 2.2-4017 of the Administrative Process Act to receive comment on all existing regulations as to their effectiveness, efficiency, necessity, clarity, and cost of compliance; and

2. The requirements in § 2.2-4007.1 of the Administrative Process Act regarding regulatory flexibility for small businesses.

B. A periodic review may be conducted separately or in conjunction with other regulatory actions.

C. Notice of a periodic review shall be posted on the Town Hall and published in the Virginia Register.

Title of Regulation: 6VAC15-70. Standards for Community Residential Programs (amending 6VAC15-70-10 through 6VAC15-70-160).

Statutory Authority: §53.1-5 of the Code of Virginia.

Effective Date: November 15, 2008.

Agency Contact: Beverly Hill-Murray, Compliance and Accreditation Unit, Department of Corrections, 6900 Atmore Drive, Richmond, VA 23235, telephone (804) 674-3499 ext: 1145, FAX (804) 674-3587, or email beverly.hill-murray@vadoc.virginia.gov.

Summary:

The amendments include requirements for an annual review of the operations manual; require procedures governing residents’ money to be incompliance with current Community Corrections Operating Procedures; require the agency administrator to distribute designated documents to the governing authority annually; include fraternization procedures (per Prison Rape Elimination Act) in the list of written personnel policies approved by the governing authority; add formal training in addition to orientation as a requirement prior to an employee assuming sole responsibility for any working shift; clarify staffing schedules; amend a population count conducted by staff from every two hours to three times daily; allow random as well as monthly fire drills; and add sexual abuse history (per Prison Rape Elimination Act) to the list of initial intake information form on each resident.

6VAC15-70-10. Definitions.

The following words and terms when used in these standards shall have the following meaning, unless the context clearly indicates otherwise:

"Agency" means the public or private organization that has direct responsibility for the operation of a community residential program including the implementation of policy established by the governing authority.

"Agency staff" means any agency administrator, facility director, counselor, case manager, clerical worker or supervisor or others who are employed by, contract with, or volunteer services to the program.

"Community residential program" means any group home, halfway house, or other physically unrestricting facility used for the housing treatment or care of adult offenders established or operated with funds appropriated to the Department of Corrections from the state treasury and maintained or operated by any political subdivision, combination of political subdivisions or privately operated agency within the Commonwealth.

"Contraband" means items prohibited on facility premises by statute, regulation, or policy.

"Facility" means the physical plant.

"Foot-candle" means a unit for measuring the intensity of illumination defined as the amount of light thrown on a surface one foot away from the light source.

"Furlough" means a written approval that allows a resident to leave the facility for a period of time, including overnight.

"Governing authority" means those persons responsible for facilitating communication with program administrators, establishing policy, exploring problems, ensuring conformity to legal and fiscal requirements, and implementing community residential programs.

"Pass" means a written approval that allows a resident to leave the facility for a period of time, other than overnight.

"Program" means the plan or system of residential services of a public or private agency.

"Recognized health authority" means health authority as defined by the American Red Cross or the American Heart Association.

"Resident" means an individual participating in a community residential program under the purview of a contractual agreement.

6VAC15-70-40. Organization and administration.

A. The agency shall appoint a governing authority that serves as a link between the residential program and the community.

B. The governing authority of the public or private community residential program shall hold meetings at least quarterly with the community residential program administrator in order to facilitate communication, establish policy, explore problems, ensure conformity to legal and fiscal requirements, and implement community residential programs.

C. A single administrative officer who reports directly to the governing authority shall manage the agency and its programs.

D. The agency shall have an operations manual which summarizes approved methods of implementing agency policies and procedures and provides details for daily operations of the program that is available to all employees.

E. The governing authority or agency administrator shall annually review the operations manual at least every two years and update when necessary.

F. The administrator or designated agency staff shall monitor implementation of policies and procedures set forth in the operations manual through a review that occurs at least every 12 months.

G. There shall be a written policy that persons connected with the agency shall not use their official position to secure privileges or advantages for themselves.

H. Any community residential program operated exclusively by the Department of Corrections shall have a written policy that ensures to ensure that the program it conforms to governmental statutes and regulations relating to campaigning, lobbying and political practices.

I. The agency shall have a current organizational chart that accurately reflects the structure of authority and accountability within the agency.

J. Agency staff shall identify and document the agency's tax status with the Internal Revenue Service.

K. The agency shall have by-laws, approved by the governing authority, which shall be filed with the appropriate local, state or federal body.

L. The agency by-laws for the governing authority shall include:

1. Membership;

2. Size of the governing authority;

3. Method of selection;

4. Terms of office;

5. Duties and responsibilities of officers;

6. Times authority will meet;

7. Committees;

8. Quorums;

9. Parliamentary procedures;

10. Recording of minutes;

11. Method of amending by-laws;

12. Conflict of interest provisions; and

13. Specification of the relationship of the agency administrator to the governing authority.

M. A permanent record shall be kept of all meetings meeting minutes of the governing authority.

6VAC15-70-50. Fiscal management.

A. The agency administrator shall prepare an annual written budget of anticipated revenues and expenditures which shall be approved by the governing authority.

B. The agency administrator shall participate in budget reviews conducted by the governing authority.

C. Written procedures shall govern revisions in to the budget.

D. Written fiscal procedures shall provide for accounting of all income and expenditures.

E. D. Written procedure shall govern the handling and use of residents' money. This procedure shall comply with current Department of Corrections community corrections operating procedures.

F. E. An annual independent financial audit of the agency shall be performed by a certified public accounting firm or a governmental auditing agency.

G. Agency staff F. The agency administrator shall prepare and distribute the following documents to its governing authority and the Department of Corrections upon request annually:

1. Annual budget;

2. Income and expenditure statements;

3. Funding source financial reports; and

4. Independent audit report.

H. G. Written fiscal policies and procedures, which are adopted by the governing authority shall include at a minimum:

1. Internal controls;

2. Petty cash;

3. Bonding;

4. Signature control on checks;

5. Resident funds; and

6. Employee expense reimbursement. ; and

7. Accounting of income and expenditures.

I. H. The agency shall have insurance coverage which includes coverage for:

1. Physical plant;

2. Equipment;

3. Personal and property injury to employees, residents and third parties; and

4. Comprehensive general liability.

J. I. Written procedure shall govern vendor selection and purchasing and requisitioning of supplies and equipment.

K. J. There shall be written procedure for documenting and authorizing compensation to consultants.

6VAC15-70-60. Personnel.

A. Written personnel policies and procedures, which are approved by the governing authority, shall include at a minimum:

1. Recruitment;

2. Employment practices and procedures including in-service training and staff development;

3. Promotion;

4. Fraternization (per Prison Rape Elimination Act);

4. 5. Grievance and appeal;

5. 6. Personnel records and contents;

6. 7. Benefits;

7. 8. Holidays;

8. 9. Leave;

9. 10. Hours of work;

10. 11. Salaries;

11. 12. Disciplinary action procedures; and

12. 13. Termination and resignation.

B. Agency staff Written personnel policies and procedures shall make be made available to all employees a copy of all personnel policies and procedures. Each employee shall confirm in writing the availability and review of current policies and procedures.

C. The agency administrator shall maintain written job descriptions and job qualifications for all positions in the agency.

D. Confidentiality of personnel records shall be governed by written procedure.

E. Written procedure shall allow an employee to challenge information in their personnel file and have it corrected or removed if proven inaccurate.

F. All employees shall have a performance evaluation every 12 months. This evaluation shall be in writing and shall be based upon defined criteria. Each performance evaluation shall be reviewed and discussed with the employee.

G. Agency staff shall provide all new employees orientation, to include a review of all policies and procedures, beginning the first day of employment and concluding within 30 days. The employee shall sign and date a statement that orientation has been completed.

H. An employee shall not assume sole responsibility for any working shift prior to the completion of orientation and formal training.

I. The agency shall not discriminate or exclude from employment women from working in men's programs or nor men from working in women's programs.

J. The agency shall comply with all governmental regulatory requirements related to employment and personnel practices.

K. Written policy shall govern experience and education equivalents necessary for employment.

L. Criminal records checks shall be performed on all employees prior to hiring. The Department of Corrections regional administrator regional director must provide written authorization prior to the hiring of any exoffender who has been convicted of an offense for which a sentence of 12 months or more could have been imposed.

Part III
Facility

6VAC15-70-70. Facility operation.

A. The agency administrator shall ensure that the facility conforms to all applicable laws, codes and zoning ordinances or, through legal means, attempts to comply with or change such laws, codes, or zoning ordinances.

B. The agency administrator shall ensure that the facility complies with applicable state and local building codes.

C. The agency administrator shall ensure that the facility complies with sanitation and health codes of the state or local jurisdiction. Any sanitation and health deficiencies shall have a documented plan of corrective action that has been approved by the appropriate state or local inspector.

D. The agency administrator shall ensure that the facility complies with the regulations of the state or local fire safety authority that has jurisdiction over the facility. Any fire safety deficiencies shall have a documented plan of corrective action that has been approved by the appropriate state or local inspector.

E. Smoke detectors shall be installed, operational and inspected as recommended by the fire marshal or fire department representative.

F. Automatic, permanent emergency lights shall be installed, operational, and inspected as recommended by the fire marshal or fire department representative.

G. Agency staff shall have a housekeeping and maintenance plan. The facility shall be clean and in good repair.

H. The facility shall be located within 10 city blocks of public transportation or other means of transportation shall be available.

I. Sleeping quarters and bathroom areas shall have a minimum of 20 foot-candles of light.

J. Sleeping quarters shall be properly ventilated.

K. Sleeping quarters shall have a minimum of 60 square feet of floor space per resident.

L. Male and female residents shall not occupy the same sleeping quarters.

M. Each resident shall be provided, at a minimum, the following:

1. Bed;

2. Mattress and pillow;

3. Supply of bed linens;

4. Chair; and

5. Closet or locker space.

N. Residents shall be afforded space in the facility for:

1. Private counseling;

2. Group meetings; and

3. Visitation.

O. The facility shall have a minimum of one toilet and one shower or bathing facility for every 10 residents.

P. The facility shall have a minimum of one wash basin for every six residents.

Q. The facility shall have a minimum of one shower or bathing facility for every 10 residents.

R. Q. The facility shall have one washer and one dryer for every 16 residents, or equivalent laundry service shall be available in the immediate vicinity of the facility.

S. R. Rules and regulations pertaining to residents shall be conspicuously posted in the facility.

T. S. Written procedures shall govern transportation of residents that ensure at a minimum:

1. Those staff providing transportation shall have a valid operator's license;

2. Reporting of accidents; and

3. The vehicle's operation is in accordance with all state and local laws or ordinances.

U. T. Reasonable accommodations shall be available for the disabled.

6VAC15-70-80. Staffing.

A. The staffing pattern of the facility shall concentrate agency staff when the majority of residents are available to use facility resources schedule shall be formulated to accommodate the best possible ratio of staff to residents.

B. There shall be at least one agency staff person on facility premises who is awake, available and responsive to residents' needs available to the residents 24 hours a day.

6VAC15-70-90. Resident movement.

A. Resident movement into and out of the facility shall be governed by written procedure. The procedure shall include, at a minimum, a sign-in and sign-out system that includes:

1. Destination and phone number;

2. Reason for signing out;

3. Time and date out;

4. Expected time of return;

5. Resident's signature at time of departure;

6. Staff signature or initials at time of departure;

7. Date of return;

8. Time of return;

9. Resident's signature at time of return; and

10. Staff signature or initials at time of return.

B. Passes and furloughs shall be issued in conformance with Department of Corrections operating procedures.

C. Movement within the facility shall be governed by procedures that provide for:

1. An account of the residents' whereabouts in the facility at all times;

2. A population count, by resident name, conducted by staff every two hours three times daily;

3. Visual contact with each resident in the facility during the count; and

4. Count results documented and initialed by staff.

D. Verification of a resident's whereabouts when not in the facility shall be governed by written procedures. The forms of verification may include but not be limited to:

1. Random telephone contacts to the authorized destination;

2. Documentation from authorized destination that includes:

a. Signature of individual visited;

b. Date and time of visit; and

3. Random on-site visits to authorized destination.

6VAC15-70-100. Special procedures.

A. There shall be written emergency procedures that shall include the following:

1. Fire;

2. Evacuation;

3. Bomb or bomb threat;

4. Hostage;

5. Disturbances, which at a minimum include riots, assaults, and fights;

6. Deaths;

7. Power failure;

8. Loss of heat;

9. Loss of water;

10. Escape or absconding; and

11. Employee work stoppage.

B. Fire emergency procedures shall be posted conspicuously in the facility.

C. Agency staff shall conduct and document monthly and random emergency fire drills, including evacuation of residents.

D. No resident or group of residents shall be in a position of control or authority over other residents.

E. Written procedure shall restrict the use of physical force to instances of justifiable self-protection, protection of others, and the minimum degree necessary to control the situation.

F. Agency staff administrator shall maintain and make available to all employees written procedures for conducting searches of residents, agency staff, visitors and the facility in order to control contraband.

G. Written procedures shall govern the disposal of contraband.

H. Written procedures for reporting absconders shall comply with Department of Corrections operating procedures.

I. Written policy shall prohibit the carrying and use of weapons in the facility by both agency staff and residents.

J. Agency staff shall maintain a log of occurrences and daily events that shall:

1. Be kept in a bound book for permanent residence retention;

2. Be written legibly in ink;

3. At each entry, contain the full names, at least once, of the residents involved in the events;

4. Document a briefing of occurrences and important events between outgoing and incoming staff; and

5. Contain a signature or initials of staff at the conclusion of their shift; and

6. Become a legal document of the facility and shall be maintained as such.

Part IV
Program Services

6VAC15-70-110. Intake.

A. Criteria for acceptance into the program and intake shall be governed by written procedure.

B. Agency staff shall complete an initial intake information form on each resident admitted which, unless prohibited by statute, includes at a minimum:

1. Name;

2. Address;

3. Date of birth;

4. Social Security number;

5. Current photograph;

6. Sex Gender;

7. Race or ethnic origin;

8. Reason for referral;

9. Whom to notify in case of emergency;

10. Date information gathered;

11. Signature of both interviewee resident and employee gathering information;

12. Name and telephone number of referring agency or committing authority;

13. Special medical problems or needs;

14. Personal physician, if applicable; and

15. Legal status, including jurisdiction, and length and conditions of sentence. ; and

16. Sexual abuse history (per Prison Rape Elimination Act).

C. Agency staff shall distribute a copy of the criteria for acceptance into the program and intake procedures to referral agencies and interested parties.

D. Agency staff shall provide in writing to the referral agency and prospective resident, reasons for nonacceptance into the program.

E. At the time of intake, agency staff shall review goals, services available, program rules, and disciplinary actions with the resident. This procedure shall be documented by employee and resident signatures.

F. Written procedure shall govern the assignment of case management of each resident to a staff member.

G. Where a language or literacy problem exists which can may lead to a resident's misunderstanding of agency rules and regulations, assistance shall be provided to the resident either by staff or by another qualified individual under the supervision of a staff member.

6VAC15-70-120. Programs.

A. Agency staff shall design a personalized program with and for each resident that includes:

1. Measurable criteria of expected behavior and accomplishments;

2. Time schedule for achievement; and

3. Staff and resident signatures Signatures of employee and resident.

B. Agency staff shall review changes in the personalized program with the resident and document this procedure with staff employee and resident signatures.

C. Agency staff shall review resident progress with the resident every two weeks. The outcome of each review shall be documented in the resident's case file.

D. Written procedures shall provide residents increasing involvement with family and community activities prior to final release.

E. Residents' attendance and participation in religious services and activities shall be voluntary. Residents shall be permitted to attend religious services of their choice in the community once eligible to go out on pass and to receive visits from representatives of their respective faiths religious affiliation.

F. Written procedures shall ensure that residents receive approved visitors during established visiting hours, except where there is substantial evidence that a visitor poses a threat to the safety of the resident or the security of the facility.

G. Agency staff The agency program shall provide for recreational and leisure time activities.

H. Agency staff shall provide, or make referrals when needed, for the following services:

1. Supervision in the community;

2. Shelter;

3. Food service (where applicable);

4. Financial assistance;

5. Individual counseling;

6. Assistance with transportation;

7. Medical health services;

8. Mental health services;

9. Vocational evaluation, counseling and training;

10. Employment counseling and placement;

11. Education or training counseling and placement; and

12. Group counseling.

I. Agency staff shall use community resources, either through referrals for service or by contractual agreement, to provide residents with the services to become self-sufficient.

J. Agency staff shall ensure that residents' mail, both incoming and outgoing, is not read or withheld and that inspection of residents' mail for money or contraband shall occur in the presence of the resident.

K. Resident grievances shall be governed by written procedures that shall include an appeals process.

6VAC15-70-130. Case records.

A. Agency staff shall maintain a case record for each resident in which all significant decisions and events are recorded. The records shall include, at a minimum, but are not limited to, the following information:

1. Initial intake information form;

2. Case information from referral source;

3. Case and social history;

4. Emergency contact information;

5. Medical record, when available;

6. Individual plan or program, group and family counseling shall be documented;

7. Signed release of information forms;

8. Evaluation and progress reports;

9. Current employment data;

10. Program rules and disciplinary policy, signed by resident and agency staff Documentation that program rules and policies have been reviewed with the resident;

11. Grievance and disciplinary record;

12. Subsequent referrals to other agencies by the program; and

13. Termination summary.

B. Agency staff shall make entries into the case records and date and initial each entry.

C. Case records shall be marked "confidential" and maintained in locked file cabinets or rooms to minimize the possibility of theft, loss, destruction or unauthorized use.

D. Supervisory staff or a designee shall review case records monthly to ensure that the case is current and accurate.

E. The confidentiality of case records shall be maintained in accordance with federal and state laws. Written procedures shall govern access to case records and designate personnel responsible for release of resident information.

F. Written procedure shall govern the retention and destruction of case records in accordance with state law.

G. Agency staff shall provide a "Release of Information Consent Form" which at a minimum complies with applicable federal and state laws and includes:

1. Person, agency or organization requesting information;

2. Person, agency or organization releasing information;

3. Specific information to be disclosed;

4. Purpose or need for the information;

5. Expiration date;

6. Date consent form is signed;

7. Signature of the resident; and

8. Signature of individual witnessing resident's signature.

6VAC15-70-160. Medical care and health services.

A. Agency staff shall maintain first aid equipment approved by a recognized health authority for medical emergencies.

B. Written procedure shall ensure perpetual availability of first aid equipment and supplies.

C. Agency staff shall maintain a current inventory control list of first aid equipment and supplies.

D. One agency staff employee on each shift of the community residential program shall be trained in emergency first aid procedures, including cardiopulmonary resuscitation.

E. Routine medical services care and 24-hour emergency medical services shall be available to residents.

F. At the time of the offender's resident’s referral, a medical assessment shall be completed to determine if the resident has any special medical needs. Agency staff shall be made aware of offenders' residents’ special medical problems.

G. Written procedures shall provide for medical examination of any agency staff employee or resident suspected of having a communicable disease.

H. Written procedures shall address the management of serious and infectious diseases for residents and agency staff.

I. When a urine surveillance screening program is in effect, written procedures shall govern collection of samples and interpretation of results.

J. Written procedures shall govern the possession and control of prescribed medications and over-the-counter drugs medication.

Title of Regulation: 6VAC35-20. Regulations Governing the Monitoring, Approval, and Certification of Juvenile Justice Programs (amending 6VAC35-20-37).

Statutory Authority: §§16.1-233 and 66-10 of the Code of Virginia.

Effective Dates: August 1, 2007, through January 31, 2009.

The Department of Juvenile Justice requested an extension of the emergency regulations, 6VAC35-20, pursuant to § 2.2-4011 of the Code of Virginia to allow time for the permanent fast-track regulations to complete the executive review process and the requirements of the Administrative Process Act. The emergency regulations were published in 23:25 VA.R. 4180-4181 August 20, 2007 (http://legis.state.va.us/codecomm/register/vol23/iss25/ v23i25.pdf) with effective dates of August 1, 2007, through July 31, 2008.

The Governor approved the department's request to extend the expiration date of the emergency regulations for six months as provided in § 2.2-4011 D of the Code of Virginia. Therefore, the regulations will continue in effect through January 31, 2009.

Agency Contact: Deron Phipps, Regulatory Coordinator, Department of Juvenile Justice, Dept of Juvenile Justice, PO Box 1110, Richmond, VA 23218-1110, telephone (804) 746-6407, FAX (804) 371-0773, or email deron.phipps@djj.virginia.gov.

Title of Regulation: 6VAC35-140. Standards for Juvenile Residential Facilities (adding 6VAC35-140-46).

Statutory Authority: §§16.1-309.9, 66-10 and 66-25.1 of the Code of Virginia.

Public Hearing Information: No public hearings are scheduled.

Public Comments: Public comments may be submitted until November 12, 2008.

Effective Date: December 12, 2008.

Agency Contact: Janet P. VanCuyk, Legislative and Regulatory Coordinator, Department of Juvenile Justice, 700 E. Franklin Street, Richmond, VA 23218-1110, telephone (804) 371-4097, FAX (804) 371-0773, or email janet.vancuyk@djj.virginia.gov.

Basis: The Board of Juvenile Justice is entrusted with general authority to promulgate regulations by § 66-10 of the Code of Virginia, which states the board may "promulgate such regulations as may be necessary to carry out the provisions of this title and other laws of the Commonwealth administered by the Director or the Department." Additional statutory provisions address the board’s responsibility to promulgate regulations governing residential facilities. These are §§ 16.1-309.9, governing facilities receiving funding through the Virginia Juvenile Community Crime Control Act (Chapter 11, Article 12.1 of Title 16.1 of the Code of Virginia); 16.1-322.5, governing local or regional detention homes; and 66-24, governing community group homes and other residential facilities.

Purpose: Juvenile residential facilities regulated by the Board of Juvenile Justice currently must meet the requirements of the Standards for Interdepartmental Regulation of Children’s Residential Facilities (22VAC42-11) and the Standards for Juvenile Residential Facilities (6VAC35-140). 22VAC42-11-830 of the Standards for Interdepartmental Regulation of Children’s Residential Facilities (22VAC42-11) regulates the staff supervision of residents in all children’s residential facilities. This provision specifies that "The Board of Juvenile Justice shall determine the supervision ratios for facilities regulated by the Department of Juvenile Justice." No regulations or policies adopted by the Board of Juvenile Justice set the required staffing ratio for the nonsecure facilities it regulates.

Prior to December 27, 2007, when the Standards for Interdepartmental Regulation of Children’s Residential Facilities were amended, all nonsecure children’s residential facilities were subject to the same staffing ratio, which required each facility to have one staff person supervising every 10 residents during scheduled awake hours. As amended, the Standards for Interdepartmental Regulation of Children’s Residential Facilities (22VAC42-11), 6VAC42-11-830 provides that facilities regulated by the Departments of Education, Social Services, and Mental Health, Mental Retardation, and Substance Abuse Services must maintain a staffing ratio of one staff person for each eight residents. 22VAC42-11-830 specifically excludes facilities regulated by the Board of Juvenile Justice and provides that the Board of Juvenile Justice shall determine the applicable supervision ratios. This exclusion applies to both secure and nonsecure facilities regulated by the board.

6VAC35-140-545 sets the staffing pattern for secure facilities regulated by the Board of Juvenile Justice. No regulations or policies adopted by the Board of Juvenile Justice set the required staffing ratio for the nonsecure facilities it regulates. This regulation is essential to protect the health, safety, or welfare of both juveniles who reside in juvenile residential facilities and the staff who work there. Absent this regulation, an operator of a nonsecure residential facility regulated by the Board of Juvenile Justice may elect to set a higher staffing ratio that could potentially adversely affect the care of the residents and result in the residents’ needs being unmet. This proposed regulatory action would close that gap.

Rationale for Using Fast-Track Process: This regulation is being promulgated through the fast-track process because it is expected to be noncontroversial as the proposed section: (i) adopts the prior regulatory requirements (which were required of these facilities before the December 2007 amendments to the Standards for Interdepartmental Regulation of Children’s Residential Facilities); (ii) makes current practice a regulatory requirement (as the affected facilities have continued to operate under the prior regulatory requirement); (iii) corrects a gap in the current regulatory scheme; and (iv) results in continued uniform staffing patterns in these facilities throughout the Commonwealth.

Under the current regulatory scheme, there is a gap in which no staffing ratio has been set for nonsecure residential facilities regulated by the Board of Juvenile Justice. The proposed section would adopt the same language governing the staffing pattern for secure residential facilities regulated by the Board of Juvenile Justice and apply it to the nonsecure juvenile residential facilities regulated by the board.

This staffing ratio is also consistent with the ratio required by the Standards for Interdepartmental Regulation of Children’s Residential Facilities (22VAC42-11) prior to its amendment in December 2007. The proposed staffing ratio is different from the general rule currently governing residential programs regulated by the Departments of Education, Social Services, and Mental Health, Mental Retardation, and Substance Abuse Services. However, 22VAC42-11-830 of the Standards for the Interdepartmental Regulation of Children’s Residential Facilities allows each of these boards to, upon request of a provider, approve a ratio that allows a higher number of residents to be supervised by one staff if the requested staffing ratio will not adversely affect the care of the residents and if the residents’ needs will continue to be met on an individual as well as a group basis. The department asserts that the requested staffing ratio will not adversely affect the care of the residents and the residents’ needs will continue to be met on an individual as well as a group basis and thus expects this regulatory action to be noncontroversial.

Substance: This action will create a new section (6VAC35-140-46) in the Board of Juvenile Justice’s Standards for Juvenile Residential Facilities (6VAC35-140). The proposed section adopts the prior regulatory requirements (which were required of these facilities before the December 2007 amendments to the Standards for Interdepartmental Regulation of Children’s Residential Facilities), will make current practice a regulatory requirement, and will result in continued uniform application in these facilities throughout the Commonwealth.

This new section sets the staffing pattern for nonsecure facilities regulated by the board. The amendment sets the staffing ratio at one staff for 10 residents during scheduled awake hours (except independent living programs where it is set at one to 15) and one staff for every 16 residents during scheduled sleep hours. Additionally, when the residents are sleeping, at least one staff member must be in each building and on each floor where residents sleep (except independent living programs).

Issues: 22VAC42-11-830 of the Standards for Interdepartmental Regulation of Children’s Residential Facilities (22VAC42-11) provides that facilities regulated by the Departments of Education, Social Services, and Mental Health, Mental Retardation, and Substance Abuse Services must maintain a staffing ratio of one staff person for each eight residents. 22VAC42-11-830 specifically excludes facilities regulated by the Board of Juvenile Justice and provides the Board of Juvenile Justice shall determine the applicable supervision ratios. This exclusion applies to both secure and nonsecure facilities regulated by the board.

6VAC35-140-545 sets the staffing pattern for secure facilities regulated by the Board of Juvenile Justice. No regulations or policies adopted by the Board of Juvenile Justice set the required staffing ratio for nonsecure facilities it regulates. Thus, the proposed regulation is essential to protect the health, safety, or welfare of both juveniles who reside in juvenile residential facilities and the staff who work there. Absent this regulation, an operator of a nonsecure residential facility regulated by the Board of Juvenile Justice may elect to set a higher staffing ratio that could potentially adversely affect the care of the residents and result in the residents’ needs being unmet. This proposed regulatory action could close that gap.

Thus, the proposed provision is advantageous to the public because it provides additional protections for the health, safety, and welfare of the residents in juvenile residential facilities regulated by the Board of Juvenile Justice.

There are no known disadvantages to this regulation.

The Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The Board of Juvenile Justice proposes to adopt staffing ratios for non-secure juvenile residential facilities.

Result of Analysis. The benefits likely exceed the costs for this proposed action.

Estimated Economic Impact. Prior to December, 2007, the Standards for Interdepartmental Regulation of Children’s Residential facilities set staffing ratios for non-secure juvenile residential facilities. Under Interdepartmental Regulations, most of these facilities maintained a staff to child ratio of at least one staff member for every ten children during hours when the children were awake. During sleeping hours, the general staff to child ratio had to be, at most, one to sixteen. Of the staff required during sleeping hours: 1) at least one staff member had to be on duty in each building where children were sleeping and 2) there had to be at least one staff member on duty on floors where children were sleeping for every thirty children on that floor.

Under pre-December 2007 Interdepartmental Regulations, independent living programs had different staffing ratio requirements. During waking hours independent living programs had to have at least one staff member on duty for every fifteen teenagers/young adults. There were no staffing requirements for independent living programs during traditional sleeping hours.

In December 2007 new Interdepartmental Regulations were promulgated that allowed the Board of Juvenile Justice to determine staffing ratios for its own facilities. The Board of Juvenile Justice now proposes to adopt staffing ratios that were set by pre-December 2007 Interdepartmental Regulations. These staffing ratios represent current practice so there will likely be no costs that will be accrued on account of these proposed standards. To the extent that any interested parties may have been unsure as to what staffing standards are, promulgating these standards will provide the benefit of clarity.

Businesses and Entities Affected. The Department of Juvenile Justice reports that this regulatory action will affect 29 non-secure juvenile residential facilities. Some of these facilities are private, for-profit operations and would, therefore, qualify as small businesses.

Localities Particularly Affected. No locality will be particularly affected by this proposed regulatory action.

Projected Impact on Employment. This regulatory action will likely have no impact on employment in the Commonwealth.

Effects on the Use and Value of Private Property. This regulatory action will likely have no effect on the use or value of private property in the Commonwealth.

Small Businesses: Costs and Other Effects. Small businesses in the Commonwealth are unlikely to incur any costs on account of this regulatory action.

Small Businesses: Alternative Method that Minimizes Adverse Impact. Small businesses in the Commonwealth are unlikely to incur any costs on account of this regulatory action.

Real Estate Development Costs. This regulatory action will likely have no effect on real estate development costs in the Commonwealth.

Legal Mandate. The Department of Planning and Budget (DPB) has analyzed the economic impact of this proposed regulation in accordance with § 2.2-4007.04 of the Administrative Process Act and Executive Order Number 36 (06). Section 2.2-4007.04 requires that such economic impact analyses include, but need not be limited to, the projected number of businesses or other entities to whom the regulation would apply, the identity of any localities and types of businesses or other entities particularly affected, the projected number of persons and employment positions to be affected, the projected costs to affected businesses or entities to implement or comply with the regulation, and the impact on the use and value of private property. Further, if the proposed regulation has adverse effect on small businesses, § 2.2-4007.04 requires that such economic impact analyses include (i) an identification and estimate of the number of small businesses subject to the regulation; (ii) the projected reporting, recordkeeping, and other administrative costs required for small businesses to comply with the regulation, including the type of professional skills necessary for preparing required reports and other documents; (iii) a statement of the probable effect of the regulation on affected small businesses; and (iv) a description of any less intrusive or less costly alternative methods of achieving the purpose of the regulation. The analysis presented above represents DPB’s best estimate of these economic impacts.

Agency's Response to the Department of Planning and Budget's Economic Impact Analysis: The Department of Juvenile Justice concurs with the economic impact analysis as submitted by the Department of Planning and Budget.

Summary:

The amendment adds a new section that sets the staffing pattern for nonsecure facilities regulated by the board. The amendment sets the staffing ratio at one staff for every 10 residents during scheduled awake hours (except independent living programs where it is set at one for every 15) and one staff for every 16 residents during scheduled sleep hours. Additionally, when the residents are sleeping, at least one staff member must be in each building and at least one staff member for every 30 residents must be on each floor where residents sleep (except independent living programs).

6VAC35-140-46. Staffing pattern.

A. During the hours that residents are scheduled to be awake, there shall be at least one child care staff member awake, on duty, and responsible for supervision of every 10 residents, or portion thereof, on the premises or participating in off-campus, facility-sponsored activities except that independent living programs shall have at least one child care staff member awake, on duty, and responsible for supervision of every 15 children on the premises or participating in off-campus, facility-sponsored activities.

B. During the hours that residents are scheduled to sleep there shall be no less than one child care staff member on duty and responsible for supervision of every 16 residents, or portion thereof, on the premises.

C. There shall be at least one child care staff member on duty and responsible for the supervision of residents in each building where residents are sleeping. This requirement does not apply to approved independent living programs.

D. On each floor where children are sleeping, there shall be at least one child care staff member awake and on duty for every 30 children or portion thereof.

Titles of Regulations: 8VAC40-10. Public Participation Guidelines (repealing 8VAC40-10-10 through 8VAC40-10-90).

8VAC40-11. Public Participation Guidelines (adding 8VAC40-11-10 through 8VAC40-11-110).

Statutory Authority: §§2.2-4007.02 and 23-9.6:1 of the Code of Virginia.

Effective Date: January 1, 2009.

Agency Contact: Linda H. Woodley, Regulatory Coordinator, State Council of Higher Education for Virginia, James Monroe Bldg., 101 North 14th St., 9th Floor, Richmond, VA 23219, telephone (804) 371-2938, FAX (804) 786-2027, or email lindawoodley@schev.edu.

Summary:

The regulations comply with the legislative mandate (Chapter 321, 2008 Acts of Assembly) that agencies adopt model public participation guidelines issued by the Department of Planning and Budget by December 1, 2008. Public participation guidelines exist to promote public involvement in the development, amendment, or repeal of an agency's regulations.

This regulatory action repeals the current public participation guidelines and promulgates new public participation guidelines as required by Chapter 321 of the 2008 Acts of Assembly. Highlights of the public participation guidelines include (i) providing for the establishment and maintenance of notification lists of interested persons and specifying the information to be sent to such persons; (ii) providing for public comments on regulatory action; (iii) establishing the time period during which public comments shall be accepted; (iv) providing that the plan to hold a public meeting shall be indicated in any notice of intended regulatory action; (v) providing for the appointment, when necessary, of regulatory advisory panels to provide professional specialization or technical assistance and negotiated rulemaking panels if a regulatory action is expected to be controversial; and (vi) providing for the periodic review of regulations.

CHAPTER 11
PUBLIC PARTICIPATION GUIDELINES

Part I
Purpose and Definitions

8VAC40-11-10. Purpose.

The purpose of this chapter is to promote public involvement in the development, amendment or repeal of the regulations of the State Council of Higher Education for Virginia. This chapter does not apply to regulations, guidelines, or other documents exempted or excluded from the provisions of the Administrative Process Act (§2.2-4000 et seq. of the Code of Virginia).

8VAC40-11-20. Definitions.

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Administrative Process Act" means Chapter 40 (§2.2-4000 et seq.) of Title 2.2 of the Code of Virginia.

"Agency" means the State Council of Higher Education for Virginia, which is the unit of state government empowered by the agency's basic law to make regulations or decide cases. Actions specified in this chapter may be fulfilled by state employees as delegated by the agency.

"Basic law" means provisions in the Code of Virginia that delineate the basic authority and responsibilities of an agency.

"Commonwealth Calendar" means the electronic calendar for official government meetings open to the public as required by § 2.2-3707 C of the Freedom of Information Act.

''Negotiated rulemaking panel'' or ''NRP'' means an ad hoc advisory panel of interested parties established by an agency to consider issues that are controversial with the assistance of a facilitator or mediator, for the purpose of reaching a consensus in the development of a proposed regulatory action.

"Notification list" means a list used to notify persons pursuant to this chapter. Such a list may include an electronic list maintained through the Virginia Regulatory Town Hall or other list maintained by the agency.

"Open meeting" means any scheduled gathering of a unit of state government empowered by an agency's basic law to make regulations or decide cases, which is related to promulgating, amending or repealing a regulation.

"Person" means any individual, corporation, partnership, association, cooperative, limited liability company, trust, joint venture, government, political subdivision, or any other legal or commercial entity and any successor, representative, agent, agency, or instrumentality thereof.

"Public hearing" means a scheduled time at which members or staff of the agency will meet for the purpose of receiving public comment on a regulatory action.

"Regulation" means any statement of general application having the force of law, affecting the rights or conduct of any person, adopted by the agency in accordance with the authority conferred on it by applicable laws.

"Regulatory action" means the promulgation, amendment, or repeal of a regulation by the agency.

"Regulatory advisory panel" or "RAP" means a standing or ad hoc advisory panel of interested parties established by the agency for the purpose of assisting in regulatory actions.

"Town Hall" means the Virginia Regulatory Town Hall, the website operated by the Virginia Department of Planning and Budget at www.townhall.virginia.gov, which has online public comment forums and displays information about regulatory meetings and regulatory actions under consideration in Virginia and sends this information to registered public users.

"Virginia Register" means the Virginia Register of Regulations, the publication that provides official legal notice of new, amended and repealed regulations of state agencies, which is published under the provisions of Article 6 (§2.2-4031 et seq.) of the Administrative Process Act.

Part II
Notification of Interested Persons

8VAC40-11-30. Notification list.

A. The agency shall maintain a list of persons who have requested to be notified of regulatory actions being pursued by the agency.

B. Any person may request to be placed on a notification list by registering as a public user on the Town Hall or by making a request to the agency. Any person who requests to be placed on a notification list shall elect to be notified either by electronic means or through a postal carrier.

C. The agency may maintain additional lists for persons who have requested to be informed of specific regulatory issues, proposals, or actions.

D. When electronic mail is returned as undeliverable on multiple occasions at least 24 hours apart, that person may be deleted from the list. A single undeliverable message is insufficient cause to delete the person from the list.

E. When mail delivered by a postal carrier is returned as undeliverable on multiple occasions, that person may be deleted from the list.

F. The agency may periodically request those persons on the notification list to indicate their desire to either continue to be notified electronically, receive documents through a postal carrier, or be deleted from the list.

8VAC40-11-40. Information to be sent to persons on the notification list.

A. To persons electing to receive electronic notification or notification through a postal carrier as described in 8VAC40-11-30, the agency shall send the following information:

1. A notice of intended regulatory action (NOIRA).

2. A notice of the comment period on a proposed, a reproposed, or a fast-track regulation and hyperlinks to, or instructions on how to obtain, a copy of the regulation and any supporting documents.

3. A notice soliciting comment on a final regulation when the regulatory process has been extended pursuant to § 2.2-4007.06 or 2.2-4013 C of the Code of Virginia.

B. The failure of any person to receive any notice or copies of any documents shall not affect the validity of any regulation or regulatory action.

Part III
Public Participation Procedures

8VAC40-11-50. Public comment.

A. In considering any nonemergency, nonexempt regulatory action, the agency shall afford interested persons an opportunity to submit data, views, and arguments, either orally or in writing, to the agency. Such opportunity to comment shall include an online public comment forum on the Town Hall.

1. To any requesting person, the agency shall provide copies of the statement of basis, purpose, substance, and issues; the economic impact analysis of the proposed or fast-track regulatory action; and the agency's response to public comments received.

2. The agency may begin crafting a regulatory action prior to or during any opportunities it provides to the public to submit comments.

B. The agency shall accept public comments in writing after the publication of a regulatory action in the Virginia Register as follows:

1. For a minimum of 30 calendar days following the publication of the notice of intended regulatory action (NOIRA).

2. For a minimum of 60 calendar days following the publication of a proposed regulation.

3. For a minimum of 30 calendar days following the publication of a reproposed regulation.

4. For a minimum of 30 calendar days following the publication of a final adopted regulation.

5. For a minimum of 30 calendar days following the publication of a fast-track regulation.

6. For a minimum of 21 calendar days following the publication of a notice of periodic review.

7. Not later than 21 calendar days following the publication of a petition for rulemaking.

C. The agency may determine if any of the comment periods listed in subsection B of this section shall be extended.

D. If the Governor finds that one or more changes with substantial impact have been made to a proposed regulation, he may require the agency to provide an additional 30 calendar days to solicit additional public comment on the changes in accordance with § 2.2-4013 C of the Code of Virginia.

E. The agency shall send a draft of the agency's summary description of public comment to all public commenters on the proposed regulation at least five days before final adoption of the regulation pursuant to § 2.2-4012 E of the Code of Virginia.

8VAC40-11-60. Petition for rulemaking.

A. As provided in § 2.2-4007 of the Code of Virginia, any person may petition the agency to consider a regulatory action.

B. A petition shall include but is not limited to the following information:

1. The petitioner's name and contact information;

2. The substance and purpose of the rulemaking that is requested, including reference to any applicable Virginia Administrative Code sections; and

3. Reference to the legal authority of the agency to take the action requested.

C. The agency shall receive, consider and respond to a petition pursuant to § 2.2-4007 and shall have the sole authority to dispose of the petition.

D. The petition shall be posted on the Town Hall and published in the Virginia Register.

E. Nothing in this chapter shall prohibit the agency from receiving information or from proceeding on its own motion for rulemaking.

8VAC40-11-70. Appointment of regulatory advisory panel.

A. The agency may appoint a regulatory advisory panel (RAP) to provide professional specialization or technical assistance when the agency determines that such expertise is necessary to address a specific regulatory issue or action or when individuals indicate an interest in working with the agency on a specific regulatory issue or action.

B. Any person may request the appointment of a RAP and request to participate in its activities. The agency shall determine when a RAP shall be appointed and the composition of the RAP.

C. A RAP may be dissolved by the agency if:

1. The proposed text of the regulation is posted on the Town Hall, published in the Virginia Register, or such other time as the agency determines is appropriate; or

2. The agency determines that the regulatory action is either exempt or excluded from the requirements of the Administrative Process Act.

8VAC40-11-80. Appointment of negotiated rulemaking panel.

A. The agency may appoint a negotiated rulemaking panel (NRP) if a regulatory action is expected to be controversial.

B. An NRP that has been appointed by the agency may be dissolved by the agency when:

1. There is no longer controversy associated with the development of the regulation;

2. The agency determines that the regulatory action is either exempt or excluded from the requirements of the Administrative Process Act; or

3. The agency determines that resolution of a controversy is unlikely.

8VAC40-11-90. Meetings.

Notice of any open meeting, including meetings of a RAP or NRP, shall be posted on the Virginia Regulatory Town Hall and Commonwealth Calendar at least seven working days prior to the date of the meeting. The exception to this requirement is any meeting held in accordance with § 2.2-3707 D of the Code of Virginia allowing for contemporaneous notice to be provided to participants and the public.

8VAC40-11-100. Public hearings on regulations.

A. The agency shall indicate in its notice of intended regulatory action whether it plans to hold a public hearing following the publication of the proposed stage of the regulatory action.

B. The agency may conduct one or more public hearings during the comment period following the publication of a proposed regulatory action.

C. An agency is required to hold a public hearing following the publication of the proposed regulatory action when:

1. The agency's basic law requires the agency to hold a public hearing;

2. The Governor directs the agency to hold a public hearing; or

3. The agency receives requests for a public hearing from at least 25 persons during the public comment period following the publication of the notice of intended regulatory action.

D. Notice of any public hearing shall be posted on the Town Hall and Commonwealth Calendar at least seven working days prior to the date of the hearing. The agency shall also notify those persons who requested a hearing under subdivision C 3 of this section.

8VAC40-11-110. Periodic review of regulations.

A. The agency shall conduct a periodic review of its regulations consistent with:

1. An executive order issued by the Governor pursuant to § 2.2-4017 of the Administrative Process Act to receive comment on all existing regulations as to their effectiveness, efficiency, necessity, clarity, and cost of compliance; and

2. The requirements in § 2.2-4007.1 of the Administrative Process Act regarding regulatory flexibility for small businesses.

B. A periodic review may be conducted separately or in conjunction with other regulatory actions.

C. Notice of a periodic review shall be posted on the Town Hall and published in the Virginia Register.

Titles of Regulations: 8VAC40-10. Public Participation Guidelines (repealing 8VAC40-10-10 through 8VAC40-10-90).

8VAC40-11. Public Participation Guidelines (adding 8VAC40-11-10 through 8VAC40-11-110).

Statutory Authority: §§2.2-4007.02 and 23-9.6:1 of the Code of Virginia.

Effective Date: January 1, 2009.

Agency Contact: Linda H. Woodley, Regulatory Coordinator, State Council of Higher Education for Virginia, James Monroe Bldg., 101 North 14th St., 9th Floor, Richmond, VA 23219, telephone (804) 371-2938, FAX (804) 786-2027, or email lindawoodley@schev.edu.

Summary:

The regulations comply with the legislative mandate (Chapter 321, 2008 Acts of Assembly) that agencies adopt model public participation guidelines issued by the Department of Planning and Budget by December 1, 2008. Public participation guidelines exist to promote public involvement in the development, amendment, or repeal of an agency's regulations.

This regulatory action repeals the current public participation guidelines and promulgates new public participation guidelines as required by Chapter 321 of the 2008 Acts of Assembly. Highlights of the public participation guidelines include (i) providing for the establishment and maintenance of notification lists of interested persons and specifying the information to be sent to such persons; (ii) providing for public comments on regulatory action; (iii) establishing the time period during which public comments shall be accepted; (iv) providing that the plan to hold a public meeting shall be indicated in any notice of intended regulatory action; (v) providing for the appointment, when necessary, of regulatory advisory panels to provide professional specialization or technical assistance and negotiated rulemaking panels if a regulatory action is expected to be controversial; and (vi) providing for the periodic review of regulations.

CHAPTER 11
PUBLIC PARTICIPATION GUIDELINES

Part I
Purpose and Definitions

8VAC40-11-10. Purpose.

The purpose of this chapter is to promote public involvement in the development, amendment or repeal of the regulations of the State Council of Higher Education for Virginia. This chapter does not apply to regulations, guidelines, or other documents exempted or excluded from the provisions of the Administrative Process Act (§2.2-4000 et seq. of the Code of Virginia).

8VAC40-11-20. Definitions.

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Administrative Process Act" means Chapter 40 (§2.2-4000 et seq.) of Title 2.2 of the Code of Virginia.

"Agency" means the State Council of Higher Education for Virginia, which is the unit of state government empowered by the agency's basic law to make regulations or decide cases. Actions specified in this chapter may be fulfilled by state employees as delegated by the agency.

"Basic law" means provisions in the Code of Virginia that delineate the basic authority and responsibilities of an agency.

"Commonwealth Calendar" means the electronic calendar for official government meetings open to the public as required by § 2.2-3707 C of the Freedom of Information Act.

''Negotiated rulemaking panel'' or ''NRP'' means an ad hoc advisory panel of interested parties established by an agency to consider issues that are controversial with the assistance of a facilitator or mediator, for the purpose of reaching a consensus in the development of a proposed regulatory action.

"Notification list" means a list used to notify persons pursuant to this chapter. Such a list may include an electronic list maintained through the Virginia Regulatory Town Hall or other list maintained by the agency.

"Open meeting" means any scheduled gathering of a unit of state government empowered by an agency's basic law to make regulations or decide cases, which is related to promulgating, amending or repealing a regulation.

"Person" means any individual, corporation, partnership, association, cooperative, limited liability company, trust, joint venture, government, political subdivision, or any other legal or commercial entity and any successor, representative, agent, agency, or instrumentality thereof.

"Public hearing" means a scheduled time at which members or staff of the agency will meet for the purpose of receiving public comment on a regulatory action.

"Regulation" means any statement of general application having the force of law, affecting the rights or conduct of any person, adopted by the agency in accordance with the authority conferred on it by applicable laws.

"Regulatory action" means the promulgation, amendment, or repeal of a regulation by the agency.

"Regulatory advisory panel" or "RAP" means a standing or ad hoc advisory panel of interested parties established by the agency for the purpose of assisting in regulatory actions.

"Town Hall" means the Virginia Regulatory Town Hall, the website operated by the Virginia Department of Planning and Budget at www.townhall.virginia.gov, which has online public comment forums and displays information about regulatory meetings and regulatory actions under consideration in Virginia and sends this information to registered public users.

"Virginia Register" means the Virginia Register of Regulations, the publication that provides official legal notice of new, amended and repealed regulations of state agencies, which is published under the provisions of Article 6 (§2.2-4031 et seq.) of the Administrative Process Act.

Part II
Notification of Interested Persons

8VAC40-11-30. Notification list.

A. The agency shall maintain a list of persons who have requested to be notified of regulatory actions being pursued by the agency.

B. Any person may request to be placed on a notification list by registering as a public user on the Town Hall or by making a request to the agency. Any person who requests to be placed on a notification list shall elect to be notified either by electronic means or through a postal carrier.

C. The agency may maintain additional lists for persons who have requested to be informed of specific regulatory issues, proposals, or actions.

D. When electronic mail is returned as undeliverable on multiple occasions at least 24 hours apart, that person may be deleted from the list. A single undeliverable message is insufficient cause to delete the person from the list.

E. When mail delivered by a postal carrier is returned as undeliverable on multiple occasions, that person may be deleted from the list.

F. The agency may periodically request those persons on the notification list to indicate their desire to either continue to be notified electronically, receive documents through a postal carrier, or be deleted from the list.

8VAC40-11-40. Information to be sent to persons on the notification list.

A. To persons electing to receive electronic notification or notification through a postal carrier as described in 8VAC40-11-30, the agency shall send the following information:

1. A notice of intended regulatory action (NOIRA).

2. A notice of the comment period on a proposed, a reproposed, or a fast-track regulation and hyperlinks to, or instructions on how to obtain, a copy of the regulation and any supporting documents.

3. A notice soliciting comment on a final regulation when the regulatory process has been extended pursuant to § 2.2-4007.06 or 2.2-4013 C of the Code of Virginia.

B. The failure of any person to receive any notice or copies of any documents shall not affect the validity of any regulation or regulatory action.

Part III
Public Participation Procedures

8VAC40-11-50. Public comment.

A. In considering any nonemergency, nonexempt regulatory action, the agency shall afford interested persons an opportunity to submit data, views, and arguments, either orally or in writing, to the agency. Such opportunity to comment shall include an online public comment forum on the Town Hall.

1. To any requesting person, the agency shall provide copies of the statement of basis, purpose, substance, and issues; the economic impact analysis of the proposed or fast-track regulatory action; and the agency's response to public comments received.

2. The agency may begin crafting a regulatory action prior to or during any opportunities it provides to the public to submit comments.

B. The agency shall accept public comments in writing after the publication of a regulatory action in the Virginia Register as follows:

1. For a minimum of 30 calendar days following the publication of the notice of intended regulatory action (NOIRA).

2. For a minimum of 60 calendar days following the publication of a proposed regulation.

3. For a minimum of 30 calendar days following the publication of a reproposed regulation.

4. For a minimum of 30 calendar days following the publication of a final adopted regulation.

5. For a minimum of 30 calendar days following the publication of a fast-track regulation.

6. For a minimum of 21 calendar days following the publication of a notice of periodic review.

7. Not later than 21 calendar days following the publication of a petition for rulemaking.

C. The agency may determine if any of the comment periods listed in subsection B of this section shall be extended.

D. If the Governor finds that one or more changes with substantial impact have been made to a proposed regulation, he may require the agency to provide an additional 30 calendar days to solicit additional public comment on the changes in accordance with § 2.2-4013 C of the Code of Virginia.

E. The agency shall send a draft of the agency's summary description of public comment to all public commenters on the proposed regulation at least five days before final adoption of the regulation pursuant to § 2.2-4012 E of the Code of Virginia.

8VAC40-11-60. Petition for rulemaking.

A. As provided in § 2.2-4007 of the Code of Virginia, any person may petition the agency to consider a regulatory action.

B. A petition shall include but is not limited to the following information:

1. The petitioner's name and contact information;

2. The substance and purpose of the rulemaking that is requested, including reference to any applicable Virginia Administrative Code sections; and

3. Reference to the legal authority of the agency to take the action requested.

C. The agency shall receive, consider and respond to a petition pursuant to § 2.2-4007 and shall have the sole authority to dispose of the petition.

D. The petition shall be posted on the Town Hall and published in the Virginia Register.

E. Nothing in this chapter shall prohibit the agency from receiving information or from proceeding on its own motion for rulemaking.

8VAC40-11-70. Appointment of regulatory advisory panel.

A. The agency may appoint a regulatory advisory panel (RAP) to provide professional specialization or technical assistance when the agency determines that such expertise is necessary to address a specific regulatory issue or action or when individuals indicate an interest in working with the agency on a specific regulatory issue or action.

B. Any person may request the appointment of a RAP and request to participate in its activities. The agency shall determine when a RAP shall be appointed and the composition of the RAP.

C. A RAP may be dissolved by the agency if:

1. The proposed text of the regulation is posted on the Town Hall, published in the Virginia Register, or such other time as the agency determines is appropriate; or

2. The agency determines that the regulatory action is either exempt or excluded from the requirements of the Administrative Process Act.

8VAC40-11-80. Appointment of negotiated rulemaking panel.

A. The agency may appoint a negotiated rulemaking panel (NRP) if a regulatory action is expected to be controversial.

B. An NRP that has been appointed by the agency may be dissolved by the agency when:

1. There is no longer controversy associated with the development of the regulation;

2. The agency determines that the regulatory action is either exempt or excluded from the requirements of the Administrative Process Act; or

3. The agency determines that resolution of a controversy is unlikely.

8VAC40-11-90. Meetings.

Notice of any open meeting, including meetings of a RAP or NRP, shall be posted on the Virginia Regulatory Town Hall and Commonwealth Calendar at least seven working days prior to the date of the meeting. The exception to this requirement is any meeting held in accordance with § 2.2-3707 D of the Code of Virginia allowing for contemporaneous notice to be provided to participants and the public.

8VAC40-11-100. Public hearings on regulations.

A. The agency shall indicate in its notice of intended regulatory action whether it plans to hold a public hearing following the publication of the proposed stage of the regulatory action.

B. The agency may conduct one or more public hearings during the comment period following the publication of a proposed regulatory action.

C. An agency is required to hold a public hearing following the publication of the proposed regulatory action when:

1. The agency's basic law requires the agency to hold a public hearing;

2. The Governor directs the agency to hold a public hearing; or

3. The agency receives requests for a public hearing from at least 25 persons during the public comment period following the publication of the notice of intended regulatory action.

D. Notice of any public hearing shall be posted on the Town Hall and Commonwealth Calendar at least seven working days prior to the date of the hearing. The agency shall also notify those persons who requested a hearing under subdivision C 3 of this section.

8VAC40-11-110. Periodic review of regulations.

A. The agency shall conduct a periodic review of its regulations consistent with:

1. An executive order issued by the Governor pursuant to § 2.2-4017 of the Administrative Process Act to receive comment on all existing regulations as to their effectiveness, efficiency, necessity, clarity, and cost of compliance; and

2. The requirements in § 2.2-4007.1 of the Administrative Process Act regarding regulatory flexibility for small businesses.

B. A periodic review may be conducted separately or in conjunction with other regulatory actions.

C. Notice of a periodic review shall be posted on the Town Hall and published in the Virginia Register.

Titles of Regulations: 12VAC30-5. Public Participation Guidelines (adding 12VAC30-5-10 through 12VAC30-5-110).

12VAC30-100. State Programs (repealing 12VAC30-100-10 through 12VAC30-100-60).

Statutory Authority: §§2.2-4007.02 et seq. and 32.1-324 of the Code of Virginia.

Effective Date: November 12, 2008.

Agency Contact: Brian McCormick, Regulatory Supervisor, Department of Medical Assistance Services, 600 E. Broad St., Suite 1300, Richmond, VA 23219, telephone (804) 371-8856, FAX (804) 786-1680, TTY (800) 343-0634, or email brian.mccormick@dmas.virginia.gov.

Summary:

The regulations comply with the legislative mandate (Chapter 321, 2008 Acts of Assembly) that agencies adopt model public participation guidelines issued by the Department of Planning and Budget by December 1, 2008. Public participation guidelines exist to promote public involvement in the development, amendment, or repeal of an agency's regulations.

This regulatory action repeals the current public participation guidelines and promulgates new public participation guidelines as required by Chapter 321 of the 2008 Acts of Assembly. Highlights of the public participation guidelines include (i) providing for the establishment and maintenance of notification lists of interested persons and specifying the information to be sent to such persons; (ii) providing for public comments on regulatory action; (iii) establishing the time period during which public comments shall be accepted; (iv) providing that the plan to hold a public meeting shall be indicated in any notice of intended regulatory action; (v) providing for the appointment, when necessary, of regulatory advisory panels to provide professional specialization or technical assistance and negotiated rulemaking panels if a regulatory action is expected to be controversial; and (vi) providing for the periodic review of regulations.

CHAPTER 5
PUBLIC PARTICIPATION GUIDELINES

Part I
Purpose and Definitions

12VAC30-5-10. Purpose.

The purpose of this chapter is to promote public involvement in the development, amendment or repeal of the regulations of the Department of Medical Assistance Services. This chapter does not apply to regulations, guidelines, or other documents exempted or excluded from the provisions of the Administrative Process Act (§2.2-4000 et seq. of the Code of Virginia).

12VAC30-5-20. Definitions.

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Administrative Process Act" means Chapter 40 (§2.2-4000 et seq.) of Title 2.2 of the Code of Virginia.

"Agency" means the Department of Medical Assistance Services, which is the unit of state government empowered by the agency's basic law to make regulations or decide cases. Actions specified in this chapter may be fulfilled by state employees as delegated by the agency.

"Basic law" means provisions in the Code of Virginia that delineate the basic authority and responsibilities of an agency.

"Commonwealth Calendar" means the electronic calendar for official government meetings open to the public as required by § 2.2-3707 C of the Freedom of Information Act.

''Negotiated rulemaking panel'' or ''NRP'' means an ad hoc advisory panel of interested parties established by an agency to consider issues that are controversial with the assistance of a facilitator or mediator, for the purpose of reaching a consensus in the development of a proposed regulatory action.

"Notification list" means a list used to notify persons pursuant to this chapter. Such a list may include an electronic list maintained through the Virginia Regulatory Town Hall or other list maintained by the agency.

"Open meeting" means any scheduled gathering of a unit of state government empowered by an agency's basic law to make regulations or decide cases, which is related to promulgating, amending or repealing a regulation.

"Person" means any individual, corporation, partnership, association, cooperative, limited liability company, trust, joint venture, government, political subdivision, or any other legal or commercial entity and any successor, representative, agent, agency, or instrumentality thereof.

"Public hearing" means a scheduled time at which members or staff of the agency will meet for the purpose of receiving public comment on a regulatory action.

"Regulation" means any statement of general application having the force of law, affecting the rights or conduct of any person, adopted by the agency in accordance with the authority conferred on it by applicable laws.

"Regulatory action" means the promulgation, amendment, or repeal of a regulation by the agency.

"Regulatory advisory panel" or "RAP" means a standing or ad hoc advisory panel of interested parties established by the agency for the purpose of assisting in regulatory actions.

"Town Hall" means the Virginia Regulatory Town Hall, the website operated by the Virginia Department of Planning and Budget at www.townhall.virginia.gov, which has online public comment forums and displays information about regulatory meetings and regulatory actions under consideration in Virginia and sends this information to registered public users.

"Virginia Register" means the Virginia Register of Regulations, the publication that provides official legal notice of new, amended and repealed regulations of state agencies, which is published under the provisions of Article 6 (§2.2-4031 et seq.) of the Administrative Process Act.

Part II
Notification of Interested Persons

12VAC30-5-30. Notification list.

A. The agency shall maintain a list of persons who have requested to be notified of regulatory actions being pursued by the agency.

B. Any person may request to be placed on a notification list by registering as a public user on the Town Hall or by making a request to the agency. Any person who requests to be placed on a notification list shall elect to be notified either by electronic means or through a postal carrier.

C. The agency may maintain additional lists for persons who have requested to be informed of specific regulatory issues, proposals, or actions.

D. When electronic mail is returned as undeliverable on multiple occasions at least 24 hours apart, that person may be deleted from the list. A single undeliverable message is insufficient cause to delete the person from the list.

E. When mail delivered by a postal carrier is returned as undeliverable on multiple occasions, that person may be deleted from the list.

F. The agency may periodically request those persons on the notification list to indicate their desire to either continue to be notified electronically, receive documents through a postal carrier, or be deleted from the list.

12VAC30-5-40. Information to be sent to persons on the notification list.

A. To persons electing to receive electronic notification or notification through a postal carrier as described in 12VAC30-5-30, the agency shall send the following information:

1. A notice of intended regulatory action (NOIRA).

2. A notice of the comment period on a proposed, a reproposed, or a fast-track regulation and hyperlinks to, or instructions on how to obtain, a copy of the regulation and any supporting documents.

3. A notice soliciting comment on a final regulation when the regulatory process has been extended pursuant to § 2.2-4007.06 or 2.2-4013 C of the Code of Virginia.

B. The failure of any person to receive any notice or copies of any documents shall not affect the validity of any regulation or regulatory action.

Part III
Public Participation Procedures

12VAC30-5-50. Public comment.

A. In considering any nonemergency, nonexempt regulatory action, the agency shall afford interested persons an opportunity to submit data, views, and arguments, either orally or in writing, to the agency. Such opportunity to comment shall include an online public comment forum on the Town Hall.

1. To any requesting person, the agency shall provide copies of the statement of basis, purpose, substance, and issues; the economic impact analysis of the proposed or fast-track regulatory action; and the agency's response to public comments received.

2. The agency may begin crafting a regulatory action prior to or during any opportunities it provides to the public to submit comments.

B. The agency shall accept public comments in writing after the publication of a regulatory action in the Virginia Register as follows:

1. For a minimum of 30 calendar days following the publication of the notice of intended regulatory action (NOIRA).

2. For a minimum of 60 calendar days following the publication of a proposed regulation.

3. For a minimum of 30 calendar days following the publication of a reproposed regulation.

4. For a minimum of 30 calendar days following the publication of a final adopted regulation.

5. For a minimum of 30 calendar days following the publication of a fast-track regulation.

6. For a minimum of 21 calendar days following the publication of a notice of periodic review.

7. Not later than 21 calendar days following the publication of a petition for rulemaking.

C. The agency may determine if any of the comment periods listed in subsection B of this section shall be extended.

D. If the Governor finds that one or more changes with substantial impact have been made to a proposed regulation, he may require the agency to provide an additional 30 calendar days to solicit additional public comment on the changes in accordance with § 2.2-4013 C of the Code of Virginia.

E. The agency shall send a draft of the agency's summary description of public comment to all public commenters on the proposed regulation at least five days before final adoption of the regulation pursuant to § 2.2-4012 E of the Code of Virginia.

12VAC30-5-60. Petition for rulemaking.

A. As provided in § 2.2-4007 of the Code of Virginia, any person may petition the agency to consider a regulatory action.

B. A petition shall include but is not limited to the following information:

1. The petitioner's name and contact information;

2. The substance and purpose of the rulemaking that is requested, including reference to any applicable Virginia Administrative Code sections; and

3. Reference to the legal authority of the agency to take the action requested.

C. The agency shall receive, consider and respond to a petition pursuant to § 2.2-4007 and shall have the sole authority to dispose of the petition.

D. The petition shall be posted on the Town Hall and published in the Virginia Register.

E. Nothing in this chapter shall prohibit the agency from receiving information or from proceeding on its own motion for rulemaking.

12VAC30-5-70. Appointment of regulatory advisory panel.

A. The agency may appoint a regulatory advisory panel (RAP) to provide professional specialization or technical assistance when the agency determines that such expertise is necessary to address a specific regulatory issue or action or when individuals indicate an interest in working with the agency on a specific regulatory issue or action.

B. Any person may request the appointment of a RAP and request to participate in its activities. The agency shall determine when a RAP shall be appointed and the composition of the RAP.

C. A RAP may be dissolved by the agency if:

1. The proposed text of the regulation is posted on the Town Hall, published in the Virginia Register, or such other time as the agency determines is appropriate; or

2. The agency determines that the regulatory action is either exempt or excluded from the requirements of the Administrative Process Act.

12VAC30-5-80. Appointment of negotiated rulemaking panel.

A. The agency may appoint a negotiated rulemaking panel (NRP) if a regulatory action is expected to be controversial.

B. An NRP that has been appointed by the agency may be dissolved by the agency when:

1. There is no longer controversy associated with the development of the regulation;

2. The agency determines that the regulatory action is either exempt or excluded from the requirements of the Administrative Process Act; or

3. The agency determines that resolution of a controversy is unlikely.

12VAC30-5-90. Meetings.

Notice of any open meeting, including meetings of a RAP or NRP, shall be posted on the Virginia Regulatory Town Hall and Commonwealth Calendar at least seven working days prior to the date of the meeting. The exception to this requirement is any meeting held in accordance with § 2.2-3707 D of the Code of Virginia allowing for contemporaneous notice to be provided to participants and the public.

12VAC30-5-100. Public hearings on regulations.

A. The agency shall indicate in its notice of intended regulatory action whether it plans to hold a public hearing following the publication of the proposed stage of the regulatory action.

B. The agency may conduct one or more public hearings during the comment period following the publication of a proposed regulatory action.

C. An agency is required to hold a public hearing following the publication of the proposed regulatory action when:

1. The agency's basic law requires the agency to hold a public hearing;

2. The Governor directs the agency to hold a public hearing; or

3. The agency receives requests for a public hearing from at least 25 persons during the public comment period following the publication of the notice of intended regulatory action.

D. Notice of any public hearing shall be posted on the Town Hall and Commonwealth Calendar at least seven working days prior to the date of the hearing. The agency shall also notify those persons who requested a hearing under subdivision C 3 of this section.

12VAC30-5-110. Periodic review of regulations.

A. The agency shall conduct a periodic review of its regulations consistent with:

1. An executive order issued by the Governor pursuant to § 2.2-4017 of the Administrative Process Act to receive comment on all existing regulations as to their effectiveness, efficiency, necessity, clarity, and cost of compliance; and

2. The requirements in § 2.2-4007.1 of the Administrative Process Act regarding regulatory flexibility for small businesses.

B. A periodic review may be conducted separately or in conjunction with other regulatory actions.

C. Notice of a periodic review shall be posted on the Town Hall and published in the Virginia Register.

Part I
Public Participation Guidelines

12VAC30-100-10. Definitions. (Repealed.)

The following words and terms, when used in this part, shall have the following meaning, unless the content clearly indicates otherwise.

"Board" means the Board of Medical Assistance Services.

"Director" means the Director of the Department of Medical Assistance Services.

"Department" or "DMAS" means the Department of Medical Assistance Services.

"Formation and development process" means those activities with respect to a specific regulation which occur between the publication of a notice of intent to develop or modify regulations, and the release of the proposed regulation for public comment.

"Regulation" means any statement of general application, having the force of law, affecting the rights or conduct of any person, promulgated by an agency in accordance with the authority conferred on it by applicable basic law.

12VAC30-100-20. General information. (Repealed.)

A. Authority. Chapter 1.1:1 of Title 9 of the Code of Virginia, deals with the promulgation of rules and regulations. Specifically, §9.6.14:7.1 directs agencies of the Commonwealth to develop public participation guidelines for soliciting the input of interested parties in the formation and development of regulations. Section 32.1-325 of the Code of Virginia empowers the Board of Medical Assistance Services to make, adopt, and promulgate regulations.

B. Purpose. This part is designed to provide consistent, written guidelines in order to ensure input from interested parties at all stages of the regulatory process.

C. Administration. The Board of Medical Assistance Services shall have the responsibility for promulgating regulations pertaining to public input in the regulatory process. Pursuant to § 32.1-324 C, the director shall have this responsibility and authority when the board is not in session, subject to such rules and regulations as may be prescribed by the board.

D. Application of regulations. This part shall have general application throughout the Commonwealth.

E. Application of the Administrative Process Act. The provisions of the Virginia Administrative Process Act, which is codified as Chapter 1.1:1 of Title 9 of the Code of Virginia, shall govern the adoption, amendment, modification, and revision of these regulations. All hearings deemed necessary by the director on such regulations, shall be conducted in accordance with §9-6.14:7.1.

12VAC30-100-30. Identification of interested parties. (Repealed.)

A. Existing data. The department will maintain a list of those persons and organizations who have demonstrated an interest in certain program regulations in the past through participation in regulatory hearings, correspondence, or other activities with the department.

B. Development of new lists. Periodically, the department shall publish a notice in The Virginia Register of Regulations, in a newspaper published in Richmond, and in other newspapers in Virginia localities, a request that any individual or organization interested in participating in the development of specific rules and regulations notify the office of the director. Any persons or organizations identified in this process will be incorporated in the lists developed under 12VAC30-100-30 A. The director may periodically remove from the lists persons or organizations that request to be removed or who fail to respond to an inquiry regarding continued interest.

12VAC30-100-40. Notification of interested parties. (Repealed.)

A. Individual mailings. When the Director of DMAS determines that specific regulations need to be developed or modified, the program shall notify by mail the individuals and organizations identified in 12VAC30-100-30. The notice shall include the title of the regulation to be developed or modified; a summary of the subject matter; the program contact person, mailing address, and telephone number; and the date by which a notice of a desire to participate in the formation and development process must be received. This rule shall not be mandatory where the department is formulating and developing regulations pursuant to court order, or federally required action or General Assembly action, but whenever time permits every effort will be made to provide such notice.

B. Notice of intent. When the department determines that specific regulations need to be developed or modified, the department will publish a Notice of Intent in The Virginia Register of Regulations. This notice will include the title of the regulation to be developed or modified; a summary of the subject matter; the program contact person, mailing address and telephone number; and the date by which a notice of a desire to participate must be received.

C. An announcement shall be sent to members of the Governor's Advisory Committee on Medicare and Medicaid and the board of the department.

12VAC30-100-50. Solicitation of input from interested parties. (Repealed.)

A. Advisory panels. The department's rule-making is so frequent that the Governor's Advisory Committee on Medicare and Medicaid will function as the department's on-going advisory panel. Based on the scope and nature of the regulatory issue, the director may, at his discretion, establish a sole function advisory panel to assist in this development or modification.

B. Membership of panels. Members of these sole-function advisory panels will be individuals and organization representatives identified under 12VAC30-100-30 and who have expressed the desire to participate in the department's regulatory process. Panel membership will consist of individuals oriented to the department, program issues and constraints of the intended regulations and representatives of entities governed by the proposed regulations. Advisory panels will consist of no less than three nor more than seven members.

C. Operation of panels. Individual panels will establish their own operating procedures, but in every case a panel will meet once and then will decide on subsequent meetings. All panel comments and other comments on proposed regulations will be documented by the program and a response will be developed for each comment. A written report on the public and panel comments will be prepared and the subsequent decision or action recommended shall be prepared by departmental staff and submitted to the Board of the Department of Medical Assistance Services for review and approval.

D. Exceptions. The use of an advisory panel may be waived at the director's discretion when:

1. There is no response to the notice of intent,

2. The office of the Attorney General determines that regulations are promulgated to comply with state or federal law or federal regulation and that no agency discretion is involved, or

3. When the program is formulating and developing regulations pursuant to a court order.

E. Other comments. All persons and organizations who notify the Department of Medical Assistance Services under 12VAC30-100-40 of their desire to comment shall be provided an opportunity to examine regulations in their developmental stage and to provide written comments on these regulations to the department. The department shall document the receipt of these comments and will respond to all comments. This rule shall not be mandatory when the department is formulating and developing regulations pursuant to a court order but every effort will be made to comply.

12VAC30-100-60. Administrative Process Act procedures. (Repealed.)

After regulations have been developed according to these guidelines they shall be submitted for public comment in accordance with the Administrative Process Act.

Titles of Regulations: 12VAC30-50. Amount, Duration, and Scope of Medical and Remedial Care Services (amending 12VAC30-50-140, 12VAC30-50-150, 12VAC30-50-180; adding 12VAC30-50-228, 12VAC30-50-491).

12VAC30-60. Standards Established and Methods Used to Assure High Quality Care (adding 12VAC30-60-180, 12VAC30-60-185).

12VAC30-80. Methods and Standards for Establishing Payment Rates; other Types of Care (adding 12VAC30-80-32).

12VAC30-120. Waivered Services (amending 12VAC30-120-310, 12VAC30-120-380).

Statutory Authority: §§32.1-324 and 32.1-325 of the Code of Virginia.

Effective Dates: July 1, 2007, through December 29, 2008.

The Department of Medical Assistance Services requested an extension of the above-referenced emergency regulations pursuant to § 2.2-4011 of the Code of Virginia. The emergency regulations were published in 23:21 3510-3519 June 25, 2007 (http://legis.state.va.us/codecomm/register/vol23/iss21/v23i21.pdf) with effective dates of July 1, 2007, through June 30, 2008.

The 2007 Acts of Assembly, Chapter 847, Item 302 PPP required that the Department of Medical Assistance Services (DMAS) amend the State Plan for Medical Assistance to provide coverage of substance abuse treatment services for children and adults, effective July 1, 2007. Substance Abuse Treatment Services were implemented on that date, with a proposed regulation following the emergency regulation. Following the implementation of the services, DMAS submitted to the Centers for Medicare and Medicaid Services (CMS), the federal agency that authorizes states to make changes to their Medicaid programs, would require substantial changes to Virginia’s new coverage of Substance Abuse Treatment Services (SAS). DMAS is still involved in protracted negotiations with CMS regarding reimbursement for SAS, as well the implementation of case management services for SAS. This last issue is one of national importance, with Congress currently passing legislation to put a moratorium on CMS’ regulations on this issue. The final nature of the SAS regulations is therefore yet to be determined.

The Governor approved the department's request to extend the expiration date of the emergency regulations for six months as provided in § 2.2-4011 D of the Code of Virginia. Therefore, the regulations will continue in effect through December 29, 2008.

Agency Contact: Catherine Hancock, Policy & Research Division, Department of Medical Assistance Services, 600 East Broad Street, Suite 1300, Richmond, VA 23219, telephone (804) 225-4272, FAX (804) 786-1680, or email catherine.hancock@dmas.virginia.gov.

Titles of Regulations: 12VAC30-50. Amount, Duration, and Scope of Medical and Remedial Care Services (amending 12VAC30-50-140, 12VAC30-50-150, 12VAC30-50-180; adding 12VAC30-50-228, 12VAC30-50-491).

12VAC30-60. Standards Established and Methods Used to Assure High Quality Care (adding 12VAC30-60-180, 12VAC30-60-185).

12VAC30-80. Methods and Standards for Establishing Payment Rates; other Types of Care (adding 12VAC30-80-32).

12VAC30-120. Waivered Services (amending 12VAC30-120-310, 12VAC30-120-380).

Statutory Authority: §§32.1-324 and 32.1-325 of the Code of Virginia.

Effective Dates: July 1, 2007, through December 29, 2008.

The Department of Medical Assistance Services requested an extension of the above-referenced emergency regulations pursuant to § 2.2-4011 of the Code of Virginia. The emergency regulations were published in 23:21 3510-3519 June 25, 2007 (http://legis.state.va.us/codecomm/register/vol23/iss21/v23i21.pdf) with effective dates of July 1, 2007, through June 30, 2008.

The 2007 Acts of Assembly, Chapter 847, Item 302 PPP required that the Department of Medical Assistance Services (DMAS) amend the State Plan for Medical Assistance to provide coverage of substance abuse treatment services for children and adults, effective July 1, 2007. Substance Abuse Treatment Services were implemented on that date, with a proposed regulation following the emergency regulation. Following the implementation of the services, DMAS submitted to the Centers for Medicare and Medicaid Services (CMS), the federal agency that authorizes states to make changes to their Medicaid programs, would require substantial changes to Virginia’s new coverage of Substance Abuse Treatment Services (SAS). DMAS is still involved in protracted negotiations with CMS regarding reimbursement for SAS, as well the implementation of case management services for SAS. This last issue is one of national importance, with Congress currently passing legislation to put a moratorium on CMS’ regulations on this issue. The final nature of the SAS regulations is therefore yet to be determined.

The Governor approved the department's request to extend the expiration date of the emergency regulations for six months as provided in § 2.2-4011 D of the Code of Virginia. Therefore, the regulations will continue in effect through December 29, 2008.

Agency Contact: Catherine Hancock, Policy & Research Division, Department of Medical Assistance Services, 600 East Broad Street, Suite 1300, Richmond, VA 23219, telephone (804) 225-4272, FAX (804) 786-1680, or email catherine.hancock@dmas.virginia.gov.

Title of Regulation: 12VAC30-60. Standards Established and Methods Used to Assure High Quality Care (adding 12VAC30-60-500).

Statutory Authority: §§32.1-324 and 32.1-325 of the Code of Virginia.

Effective Dates: August 8, 2007, through February 7, 2009.

The Department of Medical Assistance Services requested an extension of the emergency regulations, 12VAC30-60, pursuant to § 2.2-4011 of the Code of Virginia. The emergency regulations, relating to disease management, were published in 23:26 VA.R. 4427-4429 September 3, 2007 (http://legis.state.va.us/codecomm/register/vol23/iss26/ v23i26.pdf) with effective dates of August 8, 2007, through August 7, 2008.

The original emergency regulation was followed by a proposed regulation. Upon further research it was determined that the national evidence-based guidelines for the specialized conditions were designed for individuals 18 years and older. Therefore, substantive changes were made to the original proposed regulation specifically dropping the age limit of 21 years and older to 18 years and older for individuals in the fee-for service, who have congestive heart failure (CHF), coronary artery disease (CAD), or chronic obstructive pulmonary disease (COPD). Due to unforeseen delays, it is not possible that the regulatory process will be complete prior to the expiration of the emergency regulation, despite the best efforts of those involved.

The Governor approved the department's request to extend the expiration date of the emergency regulations for six months as provided in § 2.2-4011D of the Code of Virginia. Therefore, the regulations will continue in effect through February 2, 2009.

Agency Contact: Meredith Lee, Health Care Services Division, Department of Medical Assistance Services, 600 East Broad Street, Suite 1300, Richmond, VA 23219, telephone (804) 786-5040, FAX (804) 786-1680, or email meredith.lee@dmas.virginia.gov.

Titles of Regulations: 12VAC30-70. Methods and Standards for Establishing Payment Rates - Inpatient Hospital Services (amending 12VAC30-70-70, 12VAC30-70-261, 12VAC30-70-271, 12VAC30-70-500).

12VAC30-90. Methods and Standards for Establishing Payment Rates for Long-Term Care (amending 12VAC30-90-264).

Statutory Authority: §§32.1-324 and 32.1-325 of the Code of Virginia.

Public Hearing Information: No public hearings are scheduled.

Public Comments: Public comments may be submitted until November 12, 2008.

Effective Date: November 27, 2008.

Agency Contact: James Branham, Project Manager, Department of Medical Assistance Services, 600 East Broad Street, Richmond, VA 23219, telephone (804) 225-4587, FAX (804) 786-1680, or email james.branham@dmas.virginia.gov.

Basis: Section 32.1-325 of the Code of Virginia grants to the Board of Medical Assistance Services the authority to administer and amend the Plan for Medical Assistance. Section 32.1-324 of the Code of Virginia authorizes the Director of DMAS to administer and amend the Plan for Medical Assistance according to the board's requirements. The Medicaid authority as established by § 1902 (a) of the Social Security Act (42 USC §1396a) provides governing authority for payments for services.

Purpose: The purpose of the regulation is to simplify hospital and specialized care nursing facility reimbursement either by eliminating unnecessary hospital and specialized care nursing facility requirements or by making the specialized care nursing facility reimbursement similar to the regular nursing facility reimbursement. Both proposals are budget neutral and the reimbursement impact on providers would be negligible. Both proposals would reduce DMAS and provider administrative costs associated with reporting and recordkeeping activities.

Rationale for Using Fast-Track Process: DMAS consulted with the Virginia Hospital and Healthcare Association and the Association (VHHA) representative indicated that the VHHA would not object to eliminating recapture of hospital depreciation. Medicare has already eliminated hospital depreciation recapture. Sometimes hospital depreciation recapture benefits DMAS and other times it benefits the provider. However, in either case the funds involved are not material and it is necessary for DMAS and the provider to review cost reports related to the original hospital depreciation, which may be many years old. Neither party considers the recordkeeping a good use of resources. The VHHA also agrees that it is not necessary to have the hospital outlier methodology illustration in regulation. DMAS intends to put an outlier calculation spreadsheet on its website.

DMAS consulted with the Virginia Health Care Association and providers receiving specialized care reimbursement under the current system. DMAS presented information regarding how the proposed simplification would have effected reimbursement if the simplification had been in place. Providers agreed that simplification would reduce administrative reporting requirements and make it easier for providers to estimate reimbursement.

Substance:

Eliminate Recapture of Hospital Depreciation

Under current policy, DMAS must “recapture” depreciation when a hospital is sold. DMAS reimburses hospitals for depreciation based on standard depreciation schedules. When a hospital is sold, the seller may experience a windfall if the sale price exceeds the reimbursed depreciation or the seller may experience a loss if the sale price is less than the reimbursed depreciation. If the seller experiences a windfall, DMAS will recapture hospital depreciation; if the seller experiences a loss, DMAS will cover the loss. When a sale occurs, therefore, the seller and DMAS have to calculate the windfall or loss based on the original records. Hospital sales are relatively infrequent, the windfall or loss is usually not large and the net payments/recoveries for DMAS are close to zero. In many cases, this is the only reason for storing older cost reports since Medicare eliminated recapture of hospital depreciation a number of years ago. DMAS and the hospital association agree that there is little cost/benefit in continuing the recapture of hospital depreciation and therefore this regulation would eliminate it.

Eliminate Hospital Outlier Illustration

12VAC30-70-261 are the regulations for the hospital outlier methodology. The subsection to be eliminated is only an illustration that is now more than 10 years out of date. DMAS intends to publish annual hospital outlier calculation worksheets on the DMAS website and therefore it makes more sense to eliminate this subsection than to revise it.

Simplify Reimbursement of Specialized Care Nursing Facility Services

The goals of the planned regulatory action are to reduce unnecessary complexity and reduce administrative burden associated with the method used to determine nursing facility payment rates for adult and pediatric specialized care.

The current specialized care payment rate calculation method uses the Resource Utilization Group System (RUGS III) nursing only index to calculate each facility’s average normalized case mix index (NCMI), which is the measure of each facility’s average patient severity level normalized by the average of all specialized care patients in the state. Ceilings and payment rates are adjusted by the NCMI, in order to avoid overpayments to facilities with a less severe patient population and to ensure adequate payments to facilities that have a more severe patient population, relative to the state average. When this reimbursement methodology was developed there were approximately 40 adult specialized care providers serving recipients with ventilator, rehabilitation and complex care needs. Since 2003, however, adult specialized care serves only ventilator patients. As a result, there are less than 10 adult specialized care providers with a much more homogenous patient population. Pediatric specialized care still covers all categories, but the patients in the two pediatric specialized care facilities have very similar resource needs. In both the adult and pediatric specialized care facilities, specialized care facility NCMI scores are very close to 1.0 (the same as the state average) and application of the NCMI adjustment has a negligible effect on payment rates and is unnecessary.

Based on the provider and patient changes, there is no longer a compelling reason to continue adjusting rates and ceilings by the NCMI, especially given the extra work this requires and other disadvantages. DMAS uses the services of an outside accounting firm to calculate specialized care NCMI scores and rate adjustments. Specialized care facilities are required to send in additional MDS data on a monthly basis and the calculations cannot be completed until all facilities have sent in this data. Providers have indicated to DMAS that the additional work is a burden and the lack of timeliness in finalizing rates is frustrating.

Along with eliminating the NCMI, DMAS is proposing two additional changes to further simplify the methodology by conforming the inflation adjustment and occupancy requirements to the methodology used in regular nursing facility reimbursement.

The current inflation methodology for specialized care reimbursement was also used for regular nursing facility reimbursement until July 1, 2002. This methodology involves a combination of historical and anticipated inflation, annual revisions and quarterly inflation updates. The new, simpler inflation methodology adopted effective July 1, 2002, for regular nursing facility reimbursement updates inflation annually using a single inflation factor. The inflation methodology used for specialized care reimbursement, however, was not changed. This regulation would require that the specialized care reimbursement use the simpler inflation methodology utilized for regular nursing facility reimbursement.

Additionally, this regulatory action will require adult specialized care reimbursement to use the same 90% occupancy requirement used in the regular nursing facility reimbursement. Under current regulations the occupancy requirement only applies to regular nursing facilities not to adult specialized care even though occupancy is already calculated by using total facility paid days, including specialized care days, as a percentage of total available days. DMAS does not anticipate that capital reimbursement for specialized care facilities would be frequently affected by this change, but, in any event, the special consideration is not justified. The lower 70% occupancy requirement for pediatric specialized care would not change.

Issues: The advantage to both the hospital and nursing facility providers of this change is the reduction of paperwork that is required by the policies being changed by this action. The advantage to DMAS with this change will be the simplification of both the inpatient hospital and nursing facility cost settlement process. There are no disadvantages to the Commonwealth for this action. The changes do not have a fiscal impact and they eliminate unnecessary administrative burdens on both DMAS and providers.

The Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The proposed regulations will simplify Medicaid hospital and specialized care reimbursement methodologies.

Result of Analysis. The benefits likely exceed the costs for all proposed changes.

Estimated Economic Impact. Department of Medical Assistance Services (DMAS) proposes to simplify Medicaid hospital and specialized care reimbursement methodologies.

The specialized care nursing facility reimbursement will be simplified by eliminating the case mix adjustment and using the same inflation method used in the regular nursing facility reimbursement methodology. The reason for eliminating case mix adjustment is the fact that these facilities currently cover only ventilator dependent patients leading to very homogeneous mix of cases. In the past, the patient mix was heterogeneous because complex health and comprehensive services were covered by adult specialized care facilities.

Also, the specialized care nursing facility inflation methodology is much more complex than the inflation methodology for regular nursing facilities. The proposed changes will adopt the simpler regular nursing facility inflation methodology for specialized care nursing facilities.

Furthermore, DMAS proposes a new statewide ceiling so as to maintain the budget neutrality after the proposed changes. So, there is no net significant fiscal effect is expected as a result of the proposed changes. However, simplified reimbursement methodology is expected to reduce administrative costs and staff time at DMAS. Providers are expected to experience similar benefits.

Another change proposed will eliminate recapture of hospital depreciation when a provider hospital is sold. DMAS currently reimburses hospitals for depreciation. Any loss or gain that may accrue to the seller when a hospital is sold is paid or recovered by DMAS. It is reported that hospital sales are rare, the seller losses or gains are insignificant, and net payments or recoveries by DMAS are close to zero. Thus, no large fiscal effect is expected from eliminating the recapture of hospital depreciation as proposed. However, this proposed change will remove the sole reason that many hospitals and DMAS have been storing older cost reports and provide some savings.

The fiscal savings in administrative expenses and staff time at DMAS are estimated to be about $50,000. Similar savings are likely to accrue to the providers as well.

Finally, DMAS is proposing to remove an example contained in the regulations. DMAS intends to provide access to a similar example on its website. Thus, while providers will likely still have access to the same information through the website, DMAS will not be required to update its regulations every time when assumptions in the example changes.

Businesses and Entities Affected. These regulations apply to 8 providers of specialized care and approximately 95 hospitals.

Localities Particularly Affected. The proposed regulations apply throughout the commonwealth.

Projected Impact on Employment. The proposed simplified methodologies and reduced recordkeeping requirements are expected to reduce demand for labor.

Effects on the Use and Value of Private Property. No significant effect on the use and value of private property is expected.

Small Businesses: Costs and Other Effects. None of the effected entities are believed to be small businesses.

Small Businesses: Alternative Method that Minimizes Adverse Impact. The proposed changes are not estimated to have an adverse impact on small businesses.

Real Estate Development Costs. No significant effect on the real estate development costs is expected.

Legal Mandate. The Department of Planning and Budget (DPB) has analyzed the economic impact of this proposed regulation in accordance with § 2.2-4007.04 of the Administrative Process Act and Executive Order Number 36 (06). Section 2.2-4007.04 requires that such economic impact analyses include, but need not be limited to, the projected number of businesses or other entities to whom the regulation would apply, the identity of any localities and types of businesses or other entities particularly affected, the projected number of persons and employment positions to be affected, the projected costs to affected businesses or entities to implement or comply with the regulation, and the impact on the use and value of private property. Further, if the proposed regulation has adverse effect on small businesses, § 2.2-4007.04 requires that such economic impact analyses include (i) an identification and estimate of the number of small businesses subject to the regulation; (ii) the projected reporting, recordkeeping, and other administrative costs required for small businesses to comply with the regulation, including the type of professional skills necessary for preparing required reports and other documents; (iii) a statement of the probable effect of the regulation on affected small businesses; and (iv) a description of any less intrusive or less costly alternative methods of achieving the purpose of the regulation. The analysis presented above represents DPB’s best estimate of these economic impacts.

Agency's Response to the Department of Planning and Budget's Economic Impact Analysis: The agency concurs with the economic impact analysis prepared by the Department of Planning and Budget regarding the regulations concerning Simplify Hospital and Specialized Care Reimbursement (12VAC30-70-70, 12VAC30-70-261, 12VAC30-70-271, 12VAC30-70-500 and 12VAC30-90-264).

Summary:

The amendments accomplish several reimbursement methodology changes designed to simplify provider reimbursement. The first is to simplify hospital reimbursement by eliminating recapture of hospital depreciation when a hospital is sold; this also eliminates the associated recordkeeping. The amendments also eliminate the hospital outlier illustration, which is outdated.

The regulation simplifies reimbursement for specialized care nursing facilities by (i) eliminating the case mix adjustment and (ii) using the same inflation method and capital rate calculation used in the regular nursing facility reimbursement methodology. After recent changes to the covered groups, there is no longer a justification for the case mix adjustment and the associated reporting. The changes are budget neutral.

12VAC30-70-70. Revaluation of assets.

A. Effective October 1, 1984 July 1, 2008, the valuation of an asset of a hospital or long-term care facility which has undergone a change of ownership on or after July 18, 1984, shall be the lesser of the seller's allowable acquisition depreciated historical cost to (net book value) as determined for Medicaid reimbursement of the owner of record as of July 18, 1984, or the acquisition cost to the new owner.

B. In the case of an asset not in existence as of July 18, 1984, the valuation of an asset of a hospital or long-term care facility shall be the lesser of the seller's allowable depreciated historical cost (net book value) as determined for Medicaid reimbursement of the first owner of record, or the acquisition cost to the new owner.

C. In establishing appropriate allowance for depreciation, interest on capital indebtedness, and return on equity (if applicable prior to July 1, 1986) the base to be used for such computations shall be limited to subsection A or B above of this section.

D. Costs (including legal fees, accounting and administrative costs, travel costs, and feasibility studies) attributable to the negotiation or settlement of the sale or purchase of any capital asset (by acquisition or merger) shall be reimbursable only to the extent that they have not been previously reimbursed by Medicaid.

E. The recapture of depreciation up to the full value of the asset is required.

F. E. Rental charges in sale and leaseback agreements shall be restricted to the depreciation, mortgage interest and (if applicable prior to July 1, 1986) return on equity based on cost of ownership as determined in accordance with subsections A. and B. above of this section.

12VAC30-70-261. Outlier operating payment.

A. An outlier operating payment shall be made for outlier cases. This payment shall be added to the operating payments determined in 12VAC30-70-231 and 12VAC30-70-251. Eligibility for the outlier operating payment and the amount of the outlier operating payment shall be determined as follows:

1. The hospital's adjusted operating cost for the case shall be estimated. This shall be equal to the hospital's total charges for the case times the hospital's operating cost-to-charge ratio, as defined in subsection C of 12VAC30-70-221, times the adjustment factor specified in 12VAC30-70-331 B.

2. The adjusted outlier operating fixed loss threshold shall be calculated as follows:

a. The outlier operating fixed loss threshold shall be multiplied by the statewide average labor portion of operating costs, yielding the labor portion of the outlier operating fixed loss threshold. Hence, the nonlabor portion of the outlier operating fixed loss threshold shall constitute one minus the statewide average labor portion of operating costs times the outlier operating fixed loss threshold.

b. The labor portion of the outlier operating fixed loss threshold shall be multiplied by the hospital's Medicare wage index, yielding the wage adjusted labor portion of the outlier operating fixed loss threshold.

c. The wage adjusted labor portion of the outlier operating fixed loss threshold shall be added to the nonlabor portion of the outlier operating fixed loss threshold, yielding the wage adjusted outlier operating fixed loss threshold.

3. The hospital's outlier operating threshold for the case shall be calculated. This shall be equal to the wage adjusted outlier operating fixed loss threshold times the adjustment factor specified in 12VAC30-70-331 B plus the hospital's operating payment for the case, as determined in 12VAC30-70-231 or 12VAC30-70-251.

4. The hospital's outlier operating payment for the case shall be calculated. This shall be equal to the hospital's adjusted operating cost for the case minus the hospital's outlier operating threshold for the case. If the difference is less than or equal to zero, then no outlier operating payment shall be made. If the difference is greater than zero, then the outlier operating payment shall be equal to the difference times the outlier adjustment factor.

B. An illustration of the above methodology is found in 12VAC30-70-500.

C. B. The outlier operating fixed loss threshold shall be recalculated using base year data when the DRG payment system is recalibrated and rebased. The threshold shall be calculated so as to result in an expenditure for outlier operating payments equal to 5.1% of total operating payments, including outlier operating payments, for DRG cases. The methodology described in subsection A of this section shall be applied to all base year DRG cases on an aggregate basis, and the amount of the outlier operating fixed loss threshold shall be calculated so as to exhaust the available pool for outlier operating payments.

12VAC30-70-271. Payment for capital costs.

A. Inpatient capital costs shall be determined on an allowable cost basis and settled at the hospital's fiscal year end. Allowable cost shall be determined following the methodology described in Supplement 3 (12VAC30-70-10 through 12VAC30-70-130). Inpatient capital costs of Type One hospitals shall continue to be settled at 100% of allowable cost. For services beginning July 1, 2003, inpatient capital costs of Type Two hospitals shall be settled at 80% of allowable cost. For hospitals with fiscal years that do not begin on July 1, 2003, inpatient capital costs for the fiscal year in progress on that date shall be apportioned between the time period before and the time period after that date based on the number of calendar months before and after that date. Capital costs apportioned before that date shall be settled at 100% of allowable cost, and those after at 80% of allowable cost.

B. The exception to the policy in subsection A of this section is that the hospital specific rate per day for services in freestanding psychiatric facilities licensed as hospitals, as determined in 12VAC30-70-321 B, shall be an all-inclusive payment for operating and capital costs.

C. Until prospective payment for capital costs is implemented, the provisions of 12VAC30-70-70 regarding recapture of depreciation shall remain in effect.

12VAC30-70-500. Outlier methodology illustration. (Repealed.)

OUTLIER METHODOLOGY ILLUSTRATION (dollar amounts and other values are for illustration purposes only)
	Assume the Following:
	Medicare: Fixed Loss Cost Outlier Threshold for Fiscal Year 1996		$15,150.00
	Medicare: Marginal Cost Factor for Cost Outliers for Fiscal Year 1996		0.8000
	Hospital X Operating Cost-to-Charge Ratio		0.7200
	Hospital X Capital Cost-to-Charge Ratio		0.0600
	Medicare Wage Index for Hospital X		0.9413
	Statewide Average Labor Portion of Operating Costs		0.5977
	Hospital X Billed Charges for Case Y		$100,000.00
	Total Adjusted Costs per Case for Hospital X		$3,115.00
	Relative Weight for Case Y		3.1790
	Adjustment Factor for DRG Cases		0.6197
Step 1	Calculate Hospital X Operating Costs for Case Y:
	Hospital X Billed Charges for Case Y		$100,000.00
	Hospital X Operating Cost-to-Charge Ratio	x	.7200
	Hospital X Operating Costs for Case Y		$72,000.00
Step 2	Calculate Hospital X DRG Operating Amount for Case Y:
	Total Adjusted Operating Costs per Case for Hospital X		$3,115.00
	Relative Weight for Case Y	x	3.1790
	Hospital X DRG Operating Amount for Case Y		$9,902.59
Step 3	Calculate Hospital X Cost Outlier Threshold for Case Y:
	Fixed Loss Cost Outlier Threshold		$15,150.00
	Statewide Average Labor Portion of Operating Costs	x	0.5977
	Labor Portion of Fixed Loss Cost Outlier Threshold		$9,055.16
	Wage Index for Hospital X	x	0.9413
	Wage Adjusted Labor Portion of Fixed Loss Cost Outlier Threshold		$8,523.62
	Non-Labor Portion of Fixed Loss Cost Outlier Threshold	+	$6,094.85
	Wage Adjusted Fixed Loss Cost Outlier Threshold		$14,618.46
	Hospital X DRG Operating Amount for Case Y	+	$9,902.59
	Hospital X Cost Outlier Threshold for Case Y		$24,521.05
Step 4	Calculate Hospital X Operating Outlier Amount for Case Y:
	Hospital X Operating Costs for Case Y		$72,000.00
	Hospital X Cost Outlier Threshold for Case Y	-	$24,521.05
	Hospital X Operating Outlier Costs for Case Y		$47,478.95
	Marginal Cost Factor for Cost Outliers	x	0.8000
	Hospital X Operating Outlier Amount for Case Y		$37,983.16
Step 5	Calculate Hospital X Total Payment for Case Y:
	Hospital X DRG Operating Amount for Case Y		$9,902.59
	Hospital X Operating Outlier Amount for Case Y	+	$37,983.16
	Hospital X Total Amount for Case Y		$47,885.75
	Adjustment Factor for DRG Cases	x	0.6197
	Hospital X Total Payment for Case Y		$29,674.80

Subpart XVII
Specialized Care Services

12VAC30-90-264. Specialized care services.

Specialized care services provided in conformance with 12VAC30-60-40 E and H, 12VAC30-60-320 and 12VAC30-60-340 shall be reimbursed under the following methodology. The nursing facilities that provide adult specialized care for the categories of Ventilator Dependent Care, will be placed in one group for rate determination. The nursing facilities that provide pediatric specialized care in a dedicated pediatric unit of eight beds or more will be placed in a second group for rate determination.

1. Routine operating cost. Routine operating cost shall be defined as in 12VAC30-90-271 and 12VAC30-90-272. To calculate the routine operating cost reimbursement rate, routine operating cost shall be converted to a per diem amount by dividing it by actual patient days.

2. Allowable cost identification and cost reimbursement limitations. The provisions of Article 5 (12VAC30-90-50 et seq.) of Subpart II of Part II of this chapter and of Appendix III (12VAC30-90-290) of Part III of this chapter shall apply to specialized care cost and reimbursement.

3. Routine operating cost rates. Each facility shall be reimbursed a prospective rate for routine operating costs. This rate will be the lesser of the facility-specific prospective routine operating ceiling, or the facility-specific prospective routine operating cost per day plus an efficiency incentive. This efficiency incentive shall be calculated by the same method as in 12VAC30-90-41.

4. Facility-specific prospective routine operating ceiling. Each nursing facility's prospective routine operating ceiling shall be calculated as:

a. Statewide ceiling. The statewide routine operating ceiling shall be $415 as of July 1, 2002. the weighted average (weighted by 1994 days) of specialized care rates in effect on July 1, 1996, reduced by statewide weighted average ancillary and capital cost per day amounts based on audited 1994 cost data from the 12 facilities whose 1994 FY specialized care costs were audited during 1996. This routine operating ceiling amount shall be adjusted for inflation by the percentage of change in the moving average of the Virginia specific Skilled Nursing Facility Market Basket of Routine Service Costs, as developed by DRI/McGraw-Hill, using the second quarter 1996 DRI table. The respective statewide operating ceilings will be adjusted each quarter in which the provider's most recent fiscal year ends, by adjusting the most recent interim ceiling by 100% of historical inflation and 50% of forecasted inflation to the end of the provider's next fiscal year based on 12VAC30-90-41.

b. The portion of the statewide routine operating ceiling relating to nursing salaries (as determined by the 1994 audited cost report data, or 67.22%) will be wage adjusted using a normalized wage index. The normalized wage index shall be the wage index applicable to the individual provider's geographic location under Medicare rules of reimbursement for skilled nursing facilities, divided by the statewide average of such wage indices across the state. This normalization of wage indices shall be updated January 1, after each time the Health Care Financing Administration (HCFA) publishes wage indices for skilled nursing facilities. Updated normalization shall be effective for fiscal years starting on and after the January 1 for which the normalization is calculated.

c. The percentage of the statewide routine operating ceiling relating to the nursing labor and nonlabor costs (as determined by the 1994 audited cost report data or 71.05%) will be adjusted by the nursing facility's specialized care average Resource Utilization Groups, Version III (RUG-III) Nursing-Only Normalized Case Mix Index (NCMI). The NCMI for each nursing facility will be based on all specialized care patient days rendered during the six-month period prior to that in which the ceiling applies (see subdivision 6 of this section).

5. Normalized case mix index (NCMI). Case mix shall be measured by RUG-III nursing-only index scores based on Minimum Data Set (MDS) data. The RUG-III nursing-only weights developed at the national level by the Health Care Financing Administration (HCFA) (see 12VAC30-90-320) shall be used to calculate a facility-specific case mix index (CMI). The facility-specific CMI, divided by the statewide CMI shall be the facility's NCMI. The steps in the calculation are as follows:

a. The facility-specific CMI for purposes of this rate calculation shall be the average of the national RUG-III Nursing-Only weights calculated across all patient days in the facility during the six months prior to the six-month period to which the NCMI shall be applied to the facility's routine operating cost and ceiling.

b. The statewide CMI for purposes of this rate calculation shall be the average of the national RUG-III Nursing-Only weights calculated across all specialized care patient days in all Specialized Care Nursing facilities in the state during the six months prior to the six-month period to which the NCMI shall be applied. A new statewide CMI shall be calculated for each six-month period for which a provider-specific rate must be set.

c. The facility-specific NCMI for purposes of this rate calculation shall be the facility-specific CMI from subdivision 5 a of this section divided by the statewide CMI from subdivision 5 b of this section.

d. Each facility's NCMI shall be updated semiannually, at the start and the midpoint of the facility's fiscal year.

e. Patient days for which the lowest RUG-III weight is imputed, as provided in subdivision 14 c of this section, shall not be included in the calculation of the NCMI.

6. 5. Facility-specific prospective routine operating base cost per day: The facility-specific routine operating cost per day to be used in the calculation of the routine operating rate and the efficiency incentive shall be the actual routine cost per day from the most recent fiscal year's cost report, adjusted (using DRI-Virginia inflation factors) by 50% of historical inflation and 50% of the forecasted inflation, and adjusted for case mix as described below: for inflation based on 12VAC30-90-41.

a. An NCMI rate adjustment shall be applied to each facility's prospective routine nursing labor and nonlabor operating base cost per day for each semiannual period of the facility's fiscal year.

b. The NCMI calculated for the second semiannual period of the previous fiscal year shall be divided by the average of that (previous) fiscal year's two semiannual NCMIs to yield an "NCMI cost rate adjustment" to the prospective nursing labor and nonlabor operating cost base rate in the first semiannual period of the subsequent fiscal year.

c. The NCMI determined in the first semiannual period of the subsequent fiscal year shall be divided by the average of the previous fiscal year's two semiannual NCMIs to determine the NCMI cost rate adjustment to the prospective nursing labor and nonlabor operating base cost per day in the second semiannual period of the subsequent fiscal year.

See 12VAC30-90-310 for an illustration of how the NCMI is used to adjust routine operating cost ceilings and semiannual NCMI adjustments to the prospective routine operating base cost rates.

7. 6. Interim rates. Interim rates, for processing claims during the year, shall be calculated from the most recent settled cost report and Minimum Data Set (MDS) data available at the time the interim rates must be set, except that failure to submit a cost and MDS data report timely may result in adjustment to interim rates as provided elsewhere.

8. 7. Ancillary costs. Specialized care ancillary costs will be paid on a pass-through basis for those Medicaid specialized care patients who do not have Medicare or any other sufficient third-party insurance coverage. Ancillary costs will be reimbursed as follows:

a. All covered ancillary services, except kinetic therapy devices, will be reimbursed for reasonable costs as defined in the current NHPS. Effective for specialized care days on or after January 15, 2007, reimbursement for reasonable costs shall be subject to a ceiling. The ceiling shall be $238.81 per day for calendar year 2004 (150% of average costs) and shall be inflated to the appropriate provider fiscal year. For cost report years beginning in each calendar year, ancillary ceilings will be inflated using the moving average for the second quarter of the year, taken from the Virginia Specific Nursing Home Input Price Index published by Global Insight or its successor for the fourth quarter of the previous year based on 12VAC30-90-41. See 12VAC30-90-290 for the cost reimbursement limitations.

b. Kinetic therapy devices will have a limit per day (based on 1994 audited cost report data inflated to the rate period). See 12VAC30-90-290 for the cost reimbursement limitations.

c. Kinetic therapy devices will be reimbursed only if a resident is being treated for wounds that meet the following wound care criteria. Residents receiving this wound care must require kinetic bed therapy (that is, low air loss mattresses, fluidized beds, and/or rotating/turning beds) and require treatment for a grade (stage) IV decubitus, a large surgical wound that cannot be closed, or second to third degree burns covering more than 10% of the body.

9. 8. Covered ancillary services are defined as follows: laboratory, X-ray, medical supplies (e.g., infusion pumps, incontinence supplies), physical therapy, occupational therapy, speech therapy, inhalation therapy, IV therapy, enteral feedings, and kinetic therapy. The following are not specialized care ancillary services and are excluded from specialized care reimbursement: physician services, psychologist services, total parenteral nutrition (TPN), and drugs. These services must be separately billed to DMAS. An interim rate for the covered ancillary services will be determined (using data from the most recent settled cost report) by dividing allowable ancillary costs by the number of patient days for the same cost reporting period. The interim rate will be retroactively cost settled based on the specialized care nursing facility cost reporting period.

10. 9. Capital costs. Effective July 1, 2001, capital cost reimbursement shall be in accordance with 12VAC30-90-35 through 12VAC30-90-37 inclusive, except that the 90% occupancy requirement shall not be separately applied to specialized care. Capital cost related to specialized care patients will be cost settled on the respective nursing facility's cost reporting period. In this cost settlement the 90% occupancy requirement shall be applied to all the nursing facility's licensed nursing facility beds inclusive of specialized care.

To apply this requirement, the following calculation shall be carried out:

a. Licensed beds, including specialized care beds, times days in the cost reporting period shall equal available days.

b. 90% of available days shall equal 90% occupancy days.

c. 90% occupancy days, minus actual resident days including specialized care days shall equal the shortfall of days if it is positive. It shall be set to zero if it is negative.

d. Actual resident days not including specialized care days, plus the shortfall of days shall equal the minimum number of days to be used to calculate the capital cost per day.

11. 10. Nurse aide training and competency evaluation programs and competency evaluation programs (NATCEP) costs. NATCEPS costs will be paid on a pass-through basis in accordance with the current NHPS.

12. 11. Pediatric routine operating cost rate. For pediatric specialized care in a distinct part pediatric specialized care unit, one routine operating cost ceiling will be developed. The routine operating cost ceiling will be computed as follows: $418 as of July 1, 2002.

a. The Complex Health Care Payment Rate effective July 1, 1996, and updated for inflation, will be reduced by (i) the weighted average capital cost per day developed from the 1994 audit data and (ii) the weighted average ancillary cost per day from the 1994 audit data updated for inflation in the same manner as described in subdivision 4 a of this subsection.

b. a. The statewide operating ceiling shall be adjusted for each nursing facility in the same manner as described in subdivisions subdivision 4 and 5 of this section.

c. b. The final routine operating cost reimbursement rate shall be computed as described for other than pediatric units in subdivision 3 of this section.

13. 12. Pediatric unit capital cost. Pediatric unit capital costs will be reimbursed in accordance with the current NHPS, except that the occupancy requirement shall be 70% rather than 90%.

14. MDS data submission. MDS data relating to specialized care patients must be submitted to the department in a submission separate from that which applies to all nursing facility patients.

a. Within 30 days of the end of each month, each specialized care nursing facility shall submit to the department, separately from its submission of MDS data for all patients, a copy of each MDS Version 2.0 which has been completed in the month for a Medicaid specialized care patient in the nursing facility. This shall include (i) the MDS required within 14 days of admission to the nursing facility (if the patient is admitted as a specialized care patient), (ii) the one required by the department upon admission to specialized care, (iii) the one required within 12 months of the most recent full assessment, and (iv) the one required whenever there is a significant change of status.

b. In addition to the monthly data submission required in subdivision 14 a of this section, the same categories of MDS data required in subdivision 14 a of this section shall be submitted for all patients receiving specialized care from January 1, 1996, through December 31, 1996, and shall be due February 28, 1997.

c. If a provider does not submit a complete MDS record for any patient within the required timeframe, the department shall assume that the RUG-III weight for that patient, for any time period for which a complete record is not provided, is the lowest RUG-III weight in use for specialized care patients. A complete MDS record is one that is complete for purposes of transmission and acceptance by the Health Care Financing Administration.

15. Case mix measures in the initial semiannual periods. In any semiannual periods for which calculations in 12VAC39-90-310 requires an NCMI from a semiannual period beginning before January 1996, the case mix used shall be the case mix applicable to the first semiannual period beginning after January 1, 1996, that is a semiannual period in the respective provider's fiscal period. For example, December year-end providers' rates applicable to the month of December 1996, would normally require (in Appendix I (12VAC30-90-270 et seq.) of Part III of this chapter) an NCMI from July to December 1995, and one from January to June 1996, to calculate a rate for July to December 1996. However, because this calculation requires an NCMI from a period before January 1996, the NCMIs that shall be used will be those applicable to the next semiannual period. The NCMI from January to June 1996, and from July to December 1996, shall be applied to December 1996, as well as to January to June 1997. Similarly, a provider with a March year end would have it's rate in December 1996, through March 1997, calculated based on an NCMI from April through September 1996, and October 1996, through March 1997.

16. Cost reports of specialized care providers are due not later than 150 days after the end of the provider's fiscal year. Except for this provision, the 13. The cost reporting requirements of 12VAC30-90-70 and 12VAC30-90-80 shall apply to specialized care providers.

Titles of Regulations: 12VAC30-50. Amount, Duration, and Scope of Medical and Remedial Care Services (amending 12VAC30-50-140, 12VAC30-50-150, 12VAC30-50-180; adding 12VAC30-50-228, 12VAC30-50-491).

12VAC30-60. Standards Established and Methods Used to Assure High Quality Care (adding 12VAC30-60-180, 12VAC30-60-185).

12VAC30-80. Methods and Standards for Establishing Payment Rates; other Types of Care (adding 12VAC30-80-32).

12VAC30-120. Waivered Services (amending 12VAC30-120-310, 12VAC30-120-380).

Statutory Authority: §§32.1-324 and 32.1-325 of the Code of Virginia.

Effective Dates: July 1, 2007, through December 29, 2008.

The Department of Medical Assistance Services requested an extension of the above-referenced emergency regulations pursuant to § 2.2-4011 of the Code of Virginia. The emergency regulations were published in 23:21 3510-3519 June 25, 2007 (http://legis.state.va.us/codecomm/register/vol23/iss21/v23i21.pdf) with effective dates of July 1, 2007, through June 30, 2008.

The 2007 Acts of Assembly, Chapter 847, Item 302 PPP required that the Department of Medical Assistance Services (DMAS) amend the State Plan for Medical Assistance to provide coverage of substance abuse treatment services for children and adults, effective July 1, 2007. Substance Abuse Treatment Services were implemented on that date, with a proposed regulation following the emergency regulation. Following the implementation of the services, DMAS submitted to the Centers for Medicare and Medicaid Services (CMS), the federal agency that authorizes states to make changes to their Medicaid programs, would require substantial changes to Virginia’s new coverage of Substance Abuse Treatment Services (SAS). DMAS is still involved in protracted negotiations with CMS regarding reimbursement for SAS, as well the implementation of case management services for SAS. This last issue is one of national importance, with Congress currently passing legislation to put a moratorium on CMS’ regulations on this issue. The final nature of the SAS regulations is therefore yet to be determined.

The Governor approved the department's request to extend the expiration date of the emergency regulations for six months as provided in § 2.2-4011 D of the Code of Virginia. Therefore, the regulations will continue in effect through December 29, 2008.

Agency Contact: Catherine Hancock, Policy & Research Division, Department of Medical Assistance Services, 600 East Broad Street, Suite 1300, Richmond, VA 23219, telephone (804) 225-4272, FAX (804) 786-1680, or email catherine.hancock@dmas.virginia.gov.

Titles of Regulations: 12VAC30-70. Methods and Standards for Establishing Payment Rates - Inpatient Hospital Services (amending 12VAC30-70-70, 12VAC30-70-261, 12VAC30-70-271, 12VAC30-70-500).

12VAC30-90. Methods and Standards for Establishing Payment Rates for Long-Term Care (amending 12VAC30-90-264).

Statutory Authority: §§32.1-324 and 32.1-325 of the Code of Virginia.

Public Hearing Information: No public hearings are scheduled.

Public Comments: Public comments may be submitted until November 12, 2008.

Effective Date: November 27, 2008.

Agency Contact: James Branham, Project Manager, Department of Medical Assistance Services, 600 East Broad Street, Richmond, VA 23219, telephone (804) 225-4587, FAX (804) 786-1680, or email james.branham@dmas.virginia.gov.

Basis: Section 32.1-325 of the Code of Virginia grants to the Board of Medical Assistance Services the authority to administer and amend the Plan for Medical Assistance. Section 32.1-324 of the Code of Virginia authorizes the Director of DMAS to administer and amend the Plan for Medical Assistance according to the board's requirements. The Medicaid authority as established by § 1902 (a) of the Social Security Act (42 USC §1396a) provides governing authority for payments for services.

Purpose: The purpose of the regulation is to simplify hospital and specialized care nursing facility reimbursement either by eliminating unnecessary hospital and specialized care nursing facility requirements or by making the specialized care nursing facility reimbursement similar to the regular nursing facility reimbursement. Both proposals are budget neutral and the reimbursement impact on providers would be negligible. Both proposals would reduce DMAS and provider administrative costs associated with reporting and recordkeeping activities.

Rationale for Using Fast-Track Process: DMAS consulted with the Virginia Hospital and Healthcare Association and the Association (VHHA) representative indicated that the VHHA would not object to eliminating recapture of hospital depreciation. Medicare has already eliminated hospital depreciation recapture. Sometimes hospital depreciation recapture benefits DMAS and other times it benefits the provider. However, in either case the funds involved are not material and it is necessary for DMAS and the provider to review cost reports related to the original hospital depreciation, which may be many years old. Neither party considers the recordkeeping a good use of resources. The VHHA also agrees that it is not necessary to have the hospital outlier methodology illustration in regulation. DMAS intends to put an outlier calculation spreadsheet on its website.

DMAS consulted with the Virginia Health Care Association and providers receiving specialized care reimbursement under the current system. DMAS presented information regarding how the proposed simplification would have effected reimbursement if the simplification had been in place. Providers agreed that simplification would reduce administrative reporting requirements and make it easier for providers to estimate reimbursement.

Substance:

Eliminate Recapture of Hospital Depreciation

Under current policy, DMAS must “recapture” depreciation when a hospital is sold. DMAS reimburses hospitals for depreciation based on standard depreciation schedules. When a hospital is sold, the seller may experience a windfall if the sale price exceeds the reimbursed depreciation or the seller may experience a loss if the sale price is less than the reimbursed depreciation. If the seller experiences a windfall, DMAS will recapture hospital depreciation; if the seller experiences a loss, DMAS will cover the loss. When a sale occurs, therefore, the seller and DMAS have to calculate the windfall or loss based on the original records. Hospital sales are relatively infrequent, the windfall or loss is usually not large and the net payments/recoveries for DMAS are close to zero. In many cases, this is the only reason for storing older cost reports since Medicare eliminated recapture of hospital depreciation a number of years ago. DMAS and the hospital association agree that there is little cost/benefit in continuing the recapture of hospital depreciation and therefore this regulation would eliminate it.

Eliminate Hospital Outlier Illustration

12VAC30-70-261 are the regulations for the hospital outlier methodology. The subsection to be eliminated is only an illustration that is now more than 10 years out of date. DMAS intends to publish annual hospital outlier calculation worksheets on the DMAS website and therefore it makes more sense to eliminate this subsection than to revise it.

Simplify Reimbursement of Specialized Care Nursing Facility Services

The goals of the planned regulatory action are to reduce unnecessary complexity and reduce administrative burden associated with the method used to determine nursing facility payment rates for adult and pediatric specialized care.

The current specialized care payment rate calculation method uses the Resource Utilization Group System (RUGS III) nursing only index to calculate each facility’s average normalized case mix index (NCMI), which is the measure of each facility’s average patient severity level normalized by the average of all specialized care patients in the state. Ceilings and payment rates are adjusted by the NCMI, in order to avoid overpayments to facilities with a less severe patient population and to ensure adequate payments to facilities that have a more severe patient population, relative to the state average. When this reimbursement methodology was developed there were approximately 40 adult specialized care providers serving recipients with ventilator, rehabilitation and complex care needs. Since 2003, however, adult specialized care serves only ventilator patients. As a result, there are less than 10 adult specialized care providers with a much more homogenous patient population. Pediatric specialized care still covers all categories, but the patients in the two pediatric specialized care facilities have very similar resource needs. In both the adult and pediatric specialized care facilities, specialized care facility NCMI scores are very close to 1.0 (the same as the state average) and application of the NCMI adjustment has a negligible effect on payment rates and is unnecessary.

Based on the provider and patient changes, there is no longer a compelling reason to continue adjusting rates and ceilings by the NCMI, especially given the extra work this requires and other disadvantages. DMAS uses the services of an outside accounting firm to calculate specialized care NCMI scores and rate adjustments. Specialized care facilities are required to send in additional MDS data on a monthly basis and the calculations cannot be completed until all facilities have sent in this data. Providers have indicated to DMAS that the additional work is a burden and the lack of timeliness in finalizing rates is frustrating.

Along with eliminating the NCMI, DMAS is proposing two additional changes to further simplify the methodology by conforming the inflation adjustment and occupancy requirements to the methodology used in regular nursing facility reimbursement.

The current inflation methodology for specialized care reimbursement was also used for regular nursing facility reimbursement until July 1, 2002. This methodology involves a combination of historical and anticipated inflation, annual revisions and quarterly inflation updates. The new, simpler inflation methodology adopted effective July 1, 2002, for regular nursing facility reimbursement updates inflation annually using a single inflation factor. The inflation methodology used for specialized care reimbursement, however, was not changed. This regulation would require that the specialized care reimbursement use the simpler inflation methodology utilized for regular nursing facility reimbursement.

Additionally, this regulatory action will require adult specialized care reimbursement to use the same 90% occupancy requirement used in the regular nursing facility reimbursement. Under current regulations the occupancy requirement only applies to regular nursing facilities not to adult specialized care even though occupancy is already calculated by using total facility paid days, including specialized care days, as a percentage of total available days. DMAS does not anticipate that capital reimbursement for specialized care facilities would be frequently affected by this change, but, in any event, the special consideration is not justified. The lower 70% occupancy requirement for pediatric specialized care would not change.

Issues: The advantage to both the hospital and nursing facility providers of this change is the reduction of paperwork that is required by the policies being changed by this action. The advantage to DMAS with this change will be the simplification of both the inpatient hospital and nursing facility cost settlement process. There are no disadvantages to the Commonwealth for this action. The changes do not have a fiscal impact and they eliminate unnecessary administrative burdens on both DMAS and providers.

The Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The proposed regulations will simplify Medicaid hospital and specialized care reimbursement methodologies.

Result of Analysis. The benefits likely exceed the costs for all proposed changes.

Estimated Economic Impact. Department of Medical Assistance Services (DMAS) proposes to simplify Medicaid hospital and specialized care reimbursement methodologies.

The specialized care nursing facility reimbursement will be simplified by eliminating the case mix adjustment and using the same inflation method used in the regular nursing facility reimbursement methodology. The reason for eliminating case mix adjustment is the fact that these facilities currently cover only ventilator dependent patients leading to very homogeneous mix of cases. In the past, the patient mix was heterogeneous because complex health and comprehensive services were covered by adult specialized care facilities.

Also, the specialized care nursing facility inflation methodology is much more complex than the inflation methodology for regular nursing facilities. The proposed changes will adopt the simpler regular nursing facility inflation methodology for specialized care nursing facilities.

Furthermore, DMAS proposes a new statewide ceiling so as to maintain the budget neutrality after the proposed changes. So, there is no net significant fiscal effect is expected as a result of the proposed changes. However, simplified reimbursement methodology is expected to reduce administrative costs and staff time at DMAS. Providers are expected to experience similar benefits.

Another change proposed will eliminate recapture of hospital depreciation when a provider hospital is sold. DMAS currently reimburses hospitals for depreciation. Any loss or gain that may accrue to the seller when a hospital is sold is paid or recovered by DMAS. It is reported that hospital sales are rare, the seller losses or gains are insignificant, and net payments or recoveries by DMAS are close to zero. Thus, no large fiscal effect is expected from eliminating the recapture of hospital depreciation as proposed. However, this proposed change will remove the sole reason that many hospitals and DMAS have been storing older cost reports and provide some savings.

The fiscal savings in administrative expenses and staff time at DMAS are estimated to be about $50,000. Similar savings are likely to accrue to the providers as well.

Finally, DMAS is proposing to remove an example contained in the regulations. DMAS intends to provide access to a similar example on its website. Thus, while providers will likely still have access to the same information through the website, DMAS will not be required to update its regulations every time when assumptions in the example changes.

Businesses and Entities Affected. These regulations apply to 8 providers of specialized care and approximately 95 hospitals.

Localities Particularly Affected. The proposed regulations apply throughout the commonwealth.

Projected Impact on Employment. The proposed simplified methodologies and reduced recordkeeping requirements are expected to reduce demand for labor.

Effects on the Use and Value of Private Property. No significant effect on the use and value of private property is expected.

Small Businesses: Costs and Other Effects. None of the effected entities are believed to be small businesses.

Small Businesses: Alternative Method that Minimizes Adverse Impact. The proposed changes are not estimated to have an adverse impact on small businesses.

Real Estate Development Costs. No significant effect on the real estate development costs is expected.

Legal Mandate. The Department of Planning and Budget (DPB) has analyzed the economic impact of this proposed regulation in accordance with § 2.2-4007.04 of the Administrative Process Act and Executive Order Number 36 (06). Section 2.2-4007.04 requires that such economic impact analyses include, but need not be limited to, the projected number of businesses or other entities to whom the regulation would apply, the identity of any localities and types of businesses or other entities particularly affected, the projected number of persons and employment positions to be affected, the projected costs to affected businesses or entities to implement or comply with the regulation, and the impact on the use and value of private property. Further, if the proposed regulation has adverse effect on small businesses, § 2.2-4007.04 requires that such economic impact analyses include (i) an identification and estimate of the number of small businesses subject to the regulation; (ii) the projected reporting, recordkeeping, and other administrative costs required for small businesses to comply with the regulation, including the type of professional skills necessary for preparing required reports and other documents; (iii) a statement of the probable effect of the regulation on affected small businesses; and (iv) a description of any less intrusive or less costly alternative methods of achieving the purpose of the regulation. The analysis presented above represents DPB’s best estimate of these economic impacts.

Agency's Response to the Department of Planning and Budget's Economic Impact Analysis: The agency concurs with the economic impact analysis prepared by the Department of Planning and Budget regarding the regulations concerning Simplify Hospital and Specialized Care Reimbursement (12VAC30-70-70, 12VAC30-70-261, 12VAC30-70-271, 12VAC30-70-500 and 12VAC30-90-264).

Summary:

The amendments accomplish several reimbursement methodology changes designed to simplify provider reimbursement. The first is to simplify hospital reimbursement by eliminating recapture of hospital depreciation when a hospital is sold; this also eliminates the associated recordkeeping. The amendments also eliminate the hospital outlier illustration, which is outdated.

The regulation simplifies reimbursement for specialized care nursing facilities by (i) eliminating the case mix adjustment and (ii) using the same inflation method and capital rate calculation used in the regular nursing facility reimbursement methodology. After recent changes to the covered groups, there is no longer a justification for the case mix adjustment and the associated reporting. The changes are budget neutral.

12VAC30-70-70. Revaluation of assets.

A. Effective October 1, 1984 July 1, 2008, the valuation of an asset of a hospital or long-term care facility which has undergone a change of ownership on or after July 18, 1984, shall be the lesser of the seller's allowable acquisition depreciated historical cost to (net book value) as determined for Medicaid reimbursement of the owner of record as of July 18, 1984, or the acquisition cost to the new owner.

B. In the case of an asset not in existence as of July 18, 1984, the valuation of an asset of a hospital or long-term care facility shall be the lesser of the seller's allowable depreciated historical cost (net book value) as determined for Medicaid reimbursement of the first owner of record, or the acquisition cost to the new owner.

C. In establishing appropriate allowance for depreciation, interest on capital indebtedness, and return on equity (if applicable prior to July 1, 1986) the base to be used for such computations shall be limited to subsection A or B above of this section.

D. Costs (including legal fees, accounting and administrative costs, travel costs, and feasibility studies) attributable to the negotiation or settlement of the sale or purchase of any capital asset (by acquisition or merger) shall be reimbursable only to the extent that they have not been previously reimbursed by Medicaid.

E. The recapture of depreciation up to the full value of the asset is required.

F. E. Rental charges in sale and leaseback agreements shall be restricted to the depreciation, mortgage interest and (if applicable prior to July 1, 1986) return on equity based on cost of ownership as determined in accordance with subsections A. and B. above of this section.

12VAC30-70-261. Outlier operating payment.

A. An outlier operating payment shall be made for outlier cases. This payment shall be added to the operating payments determined in 12VAC30-70-231 and 12VAC30-70-251. Eligibility for the outlier operating payment and the amount of the outlier operating payment shall be determined as follows:

1. The hospital's adjusted operating cost for the case shall be estimated. This shall be equal to the hospital's total charges for the case times the hospital's operating cost-to-charge ratio, as defined in subsection C of 12VAC30-70-221, times the adjustment factor specified in 12VAC30-70-331 B.

2. The adjusted outlier operating fixed loss threshold shall be calculated as follows:

a. The outlier operating fixed loss threshold shall be multiplied by the statewide average labor portion of operating costs, yielding the labor portion of the outlier operating fixed loss threshold. Hence, the nonlabor portion of the outlier operating fixed loss threshold shall constitute one minus the statewide average labor portion of operating costs times the outlier operating fixed loss threshold.

b. The labor portion of the outlier operating fixed loss threshold shall be multiplied by the hospital's Medicare wage index, yielding the wage adjusted labor portion of the outlier operating fixed loss threshold.

c. The wage adjusted labor portion of the outlier operating fixed loss threshold shall be added to the nonlabor portion of the outlier operating fixed loss threshold, yielding the wage adjusted outlier operating fixed loss threshold.

3. The hospital's outlier operating threshold for the case shall be calculated. This shall be equal to the wage adjusted outlier operating fixed loss threshold times the adjustment factor specified in 12VAC30-70-331 B plus the hospital's operating payment for the case, as determined in 12VAC30-70-231 or 12VAC30-70-251.

4. The hospital's outlier operating payment for the case shall be calculated. This shall be equal to the hospital's adjusted operating cost for the case minus the hospital's outlier operating threshold for the case. If the difference is less than or equal to zero, then no outlier operating payment shall be made. If the difference is greater than zero, then the outlier operating payment shall be equal to the difference times the outlier adjustment factor.

B. An illustration of the above methodology is found in 12VAC30-70-500.

C. B. The outlier operating fixed loss threshold shall be recalculated using base year data when the DRG payment system is recalibrated and rebased. The threshold shall be calculated so as to result in an expenditure for outlier operating payments equal to 5.1% of total operating payments, including outlier operating payments, for DRG cases. The methodology described in subsection A of this section shall be applied to all base year DRG cases on an aggregate basis, and the amount of the outlier operating fixed loss threshold shall be calculated so as to exhaust the available pool for outlier operating payments.

12VAC30-70-271. Payment for capital costs.

A. Inpatient capital costs shall be determined on an allowable cost basis and settled at the hospital's fiscal year end. Allowable cost shall be determined following the methodology described in Supplement 3 (12VAC30-70-10 through 12VAC30-70-130). Inpatient capital costs of Type One hospitals shall continue to be settled at 100% of allowable cost. For services beginning July 1, 2003, inpatient capital costs of Type Two hospitals shall be settled at 80% of allowable cost. For hospitals with fiscal years that do not begin on July 1, 2003, inpatient capital costs for the fiscal year in progress on that date shall be apportioned between the time period before and the time period after that date based on the number of calendar months before and after that date. Capital costs apportioned before that date shall be settled at 100% of allowable cost, and those after at 80% of allowable cost.

B. The exception to the policy in subsection A of this section is that the hospital specific rate per day for services in freestanding psychiatric facilities licensed as hospitals, as determined in 12VAC30-70-321 B, shall be an all-inclusive payment for operating and capital costs.

C. Until prospective payment for capital costs is implemented, the provisions of 12VAC30-70-70 regarding recapture of depreciation shall remain in effect.

12VAC30-70-500. Outlier methodology illustration. (Repealed.)

OUTLIER METHODOLOGY ILLUSTRATION (dollar amounts and other values are for illustration purposes only)
	Assume the Following:
	Medicare: Fixed Loss Cost Outlier Threshold for Fiscal Year 1996		$15,150.00
	Medicare: Marginal Cost Factor for Cost Outliers for Fiscal Year 1996		0.8000
	Hospital X Operating Cost-to-Charge Ratio		0.7200
	Hospital X Capital Cost-to-Charge Ratio		0.0600
	Medicare Wage Index for Hospital X		0.9413
	Statewide Average Labor Portion of Operating Costs		0.5977
	Hospital X Billed Charges for Case Y		$100,000.00
	Total Adjusted Costs per Case for Hospital X		$3,115.00
	Relative Weight for Case Y		3.1790
	Adjustment Factor for DRG Cases		0.6197
Step 1	Calculate Hospital X Operating Costs for Case Y:
	Hospital X Billed Charges for Case Y		$100,000.00
	Hospital X Operating Cost-to-Charge Ratio	x	.7200
	Hospital X Operating Costs for Case Y		$72,000.00
Step 2	Calculate Hospital X DRG Operating Amount for Case Y:
	Total Adjusted Operating Costs per Case for Hospital X		$3,115.00
	Relative Weight for Case Y	x	3.1790
	Hospital X DRG Operating Amount for Case Y		$9,902.59
Step 3	Calculate Hospital X Cost Outlier Threshold for Case Y:
	Fixed Loss Cost Outlier Threshold		$15,150.00
	Statewide Average Labor Portion of Operating Costs	x	0.5977
	Labor Portion of Fixed Loss Cost Outlier Threshold		$9,055.16
	Wage Index for Hospital X	x	0.9413
	Wage Adjusted Labor Portion of Fixed Loss Cost Outlier Threshold		$8,523.62
	Non-Labor Portion of Fixed Loss Cost Outlier Threshold	+	$6,094.85
	Wage Adjusted Fixed Loss Cost Outlier Threshold		$14,618.46
	Hospital X DRG Operating Amount for Case Y	+	$9,902.59
	Hospital X Cost Outlier Threshold for Case Y		$24,521.05
Step 4	Calculate Hospital X Operating Outlier Amount for Case Y:
	Hospital X Operating Costs for Case Y		$72,000.00
	Hospital X Cost Outlier Threshold for Case Y	-	$24,521.05
	Hospital X Operating Outlier Costs for Case Y		$47,478.95
	Marginal Cost Factor for Cost Outliers	x	0.8000
	Hospital X Operating Outlier Amount for Case Y		$37,983.16
Step 5	Calculate Hospital X Total Payment for Case Y:
	Hospital X DRG Operating Amount for Case Y		$9,902.59
	Hospital X Operating Outlier Amount for Case Y	+	$37,983.16
	Hospital X Total Amount for Case Y		$47,885.75
	Adjustment Factor for DRG Cases	x	0.6197
	Hospital X Total Payment for Case Y		$29,674.80

Subpart XVII
Specialized Care Services

12VAC30-90-264. Specialized care services.

Specialized care services provided in conformance with 12VAC30-60-40 E and H, 12VAC30-60-320 and 12VAC30-60-340 shall be reimbursed under the following methodology. The nursing facilities that provide adult specialized care for the categories of Ventilator Dependent Care, will be placed in one group for rate determination. The nursing facilities that provide pediatric specialized care in a dedicated pediatric unit of eight beds or more will be placed in a second group for rate determination.

1. Routine operating cost. Routine operating cost shall be defined as in 12VAC30-90-271 and 12VAC30-90-272. To calculate the routine operating cost reimbursement rate, routine operating cost shall be converted to a per diem amount by dividing it by actual patient days.

2. Allowable cost identification and cost reimbursement limitations. The provisions of Article 5 (12VAC30-90-50 et seq.) of Subpart II of Part II of this chapter and of Appendix III (12VAC30-90-290) of Part III of this chapter shall apply to specialized care cost and reimbursement.

3. Routine operating cost rates. Each facility shall be reimbursed a prospective rate for routine operating costs. This rate will be the lesser of the facility-specific prospective routine operating ceiling, or the facility-specific prospective routine operating cost per day plus an efficiency incentive. This efficiency incentive shall be calculated by the same method as in 12VAC30-90-41.

4. Facility-specific prospective routine operating ceiling. Each nursing facility's prospective routine operating ceiling shall be calculated as:

a. Statewide ceiling. The statewide routine operating ceiling shall be $415 as of July 1, 2002. the weighted average (weighted by 1994 days) of specialized care rates in effect on July 1, 1996, reduced by statewide weighted average ancillary and capital cost per day amounts based on audited 1994 cost data from the 12 facilities whose 1994 FY specialized care costs were audited during 1996. This routine operating ceiling amount shall be adjusted for inflation by the percentage of change in the moving average of the Virginia specific Skilled Nursing Facility Market Basket of Routine Service Costs, as developed by DRI/McGraw-Hill, using the second quarter 1996 DRI table. The respective statewide operating ceilings will be adjusted each quarter in which the provider's most recent fiscal year ends, by adjusting the most recent interim ceiling by 100% of historical inflation and 50% of forecasted inflation to the end of the provider's next fiscal year based on 12VAC30-90-41.

b. The portion of the statewide routine operating ceiling relating to nursing salaries (as determined by the 1994 audited cost report data, or 67.22%) will be wage adjusted using a normalized wage index. The normalized wage index shall be the wage index applicable to the individual provider's geographic location under Medicare rules of reimbursement for skilled nursing facilities, divided by the statewide average of such wage indices across the state. This normalization of wage indices shall be updated January 1, after each time the Health Care Financing Administration (HCFA) publishes wage indices for skilled nursing facilities. Updated normalization shall be effective for fiscal years starting on and after the January 1 for which the normalization is calculated.

c. The percentage of the statewide routine operating ceiling relating to the nursing labor and nonlabor costs (as determined by the 1994 audited cost report data or 71.05%) will be adjusted by the nursing facility's specialized care average Resource Utilization Groups, Version III (RUG-III) Nursing-Only Normalized Case Mix Index (NCMI). The NCMI for each nursing facility will be based on all specialized care patient days rendered during the six-month period prior to that in which the ceiling applies (see subdivision 6 of this section).

5. Normalized case mix index (NCMI). Case mix shall be measured by RUG-III nursing-only index scores based on Minimum Data Set (MDS) data. The RUG-III nursing-only weights developed at the national level by the Health Care Financing Administration (HCFA) (see 12VAC30-90-320) shall be used to calculate a facility-specific case mix index (CMI). The facility-specific CMI, divided by the statewide CMI shall be the facility's NCMI. The steps in the calculation are as follows:

a. The facility-specific CMI for purposes of this rate calculation shall be the average of the national RUG-III Nursing-Only weights calculated across all patient days in the facility during the six months prior to the six-month period to which the NCMI shall be applied to the facility's routine operating cost and ceiling.

b. The statewide CMI for purposes of this rate calculation shall be the average of the national RUG-III Nursing-Only weights calculated across all specialized care patient days in all Specialized Care Nursing facilities in the state during the six months prior to the six-month period to which the NCMI shall be applied. A new statewide CMI shall be calculated for each six-month period for which a provider-specific rate must be set.

c. The facility-specific NCMI for purposes of this rate calculation shall be the facility-specific CMI from subdivision 5 a of this section divided by the statewide CMI from subdivision 5 b of this section.

d. Each facility's NCMI shall be updated semiannually, at the start and the midpoint of the facility's fiscal year.

e. Patient days for which the lowest RUG-III weight is imputed, as provided in subdivision 14 c of this section, shall not be included in the calculation of the NCMI.

6. 5. Facility-specific prospective routine operating base cost per day: The facility-specific routine operating cost per day to be used in the calculation of the routine operating rate and the efficiency incentive shall be the actual routine cost per day from the most recent fiscal year's cost report, adjusted (using DRI-Virginia inflation factors) by 50% of historical inflation and 50% of the forecasted inflation, and adjusted for case mix as described below: for inflation based on 12VAC30-90-41.

a. An NCMI rate adjustment shall be applied to each facility's prospective routine nursing labor and nonlabor operating base cost per day for each semiannual period of the facility's fiscal year.

b. The NCMI calculated for the second semiannual period of the previous fiscal year shall be divided by the average of that (previous) fiscal year's two semiannual NCMIs to yield an "NCMI cost rate adjustment" to the prospective nursing labor and nonlabor operating cost base rate in the first semiannual period of the subsequent fiscal year.

c. The NCMI determined in the first semiannual period of the subsequent fiscal year shall be divided by the average of the previous fiscal year's two semiannual NCMIs to determine the NCMI cost rate adjustment to the prospective nursing labor and nonlabor operating base cost per day in the second semiannual period of the subsequent fiscal year.

See 12VAC30-90-310 for an illustration of how the NCMI is used to adjust routine operating cost ceilings and semiannual NCMI adjustments to the prospective routine operating base cost rates.

7. 6. Interim rates. Interim rates, for processing claims during the year, shall be calculated from the most recent settled cost report and Minimum Data Set (MDS) data available at the time the interim rates must be set, except that failure to submit a cost and MDS data report timely may result in adjustment to interim rates as provided elsewhere.

8. 7. Ancillary costs. Specialized care ancillary costs will be paid on a pass-through basis for those Medicaid specialized care patients who do not have Medicare or any other sufficient third-party insurance coverage. Ancillary costs will be reimbursed as follows:

a. All covered ancillary services, except kinetic therapy devices, will be reimbursed for reasonable costs as defined in the current NHPS. Effective for specialized care days on or after January 15, 2007, reimbursement for reasonable costs shall be subject to a ceiling. The ceiling shall be $238.81 per day for calendar year 2004 (150% of average costs) and shall be inflated to the appropriate provider fiscal year. For cost report years beginning in each calendar year, ancillary ceilings will be inflated using the moving average for the second quarter of the year, taken from the Virginia Specific Nursing Home Input Price Index published by Global Insight or its successor for the fourth quarter of the previous year based on 12VAC30-90-41. See 12VAC30-90-290 for the cost reimbursement limitations.

b. Kinetic therapy devices will have a limit per day (based on 1994 audited cost report data inflated to the rate period). See 12VAC30-90-290 for the cost reimbursement limitations.

c. Kinetic therapy devices will be reimbursed only if a resident is being treated for wounds that meet the following wound care criteria. Residents receiving this wound care must require kinetic bed therapy (that is, low air loss mattresses, fluidized beds, and/or rotating/turning beds) and require treatment for a grade (stage) IV decubitus, a large surgical wound that cannot be closed, or second to third degree burns covering more than 10% of the body.

9. 8. Covered ancillary services are defined as follows: laboratory, X-ray, medical supplies (e.g., infusion pumps, incontinence supplies), physical therapy, occupational therapy, speech therapy, inhalation therapy, IV therapy, enteral feedings, and kinetic therapy. The following are not specialized care ancillary services and are excluded from specialized care reimbursement: physician services, psychologist services, total parenteral nutrition (TPN), and drugs. These services must be separately billed to DMAS. An interim rate for the covered ancillary services will be determined (using data from the most recent settled cost report) by dividing allowable ancillary costs by the number of patient days for the same cost reporting period. The interim rate will be retroactively cost settled based on the specialized care nursing facility cost reporting period.

10. 9. Capital costs. Effective July 1, 2001, capital cost reimbursement shall be in accordance with 12VAC30-90-35 through 12VAC30-90-37 inclusive, except that the 90% occupancy requirement shall not be separately applied to specialized care. Capital cost related to specialized care patients will be cost settled on the respective nursing facility's cost reporting period. In this cost settlement the 90% occupancy requirement shall be applied to all the nursing facility's licensed nursing facility beds inclusive of specialized care.

To apply this requirement, the following calculation shall be carried out:

a. Licensed beds, including specialized care beds, times days in the cost reporting period shall equal available days.

b. 90% of available days shall equal 90% occupancy days.

c. 90% occupancy days, minus actual resident days including specialized care days shall equal the shortfall of days if it is positive. It shall be set to zero if it is negative.

d. Actual resident days not including specialized care days, plus the shortfall of days shall equal the minimum number of days to be used to calculate the capital cost per day.

11. 10. Nurse aide training and competency evaluation programs and competency evaluation programs (NATCEP) costs. NATCEPS costs will be paid on a pass-through basis in accordance with the current NHPS.

12. 11. Pediatric routine operating cost rate. For pediatric specialized care in a distinct part pediatric specialized care unit, one routine operating cost ceiling will be developed. The routine operating cost ceiling will be computed as follows: $418 as of July 1, 2002.

a. The Complex Health Care Payment Rate effective July 1, 1996, and updated for inflation, will be reduced by (i) the weighted average capital cost per day developed from the 1994 audit data and (ii) the weighted average ancillary cost per day from the 1994 audit data updated for inflation in the same manner as described in subdivision 4 a of this subsection.

b. a. The statewide operating ceiling shall be adjusted for each nursing facility in the same manner as described in subdivisions subdivision 4 and 5 of this section.

c. b. The final routine operating cost reimbursement rate shall be computed as described for other than pediatric units in subdivision 3 of this section.

13. 12. Pediatric unit capital cost. Pediatric unit capital costs will be reimbursed in accordance with the current NHPS, except that the occupancy requirement shall be 70% rather than 90%.

14. MDS data submission. MDS data relating to specialized care patients must be submitted to the department in a submission separate from that which applies to all nursing facility patients.

a. Within 30 days of the end of each month, each specialized care nursing facility shall submit to the department, separately from its submission of MDS data for all patients, a copy of each MDS Version 2.0 which has been completed in the month for a Medicaid specialized care patient in the nursing facility. This shall include (i) the MDS required within 14 days of admission to the nursing facility (if the patient is admitted as a specialized care patient), (ii) the one required by the department upon admission to specialized care, (iii) the one required within 12 months of the most recent full assessment, and (iv) the one required whenever there is a significant change of status.

b. In addition to the monthly data submission required in subdivision 14 a of this section, the same categories of MDS data required in subdivision 14 a of this section shall be submitted for all patients receiving specialized care from January 1, 1996, through December 31, 1996, and shall be due February 28, 1997.

c. If a provider does not submit a complete MDS record for any patient within the required timeframe, the department shall assume that the RUG-III weight for that patient, for any time period for which a complete record is not provided, is the lowest RUG-III weight in use for specialized care patients. A complete MDS record is one that is complete for purposes of transmission and acceptance by the Health Care Financing Administration.

15. Case mix measures in the initial semiannual periods. In any semiannual periods for which calculations in 12VAC39-90-310 requires an NCMI from a semiannual period beginning before January 1996, the case mix used shall be the case mix applicable to the first semiannual period beginning after January 1, 1996, that is a semiannual period in the respective provider's fiscal period. For example, December year-end providers' rates applicable to the month of December 1996, would normally require (in Appendix I (12VAC30-90-270 et seq.) of Part III of this chapter) an NCMI from July to December 1995, and one from January to June 1996, to calculate a rate for July to December 1996. However, because this calculation requires an NCMI from a period before January 1996, the NCMIs that shall be used will be those applicable to the next semiannual period. The NCMI from January to June 1996, and from July to December 1996, shall be applied to December 1996, as well as to January to June 1997. Similarly, a provider with a March year end would have it's rate in December 1996, through March 1997, calculated based on an NCMI from April through September 1996, and October 1996, through March 1997.

16. Cost reports of specialized care providers are due not later than 150 days after the end of the provider's fiscal year. Except for this provision, the 13. The cost reporting requirements of 12VAC30-90-70 and 12VAC30-90-80 shall apply to specialized care providers.

Titles of Regulations: 12VAC30-5. Public Participation Guidelines (adding 12VAC30-5-10 through 12VAC30-5-110).

12VAC30-100. State Programs (repealing 12VAC30-100-10 through 12VAC30-100-60).

Statutory Authority: §§2.2-4007.02 et seq. and 32.1-324 of the Code of Virginia.

Effective Date: November 12, 2008.

Agency Contact: Brian McCormick, Regulatory Supervisor, Department of Medical Assistance Services, 600 E. Broad St., Suite 1300, Richmond, VA 23219, telephone (804) 371-8856, FAX (804) 786-1680, TTY (800) 343-0634, or email brian.mccormick@dmas.virginia.gov.

Summary:

The regulations comply with the legislative mandate (Chapter 321, 2008 Acts of Assembly) that agencies adopt model public participation guidelines issued by the Department of Planning and Budget by December 1, 2008. Public participation guidelines exist to promote public involvement in the development, amendment, or repeal of an agency's regulations.

This regulatory action repeals the current public participation guidelines and promulgates new public participation guidelines as required by Chapter 321 of the 2008 Acts of Assembly. Highlights of the public participation guidelines include (i) providing for the establishment and maintenance of notification lists of interested persons and specifying the information to be sent to such persons; (ii) providing for public comments on regulatory action; (iii) establishing the time period during which public comments shall be accepted; (iv) providing that the plan to hold a public meeting shall be indicated in any notice of intended regulatory action; (v) providing for the appointment, when necessary, of regulatory advisory panels to provide professional specialization or technical assistance and negotiated rulemaking panels if a regulatory action is expected to be controversial; and (vi) providing for the periodic review of regulations.

CHAPTER 5
PUBLIC PARTICIPATION GUIDELINES

Part I
Purpose and Definitions

12VAC30-5-10. Purpose.

The purpose of this chapter is to promote public involvement in the development, amendment or repeal of the regulations of the Department of Medical Assistance Services. This chapter does not apply to regulations, guidelines, or other documents exempted or excluded from the provisions of the Administrative Process Act (§2.2-4000 et seq. of the Code of Virginia).

12VAC30-5-20. Definitions.

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Administrative Process Act" means Chapter 40 (§2.2-4000 et seq.) of Title 2.2 of the Code of Virginia.

"Agency" means the Department of Medical Assistance Services, which is the unit of state government empowered by the agency's basic law to make regulations or decide cases. Actions specified in this chapter may be fulfilled by state employees as delegated by the agency.

"Basic law" means provisions in the Code of Virginia that delineate the basic authority and responsibilities of an agency.

"Commonwealth Calendar" means the electronic calendar for official government meetings open to the public as required by § 2.2-3707 C of the Freedom of Information Act.

''Negotiated rulemaking panel'' or ''NRP'' means an ad hoc advisory panel of interested parties established by an agency to consider issues that are controversial with the assistance of a facilitator or mediator, for the purpose of reaching a consensus in the development of a proposed regulatory action.

"Notification list" means a list used to notify persons pursuant to this chapter. Such a list may include an electronic list maintained through the Virginia Regulatory Town Hall or other list maintained by the agency.

"Open meeting" means any scheduled gathering of a unit of state government empowered by an agency's basic law to make regulations or decide cases, which is related to promulgating, amending or repealing a regulation.

"Person" means any individual, corporation, partnership, association, cooperative, limited liability company, trust, joint venture, government, political subdivision, or any other legal or commercial entity and any successor, representative, agent, agency, or instrumentality thereof.

"Public hearing" means a scheduled time at which members or staff of the agency will meet for the purpose of receiving public comment on a regulatory action.

"Regulation" means any statement of general application having the force of law, affecting the rights or conduct of any person, adopted by the agency in accordance with the authority conferred on it by applicable laws.

"Regulatory action" means the promulgation, amendment, or repeal of a regulation by the agency.

"Regulatory advisory panel" or "RAP" means a standing or ad hoc advisory panel of interested parties established by the agency for the purpose of assisting in regulatory actions.

"Town Hall" means the Virginia Regulatory Town Hall, the website operated by the Virginia Department of Planning and Budget at www.townhall.virginia.gov, which has online public comment forums and displays information about regulatory meetings and regulatory actions under consideration in Virginia and sends this information to registered public users.

"Virginia Register" means the Virginia Register of Regulations, the publication that provides official legal notice of new, amended and repealed regulations of state agencies, which is published under the provisions of Article 6 (§2.2-4031 et seq.) of the Administrative Process Act.

Part II
Notification of Interested Persons

12VAC30-5-30. Notification list.

A. The agency shall maintain a list of persons who have requested to be notified of regulatory actions being pursued by the agency.

B. Any person may request to be placed on a notification list by registering as a public user on the Town Hall or by making a request to the agency. Any person who requests to be placed on a notification list shall elect to be notified either by electronic means or through a postal carrier.

C. The agency may maintain additional lists for persons who have requested to be informed of specific regulatory issues, proposals, or actions.

D. When electronic mail is returned as undeliverable on multiple occasions at least 24 hours apart, that person may be deleted from the list. A single undeliverable message is insufficient cause to delete the person from the list.

E. When mail delivered by a postal carrier is returned as undeliverable on multiple occasions, that person may be deleted from the list.

F. The agency may periodically request those persons on the notification list to indicate their desire to either continue to be notified electronically, receive documents through a postal carrier, or be deleted from the list.

12VAC30-5-40. Information to be sent to persons on the notification list.

A. To persons electing to receive electronic notification or notification through a postal carrier as described in 12VAC30-5-30, the agency shall send the following information:

1. A notice of intended regulatory action (NOIRA).

2. A notice of the comment period on a proposed, a reproposed, or a fast-track regulation and hyperlinks to, or instructions on how to obtain, a copy of the regulation and any supporting documents.

3. A notice soliciting comment on a final regulation when the regulatory process has been extended pursuant to § 2.2-4007.06 or 2.2-4013 C of the Code of Virginia.

B. The failure of any person to receive any notice or copies of any documents shall not affect the validity of any regulation or regulatory action.

Part III
Public Participation Procedures

12VAC30-5-50. Public comment.

A. In considering any nonemergency, nonexempt regulatory action, the agency shall afford interested persons an opportunity to submit data, views, and arguments, either orally or in writing, to the agency. Such opportunity to comment shall include an online public comment forum on the Town Hall.

1. To any requesting person, the agency shall provide copies of the statement of basis, purpose, substance, and issues; the economic impact analysis of the proposed or fast-track regulatory action; and the agency's response to public comments received.

2. The agency may begin crafting a regulatory action prior to or during any opportunities it provides to the public to submit comments.

B. The agency shall accept public comments in writing after the publication of a regulatory action in the Virginia Register as follows:

1. For a minimum of 30 calendar days following the publication of the notice of intended regulatory action (NOIRA).

2. For a minimum of 60 calendar days following the publication of a proposed regulation.

3. For a minimum of 30 calendar days following the publication of a reproposed regulation.

4. For a minimum of 30 calendar days following the publication of a final adopted regulation.

5. For a minimum of 30 calendar days following the publication of a fast-track regulation.

6. For a minimum of 21 calendar days following the publication of a notice of periodic review.

7. Not later than 21 calendar days following the publication of a petition for rulemaking.

C. The agency may determine if any of the comment periods listed in subsection B of this section shall be extended.

D. If the Governor finds that one or more changes with substantial impact have been made to a proposed regulation, he may require the agency to provide an additional 30 calendar days to solicit additional public comment on the changes in accordance with § 2.2-4013 C of the Code of Virginia.

E. The agency shall send a draft of the agency's summary description of public comment to all public commenters on the proposed regulation at least five days before final adoption of the regulation pursuant to § 2.2-4012 E of the Code of Virginia.

12VAC30-5-60. Petition for rulemaking.

A. As provided in § 2.2-4007 of the Code of Virginia, any person may petition the agency to consider a regulatory action.

B. A petition shall include but is not limited to the following information:

1. The petitioner's name and contact information;

2. The substance and purpose of the rulemaking that is requested, including reference to any applicable Virginia Administrative Code sections; and

3. Reference to the legal authority of the agency to take the action requested.

C. The agency shall receive, consider and respond to a petition pursuant to § 2.2-4007 and shall have the sole authority to dispose of the petition.

D. The petition shall be posted on the Town Hall and published in the Virginia Register.

E. Nothing in this chapter shall prohibit the agency from receiving information or from proceeding on its own motion for rulemaking.

12VAC30-5-70. Appointment of regulatory advisory panel.

A. The agency may appoint a regulatory advisory panel (RAP) to provide professional specialization or technical assistance when the agency determines that such expertise is necessary to address a specific regulatory issue or action or when individuals indicate an interest in working with the agency on a specific regulatory issue or action.

B. Any person may request the appointment of a RAP and request to participate in its activities. The agency shall determine when a RAP shall be appointed and the composition of the RAP.

C. A RAP may be dissolved by the agency if:

1. The proposed text of the regulation is posted on the Town Hall, published in the Virginia Register, or such other time as the agency determines is appropriate; or

2. The agency determines that the regulatory action is either exempt or excluded from the requirements of the Administrative Process Act.

12VAC30-5-80. Appointment of negotiated rulemaking panel.

A. The agency may appoint a negotiated rulemaking panel (NRP) if a regulatory action is expected to be controversial.

B. An NRP that has been appointed by the agency may be dissolved by the agency when:

1. There is no longer controversy associated with the development of the regulation;

2. The agency determines that the regulatory action is either exempt or excluded from the requirements of the Administrative Process Act; or

3. The agency determines that resolution of a controversy is unlikely.

12VAC30-5-90. Meetings.

Notice of any open meeting, including meetings of a RAP or NRP, shall be posted on the Virginia Regulatory Town Hall and Commonwealth Calendar at least seven working days prior to the date of the meeting. The exception to this requirement is any meeting held in accordance with § 2.2-3707 D of the Code of Virginia allowing for contemporaneous notice to be provided to participants and the public.

12VAC30-5-100. Public hearings on regulations.

A. The agency shall indicate in its notice of intended regulatory action whether it plans to hold a public hearing following the publication of the proposed stage of the regulatory action.

B. The agency may conduct one or more public hearings during the comment period following the publication of a proposed regulatory action.

C. An agency is required to hold a public hearing following the publication of the proposed regulatory action when:

1. The agency's basic law requires the agency to hold a public hearing;

2. The Governor directs the agency to hold a public hearing; or

3. The agency receives requests for a public hearing from at least 25 persons during the public comment period following the publication of the notice of intended regulatory action.

D. Notice of any public hearing shall be posted on the Town Hall and Commonwealth Calendar at least seven working days prior to the date of the hearing. The agency shall also notify those persons who requested a hearing under subdivision C 3 of this section.

12VAC30-5-110. Periodic review of regulations.

A. The agency shall conduct a periodic review of its regulations consistent with:

1. An executive order issued by the Governor pursuant to § 2.2-4017 of the Administrative Process Act to receive comment on all existing regulations as to their effectiveness, efficiency, necessity, clarity, and cost of compliance; and

2. The requirements in § 2.2-4007.1 of the Administrative Process Act regarding regulatory flexibility for small businesses.

B. A periodic review may be conducted separately or in conjunction with other regulatory actions.

C. Notice of a periodic review shall be posted on the Town Hall and published in the Virginia Register.

Part I
Public Participation Guidelines

12VAC30-100-10. Definitions. (Repealed.)

The following words and terms, when used in this part, shall have the following meaning, unless the content clearly indicates otherwise.

"Board" means the Board of Medical Assistance Services.

"Director" means the Director of the Department of Medical Assistance Services.

"Department" or "DMAS" means the Department of Medical Assistance Services.

"Formation and development process" means those activities with respect to a specific regulation which occur between the publication of a notice of intent to develop or modify regulations, and the release of the proposed regulation for public comment.

"Regulation" means any statement of general application, having the force of law, affecting the rights or conduct of any person, promulgated by an agency in accordance with the authority conferred on it by applicable basic law.

12VAC30-100-20. General information. (Repealed.)

A. Authority. Chapter 1.1:1 of Title 9 of the Code of Virginia, deals with the promulgation of rules and regulations. Specifically, §9.6.14:7.1 directs agencies of the Commonwealth to develop public participation guidelines for soliciting the input of interested parties in the formation and development of regulations. Section 32.1-325 of the Code of Virginia empowers the Board of Medical Assistance Services to make, adopt, and promulgate regulations.

B. Purpose. This part is designed to provide consistent, written guidelines in order to ensure input from interested parties at all stages of the regulatory process.

C. Administration. The Board of Medical Assistance Services shall have the responsibility for promulgating regulations pertaining to public input in the regulatory process. Pursuant to § 32.1-324 C, the director shall have this responsibility and authority when the board is not in session, subject to such rules and regulations as may be prescribed by the board.

D. Application of regulations. This part shall have general application throughout the Commonwealth.

E. Application of the Administrative Process Act. The provisions of the Virginia Administrative Process Act, which is codified as Chapter 1.1:1 of Title 9 of the Code of Virginia, shall govern the adoption, amendment, modification, and revision of these regulations. All hearings deemed necessary by the director on such regulations, shall be conducted in accordance with §9-6.14:7.1.

12VAC30-100-30. Identification of interested parties. (Repealed.)

A. Existing data. The department will maintain a list of those persons and organizations who have demonstrated an interest in certain program regulations in the past through participation in regulatory hearings, correspondence, or other activities with the department.

B. Development of new lists. Periodically, the department shall publish a notice in The Virginia Register of Regulations, in a newspaper published in Richmond, and in other newspapers in Virginia localities, a request that any individual or organization interested in participating in the development of specific rules and regulations notify the office of the director. Any persons or organizations identified in this process will be incorporated in the lists developed under 12VAC30-100-30 A. The director may periodically remove from the lists persons or organizations that request to be removed or who fail to respond to an inquiry regarding continued interest.

12VAC30-100-40. Notification of interested parties. (Repealed.)

A. Individual mailings. When the Director of DMAS determines that specific regulations need to be developed or modified, the program shall notify by mail the individuals and organizations identified in 12VAC30-100-30. The notice shall include the title of the regulation to be developed or modified; a summary of the subject matter; the program contact person, mailing address, and telephone number; and the date by which a notice of a desire to participate in the formation and development process must be received. This rule shall not be mandatory where the department is formulating and developing regulations pursuant to court order, or federally required action or General Assembly action, but whenever time permits every effort will be made to provide such notice.

B. Notice of intent. When the department determines that specific regulations need to be developed or modified, the department will publish a Notice of Intent in The Virginia Register of Regulations. This notice will include the title of the regulation to be developed or modified; a summary of the subject matter; the program contact person, mailing address and telephone number; and the date by which a notice of a desire to participate must be received.

C. An announcement shall be sent to members of the Governor's Advisory Committee on Medicare and Medicaid and the board of the department.

12VAC30-100-50. Solicitation of input from interested parties. (Repealed.)

A. Advisory panels. The department's rule-making is so frequent that the Governor's Advisory Committee on Medicare and Medicaid will function as the department's on-going advisory panel. Based on the scope and nature of the regulatory issue, the director may, at his discretion, establish a sole function advisory panel to assist in this development or modification.

B. Membership of panels. Members of these sole-function advisory panels will be individuals and organization representatives identified under 12VAC30-100-30 and who have expressed the desire to participate in the department's regulatory process. Panel membership will consist of individuals oriented to the department, program issues and constraints of the intended regulations and representatives of entities governed by the proposed regulations. Advisory panels will consist of no less than three nor more than seven members.

C. Operation of panels. Individual panels will establish their own operating procedures, but in every case a panel will meet once and then will decide on subsequent meetings. All panel comments and other comments on proposed regulations will be documented by the program and a response will be developed for each comment. A written report on the public and panel comments will be prepared and the subsequent decision or action recommended shall be prepared by departmental staff and submitted to the Board of the Department of Medical Assistance Services for review and approval.

D. Exceptions. The use of an advisory panel may be waived at the director's discretion when:

1. There is no response to the notice of intent,

2. The office of the Attorney General determines that regulations are promulgated to comply with state or federal law or federal regulation and that no agency discretion is involved, or

3. When the program is formulating and developing regulations pursuant to a court order.

E. Other comments. All persons and organizations who notify the Department of Medical Assistance Services under 12VAC30-100-40 of their desire to comment shall be provided an opportunity to examine regulations in their developmental stage and to provide written comments on these regulations to the department. The department shall document the receipt of these comments and will respond to all comments. This rule shall not be mandatory when the department is formulating and developing regulations pursuant to a court order but every effort will be made to comply.

12VAC30-100-60. Administrative Process Act procedures. (Repealed.)

After regulations have been developed according to these guidelines they shall be submitted for public comment in accordance with the Administrative Process Act.

Title of Regulation: 12VAC30-120. Waivered Services (amending 12VAC30-120-370, 12VAC30-120-380).

Statutory Authority: §§32.1-324 and 32.1-325 of the Code of Virginia.

Effective Dates: September 1, 2007, through March 3, 2009.

The Department of Medical Assistance Services requested an extension of the emergency regulations, 12VAC30-120, pursuant to § 2.2-4011 of the Code of Virginia. The emergency regulations were published in 23:24 VA.R. 4030-4034 August 6, 2007 (http://legis.state.va.us/codecomm/register/vol23/iss24/v23i24.pdf) with effective dates of September 1, 2007, through August 31, 2008.

Acute and long-term care is a new initiative that has an impact on almost all aspects of the Medicaid program. It is a large and complex overlay on the entire Medicaid program. Although the initiative focuses on the integration of acute and long-term care, the Department of Medical Assistance Services (DMAS) has had to develop and implement the program while integrating its various features into every aspect of Medicaid. The difficulties involved in the seamless integration of acute and long-term care created unforeseen delays, including harmonizing state program features with applicable federal requirements. Quite simply, despite the best efforts of those involved, DMAS has concluded that it will not be able to complete the regulatory process prior to the expiration of the emergency regulations.

The Governor approved the department's request to extend the expiration date of the emergency regulations for six months as provided in § 2.2-4011 D of the Code of Virginia. Therefore, the regulations will continue in effect through March 3, 2009.

Agency Contact: Adrienne Fegans, Program Operations Administrator, Department of Medical Assistance Services, 600 East Broad Street, Suite 1300, Richmond, VA 23219, telephone (804) 786-4112, FAX (804) 786-1680, or email adrienne.fegans@dmas.virginia.gov.

Titles of Regulations: 12VAC30-50. Amount, Duration, and Scope of Medical and Remedial Care Services (amending 12VAC30-50-140, 12VAC30-50-150, 12VAC30-50-180; adding 12VAC30-50-228, 12VAC30-50-491).

12VAC30-60. Standards Established and Methods Used to Assure High Quality Care (adding 12VAC30-60-180, 12VAC30-60-185).

12VAC30-80. Methods and Standards for Establishing Payment Rates; other Types of Care (adding 12VAC30-80-32).

12VAC30-120. Waivered Services (amending 12VAC30-120-310, 12VAC30-120-380).

Statutory Authority: §§32.1-324 and 32.1-325 of the Code of Virginia.

Effective Dates: July 1, 2007, through December 29, 2008.

The Department of Medical Assistance Services requested an extension of the above-referenced emergency regulations pursuant to § 2.2-4011 of the Code of Virginia. The emergency regulations were published in 23:21 3510-3519 June 25, 2007 (http://legis.state.va.us/codecomm/register/vol23/iss21/v23i21.pdf) with effective dates of July 1, 2007, through June 30, 2008.

The 2007 Acts of Assembly, Chapter 847, Item 302 PPP required that the Department of Medical Assistance Services (DMAS) amend the State Plan for Medical Assistance to provide coverage of substance abuse treatment services for children and adults, effective July 1, 2007. Substance Abuse Treatment Services were implemented on that date, with a proposed regulation following the emergency regulation. Following the implementation of the services, DMAS submitted to the Centers for Medicare and Medicaid Services (CMS), the federal agency that authorizes states to make changes to their Medicaid programs, would require substantial changes to Virginia’s new coverage of Substance Abuse Treatment Services (SAS). DMAS is still involved in protracted negotiations with CMS regarding reimbursement for SAS, as well the implementation of case management services for SAS. This last issue is one of national importance, with Congress currently passing legislation to put a moratorium on CMS’ regulations on this issue. The final nature of the SAS regulations is therefore yet to be determined.

The Governor approved the department's request to extend the expiration date of the emergency regulations for six months as provided in § 2.2-4011 D of the Code of Virginia. Therefore, the regulations will continue in effect through December 29, 2008.

Agency Contact: Catherine Hancock, Policy & Research Division, Department of Medical Assistance Services, 600 East Broad Street, Suite 1300, Richmond, VA 23219, telephone (804) 225-4272, FAX (804) 786-1680, or email catherine.hancock@dmas.virginia.gov.

Titles of Regulations: 13VAC6-10. Public Participation Guidelines (repealing 13VAC6-10-10 through 13VAC6-10-120).

13VAC6-11. Public Participation Guidelines (adding 13VAC6-11-10 through 13VAC6-11-110).

Statutory Authority: §§2.2-4007.02 and 36-85.18 of the Code of Virginia.

Effective Date: November 13, 2008.

Agency Contact: Lorenzo Dyer, State Building Code Administrator, Department of Housing and Community Development, The Jackson Center, 501 N. 2nd St., Richmond, VA 23219-1321, telephone (804) 371-7163, FAX (804) 371-7092, TTY (804) 371-7089, or email lorenzo.dyer@dhcd.virginia.gov.

Summary:

The regulations comply with the legislative mandate (Chapter 321, 2008 Acts of Assembly) that agencies adopt model public participation guidelines issued by the Department of Planning and Budget by December 1, 2008. Public participation guidelines exist to promote public involvement in the development, amendment, or repeal of an agency's regulations.

This regulatory action repeals the current public participation guidelines and promulgates new public participation guidelines as required by Chapter 321 of the 2008 Acts of Assembly. Highlights of the public participation guidelines include (i) providing for the establishment and maintenance of notification lists of interested persons and specifying the information to be sent to such persons; (ii) providing for public comments on regulatory action; (iii) establishing the time period during which public comments shall be accepted; (iv) providing that the plan to hold a public meeting shall be indicated in any notice of intended regulatory action; (v) providing for the appointment, when necessary, of regulatory advisory panels to provide professional specialization or technical assistance and negotiated rulemaking panels if a regulatory action is expected to be controversial; and (vi) providing for the periodic review of regulations.

CHAPTER 11
PUBLIC PARTICIPATION GUIDELINES

Part I
Purpose and Definitions

13VAC6-11-10. Purpose.

The purpose of this chapter is to promote public involvement in the development, amendment or repeal of the regulations of the Virginia Manufactured Housing Board. This chapter does not apply to regulations, guidelines, or other documents exempted or excluded from the provisions of the Administrative Process Act (§2.2-4000 et seq. of the Code of Virginia).

13VAC6-11-20. Definitions.

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Administrative Process Act" means Chapter 40 (§2.2-4000 et seq.) of Title 2.2 of the Code of Virginia.

"Agency" means the Virginia Manufactured Housing Board, which is the unit of state government empowered by the agency's basic law to make regulations or decide cases. Actions specified in this chapter may be fulfilled by state employees as delegated by the agency.

"Basic law" means provisions in the Code of Virginia that delineate the basic authority and responsibilities of an agency.

"Commonwealth Calendar" means the electronic calendar for official government meetings open to the public as required by § 2.2-3707 C of the Freedom of Information Act.

''Negotiated rulemaking panel'' or ''NRP'' means an ad hoc advisory panel of interested parties established by an agency to consider issues that are controversial with the assistance of a facilitator or mediator, for the purpose of reaching a consensus in the development of a proposed regulatory action.

"Notification list" means a list used to notify persons pursuant to this chapter. Such a list may include an electronic list maintained through the Virginia Regulatory Town Hall or other list maintained by the agency.

"Open meeting" means any scheduled gathering of a unit of state government empowered by an agency's basic law to make regulations or decide cases, which is related to promulgating, amending or repealing a regulation.

"Person" means any individual, corporation, partnership, association, cooperative, limited liability company, trust, joint venture, government, political subdivision, or any other legal or commercial entity and any successor, representative, agent, agency, or instrumentality thereof.

"Public hearing" means a scheduled time at which members or staff of the agency will meet for the purpose of receiving public comment on a regulatory action.

"Regulation" means any statement of general application having the force of law, affecting the rights or conduct of any person, adopted by the agency in accordance with the authority conferred on it by applicable laws.

"Regulatory action" means the promulgation, amendment, or repeal of a regulation by the agency.

"Regulatory advisory panel" or "RAP" means a standing or ad hoc advisory panel of interested parties established by the agency for the purpose of assisting in regulatory actions.

"Town Hall" means the Virginia Regulatory Town Hall, the website operated by the Virginia Department of Planning and Budget at www.townhall.virginia.gov, which has online public comment forums and displays information about regulatory meetings and regulatory actions under consideration in Virginia and sends this information to registered public users.

"Virginia Register" means the Virginia Register of Regulations, the publication that provides official legal notice of new, amended and repealed regulations of state agencies, which is published under the provisions of Article 6 (§2.2-4031 et seq.) of the Administrative Process Act.

Part II
Notification of Interested Persons

13VAC6-11-30. Notification list.

A. The agency shall maintain a list of persons who have requested to be notified of regulatory actions being pursued by the agency.

B. Any person may request to be placed on a notification list by registering as a public user on the Town Hall or by making a request to the agency. Any person who requests to be placed on a notification list shall elect to be notified either by electronic means or through a postal carrier.

C. The agency may maintain additional lists for persons who have requested to be informed of specific regulatory issues, proposals, or actions.

D. When electronic mail is returned as undeliverable on multiple occasions at least 24 hours apart, that person may be deleted from the list. A single undeliverable message is insufficient cause to delete the person from the list.

E. When mail delivered by a postal carrier is returned as undeliverable on multiple occasions, that person may be deleted from the list.

F. The agency may periodically request those persons on the notification list to indicate their desire to either continue to be notified electronically, receive documents through a postal carrier, or be deleted from the list.

13VAC6-11-40. Information to be sent to persons on the notification list.

A. To persons electing to receive electronic notification or notification through a postal carrier as described in 13VAC6-11-30, the agency shall send the following information:

1. A notice of intended regulatory action (NOIRA).

2. A notice of the comment period on a proposed, a reproposed, or a fast-track regulation and hyperlinks to, or instructions on how to obtain, a copy of the regulation and any supporting documents.

3. A notice soliciting comment on a final regulation when the regulatory process has been extended pursuant to § 2.2-4007.06 or 2.2-4013 C of the Code of Virginia.

B. The failure of any person to receive any notice or copies of any documents shall not affect the validity of any regulation or regulatory action.

Part III
Public Participation Procedures

13VAC6-11-50. Public comment.

A. In considering any nonemergency, nonexempt regulatory action, the agency shall afford interested persons an opportunity to submit data, views, and arguments, either orally or in writing, to the agency. Such opportunity to comment shall include an online public comment forum on the Town Hall.

1. To any requesting person, the agency shall provide copies of the statement of basis, purpose, substance, and issues; the economic impact analysis of the proposed or fast-track regulatory action; and the agency's response to public comments received.

2. The agency may begin crafting a regulatory action prior to or during any opportunities it provides to the public to submit comments.

B. The agency shall accept public comments in writing after the publication of a regulatory action in the Virginia Register as follows:

1. For a minimum of 30 calendar days following the publication of the notice of intended regulatory action (NOIRA).

2. For a minimum of 60 calendar days following the publication of a proposed regulation.

3. For a minimum of 30 calendar days following the publication of a reproposed regulation.

4. For a minimum of 30 calendar days following the publication of a final adopted regulation.

5. For a minimum of 30 calendar days following the publication of a fast-track regulation.

6. For a minimum of 21 calendar days following the publication of a notice of periodic review.

7. Not later than 21 calendar days following the publication of a petition for rulemaking.

C. The agency may determine if any of the comment periods listed in subsection B of this section shall be extended.

D. If the Governor finds that one or more changes with substantial impact have been made to a proposed regulation, he may require the agency to provide an additional 30 calendar days to solicit additional public comment on the changes in accordance with § 2.2-4013 C of the Code of Virginia.

E. The agency shall send a draft of the agency's summary description of public comment to all public commenters on the proposed regulation at least five days before final adoption of the regulation pursuant to § 2.2-4012 E of the Code of Virginia.

13VAC6-11-60. Petition for rulemaking.

A. As provided in § 2.2-4007 of the Code of Virginia, any person may petition the agency to consider a regulatory action.

B. A petition shall include but is not limited to the following information:

1. The petitioner's name and contact information;

2. The substance and purpose of the rulemaking that is requested, including reference to any applicable Virginia Administrative Code sections; and

3. Reference to the legal authority of the agency to take the action requested.

C. The agency shall receive, consider and respond to a petition pursuant to § 2.2-4007 and shall have the sole authority to dispose of the petition.

D. The petition shall be posted on the Town Hall and published in the Virginia Register.

E. Nothing in this chapter shall prohibit the agency from receiving information or from proceeding on its own motion for rulemaking.

13VAC6-11-70. Appointment of regulatory advisory panel.

A. The agency may appoint a regulatory advisory panel (RAP) to provide professional specialization or technical assistance when the agency determines that such expertise is necessary to address a specific regulatory issue or action or when individuals indicate an interest in working with the agency on a specific regulatory issue or action.

B. Any person may request the appointment of a RAP and request to participate in its activities. The agency shall determine when a RAP shall be appointed and the composition of the RAP.

C. A RAP may be dissolved by the agency if:

1. The proposed text of the regulation is posted on the Town Hall, published in the Virginia Register, or such other time as the agency determines is appropriate; or

2. The agency determines that the regulatory action is either exempt or excluded from the requirements of the Administrative Process Act.

13VAC6-11-80. Appointment of negotiated rulemaking panel.

A. The agency may appoint a negotiated rulemaking panel (NRP) if a regulatory action is expected to be controversial.

B. An NRP that has been appointed by the agency may be dissolved by the agency when:

1. There is no longer controversy associated with the development of the regulation;

2. The agency determines that the regulatory action is either exempt or excluded from the requirements of the Administrative Process Act; or

3. The agency determines that resolution of a controversy is unlikely.

13VAC6-11-90. Meetings.

Notice of any open meeting, including meetings of a RAP or NRP, shall be posted on the Virginia Regulatory Town Hall and Commonwealth Calendar at least seven working days prior to the date of the meeting. The exception to this requirement is any meeting held in accordance with § 2.2-3707 D of the Code of Virginia allowing for contemporaneous notice to be provided to participants and the public.

13VAC6-11-100. Public hearings on regulations.

A. The agency shall indicate in its notice of intended regulatory action whether it plans to hold a public hearing following the publication of the proposed stage of the regulatory action.

B. The agency may conduct one or more public hearings during the comment period following the publication of a proposed regulatory action.

C. An agency is required to hold a public hearing following the publication of the proposed regulatory action when:

1. The agency's basic law requires the agency to hold a public hearing;

2. The Governor directs the agency to hold a public hearing; or

3. The agency receives requests for a public hearing from at least 25 persons during the public comment period following the publication of the notice of intended regulatory action.

D. Notice of any public hearing shall be posted on the Town Hall and Commonwealth Calendar at least seven working days prior to the date of the hearing. The agency shall also notify those persons who requested a hearing under subdivision C 3 of this section.

13VAC6-11-110. Periodic review of regulations.

A. The agency shall conduct a periodic review of its regulations consistent with:

1. An executive order issued by the Governor pursuant to § 2.2-4017 of the Administrative Process Act to receive comment on all existing regulations as to their effectiveness, efficiency, necessity, clarity, and cost of compliance; and

2. The requirements in § 2.2-4007.1 of the Administrative Process Act regarding regulatory flexibility for small businesses.

B. A periodic review may be conducted separately or in conjunction with other regulatory actions.

C. Notice of a periodic review shall be posted on the Town Hall and published in the Virginia Register.

Titles of Regulations: 13VAC6-10. Public Participation Guidelines (repealing 13VAC6-10-10 through 13VAC6-10-120).

13VAC6-11. Public Participation Guidelines (adding 13VAC6-11-10 through 13VAC6-11-110).

Statutory Authority: §§2.2-4007.02 and 36-85.18 of the Code of Virginia.

Effective Date: November 13, 2008.

Agency Contact: Lorenzo Dyer, State Building Code Administrator, Department of Housing and Community Development, The Jackson Center, 501 N. 2nd St., Richmond, VA 23219-1321, telephone (804) 371-7163, FAX (804) 371-7092, TTY (804) 371-7089, or email lorenzo.dyer@dhcd.virginia.gov.

Summary:

The regulations comply with the legislative mandate (Chapter 321, 2008 Acts of Assembly) that agencies adopt model public participation guidelines issued by the Department of Planning and Budget by December 1, 2008. Public participation guidelines exist to promote public involvement in the development, amendment, or repeal of an agency's regulations.

This regulatory action repeals the current public participation guidelines and promulgates new public participation guidelines as required by Chapter 321 of the 2008 Acts of Assembly. Highlights of the public participation guidelines include (i) providing for the establishment and maintenance of notification lists of interested persons and specifying the information to be sent to such persons; (ii) providing for public comments on regulatory action; (iii) establishing the time period during which public comments shall be accepted; (iv) providing that the plan to hold a public meeting shall be indicated in any notice of intended regulatory action; (v) providing for the appointment, when necessary, of regulatory advisory panels to provide professional specialization or technical assistance and negotiated rulemaking panels if a regulatory action is expected to be controversial; and (vi) providing for the periodic review of regulations.

CHAPTER 11
PUBLIC PARTICIPATION GUIDELINES

Part I
Purpose and Definitions

13VAC6-11-10. Purpose.

The purpose of this chapter is to promote public involvement in the development, amendment or repeal of the regulations of the Virginia Manufactured Housing Board. This chapter does not apply to regulations, guidelines, or other documents exempted or excluded from the provisions of the Administrative Process Act (§2.2-4000 et seq. of the Code of Virginia).

13VAC6-11-20. Definitions.

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Administrative Process Act" means Chapter 40 (§2.2-4000 et seq.) of Title 2.2 of the Code of Virginia.

"Agency" means the Virginia Manufactured Housing Board, which is the unit of state government empowered by the agency's basic law to make regulations or decide cases. Actions specified in this chapter may be fulfilled by state employees as delegated by the agency.

"Basic law" means provisions in the Code of Virginia that delineate the basic authority and responsibilities of an agency.

"Commonwealth Calendar" means the electronic calendar for official government meetings open to the public as required by § 2.2-3707 C of the Freedom of Information Act.

''Negotiated rulemaking panel'' or ''NRP'' means an ad hoc advisory panel of interested parties established by an agency to consider issues that are controversial with the assistance of a facilitator or mediator, for the purpose of reaching a consensus in the development of a proposed regulatory action.

"Notification list" means a list used to notify persons pursuant to this chapter. Such a list may include an electronic list maintained through the Virginia Regulatory Town Hall or other list maintained by the agency.

"Open meeting" means any scheduled gathering of a unit of state government empowered by an agency's basic law to make regulations or decide cases, which is related to promulgating, amending or repealing a regulation.

"Person" means any individual, corporation, partnership, association, cooperative, limited liability company, trust, joint venture, government, political subdivision, or any other legal or commercial entity and any successor, representative, agent, agency, or instrumentality thereof.

"Public hearing" means a scheduled time at which members or staff of the agency will meet for the purpose of receiving public comment on a regulatory action.

"Regulation" means any statement of general application having the force of law, affecting the rights or conduct of any person, adopted by the agency in accordance with the authority conferred on it by applicable laws.

"Regulatory action" means the promulgation, amendment, or repeal of a regulation by the agency.

"Regulatory advisory panel" or "RAP" means a standing or ad hoc advisory panel of interested parties established by the agency for the purpose of assisting in regulatory actions.

"Town Hall" means the Virginia Regulatory Town Hall, the website operated by the Virginia Department of Planning and Budget at www.townhall.virginia.gov, which has online public comment forums and displays information about regulatory meetings and regulatory actions under consideration in Virginia and sends this information to registered public users.

"Virginia Register" means the Virginia Register of Regulations, the publication that provides official legal notice of new, amended and repealed regulations of state agencies, which is published under the provisions of Article 6 (§2.2-4031 et seq.) of the Administrative Process Act.

Part II
Notification of Interested Persons

13VAC6-11-30. Notification list.

A. The agency shall maintain a list of persons who have requested to be notified of regulatory actions being pursued by the agency.

B. Any person may request to be placed on a notification list by registering as a public user on the Town Hall or by making a request to the agency. Any person who requests to be placed on a notification list shall elect to be notified either by electronic means or through a postal carrier.

C. The agency may maintain additional lists for persons who have requested to be informed of specific regulatory issues, proposals, or actions.

D. When electronic mail is returned as undeliverable on multiple occasions at least 24 hours apart, that person may be deleted from the list. A single undeliverable message is insufficient cause to delete the person from the list.

E. When mail delivered by a postal carrier is returned as undeliverable on multiple occasions, that person may be deleted from the list.

F. The agency may periodically request those persons on the notification list to indicate their desire to either continue to be notified electronically, receive documents through a postal carrier, or be deleted from the list.

13VAC6-11-40. Information to be sent to persons on the notification list.

A. To persons electing to receive electronic notification or notification through a postal carrier as described in 13VAC6-11-30, the agency shall send the following information:

1. A notice of intended regulatory action (NOIRA).

2. A notice of the comment period on a proposed, a reproposed, or a fast-track regulation and hyperlinks to, or instructions on how to obtain, a copy of the regulation and any supporting documents.

3. A notice soliciting comment on a final regulation when the regulatory process has been extended pursuant to § 2.2-4007.06 or 2.2-4013 C of the Code of Virginia.

B. The failure of any person to receive any notice or copies of any documents shall not affect the validity of any regulation or regulatory action.

Part III
Public Participation Procedures

13VAC6-11-50. Public comment.

A. In considering any nonemergency, nonexempt regulatory action, the agency shall afford interested persons an opportunity to submit data, views, and arguments, either orally or in writing, to the agency. Such opportunity to comment shall include an online public comment forum on the Town Hall.

1. To any requesting person, the agency shall provide copies of the statement of basis, purpose, substance, and issues; the economic impact analysis of the proposed or fast-track regulatory action; and the agency's response to public comments received.

2. The agency may begin crafting a regulatory action prior to or during any opportunities it provides to the public to submit comments.

B. The agency shall accept public comments in writing after the publication of a regulatory action in the Virginia Register as follows:

1. For a minimum of 30 calendar days following the publication of the notice of intended regulatory action (NOIRA).

2. For a minimum of 60 calendar days following the publication of a proposed regulation.

3. For a minimum of 30 calendar days following the publication of a reproposed regulation.

4. For a minimum of 30 calendar days following the publication of a final adopted regulation.

5. For a minimum of 30 calendar days following the publication of a fast-track regulation.

6. For a minimum of 21 calendar days following the publication of a notice of periodic review.

7. Not later than 21 calendar days following the publication of a petition for rulemaking.

C. The agency may determine if any of the comment periods listed in subsection B of this section shall be extended.

D. If the Governor finds that one or more changes with substantial impact have been made to a proposed regulation, he may require the agency to provide an additional 30 calendar days to solicit additional public comment on the changes in accordance with § 2.2-4013 C of the Code of Virginia.

E. The agency shall send a draft of the agency's summary description of public comment to all public commenters on the proposed regulation at least five days before final adoption of the regulation pursuant to § 2.2-4012 E of the Code of Virginia.

13VAC6-11-60. Petition for rulemaking.

A. As provided in § 2.2-4007 of the Code of Virginia, any person may petition the agency to consider a regulatory action.

B. A petition shall include but is not limited to the following information:

1. The petitioner's name and contact information;

2. The substance and purpose of the rulemaking that is requested, including reference to any applicable Virginia Administrative Code sections; and

3. Reference to the legal authority of the agency to take the action requested.

C. The agency shall receive, consider and respond to a petition pursuant to § 2.2-4007 and shall have the sole authority to dispose of the petition.

D. The petition shall be posted on the Town Hall and published in the Virginia Register.

E. Nothing in this chapter shall prohibit the agency from receiving information or from proceeding on its own motion for rulemaking.

13VAC6-11-70. Appointment of regulatory advisory panel.

A. The agency may appoint a regulatory advisory panel (RAP) to provide professional specialization or technical assistance when the agency determines that such expertise is necessary to address a specific regulatory issue or action or when individuals indicate an interest in working with the agency on a specific regulatory issue or action.

B. Any person may request the appointment of a RAP and request to participate in its activities. The agency shall determine when a RAP shall be appointed and the composition of the RAP.

C. A RAP may be dissolved by the agency if:

1. The proposed text of the regulation is posted on the Town Hall, published in the Virginia Register, or such other time as the agency determines is appropriate; or

2. The agency determines that the regulatory action is either exempt or excluded from the requirements of the Administrative Process Act.

13VAC6-11-80. Appointment of negotiated rulemaking panel.

A. The agency may appoint a negotiated rulemaking panel (NRP) if a regulatory action is expected to be controversial.

B. An NRP that has been appointed by the agency may be dissolved by the agency when:

1. There is no longer controversy associated with the development of the regulation;

2. The agency determines that the regulatory action is either exempt or excluded from the requirements of the Administrative Process Act; or

3. The agency determines that resolution of a controversy is unlikely.

13VAC6-11-90. Meetings.

Notice of any open meeting, including meetings of a RAP or NRP, shall be posted on the Virginia Regulatory Town Hall and Commonwealth Calendar at least seven working days prior to the date of the meeting. The exception to this requirement is any meeting held in accordance with § 2.2-3707 D of the Code of Virginia allowing for contemporaneous notice to be provided to participants and the public.

13VAC6-11-100. Public hearings on regulations.

A. The agency shall indicate in its notice of intended regulatory action whether it plans to hold a public hearing following the publication of the proposed stage of the regulatory action.

B. The agency may conduct one or more public hearings during the comment period following the publication of a proposed regulatory action.

C. An agency is required to hold a public hearing following the publication of the proposed regulatory action when:

1. The agency's basic law requires the agency to hold a public hearing;

2. The Governor directs the agency to hold a public hearing; or

3. The agency receives requests for a public hearing from at least 25 persons during the public comment period following the publication of the notice of intended regulatory action.

D. Notice of any public hearing shall be posted on the Town Hall and Commonwealth Calendar at least seven working days prior to the date of the hearing. The agency shall also notify those persons who requested a hearing under subdivision C 3 of this section.

13VAC6-11-110. Periodic review of regulations.

A. The agency shall conduct a periodic review of its regulations consistent with:

1. An executive order issued by the Governor pursuant to § 2.2-4017 of the Administrative Process Act to receive comment on all existing regulations as to their effectiveness, efficiency, necessity, clarity, and cost of compliance; and

2. The requirements in § 2.2-4007.1 of the Administrative Process Act regarding regulatory flexibility for small businesses.

B. A periodic review may be conducted separately or in conjunction with other regulatory actions.

C. Notice of a periodic review shall be posted on the Town Hall and published in the Virginia Register.

Title of Regulation: 18VAC10-20. Board for Architects, Professional Engineers, Land Surveyors, Certified Interior Designers and Landscape Architects Regulations (amending 18VAC10-20-10, 18VAC10-20-120, 18VAC10-20-280, 18VAC10-20-295, 18VAC10-20-310, 18VAC10-20-340, 18VAC10-20-350, 18VAC10-20-360, 18VAC10-20-380, 18VAC10-20-760; adding 18VAC10-20-382, 18VAC10-20-392, 18VAC10-20-395).

Statutory Authority: §§54.1-201, 54.1-404, and 54.1-411 of the Code of Virginia.

Effective Date: December 1, 2008.

Agency Contact: Mark N. Courtney, Executive Director, Board for Architects, Professional Engineers, Land Surveyors, Certified Interior Designers, and Landscape Architects, 9960 Mayland Drive, Suite 400, Richmond, VA 23233, telephone (804) 367-8514, FAX (804) 527-4294, or email apelscidla@dpor.virginia.gov.

Summary:

The amendments implement a regulatory program for photogrammetrists, including standards for determination of topography, as permitted by Chapter 440 of the 2005 Acts of Assembly.

Summary of Public Comments and Agency's Response: A summary of comments made by the public and the agency's response may be obtained from the promulgating agency or viewed at the office of the Registrar of Regulations.

Part I
General

18VAC10-20-10. Definitions.

Section 54.1-400 of the Code of Virginia provides definitions of the following terms and phrases as used in this chapter:

Architect

Board

Certified interior designer

Certified landscape architect

Interior design by a certified interior designer

Land surveyor. When used in this chapter, land surveyor shall include surveyor photogrammetrist unless stated otherwise or the context requires a different meaning.

Practice of architecture

Practice of engineering

Practice of land surveying

Practice of landscape architecture

Professional engineer

The following words, terms, and phrases when used in this chapter shall have the meanings ascribed to them except where the context clearly indicates or requires different meanings:

"Application" means a completed application with the appropriate fee and any other required documentation, including, but not limited to, references, employment verification, degree verification, and verification of examination and licensure or certification.

"Certified" means an individual holding a valid certification issued by the board that has not been suspended, revoked, or surrendered, and is currently registered with the board to practice in the Commonwealth in accordance with § 54.1-405 or 54.1-414 of the Code of Virginia.

"Comity" means the recognition of licenses or certificates issued by other states, the District of Columbia, or any territory or possession of the United States as permitted by § 54.1-103 C of the Code of Virginia.

"Department" means the Department of Professional and Occupational Regulation.

"Direct control and personal supervision" shall be that degree of supervision by a person overseeing the work of another whereby the supervisor has both control over and detailed professional knowledge of the work prepared under his supervision and words and phrases of similar import mean that the professional shall have control over the decisions on technical matters of policy and design, and exercises his professional judgment in all professional matters that are embodied in the work and the drawings, specifications, or other documents involved in the work; and the professional has exercised critical examination and evaluation of an employee's, consultant's, subcontractor's, or project team members' work product, during and after preparation, for purposes of compliance with applicable laws, codes, ordinances, regulations and usual and customary standards of care pertaining to professional practice. Further, it is that degree of control a professional is required to maintain over decisions made personally or by others over which the professional exercises direct control and personal supervision. "Direct control and personal supervision" also includes the following:

1. The degree of control necessary for a professional to be in direct control and personal supervision shall be such that the professional:

a. Personally makes professional decisions or reviews and approves proposed decisions prior to their implementation, including the consideration of alternatives, whenever professional decisions that could affect the health, safety, and welfare of the public are made; and

b. Determines the validity and applicability of recommendations prior to their incorporation into the work, including the qualifications of those making the recommendations.

2. Professional decisions that must be made by and are the responsibility of the professional in direct control and personal supervision are those decisions concerning permanent or temporary work that could affect the health, safety, and welfare of the public, and may include, but are not limited to, the following:

a. The selection of alternatives to be investigated and the comparison of alternatives for designed work; and

b. The selection or development of design standards and materials to be used.

3. A professional shall be able to clearly define the scope and degree of direct control and personal supervision and how it was exercised and to demonstrate that the professional was answerable within said scope and degree of direct control and personal supervision necessary for the work for which the professional has signed and sealed; and

4. No sole proprietorship, partnership, corporation, limited liability company, joint venture, professional corporation, professional limited liability corporation, or other entity shall practice, or offer to practice, any profession regulated under this chapter unless there is a resident professional for that service providing direct control and personal supervision of such service in each separate office in which such service is performed or offered to be performed.

"Good moral character" may be established if the applicant or regulant:

1. Has not been convicted of a felony or misdemeanor that has a reasonable relationship to the functions of the employment or category for which the license or certification is sought;

2. Has not, within 10 years of application for licensure, certification, or registration, committed any act involving dishonesty, fraud, misrepresentation, breach of fiduciary duty, negligence, or incompetence reasonably related to the applicant's proposed area of practice;

3. Has not engaged in fraud or misrepresentation in connection with the application for licensure, certification, or registration, or related examination;

4. Has not had a license, certification or registration revoked or suspended for cause by this state or by any other jurisdiction, or surrendered a license, certificate, or registration in lieu of disciplinary action;

5. Has not practiced without the required license, registration, or certification in this state or in another jurisdiction within the five years immediately preceding the filing of the application for licensure, certification, or registration by this Commonwealth; or

6. Has not, within 10 years of application for licensure, certification, or registration, committed an act that would constitute unprofessional conduct, as set forth in Part XII of this chapter.

"Landscape architect" means an individual who has been certified as a landscape architect pursuant to the provisions of this chapter and is in good standing with the board to practice in the Commonwealth in accordance with § 54.1-409 of the Code of Virginia.

"Licensed" means an individual who holds a valid license issued by the board that has not been suspended, or revoked, or surrendered and who is currently registered with the board to practice in the Commonwealth in accordance with § 54.1-405 of the Code of Virginia.

"Place of business" means any location which offers to practice or practices through licensed or certified professionals the services of architecture, engineering, land surveying, certified landscape architecture or certified interior design, or any combination thereof. A temporary field office established and utilized for the duration of a specific project shall not qualify as a place of business under this chapter.

"Profession" means the practice of architecture, engineering, land surveying, certified landscape architecture, or certified interior design.

"Professional" means an architect, professional engineer, land surveyor, landscape architect or interior designer who is licensed or certified, as appropriate, pursuant to the provisions of this chapter and is in good standing with the board to practice his profession in this Commonwealth.

"Registrant" means a business currently registered with the board to offer or provide one or more of the professions regulated by the board.

"Regulant" means a licensee, certificate holder or registrant.

"Resident" means physically present in said place of business a majority of the operating hours of the place of business.

"Responsible person" means the individual named by the entity to be responsible and have control of the regulated services offered, or rendered, or both, by the entity.

"Surveyor photogrammetrist" means a person who by reason of specialized knowledge in the area of photogrammetry has been granted a license by the board to survey land in accordance with Chapter 4 (§54.1-400 et seq.) of Title 54.1 of the Code of Virginia for the determination of topography, contours and/or location of planimetric features using photogrammetric methods or similar remote sensing technology.

[ 18VAC10-20-120. Experience.

A. The successful completion of the National Council of Architectural Registration Boards (NCARB) Intern Development Program (IDP) shall be required of all applicants for original licensure. IDP training requirements shall be in accordance with NCARB's Handbook for Interns and Architects, 2006-2007 2008-2009 Edition.

B. All applicants must have a minimum of 36 months experience/training prior to submitting an application for examination. Any experience/training of less than eight consecutive weeks will not be considered in satisfying this requirement.

C. All applicants must have a minimum of 12 months experience/training in architecture as an employee in the office of a licensed architect prior to submitting an application for examination. An organization will be considered to be an office of a licensed architect if:

1. The architectural practice of the organization in which the applicant works is under the charge of a person practicing as a principal, where a principal is a licensed architect in charge of an organization's architectural practice either alone or with other licensed architects, and the applicant works under the direct supervision of a licensed architect; and

2. The practice of the organization encompasses the comprehensive practice of architecture, including the categories set forth in the NCARB IDP requirements. ]

Part V
Qualifications for Licensing and Standards of Procedure for Land Surveyors

18VAC10-20-280. Fee schedule.

All fees are nonrefundable and shall not be prorated.

	Application for Fundamentals of Land Surveying	$60
	Application for Principles and Practice of Land Surveying	$90
	Application for Surveyor Photogrammetrist	$90
	Application for Land Surveyor B	$90
	Renewal	$90
	Comity	$90
	Out-of-state proctor	$100

18VAC10-20-295. Definitions.

"Absolute horizontal positional accuracy" means the value expressed in feet or meters that represents the uncertainty due to systematic and random errors in measurements in the location of any point on a survey relative to the defined datum at the 95% confidence level.

"Approved land surveying experience" means a record of progressive experience under the direct control and personal supervision of a licensed land surveyor, or an individual authorized by statute to practice land surveying, on land surveying work during which the applicant has made practical utilization of acquired knowledge and has demonstrated continuous improvement, growth, and development through the utilization of that knowledge as revealed in the complexity and technical detail of the applicant's work product or work record. The applicant must show continuous assumption of greater individual responsibility for the work product over the relevant period. The progressive experience on land surveying work shall be of a grade and character that indicates to the board that the applicant is minimally competent to practice land surveying. Notwithstanding the definition of "approved land surveying experience," the requirements set forth in 18VAC10-20-310 shall not be waived.

"Approved photogrammetric surveying or similar remote sensing technology experience" means diversified training in photogrammetric land surveying under the supervision and direction of a licensed land surveyor, licensed surveyor photogrammetrist, or under the supervision and direction of an individual authorized by statute to practice land surveying or photogrammetry. This experience shall have been acquired in positions requiring the exercise of independent judgment, initiative and professional skill in the office and field and written verification of such work experience shall be on forms provided by the board. Experience may be gained either prior to or after education is obtained. Notwithstanding the definition of "approved photogrammetric surveying or similar remote sensing technology experience," the requirements set forth in 18VAC10-20-310 shall not be waived.

"Relative horizontal positional accuracy" means the value expressed in feet or meters that represents the uncertainty due to random errors in measurements in the location of any point on a survey relative to any other point on the same survey at the 95% confidence level.

18VAC10-20-310. Requirements for a licensed land surveyor or surveyor photogrammetrist.

A. An SIT who, after meeting the requirements of 18VAC10-20-300, has a minimum of four years of approved land surveying experience, and has been land surveying under the direct control and personal supervision of a licensed land surveyor, shall be admitted to an examination in the Principles and Practice of Land Surveying and the Virginia state-specific examination, provided the applicant is otherwise qualified. Upon passing such examination, the applicant shall be granted a license to practice land surveying, provided the applicant is otherwise qualified.

B. An SIT who, after meeting the requirements of 18VAC10-20-300, has a specific record of four years of approved photogrammetric surveying or similar remote sensing technology experience of which a minimum of three years experience has been progressive in complexity and has been on photogrammetric surveying or similar remote sensing technology projects under the supervision of a licensed land surveyor or licensed surveyor photogrammetrist shall be admitted to a board-approved surveyor photogrammetrist examination and the Virginia state specific examination. Upon passing such examinations, the applicant shall be granted a license to practice photogrammetric surveying, provided the applicant is otherwise qualified.

C. In lieu of the provisions of subsection B of this section, any person presently providing photogrammetric or similar remote sensing technology services with any combination of at least eight years of board-approved education and progressive experience in photogrammetry or similar remote sensing technology, four or more of which shall have been in responsible charge of photogrammetric mapping projects meeting National Map Accuracy Standards or National Standard for Spatial Data Accuracy, or equivalent, may be licensed to practice photogrammetric surveying provided an individual submits an application to the board that provides evidence to the satisfaction of the board of the following:

1. The applicant submits to the board certified proof of graduation from high school or high school equivalency that is acceptable to the board, both with evidence of successful completion of courses in algebra, geometry and trigonometry either by transcript or examination, or certified proof of a related higher degree of education, or other evidence of progressive related higher education acceptable to the board;

2. The applicant submits to the board satisfactory proof and evidence of employment as a photogrammetrist or similar remote sensing technology in responsible charge as defined in 18VAC10-20-310 D providing such services within any of the 50 states, the District of Columbia, or any territory or possession of the United States. Evidence of employment shall include verification of the applicant’s progressive experience by his supervisor and by the applicant’s clients of the applicant’s personal involvement in a minimum of five projects;

3. The applicant must submit three references with the application, all of whom shall be licensed land surveyors in a state or territory of the United States;

4. The applicant shall certify that they have read and understood Chapter 4 (§54.1-400 et seq.) of Title 54.1 and Chapter 17 (§54.1-1700 et seq.) of Title 55 of the Code of Virginia, and this chapter; and

5. The applicant shall apply to the board and submit an application fee for licensure within one year of [ (insert the effective date of these regulations) December 1, 2008 ] or until such time as the examinations required by 18VAC10-20-310 B are available, whichever is later. After [ (insert the effective date of these regulations plus one year) December 1, 2009 ] , or when the examinations required by subsection B of this section become available, whichever is later, no person shall be eligible to apply for licensure as a surveyor photogrammetrist pursuant to this section.

D. Within the context of subsection C of this section, responsible charge of photogrammetric or similar remote sensing technology mapping projects means technical supervision of:

1. Assessing the project needs and constraints and accuracies;

2. Creating the project plan including determining data standards;

3. Creating overall project specifications;

4. Determining flight lines and appropriate photogrammetric control required for project accuracies and constraints;

5. Reviewing and approval of aerotriangulation results, prior to map compilation and certification of the final report of project control;

6. Determining the appropriate features to be collected, how they are to be collected, annotated, stored;

7. Editing and reviewing of collected data and features;

8. Reviewing of equipment, technology, and procedures that meet project requirements;

9. Determining final data standards and quality control for a project;

10. Reviewing and approving the final map products, deliverables, files, and spatial data;

11. Checking and editing final map data for specified completeness and accuracies including project reports, metadata, and any associated databases;

12. Project management; and

13. Other duties requiring decision-making, control, influence, and accountability of the project.

E. Any person licensed pursuant to the terms of subsection B or C of this section shall be licensed as a surveyor photogrammetrist.

18VAC10-20-340. Experience standards.

An applicant shall submit written verification from each employment engagement that has been gained under the direct control and personal supervision of a licensed land surveyor, licensed surveyor photogrammetrist or an individual authorized by statute to practice land surveying on forms provided by the board to be considered by the board as approved land surveying experience.

18VAC10-20-350. Examinations.

A. The Fundamentals of Land Surveying examination consists of the National Council of Examiners for Engineering and Surveying (NCEES) examination on the fundamentals of land surveying.

B. The Principles and Practice of Land Surveying examination consists of an NCEES examination on applied land surveying, or a board-approved surveyor photogrammetrist examination, and a Virginia state-specific examination.

C. The examination for land surveying under § 54.1-408 of the Code of Virginia (Land Surveyor B) shall be given at times designated by the board.

D. Unless otherwise stated, applicants approved to sit for an examination must register and submit the required examination fee to be received in the board office, or by the board's designee, at a time designated by the board. Applicants not properly registered will not be allowed into the examination site.

E. Applicants shall be notified by the board of passing or failing the examination but shall not be notified of actual scores. Only the board and its staff shall have access to examination papers, scores, and answer sheets. Examinations may not be reviewed.

F. Should the applicant fail to pass an examination within three years after being authorized to take the examination, the applicant must reapply and meet all current entry requirements at the time of reapplication.

18VAC10-20-360. Licensure by comity.

A. A person in good standing and holding a valid license to engage in the practice of land surveying in another state, the District of Columbia, or any territory or possession of the United States may be licensed, provided the applicant submits verifiable documentation to the board that the education, experience, and examination requirements by which the applicant was first licensed in the original jurisdiction were substantially equivalent to those existing in Virginia at the time of the applicant's original licensure. No person shall be so licensed, however, who has not passed an examination in another jurisdiction that was substantially equivalent to that approved by the board at the time of the applicant's original licensure. If the applicant does not meet the requirements for licensure in Virginia that were in effect at the time of original licensure, the applicant shall be required to meet the entry requirements current at the time the completed application for comity is received in the board's office. All applicants shall be required to pass a written Virginia state-specific examination. The examination shall include questions on law, procedures and practices pertaining to land surveying in Virginia.

B. A person holding a current license to engage in the practice of land surveying or photogrammetric surveying issued to the applicant by other states, the District of Columbia or any territory or possession of the United States based on requirements that do not conflict with and are at least as rigorous as the provisions contained in 18VAC10-20-310 C may be licensed as a surveyor photogrammetrist without further examination except for the Virginia state examination provided that the applicant was originally licensed prior to the ending date of the provisions contained in 18VAC10-20-310 C.

18VAC10-20-380. Minimum standards and procedures for surveys determining the location of physical improvements; field procedures; office procedures.

A. The following minimum standards and procedures are to be used for surveys determining the location of physical improvements on any parcel of land or lot containing less than two acres or metric equivalent (sometimes also known as "building location survey," "house location surveys," "physical surveys," and the like) in the Commonwealth of Virginia. The application of the professional's seal, signature and date as required by these regulations shall be evidence that the survey determining the location of physical improvements is correct to the best of the professional's knowledge, information, and belief, and complies with the minimum standards and procedures set forth in this chapter.

B. The professional shall determine the position of the lot or parcel of land in accordance with the intent of the original survey and shall set or verify permanent monumentation at each corner of the property, consistent with the monumentation provisions of subdivision C 4 of 18VAC10-20-370. All such monumentation, other than natural monumentation, shall, when feasible, be identified by temporary witness markers.

When the professional finds discrepancies of sufficient magnitude to warrant, in his opinion, the performance of a land boundary survey (pursuant to the provisions of 18VAC10-20-370), he shall so inform the client or the client's agent that such land boundary survey is deemed warranted as a requisite to completion of the physical improvements survey.

The location of the following shall be determined in the field:

1. Fences in near proximity to the land boundary lines and other fences which may reflect lines of occupancy or possession.

2. Other physical improvements on the property and all man-made or installed structures, including buildings, stoops, porches, chimneys, visible evidence of underground features (such as manholes, catch basins, telephone pedestals, power transformers, etc.), utility lines and poles.

3. Cemeteries, if known or disclosed in the process of performing the survey; roads or travelways crossing the property which serve other properties; and streams, creeks, and other defined drainage ways.

4. Other visible evidence of physical encroachment on the property.

C. The plat reflecting the work product shall be drawn to scale and shall show the following, unless requested otherwise by the client and so noted on the plat:

1. The bearings and distances for the boundaries and the area of the lot or parcel of land shall be shown in accordance with record data, unless a current, new land boundary survey has been performed in conjunction with the physical improvements survey. If needed to produce a closed polygon, the meander lines necessary to verify locations of streams, tidelands, lakes and swamps shall be shown. All bearings shall be shown in a clockwise direction, unless otherwise indicated.

2. North arrow, in accordance with record data.

3. Fences in the near proximity to the land boundary lines and other fences which may reflect lines of occupancy or possession.

4. Improvements and other pertinent features on the property as located in the field pursuant to subsection B of this section.

5. Physical encroachment, including fences, across a property line shall be identified and dimensioned with respect to the property line.

6. On parcels where compliance with restriction is in question, provide the closest dimension (to the nearest 0.1 foot or metric equivalent) from the front property line, side property line, and if pertinent, rear property line to the principal walls of each building. Also, all principal building dimensions (to the nearest 0.1 foot or metric equivalent).

7. Building street address numbers, as displayed on the premises, or so noted if no numbers are displayed.

8. Stoops, decks, porches, chimneys, balconies, floor projections, and other similar type features.

9. Street name(s), as posted or currently identified, and as per record data, if different from posted name.

10. Distance to nearest intersection, based upon record data. If not available from record data, distance to nearest intersection may be determined from best available data, and so qualified.

11. Building restriction or setback line(s) per restrictive covenants, if shown or noted on the record subdivision plat.

12. The caption or title of the plat shall include the type of survey performed; lot number, block number, section number, and name of subdivision, as appropriate, or if not in a subdivision, the name(s) of the record owner; town or county, or city; date of survey; and scale of drawing.

13. Adjoining property identification.

14. Easements and other encumbrances set forth on the record subdivision plat, and those otherwise known to the professional.

15. A statement as to whether or not a current title report has been furnished to the professional.

16. The professional shall clearly note inconsistencies found in the research of common boundaries between the land being surveyed and the adjoining land(s).

17. Professional's seal, signature and date.

18. Name and address of the land surveyor or registered business.

D. Notwithstanding the monumentation provisions of subsection B of this section or any other provision of these regulations, a professional, in performing a physical improvements survey, shall not be required to set corner monumentation on any property when corner monumentation is otherwise required to be set pursuant to the provisions of a local subdivision ordinance as mandated by § 15.2-2240 of the Code of Virginia, or by subdivision A 7 of § 15.2-2241 of the Code of Virginia, or where the placing of such monumentation is covered by a surety bond, cash escrow, set-aside letter, letter of credit, or other performance guaranty. When monumentation is not required, the surveyor shall clearly note on the plat "no corner markers set" and the reason to include name of guarantors.

E. Notwithstanding anything to the contrary in this chapter, this chapter shall be construed as to comply in all respects with § 54.1-407 of the Code of Virginia.

F. In no event may this chapter be interpreted or construed to require the professional to perform work of a lesser quality or quantity than that which is prudent or warranted under the existing field conditions and circumstances.

18VAC10-20-382. Minimum standards and procedures for surveys determining topography; field procedures; office procedures.

A. The minimum standards and procedures set forth in this section are to be used for topographic surveys performed in the Commonwealth of Virginia pursuant to Chapter 4 (§54.1-400 et seq.) of Title 54.1 of the Code of Virginia. The application of the professional's seal, signature and date as required by these regulations shall be evidence that the topographic survey is correct to the best of the professional's knowledge and belief, and complies with the minimum standards and procedures.

B. Minimum field and office procedures. The following information shall be shown on or contained in all plats, maps, or digital geospatial data including metadata used to depict the results of the topographic survey:

1. Physical improvements on the property, all man-made or installed structures, as well as visible evidence of underground features (such as manholes, catch basins, telephone pedestals, power transformers, etc.), and utility lines and poles shall be shown or depicted when they are visible based on the methodology and scale. If the methodology or scale prevents the depiction of physical improvements on the property, all man-made or installed structures, as well as visible evidence of underground features (such as manholes, catch basins, telephone pedestals, power transformers, etc.), and utility lines and poles, then such notice shall be clearly stated on or contained in the map, plat, or digital geospatial data including metadata.

2. Elevations shall be provided as spot elevations, contours or digital terrain models.

3. Onsite bench mark(s) shall be established with reference to vertical datum, preferably North American Vertical Datum (NAVD), and shown in the correct location.

4. The title of the topographic survey identifying the land surveyed and showing the state, county or city in which property is located.

5. Name of the individual or entity for whom the survey is being performed.

6. Date, graphic scale, numerical scale, and contour interval of plat, map, or digital geospatial data including metadata.

7. Depiction and definition of north used for the survey.

8. Names of highways, streets and named waterways shall be shown.

9. The horizontal and vertical unit of measurement, coordinate system, and datums, including adjustments if applicable.

10. The following minimum positional accuracies shall be met:

a. Scale and contour interval combinations.

Map or Plat Scale	Contour Interval
1" = 20'	1 or 2 feet
1" = 30'	1 or 2 feet
1" = 40'	1 or 2 feet
1" = 50'	1 or 2 feet
1" = 100'	1 or 2 feet
1" = 200'	2, 4 or 5 feet
1" = 400'	4, 5 or 10 feet

b. Vertical accuracy standards.

	Contours - Vertical Positional Accuracy	Spot Elevations - Vertical Positional Accuracy
Contour line 1' interval	± 0.60 feet	± 0.30 feet
Contour line 2' interval	± 1.19 feet	± 0.60 feet
Contour line 4' interval	± 2.38 feet	± 1.19 feet
Contour line 5' interval	± 2.98 feet	± 1.49 feet
Contour line 10' interval	± 5.96 feet	± 2.98 feet
Positional Accuracy is given at the 95% confidence level.

c. Horizontal accuracy standards.

Well defined ground points - Horizontal (Radial) Positional Accuracy
Map or Plat Scale	Absolute Horizontal Positional Accuracy	Relative Horizontal Positional Accuracy
1" = 20'	± 0.8 feet	± 0.20 feet
1" = 30'	± 1.1 feet	± 0.30 feet
1" = 40'	± 1.5 feet	± 0.40 feet
1" = 50'	± 1.9 feet	± 0.50 feet
1" = 100'	± 3.8 feet	± 1.00 feet
1" = 200'	± 7.6 feet	± 2.00 feet
1" = 400'	± 15.2 feet	± 4.00 feet
Positional Accuracy is given at the 95% confidence level.

The accuracy standards tables as shown are not intended to be acceptable in all situations. The professional shall be responsible to perform the work to the appropriate quality and extent that is prudent or warranted under the existing field conditions and circumstances.

Metric or other unit of measurements shall meet an equivalent positional accuracy.

Map or plat scales, or contour intervals, other than those defined in these tables shall meet an equivalent positional accuracy.

11. A statement, in the following form, shall be shown on or contained in plats, maps, or digital geospatial data including metadata:

This ________________ (provide description of the project) was completed under the direct and responsible charge of, _______________________________ (Name of Surveyor or Surveyor Photogrammetrist) from an actual  Ground or  Airborne (check the one that is applicable) survey made under my supervision; that the imagery and/or original data was obtained on ______________ (Date); and that this plat, map, or digital geospatial data including metadata meets minimum accuracy standards unless otherwise noted.

18VAC10-20-392. Photogrammetric surveys.

The use of photogrammetric methods or similar remote sensing technology to perform any part of the practice of land surveying as defined in Chapter 4 (§54.1-400 et seq.) of Title 54.1 of the Code of Virginia, shall be performed under the direct control and supervision of a licensed land surveyor or a licensed surveyor photogrammetrist.

18VAC10-20-395. Standard of care.

In no event may the requirements contained in 18VAC10-20-280 through 18VAC10-20-392 be interpreted or construed to require the professional to perform work of a lesser quality or quantity than that which is prudent or warranted under the existing field conditions and circumstances.

18VAC10-20-760. Use of seal.

A. The application of a professional seal shall indicate that the professional has exercised direct control and personal supervision over the work to which it is affixed. Therefore, no professional shall affix a name, seal or certification to a plat, design, specification or other work constituting the practice of the professions regulated which has been prepared by an unlicensed or uncertified person unless such work was performed under the direct control and personal supervision of the professional while said unlicensed or uncertified person was an employee of the same firm as the professional or was under written contract to the same firm that employs the professional. If the original professional of record is no longer employed by the regulant or is otherwise unable to seal completed professional work, such work may be sealed by another professional, but only after a thorough review of the work by the professional affixing the professional seal to verify that the work has been accomplished to the same extent that would have been exercised if the work had been done under the direct control and personal supervision of the professional affixing the professional seal.

B. An appropriately licensed or certified professional shall apply a seal to final and complete original cover sheets of plans, drawings, plats, technical reports and specifications and to each original sheet of plans, drawings or plats, prepared by the professional or someone under his direct control and personal supervision.

1. All seal imprints on the cover or first sheet of final documents shall bear an original signature and date. "Final Documents" are completed documents or copies submitted on a client's behalf for approval by authorities or recordation. In such cases, the cover sheet of the documents or copies shall contain a list of drawings or plats included in the set on which a seal, original signature and date shall be affixed for all regulated disciplines. Every page of the submission, other than the cover, may be reproduced from originals which contain the seal, original signature and date by each discipline responsible for the work.

a. An electronic seal, signature and date are permitted to be used in lieu of an original seal, signature and date when the following criteria, and all other requirements of this section, are met:

(1) It is a unique identification of the professional;

(2) It is verifiable; and

(3) It is under the professional's direct control.

b. A professional should not seal original documents made of mylar, linen, sepia, or other materials, or that are transmitted electronically, which can be changed by the person or entity with whom the documents are filed, unless the professional accompanies such documents with a signed and sealed letter making the recipient of such documents aware that copies of the original documents as designed by the professional have been retained by the professional and that the professional cannot assume responsibility for any subsequent changes to the reproducible original documents that are not made by the professional or those working under his direct control and personal supervision.

2. Incomplete plans, documents and sketches, whether advance or preliminary copies, shall be so identified on the plan, document or sketch and need not be sealed, signed or dated.

3. All plans, drawings or plats prepared by the professional shall bear the professional's name or firm name, address and project name.

4. The seal of each professional responsible for each profession shall be used and shall be on each document that was prepared under the professional's direction and for which that professional is responsible. If one of the exemptions found in § 54.1-402 of the Code of Virginia is applicable, a professional licensed or certified by this board shall nevertheless apply his seal to the exempt work.

5. Application of the seal and signature indicates acceptance of responsibility for work shown thereon.

6. The seal shall conform in detail and size to the design illustrated below and shall be two inches in diameter. The designs below may not be shown to scale:

Title of Regulation: 18VAC30-20. Regulations Governing the Practice of Audiology and Speech-Language Pathology (amending 18VAC30-20-160; adding 18VAC30-20-185).

Statutory Authority: §§54.1-2400 and 54.1-2604 of the Code of Virginia.

Public Hearing Information: No public hearings are scheduled.

Public Comments: Public comments may be submitted until 5 p.m. on December 12, 2008.

Agency Contact: Lisa R. Hahn, Executive Director, Board of Audiology and Speech-Language Pathology, 9960 Mayland Drive, Suite 300, Richmond, VA 23233-1463, telephone (804) 367-4630, FAX (804) 527-4413, or email lisa.hahn@dhp.virginia.gov.

Basis: Section 54.1-2400 of the Code of Virginia establishes the general powers and duties of the Board of Audiology & Speech-Language Pathology, including the authority to establish qualifications for licensure and promulgate regulations. Section 54.1-2604 establishes the board’s authority to issue a provisional license in audiology.

Purpose: The board’s purpose is to modify requirements for initial licensure to allow an applicant who has been licensed and has practiced in another jurisdiction but who does not possess current certification from the American Speech-Language-Hearing Association (ASHA) or the American Board of Audiology (ABA) to present other qualifications that indicate current competency to practice. The board has also amended requirements for reinstatement of a lapsed license to allow someone who has not practiced in recent years to work with a provisional license under direct supervision for a specified period of time. The goal of the amended regulations is to remove any barriers to licensure that are not necessary to ensure an ability to practice with safety and competency. Evidence of continuing education, current licensure and practice in another jurisdiction, and/or provisional practice under supervision will assure that applicants are adequately competent to protect the health and safety of the clients they serve. Access to audiology and speech-language pathology services should not be hampered by enacting unreasonable rules that make it overly burdensome for a qualified person to be licensed. Conversely, the board has an obligation to ensure that requirements in Virginia are not distinctly less restrictive than other states to the point that persons who would be unqualified in other states are able to obtain a Virginia license.

Substance: Currently, regulations of the board require an applicant for licensure as an audiologist to hold a current and unrestricted Certificate of Clinical Competence in the area in which he seeks licensure issued by the American Speech‑Language‑Hearing Association (ASHA) or certification issued by the American Board of Audiology (ABA). For an applicant who has been licensed in another state, the requirement for current certification may be problematic. The purpose of certification is to provide evidence of completion of a degree, educational courses, a practicum, and clinical experience required for licensure. If an applicant met that requirement at the time of initial licensure and has evidence of continuing education and clinical practice, it may not be necessary to show evidence of holding current certification from ASHA or ABA. Therefore, the board adopted endorsement provisions that allow an applicant three pathways in which to be licensed: (i) meet the qualifications for licensure as prescribed by 18VAC30-20-170 of this chapter; (ii) provide documentation of continuing education, a current license in another jurisdiction in the United States and evidence of active practice for at least three of the past five years; or (iii) if the applicant does not meet the those qualifications, he may be qualified by practicing under supervision for six months with a provisional license in audiology if he can provide evidence of having met the educational qualifications and passed the qualifying examination at the time of initial licensure. Additionally, an applicant who has been licensed in another jurisdiction must submit documentation of 15 continuing competency hours for each year in which he has been licensed in the other jurisdiction, not to exceed 60 hours.

To reinstate a lapsed license within five years, an applicant is required to provide evidence of continuing education equal to the number of hours required for the years the license was lapsed, not to exceed 60 hours. To reinstate a license lapsed for more than five years, an applicant is required to meet the requirements for initial licensure. The board has adopted provisions for reinstatement of a lapsed license identical to those for endorsement of a license from another jurisdiction. The intent of requirements for licensure, whether by endorsement or reinstatement, is to ensure that an applicant is competent to practice in Virginia in a safe, professional manner with current skills and abilities.

Issues: The primary advantage to the public would be the possibility of increasing the number of licensees available in audiology and speech-language pathology. By adding pathways to licensure for persons who have "retired" from practice to raise a family or who are moving to Virginia from another state, the board has made it less burdensome to obtain a license but has concurrently retained the essential requirements for evidence of competency to practice. There are no disadvantages. There are no advantages or disadvantages to the agency. There are no other pertinent matters of interest.

The Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The Board of Audiology and Speech-Language Pathology (Board) proposes to amend its regulations to make requirements for reinstatement of lapsed audiology and speech-language pathology licenses less restrictive. The Board also proposes to allow licensure by endorsement for individuals who hold a current license from another jurisdiction of the United States.

Result of Analysis. The benefits likely exceed the costs for all proposed changes.

Estimated Economic Impact. Currently, audiologists and speech-language pathologists may reinstate a lapsed license within four years of license expiration by paying a reinstatement fee and providing proof that they have completed 15 hours of continuing education for each year that the license has been lapsed (up to 60 hours total). Individuals whose licenses have lapsed for more than four years must meet all requirements for initial licensure in effect at the time of new application.

To gain initial licensure currently, audiologists must hold either: 1) a current and unrestricted certificate of clinical competence from the American Speech-Language-Hearing Association (ASHA), 2) a certification from the American Board of Audiology (ABA) or 3) certification from any other Board recognized accrediting body. Audiologists must also have passed a qualifying examination from a Board recognized accrediting body within three years of the date of initial licensure application or have actively practiced their profession during one of the past three consecutive years. In general, speech-language pathologists must hold a doctoral degree from a speech-language program accredited by ASHA (or an equivalent accrediting body) and must have passed a qualifying examination within three years of the date of initial licensure application or have actively practiced their profession during one of the past three consecutive years. School speech-language pathologists need only hold a master’s degree in speech-language pathology and hold an endorsement in their field from the Virginia Department of Education.

The Board proposes to amend reinstatement of lapsed license requirements so that licensees may reinstate their licenses within five (rather than four) years. The Board also proposes to allow all licensees the option of reapplying for licensure when their Virginia licenses has lapsed for more than five years if they can show proof of completion of 60 hours of continuing education since their license lapsed, have a current license from another jurisdiction in the United States and have actively practiced their profession for at least three of the past five years. Additionally, the Board proposes to allow audiologists whose licenses have lapsed for more than five years to practice under supervision with a provisional license for six months. After that six month period, with their supervisors’ recommendation, provisionally licensed audiologists may reinstate their original license. To gain provisional licensure, an applicant must meet the educational requirements for initial licensure and must have passed a qualifying exam when they were initially licensed. The fee for application for provisional licensure is $50.

Under these proposed regulations, individuals will have one more year than they currently do to reinstate their licenses and may be able to avail themselves of several other paths, depending on what type of license they hold and whether they have been working in another state, to bring their licenses current without going through the expense of initial licensure again. Specifically, licensees who meet any of the criteria for reinstating a lapsed license will not have to bear the direct and indirect costs of preparing for, and taking, a qualifying examination. These costs would include the fee required to take the exam ($80) as well as the price of any study materials that would need to be purchased and the value of the time spent on studying and taking the exam. Because these changes will likely lower the cost of reinstatement of Virginia licensure for audiologists and speech-language pathologists with lapsed licenses, a slightly greater number of these individuals may choose to reinstate licensure. To the extent that this slightly increases the pool of audiologists and speech-language pathologists practicing in the Commonwealth, the cost of their services may be slightly reduced. Consumers will likely benefit from having greater choice as to whom they see for these services and may also see costs for these services reduced.

Current regulations do not have a special provision for audiologists and speech language pathologists who are licensed in another political jurisdiction but want to begin practicing in Virginia. Currently, these individuals would have to apply for initial licensure and meet all the requirements listed above.

The Board proposes to allow licensure by endorsement for individuals who hold current licensure in another state or United States territory. Individuals who are to be licensed under this provision must provide evidence of a current license and must have actively practiced their profession for three of the last five years. Individuals who do not meet these criteria, but who want to be licensed by endorsement in audiology, may follow the same provisional licensure path that is available to individuals whose Virginia licenses have lapsed for longer than five years.

Applicants for Virginia licensure who are currently licensed in another jurisdiction will likely benefit from this regulatory change because they will likely be able to avoid the expense of retaking an exam that they have already passed. Because these changes will likely lower the cost of Virginia licensure for audiologists and speech-language pathologists coming from other political jurisdictions, a slightly greater number of these individuals may seek licensure. To the extent that this slightly increases the pool of audiologists and speech-language pathologists practicing in the Commonwealth, the cost of their services may be slightly reduced Consumers will likely benefit from having greater choice as to whom they see for these services and may also see costs for these services reduced.

Businesses and Entities Affected. These regulatory changes will affect all audiologists and speech-language pathologists licensed by the Board and any audiologists and speech-language pathologists who are licensed by another state or U.S. Territory but who want to gain Virginia licensure. The Department of Health Professions (DHP) reports that the Board currently licenses 413 audiologists and 2408 speech-language pathologists.

Localities Particularly Affected. No locality will be particularly affected by this proposed regulatory action.

Projected Impact on Employment. This regulatory action may slightly increase the number of audiologists and speech-language pathologists licensed by the Commonwealth. To the extent that these individuals practice independently, employment in these fields will likely be slightly increased.

Effects on the Use and Value of Private Property. To the extent that this regulatory action slightly decreases the cost of hiring audiologists and speech-language pathologists, firms that employ these professionals may see a very slight increase in the value of their businesses.

Small Businesses: Costs and Other Effects. Small businesses in the Commonwealth are unlikely to incur any costs on account of this regulatory action but may see some cost savings cost savings.

Small Businesses: Alternative Method that Minimizes Adverse Impact. Small businesses in the Commonwealth are unlikely to incur any costs on account of this regulatory action.

Real Estate Development Costs. This regulatory action will likely have no effect on real estate development costs in the Commonwealth.

Legal Mandate. The Department of Planning and Budget (DPB) has analyzed the economic impact of this proposed regulation in accordance with § 2.2-4007.04 of the Administrative Process Act and Executive Order Number 36 (06). Section 2.2-4007.04 requires that such economic impact analyses include, but need not be limited to, the projected number of businesses or other entities to whom the regulation would apply, the identity of any localities and types of businesses or other entities particularly affected, the projected number of persons and employment positions to be affected, the projected costs to affected businesses or entities to implement or comply with the regulation, and the impact on the use and value of private property. Further, if the proposed regulation has adverse effect on small businesses, § 2.2-4007.04 requires that such economic impact analyses include (i) an identification and estimate of the number of small businesses subject to the regulation; (ii) the projected reporting, recordkeeping, and other administrative costs required for small businesses to comply with the regulation, including the type of professional skills necessary for preparing required reports and other documents; (iii) a statement of the probable effect of the regulation on affected small businesses; and (iv) a description of any less intrusive or less costly alternative methods of achieving the purpose of the regulation. The analysis presented above represents DPB’s best estimate of these economic impacts.

Agency's Response to the Department of Planning and Budget's Economic Impact Analysis: The Board of Audiology and Speech-Language Pathology concurs with the analysis of the Department of Planning and Budget on the amendments for endorsement and reinstatement for 18VAC30-20, Regulations Governing the Practice of Audiology and Speech-Language Pathology.

Summary:

The amendments allow an applicant whose license has been lapsed for five or more years to apply for reinstatement based on documentation of meeting current requirements for education, examination and certification or documentation of a current license in another jurisdiction in the United States and evidence of active practice for at least three of the past five years. If an applicant for reinstatement in audiology cannot meet the current licensure requirements or cannot document current licensure and active practice for three years, a third option is provided in the amended regulation. The applicant who has the educational qualifications and has passed the examination may be granted a provisional license and practice under supervision for six months and must be recommended for licensure by his supervisor.

New regulations for licensure by endorsement mirror the provisions for reinstatement of a lapsed Virginia license as evidence of current competency to practice.

18VAC30-20-160. Reinstatement of lapsed license.

A. When a license has not been renewed within one year of the expiration date, a person may apply to reinstate his license by submission of a reinstatement application, payment of the reinstatement fee, and submission of documentation of 15 continuing competency hours equal to the requirement for the number of years for each year the license has been lapsed, not to exceed four years, in which the license has been lapsed 60 hours obtained during the time the license in Virginia was lapsed.

B. A licensee who does not reinstate within four five years as prescribed by subsection A of this section shall either:

reapply 1. Reapply for licensure as prescribed by Part III (18VAC30-20-170 et seq.) of this chapter 18VAC30-20-170 and meet the qualifications for licensure in effect at the time of the new application; or

2. Meet the continuing competency requirements specified in subsection A of this section and provide documentation of a current license in another jurisdiction in the United States and evidence of active practice for at least three of the past five years.

C. An applicant for reinstatement in audiology who does not meet one of the qualifications of subsection B of this section may qualify for reinstatement by practice under supervision with a provisional license for six months and a recommendation for reinstatement by his supervisor. The board may issue a provisional license to an applicant who can provide evidence of having met the applicable educational qualifications prescribed in 18VAC30-20-170 and passage of the qualifying examination at the time of initial licensure. Provisional licensure shall be practiced in accordance with subsections C, D, and E of 18VAC30-20-171.

C. D. If the licensee holds licensure in any other state or jurisdiction, he shall provide evidence that no disciplinary action has been taken or is pending. The board reserves the right to deny a request for reinstatement to any licensee who has been determined to have committed an act in violation of 18VAC30-20-280.

18VAC30-20-185. Licensure by endorsement.

A. An applicant who has been licensed in another jurisdiction in the United States may apply for licensure in Virginia by submission of a completed application, payment of the application fee, and submission of documentation of 15 continuing competency hours for each year in which he has been licensed in the other jurisdiction, not to exceed 60 hours.

B. An applicant shall either:

1. Meet the qualifications for licensure as prescribed by 18VAC30-20-170; or

2. Provide documentation of a current license in another jurisdiction in the United States and evidence of active practice for at least three of the past five years.

C. An applicant for licensure by endorsement in audiology who does not meet one of the qualifications of subsection B of this section may qualify for endorsement by practice under supervision with a provisional license for six months and a recommendation for licensure by his supervisor. The board may issue a provisional license to an applicant who can provide evidence of having met the educational qualifications prescribed in 18VAC30-20-170 and passage of the qualifying examination at the time of initial licensure. Provisional licensure shall be practiced in accordance with subsections C, D, and E of 18VAC30-20-171.

D. An applicant shall provide evidence that no disciplinary action has been taken or is pending against his license in another jurisdiction. The board reserves the right to deny a request for licensure to any applicant who has been determined to have committed an act in violation of 18VAC30-20-280.

Title of Regulation: 18VAC48-10. Public Participation Guidelines (adding 18VAC48-10-10 through 18VAC48-10-110).

Statutory Authority: §§2.2-4007.02 and 54.1-2349 of the Code of Virginia.

Effective Date: November 13, 2008.

Agency Contact: Trisha Henshaw, Executive Director, Common Interest Community Board, 9960 Mayland Drive, Suite 400, Richmond, VA 23233, telephone (804) 367-8510, FAX (804) 527-4298, or email cic@dpor.virginia.gov.

Summary:

The regulations comply with the legislative mandate (Chapter 321, 2008 Acts of Assembly) that agencies adopt model public participation guidelines issued by the Department of Planning and Budget by December 1, 2008. Public participation guidelines exist to promote public involvement in the development, amendment, or repeal of an agency's regulations.

This regulatory action promulgates new public participation guidelines as required by Chapter 321 of the 2008 Acts of Assembly. Highlights of the public participation guidelines include (i) providing for the establishment and maintenance of notification lists of interested persons and specifying the information to be sent to such persons; (ii) providing for public comments on regulatory actions; (iii) establishing the time period during which public comments shall be accepted; (iv) providing that the plan to hold a public meeting shall be indicated in any notice of intended regulatory action; (v) providing for the appointment, when necessary, of regulatory advisory panels to provide professional specialization or technical assistance and negotiated rulemaking panels if a regulatory action is expected to be controversial; and (vi) providing for the periodic review of regulations.

CHAPTER 10
PUBLIC PARTICIPATION GUIDELINES

Part I
Purpose and Definitions

18VAC48-10-10. Purpose.

The purpose of this chapter is to promote public involvement in the development, amendment or repeal of the regulations of the Common Interest Community Board. This chapter does not apply to regulations, guidelines, or other documents exempted or excluded from the provisions of the Administrative Process Act (§2.2-4000 et seq. of the Code of Virginia).

18VAC48-10-20. Definitions.

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Administrative Process Act" means Chapter 40 (§2.2-4000 et seq.) of Title 2.2 of the Code of Virginia.

"Agency" means the Common Interest Community Board, which is the unit of state government empowered by the agency's basic law to make regulations or decide cases. Actions specified in this chapter may be fulfilled by state employees as delegated by the agency.

"Basic law" means provisions in the Code of Virginia that delineate the basic authority and responsibilities of an agency.

"Commonwealth Calendar" means the electronic calendar for official government meetings open to the public as required by § 2.2-3707 C of the Freedom of Information Act.

''Negotiated rulemaking panel'' or ''NRP'' means an ad hoc advisory panel of interested parties established by an agency to consider issues that are controversial with the assistance of a facilitator or mediator, for the purpose of reaching a consensus in the development of a proposed regulatory action.

"Notification list" means a list used to notify persons pursuant to this chapter. Such a list may include an electronic list maintained through the Virginia Regulatory Town Hall or other list maintained by the agency.

"Open meeting" means any scheduled gathering of a unit of state government empowered by an agency's basic law to make regulations or decide cases, which is related to promulgating, amending or repealing a regulation.

"Person" means any individual, corporation, partnership, association, cooperative, limited liability company, trust, joint venture, government, political subdivision, or any other legal or commercial entity and any successor, representative, agent, agency, or instrumentality thereof.

"Public hearing" means a scheduled time at which members or staff of the agency will meet for the purpose of receiving public comment on a regulatory action.

"Regulation" means any statement of general application having the force of law, affecting the rights or conduct of any person, adopted by the agency in accordance with the authority conferred on it by applicable laws.

"Regulatory action" means the promulgation, amendment, or repeal of a regulation by the agency.

"Regulatory advisory panel" or "RAP" means a standing or ad hoc advisory panel of interested parties established by the agency for the purpose of assisting in regulatory actions.

"Town Hall" means the Virginia Regulatory Town Hall, the website operated by the Virginia Department of Planning and Budget at www.townhall.virginia.gov, which has online public comment forums and displays information about regulatory meetings and regulatory actions under consideration in Virginia and sends this information to registered public users.

"Virginia Register" means the Virginia Register of Regulations, the publication that provides official legal notice of new, amended and repealed regulations of state agencies, which is published under the provisions of Article 6 (§2.2-4031 et seq.) of the Administrative Process Act.

Part II
Notification of Interested Persons

18VAC48-10-30. Notification list.

A. The agency shall maintain a list of persons who have requested to be notified of regulatory actions being pursued by the agency.

B. Any person may request to be placed on a notification list by registering as a public user on the Town Hall or by making a request to the agency. Any person who requests to be placed on a notification list shall elect to be notified either by electronic means or through a postal carrier.

C. The agency may maintain additional lists for persons who have requested to be informed of specific regulatory issues, proposals, or actions.

D. When electronic mail is returned as undeliverable on multiple occasions at least 24 hours apart, that person may be deleted from the list. A single undeliverable message is insufficient cause to delete the person from the list.

E. When mail delivered by a postal carrier is returned as undeliverable on multiple occasions, that person may be deleted from the list.

F. The agency may periodically request those persons on the notification list to indicate their desire to either continue to be notified electronically, receive documents through a postal carrier, or be deleted from the list.

18VAC48-10-40. Information to be sent to persons on the notification list.

A. To persons electing to receive electronic notification or notification through a postal carrier as described in 18VAC48-10-30, the agency shall send the following information:

1. A notice of intended regulatory action (NOIRA).

2. A notice of the comment period on a proposed, a reproposed, or a fast-track regulation and hyperlinks to, or instructions on how to obtain, a copy of the regulation and any supporting documents.

3. A notice soliciting comment on a final regulation when the regulatory process has been extended pursuant to § 2.2-4007.06 or 2.2-4013 C of the Code of Virginia.

B. The failure of any person to receive any notice or copies of any documents shall not affect the validity of any regulation or regulatory action.

Part III
Public Participation Procedures

18VAC48-10-50. Public comment.

A. In considering any nonemergency, nonexempt regulatory action, the agency shall afford interested persons an opportunity to submit data, views, and arguments, either orally or in writing, to the agency. Such opportunity to comment shall include an online public comment forum on the Town Hall.

1. To any requesting person, the agency shall provide copies of the statement of basis, purpose, substance, and issues; the economic impact analysis of the proposed or fast-track regulatory action; and the agency's response to public comments received.

2. The agency may begin crafting a regulatory action prior to or during any opportunities it provides to the public to submit comments.

B. The agency shall accept public comments in writing after the publication of a regulatory action in the Virginia Register as follows:

1. For a minimum of 30 calendar days following the publication of the notice of intended regulatory action (NOIRA).

2. For a minimum of 60 calendar days following the publication of a proposed regulation.

3. For a minimum of 30 calendar days following the publication of a reproposed regulation.

4. For a minimum of 30 calendar days following the publication of a final adopted regulation.

5. For a minimum of 30 calendar days following the publication of a fast-track regulation.

6. For a minimum of 21 calendar days following the publication of a notice of periodic review.

7. Not later than 21 calendar days following the publication of a petition for rulemaking.

C. The agency may determine if any of the comment periods listed in subsection B of this section shall be extended.

D. If the Governor finds that one or more changes with substantial impact have been made to a proposed regulation, he may require the agency to provide an additional 30 calendar days to solicit additional public comment on the changes in accordance with § 2.2-4013 C of the Code of Virginia.

E. The agency shall send a draft of the agency's summary description of public comment to all public commenters on the proposed regulation at least five days before final adoption of the regulation pursuant to § 2.2-4012 E of the Code of Virginia.

18VAC48-10-60. Petition for rulemaking.

A. As provided in § 2.2-4007 of the Code of Virginia, any person may petition the agency to consider a regulatory action.

B. A petition shall include but is not limited to the following information:

1. The petitioner's name and contact information;

2. The substance and purpose of the rulemaking that is requested, including reference to any applicable Virginia Administrative Code sections; and

3. Reference to the legal authority of the agency to take the action requested.

C. The agency shall receive, consider and respond to a petition pursuant to § 2.2-4007 and shall have the sole authority to dispose of the petition.

D. The petition shall be posted on the Town Hall and published in the Virginia Register.

E. Nothing in this chapter shall prohibit the agency from receiving information or from proceeding on its own motion for rulemaking.

18VAC48-10-70. Appointment of regulatory advisory panel.

A. The agency may appoint a regulatory advisory panel (RAP) to provide professional specialization or technical assistance when the agency determines that such expertise is necessary to address a specific regulatory issue or action or when individuals indicate an interest in working with the agency on a specific regulatory issue or action.

B. Any person may request the appointment of a RAP and request to participate in its activities. The agency shall determine when a RAP shall be appointed and the composition of the RAP.

C. A RAP may be dissolved by the agency if:

1. The proposed text of the regulation is posted on the Town Hall, published in the Virginia Register, or such other time as the agency determines is appropriate; or

2. The agency determines that the regulatory action is either exempt or excluded from the requirements of the Administrative Process Act.

18VAC48-10-80. Appointment of negotiated rulemaking panel.

A. The agency may appoint a negotiated rulemaking panel (NRP) if a regulatory action is expected to be controversial.

B. An NRP that has been appointed by the agency may be dissolved by the agency when:

1. There is no longer controversy associated with the development of the regulation;

2. The agency determines that the regulatory action is either exempt or excluded from the requirements of the Administrative Process Act; or

3. The agency determines that resolution of a controversy is unlikely.

18VAC48-10-90. Meetings.

Notice of any open meeting, including meetings of a RAP or NRP, shall be posted on the Virginia Regulatory Town Hall and Commonwealth Calendar at least seven working days prior to the date of the meeting. The exception to this requirement is any meeting held in accordance with § 2.2-3707 D of the Code of Virginia allowing for contemporaneous notice to be provided to participants and the public.

18VAC48-10-100. Public hearings on regulations.

A. The agency shall indicate in its notice of intended regulatory action whether it plans to hold a public hearing following the publication of the proposed stage of the regulatory action.

B. The agency may conduct one or more public hearings during the comment period following the publication of a proposed regulatory action.

C. The agency is required to hold a public hearing following the publication of the proposed regulatory action when:

1. The agency's basic law requires the agency to hold a public hearing;

2. The Governor directs the agency to hold a public hearing; or

3. The agency receives requests for a public hearing from at least 25 persons during the public comment period following the publication of the notice of intended regulatory action.

D. Notice of any public hearing shall be posted on the Town Hall and Commonwealth Calendar at least seven working days prior to the date of the hearing. The agency shall also notify those persons who requested a hearing under subdivision C 3 of this section.

18VAC48-10-110. Periodic review of regulations.

A. The agency shall conduct a periodic review of its regulations consistent with:

1. An executive order issued by the Governor pursuant to § 2.2-4017 of the Administrative Process Act to receive comment on all existing regulations as to their effectiveness, efficiency, necessity, clarity, and cost of compliance; and

2. The requirements in § 2.2-4007.1 of the Administrative Process Act regarding regulatory flexibility for small businesses.

B. A periodic review may be conducted separately or in conjunction with other regulatory actions.

C. Notice of a periodic review shall be posted on the Town Hall and published in the Virginia Register.

Title of Regulation: 18VAC50-22. Board for Contractors Regulations (amending 18VAC50-22-40, 18VAC50-22-50, 18VAC50-22-60; adding 18VAC50-22-300 through 18VAC50-22-350).

Statutory Authority: §§54.1-201 and 54.1-1102 of the Code of Virginia.

Effective Date: December 1, 2008.

Agency Contact: Eric Olson, Executive Director, Board for Contractors, 9960 Mayland Drive, Suite 400, Richmond, VA 23233, telephone (804) 367-2785, FAX (804) 527-4401, or email contractors@dpor.virginia.gov.

Summary:

The amendments implement new prelicense education requirements as mandated by Chapters 454 and 475 of the 2006 Acts of Assembly and promulgated as emergency regulations by the board on August 21, 2006.

The regulations amend entry requirements for Class A, B and C contractors by adding the requirement of successful completion of board-approved prelicense education for the designated employee or responsible management. A new section (Part VI) is added to the regulations to provide eligibility and reporting criteria for education providers and education courses.

Summary of Public Comments and Agency's Response: A summary of comments made by the public and the agency's response may be obtained from the promulgating agency or viewed at the office of the Registrar of Regulations.

Part II
Entry

18VAC50-22-40. Requirements for a Class C license.

A. A firm applying for a Class C license must meet the requirements of this section.

B. For every classification or specialty in which the firm seeks to be licensed, the firm shall name a qualified individual who meets the following requirements:

1. Is at least 18 years old;

2. Has a minimum of two years experience in the classification or specialty for which he is the qualifier;

3. Is a full-time employee of the firm as defined in this chapter or is a member of the responsible management of the firm;

4. Where appropriate, has passed the trade-related examination or has completed an education and training program approved by the board and required for the specialties listed below:

Blast/explosive contracting

Electrical

Fire sprinkler

Gas fitting

HVAC

Plumbing

Blast/explosive contracting

Radon mitigation

Water well drilling

Fire sprinkler

5. Has obtained, pursuant to the tradesman regulations, a master tradesman license as required for those classifications and specialties listed in 18VAC50-22-20 and 18VAC50-22-30.

C. The firm shall provide information for the past five years prior to application on any outstanding, past-due debts and judgments; outstanding tax obligations; defaults on bonds; or pending or past bankruptcies. The firm, its qualified individual or individuals, and all members of the responsible management of the firm shall submit information on any past-due debts and judgments or defaults on bonds directly related to the practice of contracting as defined in Chapter 11 (§54.1-1100 et seq.) of Title 54.1 of the Code of Virginia.

D. The firm, the qualified individual, and all members of the responsible management of the firm shall disclose at the time of application any current or previous contractor licenses held in Virginia or in other jurisdictions and any disciplinary actions taken on these licenses. This includes but is not limited to any monetary penalties, fines, suspensions, revocations, surrender of a license in connection with a disciplinary action, or voluntary termination of a license in Virginia or in any other jurisdiction.

E. In accordance with § 54.1-204 of the Code of Virginia, each applicant shall disclose the following information about the firm, all members of the responsible management, and the qualified individual or individuals for the firm:

1. All misdemeanor convictions within three years of the date of application; and

2. All felony convictions during their lifetime.

Any plea of nolo contendere shall be considered a conviction for purposes of this subsection. The record of a conviction received from a court shall be accepted as prima facie evidence of a conviction or finding of guilt. The board, in its discretion, may deny licensure to any applicant in accordance with § 54.1-204 of the Code of Virginia.

F. A member of responsible management shall have successfully completed a board-approved basic business course.

18VAC50-22-50. Requirements for a Class B license.

A. A firm applying for a Class B license must meet the requirements of this section.

B. A firm shall name a designated employee who meets the following requirements:

1. Is at least 18 years old;

2. Is a full-time employee of the firm as defined in this chapter, or is a member of responsible management as defined in this chapter;

3. Has passed a board-approved examination as required by § 54.1-1108 of the Code of Virginia or has been exempted from the exam requirement in accordance with § 54.1-1108.1 of the Code of Virginia; and

4. Has followed all rules established by the board or by the testing service acting on behalf of the board with regard to conduct at the examination. Such rules shall include any written instructions communicated prior to the examination date and any oral or written instructions given at the site on the date of the exam.

C. For every classification or specialty in which the firm seeks to be licensed, the firm shall name a qualified individual who meets the following requirements:

1. Is at least 18 years old;

2. Has a minimum of three years experience in the classification or specialty for which he is the qualifier;

3. Is a full-time employee of the firm as defined in this chapter or is a member of the responsible management of the firm;

4. Where appropriate, has passed the trade-related examination or has completed an education and training program approved by the board and required for the classifications and specialties listed below:

Blast/explosive contracting

Electrical

Fire sprinkler

Gas fitting

HVAC

Plumbing

Radon mitigation

Water well drilling

5. Has obtained, pursuant to the tradesman regulations, a master tradesman license as required for those classifications and specialties listed in 18VAC50-22-20 and 18VAC50-22-30.

D. Each firm shall submit information on its financial position. Excluding any property owned as tenants by the entirety, the firm shall state a net worth or equity of $15,000 or more.

E. Each firm shall provide information for the five years prior to application on any outstanding, past-due debts and judgments; outstanding tax obligations; defaults on bonds; or pending or past bankruptcies. The firm, its designated employee, qualified individual or individuals, and all members of the responsible management of the firm shall submit information on any past-due debts and judgments or defaults on bonds directly related to the practice of contracting as defined in Chapter 11 (§54.1-1100 et seq.) of Title 54.1 of the Code of Virginia.

F. The firm, the designated employee, the qualified individual, and all members of the responsible management of the firm shall disclose at the time of application any current or previous substantial identities of interest with any contractor licenses issued in Virginia or in other jurisdictions and any disciplinary actions taken on these licenses. This includes but is not limited to any monetary penalties, fines, suspension, revocation, or surrender of a license in connection with a disciplinary action. The board, in its discretion, may deny licensure to any applicant when any of the parties listed above have had a substantial identity of interest (as deemed in § 54.1-1110 of the Code of Virginia) with any firm that has had a license suspended, revoked, voluntarily terminated or surrendered in connection with a disciplinary action in Virginia or any other jurisdiction.

G. In accordance with § 54.1-204 of the Code of Virginia, each applicant shall disclose the following information about the firm, designated employee, all members of the responsible management, and the qualified individual or individuals for the firm:

1. All misdemeanor convictions within three years of the date of application; and

2. All felony convictions during their lifetime.

Any plea of nolo contendere shall be considered a conviction for purposes of this subsection. The record of a conviction received from a court shall be accepted as prima facie evidence of a conviction or finding of guilt. The board, in its discretion, may deny licensure to any applicant in accordance with § 54.1-204 of the Code of Virginia.

H. The designated employee or a member of responsible management shall have successfully completed a board-approved basic business course.

18VAC50-22-60. Requirements for a Class A license.

A. A firm applying for a Class A license shall meet all of the requirements of this section.

B. A firm shall name a designated employee who meets the following requirements:

1. Is at least 18 years old;

2. Is a full-time employee of the firm as defined in this chapter or is a member of the responsible management of the firm as defined in this chapter;

3. Has passed a board-approved examination as required by § 54.1-1106 of the Code of Virginia or has been exempted from the exam requirement in accordance with § 54.1-1108.1 of the Code of Virginia; and

4. Has followed all rules established by the board or by the testing service acting on behalf of the board with regard to conduct at the examination. Such rules shall include any written instructions communicated prior to the examination date and any oral or written instructions given at the site on the day of the exam.

C. For every classification or specialty in which the firm seeks to be licensed, the firm shall name a qualified individual who meets the following requirements:

1. Is at least 18 years old;

2. Has a minimum of five years of experience in the classification or specialty for which he is the qualifier;

3. Is a full-time employee of the firm as defined in this chapter or is a member of the firm as defined in this chapter or is a member of the responsible management of the firm;

4. Where appropriate, has passed the trade-related examination or has completed an education and training program approved by the board and required for the classifications and specialties listed below:

Blast/explosive contracting

Electrical

Fire sprinkler

Gas fitting

HVAC

Plumbing

Radon mitigation

Water well drilling

5. Has obtained, pursuant to the tradesman regulations, a master tradesman license as required for those classifications and specialties listed in 18VAC50-22-20 and 18VAC50-22-30.

D. Each firm shall submit information on its financial position. Excluding any property owned as tenants by the entirety, the firm shall state a net worth or equity of $45,000.

E. The firm shall provide information for the five years prior to application on any outstanding, past-due debts and judgments; outstanding tax obligations; defaults on bonds; or pending or past bankruptcies. The firm, its designated employee, qualified individual or individuals, and all members of the responsible management of the firm shall submit information on any past-due debts and judgments or defaults on bonds directly related to the practice of contracting as defined in Chapter 11 (§54.1-1100 et seq.) of Title 54.1 of the Code of Virginia.

F. The firm, the designated employee, the qualified individual, and all members of the responsible management of the firm shall disclose at the time of application any current or previous substantial identities of interest with any contractor licenses issued in Virginia or in other jurisdictions and any disciplinary actions taken on these licenses. This includes but is not limited to, any monetary penalties, fines, suspensions, revocations, or surrender of a license in connection with a disciplinary action. The board, in its discretion, may deny licensure to any applicant when any of the parties listed above have had a substantial identity of interest (as deemed in § 54.1-1110 of the Code of Virginia) with any firm that has had a license suspended, revoked, voluntarily terminated, or surrendered in connection with a disciplinary action in Virginia or in any other jurisdiction.

G. In accordance with § 54.1-204 of the Code of Virginia, each applicant shall disclose the following information about the firm, all members of the responsible management, the designated employee and the qualified individual or individuals for the firm:

1. All misdemeanor convictions within three years of the date of application; and

2. All felony convictions during their lifetime.

Any plea of nolo contendere shall be considered a conviction for purposes of this subsection. The record of a conviction received from a court shall be accepted as prima facie evidence of a conviction or finding of guilt. The board, in its discretion, may deny licensure to any applicant in accordance with § 54.1-204 of the Code of Virginia.

H. The designated employee or a member of responsible management shall have successfully completed a board-approved basic business course.

Part VI
Prelicense Education

18VAC50-22-300. Prelicense education courses.

All courses offered by prelicense education providers must be approved by the board prior to the initial offering of the course, and shall cover business principles related to the standards of conduct found in 18VAC50-22-260 B and other applicable requirements of continued licensure set forth in this chapter. Courses must be eight hours in length. Correspondence and other distance learning courses must include appropriate testing procedures to verify completion of the course.

18VAC50-22-310. Requirements for prelicense education providers.

A. Each provider of a prelicense education course shall submit an application for course approval on a form provided by the board. The application shall include but is not limited to:

1. The name of the provider;

2. Provider contact person, address and telephone number;

3. Course contact hours;

4. Schedule of courses, if established, including dates, time and locations;

5. Instructor information, including name, license number(s) if applicable, and a list of other appropriate trade designations;

6. Course and material fees; and

7. Course syllabus.

B. All providers must establish and maintain a record for each student. The record shall include: the student’s name and address; social security number or DMV control number; the course name and clock hours attended; the course syllabus or outline; the name or names of the instructor; the date of successful completion; and the board’s course code. Records shall be available for inspection during normal business hours by authorized representatives of the board. Providers must maintain class records for a minimum of five years.

18VAC50-22-320. Reporting of course completion.

All prelicense education providers shall electronically transmit course completion data to the board in an approved format within seven days of the completion of each individual course. The transmittal will include each student’s name, social security number or DMV control number, the date of successful completion of the course and the board’s course code.

18VAC50-22-330. Posting prelicense education course certificates of approval.

Copies of prelicense education course certificates of approval must be available at the location a course is taught.

[ 18VAC50-30-340 18VAC50-22-340 ]. Reporting of changes.

Any change in the information provided in 18VAC50-22-310 A must be reported to the board within 30 days of the change with the exception of changes in the schedule of courses, which must be reported within 10 days of the change. Failure to report the changes as required may result in the withdrawal of approval of a prelicense education provider by the board.

[ 18VAC50-30-350 18VAC50-22-350 ]. Denial or withdrawal of approval.

The board may deny or withdraw approval of any prelicense education provider for the following reasons:

1. The courses being offered no longer meet the standards established by the board.

2. The provider, through an agent or otherwise, advertises its services in a fraudulent or deceptive way.

3. The provider, instructor, or designee of the provider falsifies any information relating to the application for approval, course information, student records or fails to produce records required by the Board for Contractors Tradesman Regulations.

[ FORMS

Introduction Contractor Licensing Information, 27INTRO (6/00 8/07).

Trade-Related Examinations and Qualifications Information, 27EXINFO (6/00 8/07).

License Application, 27LIC (rev. 8/05 8/08).

Class C License Application (Short Form), 27CSF (rev. 8/05 8/08).

Sample.

Sample Guidelines.

Additional License Classification/Specialty Designation Application, 27ADDCL (rev. 8/05 8/07).

Change of Qualified Individual Application, 27CHQI (rev. 8/05 8/07).

Change of Designated Employee Application, 27CHDE (rev. 8/05 8/07).

Change of Corporate Officers Form, 27CHCO (6/00).

Changes of Responsible Management Form, 27CHRM (eff. 8/07).

Experience Reference, 27EP 27EXP (6/00 8/07).

Contractor Examination Candidate Information Bulletin, copyright 2002 by PSI Corporation.

Virginia Contractors Registration Form (7/02).

Building Technical Examination Requirements (4/00).

Certificate of License Termination, 27TERM (6/00 8/07).

Education Provider Registration/Course Approval, 27CONTEDREG, (eff. 4/08).

Education Provider Listing Form, 27EDLIST, (eff. 4/08).

Financial Statement, 27FINST, (eff. 8/07).

Additional Qualified Individual Experience Reference Form, 27QIEXP, (eff. 8/07). ]

Titles of Regulations: 18VAC60-10. Public Participation Guidelines (repealing 18VAC60-10-10 through 18VAC60-10-120).

18VAC60-11. Public Participation Guidelines (adding 18VAC60-11-10 through 18VAC60-11-110).

Statutory Authority: §§2.2-4007.02 and 54.1-2400 of the Code of Virginia.

Effective Date: November 12, 2008.

Agency Contact: Sandra Reen, Executive Director, Board of Dentistry, 9960 Mayland Drive, Suite 300, Richmond, VA 23233, telephone (804) 367-4437, FAX (804) 527-4428, or email sandra.reen@dhp.virginia.gov.

Summary:

The regulations comply with the legislative mandate (Chapter 321, 2008 Acts of Assembly) that agencies adopt model public participation guidelines issued by the Department of Planning and Budget by December 1, 2008. Public participation guidelines exist to promote public involvement in the development, amendment, or repeal of an agency's regulations.

This regulatory action repeals the current public participation guidelines and promulgates new public participation guidelines as required by Chapter 321 of the 2008 Acts of Assembly. Highlights of the public participation guidelines include (i) providing for the establishment and maintenance of notification lists of interested persons and specifying the information to be sent to such persons; (ii) providing for public comments on regulatory action; (iii) establishing the time period during which public comments shall be accepted; (iv) providing that the plan to hold a public meeting shall be indicated in any notice of intended regulatory action; (v) providing for the appointment, when necessary, of regulatory advisory panels to provide professional specialization or technical assistance and negotiated rulemaking panels if a regulatory action is expected to be controversial; and (vi) providing for the periodic review of regulations.

CHAPTER 11
PUBLIC PARTICIPATION GUIDELINES

Part I
Purpose and Definitions

18VAC60-11-10. Purpose.

The purpose of this chapter is to promote public involvement in the development, amendment or repeal of the regulations of the Board of Dentistry. This chapter does not apply to regulations, guidelines, or other documents exempted or excluded from the provisions of the Administrative Process Act (§2.2-4000 et seq. of the Code of Virginia).

18VAC60-11-20. Definitions.

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Administrative Process Act" means Chapter 40 (§2.2-4000 et seq.) of Title 2.2 of the Code of Virginia.

"Agency" means the Board of Dentistry, which is the unit of state government empowered by the agency's basic law to make regulations or decide cases. Actions specified in this chapter may be fulfilled by state employees as delegated by the agency.

"Basic law" means provisions in the Code of Virginia that delineate the basic authority and responsibilities of an agency.

"Commonwealth Calendar" means the electronic calendar for official government meetings open to the public as required by § 2.2-3707 C of the Freedom of Information Act.

''Negotiated rulemaking panel'' or ''NRP'' means an ad hoc advisory panel of interested parties established by an agency to consider issues that are controversial with the assistance of a facilitator or mediator, for the purpose of reaching a consensus in the development of a proposed regulatory action.

"Notification list" means a list used to notify persons pursuant to this chapter. Such a list may include an electronic list maintained through the Virginia Regulatory Town Hall or other list maintained by the agency.

"Open meeting" means any scheduled gathering of a unit of state government empowered by an agency's basic law to make regulations or decide cases, which is related to promulgating, amending or repealing a regulation.

"Person" means any individual, corporation, partnership, association, cooperative, limited liability company, trust, joint venture, government, political subdivision, or any other legal or commercial entity and any successor, representative, agent, agency, or instrumentality thereof.

"Public hearing" means a scheduled time at which members or staff of the agency will meet for the purpose of receiving public comment on a regulatory action.

"Regulation" means any statement of general application having the force of law, affecting the rights or conduct of any person, adopted by the agency in accordance with the authority conferred on it by applicable laws.

"Regulatory action" means the promulgation, amendment, or repeal of a regulation by the agency.

"Regulatory advisory panel" or "RAP" means a standing or ad hoc advisory panel of interested parties established by the agency for the purpose of assisting in regulatory actions.

"Town Hall" means the Virginia Regulatory Town Hall, the website operated by the Virginia Department of Planning and Budget at www.townhall.virginia.gov, which has online public comment forums and displays information about regulatory meetings and regulatory actions under consideration in Virginia and sends this information to registered public users.

"Virginia Register" means the Virginia Register of Regulations, the publication that provides official legal notice of new, amended and repealed regulations of state agencies, which is published under the provisions of Article 6 (§2.2-4031 et seq.) of the Administrative Process Act.

Part II
Notification of Interested Persons

18VAC60-11-30. Notification list.

A. The agency shall maintain a list of persons who have requested to be notified of regulatory actions being pursued by the agency.

B. Any person may request to be placed on a notification list by registering as a public user on the Town Hall or by making a request to the agency. Any person who requests to be placed on a notification list shall elect to be notified either by electronic means or through a postal carrier.

C. The agency may maintain additional lists for persons who have requested to be informed of specific regulatory issues, proposals, or actions.

D. When electronic mail is returned as undeliverable on multiple occasions at least 24 hours apart, that person may be deleted from the list. A single undeliverable message is insufficient cause to delete the person from the list.

E. When mail delivered by a postal carrier is returned as undeliverable on multiple occasions, that person may be deleted from the list.

F. The agency may periodically request those persons on the notification list to indicate their desire to either continue to be notified electronically, receive documents through a postal carrier, or be deleted from the list.

18VAC60-11-40. Information to be sent to persons on the notification list.

A. To persons electing to receive electronic notification or notification through a postal carrier as described in 18VAC60-11-30, the agency shall send the following information:

1. A notice of intended regulatory action (NOIRA).

2. A notice of the comment period on a proposed, a reproposed, or a fast-track regulation and hyperlinks to, or instructions on how to obtain, a copy of the regulation and any supporting documents.

3. A notice soliciting comment on a final regulation when the regulatory process has been extended pursuant to § 2.2-4007.06 or 2.2-4013 C of the Code of Virginia.

B. The failure of any person to receive any notice or copies of any documents shall not affect the validity of any regulation or regulatory action.

Part III
Public Participation Procedures

18VAC60-11-50. Public comment.

A. In considering any nonemergency, nonexempt regulatory action, the agency shall afford interested persons an opportunity to submit data, views, and arguments, either orally or in writing, to the agency. Such opportunity to comment shall include an online public comment forum on the Town Hall.

1. To any requesting person, the agency shall provide copies of the statement of basis, purpose, substance, and issues; the economic impact analysis of the proposed or fast-track regulatory action; and the agency's response to public comments received.

2. The agency may begin crafting a regulatory action prior to or during any opportunities it provides to the public to submit comments.

B. The agency shall accept public comments in writing after the publication of a regulatory action in the Virginia Register as follows:

1. For a minimum of 30 calendar days following the publication of the notice of intended regulatory action (NOIRA).

2. For a minimum of 60 calendar days following the publication of a proposed regulation.

3. For a minimum of 30 calendar days following the publication of a reproposed regulation.

4. For a minimum of 30 calendar days following the publication of a final adopted regulation.

5. For a minimum of 30 calendar days following the publication of a fast-track regulation.

6. For a minimum of 21 calendar days following the publication of a notice of periodic review.

7. Not later than 21 calendar days following the publication of a petition for rulemaking.

C. The agency may determine if any of the comment periods listed in subsection B of this section shall be extended.

D. If the Governor finds that one or more changes with substantial impact have been made to a proposed regulation, he may require the agency to provide an additional 30 calendar days to solicit additional public comment on the changes in accordance with § 2.2-4013 C of the Code of Virginia.

E. The agency shall send a draft of the agency's summary description of public comment to all public commenters on the proposed regulation at least five days before final adoption of the regulation pursuant to § 2.2-4012 E of the Code of Virginia.

18VAC60-11-60. Petition for rulemaking.

A. As provided in § 2.2-4007 of the Code of Virginia, any person may petition the agency to consider a regulatory action.

B. A petition shall include but is not limited to the following information:

1. The petitioner's name and contact information;

2. The substance and purpose of the rulemaking that is requested, including reference to any applicable Virginia Administrative Code sections; and

3. Reference to the legal authority of the agency to take the action requested.

C. The agency shall receive, consider and respond to a petition pursuant to § 2.2-4007 and shall have the sole authority to dispose of the petition.

D. The petition shall be posted on the Town Hall and published in the Virginia Register.

E. Nothing in this chapter shall prohibit the agency from receiving information or from proceeding on its own motion for rulemaking.

18VAC60-11-70. Appointment of regulatory advisory panel.

A. The agency may appoint a regulatory advisory panel (RAP) to provide professional specialization or technical assistance when the agency determines that such expertise is necessary to address a specific regulatory issue or action or when individuals indicate an interest in working with the agency on a specific regulatory issue or action.

B. Any person may request the appointment of a RAP and request to participate in its activities. The agency shall determine when a RAP shall be appointed and the composition of the RAP.

C. A RAP may be dissolved by the agency if:

1. The proposed text of the regulation is posted on the Town Hall, published in the Virginia Register, or such other time as the agency determines is appropriate; or

2. The agency determines that the regulatory action is either exempt or excluded from the requirements of the Administrative Process Act.

18VAC60-11-80. Appointment of negotiated rulemaking panel.

A. The agency may appoint a negotiated rulemaking panel (NRP) if a regulatory action is expected to be controversial.

B. An NRP that has been appointed by the agency may be dissolved by the agency when:

1. There is no longer controversy associated with the development of the regulation;

2. The agency determines that the regulatory action is either exempt or excluded from the requirements of the Administrative Process Act; or

3. The agency determines that resolution of a controversy is unlikely.

18VAC60-11-90. Meetings.

Notice of any open meeting, including meetings of a RAP or NRP, shall be posted on the Virginia Regulatory Town Hall and Commonwealth Calendar at least seven working days prior to the date of the meeting. The exception to this requirement is any meeting held in accordance with § 2.2-3707 D of the Code of Virginia allowing for contemporaneous notice to be provided to participants and the public.

18VAC60-11-100. Public hearings on regulations.

A. The agency shall indicate in its notice of intended regulatory action whether it plans to hold a public hearing following the publication of the proposed stage of the regulatory action.

B. The agency may conduct one or more public hearings during the comment period following the publication of a proposed regulatory action.

C. An agency is required to hold a public hearing following the publication of the proposed regulatory action when:

1. The agency's basic law requires the agency to hold a public hearing;

2. The Governor directs the agency to hold a public hearing; or

3. The agency receives requests for a public hearing from at least 25 persons during the public comment period following the publication of the notice of intended regulatory action.

D. Notice of any public hearing shall be posted on the Town Hall and Commonwealth Calendar at least seven working days prior to the date of the hearing. The agency shall also notify those persons who requested a hearing under subdivision C 3 of this section.

18VAC60-11-110. Periodic review of regulations.

A. The agency shall conduct a periodic review of its regulations consistent with:

1. An executive order issued by the Governor pursuant to § 2.2-4017 of the Administrative Process Act to receive comment on all existing regulations as to their effectiveness, efficiency, necessity, clarity, and cost of compliance; and

2. The requirements in § 2.2-4007.1 of the Administrative Process Act regarding regulatory flexibility for small businesses.

B. A periodic review may be conducted separately or in conjunction with other regulatory actions.

C. Notice of a periodic review shall be posted on the Town Hall and published in the Virginia Register.

Titles of Regulations: 18VAC60-10. Public Participation Guidelines (repealing 18VAC60-10-10 through 18VAC60-10-120).

18VAC60-11. Public Participation Guidelines (adding 18VAC60-11-10 through 18VAC60-11-110).

Statutory Authority: §§2.2-4007.02 and 54.1-2400 of the Code of Virginia.

Effective Date: November 12, 2008.

Agency Contact: Sandra Reen, Executive Director, Board of Dentistry, 9960 Mayland Drive, Suite 300, Richmond, VA 23233, telephone (804) 367-4437, FAX (804) 527-4428, or email sandra.reen@dhp.virginia.gov.

Summary:

The regulations comply with the legislative mandate (Chapter 321, 2008 Acts of Assembly) that agencies adopt model public participation guidelines issued by the Department of Planning and Budget by December 1, 2008. Public participation guidelines exist to promote public involvement in the development, amendment, or repeal of an agency's regulations.

This regulatory action repeals the current public participation guidelines and promulgates new public participation guidelines as required by Chapter 321 of the 2008 Acts of Assembly. Highlights of the public participation guidelines include (i) providing for the establishment and maintenance of notification lists of interested persons and specifying the information to be sent to such persons; (ii) providing for public comments on regulatory action; (iii) establishing the time period during which public comments shall be accepted; (iv) providing that the plan to hold a public meeting shall be indicated in any notice of intended regulatory action; (v) providing for the appointment, when necessary, of regulatory advisory panels to provide professional specialization or technical assistance and negotiated rulemaking panels if a regulatory action is expected to be controversial; and (vi) providing for the periodic review of regulations.

CHAPTER 11
PUBLIC PARTICIPATION GUIDELINES

Part I
Purpose and Definitions

18VAC60-11-10. Purpose.

The purpose of this chapter is to promote public involvement in the development, amendment or repeal of the regulations of the Board of Dentistry. This chapter does not apply to regulations, guidelines, or other documents exempted or excluded from the provisions of the Administrative Process Act (§2.2-4000 et seq. of the Code of Virginia).

18VAC60-11-20. Definitions.

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Administrative Process Act" means Chapter 40 (§2.2-4000 et seq.) of Title 2.2 of the Code of Virginia.

"Agency" means the Board of Dentistry, which is the unit of state government empowered by the agency's basic law to make regulations or decide cases. Actions specified in this chapter may be fulfilled by state employees as delegated by the agency.

"Basic law" means provisions in the Code of Virginia that delineate the basic authority and responsibilities of an agency.

"Commonwealth Calendar" means the electronic calendar for official government meetings open to the public as required by § 2.2-3707 C of the Freedom of Information Act.

''Negotiated rulemaking panel'' or ''NRP'' means an ad hoc advisory panel of interested parties established by an agency to consider issues that are controversial with the assistance of a facilitator or mediator, for the purpose of reaching a consensus in the development of a proposed regulatory action.

"Notification list" means a list used to notify persons pursuant to this chapter. Such a list may include an electronic list maintained through the Virginia Regulatory Town Hall or other list maintained by the agency.

"Open meeting" means any scheduled gathering of a unit of state government empowered by an agency's basic law to make regulations or decide cases, which is related to promulgating, amending or repealing a regulation.

"Person" means any individual, corporation, partnership, association, cooperative, limited liability company, trust, joint venture, government, political subdivision, or any other legal or commercial entity and any successor, representative, agent, agency, or instrumentality thereof.

"Public hearing" means a scheduled time at which members or staff of the agency will meet for the purpose of receiving public comment on a regulatory action.

"Regulation" means any statement of general application having the force of law, affecting the rights or conduct of any person, adopted by the agency in accordance with the authority conferred on it by applicable laws.

"Regulatory action" means the promulgation, amendment, or repeal of a regulation by the agency.

"Regulatory advisory panel" or "RAP" means a standing or ad hoc advisory panel of interested parties established by the agency for the purpose of assisting in regulatory actions.

"Town Hall" means the Virginia Regulatory Town Hall, the website operated by the Virginia Department of Planning and Budget at www.townhall.virginia.gov, which has online public comment forums and displays information about regulatory meetings and regulatory actions under consideration in Virginia and sends this information to registered public users.

"Virginia Register" means the Virginia Register of Regulations, the publication that provides official legal notice of new, amended and repealed regulations of state agencies, which is published under the provisions of Article 6 (§2.2-4031 et seq.) of the Administrative Process Act.

Part II
Notification of Interested Persons

18VAC60-11-30. Notification list.

A. The agency shall maintain a list of persons who have requested to be notified of regulatory actions being pursued by the agency.

B. Any person may request to be placed on a notification list by registering as a public user on the Town Hall or by making a request to the agency. Any person who requests to be placed on a notification list shall elect to be notified either by electronic means or through a postal carrier.

C. The agency may maintain additional lists for persons who have requested to be informed of specific regulatory issues, proposals, or actions.

D. When electronic mail is returned as undeliverable on multiple occasions at least 24 hours apart, that person may be deleted from the list. A single undeliverable message is insufficient cause to delete the person from the list.

E. When mail delivered by a postal carrier is returned as undeliverable on multiple occasions, that person may be deleted from the list.

F. The agency may periodically request those persons on the notification list to indicate their desire to either continue to be notified electronically, receive documents through a postal carrier, or be deleted from the list.

18VAC60-11-40. Information to be sent to persons on the notification list.

A. To persons electing to receive electronic notification or notification through a postal carrier as described in 18VAC60-11-30, the agency shall send the following information:

1. A notice of intended regulatory action (NOIRA).

2. A notice of the comment period on a proposed, a reproposed, or a fast-track regulation and hyperlinks to, or instructions on how to obtain, a copy of the regulation and any supporting documents.

3. A notice soliciting comment on a final regulation when the regulatory process has been extended pursuant to § 2.2-4007.06 or 2.2-4013 C of the Code of Virginia.

B. The failure of any person to receive any notice or copies of any documents shall not affect the validity of any regulation or regulatory action.

Part III
Public Participation Procedures

18VAC60-11-50. Public comment.

A. In considering any nonemergency, nonexempt regulatory action, the agency shall afford interested persons an opportunity to submit data, views, and arguments, either orally or in writing, to the agency. Such opportunity to comment shall include an online public comment forum on the Town Hall.

1. To any requesting person, the agency shall provide copies of the statement of basis, purpose, substance, and issues; the economic impact analysis of the proposed or fast-track regulatory action; and the agency's response to public comments received.

2. The agency may begin crafting a regulatory action prior to or during any opportunities it provides to the public to submit comments.

B. The agency shall accept public comments in writing after the publication of a regulatory action in the Virginia Register as follows:

1. For a minimum of 30 calendar days following the publication of the notice of intended regulatory action (NOIRA).

2. For a minimum of 60 calendar days following the publication of a proposed regulation.

3. For a minimum of 30 calendar days following the publication of a reproposed regulation.

4. For a minimum of 30 calendar days following the publication of a final adopted regulation.

5. For a minimum of 30 calendar days following the publication of a fast-track regulation.

6. For a minimum of 21 calendar days following the publication of a notice of periodic review.

7. Not later than 21 calendar days following the publication of a petition for rulemaking.

C. The agency may determine if any of the comment periods listed in subsection B of this section shall be extended.

D. If the Governor finds that one or more changes with substantial impact have been made to a proposed regulation, he may require the agency to provide an additional 30 calendar days to solicit additional public comment on the changes in accordance with § 2.2-4013 C of the Code of Virginia.

E. The agency shall send a draft of the agency's summary description of public comment to all public commenters on the proposed regulation at least five days before final adoption of the regulation pursuant to § 2.2-4012 E of the Code of Virginia.

18VAC60-11-60. Petition for rulemaking.

A. As provided in § 2.2-4007 of the Code of Virginia, any person may petition the agency to consider a regulatory action.

B. A petition shall include but is not limited to the following information:

1. The petitioner's name and contact information;

2. The substance and purpose of the rulemaking that is requested, including reference to any applicable Virginia Administrative Code sections; and

3. Reference to the legal authority of the agency to take the action requested.

C. The agency shall receive, consider and respond to a petition pursuant to § 2.2-4007 and shall have the sole authority to dispose of the petition.

D. The petition shall be posted on the Town Hall and published in the Virginia Register.

E. Nothing in this chapter shall prohibit the agency from receiving information or from proceeding on its own motion for rulemaking.

18VAC60-11-70. Appointment of regulatory advisory panel.

A. The agency may appoint a regulatory advisory panel (RAP) to provide professional specialization or technical assistance when the agency determines that such expertise is necessary to address a specific regulatory issue or action or when individuals indicate an interest in working with the agency on a specific regulatory issue or action.

B. Any person may request the appointment of a RAP and request to participate in its activities. The agency shall determine when a RAP shall be appointed and the composition of the RAP.

C. A RAP may be dissolved by the agency if:

1. The proposed text of the regulation is posted on the Town Hall, published in the Virginia Register, or such other time as the agency determines is appropriate; or

2. The agency determines that the regulatory action is either exempt or excluded from the requirements of the Administrative Process Act.

18VAC60-11-80. Appointment of negotiated rulemaking panel.

A. The agency may appoint a negotiated rulemaking panel (NRP) if a regulatory action is expected to be controversial.

B. An NRP that has been appointed by the agency may be dissolved by the agency when:

1. There is no longer controversy associated with the development of the regulation;

2. The agency determines that the regulatory action is either exempt or excluded from the requirements of the Administrative Process Act; or

3. The agency determines that resolution of a controversy is unlikely.

18VAC60-11-90. Meetings.

Notice of any open meeting, including meetings of a RAP or NRP, shall be posted on the Virginia Regulatory Town Hall and Commonwealth Calendar at least seven working days prior to the date of the meeting. The exception to this requirement is any meeting held in accordance with § 2.2-3707 D of the Code of Virginia allowing for contemporaneous notice to be provided to participants and the public.

18VAC60-11-100. Public hearings on regulations.

A. The agency shall indicate in its notice of intended regulatory action whether it plans to hold a public hearing following the publication of the proposed stage of the regulatory action.

B. The agency may conduct one or more public hearings during the comment period following the publication of a proposed regulatory action.

C. An agency is required to hold a public hearing following the publication of the proposed regulatory action when:

1. The agency's basic law requires the agency to hold a public hearing;

2. The Governor directs the agency to hold a public hearing; or

3. The agency receives requests for a public hearing from at least 25 persons during the public comment period following the publication of the notice of intended regulatory action.

D. Notice of any public hearing shall be posted on the Town Hall and Commonwealth Calendar at least seven working days prior to the date of the hearing. The agency shall also notify those persons who requested a hearing under subdivision C 3 of this section.

18VAC60-11-110. Periodic review of regulations.

A. The agency shall conduct a periodic review of its regulations consistent with:

1. An executive order issued by the Governor pursuant to § 2.2-4017 of the Administrative Process Act to receive comment on all existing regulations as to their effectiveness, efficiency, necessity, clarity, and cost of compliance; and

2. The requirements in § 2.2-4007.1 of the Administrative Process Act regarding regulatory flexibility for small businesses.

B. A periodic review may be conducted separately or in conjunction with other regulatory actions.

C. Notice of a periodic review shall be posted on the Town Hall and published in the Virginia Register.

Title of Regulation: 18VAC110-20. Regulations Governing the Practice of Pharmacy (amending 18VAC110-20-10, 18VAC110-20-20 through 18VAC110-20-70, 18VAC110-20-80 through 18VAC110-20-104, 18VAC110-20-106 through 18VAC110-20-120, 18VAC110-20-130, 18VAC110-20-140, 18VAC110-20-180 through 18VAC110-20-210, 18VAC110-20-240, 18VAC110-20-270, 18VAC110-20-275, 18VAC110-20-280, 18VAC110-20-320, 18VAC110-20-340, 18VAC110-20-350, 18VAC110-20-355, 18VAC110-20-395, 18VAC110-20-410, 18VAC110-20-425, 18VAC110-20-440, 18VAC110-20-450, 18VAC110-20-460, 18VAC110-20-490, 18VAC110-20-500, 18VAC110-20-520 through 18VAC110-20-555, 18VAC110-20-570, 18VAC110-20-580, 18VAC110-20-590, 18VAC110-20-610, 18VAC110-20-620, 18VAC110-20-621, 18VAC110-20-622, 18VAC110-20-680 through 18VAC110-20-710, adding 18VAC110-20-286, 18VAC110-20-391, 18VAC110-20-535, 18VAC110-20-536).

Statutory Authority: §54.1-2400 and Chapters 33 (§54.1-3300 et seq.) and 34 (§54.1-3400 et seq.) of Title 54.1 of the Code of Virginia.

Public Hearing Information: No public hearings are scheduled.

Public Comments: Public comments may be submitted until 5 p.m. on December 12, 2008.

Agency Contact: Elizabeth Scott Russell, RPh, Executive Director, Board of Pharmacy, 9960 Mayland Drive, Suite 300, Richmond, VA 23233-1463, telephone (804) 367-4456, FAX (804) 527-4472, or email scotti.russell@dhp.virginia.gov.

Basis: Section 54.1-2400 of the Code of Virginia provides the Board of Pharmacy the authority to promulgate regulations to administer the regulatory system.

The specific authority to issue licenses and permits to pharmacists and pharmacies and to control the sale and dispensing of prescription drugs is found in Chapters 33 (§54.1-3300 et seq.) and 34 (§54.1-3400 et seq.) of Title 54.1 of the Code of Virginia.

Purpose: Regulations of the Board of Pharmacy are complex and broad in scope and applicability to a variety of practice settings. Periodically, it is necessary to review and revise to clarify existing requirements, add new language to address problems that have arisen, delete outmoded regulation, or revise requirements to allow for newer technologies. In revising requirements adapted to the current practice of pharmacy, the board has acted to preserve or construct appropriate safeguards to help ensure safety in practice and in the efficacy and integrity of the drugs being dispensed.

In its promulgation of amended regulations as described in the substance section of this document, the board has incorporated interpretative language now found in several guidance documents and included some provisions that have been tested in pilot programs that are currently approved. While guidance statements advise practitioners on policy matters, they are not enforceable and cannot be relied upon for compliance. Therefore, incorporation of guidance into regulation will make policies more explicitly clear for licensees. Likewise, less restricted policies in pilot programs that have shown to be effective and efficient without any increased risk of medication error have been incorporated in regulations.

The board identified issues with regulations that restrict practice or inhibit modernization and utilization of newer technology, provided the change is within the parameters of law and federal rules and provided it is good policy that protects the health, safety and welfare of the public.

Substance: The following sections of the regulations have been addressed in the promulgation of amended regulations:

18VAC110-20-10. Definitions. Several definitions were added to clarify existing or amended regulations. For example, the definition of a correctional facility was added to clarify the term and be more inclusive of all types of facilities. Some terms were defined, such as "chart order," for more flexibility, and others, such as "NABP" were defined to enable use of the acronym in regulation.

18VAC110-20-20. Fees. Since there is an expectation that pharmacy technician programs are modified frequently to reflect changes in medications and pharmacy practice, the board is adding a fee of $75 for renewal of program approval every two years; there are associated fees for late renewal and reinstatement.

18VAC110-20-30. Requirements for practical experience. Current requirements of the board were made consistent with new ACPE standards for preceptors and experiential training, so amendments to this section conform to national standards for pharmaceutical preceptors and practical experience in order to facilitate reciprocity.

Subsection C requires practical experience can be gained only after completion of the first professional year, but it is unclear when the first professional year ends as some schools now operate year-round rather than in semesters. The board has set completion of certain core curricula as criteria for practical experience and set time limitations on the credit that can be given.

18VAC110-20-40. Procedure for gaining practical experience. Currently, pharmacy intern permits are issued for the period of pharmacy schooling. The board will consider an extension of that time frame for good cause and with a specified expiration date and a limitation of the years of an internship.

The number of interns that may be supervised may be problematic when the internship programs at different pharmacy schools overlap. The board eliminated the restriction on supervision of one pharmacy intern during the same time period to alleviate a barrier to obtaining a preceptor, but retained the principle that the primary assignment of an intern to a preceptor must be one-to-one.

18VAC110-20-60. Content of the examination and grades required; limitation on admittance to examination. The current regulation does not require an applicant to wait a certain time period to take the jurisprudence exam if he has failed it multiple times. There is concern with the security of test items for computerized testing, so the board has set a 30-day requirement for retesting. Provisions of Guidance Document 110-39 relating to Americans with Disabilities accommodations for taking the NAPLEX and law examination have been incorporated into this section.

18VAC110-20-70. Requirements for foreign-trained applicants. The regulations are amended to clarify that an applicant must pass the Foreign Pharmacy Graduate Equivalency Examination before becoming an intern. If an applicant cannot pass the FPGEE, the years spent in an internship may be wasted and the public may not be well protected.

18VAC110-20-80. Renewal and reinstatement of license. The board added a provision to allow electronic notification when there is a change of address and also added a time frame of 14 days for notification, rather than "immediately."

18VAC110-20-90. Requirements for continuing education. In subsection A, the date listed is unnecessary and is deleted. Subsection D is amended to require maintenance of CE documentation for three years if the board chooses to audit for the previous two renewal cycles.

18VAC110-20-100. Approval of continuing education programs. Amendments will require a board-approved program to have an expiration date; ACPE has an expiration of three years for a written program and one year for a live program. If a live program is to be given more than once, all dates must be on the original application or provided in advance of the program. In addition, the requirement for maintenance of records should be increased from three years to five years for auditing purposes; ACPE requires approved programs to maintain documentation for five years.

18VAC110-20-101. Application for registration as a pharmacy technician. An amendment will clarify that an individual enrolled in a board-approved pharmacy technician training program may work for a maximum of nine months prior to board registration (would include language from 18VAC110-20-111 C).

18VAC110-20-102. Criteria for approval for training programs. There are amendments to further specify a process and requirement for submitting changes to programs and to require programs to self-evaluate the currency of a training program and renew with the board every two years.

18VAC110-20-103. Examination. Provisions of Guidance Document 110-39 relating to Americans with Disabilities accommodations for taking the pharmacy technician examination were incorporated into this section.

18VAC110-20-104. Address of record. The current provision allows 30 days for notification of a change of address; the board added a more restrictive requirement (14 days) but not as restrictive as the current requirement for pharmacists, which is to notify "immediately." There should be consistency in the rules. The board also will allow for electronic communication and will require the technician to maintain a copy of current registration at his principal place of practice.

18VAC110-20-106. Requirements for continued competency. Subsection B should appropriately reference 18VAC110-20-100, which sets out requirements for board approval of continuing education providers. The requirement to maintain documentation of CE has been changed from two years to three years to ensure CE certificates are available for board audits.

18VAC110-20-110. Pharmacy permits generally. Amendments will delete the requirement for the outgoing PIC to take a final inventory but will allow him to do so unless the owner objects and submits written notice to the board. An amendment is added to ensure that a permit cannot be issued to operate a pharmacy from a private residence or dwelling and that more than one permit may not be issued to operate other types of permits out of the same Rx department space; e.g. a pharmacy could not also get a second pharmacy permit, or a manufacturer's permit to operate both businesses out of the same physical space. There may be an exception for special or limited-use pharmacy permits.

18VAC110-20-111. Pharmacy technicians. The board has added a requirement for a pharmacy to maintain the start date and completion date for each pharmacy technician in training; there is a nine-month limitation on performing pharmacy technician related duties when in training, but inspectors are not readily able to check whether the individual is in compliance.

18VAC110-20-120. Special or limited-use pharmacy permits. Guidance Document 110-22 provides guidelines for granting waivers relating to restricted access to a free clinic pharmacy under a special-use permit; the board has placed the criteria in regulation.

18VAC110-20-130. Pharmacy closings; going out of business; change of ownership. An amendment is needed to require a closing pharmacy to transfer prescription files somewhere where a patient can access.

18VAC110-20-140. New pharmacies, acquisitions and changes to existing pharmacies. Language is added to specify that once a pharmacy permit is issued, drugs cannot be stocked earlier than two weeks prior to the opening date, and that a pharmacist must be present on a daily bases to ensure safety and integrity of the drugs. If the pharmacy is not ready to open within two weeks, the permit holder must notify the board.

18VAC110-20-180. Security system. The regulation requires all alarms to be monitored in accordance with accepted industry standards and be capable of sending a signal to the monitoring entity. The board will require an alarm that was "grandfathered" to be upgraded if there is a break-in and loss of drugs. If a pharmacy that is open 24 hours a day changes its hours, it must have an alarm system installed before it closes.

18VAC110-20-190. Prescription department enclosures; access to prescription department. Subsection A is amended to eliminate the specific requirement for a door to the prescription enclosure and provided that the enclosure must be locked and alarmed when the pharmacist is not on duty and that it must be capable of being locked whenever the pharmacist is out of the prescription department. Subsection B is clarified with updated terminology. Language is added to allow interns, technicians and other persons authorized by the pharmacist to possess a means of entry only when a pharmacist is on duty.

18VAC110-20-200. Storage of drugs, devices, and controlled paraphernalia; expired drugs. There is a clarification of the storage and security of will-call drugs, and the board has added medical devices similar to drug paraphernalia that cannot be displayed outside the Rx department. It has also clarified that adulterated or misbranded drugs must be separated from other stock used for dispensing.

18VAC110-20-210. Disposal of drugs by pharmacies. The board has added "other board-approved methods" to disposal by incineration, in case other methods become DEA or EPA approved.

18VAC110-20-240. Manner of maintaining records, prescriptions, inventory records. The board has required a perpetual inventory for Schedule II drugs to include a monthly count-back to reconcile count at least every 30 days. Electronic monitoring is acceptable provided alerts of discrepancies are reviewed at least monthly.

The board has clarified that storage of records for Schedule II through V drugs must be at the same address as the pharmacy within the building where drugs are located, but amendments provide for an electronic database or storage offsite for Schedule VI drugs provided they are retrievable within 48 hours of request. The records are required to be maintained for not less than two years from the date of transaction.

18VAC110-20-270. Dispensing of prescriptions; certification of completed prescriptions; supervision of pharmacy technicians. The board has eliminated the ratios of pharmacist to technician trainee and pharmacy technicians; the pharmacist may determine the number that he can safety and competently supervise at any one time.

In subsection E, the board added a requirement to retain knowingly forged prescriptions for at least 30 days in the event it is needed for an investigation.

18VAC110-20-275. Delivery of dispensed prescriptions. A rule is necessary to require that the contract and policy and procedure manual for alternate delivery sites be maintained at both pharmacy and the alternate site. A controlled substance registration can only be issued for alternate delivery sites if there are patient safety reasons not to deliver directly to the consumer and if compliance are not being compromised for convenience. The language "if required by law" will be removed in subsections B and C.

18VAC110-20-280. Transmission of a prescription order by facsimile machine. The rule is clarified to mean that a hospice can be home hospice, and the term "nursing home" should be changed to long-term care facility. Amendments will also provide that a nurse may fax a verbal order as a prescriber's agent even though the order is not being faxed from prescriber's practice location.

18VAC110-20-286. Chart orders for outpatients. New language was added to set out conditions from guidance document 110-35 that would allow retail pharmacies to use chart orders.

18VAC110-20-320. Refilling of Schedule III through VI prescriptions. Subsection D is amended to allow for early refill due to good cause or absence (vacation). That subsection is also amended to clarify that the intent is referring to the timing of refills and not about the ability to change Rx based on the strength of drug in stock.

18VAC110-20-340. Packaging standards for dispensed prescriptions. The board has included provisions of Guidance Document 110-12 and Guidance Document 110-23 on packaging.

18VAC110-20-350. Special packaging. Amendments eliminate language redundant with the statute and update the language consistent with electronic records.

18VAC110-20-355. Pharmacy repackaging of drug; records required; labeling requirements. An amendment will require pharmacist's initials to filling record for automated counting devices or dispensers to verify process as stated in subsection A. Amendments to add language from Guidance Document 110-16 related to returning drugs to stock that are dispensed to a patient but not picked up from the pharmacy.

18VAC110-20-391. Prescription blanks. Language from a board guidance document related to what can be on the face of a prescription blank provided by a pharmacy to a provider is included in regulation. It prohibits nonessential information from being put on the face of the prescription blank.

18VAC110-20-395. Purchase of drugs. An amendment is necessary to allow for a nonlicensed warehouse to sell to pharmacy through intra-company sales.

18VAC110-20-425. Robotic pharmacy systems. The board has eliminated the requirement for an application and approval of a robotic pharmacy system and included the requirements for such a system in regulation. Among the rules set out are packaging standards for drugs stored in robotics and consistency with USP standards.

18VAC110-20-440. Responsibilities of the pharmacist-in-charge. An amendment is for clarity only.

18VAC110-20-450. After-hours access to the pharmacy. The rules for after-hours access to pharmacy are now in conflict with JCHAO standards, so the board has revised this section to permit a nurse to have access to drugs maintained by the pharmacy outside the pharmacy. There are also provisions for security of such drugs.

18VAC110-20-460. Floor stock drugs; proof of delivery; distribution records. Amendments were added to (i) require a pharmacist to check drugs before leaving the pharmacy to be stocked on the floor, (ii) require maintenance of manual or electronic delivery records for at least 2 years, and (iii) require records to be maintained for Schedule VI, as well as II-V, but allow the records to be kept off site.

18VAC110-20-490. Automated devices for dispensing and administration of drugs. The board tracked the language in subdivision 5 of 18VAC110-20-555 related to requiring a pharmacist to check delivery orders before they leave the pharmacy. It requires maintenance of records of filling for Schedule VI and auditing records of Schedule VI, but allows pharmacies to keep these records electronically or off site. There is a clarification of what a "sample of administration" and a requirement to retain all records required by this section for 24 months.

18VAC110-20-500. Licensed emergency medical services agencies program. Amendments will (i) require a pharmacist to check before sealing the drug kit used by EMS agencies, and (ii) allow for intravenous solutions to be stored outside the drug box.

18VAC110-20-535. Repackaging of already dispensed prescriptions. This is a new section that incorporates a board guidance document into regulation. This section will allow a provider pharmacy for a LTCF to repackage a patient's medications that have been dispensed by another pharmacy into unit-dose or compliance packaging to conform to the system used in the LTCF under certain conditions.

18VAC110-20-536. Prescription drugs sent outside the facility. This new section, which incorporates language from a board guidance document into regulation, allows a long-term care facility to send a patient's medication out on pass with the patient, provided the medication is appropriately packaged and labeled for outpatient use.

18VAC110-20-540. Emergency drug kit and 18VAC110-20-550. Stat-drug box. These section was amended by incorporating language from guidance document 110-11 to clarify that emergency drug kits and stat-drug boxes may only be provided to those facilities that have licensed individuals to access the drugs, so assisted living facilities that use med aides to administer could have a stat-drug box if they have a nurse on duty for accessing the box.

18VAC110-20-555. Use of automated dispensing devices. Amendments allow the device in nursing homes to be use to house drugs that would be in the emergency kit and be accessed prior to receiving electronic authorization from the pharmacy reviewer. They also require that the device be able to produce a record of each distribution from the device. This is consistent with hospital language for these devices.

18VAC110-20-570. Drugs in infirmaries/first aid rooms. Subsection D was deleted as it pertains to administration of over-the-counter drugs, which are not regulated by the Board of Pharmacy.

18VAC110-20-580. Humane societies and animal shelters. An amendment specifies that the record of training for persons at a humane society or animal shelter should be maintained at the facility and retained for two years. It is also clarified that only euthanasia drugs can be stored or administered at permitted facility.

18VAC110-20-590. Drugs in correctional institutions. Amendments allow for the use of other types of forms to accompany returned drugs to the pharmacy; it is currently restricted to drug administration record and facilities to stock certain prescription drugs, including vaccines, with a controlled substances registration.

18VAC110-20-690. Persons or entities authorized or required to obtain a controlled substances registration. Amendments conform requirements for inspection to other pharmacy types and clearly specify who can be a responsible party for a controlled substance registration (CSR).

18VAC110-20-700. Requirements for supervision for controlled substances registrants. The board has amended to (i) require the responsible party to inform the board of a change within 14 days and submit a new application naming the responsible party for the CSR, (ii) allow pharmacy techs to have access to the controlled substances to perform certain tasks, and (iii) clarify who may qualify as supervising practitioner to include all practitioners with prescriptive authority.

18VAC110-20-710. Requirements for storage and security for controlled substances registrants. Changes were made to the requirements for the security system to mirror the language for pharmacies.

Issues: There are no particular advantages or disadvantages to the public or the Commonwealth. Amendments that clarify the requirements for regulants may reduce noncompliance. Amendments that facilitate the use of technology, such as those for robotic pharmacy systems, may improve access and accuracy in the dispensing process.

The Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The Board of Pharmacy (Board) proposes to make many clarifying and substantive changes to its regulations as a part of the periodic review process. The Board proposes to:

1. Add several definitions to aid readers in understanding these regulations,

2. Require pharmacy technician training programs to apply for renewal every two years; to pay for staff time to process renewal and other forms, the Board has added fees for program renewal, late renewal and reinstatement; the Board also proposes that pharmacy continuing education programs expire after two years,

3. Remove a requirement for the Board to approve robotic pharmacy systems and also remove the fee that pharmacies were charged for this from the fee schedule,

4. Rewrite requirements and procedures for gaining pharmacy practical experience so these requirements apply to all individuals seeking practical experience and so pharmacists are not limited to supervising one intern at a time,

5. Require foreign trained pharmacy students to get their certification from the Foreign Pharmacy Graduate Equivalency Committee (FPGEC) before they apply to be interns,

6. Require a 30 day waiting period before an applicant who has taken and failed the jurisprudence exam can take it again,

7. Require pharmacy interns to report within 14 days (by email or regular mail) any change of address; the Board also proposes to extend to 14 days the time that Board licensees have to report a change of address, shorten the time registration certificate holders have to report a change of address to 14 days and to require pharmacy technician training programs to report any substantive changes to the program within 14 days,

8. Require licensees to maintain proof of completion of continuing education for three (rather than two) years following license renewal; continuing education providers will be required to maintain records on all programs, program participants and continuing education hours earned for five (rather than three) years,

9. Specify that pharmacy technician trainees may only perform tasks restricted to pharmacy technicians for nine months and require pharmacies to maintain employment records that show a start and end date for employment of trainees,

10. Allow pharmacists with restricted licenses to serve as program directors for pharmacy technician training programs,

11. Require pharmacy technicians to maintain their certificates at their principal places of practice. Pharmacy technicians who work at more than one pharmacy will be able to keep their certificates either at the home addresses that they have reported to the Board or at one of their workplaces,

12. Restrict private residences from being licensed as pharmacies,

13. Require that pharmacies maintain a perpetual inventory with reconciliation of that inventory every thirty days,

14. Move guidance language for approving special use pharmacies within free clinics to these regulations,

15. Require pharmacies that are going out of business to transfer prescription files to another pharmacy so that customers can still access their records,

16. Specify that drugs may not be stocked by a new pharmacy more than two weeks before the pharmacy opens and require that a pharmacist be at the pharmacy on a daily basis while drugs are stocked but the pharmacy has yet to open so that security for all drug supplies is maintained,

17. Clarify that all pharmacies that have any hours that they are not open, whether daily or sporadically, must have an approved alarm system in place before they close,

18. Simplify rules for prescription department enclosures to allow greater flexibility to pharmacies,

19. Clarify standards for storage of drugs and require pharmacies to put medical devises that require a prescription where the pharmacist can supervise who accesses them,

20. Allow drugs to be destroyed by incineration or any other method that the Board approves,

21. Require that all records for schedule six drugs be maintained under the same rules as records for schedule II through V drugs; all records for these drugs will have to be kept for at least two years,

22. Eliminate restrictions on the number of pharmacy technician trainees that a pharmacist can supervise at one time and require pharmacies to retain forged prescriptions at least 30 days,

23. Require all contracts, agreements and policy and procedures manuals for alternate delivery sites be maintained both at the alternate site and the originating pharmacy,

24. Clarify that hospices that can fax chart orders to pharmacies include home hospices and that nurses may fax verbal orders. Additionally, the Board proposes to transfer language from guidance that would allow chart orders to serve as valid prescriptions that may be filled at a retail pharmacy,

25. Allow prescriptions refills to be dispensed early so long as the pharmacist documents a valid reason for doing so,

26. Move guidance language that outline packaging standards for dispensed prescriptions to these regulations,

27. Update special packaging rules to allow for electronic recordkeeping,

28. Limit the time that a bulk bin filling record must be maintained to one year and require a pharmacist’s initials in this record as verification that he has checked the accuracy the bin,

29. Move guidance language for the re-dispensing of prescription drugs to these regulations,

30. Move guidance language that prohibits pharmacies from printing non-essential information on the front of prescription pads that they provide to prescribers to these regulations,

31. Allow licensed warehouses to sell Schedule II through VI drugs to pharmacies,

32. Allow nurses to access a “supply of drugs maintained by the pharmacy at a location outside of the pharmacy in order to obtain emergency medication during hours that the pharmacy is closed”; the location of any supply of medication in such cases must be kept secure,

33. Require pharmacists to check all Schedule II-VI drugs as floor stock before they are delivered to a hospital unit and to initial or sign that the record of distribution is accurate; all records will have to be maintained for two years,

34. Requires all records required for automated devises for dispensing and administration of drugs be retained for two years,

35. Allow intravenous solutions provided by a hospital pharmacy to an emergency services agency to be stored outside of a secured drug kit,

36. Allow pharmacies that serve long-term care facilities to repackage residents’ medicines as unit doses to facilitate dispensing of medication in an institutional setting,

37. Move guidance language the governs how prescription drugs may be sent outside of a long-term care facility (when the resident is leaving for a short time or is being discharged from the facility altogether) to these regulations,

38. Clarify rules governing emergency drug kits by listing the licensed entities that are allowed to access these kits,

39. Allow drugs stocked in automated dispensing devises that would be appropriate for an emergency drug kit to be accessed prior to authorization from a pharmacist if not accessing the drugs would threaten the survival of a patient; these devises will have to be able to produce a hard-copy record of all distributions,

40. Require training records for animal shelter and humane society staff that are trained to euthanize animals be retained for two years,

41. Allow correctional facilities greater flexibility to return drugs to a provider pharmacy accompanied by one of a number of forms that would contain the same information,

42. Clarify rules that govern application for controlled substances registration and

43. Require any change in the responsible party for controlled substance registration to be reported to the Board within 14 days.

Result of Analysis. For many of these proposed changes, benefits likely outweigh the costs. For several other changes there is insufficient information to measure the magnitude of costs versus benefits. Costs and benefits for proposed changes are discussed below.

Estimated Economic Impact. About a quarter of the regulatory changes listed above (specifically, changes numbered 1, 9, 14, 16, 17, 19, 24, 26, 29, 30, 37, 38 and 42) are being made to bring greater clarity to these regulations. These changes are either standing Board policy being moved to regulation or other clarifications; for example, listing the specific licensed entities who are allowed to access emergency drug kits rather than stating that “only those persons licensed to administer drugs” are allowed access. These changes ought not represent a change in practice for regulated entities of the Board and, so, regulated entities will likely not incur any costs on account of these changes. Having these rules more clearly spelled out ought to, however, provide a benefit for individuals who are either affected by these regulations or are interested in knowing the rules under which Board licensees and certificate holders must operate.

Current regulations do not specify an expiration date for pharmacy continuing education or pharmacy technician training programs. Regulations for pharmacy continuing education classes state that continuing education programs must be approved by the Accreditation Council of Pharmacy Education (ACPE), be approved as a Category I continuing Medical Education (CME) course or be approved by the Board. While ACPE courses are not approved for more than two years before they have to be re-approved and CME courses already require periodic re-approval, there has been no such limitation on Board approved classes.

In order to make sure all types of continuing education classes are consistent and to insure that class materials and subjects are not outdated, the Board proposes to require that all Board approved continuing education classes expire after two years. After that, old but still relevant, and new programs can be approved by meeting Board criteria for continuing educational programs and paying the $100 fee for program approval. Individuals and groups who teach continuing education programs approved by the Board will incur extra costs in time and resources for getting course materials re-approved, or for gathering and submitting new course material, and for the fee charged by the Board. Individuals who take continuing education classes that are Board approved will benefit from this regulatory change if continuing education classes do a better job of keeping course material current and relevant than they would absent Board action. Whether benefits for this change outweigh costs will depend on whether courses improve enough, on average, to outweigh the costs of going through the program approval process again.

The Board also proposes to amend regulations to require pharmacy technician training programs be re-approved every two years and to add fees to the fee schedule to cover re-approval of a training program, late (within two years of approval expiration) re-approval of a program and reinstatement of approval of a program when approval has expired more than two years ago. These fees are $75, $15 and $75, respectively. The Board proposes this change to address problems with programs that change instructors, programs that teach out-dated material and programs that just go out of business without informing the Board. Individuals and groups who teach training programs approved by the Board will incur extra costs in time and resources for getting course materials re-approved and for fees charged by the Board. Individuals who take continuing education classes that are Board approved will benefit from this regulatory change to the extent that it is easier to find correct information about available programs and to the extent that classes do a better job of keeping course material current and relevant. Whether benefits for this change outweigh costs will depend on whether the value of more accurate information on available courses plus the value of courses improvement, on average, outweighs the costs of re-approval.

Current regulations require that all robotic pharmacy systems be approved by the Board. The fee for this approval is $150. The Board proposes to eliminate both the requirement that all robotic systems be approved by the Board and the fee that paid for staff time for that approval. Instead of requiring all pharmacies go through the time and expense of gaining approval for each robotic system, the Board proposes to put the requirements that are currently part of each approval order into the text of these regulations. These changes are likely to lower costs for pharmacies wanting to install these labor saving robotic systems while still protecting the public from any harm caused by prescription errors.

Current requirements that govern how and when pharmacy students can gain practical experience before they are licensed require licensure applicants who graduated from an approved school of pharmacy before January 1, 2003 to work at least 1,000 in a practical setting; at least 300 of those hours had to be worked outside of a school of pharmacy’s practical experience program. Students graduating after January 1, 2003 are required to complete 1,500 hours of practical experience, 300 of these hours outside of any school practical experience program, before they could be licensed.

Because ACPE accredited schools now require at least 1,700 hours of practical experience before graduation, the Board proposes to eliminate the requirement that pharmacy graduates gain 300 hours of experience outside of their school setting. The Board also proposes to eliminate the language that allowed pre-2003 graduates to be licensed with only 1,000 hours of practical experience. The Board believes that any individuals who graduated that long ago and still have not been licensed likely would need the extra hours of practical experience should they choose to pursue licensure at this late date. Pharmacists who were licensed in other states that require fewer hours of pre-licensure practical experience, and who want to be licensed in Virginia, may count hours worked post-licensure toward practical experience requirements. Some individuals who graduated from pharmacy school before 2003 may incur extra costs for gaining practical experience if they choose to seek licensure after these amended regulations are promulgated. These costs are likely outweighed by the benefit to the public of ensuring individuals who have been out of school, and away from a pharmacy setting, for a number of years gain additional practical experience before they are licensed.

Current regulations only allow pharmacists to supervise one pharmacy intern and two pharmacy technician trainees at one time. Currently, pharmacists are allowed to supervise no more than four individuals performing technician functions (pharmacy technicians and pharmacy technician trainees) at one time. The Board proposes to eliminate these restrictions and allow pharmacists to determine how many interns, technician trainees and technicians he can safely and effectively supervise at one time. These proposed changes will give pharmacists greater flexibility to staff their pharmacy in the way that works most efficiently for them. Pharmacists will still be accountable for the accuracy of prescriptions that are dispensed under their supervision so these changes should not adversely affect the public.

Currently, foreign-trained pharmacy students are required to go through several steps before they are eligible for licensure. They must 1) obtain verification from the FPGEC that they are a graduate of a foreign school of pharmacy, 2) pass the Foreign Pharmacy Graduate Equivalency Examination (FPGEE), 3) pass the Test of English as a Foreign Language (TOEFL) or TOEFL iBT (internet based test), 4) pass the Test of Spoken English (TSE) and 5) complete practical experience requirements before they can sit for the other exams required for Virginia licensure. Regulations do not, however, list the order in which these steps must be accomplished. As a consequence, there has been some confusion as to whether foreign-trained pharmacy applicants need to prove proficiency in English before they become pharmacy interns.

The Board proposes to simplify rules for foreign-trained pharmacy graduates by removing requirements 1 through 4 in the preceding paragraph and, instead, only requiring that applicants obtain an FPGEC certificate. FPGEC verifies that applicants have graduated from a foreign school of pharmacy, that they have passed the FPGEE and that they are proficient in English. The Board also proposes to specify that an FPGEC certificate must be obtained before foreign students can register as pharmacy interns and complete their practical experience requirements.

Only requiring a FPGEC certificate will likely eliminate duplicative record keeping on the part of the Board and the FPGEC. This will also save foreign-trained applicants for licensure some amount of time, effort and expense that they previously would have spent gathering all their records and getting them to Board staff. Requiring that these applicants attain FPGEC certification before they can complete practical experience hours may cause some applicants to incur costs (foregone wages, time spent waiting for the certification process to be completed, etc) that they would not have under the current regulatory scheme. Foreign-trained student interns, and the public they will work with, may, however, benefit from these interns mastering the language that is in predominant use in Virginia before they are thrown into situations where such proficiency is necessary.

Currently, there is no practical limit on the frequency with which applicants for pharmacy licensure can take the required jurisprudence exam. As a consequence, problems have arisen with the integrity of the test question bank. The Board proposes to require applicants who have failed this exam to wait 30 days before they take it again. This change may slightly inconvenience applicants but will also help insure that current test bank questions are not available to applicants before they actually take the test.

Current regulations do not contain a requirement that pharmacy interns report any changes of address of record to the Board. Since the Board has an interest in having a way to communicate with these interns, the Board proposes to require interns to report any change of address, in writing, within 14 day. Interns will likely incur minimal cost for complying with this requirement because they have the option of notifying the Board electronically. The benefit to them of the Board having a valid address (so they can get notices from the Board in a timely fashion) very likely outweigh the costs.

To make all such reporting consistent, the Board also proposes to lengthen the time that licensees have to report a change of address from “immediately” to 14 days, shorten the time that certificate holders have to report address changes from 30 days to 14 days (both of these groups can electronically correct this information on the Board’s website), require pharmacy technician training programs to report any substantive changes within 14 days and require that any change in the responsible party for a controlled substances registration be reported within 14 days. Again the costs of these changes are likely very minimal, even for certificate holders whose time limit is being shortened. The benefits of having a consistent, easily remembered, standard likely outweigh any costs.

Current regulations require licensees to maintain proof of continuing education completed for two years; continuing education providers are currently required to retain records for three years on all programs, program participants and continuing education hours earned through them. Because record auditing lags behind the renewal cycle, this can mean that some licensees will have gotten rid of half the records required for an audit before the audit can occur. The Board proposes to extend these record keeping requirements so that licensees will have to retain their records for three years and continuing education programs will have to retain their records for five years. These changes will increase record keeping costs for affected entities but will also make auditing these records for regulatory compliance much easier.

The Board has also addressed other record keeping requirements in this regulatory action. Records for drug floor stocks delivered to hospital units, records for automated devises for dispensing and administration of drugs, records of inventories for schedule II through VI and records that document euthanasia training for humane society workers will all need to be retained for two years. Although these record keeping requirements are new to regulations, they are already Board policy and are consistent with the time inspectors would be auditing drug records. Any increased record keeping costs that may be incurred by affected entities will likely be outweighed by the benefit of more effective drug auditing.

Currently, regulations require that program directors for pharmacy technician training programs have current, unrestricted pharmacy licenses. The Board proposes to allow pharmacists with restricted licenses to serve as directors of such programs. The Board feels that license restrictions should not preclude an otherwise qualified candidate from serving as a program director. This regulatory change will likely increase the number of pharmacists who are willing to take on this job. This may encourage more programs to open and may increase the number of pharmacy technicians available for employment in Virginia.

Current regulations do not require pharmacy technicians to keep their certificates where they are readily available for inspection. The Board proposes to require technicians to maintain their certificates at their principal place of employment. Technicians who work at more than one location will be able to maintain their certificates either at their address of record with the Board or at one of their workplaces. Technicians are unlikely to incur anything but trivial costs on account of this regulatory change. Any costs that are incurred will likely be outweighed by the benefit of having these certificates readily available for inspectors and any other interested parties.

Currently, regulations for permitting of pharmacies have many requirements and restrictions but there is no restriction on opening a pharmacy in a private residence. Two years ago, an individual applied to operate a pharmacy in her garage. Since this space met all requirements for pharmacies, the Board issued a permit. The Board believes that a residential setting is not conducive to maintaining security and accountability of drug stocks, and is proposing to prohibit any other residences from being permitted as pharmacies. A Board representative reports that there have been no security violations or instances of drugs going missing from this residential pharmacy thus far. Individuals who may have wanted to open pharmacies in their residences at some point in the future would lose that opportunity on account of this proposed regulatory change. Whether the benefits of this proposed change outweigh the costs will depend on whether any actual improvements in drug security outweigh the profits lost to future entrepreneurs who might have chosen to open such a pharmacy.

Current regulations require pharmacies to take an inventory of schedule I through VI drugs at least biennially. The Board reports that, in the past, there have been instances where “tens of thousands of dosage units of (schedule II) drugs were diverted without detection for a year or more in some cases.” Because of this, the Board proposes to require that all pharmacies maintain a perpetual inventory of schedule II drugs and that this inventory be reconciled against actual drug stocks monthly. The Board reports that all hospital pharmacies and most chain drug stores already maintain a perpetual inventory but they may or may not review them for discrepancies on a monthly basis. This regulatory change may drive up costs for some pharmacies, particularly small pharmacies that don’t already have some kind of electronic record of drug stores. Overall, pharmacies may actually save money from an inventory system that helps them quickly catch or even prevent drug losses.

Currently there is no regulatory provision for pharmacies that go out of business to make sure their customers can still access pertinent records. Although this lack of regulatory provision is apparently not usually a problem, the Board reports that these records are a salable asset, there have been instances where pharmacies have closed and just abandoned customer records. The Board proposes to require that customer records be transferred to another pharmacy where customers can access them when the originating pharmacy closes. Both customers and receiving pharmacies will likely benefit from this required records transfer.

Current regulations contain very specific, prescriptive requirements for prescription department enclosures. For example, entrances to enclosed areas must currently have doors with no more than a six inch gap from the floor. The Board proposes to remove some of the more prescriptive requirements for these enclosures and instead allow pharmacies more flexibility in securing the drugs they are responsible for. Instead of exactly describing how far from the floor a door may be, for instance, the proposed regulations only stipulate that an enclosure must be capable of being securely locked when the pharmacist is not present. This proposed change will benefit pharmacies which will now have the flexibility to meet security requirements in the most cost effective manner available. Since drugs will still be required to be secured, there will likely be no offsetting costs.

Current regulations only allow drugs to be destroyed by incineration. The Board proposes to also allow drugs to be destroyed in other Board approved ways. Although there are no methods for disposal of drugs currently that are as safe and effective as incineration, the Board wants the freedom to approve other methods when they are developed. This change will give the Board benefit of flexibility.

Current regulations do not allow prescriptions to be refilled early to accommodate patients who are, for instance, going on vacation. The Board proposes to allow pharmacists to dispense refills early so long as they can document good cause for doing so. This change will likely benefit pharmacy customers who will have greater flexibility to coordinate drug refills so that they do not interfere with other plans.

Businesses and Entities Affected. These regulatory changes will affect 1,647 pharmacies that are permitted in Virginia, 513 non-resident pharmacies, 9,491 pharmacists, 1,415 pharmacist interns, 8,750 pharmacist technicians and all pharmacist technician trainees working in the Commonwealth. These regulatory changes will also affect 613 controlled substance registrations and 34 humane societies.

Localities Particularly Affected. No locality will be particularly affected by this proposed regulatory action.

Projected Impact on Employment. Requiring English proficiency before internship may lower in the short-term the number of foreign-trained pharmacy students that are available for employment as interns. This effect will likely be short lived as current and future students will adjust to the time-table of licensure requirements.

Effects on the Use and Value of Private Property. Putting an expiration date on continuing education programs and pharmacy technician training programs will increase costs for these programs. To the extent that these programs are a profit-making venture, these regulatory changes will likely decrease profits.

Small Businesses: Costs and Other Effects. The Department of Health Professions (DHP) reports that the number of pharmacies that qualify as small businesses is unknown but is likely a small minority of 1,647 pharmacies in Virginia. These businesses may incur some additional bookkeeping costs because of some of these regulatory changes. These costs will likely be outweighed by savings accrued on account of other regulatory changes in this action.

Small Businesses: Alternative Method that Minimizes Adverse Impact. Absent proof that home pharmacies are inherently more likely to be unsafe and non-securable, the Board may wish to reconsider banning licensure for pharmacies in private residences.

Real Estate Development Costs. This regulatory action will likely have no effect on real estate development costs in the Commonwealth.

Legal Mandate. The Department of Planning and Budget (DPB) has analyzed the economic impact of this proposed regulation in accordance with § 2.2-4007.04 of the Administrative Process Act and Executive Order Number 36 (06). Section 2.2-4007.04 requires that such economic impact analyses include, but need not be limited to, the projected number of businesses or other entities to whom the regulation would apply, the identity of any localities and types of businesses or other entities particularly affected, the projected number of persons and employment positions to be affected, the projected costs to affected businesses or entities to implement or comply with the regulation, and the impact on the use and value of private property. Further, if the proposed regulation has adverse effect on small businesses, § 2.2-4007.04 requires that such economic impact analyses include (i) an identification and estimate of the number of small businesses subject to the regulation; (ii) the projected reporting, recordkeeping, and other administrative costs required for small businesses to comply with the regulation, including the type of professional skills necessary for preparing required reports and other documents; (iii) a statement of the probable effect of the regulation on affected small businesses; and (iv) a description of any less intrusive or less costly alternative methods of achieving the purpose of the regulation. The analysis presented above represents DPB’s best estimate of these economic impacts.

Agency's Response to the Department of Planning and Budget's Economic Impact Analysis: The Board of Pharmacy concurs with the economic impact analysis (EIA) of the Department of Planning and Budget on proposed regulations resulting from a periodic review with one exception. On pages 10 and 11, the EIA questions whether benefits outweigh costs for persons who will not be allowed to open a pharmacy in a private residence. The primary concern of the board in restricting licensure of a pharmacy in a private residence is security of such a pharmacy and the inherent risk to the residents and neighbors. The availability of quantities of drugs in a private residence makes that location vulnerable to criminal activity. In 2005, there were 13 armed robberies of pharmacies and 17 night break-ins; in 2006, there were 11 armed robberies and 18 night break-ins in Virginia. In addition, there are numerous attempted robberies that are foiled or aborted. It appears to the board that there are significant costs in terms of public safety and loss of property, so the benefit of avoiding those costs would outweigh any lost entrepreneurial opportunity.

Summary:

The agency is amending regulations to address the numerous questions and recommendations that arose from the periodic review conducted by board members and advisors from all aspects of pharmacy practice. In some cases, there is a need for clarification of a rule; in others there is a need to amend the regulation to allow the practice of pharmacy to be more responsive to patient needs and changing times.

Some of the issues addressed include: (i) practical experience leading up to licensure by allowing interns to count hours within the school curriculum and by clearly delineating expiration dates for internships; (ii) oversight of continuing education approval by setting expiration dates for courses; (iii) guidance for free clinics to allow greater access to areas where drugs are kept; (iv) oversight of pharmacy technician training by setting a time limit on work by a person engaged in a program and an expiration for programs approved by the board; and (v) elimination of board approval of robotic systems by incorporating criteria for such systems in regulation.

Part I
General Provisions

18VAC110-20-10. Definitions.

In addition to words and terms defined in §§ 54.1-3300 and 54.1-3401 of the Code of Virginia, the following words and terms when used in this chapter shall have the following meanings, unless the context clearly indicates otherwise:

"ACPE" means the Accreditation Council for Pharmacy Education.

"Acquisition" of an existing entity permitted, registered or licensed by the board means (i) the purchase or transfer of all or substantially all of the assets of the entity or of any corporation that owns or controls the entity; (ii) the creation of a partnership by a sole proprietor or change in partnership composition; (iii) the acquiring of 50% or more of the outstanding shares of voting stock of a corporation owning the entity or of the parent corporation of a wholly owned subsidiary owning the entity, except that this shall not apply to any corporation the voting stock of which is actively traded on any securities exchange or in any over-the-counter market; or (iv) the merger of a corporation owning the entity, or of the parent corporation of a wholly owned subsidiary owning the entity, with another business or corporation.

"Alternate delivery site" means a location authorized in 18VAC110-20-275 to receive dispensed prescriptions on behalf of and for further delivery or administration to a patient.

"Beyond-use date" means the date beyond which the integrity of a compounded, repackaged, or dispensed drug can no longer be assured and as such is deemed to be adulterated or misbranded as defined in §§ 54.1-3461 and 54.1-3462 of the Code of Virginia.

"Board" means the Virginia Board of Pharmacy.

"CE" means continuing education as required for renewal of licensure by the Board of Pharmacy.

"CEU" means a continuing education unit awarded for credit as the equivalent of 10 contact hours.

"Chart order" means a lawful order for a drug or device entered on the chart or in a medical record of a patient by a prescriber or his designated agent.

"Compliance packaging" means packaging for dispensed drugs which is comprised of a series of containers for solid oral dosage forms and which is designed to assist the user in administering or self-administering the drugs in accordance with directions for use.

"Contact hour" means the amount of credit awarded for 60 minutes of participation in and successful completion of a continuing education program.

"Correctional facility" means any prison, penitentiary, penal facility, jail, detention unit, or other facility in which persons are incarcerated by government officials.

"DEA" means the United States Drug Enforcement Administration.

"Electronic transmission prescription" means any prescription, other than an oral or written prescription or a prescription transmitted by facsimile machine, that is electronically transmitted from a practitioner authorized to prescribe directly to a pharmacy without interception or intervention from a third party, or from one pharmacy to another pharmacy.

"Expiration date" means that date placed on a drug package by the manufacturer or repacker beyond which the product may not be dispensed or used.

"Facsimile (FAX) prescription" means a written prescription or order which is transmitted by an electronic device over telephone lines which sends the exact image to the receiver (pharmacy) in a hard copy form.

"FDA" means the United States Food and Drug Administration.

"Floor stock" means a supply of drugs that have been distributed for the purpose of general administration by a prescriber or other authorized person pursuant to a valid order of a prescriber.

"Foreign school of pharmacy" means a school outside the United States and its territories offering a course of study in basic sciences, pharmacology, and pharmacy of at least four years in duration resulting in a degree that qualifies a person to practice pharmacy in that country.

"Forgery" means a prescription that was falsely created, falsely signed, or altered.

"FPGEC certificate" means the certificate given by the Foreign Pharmacy Equivalency Committee of NABP that certifies that the holder of such certificate has passed the Foreign Pharmacy Equivalency Examination and a credential review of foreign training to establish educational equivalency to board approved schools of pharmacy, and has passed approved examinations establishing proficiency in English.

"Generic drug name" means the nonproprietary name listed in the United States Pharmacopeia-National Formulary (USP-NF) or in the USAN and the USP Dictionary of Drug Names.

"Hospital" or "nursing home" means those facilities as defined in Title 32.1 of the Code of Virginia or as defined in regulations by the Virginia Department of Health.

"Inactive license" means a license which is registered with the Commonwealth but does not entitle the licensee to practice, the holder of which is not required to submit documentation of CE necessary to hold an active license.

"Long-term care facility" means a nursing home, retirement care, mental care or other facility or institution which provides extended health care to resident patients.

"NABP" means the National Association of Boards of Pharmacy.

"Nuclear pharmacy" means a pharmacy providing radiopharmaceutical services.

"On duty" means that a pharmacist is on the premises at the address of the permitted pharmacy and is available as needed.

"Permitted physician" means a physician who is licensed pursuant to § 54.1-3304 of the Code of Virginia to dispense drugs to persons to whom or for whom pharmacy services are not reasonably available.

"Perpetual inventory" means an ongoing system for recording quantities of drugs received, dispensed or otherwise distributed, and drugs on hand by a pharmacy.

"Personal supervision" means the pharmacist must be physically present and render direct, personal control over the entire service being rendered or act being performed. Neither prior nor future instructions shall be sufficient nor, shall supervision rendered by telephone, written instructions, or by any mechanical or electronic methods be sufficient.

"Pharmacy closing" means that the permitted pharmacy ceases pharmacy services or fails to provide for continuity of pharmacy services or lawful access to patient prescription records or other required patient records for the purpose of continued pharmacy services to patients.

"Pharmacy technician trainee" means a person who is currently enrolled in an approved pharmacy technician training program and is performing duties restricted to pharmacy technicians for the purpose of obtaining practical experience in accordance with § 54.1-3321 D of the Code of Virginia.

"PIC" means the pharmacist-in-charge of a permitted pharmacy.

"Practice location" means any location in which a prescriber evaluates or treats a patient.

"Prescription department" means any contiguous or noncontiguous areas used for the compounding, dispensing and storage of all Schedule II through VI drugs and devices and any Schedule I investigational drugs.

"PTCB" means the Pharmacy Technician Certification Board, co-founded by the American Pharmaceutical Association and the American Society of Health System Pharmacists, as the national organization for voluntary examination and certification of pharmacy technicians.

"Quality assurance plan" means a plan approved by the board for continuous ongoing monitoring, measuring, evaluating, and, if necessary, improving the performance of a pharmacy function or system.

"Radiopharmaceutical" means any drug that exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons and includes any nonradioactive reagent kit or radionuclide generator that is intended to be used in the preparation of any such substance, but does not include drugs such as carbon-containing compounds or potassium-containing salts that include trace quantities of naturally occurring radionuclides. The term also includes any biological product that is labeled with a radionuclide or intended solely to be labeled with a radionuclide.

"Repackaged drug" means any drug removed from the manufacturer's original package and placed in different packaging.

"Robotic pharmacy system" means a mechanical system controlled by a computer that performs operations or activities relative to the storage, packaging, labeling, dispensing, or distribution of medications, and collects, controls, and maintains all transaction information.

"Safety closure container" means a container which meets the requirements of the federal Poison Prevention Packaging Act of 1970 (15 USC §§1471-1476), i.e., in testing such containers, that 85% of a test group of 200 children of ages 41-52 months are unable to open the container in a five-minute period and that 80% fail in another five minutes after a demonstration of how to open it and that 90% of a test group of 100 adults must be able to open and close the container.

"Satellite pharmacy" means a pharmacy which is noncontiguous to the centrally permitted pharmacy of a hospital but at the location designated on the pharmacy permit.

"Special packaging" means packaging that is designed or constructed to be significantly difficult for children under five years of age to open to obtain a toxic or harmful amount of the drug contained therein within a reasonable time and not difficult for normal adults to use properly, but does not mean packaging which all such children cannot open or obtain a toxic or harmful amount within a reasonable time.

"Special use permit" means a permit issued to conduct a pharmacy of a special scope of service that varies in any way from the provisions of any board regulation.

"Storage temperature" means those specific directions stated in some monographs with respect to the temperatures at which pharmaceutical articles shall be stored, where it is considered that storage at a lower or higher temperature may produce undesirable results. The conditions are defined by the following terms:

1. "Cold" means any temperature not exceeding 8°C (46°F). A refrigerator is a cold place in which temperature is maintained thermostatically between 2° and 8°C (36° and 46°F). A freezer is a cold place in which the temperature is maintained thermostatically between -20° and -10°C (-4° and 14°F).

2. "Room temperature" means the temperature prevailing in a working area.

3. "Controlled room temperature" means a temperature maintained thermostatically that encompasses the usual and customary working environment of 20° to 25°C (68° to 77°F); that results in a mean kinetic temperature calculated to be not more than 25°C; and that allows for excursions between 15° and 30°C (59° and 86°F) that are experienced in pharmacies, hospitals, and warehouses.

4. "Warm" means any temperature between 30° and 40°C (86° and 104°F).

5. "Excessive heat" means any temperature above 40°C (104°F).

6. "Protection from freezing" means where, in addition to the risk of breakage of the container, freezing subjects a product to loss of strength or potency, or to the destructive alteration of its characteristics, the container label bears an appropriate instruction to protect the product from freezing.

7. "Cool" means any temperature between 8° and 15°C (46° and 59°F).

"Terminally ill" means a patient with a terminal condition as defined in § 54.1-2982 of the Code of Virginia.

"Unit dose container" means a container that is a single-unit container, as defined in United States Pharmacopeia-National Formulary, for articles intended for administration by other than the parenteral route as a single dose, direct from the container.

"Unit dose package" means a container that contains a particular dose ordered for a patient.

"Unit dose system" means a system in which multiple drugs in unit dose packaging are dispensed in a single container, such as a medication drawer or bin, labeled only with patient name and location. Directions for administration are not provided by the pharmacy on the drug packaging or container but are obtained by the person administering directly from a prescriber's order or medication administration record.

"USP-NF" means the United States Pharmacopeia-National Formulary.

"Well-closed container" means a container that protects the contents from extraneous solids and from loss of the drug under the ordinary or customary conditions of handling, shipment, storage, and distribution.

18VAC110-20-20. Fees.

A. Unless otherwise provided, fees listed in this section shall not be refundable.

B. Unless otherwise provided, any fees for taking required examinations shall be paid directly to the examination service as specified by the board.

C. Initial application fees.

	1. Pharmacist license	$180
	2. Pharmacy intern registration	$15
	3. Pharmacy technician registration	$25
	4. Pharmacy permit	$270
	5. Permitted physician licensed to dispense drugs	$270
	6. Medical equipment supplier permit	$180
	7. Humane society permit	$20
	8. Nonresident pharmacy	$270
	9. Controlled substances registrations (Between November 2, 2005, and December 31, 2006, the application fee for a controlled substance registration shall be $50)	$90
	10. Robotic pharmacy system approval	$150
	11. 10. Innovative program approval. If the board determines that a technical consultant is required in order to make a decision on approval, any consultant fee, not to exceed the actual cost, shall also be paid by the applicant in addition to the application fee.	$250
	12. 11. Approval of a pharmacy technician training program	$150
	13. 12. Approval of a continuing education program	$100

D. Annual renewal fees.

	1. Pharmacist active license	$90
	2. Pharmacist inactive license	$45
	3. Pharmacy technician registration	$25
	4. Pharmacy permit	$270
	5. Physician permit to practice pharmacy	$270
	6. Medical equipment supplier permit	$180
	7. Humane society permit	$20
	8. Nonresident pharmacy	$270
	9. Controlled substances registrations	$90
	10. Innovative program continued approval based on board order not to exceed $200 per approval period.
	11. Approval of a pharmacy technician training program	$75 every two years

E. Late fees. The following late fees shall be paid in addition to the current renewal fee to renew an expired license within one year of the expiration date or within two years in the case of a pharmacy technician training program. In addition, engaging in activities requiring a license, permit, or registration after the expiration date of such license, permit, or registration shall be grounds for disciplinary action by the board.

	1. Pharmacist license	$30
	2. Pharmacist inactive license	$15
	3. Pharmacy technician registration	$10
	4. Pharmacy permit	$90
	5. Physician permit to practice pharmacy	$90
	6. Medical equipment supplier permit	$60
	7. Humane society permit	$5
	8. Nonresident pharmacy	$90
	9. Controlled substances registrations	$30
	10. Approval of a pharmacy technician training program	$15

F. Reinstatement fees. Any person or entity attempting to renew a license, permit, or registration more than one year after the expiration date, or more than two years after the expiration date in the case of a pharmacy technician training program, shall submit an application for reinstatement with any required fees. Reinstatement is at the discretion of the board and, except for reinstatement following license revocation or suspension, may be granted by the executive director of the board upon completion of an application and payment of any required fees.

	1. Pharmacist license		$210
	2. Pharmacist license after revocation or suspension		$500
	3. Pharmacy technician registration		$35
	4. Pharmacy technician registration after revocation or suspension		$125
	5. Facilities or entities that cease operation and wish to resume shall not be eligible for reinstatement but shall apply for a new permit or registration. Facilities or entities that failed to renew and continued to operate for more than one renewal cycle shall pay the current and all back renewal fees for the years in which they were operating plus the following reinstatement fees:
		a. Pharmacy permit	$240
		b. Physician permit to practice pharmacy	$240
		c. Medical equipment supplier permit	$210
		d. Humane society permit	$30
		e. Nonresident pharmacy	$115
		f. Controlled substances registration	$180
		g. Approval of a pharmacy technician training program	$75

G. Application for change or inspection fees for facilities or other entities.

	1. Change of pharmacist-in-charge	$50
	2. Change of ownership for any facility	$50
	3. Inspection for remodeling or change of location for any facility	150
	4. Reinspection of any facility	$150
	5. Board-required inspection for a robotic pharmacy system	$150
	6. Board-required inspection of an innovative program location	$150
	7. Change of pharmacist responsible for an approved innovative program	$25

H. Miscellaneous fees.

	1. Duplicate wall certificate	$25
	2. Returned check	$35

I. For the annual renewal due on or before December 31, 2006, the following fees shall be imposed for a license, permit or registration:

	1. Pharmacist active license	$50
	2. Pharmacist inactive license	$25
	3. Pharmacy technician registration	$15
	4. Pharmacy permit	$210
	5. Physician permit to practice pharmacy	$210
	6. Medical equipment supplier permit	$140
	7. Humane society permit	$20
	8. Nonresident pharmacy	$210
	9. Controlled substances registrations	$50

Part II
Licensure Requirements for Pharmacists

18VAC110-20-30. Requirements for pharmacy practical experience.

A. Each applicant for licensure by examination as a pharmacist shall have gained practical experience in the practice of pharmacy, to include no less than 300 hours in the area of prescription compounding and dispensing within a pharmacy as set forth in this section and 18VAC110-20-40.

B. An applicant who graduated from an approved school of pharmacy after January 1, 2003 shall accumulate for licensure as a pharmacist shall attain a minimum of 1,500 hours of practical experience, of which at least 300 hours shall be gained outside of a school of pharmacy practical experience program. For purposes of this chapter, credit will not be given for more than 50 hours in any one week. Applicants who graduated from an approved school of pharmacy prior to January 1, 2003 shall have gained at least 1,000 hours of practical experience.

C. Practical experience that is gained within an ACPE-accredited school of pharmacy, that conforms to the current ACPE standards, and that allows the student to gain at least 1,500 hours of practical experience, shall meet the board's practical experience requirements for licensure as a pharmacist.

C. D. All practical experience credit required gained outside of an ACPE-accredited school of pharmacy program shall only be gained after successful completion of the first professional year in an approved school of pharmacy equivalent of at least two semesters in an ACPE-accredited school of pharmacy. Credit shall not be given for more than 50 hours in one week and not less than an average of 20 hours per week averaged over a month. The board may grant an exception to the minimum number of hours for good cause shown.

D. Practical experience gained in a school of pharmacy which has a program designed to provide the applicant with practical experience in all phases of pharmacy practice and which program is approved by the American Council on Pharmaceutical Education will be accepted by the board for the time period during which the student is actually enrolled. The applicant will be required to gain any additional experience outside the school program as needed to meet the requirements of subsections A and B of this section.

E. In accordance with § 54.1-3312 of the Code of Virginia, all practical experience required by this section shall be gained within the United States.

18VAC110-20-40. Procedure for gaining practical experience.

A. Each pharmacy student or graduate of an approved school of pharmacy who desires to gain practical experience in a pharmacy within the Commonwealth shall person desiring to gain practical pharmacy experience in Virginia shall first register with the board as a pharmacy intern on a form provided by the board prior to becoming so engaged as a pharmacy intern. This requirement shall also apply to students any person gaining practical experience within the Commonwealth whether for licensure in Virginia or in another state.

B. In order to be eligible to register as a pharmacy intern, an applicant shall meet at least one of the following criteria:

1. The applicant shall be enrolled in and have started course work in a professional degree program of a board-approved school of pharmacy. Such registration is only valid while the student is enrolled in the school of pharmacy and is satisfactorily progressing toward meeting the requirements for licensure as a pharmacist. An expiration date shall be assigned to the registration to cover the estimated time period for the student to complete the school program and pass the required examinations. If the student is no longer enrolled in the school program, takes a voluntary break from the program, or is otherwise not actively participating in the school program, except for regularly scheduled school breaks, the registration is no longer valid and shall be returned to the board immediately;

2. The applicant is a graduate of a board-approved school of pharmacy or a graduate of a foreign school of pharmacy, has established educational equivalency and proficiency in English by obtaining the FPGEC certificate, and desires to gain required practical experience required for licensure as a pharmacist. Such applicant shall provide documentation on a board-approved form of current employment or an employment start date within 90 days in a pharmacy in Virginia with approval by the supervising pharmacist. An expiration date shall be assigned to cover the estimated time period needed to obtain the required practical experience hours and take the required examinations to become licensed as a pharmacist;

3. The applicant has already gained the required practical experience, but is an otherwise qualified applicant awaiting examination for licensure. A three-month expiration date shall be assigned to allow the applicant time to take required examinations; or

4. The applicant is an applicant for reactivation or reinstatement of a previously issued pharmacist license and is meeting board requirements for relicensure. An expiration date shall be assigned to reasonably cover the period of time necessary to meet the board requirements.

C. For documented, good cause shown, the executive director of the board may extend the expiration date of the intern registration upon submission of an application form approved by the board and payment of the initial application fee.

B. The applicant D. A pharmacy intern shall be supervised by a pharmacist who holds an a current, unrestricted license and assumes full responsibility for the training, supervision and conduct of the intern. The supervising pharmacist shall not supervise more than one pharmacy intern during the same time period.

C. E. The intern registration of a pharmacy student shall be valid only while the student is enrolled in a school of pharmacy. The registration card issued by the board shall be returned to the board upon failure to be enrolled.

D. F. Practical experience gained within any other state must be registered with and certified by the board of that state in order to be accepted or certified by this board. In the event that a state does not use internships to gain practical experience in pharmacy but relies on the pharmacy school to certify the hours of experience, an affidavit from the pharmacy school certifying the hours of experience gained in the United States may be accepted in lieu of board certification.

E. G. All practical experience of the pharmacy intern shall be evidenced by an affidavit approved by the board, which shall be filed prior to or with the application for examination for licensure.

F. H. An applicant for licensure by endorsement may provide verification acceptable to the board of practical experience hours worked as a pharmacist in another state within the United States in lieu of prelicensure intern hours in order to meet the practical experience requirement

I. A pharmacy intern shall notify the board in writing of any change in address of record within 14 days of such change.

18VAC110-20-50. Curriculum and approved schools of pharmacy.

A. The following minimum educational requirements for the specified periods shall be recognized by the board for the purpose of licensure.

1. On and after June 1, 1928, but before June 1, 1936, the applicant for licensure shall have been graduated from a three-year course of study with a pharmacy graduate or pharmacy college degree in pharmacy awarded.

2. 1. On and after June 1, 1936, but before June 1, 1964, the applicant for licensure shall have been graduated from a four-year course of study with a Bachelor of Science degree in pharmacy awarded.

3. 2. On and after June 1, 1964, the applicant for licensure shall have been graduated from at least a five-year course of study with a Bachelor of Science degree in pharmacy or a Doctorate of Pharmacy degree awarded.

B. In order to be licensed as a pharmacist within this Commonwealth, the applicant shall have been granted the first professional degree from a program of a school of pharmacy which meets the requirements of § 54.1-3312 of the Code of Virginia.

18VAC110-20-60. Content of the examination and grades required; limitation on admittance to examination.

A. Prior to admission to any examination required for licensure, the applicant shall have met all other requirements to include education and practical experience requirements, but in no case shall the applicant be admitted if grounds exist to deny licensure under § 54.1-3316 of the Code of Virginia.

B. The applicant shall achieve a passing score as determined by the board on the licensure examination which is approved by the board and which shall consist of an integrated examination of pharmacy practice, pharmacology, pharmacy mathematics, and such other subjects as are necessary to assure that the candidate possesses the necessary knowledge and skills to practice pharmacy.

C. The applicant shall also achieve a passing score as determined by the board on an examination which tests the candidate's knowledge of federal and state laws related to pharmacy practice.

D. C. When an applicant for licensure by examination fails to meet the passing requirements of the board-approved integrated pharmacy examination on three occasions, he shall not be readmitted to the examination until he has completed an additional 1,000 hours of practical experience as a pharmacy intern as set forth in 18VAC110-20-40.

D. The applicant shall also achieve a passing score as determined by the board on an examination that tests the candidate's knowledge of federal and state laws related to pharmacy practice.

E. When an applicant fails to pass the law examination, he shall not be allowed to retake it for a period of 30 days.

F. If an applicant requests a testing accommodation for either examination based on a physical or mental impairment that substantially limits one or more major life activities, subject to the Americans with Disabilities Act, the board may approve a reasonable accommodation that does not compromise the security or integrity of the examination.

1. Supporting documentation shall be provided by the applicant to include the following to be considered for review:

a. A letter of request from the candidate that specifies the testing accommodation requested;

b. A written report of an evaluation (educational, psychological, or physical) within the preceding two years from a qualified professional that states a diagnosis of the disability, describes the disability, recommends specific accommodations, and provides justification that the accommodation is appropriate and necessary for the diagnosed disability. If the comprehensive evaluation was done more than two years ago and the condition is one that is not subject to change, the original evaluation report may be submitted along with a current letter from the qualified professional stating that there has been no change in the condition since the time of the evaluation; and

c. A written statement from the appropriate person at the applicant’s school of pharmacy that describes any testing accommodations made while the student was enrolled, if applicable.

2. The applicant will be notified in writing of the decision. If the request for accommodation is granted, the approval information will be forwarded to the examination contractor and the form of the accommodation will be coordinated with the contractor.

18VAC110-20-70. Requirements for foreign-trained applicants.

A. Applicants for licensure who were trained in foreign schools of pharmacy shall meet the following additional requirements obtain the FPGEC certificate prior to being allowed to take the examinations required by 18VAC110-20-60: register as a pharmacy intern and gain required practical experience in Virginia.

1. Obtain verification from the Foreign Pharmacy Graduate Examination Committee (FPGEC) of the National Association of Boards of Pharmacy (NABP) that the applicant is a graduate of a foreign school of pharmacy.

2. Complete and receive a score acceptable to the board on the Foreign Pharmacy Graduate Equivalency Examination (FPGEE).

3. Complete and receive a score acceptable to the board on the Test of English as a Foreign Language (TOEFL) or on the TOEFL iBT, the Internet-based tests of listening, reading, speaking and writing.

4. Complete the Test of Spoken English (TSE) or the TOEFL iBT as given by the Educational Testing Service with a score acceptable to the board.

5. Fulfill B. After obtaining the FPGEC certificate, the applicant may apply for a pharmacy intern registration and shall fulfill the requirements for practical experience as prescribed set forth in 18VAC110-20-30 A, B and E and 18VAC110-20-40 A, B, D, E and F before being admitted to examinations required by 18VAC110-20-60.

B. C. Applicants for licensure who were trained in foreign schools of pharmacy shall also complete and achieve passing scores on the examinations as prescribed set forth in 18VAC110-20-60 before being licensed as a pharmacist.

18VAC110-20-80. Renewal and reinstatement of license.

A. Pharmacist licenses expire on December 31 and shall be renewed annually prior to that date by the submission of a renewal fee, renewal form, and statement of compliance with continuing education requirements.

B. A pharmacist newly licensed on or after October 1 shall not be required to renew that license until December 31 of the following year.

C. A pharmacist who fails to renew his license by the expiration date may renew his license at any time within one year of its expiration by submission of the renewal fee and late fee, renewal form, and statement of compliance with continuing education requirements.

D. A pharmacist who fails to renew his license for more than one year following expiration and who wishes to reinstate such license shall submit an application for reinstatement, pay the current renewal fee and a reinstatement fee, and submit documentation showing compliance with continuing education requirements. Reinstatement is at the discretion of the board and may be granted by the executive director of the board provided no grounds exist to deny said reinstatement.

E. A pharmacist who has been registered as inactive for more than one year must apply for reinstatement, submit documentation showing compliance with continuing education requirements, and pay the current year active renewal fee in order to resume active licensure.

F. In order to reactivate or reinstate a license to active status, a pharmacist who holds an inactive license, who has allowed his license to lapse, or who has had his license suspended or revoked must submit evidence of completion of CEU's or hours equal to the requirements for the number of years in which his license has not been active, not to exceed a total of 60 hours of CE.

G. A pharmacist whose license has been lapsed, in inactive status, or suspended or revoked for more than five years shall, as a condition of reinstatement in addition to 60 hours CE, take and receive a passing score on the board-approved law examination and furnish acceptable documentation of one of the following:

1. Active pharmacy practice within the past five years as a properly licensed pharmacist in another state; or

2. Practical experience as a pharmacy intern registered with the board of at least 160 hours within six months immediately prior to being reinstated.

H. The practice of pharmacy without a current, active pharmacist license is unlawful and shall constitute grounds for disciplinary action by the board.

I. It shall be the duty and responsibility of each licensee to inform the board of his current address. A licensee shall immediately notify the board within 14 days in writing or electronically of any change of an address of record. Properly updating address of record directly through the board’s web-based application or other approved means shall constitute lawful notification. All notices required by law or by these rules and regulations are deemed to be legally given when mailed to the address given of record and shall not relieve the licensee of the obligation to comply.

18VAC110-20-90. Requirements for continuing education.

A. On and after December 31, 1993, a A pharmacist shall be required to have completed a minimum of 1.5 CEUs or 15 contact hours of continuing pharmacy education in an approved program for each annual renewal of licensure. CEUs or hours in excess of the number required for renewal may not be transferred or credited to another year.

B. A pharmacy education program approved for continuing pharmacy education is:

1. One that is approved by the Accreditation Council for Pharmacy Education (ACPE);

2. One that is approved as a Category I Continuing Medical Education (CME) course, the primary focus of which is pharmacy, pharmacology or drug therapy; or

3. One that is approved by the board in accordance with the provisions of 18VAC110-20-100.

C. The board may grant an extension pursuant to §54.1-3314 §54.1-3314.1 E of the Code of Virginia. Any subsequent extension shall be granted only for good cause shown.

D. Pharmacists are required to attest to compliance with CE requirements in a manner approved by the board at the time of their annual license renewal. Following each renewal period, the board may conduct an audit of the immediate past two years' CE documents to verify compliance with requirements. Pharmacists are required to maintain, for two three years following renewal, the original certificates documenting successful completion of CE, showing date and title of the CE program or activity, the number of CEU's or contact hours awarded, and a certifying signature or other certification of the approved provider. Pharmacists selected for audit must provide these original documents to the board by the deadline date specified by the board in the audit notice.

18VAC110-20-100. Approval of continuing education programs.

A. The board will approve without application or further review any program offered by an ACPE-approved provider and will accept for credit certificates bearing the official ACPE logo and program number.

B. The board may approve an individual CE program under the following provisions:

1. An approved individual program is a course, activity, or lecture which includes subject matter related to the competency of the practice of pharmacy and which has been approved for CE credit by the board.

2. In order to receive approval for an individual program, the sponsor or provider must make application apply prior to the program offering on a form provided by the board. The information which must be provided shall include but not be limited to: name of provider, location, date and time of program, charges to participants, description of program content and objectives, credentials of speaker or author, method of delivery, evaluation procedure, evidence of a pre and post test assessment, credits requested, mechanism for recordkeeping, and any such information as the board deems necessary to assure quality and compliance.

3. The sponsor making application applying for board approval of an individual program must pay a fee as required in 18VAC110-20-20 C 18.

4. The board shall notify the provider or sponsor within 60 days following the receipt of a completed application of approval or disapproval of a program and the number of credits which may be awarded. The board shall also assign an expiration date for approval of the program not to exceed two years from the date of approval.

5. The provider of an approved program shall provide to each participant who completes the required hours and passes the post test a certification with the name of the provider, name of the participant, description of course and method of delivery, number of hours credited, date of completion, and program identification number.

6. The provider of an approved program shall maintain all records on that program, its participants, and hours awarded for a period of three five years and shall make those records available to the board upon request.

7. The board shall periodically review and monitor programs. The provider of a CE program shall waive registration fees for a representative of the board for that purpose.

8. Any changes in the information previously provided about an approved program or provider must be submitted or the board may withdraw its approval. If a provider wants to give a live program more than once, all program dates must either be submitted on the original application or provided to the board in subsequent correspondence at least five days prior to giving the program.

Part III
Requirements for Pharmacy Technician Registration

18VAC110-20-101. Application for registration as a pharmacy technician.

A. Any person wishing to apply for registration as a pharmacy technician shall submit the application fee and an application on a form approved by the board.

B. In order to be registered as a pharmacy technician, an applicant shall provide evidence of the following:

1. Satisfactory completion of an approved training program, and

2. A passing score on a board-approved examination.

C. In lieu of the requirements of subsection B of this section, an applicant may provide evidence of current PTCB certification.

D. A pharmacy technician trainee may perform tasks restricted to pharmacy technicians for no more than nine months without becoming registered as a pharmacy technician.

18VAC110-20-102. Criteria for approval for training programs.

A. Any person wishing to apply for approval of a pharmacy technician training program shall submit the application fee and an application on a form approved by the board and meet the criteria established in this section.

B. The curriculum of a training program for pharmacy technicians shall include instruction in applicable, current laws and regulations and in the tasks that may be performed by a pharmacy technician to include the following or any other task restricted to pharmacy technicians in regulation:

1. The entry of prescription information and drug history into a data system or other recordkeeping system;

2. The preparation of prescription labels or patient information;

3. The removal of the drug to be dispensed from inventory;

4. The counting, measuring, or compounding of the drug to be dispensed;

5. The packaging and labeling of the drug to be dispensed and the repackaging thereof;

6. The stocking or loading of automated dispensing devices or other devices used in the dispensing process; and

7. The acceptance of refill authorization from a prescriber or his authorized agent provided there is no change to the original prescription.

C. Instructors Each program shall have a program director who shall be either (i) a pharmacist with a current unrestricted license in any jurisdiction and who is not currently suspended or revoked in any jurisdiction in the United States; (ii) a pharmacy technician with at least one year of experience performing technician tasks who holds a current unrestricted registration in Virginia or a current PTCB certification and who is not currently suspended or revoked as a pharmacy technician in any jurisdiction; or (iii) other person approved and deemed qualified by the board to be an instructor a program director.

D. Instructors for the core components listed in subsection B of this section shall meet the requirements for the program director listed in subsection C of this section. The program director may serve as an instructor.

D. E. The length of the program shall be sufficient to prepare a program participant to sit for the board-approved examination and demonstrate entry-level competency.

E. F. The program shall maintain records of program participants either on-site or at another location where the records are readily retrievable upon request for inspection. A program shall provide a certificate of completion to participants who successfully complete the program and provide verification of completion of the program for a participant upon request by the board. Records shall be maintained for two years from date of completion or termination of program.

G. The program shall report within 14 days any substantive change in the program to include a change in program name, program director, instructors, name of institution or business if applicable, address, program content, length of program, or location of records.

H. A pharmacy technician training program approval expires after two years, after which the program may apply for renewal. For continued approval, the program shall submit the renewal application, renewal fee, and a self-evaluation report on a form provided by the board at the time of renewal notification. Renewal of a program's approval is at the discretion of the board, and the decision to renew shall be based on documentation of continued compliance with the criteria set forth in this section.

18VAC110-20-103. Examination.

A. The board shall approve one or more examinations to test entry-level competency for pharmacy technicians. In order to be approved, a competency examination shall be developed in accordance with and meet the recognized acceptable test measurement standards of the Joint Technical Standards for Education and Psychological Testing (American Psychological Association, current edition), and shall be administered by an independent third party.

B. The board may contract with an examination service for the development and administration of a competency examination.

C. The board shall determine the minimum passing standard on the competency examination.

D. Any requests for testing accommodations under the Americans with Disabilities Act shall be in accordance with the provisions of 18VAC110-20-60 F.

18VAC110-20-104. Address of record; maintenance of certificate.

A. It shall be the duty and responsibility of each pharmacy technician to inform the board of his current address. A pharmacy technician shall notify the board in writing or electronically of any change of an address of record within 30 14 days. Properly updating address of record directly through the board’s web-based application or other approved means shall constitute lawful notification. All notices required by law or by these rules and regulations are deemed to be legally given when mailed to the address given of record and shall not relieve the registrant of the obligation to comply.

B. A pharmacy technician shall maintain his current registration certificate at his principal place of practice available for inspection upon request. A pharmacy technician who does not have a principal place of practice may maintain it at any pharmacy in which he practices or his address of record.

18VAC110-20-106. Requirements for continued competency.

A. A pharmacy technician shall be required to have completed a minimum of 0.5 CEUs or five contact hours of approved continuing education for each annual renewal of registration. Hours in excess of the number required for renewal may not be transferred or credited to another year.

B. An approved continuing education program shall meet the requirements as set forth in subsection B of 18VAC110-20-90 18VAC110-20-100.

C. Upon written request of a pharmacy technician, the board may grant an extension of up to one year in order for the pharmacy technician to fulfill the continuing education requirements for the period of time in question. The granting of an extension shall not relieve the pharmacy technician from complying with current year requirements. Any subsequent extension shall be granted for good cause shown.

D. Original certificates showing successful completion of continuing education programs shall be maintained by the pharmacy technician for a period of two three years following the renewal of his registration. The pharmacy technician shall provide such original certificates to the board upon request in a manner to be determined by the board.

Part IV
Pharmacies

18VAC110-20-110. Pharmacy permits generally.

A. A pharmacy permit shall not be issued to a pharmacist to be simultaneously in charge of more than two pharmacies.

B. The pharmacist-in-charge (PIC) or the pharmacist on duty shall control all aspects of the practice of pharmacy. Any decision overriding such control of the PIC or other pharmacist on duty shall be deemed the practice of pharmacy and may be grounds for disciplinary action against the pharmacy permit.

C. When the PIC ceases practice at a pharmacy or no longer wishes to be designated as PIC, he shall take a complete and accurate inventory of all Schedule II through V controlled substances on hand and shall immediately return the pharmacy permit to the board indicating the effective date on which he ceased to be the PIC.

D. Although not required by law or regulation, an outgoing PIC shall have the opportunity to take a complete and accurate inventory of all Schedule II through V controlled substances on hand on the date he ceases to be the PIC, unless the owner submits written notice to the board showing good cause as to why this opportunity should not be allowed.

E. A PIC who is absent from practice for more than 30 consecutive days shall be deemed to no longer be the PIC. Pharmacists-in-charge having knowledge of upcoming absences for longer than 30 days shall be responsible for notifying the board, returning the permit, and taking the required inventory. For unanticipated absences by the PIC, which exceed 15 days with no known return date within the next 15 days, the owner shall immediately notify the board and shall obtain a new PIC.

D. F. An application for a permit designating the new PIC shall be filed with the required fee within 14 days of the original date of resignation or termination of the PIC on a form provided by the board. It shall be unlawful for a pharmacy to operate without a new permit past the 14-day deadline unless the board receives a request for an extension prior to the deadline. The executive director for the board may grant an extension for up to an additional 14 days for good cause shown.

G. Only one pharmacy permit shall be issued to conduct a pharmacy occupying the same designated prescription department space. A pharmacy shall not engage in any other activity requiring a license or permit from the board, such as manufacturing or wholesale-distributing, out of the same designated prescription department space.

H. Before any permit is issued, the applicant shall attest to compliance with all federal, state and local laws and ordinances. A pharmacy permit shall not be issued to any person to operate from a private dwelling or residence after (effective date of this subsection).

18VAC110-20-111. Pharmacy technicians.

A. Every pharmacy that employs or uses pharmacy technicians shall maintain a site-specific training program and manual for training pharmacy technicians to work at that pharmacy. The program shall include training consistent with that specific pharmacy practice to include, but not be limited to, training in proper use of site-specific computer programs and equipment, proper use of other equipment used at the pharmacy in performing technician duties, and pharmacy calculations consistent with the duties at that pharmacy.

B. Every pharmacy shall maintain documentation of successful completion of the site specific training program for each pharmacy technician for the duration of the employment and for a period of two years from date of termination of employment. Documentation for currently employed pharmacy technicians shall be maintained on site or at another location where the records are readily retrievable upon request for inspection. After employment is terminated, such documentation may be maintained at an off-site location where it is retrievable upon request.

C. Every pharmacy that employs or uses a person enrolled in an approved pharmacy technician training program pursuant to § 54.1-3321 D of the Code of Virginia shall allow such person to conduct tasks restricted to pharmacy technicians for no more than nine months without that person becoming registered as a pharmacy technician with the board as set forth in 18VAC110-20-101. Every pharmacy using such a person shall have documentation on site and available for inspection showing that the person is currently enrolled in an approved training program and the start date for each pharmacy technician in training.

18VAC110-20-120. Special or limited-use pharmacy permits.

A. For good cause shown, the board may issue a special or limited-use pharmacy permit, when the scope, degree or type of pharmacy practice or service to be provided is of a special, limited or unusual nature as compared to a regular pharmacy service. The permit to be issued shall be based on special conditions of use requested by the applicant and imposed by the board in cases where certain requirements of regulations may be waived. The following conditions shall apply:

1. The application shall list the regulatory requirements for which a waiver is requested and a brief explanation as to why each requirement should not apply to that practice.

2. A policy and procedure manual detailing the type and method of operation, hours of operation, schedules of drugs to be maintained by the pharmacy, and method of documentation of continuing pharmacist control must accompany the application.

3. The issuance and continuation of such permits shall be subject to continuing compliance with the conditions set forth by the board.

B. For a special-use pharmacy located in or providing services to a free clinic that uses volunteer pharmacists on a part-time basis with pharmacy business hours less than 20 hours a week, the board may grant a waiver to the restricted access provisions of 18VAC110-20-190 under the following conditions:

1. The access is only for the purpose of repairing or upgrading essential equipment or for the purpose of securing a delivered drug order in the pharmacy.

2. The PIC shall be notified prior to each entry and give permission for the designated, specific individuals to enter.

3. If entry is by a nonpharmacist, two persons must enter together, one of whom must be an employee or volunteer of the free clinic who holds a license as a nurse, physician, or a physician assistant. Both persons must remain in the pharmacy the entire time that access is required.

4. The key or other means of unlocking the pharmacy and the alarm access code shall be maintained in a secure location within the facility in a sealed envelope or other container with the name of the "sealing" pharmacist written across the seal. If a nonpharmacist accesses the pharmacy, this means of access may be used, and the licensed health professional, as set forth in subdivision 3 of this subsection, is responsible for resealing the means of access and writing his name across the seal. The PIC shall ensure that the alarm access code is changed within 48 hours. In lieu of the pharmacist's signature across a seal, the executive director for the board may approve other methods of securing the emergency access to the prescription department.

5. A log must be maintained of each nonpharmacist entry showing date and time of entry, names of the two persons entering, purpose for entry, and notation that permission was granted by the pharmacist-in-charge and the date it was granted. Such log shall be maintained on premises for one year.

18VAC110-20-130. Pharmacy closings; going out of business; change of ownership.

A. At least 14 days prior to the date a pharmacy closes in accordance with § 54.1-3434.01 of the Code of Virginia or goes out of business, the owner shall notify the board. The proposed disposition of all Schedule II through VI drugs, prescription dispensing records, patient information records, and other required records shall be reported to the board. If the pharmacy drug stock and records are to be transferred to another licensee, the owner shall inform the board of the name and address of the licensee to whom the drugs and records are being transferred and the date of transfer. Prescription records for prescriptions with active refills shall be transferred to another pharmacy where a patient may obtain access for the purpose of obtaining refills either at that location or in accordance with the transfer provisions of 18VAC110-20-360.

B. Exceptions to the public notice as required in § 54.1-3434.01 of the Code of Virginia and the notice required in subsection A of this section shall be approved by the board and may include sudden closing due to fire, destruction, natural disaster, death, property seizure, eviction, bankruptcy, or other emergency circumstances. If the pharmacy is not able to meet the notification requirements of § 54.1-3434.01, the owner shall ensure that the board and public are properly notified as soon as he knows of the closure and shall disclose the emergency circumstances preventing the notification within the required deadlines.

C. In the event of an exception to the notice as required in § 54.1-3434.01 of the Code of Virginia and in subsection A of this section, the PIC or owner shall provide notice as far in advance of closing as allowed by the circumstances.

D. At least 14 days prior to any change in ownership of an existing pharmacy, the owner shall notify the board of the pending change.

1. Upon any change in ownership of an existing pharmacy, the prescription dispensing records for the two years immediately preceding the date of change of ownership and other required patient information shall be provided to the new owners on the date of change of ownership in substantially the same format as previously used immediately prior to the transfer to provide continuity of pharmacy services.

2. The previous owner shall be held responsible for assuring the proper and lawful transfer of records on the date of the transfer.

3. The format of the prescription dispensing records which are transferred to a new owner shall comply with the requirements of Chapter 34 (§54.1-3400 et seq.) of Title 54.1 of the Code of Virginia, and this chapter. Failure to comply with this chapter during a change in ownership shall be deemed to be a closing of the existing pharmacy for which the existing pharmacy owner shall be required to provide notice to the board and public in accordance with § 54.1-3434.01 of the Code of Virginia and subsection A of this section.

18VAC110-20-140. New pharmacies, acquisitions and changes to existing pharmacies.

A. Any person wishing to open a new pharmacy, engage in the acquisition of an existing pharmacy, change the location of an existing pharmacy, move the location or make structural changes to an existing prescription department, or make changes to a previously approved security system shall file an application with the board.

B. In the acquisition of an existing pharmacy, if prescription records are to be accessible to anyone for purposes other than for continuity of pharmacy services at substantially the same level offered by the previous owner or for the necessary transfer of prescription records, the owner of the pharmacy acquiring the records shall disclose such information in writing to each patient 14 days prior to the acquisition. Such release of prescription records shall be allowed only to the extent authorized by § 32.1-127.1:03 of the Code of Virginia.

C. The proposed location or structural changes shall be inspected by an authorized agent of the board prior to issuance of a permit.

1. Pharmacy permit applications which indicate a requested inspection date, or requests which are received after the application is filed, shall be honored provided a 14-day notice is allowed prior to the requested inspection date.

2. Requested inspection dates which do not allow a 14-day notice to the board may be adjusted by the board to provide 14 days for the scheduling of the inspection.

3. At the time of the inspection, the dispensing area shall comply with 18VAC110-20-150, 18VAC110-20-160, 18VAC110-20-170, 18VAC110-20-180, and 18VAC110-20-190.

4. If an applicant substantially fails to meet the requirements for issuance of a permit and a reinspection is required, or if the applicant is not ready for the inspection on the established date and fails to notify the inspector or the board at least 24 hours prior to the inspection, the applicant shall pay a reinspection fee as specified in 18VAC110-20-20 prior to a reinspection being conducted.

D. Drugs shall not be stocked within the proposed pharmacy or moved to a new location until approval is granted by the inspector or board staff.

E. Once the permit is issued, prescription drugs may not be stocked earlier than two weeks prior to the designated opening date. Once prescription drugs have been placed in the pharmacy, a pharmacist shall be present on a daily basis to ensure the safety and integrity of the drugs. If there is a change in the designated opening date, the pharmacy shall notify the board office, and a pharmacist shall continue to be on site on a daily basis.

18VAC110-20-180. Security system.

A. A device for the detection of breaking shall be installed in each prescription department of each pharmacy. The installation and the device shall be based on accepted burglar alarm industry standards, and shall be subject to the following conditions:

1. The device shall be a sound, microwave, photoelectric, ultrasonic, or any other generally accepted and suitable device.

2. The device shall be monitored in accordance with accepted industry standards, maintained in operating order and shall , have an auxiliary source of power, and be capable of sending an alarm signal to the monitoring entity when breached if the communication line is not operational.

3. The device shall fully protect the prescription department and shall be capable of detecting breaking by any means when activated.

4. Access to the alarm system for the prescription department area of the pharmacy shall be restricted to the pharmacists working at the pharmacy, except for access by other persons in accordance with 18VAC110-20-190 B 2, and the system shall be activated whenever the prescription department is closed for business.

B. Exceptions to provisions in this section:

5. This regulation shall not apply to pharmacies which have been granted a permit 1. Alarm systems approved prior to November 4, 1993, will be deemed to meet the requirements of subdivisions A 1, 2, and 3, provided that a previously approved security alarm system is in place, that no structural changes are made in the prescription department, that no changes are made in the security system, that the prescription department is not closed while the rest of the business remains open, and provided further that a breaking and loss of drugs does not occur. If a breaking with a loss of drugs occurs, the pharmacy shall immediately upgrade the alarm to meet the current standards and shall file an application with the board in accordance with 18VAC110-20-140 A.

6. 2. If the prescription department was located in a business with extended hours prior to November 4, 1993, and had met the special security requirements by having a floor to ceiling enclosure, a separately activated alarm system shall not be required.

7. 3. This section shall not apply to pharmacies which are open and staffed by pharmacists 24 hours a day. If the pharmacy changes its hours or if it must be closed for any reason, the PIC or owner must immediately notify the board, file an application in accordance with 18VAC110-20-140 A, and have installed within 72 hours prior to closing, a security system which that meets the requirements of subdivisions A 1 through 4 of this section.

18VAC110-20-190. Prescription department enclosures; access to prescription department.

A. The prescription departments department of each pharmacy shall be provided with enclosures subject to the following conditions:

1. The enclosure shall be constructed in such a manner that it protects the controlled drug stock prescription drugs from unauthorized entry and from pilferage at all times whether or not a pharmacist is on duty.

2. The enclosure shall be of sufficient height as to prevent a person from reaching over to gain access to the drugs locked and alarmed at all times when a pharmacist is not on duty.

3. Entrances to the enclosed area must have a door with no more than a six-inch gap from the floor and which is at least as high as the adjacent structure. The requirement for a maximum six-inch gap shall not apply to those pharmacies in existence prior to February 3, 1999, with the exception of any pharmacy which experiences a related diversion or theft. The enclosure shall be capable of being locked in a secure manner at any time the pharmacist on duty is not present in the prescription department.

4. Doors to the area must have locking devices which will prevent unauthorized entry in the absence of the pharmacist.

B. The door keys or other means of entry into a locked prescription department and the alarm access code to the dispensing areas shall be subject to the following requirements: 1. Only restricted to pharmacists practicing at the pharmacy and authorized by the PIC shall be in possession of any keys to or other means of opening the locking device on the door to such enclosure, or to the alarm access code. with the following exceptions:

2. 1. The PIC or a pharmacist on duty, for emergency access, may place a key or other means of opening the locking device unlocking the prescription department and the alarm access code in a sealed envelope or other container with the pharmacist's signature across the seal in a safe or vault or other secured place within the pharmacy or other secured place. This key or code means of emergency access shall only be used to allow entrance to the prescription department by other pharmacists, or by a pharmacy technician in accordance with subsection D of this section. In lieu of the pharmacist's signature across a seal, the executive director for the board may approve other methods of securing the emergency keys or access codes to the prescription department.

2. Pharmacy interns, pharmacy technicians, and other persons authorized by the PIC or pharmacist on duty may possess a key or other means of entry into a locked prescription department only when a pharmacist is on duty. Such key or other means of entry shall not allow entry when a pharmacist is not on duty.

C. The prescription department is restricted to pharmacists who are practicing at the pharmacy. Interns Pharmacy interns, pharmacy technicians, and other persons designated by the pharmacist on duty may be allowed access by the pharmacist but only during the hours when the pharmacist is on duty. Each pharmacist while on duty shall be responsible for the security of the pharmacy, including provisions for effective control against theft or diversion of prescription drugs and devices.

D. Upon a request by a patient to obtain an already-dispensed prescription, a pharmacy technician may enter the pharmacy for the sole purpose of retrieving filled prescriptions that have already been reviewed and certified for accuracy by a pharmacist and deemed ready for delivery to the patient if:

1. There is an unforeseen, unplanned absence of a pharmacist scheduled to work during regular prescription department hours;

2. Alternate pharmacist coverage cannot immediately be obtained;

3. The technician is accompanied by a member of the pharmacy's management or administration; and

4. All requirements of subsection E of this section are met.

E. Requirements for entry into the prescription department in the absence of a pharmacist.

1. The requirements for prescriptions awaiting delivery in subsection A of 18VAC110-20-200 are followed.

2. Prior to entry into the prescription department, the pharmacy technician shall obtain verbal permission from the PIC or another pharmacist regularly employed by that pharmacy to obtain and use the emergency key or other access and alarm access code and enter the pharmacy.

3. A record shall be made by the pharmacy technician of the entry to include the date and time of entry; the name and signature of the pharmacy technician; the name, title, and signature of the person accompanying the pharmacy technician; the pharmacist's name granting permission to enter and telephone number where the pharmacist was reached; the name of the patient initially requesting needed medication and the nature of the emergency; a listing of all prescriptions retrieved during that entry; and the time of exit and re-securing of the prescription department.

4. The pharmacy technician shall reseal the key and alarm access code after the pharmacy is re-secured, and the PIC shall have the alarm access code changed within 48 hours of such an entry and shall document that this has been accomplished on the record of entry.

5. All records related to entry by a pharmacy technician shall be maintained for a period of one year on premises.

18VAC110-20-200. Storage of drugs, devices, and controlled paraphernalia; expired drugs.

A. Prescriptions awaiting delivery. Prescriptions prepared for delivery to the patient may be placed in a secure place secured area outside of the prescription department and, not accessible to the public, where access to the prescriptions is restricted to individuals designated by the pharmacist to designated clerical assistants. With the permission of the pharmacist, the prepared prescriptions may be transferred to the patient at a time when the pharmacist is not on duty. If a prescription is delivered at a time when the pharmacist is not on duty, written procedures shall be established and followed by the pharmacy which detail security of the dispensed prescriptions and a method of compliance with counseling requirements of § 54.1-3319 of the Code of Virginia. Additionally, a log shall be made and maintained of all prescriptions delivered to a patient when a pharmacist is not present to include the patient's name, prescription number(s), date of delivery, and the signature of the person receiving the prescription. Such log shall be maintained for a period of one year.

B. Dispersion of Schedule II drugs. Schedule II drugs shall either be dispersed with other schedules of drugs or shall be maintained within a securely locked cabinet, drawer, or safe. The cabinet, drawer, or safe may remain unlocked during hours that the prescription department is open and a pharmacist is on duty.

C. Safeguards for controlled paraphernalia and Schedule VI medical devices. Controlled paraphernalia and Schedule VI medical devices shall not be placed in an area completely removed from the prescription department whereby patrons will have free access to such items or where the pharmacist cannot exercise reasonable supervision and control.

D. Expired, or otherwise adulterated or misbranded drugs; security. Any drug which has exceeded the expiration date, or is otherwise adulterated or misbranded, shall not be dispensed or sold; it shall be separated from the stock used for dispensing. Expired prescription drugs shall be maintained in a designated area within the prescription department until proper disposal.

18VAC110-20-210. Disposal of drugs by pharmacies.

If a PIC wishes to dispose of unwanted drugs, he shall use one of the following procedures:

1. Transfer the drugs to another person or entity authorized to possess or provide for proper disposal of such drugs; or

2. Destroy the drugs by burning in an incinerator, or other board-approved method, in compliance with all applicable local, state, and federal laws and regulations. If Schedule II through V drugs are to be destroyed, the following procedures shall apply:

a. At least 14 days prior to the destruction date, the PIC shall provide a written notice to the board office; the notice shall state the following:

(1) Date, time, manner, and place of destruction.

(2) The names of the pharmacists who will witness the destruction process.

b. If the destruction date is to be changed or the destruction does not occur, a new notice shall be provided to the board office as set forth above in subdivision 2 of this section.

c. The actual destruction shall be witnessed by the PIC and another pharmacist not employed by the pharmacy.

d. The DEA drug destruction form shall be fully completed and used as the record of all drugs to be destroyed. A copy of the destruction form shall be retained at the pharmacy with other inventory records.

Part VI
Drug Inventory and Records

18VAC110-20-240. Manner of maintaining records, prescriptions, inventory records.

A. Each pharmacy shall maintain the inventories and records of drugs as follows:

1. Inventories and records of all drugs listed in Schedules I and II shall be maintained separately from all other records of the pharmacy. Each pharmacy shall maintain a perpetual inventory of all Schedule II drugs received and dispensed, with reconciliation at least every 30 days. Electronic monitoring at the pharmacy or by another entity that provides alerts for discrepancies between drugs received and drugs dispensed is acceptable provided such alerts are reviewed at least monthly.

2. Inventories and records of drugs listed in Schedules III, IV, and V may be maintained separately or with records of Schedule VI drugs but shall not be maintained with other records of the pharmacy.

3. All executed order forms, prescriptions, and inventories of Schedule II through V drugs shall be maintained at the same location address as the stock of drugs to which the records pertain. If authorized by DEA, other records pertaining to Schedule II through V drugs, such as invoices, may be maintained in an off-site database or in secured storage. All records in off-site storage shall be retrieved and made available for inspection or audit within 48 hours of a request by the board or an authorized agent.

4. In the event that an inventory is taken as the result of a theft of drugs pursuant to § 54.1-3404 of the Drug Control Act, the inventory shall be used as the opening inventory within the current biennial period. Such an inventory does not preclude the taking of the required inventory on the required biennial inventory date.

5. 4. All inventories required by § 54.1-3404 of the Code of Virginia shall be signed and dated by the person taking the inventory and shall indicate whether the inventory was taken prior to the opening of business or after close of business. A 24-hour pharmacy with no opening or closing of business shall clearly document whether the receipt or distribution of drugs on the inventory date occurred before or after the inventory was taken.

5. Invoices or other records showing receipts of Schedule VI drugs shall be maintained, but may be stored in an electronic database or record as an electronic image that provides an exact, clearly legible, image of the document or in secured storage either on or off site. All records in off-site storage or database shall be retrieved and made available for inspection or audit within 48 hours of a request by the board or an authorized agent.

6. All records required by this section shall be filed chronologically and maintained for a period of not less than two years from the date of transaction.

B. Prescriptions.

1. A hard copy prescription shall be placed on file for every initial prescription dispensed and be maintained for two years from the date of last refill. All prescriptions shall be filed chronologically by date of initial dispensing.

2. Schedule II drugs. Prescriptions for Schedule II drugs shall be maintained in a separate prescription file.

3. Schedule III through V drugs. Prescriptions for Schedule III through V drugs shall be maintained either in a separate prescription file for drugs listed in Schedules III, IV, and V only or in such form that they are readily retrievable from the other prescriptions of the pharmacy. Prescriptions will be deemed readily retrievable if, at the time they are initially filed, the face of the prescription is stamped in red ink in the lower right corner with the letter "C" no less than one inch high and filed in the prescription file for drugs listed in the usual consecutively numbered prescription file for Schedule VI drugs. However, if a pharmacy employs an automated data processing system or other electronic recordkeeping system for prescriptions which permits identification by prescription number and retrieval of original documents by prescriber's name, patient's name, drug dispensed, and date filled, then the requirement to mark the hard copy prescription with a red "C" is waived.

C. Chart orders.

1. A chart order written for a patient in a hospital or long-term care facility, a patient receiving home infusion services, or a hospice patient pursuant to § 54.1-3408.01 A of the Code of Virginia shall be exempt from having to contain all required information of a written prescription provided:

a. This information is contained in other readily retrievable records of the pharmacy; and

b. The pharmacy maintains a current policy and procedure manual that sets out where this information is maintained and how to retrieve it and the minimum requirements for chart orders consistent with state and federal law and accepted standard of care.

2. A chart order may serve as the hard copy prescription for those patients listed in subdivision 1 of this subsection.

3. Requirements for filing of chart orders.

a. Chart orders shall be filed chronologically by date of initial dispensing with the following exception: If dispensing data can be produced showing a complete audit trail for any requested drug for a specified time period and each chart order is readily retrievable upon request, chart orders may be filed using another method. Such alternate method shall be clearly documented in a current policy and procedure manual.

b. If a single chart order contains both an order for a Schedule II drug and one or more orders for a drug in another schedule, where the Schedule II drug is not floor stocked, but is dispensed from the pharmacy pursuant to this order for the specific patient, the original order must be filed with records of dispensing of Schedule II drugs and a copy of the order placed in the file for other schedules.

Part VII
Prescription Order and Dispensing Standards

18VAC110-20-270. Dispensing of prescriptions; certification of completed prescriptions; supervision of pharmacy technicians.

A. In addition to the acts restricted to a pharmacist in § 54.1-3320 A of the Code of Virginia, a pharmacist shall provide personal supervision of compounding of extemporaneous preparations by pharmacy technicians.

B. A pharmacist directly monitoring the activities of a person enrolled in an approved pharmacy technician training program who is performing the tasks restricted to a pharmacy technician prior to registration in accordance with § 54.1-3321 D of the Code of Virginia shall not monitor more than two such trainees at the same time, and at no time shall a pharmacist supervise more than four persons performing technician functions to include technicians and trainees. A pharmacist shall determine the number of pharmacy interns, pharmacy technicians, and pharmacy technician trainees he can safely and competently supervise at one time.

C. After the prescription has been prepared and prior to the delivery of the order, the pharmacist shall inspect the prescription product to verify its accuracy in all respects, and place his initials on the record of dispensing as a certification of the accuracy of, and the responsibility for, the entire transaction. Such record showing verification of accuracy shall be maintained on a pharmacy record for the required time period of two years, unless otherwise specified in regulation.

D. If a pharmacist declines to fill a prescription for any reason other than the unavailability of the drug prescribed, he shall record on the back of the prescription the word "declined"; the name, address, and telephone number of the pharmacy; the date filling of the prescription was declined; and the signature of the pharmacist.

E. If a pharmacist determines from a prescriber or other means that a prescription presented for dispensing is a forgery, the pharmacist shall not return the forged prescription to the person presenting it. The forged prescription may be given to a law-enforcement official investigating the forgery; or it shall be retained for a minimum of 30 days before destroying it, in the event it is needed for an investigative or other legitimate purpose.

18VAC110-20-275. Delivery of dispensed prescriptions.

A. Pursuant to § 54.1-3420.2 B of the Code of Virginia, in addition to direct hand delivery to a patient or patient's agent or delivery to a patient's residence, a pharmacy may deliver prescriptions to another pharmacy, to a practitioner of the healing arts licensed to practice pharmacy or to sell controlled substances, or to an authorized person or entity holding a controlled substances registration issued for this purpose in compliance with this section and any other applicable state or federal law.

B. Delivery to another pharmacy.

1. One pharmacy may fill prescriptions and deliver the prescriptions to a second pharmacy for patient pickup or direct delivery to the patient provided the two pharmacies have the same owner, or have a written contract or agreement specifying the services to be provided by each pharmacy, the responsibilities of each pharmacy, and the manner in which each pharmacy will comply with all applicable federal and state law.

2. Each pharmacy using such a drug delivery system shall maintain and comply with all procedures in a current policy and procedure manual that includes the following information:

a. A description of how each pharmacy will comply with all applicable federal and state law;

b. The procedure for maintaining required, retrievable dispensing records to include which pharmacy maintains the hard-copy prescription, which pharmacy maintains the active prescription record for refilling purposes, how each pharmacy will access prescription information necessary to carry out its assigned responsibilities, method of recordkeeping for identifying the pharmacist or pharmacists responsible for dispensing the prescription and counseling the patient, and how and where this information can be accessed upon request by the board;

c. The procedure for tracking the prescription during each stage of the filling, dispensing, and delivery process;

d. The procedure for identifying on the prescription label all pharmacies involved in filling and dispensing the prescription;

e. The policy and procedure for providing adequate security to protect the confidentiality and integrity of patient information;

f. The policy and procedure for ensuring accuracy and accountability in the delivery process;

g. The procedure and recordkeeping for returning to the initiating pharmacy any prescriptions that are not delivered to the patient; and

h. The procedure for informing the patient and obtaining consent if required by law for using such a dispensing and delivery process.

3. Drugs waiting to be picked up at or delivered from the second pharmacy shall be stored in accordance with subsection A of 18VAC110-20-200.

C. Delivery to a practitioner of the healing arts licensed by the board to practice pharmacy or to sell controlled substances or other authorized person or entity holding a controlled substances registration authorized for this purpose.

1. A prescription may be delivered by a pharmacy to the office of such a practitioner or other authorized person provided there is a written contract or agreement between the two parties describing the procedures for such a delivery system and the responsibilities of each party.

2. Each pharmacy using this delivery system shall maintain a policy and procedure manual that includes the following information:

a. Procedure for tracking and assuring security, accountability, integrity, and accuracy of delivery for the dispensed prescription from the time it leaves the pharmacy until it is handed to the patient or agent of the patient;

b. Procedure for providing counseling;

c. Procedure and recordkeeping for return of any prescription medications not delivered to the patient;

d. The procedure for assuring confidentiality of patient information; and

e. The procedure for informing the patient and obtaining consent if required by law for using such a delivery process.

3. Prescriptions waiting to be picked up by a patient at the alternate site shall be stored in a lockable room or lockable cabinet, cart, or other device that cannot be easily moved and that shall be locked at all times when not in use. Access shall be restricted to the licensed practitioner of the healing arts or the responsible party listed on the application for the controlled substances registration, or either person's designee.

D. The contracts or agreements and the policy and procedure manuals required by this section for alternate delivery shall be maintained both at the originating pharmacy as well as the alternate delivery site.

E. A controlled substances registration as an alternate delivery site shall only be issued to an entity without a prescriber or pharmacist present at all times the site is open if there is a valid patient health or safety reason not to deliver dispensed prescriptions directly to the patient and if compliance with all requirements for security, policies, and procedures can be reasonably assured.

18VAC110-20-280. Transmission of a prescription order by facsimile machine.

A. Prescription orders for Schedule III through VI drugs may be transmitted to pharmacies by facsimile device (FAX) upon the following conditions:

1. The prescription shall be faxed only to the pharmacy of the patient's choice.

2. A valid faxed prescription shall contain all required information for a prescription. A written prescription shall include the prescriber's signature.

3. An authorized agent, as defined in § 54.1-3408.01 D of the Code of Virginia, may transmit an oral prescription by facsimile and shall record on the faxed prescription the agent's full name and wording that clearly indicates that the prescription being transmitted is an oral prescription.

4. A faxed prescription shall be valid only if faxed from the prescriber's practice location, except in the following situations:

for forwarding a. Forwarding a faxed chart order from a long-term care facility or from a hospice, including a home hospice;

b. Faxing an oral prescription by authorized agent under the conditions set forth in subdivision 2 of this subsection; or

c. Forwarding a written prescription by an authorized agent from a long-term care facility, provided the provider pharmacy maintains written procedures for such transactions, and provided the original prescription is obtained by the provider pharmacy within seven days of dispensing. The original prescription shall be attached to the faxed copy.

5. The following additional information shall be recorded on the faxed prescription:

a. The date that the prescription was faxed;

b. The printed name, address, phone number, and fax number of the authorized prescriber; and

c. The institution, if applicable, from which the prescription was faxed, including address, phone number and fax number.

B. Prescription orders for Schedule II drugs may only be faxed for information purposes and may not serve as the original written prescription authorizing dispensing, except for orders to be administered to nursing home long-term care facility and home infusion patients in accordance with § 54.1-3408.01 C B of the Code of Virginia and except for prescriptions written for a Schedule II narcotic substance for patients residing in a hospice certified by Medicare under Title XVIII or licensed by the state, which may include home hospice. The prescriber shall note on the prescription if the patient is a hospice patient, and the prescription shall meet all requirements for a written prescription, including the prescriber's signature.

C. If the faxed prescription is of such quality that the print will fade and not remain legible for the required retention period, the receiving pharmacist shall copy or transcribe the faxed prescription on paper of permanent quality.

D. Authorizations for refills may be faxed by the prescriber to the pharmacy provided the authorization includes patient name, address, drug name and strength, quantity, directions for use, prescriber's name, prescriber's signature or agent's name, and date of authorization.

18VAC110-20-286. Chart orders for outpatients.

A chart order may be filled by an outpatient (community/retail) pharmacy for outpatient use provided the following conditions are met:

1. The chart order was written for a patient while in a hospital or long-term care facility.

2. The pharmacist has all information necessary to constitute a valid outpatient prescription.

3. The pharmacist in an outpatient setting has direction, either written or obtained verbally, that the chart order is actually intended to be outpatient or discharge prescription orders, and not merely a listing drugs the patient was taking while an inpatient.

4. The orders include some direction related to quantity to be dispensed or authorized duration of the order by which the pharmacist can calculate the authorized quantity using directions for use and duration.

18VAC110-20-320. Refilling of Schedule III through VI prescriptions.

A. A prescription for a drug listed in Schedule III, IV, or V shall not be dispensed or refilled more than six months after the date on which such prescription was issued, and no such prescription authorized to be filled may be refilled more than five times.

1. Each refilling of a prescription shall be entered on the back of the prescription or on another record in accordance with § 54.1-3412 and 18VAC110-20-255, initialed and dated by the pharmacist as of the date of dispensing. If the pharmacist merely initials and dates the prescription, it shall be presumed that the entire quantity ordered was dispensed.

2. The partial dispensing of a prescription for a drug listed in Schedule III, IV, or V is permissible, provided that:

a. Each partial dispensing is recorded in the same manner as a refilling;

b. The total quantity of drug dispensed in all partial dispensing does not exceed the total quantity prescribed; and

c. No dispensing occurs after six months after the date on which the prescription order was issued.

B. A prescription for a drug listed in Schedule VI shall be refilled only as expressly authorized by the practitioner. If no such authorization is given, the prescription shall not be refilled, except as provided in § 54.1-3410 C or subdivision 4 of § 54.1-3411 of the Code of Virginia.

A prescription for a Schedule VI drug or device shall not be dispensed or refilled more than one year after the date on which it was issued unless the prescriber specifically authorizes dispensing or refilling for a longer period of time not to exceed two years.

C. As an alternative to all manual recordkeeping requirements provided for in subsections A and B of this section, an automated data processing system as provided in 18VAC110-20-250 may be used for the storage and retrieval of all or part of dispensing information for prescription drugs dispensed.

D. Authorized refills of all prescription drugs may only be dispensed in The timing of dispensing an authorized refill of a prescription shall be within reasonable conformity with the directions for use as indicated by the practitioner; if directions have not been provided, then any authorized refills may only be dispensed in reasonable conformity with the recommended dosage and with the exercise of sound professional judgment. An authorized refill may be dispensed early provided the pharmacist documents a valid reason for the necessity of the early refill.

18VAC110-20-340. Packaging standards for dispensed prescriptions.

A. A drug shall be dispensed only in packaging approved by the current U.S.P.-N.F. for that drug. In the absence of such packaging standard for that drug, it shall be dispensed in a well-closed container.

B. Drugs may be dispensed in compliance packaging for self-administration when requested by the patient or for use in hospitals or long-term care facilities provided that such packaging meets all current U.S.P.-N.F. standards for packaging, labeling and record keeping. Compliance packaging that is comprised of a series of individual containers or pockets labeled with the specific date and time when the contents of that container are to be taken, and which may contain more than one different drug, shall comply with USP-NF standards for customized patient medication packages to include:

1. If the packaging allows for the separation of the individual containers, the labels for each individual container shall be labeled with the identity of each of the drug products contained within; and

2. The main packaging label shall contain all the required elements for any outpatient prescription label and shall contain a physical description identifying each solid dosage form contained within the individual containers.

18VAC110-20-350. Special packaging.

A. Each drug dispensed to a person in a household shall be dispensed in special packaging except when otherwise directed in a prescription by a practitioner, when otherwise requested by the purchaser, or when such drug is exempted from 16 CFR §1702.1 et seq. promulgated pursuant to the Poison Prevention Packaging Act of 1970 (15 USC §§1471-1476).

B. Each pharmacy may have a sign posted near the prescription department advising the patients that nonspecial packaging may be requested.

C. B. If nonspecial packaging is requested, a release of such request shall be obtained from the patient or the patient's authorized agent and maintained for two years from the date of dispensing a notation shall be made on the dispensing record or other retrievable record.

18VAC110-20-355. Pharmacy repackaging of drug; records required; labeling requirements.

A. Pharmacies in which bulk reconstitution of injectable, bulk compounding or the repackaging or prepackaging of drugs is performed shall maintain adequate control records for a period of one year or until the expiration, whichever is greater. The records shall show the name of the drug(s) used; strength, if any; date repackaged; quantity prepared; initials of the pharmacist verifying the process; the assigned lot or control number; the manufacturer's or distributor's name and lot or control number; and an expiration date.

B. The drug name; strength, if any; the assigned lot or control number or the manufacturer's or distributor's name and lot or control number; and an appropriate expiration date determined by the pharmacist in accordance with USP guidelines shall appear on any subsequently repackaged or reconstituted units.

C. Pharmacies using automated counting devices or dispensers in which drugs are removed from manufacturer's original packaging and placed in bulk bins shall comply with the following requirements:

1. A bin filling record shall be maintained, manually or in a computerized record for a period of one year from date of filling from which information can be readily retrieved, for each bin including:

a. The drug name and strength, if any;

b. The name of the manufacturer or distributor;

c. Manufacturer's control or lot number(s) and expiration date for all lots placed into the bin at the time of filling;

d. Any assigned lot number; and

e. An expiration date determined according to USP guidelines for repackaging;

f. The date of filling; and

g. The pharmacist's initials verifying the accuracy of the process.

2. If more than one lot is added to a bin at the same time, the lot which expires first shall be used to determine the expiration date if shorter than a calculated date based on USP guidelines.

3. Each bin shall be labeled in such a manner as to cross-reference the information on the filling record with the correct expiration date.

4. If only one lot is added to a bin at one time, but a second subsequent lot may be added before the first has cleared, the automated device shall be constructed to reasonably dispense the first lot before the second lot is dispensed, the expiration date on the bin's label shall reflect the expiration date assigned to the earlier lot, and the bin shall be allowed to "run dry" where all product is completely removed prior to filling at least once every 60 days with a record made of the run dry dates.

D. A pharmacy may return a dispensed drug to stock for redispensing that has never left the pharmacy premises or the control of the pharmacy delivery agent pursuant to § 54.1-3411.1 A 3 of the Code of Virginia under the following conditions:

1. An expiration date shall be placed on the label prior to returning the drug to stock. In the absence of stability data to the contrary, the date on the label may not exceed the expiration date on the manufacturer’s container or one year from the date the drug was originally dispensed and placed in the prescription vial, whichever date is earlier.

2. The restocked drug shall be used to fill the next prescription received for that product. In the event that the drug is not dispensed prior to the new assigned expiration date, it shall be removed from working stock as expired, and disposed of in accordance with 18VAC110-20-210.

3. If there is no lot number on the label of a drug returned to stock or on the prescription records that can be cross-referenced from the prescription label, the drug shall be removed from stock upon any recall of that drug product and returned to the manufacturer or otherwise disposed of in accordance with 18VAC110-20-210.

18VAC110-20-391. Prescription blanks.

If a pharmacy provides prescription blanks to prescribers, no advertising or other information shall be on the face of the prescription blank other than prompts for essential information required by law to be on a written prescription. Any nonessential information such as coupons or pharmacy name may be placed on the back of the prescription blank or on a separate sheet of paper, but shall not be on or attached to the face of the blank.

18VAC110-20-395. Purchase of drugs.

Except for an emergency purchase from another pharmacy, a pharmacist may only purchase Schedule II through VI drugs from a wholesale distributor or warehouser licensed or registered by the board.

18VAC110-20-410. Permitted physician licensed by the board.

A. Pursuant to § 54.1-3304 of the Code of Virginia, physicians licensed by the board to dispense drugs, when pharmacy services are not reasonably available, shall be subject to the following sections of this chapter. For purposes of this section, the terms "pharmacist," "pharmacist-in-charge," "pharmacy," and "PIC" in the following shall be deemed to mean the physician permitted by the board:

1. 18VAC110-20-110 C and D;

2. 18VAC110-20-130 A;

3. 18VAC110-20-140 A and C;

4. 18VAC110-20-150 except that these requirements shall not apply to physicians licensed prior to August 25, 2004, unless the dispensing area is relocated or remodeled;

5. 18VAC110-20-160;

6. 18VAC110-20-180;

7. 18VAC110-20-190 A, B and C;

8. 18VAC110-20-200;

9. 18VAC110-20-210; and

10. 18VAC110-20-240 through 18VAC110-20-410.

B. A physician may apply for a special or limited use permit in accordance with 18VAC110-20-120.

18VAC110-20-425. Robotic Pharmacy Systems pharmacy systems.

A. A pharmacy providing services to a hospital or a long-term care facility using a unit dose dispensing system may apply for approval of operate a robotic pharmacy system and a waiver of 18VAC110-20-270 B dispensing unit dose, bar-coded drugs, and is exempted from 18VAC110-20-270 C, provided the accuracy of the final dispensed prescription product is determined by complies with a written quality assurance plan and requirements of this chapter. An applicant shall apply using a form provided by the board and shall pay a fee as set forth in 18VAC110-20-20. The following requirements for operation of a robotic pharmacy system shall apply:

1. Pharmacists shall review for accuracy and appropriateness of therapy all data entry of prescription orders into the computer operating the system.

2. The packaging, repackaging, stocking and restocking of the robotic pharmacy system shall be performed by pharmacy technicians or pharmacists.

3. Pharmacists shall verify and check for the accuracy of all drugs packaged or repackaged for use by the robot by a visual check of both labeling and contents prior to stocking the drugs in the robotic pharmacy system. A repackaging record shall be maintained in accordance with 18VAC110-20-355 A, and the verifying pharmacist shall initial the record. Packaging and labeling, including the appropriate beyond-use date, shall conform to requirements of this chapter and current USP-NF standards.

4. A written policy and procedure must be maintained and shall include at a minimum, procedures for ensuring:

a. Accurate packaging and repackaging of all drugs for use in the robotic pharmacy system, to include properly labeled barcodes, and method for ensuring pharmacist verification of all packaged and repacked drugs compliant with this chapter;

b. Accurate stocking and restocking of the robotic pharmacy system;

c. Removing expired drugs;

d. Proper handling of drugs that may be dropped by the robotic pharmacy system;

e. Performing routine maintenance of robotic pharmacy system as indicated by manufacturer’s schedules and recommendations;

f. Accurate dispensing of drugs via robotic pharmacy system for cart fills, first doses, and cart fill updates during normal operation and during any scheduled or unscheduled downtime;

g. Appropriately investigating, identifying and correcting sources of discrepancies or errors associated with the robotic pharmacy system; and

h. Maintaining quality assurance reports.

5. Pharmacists shall perform a daily random check of medications picked by the robot for 5.0% of all patients' bins and 5.0% of all first doses or cart updates. Documentation of this check shall include the pharmacist’s initials for each medication checked and a description of all discrepancies found.

6. All manual picks shall be checked by pharmacists.

7. If the robot picks an incorrect medication, the pharmacy shall immediately institute a 100% check of all patients’ bins or doses and shall immediately report the error to the board. The 100% check procedure shall continue until such time as the pharmacy provides documentation to the board showing that the cause of the error has been determined and addressed and that the robot is no longer making errors, and the board allows the pharmacy to return to a reduction in checking.

8. Quarterly quality assurance reports demonstrating the accuracy of the robot shall be maintained. At a minimum, these reports shall include:

a. A summary indicating the date and description of all discrepancies that include but are not limited to discrepancies involving the packaging, repackaging and dispensing of drugs via the robotic pharmacy system found during that quarter plus a cumulative summary since initiation of the robotic pharmacy system.

b. The total number of doses packaged for the robotic pharmacy system and total number of doses picked by the robot during the quarter.

c. The total number of doses picked by the robot that were checked in conducting the 5.0% patient bin check, 5.0% cart updates check, and 5.0% first dose check.

d. Dates and time associated with any scheduled or unanticipated downtime with an explanation of the problem to include the time span of the downtime and the resolution.

9. All unanticipated downtime shall be immediately reported to the board.

10. All records required by this section shall be maintained at the address of the pharmacy for a minimum of two years. Records may be maintained in offsite storage or as an electronic image that provides an exact image of the document that is clearly legible provided such offsite or electronic storage is retrievable and made available for inspection or audit within 48 hours of a request by the board or an authorized agent.

B. A copy of the quality assurance plan shall be submitted as a part of the application and shall include at a minimum the following:

1. Method of ensuring accurate packaging and loading of the robotic pharmacy system.

2. Procedures for conducting quality control checks of final dispensing for accuracy.

3. Manufacturer's schedules and recommendations for maintenance of the device.

4. Plan for maintenance of all related documentation for a minimum of two years.

C. The application shall be reviewed by an informal conference committee of the board, consisting of no less than two members of the board.

1. The informal conference committee may approve or deny the application, or may approve the application upon terms and conditions.

2. The committee may require an inspection of a new or modified robotic pharmacy system prior to approval.

3. The committee may require that periodic reports be submitted detailing frequency and types of errors determined by the continuous quality assurance checks.

4. The board may withdraw the approval of a waiver for failure to comply with the quality assurance plan or with other terms and conditions which have been established by the board.

D. The board shall be notified prior to implementing any modification to the approved application and no modification may be implemented until approved by the board.

E. If a robotic pharmacy system is used, a pharmacist shall review all data entry of prescription orders into the computer operating the system for accuracy and appropriateness of therapy and shall check all repackaged medication prior to use in loading the system.

Part XI
Pharmacy Services to Hospitals

18VAC110-20-440. Responsibilities of the pharmacist-in-charge.

A. The PIC in a pharmacy located within a hospital or the PIC of any outside pharmacy providing pharmacy services to a hospital shall be responsible for establishing procedures for and assuring maintenance of the proper storage, security, and dispensing of all drugs used throughout the hospital.

B. The PIC of a pharmacy serving a hospital shall be responsible for maintaining a policy and procedure for providing reviews of drug therapy to include at a minimum any irregularities in drug therapy, drug interactions, drug administration, or transcription errors. All significant irregularities shall be brought to the attention of the attending practitioner or other person having authority to correct the potential problem consistent with § 54.1-3319 A of the Code of Virginia.

C. Prior to the opening of a satellite pharmacy within the hospital, the PIC shall notify the board as required by 18VAC110-20-140 and shall ensure compliance with subsections B through G of 18VAC110-20-150, 18VAC110-20-160, 18VAC110-20-170, 18VAC110-20-180 and 18VAC110-20-190. No drugs shall be stocked in a satellite pharmacy until an inspection has been completed and approval given for opening.

D. For the following list of Schedule VI controlled substances, the PIC of a pharmacy serving a hospital may authorize the storage in an area of the hospital outside the pharmacy, and may delegate the ordering and distribution within the hospital to nonpharmacy personnel provided the conditions for proper storage and adequate security and the procedures for distribution are set forth in the pharmacy's policy and procedure manual, and provided that the PIC assures that these storage areas are checked monthly for compliance. The storage areas must be locked when authorized staff is not present in the area. Except for nitrous oxide, medical gases may be stored in an unlocked area.

1. Large volume parenteral solutions that contain no active therapeutic drugs other than electrolytes;

2. Irrigation solutions;

3. Contrast media;

4. Medical gases;

5. Sterile sealed surgical trays that may include a Schedule VI drug; and

6. Blood components and derivatives, and synthetic blood components and products that are classified as prescription drugs.

18VAC110-20-450. After-hours access to the pharmacy.

A. When authorized by the PIC, an authorized nurse may have access to the pharmacy in the absence of the pharmacist a supply of drugs maintained by the pharmacy at a location outside the pharmacy in order to obtain emergency medication during hours the pharmacy is closed, provided that such drug is available in the manufacturer's original package or in units which have been prepared and labeled by a pharmacist and provided further that a separate record shall be made and left within the pharmacy at the location of the stock of drugs on a form prescribed by the PIC and such records are maintained within the pharmacy for a period of one year showing:

1 The date of withdrawal;

2. The patient's name;

3. The name of the drug, strength, dosage form and dose prescribed;

4. Number of doses removed; and

5. The signature of the authorized nurse.

B. If the after-hours supply of drugs is in an area that is continuously open and staffed, such as a patient floor or emergency room, then the area does not need to be alarmed. If the after-hours supply is maintained in an area of the hospital that is not open and continuously staffed, such as a floor that primarily houses departments that are closed daily, then an alarm that meets the requirements of 18VAC110-20-180 shall be installed and activated at all times.

18VAC110-20-460. Floor stock drugs; proof of delivery; distribution records.

A. A pharmacist shall check all Schedule II-VI drugs delivered to a hospital unit as floor-stock before the drugs leave the pharmacy and shall initial or sign manually or electronically the record of distribution verifying the accuracy of the distribution.

B. A delivery receipt shall be obtained for Schedule II through V drugs supplied as floor stock. This record shall include the date, drug name and strength, quantity, hospital unit receiving drug and the manual or electronic signatures of the dispensing pharmacist and the receiving nurse. Receipts shall be maintained in the pharmacy for a period of two years or in off-site storage which shall be retrievable and made available for inspection or audit within 48 hours of a request by the board or an authorized agent.

B. C. A record of disposition/administration shall be used to document administration of Schedule II through V drugs when a floor stock system is used for such drugs. The record shall be returned to the pharmacy within three months of its issue. The PIC or his designee shall:

1. Match returned records with delivery receipts to verify that all records are returned;

2. Periodically audit returned administration records for completeness as to patient's names, dose, date and time of administration, signature or initials of person administering the drug, and date the record is returned;

3. Verify that all additions to inventory are recorded, that all additions to and deductions from inventory are correctly calculated, that sums carried from one record to the next are correctly recorded, and periodically verify that doses documented on administration records are reflected in the medical record; and

4. Initial the returned record, file chronologically by date of issue, and retain for two years from the date of return or in off-site storage which shall be retrievable and made available for inspection or audit within 48 hours of a request by the board or an authorized agent.

C. D. All records required by this section shall be filed chronologically by date of issue, and retained for two years from the date of return at the address of the pharmacy. Schedule VI records may be maintained in offsite storage or as an electronic image that provides an exact image of the document that is clearly legible provided such offsite or electronic storage is retrievable and made available for inspection or audit within 48 hours of a request by the board or an authorized agent. Schedule II-V records may only be stored offsite or electronically as described in this subsection if authorized by DEA or in federal law or regulation. The filing requirements of 18VAC110-20-240 A 1 for separation of Schedule II records shall be met for administration records if the Schedule II drugs are listed in a separate section on a page that contains other schedules of drugs.

18VAC110-20-490. Automated devices for dispensing and administration of drugs.

A hospital may use automated devices for the dispensing and administration of drugs pursuant to § 54.1-3301 of the Code of Virginia and §§54.3401 and 54.1-3434.02 of the Drug Control Act and in accordance with 18VAC110-20-270, 18VAC110-20-420 or 18VAC110-20-460 as applicable. The following conditions shall apply:

1. Prior to removal of drugs from the pharmacy, a delivery record shall be generated for all drugs to be placed in an automated dispensing device which shall include the date; drug name, dosage form, and strength; quantity; hospital unit and a unique identifier for the specific device receiving the drug; initials of the person loading the automated dispensing device; and initials of the pharmacist reviewing the transaction checking the drugs to be removed from the pharmacy and the delivery record for accuracy.

2. At the time of loading, the delivery record for all Schedule II through V drugs shall be signed by a nurse or other person authorized to administer drugs from that specific device, and the record returned to the pharmacy and maintained in chronological order for a period of two years from date of delivery. The delivery record and required signatures may be generated or maintained electronically provided the system being used has the capability of recording an electronic signature which is a unique identifier and restricted to the individual receiving the drugs and provided that this record is maintained in a "read-only" format which cannot be altered after the information is recorded. The electronic record shall be readily retrievable, maintained for a period of two years, and the system used shall be capable of producing a hard-copy printout of the record upon request.

3. At the time of loading any Schedule II through V drug, the person loading will verify that the count of that drug in the automated dispensing device is correct. Any discrepancy noted shall be recorded on the delivery record and immediately reported to the pharmacist in charge, who shall be responsible for reconciliation of the discrepancy or properly reporting of a loss.

4. Automated dispensing devices in hospitals shall be capable of producing a hard-copy record of distribution which shall show patient name, drug name and strength, dose withdrawn, dose to be administered, date and time of withdrawal from the device, and identity of person withdrawing the drug.

5. The PIC or his designee shall conduct at least a monthly audit to review distribution and administration of Schedule II through V drugs from each automated dispensing device as follows:

a. The audit shall reconcile records of all quantities of Schedule II through V drugs dispensed from the pharmacy with records of all quantities loaded into each device to detect whether any drugs recorded as removed from the pharmacy were diverted rather than being placed in the proper device.

b. A discrepancy report shall be generated for each discrepancy in the count of a drug on hand in the device. Each such report shall be resolved by the PIC or his designee within 72 hours of the time the discrepancy was discovered or, if determined to be a theft or an unusual loss of drugs, shall be immediately reported to the board in accordance with § 54.1-3404 E of the Drug Control Act.

c. The audit shall include a review of a sample of administration records from each device per month for possible diversion by fraudulent charting. A sample from each device shall not be less than 24 consecutive hours within the month being audited shall include all Schedule II-V drugs administered for a time period of not less than 24 consecutive hours during the audit period.

d. The audit shall include a check of medical records to ensure that a valid order exists for a random sample of doses recorded as administered.

e. The audit shall also check for compliance with written procedures for security and use of the automated dispensing devices, accuracy of distribution from the device, and proper recordkeeping.

f. The hard-copy distribution and administration records printed out and reviewed in the audit shall be initialed and dated by the person conducting the audit and maintained in the pharmacy for a period of two years. If nonpharmacist personnel conduct the audit, a pharmacist shall review the record and shall initial and date the record. These distribution records reviewed in conducting the audit may be maintained electronically provided they can be readily retrieved upon request; provided they are maintained in a read-only format which does not allow alteration of the records; and provided a log is maintained for a period of two years showing dates of audit and review, the identity of the automated dispensing device being audited, the time period covered by the audit and review, and the initials of all reviewers.

6. If an automated dispensing device is used to obtain drugs for dispensing from an emergency room, a separate dispensing record is not required provided the automated record distinguishes dispensing from administration and records the identity of the physician who is dispensing.

7. Automated dispensing devices shall be inspected monthly by pharmacy personnel to verify proper storage, proper location of drugs within the device, expiration dates, the security of drugs and validity of access codes.

8. Personnel allowed access to an automated dispensing device shall have a specific access code which records the identity of the person accessing the device.

9. Proper use of the automated dispensing devices and means of compliance with requirements shall be set forth in the pharmacy's policy and procedure manual.

10. All records required by this section shall be filed in chronological order from date of issue and maintained for a period of not less than two years. Records shall be maintained at the address of the pharmacy providing services to the hospital except:

a. Manual Schedule VI distribution records may be maintained in offsite storage or electronically as an electronic image that provides an exact image of the document that is clearly legible provided such offsite or electronic records are retrievable and made available for inspection or audit within 48 hours of a request by the board or an authorized agent.

b. Distribution and delivery records and required signatures may be generated or maintained electronically provided:

(1) The system being used has the capability of recording an electronic signature that is a unique identifier and restricted to the individual required to initial or sign the record.

(2) The records are maintained in a read-only format that cannot be altered after the information is recorded.

(3) The system used is capable of producing a hard-copy printout of the records upon request.

c. Schedule II-V distribution and delivery records may only be stored offsite or electronically as described in subdivisions 10 a and b of this section if authorized by DEA or in federal law or regulation.

d. Hard-copy distribution and administration records that are printed and reviewed in conducting required audits may be maintained at an off-site location or electronically provided they can be readily retrieved upon request; provided they are maintained in a read-only format that does not allow alteration of the records; and provided a separate log is maintained for a period of two years showing dates of audit and review, the identity of the automated dispensing device being audited, the time period covered by the audit and review, and the initials of all reviewers.

18VAC110-20-500. Licensed emergency medical services agencies program.

The pharmacy may prepare a drug kit for a licensed emergency medical services agency provided:

1. The PIC of the hospital pharmacy shall be responsible for all controlled prescription drugs contained in this drug kit. A pharmacist shall check each drug kit after filling the kit, and initial the filling record certifying the accuracy and integrity of the contents of the kit.

2. The drug kit is sealed in such a manner that it will preclude any possibility of deter theft or loss of drugs and aid in detection of such.

3. Drugs may be administered by an emergency medical technician upon an oral order or written standing order of an authorized medical practitioner in accordance with § 54.1-3408 of the Code of Virginia. Oral orders shall be reduced to writing by the technician and shall be signed by a medical practitioner. Written standing orders shall be signed by the operational medical director for the emergency medical services agency. The emergency medical technician shall make a record of all drugs administered to a patient. This administration record shall be signed by the medical practitioner who assumes responsibility for the patient at the hospital. If the patient is not transported to the hospital or if the attending medical practitioner at the hospital refuses to sign the record, a copy of this record shall be signed and placed in delivery to the hospital pharmacy who was responsible for that kit exchange by the agency's operational medical director within seven days of the administration.

4. When the drug kit has been opened, the kit shall be returned to the pharmacy and exchanged for an unopened kit. The record of the drugs administered shall accompany the opened kit when exchanged. An accurate record shall be maintained by the pharmacy on the exchange of the drug kit for a period of one year.

5. The record of the drugs administered shall be maintained as a part of the pharmacy records pursuant to state and federal regulations for a period of not less than two years.

6. Intravenous solutions provided by a hospital pharmacy to an emergency medical services agency may be stored separately outside the drug kit.

18VAC110-20-520. Drugs in long-term care facilities.

Drugs Prescription drugs, as defined in the Drug Control Act, shall not be floor stocked by a long-term care facility, except those in the stat drug box or emergency drug box or as provided for in 18VAC110-20-560 within this chapter.

Part XII
Pharmacy Services to Long-Term Care Facilities

18VAC110-20-530. Pharmacy's responsibilities to long-term care facilities.

The pharmacy serving a long-term care facility shall:

1. Receive a valid order prior to the dispensing of any drug.

2. Ensure that personnel administering the drugs are trained in using the dispensing system provided by the pharmacy.

3. Ensure that the drugs for each patient are kept and stored in the originally received containers and that the medication of one patient shall not be transferred to another patient.

4. Ensure that each cabinet, cart or other area utilized for the storage of drugs is locked and accessible only to authorized personnel.

5. Ensure that the storage area for patients drugs is well lighted, of sufficient size to permit storage without crowding, and is maintained at appropriate temperature.

6. Ensure that poison and drugs for "external use only" are kept in a cabinet and separate from other medications.

7. Provide for the disposition of discontinued drugs under the following conditions:

a. Discontinued drugs may be returned to the pharmacy for resale or transferred to another pharmacy for redispensing to the indigent if authorized by § 54.1-3411.1 and 18VAC110-20-400, or destroyed disposed of by appropriate means in compliance with 18VAC110-20-210 and with any applicable local, state, and federal laws and regulations.

b. Drug destruction at the pharmacy shall be witnessed by the PIC and by another pharmacy employee. The pharmacy may transfer the drugs for destruction to an entity appropriately licensed to accept returns for destruction. Drug destruction at the facility shall be witnessed by the director of nursing or, if there is no director, then by the facility administrator and by a pharmacist providing pharmacy services to the facility or by another employee authorized to administer medication.

c. A complete and accurate record of the drugs returned or destroyed or both shall be made. The original of the record of destruction shall be signed and dated by the persons witnessing the destruction and maintained at the long-term care facility for a period of two years. A copy of the destruction record shall be maintained at the provider pharmacy for a period of two years.

d. Long-term care facilities shall destroy discontinued or unused drugs or return them to the pharmacy without 30 days of the date the drug was discontinued.

8. Ensure that appropriate drug reference materials are available in the facility units.

9. Ensure that a monthly review of drug therapy by a pharmacist is conducted for each patient in long-term care facilities except those licensed under Title 63.2 of the Code of Virginia. Such review shall be used to determine any irregularities, which may include but not be limited to drug therapy, drug interactions, drug administration or transcription errors. The pharmacist shall sign and date the notation of the review. All significant irregularities shall be brought to the attention of the attending practitioner or other party having authority to correct the potential problem.

18VAC110-20-535. Repackaging of already dispensed prescriptions.

The primary provider pharmacy for a long-term care facility may, but shall not be required to, repackage a resident's prescription drugs dispensed by another pharmacy into the unit-dose or compliance packaging system used by the long-term care facility to assist in maintaining a uniform or more accurate system of administration.

1. Such repackaging shall only be done at the provider pharmacy.

2. Unit dose repackaging shall comply with requirements of 18VAC110-20-420 and compliance packaging shall comply with 18VAC110-20-340 B.

3. Records shall be maintained of all such repackaging of previously dispensed medications to include date; repackaging pharmacist's initials (or those of the checking pharmacist); and the pharmacy name, address, and prescription number of the original dispensing.

4. Any portion of a resident's medication not placed into unit dose or compliance packaging may be returned to the resident or kept for subsequent repackaging at the provider pharmacy in the original labeled container. If kept at the pharmacy, the medication shall be stored within the prescription department but separate from any working stock of drugs used for dispensing by the pharmacy, and shall only be used for the patient to whom the medication was originally dispensed.

18VAC110-20-536. Prescription drugs sent outside the facility.

A. The provider pharmacy shall assure that residents who leave a long-term care facility for short periods of time or are discharged and who are allowed to take dispensed prescription medications with them, do so only in appropriate packaging, properly labeled for outpatient use.

B. Pharmacies that provide medication to residents in compliance packaging that meets the requirements of 18VAC110-20-340 B, shall assure that if the facility separates and sends only the individual containers needed during the time the resident is away without the main package label, that the resident is also given a copy of the main package label or other appropriate documentation that contains the complete labeling information on the main package label.

18VAC110-20-540. Emergency drug kit.

The pharmacist providing services may prepare an emergency kit for a long-term care facility in which only those persons licensed to administer are administering drugs access to the kit is restricted to a licensed nurse, pharmacist, or prescriber and only these licensed individuals may administer a drug taken from the kit and only under the following conditions:

1. The contents of the emergency kit shall be of such a nature that the absence of the drugs would threaten the survival of the patients.

2. The contents of the kit shall be determined by the provider pharmacist in consultation with the medical and nursing staff of the institutions and shall be limited to drugs for administration by injection or inhalation only, except that Nitroglycerin SL may be included.

3. The kit is sealed in such a manner that it will preclude any possible loss of the drug.

a. The dispensing pharmacy must have a method of sealing such kits so that once the seal is broken, it cannot be reasonably resealed without the breach being detected.

b. If a seal is used, it shall have a unique numeric or alphanumeric identifier to preclude replication and/or resealing. The pharmacy shall maintain a record of the seal identifiers when placed on a box or kit and maintain the record until such time as the seal is replaced.

c. In lieu of seals, a kit with a built-in mechanism preventing resealing or relocking once opened except by the provider pharmacy is also acceptable.

4. The kit shall have a form to be filled out upon opening the kit and removing contents to write the name of the person opening the kit, the date, time and name and quantity of item(s) removed. The opened kit is maintained under secure conditions and returned to the pharmacy within 72 hours for replenishing.

5. Any drug used from the kit shall be covered by a prescription, signed by the prescriber, when legally required, within 72 hours.

18VAC110-20-550. Stat-drug box.

An additional drug box called a stat-drug box may be prepared by a pharmacy to provide for initiating therapy prior to the receipt of ordered drugs from the pharmacy. Access to the stat-drug box is restricted to a licensed nurse, pharmacist, or prescriber and only these licensed individuals may administer a drug taken from the stat-drug box. Additionally, a valid prescription or lawful order of a prescriber must exist prior to the removal of any drug from the stat-drug box. A stat-drug box shall be provided to those facilities in which only those persons licensed to administer are administering drugs and shall be subject to the following conditions:

1. The box is sealed in such a manner that will preclude the loss of drugs.

a. The dispensing pharmacy must have a method of sealing such boxes so that once the seal is broken, it cannot be reasonably resealed without the breach being detected.

b. If a seal is used, it shall have a unique numeric or alphanumeric identifier to preclude replication or resealing, or both. The pharmacy shall maintain a record of the seal identifiers when placed on a box and maintain the record until such time as the seal is replaced.

c. In lieu of seals, a box with a built-in mechanism preventing resealing or relocking once opened except by the provider pharmacy is also acceptable.

2. The box shall have a form to be filled out upon opening the box and removing contents to write the name of the person opening the box, the date, time and name and quantity of item(s) removed. When the stat-drug box has been opened, it is returned to the pharmacy.

3. Any drug used from the box shall be covered by a drug order signed by the prescriber, when legally required, within 72 hours.

4. 3. There shall be a listing of the contents of the box maintained in the pharmacy and also attached to the box in the facility. This same listing shall become a part of the policy and procedure manual of the facility served by the pharmacy.

5. 4. The drug listing on the box shall bear an expiration date for the box. The expiration date shall be the day on which the first drug in the box will expire.

6. 5. The contents of the box shall be limited to those drugs in which a delay in initiating therapy may result in harm to the patient.

a. The listing of drugs contained in the stat-drug box shall be determined by the provider pharmacist in consultation with the medical and nursing staff of the long-term care facility.

b. The stat-drug box shall contain no Schedule II drugs.

c. The stat-drug box shall contain no more than one Schedule III through V drug in each therapeutic class and no more than five doses of each.

18VAC110-20-555. Use of automated dispensing devices.

Nursing homes licensed pursuant to Chapter 5 (§32.1-123 et seq.) of Title 32.1 of the Code of Virginia may use automated drug dispensing systems, as defined in § 54.1-3401 of the Code of Virginia, upon meeting the following conditions:

1. Drugs placed in an automated drug dispensing system in a nursing home shall be under the control of the pharmacy providing services to the nursing home, the pharmacy shall have on-line communication with and control of the automated drug dispensing system, and access to any drug for a patient shall be controlled by the pharmacy.

2. A nursing home without an in-house pharmacy shall obtain a controlled substances registration prior to using an automated dispensing system.

3. Removal of drugs from any automated drug dispensing system for administration to patients can only be made pursuant to a valid prescription or lawful order of a prescriber. under the following conditions:

a. A drug may not be administered to a patient from an automated dispensing device until a pharmacist has reviewed the prescription order and electronically authorized the access of that drug for that particular patient in accordance with the order.

b. The PIC of the provider pharmacy shall ensure that a pharmacist who has on-line access to the system is available at all times to review a prescription order as needed and authorize administering pursuant to the order reviewed.

c. Drugs that would be stocked in an emergency drug kit pursuant to 18VAC110-20-540 may be accessed prior to receiving electronic authorization from the pharmacist provided that the absence of the drugs would threaten the survival of the patients.

d. Automated dispensing devices shall be capable of producing a hard-copy record of distribution that shall show patient name, drug name and strength, dose withdrawn, dose to be administered, date and time of withdrawal from the device, and identity of person withdrawing the drug.

4. Drugs placed in automated dispensing devices shall be in the manufacturer's sealed original unit dose or unit-of-use packaging or in repackaged unit-dose containers in compliance with the requirements of 18VAC110-20-355 relating to repackaging, labeling, and records.

5. Prior to the removal of drugs from the pharmacy, a delivery record shall be generated for all drugs to be placed in an automated dispensing device which shall include the date; drug name, dosage form, and strength; quantity; nursing home; a unique identifier for the specific device receiving drugs; and initials of the pharmacist checking the order of drugs to be removed from the pharmacy and the records of distribution for accuracy.

6. At the direction of the PIC, drugs may be loaded in the device by a pharmacist or a pharmacy technician adequately trained in the proper loading of the system.

7. At the time of loading, the delivery record for all Schedule II through V VI drugs shall be signed by a nurse or other person authorized to administer drugs from that specific device, and the record returned to the pharmacy and maintained in chronological order for a period of two years from date of delivery. The delivery record and required signatures may be generated or maintained electronically provided the system being used has the capability of recording an electronic "signature" which is a unique identifier and restricted to the individual receiving the drugs and provided that this record is maintained in a "read-only" format which cannot be altered after the information is recorded. The electronic record shall be readily retrievable, maintained for a period of two years, and the system used shall be capable of producing a hard copy printout of the record upon request.

8. At the time of loading any Schedule II through V drug, the person loading will verify that the count of that drug in the automated dispensing device is correct. Any discrepancy noted shall be recorded on the delivery record and immediately reported to the PIC, who shall be responsible for reconciliation of the discrepancy or the proper reporting of a loss.

9. The PIC of the provider pharmacy or his designee shall conduct at least a monthly audit to review distribution and administration of Schedule II through V drugs from each automated dispensing device as follows:

a. The audit shall reconcile records of all quantities of Schedule II through V drugs dispensed from the pharmacy with records of all quantities loaded into each device to detect whether any drugs recorded as removed from the pharmacy were diverted rather than being placed in the proper device.

b. A discrepancy report shall be generated for each discrepancy in the count of a drug on hand in the device. Each such report shall be resolved by the PIC or his designee within 72 hours of the time the discrepancy was discovered or, if determined to be a theft or an unusual loss of drugs, shall be immediately reported to the board in accordance with § 54.1-3404 E of the Drug Control Act.

c. The audit shall include a review of a sample of administration records from each device per month for possible diversion by fraudulent charting. A sample from each device shall not be less than 24 consecutive hours within the month being audited shall include all Schedule II-V drugs administered for a time period of not less than 24 consecutive hours during the audit period.

d. The audit shall include a check of medical records to ensure that a valid order exists for a random sample of doses recorded as administered.

e. The audit shall also check for compliance with written procedures for security and use of the automated dispensing devices, accuracy of distribution from the device, and proper recordkeeping.

f. The hard copy distribution and administration records printed out and reviewed in the audit shall be initialed and dated by the person conducting the audit and maintained in the pharmacy for a period of two years. If nonpharmacist personnel conduct the audit, a pharmacist shall review the record and shall initial and date the record. These distribution records reviewed in conducting the audit may be maintained electronically provided they can be readily retrieved upon request; provided they are maintained in a "read-only' format which does not allow alteration of the records; and provided a log is maintained for a period of two years showing the dates of audit and review, the identity of the automated dispensing device being audited, the time period covered by the audit and review, and the initials of all reviewers.

10. Automated dispensing devices shall be inspected monthly by pharmacy personnel to verify proper storage, proper location of drugs within the device, expiration dates, the security of drugs and validity of access codes.

11. Personnel allowed access to an automated dispensing device shall have a specific access code which records the identity of the person accessing the device.

12. The PIC of the pharmacy providing services to the nursing home shall establish, maintain, and assure compliance with written policy and procedure for the accurate stocking and proper storage of drugs in the automated drug dispensing system, accountability for and security of all drugs maintained in the automated drug dispensing system, preventing unauthorized access to the system, tracking access to the system, complying with federal and state regulations related to the storage and dispensing of controlled substances, maintaining patient confidentiality, maintaining required records, and assuring compliance with the requirements of this chapter. The manual shall be capable of being accessed at both the pharmacy and the nursing home.

13. All records required by this section shall be filed in chronological order from date of issue and maintained for a period of not less than two years. Records shall be maintained at the address of the pharmacy providing services to the nursing home except:

a. Manual Schedule VI distribution records may be maintained in offsite storage or electronically as an electronic image that provides an exact image of the document that is clearly legible provided such offsite or electronic storage is retrievable and made available for inspection or audit within 48 hours of a request by the board or an authorized agent.

b. Distribution and delivery records and required signatures may be generated or maintained electronically provided:

(1) The system being used has the capability of recording an electronic signature that is a unique identifier and restricted to the individual required to initial or sign the record.

(2) The records are maintained in a read-only format that cannot be altered after the information is recorded.

(3) The system used is capable of producing a hard-copy printout of the records upon request.

c. Schedule II-V distribution and delivery records may only be stored offsite or electronically as described in subdivisions 13 a and b of this section if authorized by DEA or in federal law or regulation.

d. Hard-copy distribution and administration records that are printed and reviewed in conducting required audits may be maintained off site or electronically provided they can be readily retrieved upon request; provided they are maintained in a read-only format that does not allow alteration of the records; and provided a separate log is maintained for a period of two years showing dates of audit and review, the identity of the automated dispensing device being audited, the time period covered by the audit and review, and the initials of all reviewers.

Part XIII
Other Institutions and Facilities

18VAC110-20-570. Drugs in infirmaries/first aid rooms.

A. Controlled Prescription drugs purchased by an institution, agency, or business within the Commonwealth, having been purchased in the name of a practitioner licensed by the Commonwealth of Virginia and who is employed by an institution, agency, or business which does not hold a pharmacy permit, shall be used only for administering to those persons at that institution, agency, or business.

B. All controlled prescription drugs shall be maintained and secured in a suitable locked storage area, the key to which will be in the possession of the practitioner or nurse who is under the direction and supervision of the practitioner.

C. Such institution, agency, or business shall adopt a specific protocol for the administration of prescription drugs, listing the inventory of such drugs maintained, and authorizing the administering of such drugs in the absence of a practitioner in an emergency situation when the timely prior verbal or written order of a prescriber is not possible. Administering of such drugs shall be followed by written orders.

1. For the purpose of this chapter, "emergency" means a circumstance requiring administration of controlled prescription drugs necessary to preserve life or to prevent significant or permanent injury or disability.

2. The protocol shall be maintained for inspection and documentation purposes.

D. A nurse may, in the absence of a practitioner, administer and provide nonprescription drugs in unit dose containers in quantities which in the professional judgment of the nurse will maintain the person at an optimal comfort level until the person's personal practitioner can be consulted. The administering and providing of such medication must be in accordance with explicit instructions of a specific protocol promulgated by the practitioner in charge of the institution, agency, or business.

18VAC110-20-580. Humane societies and animal shelters.

A humane society or animal shelter, after having obtained the proper permits pursuant to state and federal laws, may purchase, possess and administer any drug approved by the State Veterinarian to euthanize injured, sick, homeless and unwanted domestic pets and animals provided that these procedures are followed:

1. Drugs ordered by a humane society for euthanasia shall only be stored and administered at the address of the humane society. Humane societies shall not order or possess a stock of drugs for any purpose other than euthanasia.

1. 2. A veterinarian shall provide general supervision for the facility and shall provide and certify training in accordance with guidelines set forth by the State Veterinarian to the person(s) responsible for administration of the drugs. Certification of training signed by the veterinarian providing the training shall be maintained at the facility for each person administering drugs and must be retained for not less than two years after the person ceases administering.

2. 3. The person in charge of administration of drugs for euthanasia for the facility shall obtain the required permit and controlled substances registration from the board and shall be responsible for maintaining proper security and required records of all controlled substances obtained and administered.

a. If that person ceases employment with the facility or relinquishes his position, he shall immediately return the permit to the board and shall take a complete and accurate inventory of all drugs in stock.

b. An application for a new permit shall be filed with the required fee within 14 days on a form provided by the board. At that time, the new responsible person shall take a complete and accurate inventory of all drugs in stock.

3. 4. Drugs shall be stored in a secure, locked place and only the person(s) responsible for administering may have access to the drugs.

4. 5. Any drug used shall be obtained and administered in the injectable form only.

5. 6. All invoices and order forms shall be maintained for a period of two years.

6. 7. Complete and accurate records shall be maintained for two years on the administration of the drug. The record shall show the name and strength of the drug, date of administration, the species of the animal, the weight of animal, the amount of drug administered and the signature of the person administering the drug.

18VAC110-20-590. Drugs in correctional institutions facilities.

A. All prescription drugs at any correctional unit facility shall be obtained only on an individual prescription basis from a pharmacy and subject to the following conditions:

1. All prepared drugs shall be maintained in a suitable locked storage area with only the person responsible for administering the drugs having access.

2. Complete and accurate records shall be maintained of all drugs received, administered and discontinued. The administration record shall show the:

a. Patient name;

b. Drug name and strength;

c. Number of dosage units received;

d. Prescriber's name; and

e. Date, time and signature of the person administering the individual dose of drug.

3. All unused or discontinued drugs shall be sealed and the amount in the container at the time of the sealing shall be recorded on the drug administration record. Such drugs shall be returned to the provider pharmacy or to a secondary pharmacy along with the drug administration record, a copy of the drug administration record, or other form showing substantially the same information, within 30 days of discontinuance.

a. The provider or secondary pharmacy shall conduct random audits of returned drug administration records for accountability.

b. The drug administration records shall be filed in chronological order by the provider or secondary pharmacy and maintained for a period of one year or, at the option of the facility, the records may be returned by the pharmacy to the facility.

c. Drugs may be returned to pharmacy stock in compliance with the provisions of 18VAC110-20-400.

d. Other drugs shall be disposed of or destroyed by the provider pharmacy in accordance with local, state, and federal regulations.

4. Alternatively, drugs for destruction may be forwarded by a pharmacist directly from the correctional facility to a returns company after performing the audit required by subdivision 3 a of this subsection and ensuring the proper maintenance of the administration records.

B. Emergency and stat-drug box. An emergency box and a stat-drug box may be prepared for the a correctional facility served by the pharmacy pursuant to 18VAC110-20-540 and 18VAC110-20-550 provided that the facility employs one or more full-time physicians, registered nurses, licensed practical nurses, or physician assistants or correctional health assistants.

C. Prescription drugs, including but not limited to vaccines, may be stocked floor-stocked only at a medical clinic or surgery center that is part of a correctional facility and that is staffed by one or more physicians prescribers during the hours of operation, provided the clinic first obtains a controlled substances registration and complies with the requirements of 18VAC110-20-690, 18VAC110-20-700, 18VAC110-20-710, and 18VAC110-20-720.

18VAC110-20-610. Exempted chemical preparations.

The list of exempt chemical preparations set forth in pursuant to 21 CFR §1308.24 and maintained by the administrator of DEA is adopted pursuant to the authority set forth in §§ 54.1-3443, 54.1-3450 and 54.1-3452 of the Drug Control Act.

18VAC110-20-620. Exempted prescription products.

The list of exempt prescription products set forth in pursuant to 21 CFR 1308.32 and maintained by the administrator of DEA is adopted pursuant to the authority set forth in §§ 54.1-3443, 54.1-3450 and 54.1-3452 of the Drug Control Act; the exempted prescription products are drugs which are subject to the provisions of § 54.1-3455 of the Drug Control Act.

18VAC110-20-621. Exempted anabolic steroid products.

The list of exempt anabolic steroid products set forth in pursuant to 21 CFR 1308.34 and maintained by the administrator of DEA is adopted pursuant to the authority set forth in §§ 54.1-3443, 54.1-3450 and 54.1-3452 of the Drug Control Act; the exempted anabolic steroid products are drugs which are subject to the provisions of § 54.1-3455 of the Drug Control Act.

18VAC110-20-622. Excluded veterinary anabolic steroid implant products.

The list of excluded veterinary anabolic steroid implant products set forth in pursuant to 21 CFR 1308.26 and maintained by the administrator of DEA is adopted only for legitimate veterinary use pursuant to the authority set forth in §§ 54.1-3443, 54.1-3450 and 54.1-3452 of the Drug Control Act; the exempted anabolic steroid products are drugs which are subject to the provisions of § 54.1-3455 of the Drug Control Act when used for implant to cattle or other nonhuman species. These products are not excluded from Schedule III if prescribed, administered, dispensed, or otherwise distributed for human use.

18VAC110-20-680. Medical equipment suppliers.

A. A medical equipment supplier's location shall be inspected by the board prior to engaging in business. The location shall be clean and sanitary and shall have a system of temperature control to provide for specified storage conditions for any Schedule VI drug or device.

B. Hypodermic needles and syringes and Schedule VI drugs shall not be placed on open display or in an open area where patrons will have access to such items. No Schedule VI devices shall be placed in an area where responsible parties cannot exercise reasonable supervision and control.

C. A medical equipment supplier shall receive a valid order from a practitioner prior to dispensing and shall maintain this order on file on the premises for a period of two years from date of last dispensing. The original order may be kept at a centralized office as long as it is readily retrievable within 48 hours and a copy of the order is kept on the premises of the dispensing supplier. In lieu of a hard copy, an electronic image of an order may be maintained in an electronic database provided it preserves and provides an exact image of the order that is clearly legible and made available within 48 hours of a request by a person authorized by law to have access to prescription information.

D. Medical equipment suppliers shall make a record at the time of dispensing. This record shall be maintained on the premises for two years from date of dispensing and shall include:

1. Name and address of patient;

2. Item dispensed and quantity, if applicable; and

3. Date of dispensing.

Part XVI
Controlled Substances Registration for Other Persons or Entities

18VAC110-20-690. Persons or entities authorized or required to obtain a controlled substances registration.

A. A person or entity which maintains or intends to maintain a supply of Schedule II through Schedule VI controlled substances, other than manufacturers' samples, in order to administer such drugs in accordance with provisions of the Drug Control Act (§54.1-3400 et seq. of the Code of Virginia) may apply for a controlled substances registration on forms approved by the board.

B. Persons or entities which may be registered by the board shall include, but not be limited to, hospitals without in-house pharmacies, nursing homes without in-house pharmacies that use automated drug dispensing systems, ambulatory surgery centers, outpatient clinics, alternate delivery sites, and emergency medical services agencies provided such persons or entities are otherwise authorized by law and hold required licenses or appropriate credentials to administer the drugs for which the registration is being sought.

C. In determining whether to register an applicant, the board shall consider factors listed in subsections A and D of § 54.1-3423 of the Code of Virginia and compliance with applicable requirements of this chapter.

1. The proposed location shall be inspected by an authorized agent of the board prior to issuance of a controlled substances registration.

2. Controlled substances registration applications that indicate a requested inspection date, or requests that are received after the application is filed, shall be honored provided a 14-day notice is allowed prior to the requested inspection date.

3. Requested inspection dates that do not allow a 14-day notice to the board may be adjusted by the board to provide 14 days for the scheduling of the inspection.

4. Any person wishing to change an approved location of the drug stock, make structural changes to an existing approved drug storage location, or make changes to a previously approved security system shall file an application with the board and be inspected consistent with subsection B of this section.

5. Drugs shall not be stocked within the proposed drug storage location or moved to a new location until approval is granted by the board.

D. The application shall be signed by a person who will act as a responsible party for the controlled substances. The responsible party may be a prescriber, nurse, pharmacist, or pharmacy technician for alternate delivery sites or other person approved by the board who is authorized to administer or otherwise possess the controlled substances for that type entity.

D. E. The board may require a person or entity to obtain a controlled substances registration upon a determination that Schedule II through VI controlled substances have been obtained and are being used as common stock by multiple practitioners and that one or more of the following factors exist:

1. A federal, state, or local government agency has reported that the person or entity has made large purchases of controlled substances in comparison with other persons or entities in the same classification or category.

2. The person or entity has experienced a diversion, theft, or other unusual loss of controlled substances which requires reporting pursuant to § 54.1-3404 of the Drug Control Act.

3. The person or entity has failed to comply with recordkeeping requirements for controlled substances.

4. The person or entity or any other person with access to the common stock has violated any provision of federal, state, or local law or regulation relating to controlled substances.

18VAC110-20-700. Requirements for supervision for controlled substances registrants.

A. A practitioner licensed in Virginia shall provide supervision for all aspects of practice related to the maintenance and use of controlled substances as follows:

1. In a hospital or nursing home without an in-house pharmacy, a pharmacist shall supervise.

2. In an emergency medical services agency, the operational medical director shall supervise.

3. For any other person or entity approved by the board, a practitioner of pharmacy, medicine, osteopathy, podiatry, dentistry, or veterinary medicine type of applicant or registrant, a pharmacist or a prescriber whose scope of practice is consistent with the practice of the person or entity applicant or registrant and who is approved by the board shall may provide the required supervision.

B. The supervising practitioner shall approve the list of drugs which may be ordered by the holder of the controlled substances registration; possession of controlled substances by the entity shall be limited to such approved drugs. The list of drugs approved by the supervising practitioner shall be maintained at the address listed on the controlled substances registration.

C. Access to the controlled substances shall be limited to the supervising practitioner or to those persons who are authorized by the supervising practitioner and who are authorized by law to administer drugs in Virginia, or to other such persons as designated by the supervising practitioner or the responsible party to have access in an emergency situation. If approved by the supervising practitioner, pharmacy technicians may have access for the purpose of delivering controlled substances to the registrant, stocking controlled substances in automated dispensing devices, conducting inventories, audits and other recordkeeping requirements, and overseeing delivery of dispensed prescriptions at an alternate delivery site.

D. The supervising practitioner shall establish procedures for and provide training as necessary to ensure compliance with all requirements of law and regulation, including, but not limited to, storage, security, and recordkeeping.

E. Within 14 days of a change in the responsible party or supervising practitioner assigned to the registration, either the responsible party or outgoing responsible party shall inform the board and a new application shall be submitted indicating the name and license number, if applicable, of the new responsible party or supervising practitioner.

18VAC110-20-710. Requirements for storage and security for controlled substances registrants.

A. Drugs shall be stored under conditions which meet USP-NF specifications or manufacturers' suggested storage for each drug.

B. Any drug which has exceeded the expiration date shall not be administered; it shall be separated from the stock used for administration and maintained in a separate, locked area until properly disposed.

C. If a controlled substances registrant wishes to dispose of unwanted or expired Schedule II through VI drugs, he shall transfer the drugs to another person or entity authorized to possess and to provide for proper disposal of such drugs.

D. Drugs shall be maintained in a lockable cabinet, cart, device or other area which shall be locked at all times when not in use. The keys or access code shall be restricted to the supervising practitioner and persons designated access in accordance with 18VAC110-20-700 C.

E. In a facility not staffed 24 hours a day, the drugs shall be stored in a fixed and secured room, cabinet or area which has a security device for the detection of breaking which meets the following conditions:

1. The device shall be a sound, microwave, photoelectric, ultrasonic, or any other generally accepted and suitable device.

2. The installation shall be hard wired and both the installation and device shall be based on accepted burglar alarm industry standards.

3. The device shall be maintained in operating order and shall, have an auxiliary source of power, be monitored in accordance with accepted industry standards, be maintained in operating order; and shall be capable of sending an alarm signal to the monitoring entity if breached and the communication line is not operational.

4. The device shall fully protect all areas where prescription drugs are stored and shall be capable of detecting breaking by any means when activated.

5. Access to the alarm system shall be restricted to only designated and necessary persons, and the system shall be activated whenever the drug storage areas are closed for business.

6. An alarm system is not required for researchers, animal control officers, humane societies, or alternate delivery sites as provided in 18VAC110-20-275.