Title of Regulation: 4VAC20-290. Marking of Leased Oyster Planting Ground (amending 4VAC20-290-20, 4VAC20-290-30, 4VAC20-290-40, 4VAC20-290-50; adding 4VAC20-290-15, 4VAC20-290-45).

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

Effective Date: January 1, 2016.

Agency Contact: Jennifer Farmer, Regulatory Coordinator, Marine Resources Commission, 2600 Washington Avenue, 3rd Floor, Newport News, VA 23607, telephone (757) 247-2248 or email jennifer.farmer@mrc.virginia.gov.

Summary:

The amendments (i) add applicable definitions for marking oyster grounds; (ii) stipulate that proper marking shall be done to actively plant or harvest on grounds; (iii) update requirements for the markers and the manner in which markers shall be set, addressing active work areas as well as corner markers and boundary lines; and (iv) include maintenance and removal requirements and a provision for exceptions.

4VAC20-290-15. Definitions.

"Active work areas" means those areas inside a lease where active planting or active harvesting is being conducted, or in areas where aquaculture structures are placed within a lease.

"Aquaculture structures" means devices, such as cages, trays, and nets, used to contain or protect shellfish.

"Lease boundary lines" means the projected lines between lease corners.

"Lease corners" means boundary lease corners as depicted on the plat of record for the lease.

4VAC20-290-20. General.

Leased oyster planting ground shall can be marked by the lessee if the oyster planting ground is being worked at any time and shall be marked if the oyster planting ground is being actively planted or harvested or when aquaculture structures are present on the lease. No harvesting or planting of leased oyster planting ground shall occur unless the lessee first has properly designated and marked the lease in accordance with the provisions of this chapter. No active planting upon or harvesting from the lease shall be authorized unless the lease has first been properly marked and the lease corners identified in accordance with the marking provisions of this chapter. If aquaculture structures are deployed on leased oyster planting ground, the lessee must properly mark and identify the lease boundary or the active work areas where aquaculture structures are placed in accordance with the marking provisions of this chapter.

4VAC20-290-30. Method and manner of marking.

A. Marking requirements. When leased oyster planting ground is marked, it shall be marked with stakes or buoys so as to delineate accurately the boundary lines of the lease and prevent the corners and boundary lines or the active works areas within the lease shall be marked with markers or buoys and shall be marked in a manner that does not create any unnecessary restriction to navigation.

1. Corner markers. The corner of leased oyster planting ground shall be marked and multiple markers may be used in these corners Corners that are marked shall have a maximum of three markers per corner.

2. Boundary line markers. Under normal circumstances Individual line markers shall be set at intervals no more than 600 feet apart and may be placed at intervals no smaller less than 150 feet apart.

3. Active work area markers. Areas where aquaculture structures are being used shall be marked in conformance with subsection B of this section and as required in 4VAC20-335.

4. Marking of the corners, boundary lines, or active work areas within the lease shall constitute valid marking for enforcement purposes.

B. Description of markers.

1. Stakes shall be no longer than two inches in diameter at the mean low water line and shall extend at least four feet above the mean high water line. The stake shall be of such materials not so rigid as to harm a boat if accidentally struck. Bamboo, white oak, cedar, or gum saplings are commonly used, but not required. If polyvinyl chloride (PVC) pipe is used, and driven into the bottom, the diameter of the PVC pipe shall be two inches or less. When stakes are used for lease corner markers, lease boundary line markers, or active work area markers within a lease they shall have a diameter of no greater than two inches if solid and an inside diameter no greater than two inches if hollow, at and above the mean low water line, and shall extend at least four feet above the mean high water line, but no more than six feet above mean high water. The marker shall be made of such materials not so rigid as to harm a boat if accidently struck, such as PVC pipe, bamboo, white oak, cedar, or gum saplings. Metal pipe markers are prohibited.

2. Buoys shall be constructed of wood, PVC, or other suitable material, shall be no larger than six inches in diameter, and shall be anchored with sufficient weight to prevent their moving during adverse weather conditions. Buoys shall be constructed and anchored so as to extend at least four feet above the water line at all times. When can buoys are used they shall be constructed of suitable material, shall be no larger than six inches in diameter, and shall be anchored to the bottom with sufficient weight to prevent their moving during adverse weather conditions. Can buoys shall be constructed and anchored so as to extend at least four feet above, but not more than six feet above the water line at all times. When ball buoys are used they shall be constructed of suitable material, shall be no smaller than 45 inches in circumference, and shall be anchored to the bottom with sufficient weight to prevent their moving in adverse weather conditions.

3. Leased oyster grounds on which active shellfish propagation is occurring shall have a minimum of two placards constructed of durable material along at least two sides of the lease or active work area, and each placard shall be at least four feet above the mean high water line, depicting the initials of the leaseholder and shall conform to the dimensions established by the commissioner. No person shall dredge or scrape his oyster planting ground unless he is in conformance with § 28.2-517 of the Code of Virginia to include the marking requirements contained in that section. Oyster ground lease corner markers, boundary line markers, and active work area markers may be marked with two-inch white reflective tape, white reflective paint, or white fluorescent paint. If the lease is bisected or borders along a Virginia Department of Health, Division of Shellfish Sanitation shellfish area condemnation line, such line markers shall be marked with two-inch yellow reflective tape, yellow reflective paint, or yellow fluorescent paint.

4VAC20-290-40. Maintenance.

When oyster planting ground is marked, suitable stakes or markers shall be kept by the lessee in their proper places at all times so as to conform accurately to the original boundary survey any condemnation line within the lease, or to accurately mark the active work areas within the lease. Should such stakes or makers be removed, knocked down, or be carried away, the lessee shall replace them promptly have them replaced in their proper location and in conformance with the method and manner of marking contained within this chapter.

4VAC20-290-45. Removal of markers.

It shall be unlawful for any person to intentionally or knowingly injure, remove, or displace any boundary oyster stake, range monument, signal beacon, post, or buoy, or any part thereof, erected to designate, locate, survey, or map shellfish grounds other than the leaseholder, his agent, his employee, or commission staff.

4VAC20-290-50. Exception.

The Marine Resources Commission may require its chief engineer to describe a plan for the proper marking The chief engineer may approve an alternative plan for the proper marking of any designated oyster planting ground boundary or active work area upon request by the lessee when it he finds exceptional circumstances exist. In such a case the chief engineer shall direct the leaseholder where to place the appropriate markers.

Title of Regulation: 4VAC20-335. Pertaining to On-Bottom Shellfish Aquaculture Activities (amending 4VAC20-335-20, 4VAC20-335-30; adding 4VAC20-335-40).

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

Effective Date: January 1, 2016.

Agency Contact: Jennifer Farmer, Regulatory Coordinator, Marine Resources Commission, 2600 Washington Avenue, 3rd Floor, Newport News, VA 23607, telephone (757) 247-2248, or email jennifer.farmer@mrc.virginia.gov.

Summary:

The amendments (i) add the definition of "aquaculture structure," (i) provide marking requirements for the leaseholder of leased aquaculture grounds, and (iii) include the penalty for any violation of the chapter.

4VAC20-335-20. Definitions.

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

"Aquaculture structure" means devices, such as cages, trays, and nets, used to contain or protect shellfish.

"Commission" means the Marine Resources Commission.

"Shellfish" means native molluscan species or molluscan species imported in accordance with § 28.2-825 of the Code of Virginia.

4VAC20-335-30. Requirements and conditions.

A. The activity must be conducted on planting ground leased in accordance with Chapter 6 (§ 28.2-600 et seq.) of Title 28.2 of the Code of Virginia.

B. Leased planting ground must be properly marked in accordance with § 28.2-607 of the Code of Virginia and subsequent regulations (4VAC20-290-10 et seq.) 4VAC20-290.

C. In addition to the required marking of the boundary of the lease, the boundary of the area containing the structures Aquaculture structures shall be identified delineated with markers meeting the description for markers identified in 4VAC20-290-30 while structures are located on the bottom. The leaseholder shall also place a minimum of two placards, attached to boundary or corner markers, stating "aquaculture structures." Such placards shall be a minimum of 12 inches by 12 inches, constructed of a durable material, facing outward from the aquaculture structures, and shall be at least four feet above the mean high water line. The chief engineer may approve an alternate plan for marking aquaculture structures. In such a case the chief engineer shall direct or approve the appropriate markers.

D. Any structures placed on the bottom must be nontoxic and shall not be known to leach any materials which that would violate any water quality standards set by the Department of Environmental Quality.

E. Structures shall not extend higher than 12 inches above the bottom substrate.

F. No new structures shall be placed on existing stands of submerged aquatic vegetation.

G. No structures may cause more than a minimal adverse effect on navigation.

H. Shellfish must be harvested in accordance with all applicable laws and regulations.

I. The commission may direct removal of any structures which that fail to meet the requirements and conditions of this chapter.

4VAC20-335-40. Penalty.

As set forth in § 28.2-903 of the Code of Virginia, any person violating any provision of this chapter shall be guilty of a Class 3 misdemeanor, and a second or subsequent violation of any provision of this chapter committed by the same person within 12 months of a prior violation is a Class 1 misdemeanor.

Title of Regulation:4VAC25-35. Certification Requirements for Mineral Miners (amending 4VAC25-35-120).

Statutory Authority: § 45.1-161.292:19 of the Code of Virginia.

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: December 30, 2015.

Effective Date: January 15, 2016.

Agency Contact: Michael Skiffington, Regulatory Coordinator, Department of Mines, Minerals and Energy, 1100 Bank Street, 8th Floor, Richmond, VA 23219-3402, telephone (804) 692-3212, FAX (804) 692-3237, TTY (800) 828-1120, or email mike.skiffington@dmme.virginia.gov.

Basis: Section 45.1-161.292:19 of the Code of Virginia allows the Department of Mines, Minerals and Energy (DMME) to require certification of persons who work in mineral mines and to promulgate regulations necessary to the certification process.

Purpose: The purpose of this regulation is to allow coal miners to easily transition to other areas of the mining industry. Promoting economic development is one of the core functions of DMME, and increasing the number of certified mineral miners could help grow the mineral mine industry.

Rationale for Using Fast-Track Process: This rulemaking is noncontroversial because it removes unnecessary and duplicative barriers to certification. The training needed to safely work on a surface coal mine is virtually identical to the training needed to safely work on a mineral mine site. This regulatory action would give coal miners the opportunity to seamlessly obtain general mineral miner certification.

Substance: The only substantive change in this regulation allows for miners with a valid general coal miner surface certification to obtain general mineral miner certification without going through training they have already received.

Issues: The primary advantages to the Commonwealth are removing unnecessary and duplicative barriers to certification and allowing for employees in a depressed industry to more smoothly transition to another industry. There are no known disadvantages.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The Department of Mines, Minerals and Energy (DMME) proposes to amend this regulation to allow individuals who already possess a valid General Coal Miner Surface certification to obtain General Mineral Miner certification without having to receive additional training.

Result of Analysis. The benefits likely exceed the costs for all proposed changes.

Estimated Economic Impact. The current Certification Requirements for Mineral Miners require that applicants for General Mineral Miner certification "complete certification training in first aid and mineral mining regulations and law, which is conducted by a training instructor approved by the division, a certified MSHA¹ instructor, or a certified mine foreman." According to DMME, the training needed to safely work on a surface coal mine is virtually identical to the training needed to safely work on a mineral mine site. Individuals who already possess a valid General Coal Miner Surface certification would have had such training. Consequently DMME's proposal to specify that individuals who already have valid General Coal Miner Surface certification be deemed to have met the safety training requirements for General Mineral Miner certification will create a net benefit in that it will reduce the cost for surface coal miners to become certified general mineral miners without increasing safety risk. Specifically, the proposed amendment eliminates the need to spend approximately one work day on duplicative training.

Businesses and Entities Affected. The proposed amendment potentially affects the 441 mineral mine operators in the Commonwealth as it reduces the cost for surface coal miners to become certified mineral miners. There are currently 22,537 people with General Coal Miner Surface certification. Approximately 150 of the 441 existing mineral mine permits are held by small businesses.²

Localities Particularly Affected. The proposed amendment will potentially affect all localities in the Commonwealth that have mineral mines. According to DMME, 91% of Virginia's counties have mineral mines governed by state regulation.

Projected Impact on Employment. The proposed amendment will reduce the cost for certified surface coal miners to become certified mineral miners. This may moderately increase the number of experienced coal miners who gain employment at mineral mines.

Effects on the Use and Value of Private Property. The proposed amendment will moderately reduce training costs for mineral mine operators if they hire former surface coal miners. This may increase the likelihood that they hire former surface coal miners; and by having moderately lower costs for working mineral mines, the value of the property may moderately increase.

Real Estate Development Costs. The proposed amendment may moderately reduce mineral mine development costs in that it will reduce training costs for some potential mineral miners.

Small Businesses:

Definition. Pursuant to § 2.2-4007.04 of the Code of Virginia, small business is defined as "a business entity, including its affiliates, that (i) is independently owned and operated and (ii) employs fewer than 500 full-time employees or has gross annual sales of less than $6 million."

Costs and Other Effects. The proposed amendment reduces the cost for small mineral mine operators to hire certified surface coal miners.

Alternative Method that Minimizes Adverse Impact. The proposed amendment does not adversely affect small businesses.

Adverse Impacts:

Businesses: The proposed amendment does not adversely affect businesses.

Localities: The proposed amendment does not adversely affect localities.

Other Entities: The proposed amendment does not adversely affect other entities.

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¹MSHA refers to the federal Mine Safety and Health Administration.

²Data Source: Department of Mines, Minerals and Energy

Agency's Response to Economic Impact Analysis: The Department of Mines, Minerals and Energy concurs with the economic impact analysis conducted by the Department of Planning and Budget.

Summary:

The amendment allows an individual who possesses a valid general coal miner surface certification to obtain general mineral miner certification without having to receive additional training.

4VAC25-35-120. General mineral miner.

A. As set forth in § 45.1-161.292:28 of the Code of Virginia, miners commencing work after January 1, 1997, shall have a general mineral miner certification. Persons excluded from the general mineral miner certification are those involved in delivery, office work, maintenance, service and construction work, other than the extraction and processing of minerals, who are contracted by the mine operator. Hazard training as required by 30 CFR Part 46 or 30 CFR Part 48 shall be provided to these persons.

B. Applicants shall complete certification training in first aid and mineral mining regulations and law, which is conducted by a training instructor approved by the division, a certified MSHA instructor, or a certified mine foreman. Training shall include the following topics, subtopics and practical applications:

1. First aid training shall convey knowledge of first aid practices including identification of trauma symptoms, recognition and treatment of external and internal bleeding, shock, fractures, and exposure to extreme heat or cold. Training shall include a demonstration of skills or passing an examination, as evidenced by the instructor certification submitted in a form acceptable to the division.

2. Law and regulation training shall convey highlights of the mineral mine safety laws of Virginia and the safety and health regulations of Virginia. Specifically, information shall be provided on miner responsibilities and accountability, certification requirements, violations, penalties, appeals and reporting violations to the division. Training shall include a demonstration of skills or passing an examination, as evidenced by the instructor certification submitted in a form acceptable to the division.

C. The trainer will certify to the department that the training and demonstrations required by § 45.1-161.292:28 B of the Code of Virginia and this section have occurred.

D. Applicants who hold a valid first aid certificate as noted in 4VAC25-35-10 shall be considered to have met the first aid requirements.

E. Applicants who have completed training may commence work and shall be considered provisionally certified for up to 60 days from the date the instructor completes the training.

F. The instructor shall submit verification of certification in a form acceptable to the division and the $10 fee for each applicant who completes the training, together with a class roster of all persons who complete the training, within 30 days of the training date.

G. The mine operator shall maintain the following records for those miners required to obtain a general mineral miner certification and those who qualify for exemption, starting January 1, 1997:

1. The employee name, address, and phone number.

2. The job title, employment date and general mineral miner number if applicable.

3. The date training was completed and the instructor providing it for nonexempt employees.

4. If the employee is exempt from the requirements, the date they began working in the mineral mining industry in Virginia.

H. Applicants who already possess a valid general coal miner surface certification pursuant to 4VAC25-20 shall be deemed to have met the requirements of this section.

Title of Regulation: 8VAC20-90. Procedure for Adjusting Grievances (amending 8VAC20-90-10 through 8VAC20-90-40, 8VAC20-90-60, 8VAC20-90-70).

Statutory Authority: §§ 22.1-16 and 22.1-308 of the Code of Virginia.

Public Hearing Information:

January 28, 2016 - 11 a.m. - James Monroe Building, 101 North 14th Street, 22nd Floor Conference Room, Richmond, Virginia 23219. The public hearing will begin immediately following adjournment of the Board of Education business meeting.

Public Comment Deadline: January 31, 2016.

Agency Contact: Patty Pitts, Department of Education, P.O. Box 2120, Richmond, VA 23218, telephone (804) 371-2522, or email patty.pitts@doe.virginia.gov.

Basis: Section 4 of Article VIII of the Constitution of Virginia grants the Board of Education authority for the general supervision of the public school system, and § 22.1-16 of the Code of Virginia authorizes the board to promulgate such regulations as may be necessary to carry out its powers and duties and the provisions of Title 22.1 of the Code of Virginia.

Additional applicable sections of the Code of Virginia are §§ 2.2-507, 22.1-79, 22.1-253.13:5, 22.1-293, 22.1-294, 22.1-295, 22.1-298.1, 22.1-299, 22.1-302, 22.1-303, 22.1-304, 22.1-305, 22.1-305.1, 22.1-306, 22.1-307, 22.1-308, 22.1-309, 22.1-311, 22.1-313, and 22.1-314. These sections were amended by Chapters 588 and 650 of the 2013 Acts of Assembly.

Chapters 13 and 103 of the 2014 Acts of Assembly extended from five business days to 10 business days the deadline for a teacher to request a hearing after receiving written notice of dismissal. This new change became effective July 1, 2014, and notations of the revisions to the proposed 8VAC20-90-70 A 1 and 8VAC20-90-70 A 2 have been made.

Purpose: The Procedure for Adjusting Grievances is essential to protect the health, safety, or welfare of citizens as the regulations provide (i) an orderly procedure for resolving disputes concerning the application, interpretation, or violation of any of the provisions of local school board policies, rules, and regulations as they affect the work of teachers, other than dismissals or probation and (ii) an orderly procedure for the expeditious resolution of disputes involving the dismissal of any teacher.

Substance: The Procedure for Adjusting Grievances was last amended effective May 2, 2005. The 2013 General Assembly approved legislation resulting in the need to make revisions to the regulations. Other than changing the Procedure for Adjusting Grievances to comport with the 2013 and 2014 legislation, no additional substantive revisions were made. The major revisions to the regulations are (i) changing the grievance procedure for teachers by giving local school boards the option to assign a grievance hearing to be heard by an impartial hearing officer designated by the local school board, (ii) removing the option for a grievance to be heard before a fact-finding panel, (iii) removing "placing on probation" from the definition of "grievance," (iv) revising the Board of Education forms prescribed by the Code of Virginia, and (v) extending the time in which a teacher who received a Notice of Dismissal to request a hearing from five days to 10 days after receipt of the notice.

Issues: The regulations do not pose any major disadvantages to the public or the Commonwealth. The primary advantages of the proposed action are to align the regulations with the Code of Virginia, reducing confusion for teachers and the public about the procedure for adjusting grievances, and to provide flexibility in hearing the grievance at the local school division level. Proposed revisions to the regulations may reduce the cost of the procedure and allow for more efficient resolution.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. Pursuant to Chapter 588 of the 2013 Acts of Assembly and Chapter 103 of the 2014 Acts of Assembly, the Board of Education (Board) proposes to amend this regulation to reflect statutory changes. In particular, the proposed regulation will reflect: 1) the removal of teachers' option to have their grievance heard before a fact-finding panel,¹ 2) local school boards' new option to designate an impartial hearing officer from outside the school division to hear a teacher's grievance, 3) the elimination of probation as a form of discipline, and 4) the reduction of time in which a teacher who received a Notice of Dismissal has to request a hearing from 15 days to 10 days.

Result of Analysis. The benefits likely exceed the costs for all proposed changes to the regulation.²

Estimated Economic Impact. The proposed amendments to this regulation will make the regulation consistent with statutes and will not change effective law. Amending the regulation to reflect the law in effect will be beneficial in that it will reduce the likelihood that readers of the regulation (who do not also read the relevant statutes) will be misled as toward the actual law in effect.

Businesses and Entities Affected. The proposed amendments potentially affect the 132 public school divisions and boards in the Commonwealth, as well as the 152,301 individuals who hold an active Virginia teaching license.³

Localities Particularly Affected. The proposed amendments do not disproportionately affect particular localities.

Projected Impact on Employment. Amending this regulation to reflect statutory change does not significantly affect employment.

Effects on the Use and Value of Private Property. Amending this regulation to reflect statutory change does not significantly affect the use and value of private property.

Small Businesses: Costs and Other Effects. Amending this regulation to reflect statutory change does not affect small businesses.

Small Businesses: Alternative Method that Minimizes Adverse Impact. Amending this regulation to reflect statutory change does not adversely affect small businesses.

Real Estate Development Costs. Amending this regulation to reflect statutory change does not affect real estate development costs.

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¹The local school board formerly could also request a fact-finding panel.

²The analysis does not address the legislation.

³Data source: Department of Education

Agency's Response to Economic Impact Analysis: The agency concurs with the economic impact analysis completed by the Department of Planning and Budget. The agency will continue to examine the economic and administrative impact of the regulations as they progress through the regulatory process.

Summary:

The proposed amendments conform the regulation to changes in the Code of Virginia enacted by Chapters 588 and 650 of the 2013 Acts of Assembly and Chapters 13 and 103 of the 2014 Acts of Assembly and make other technical and clarifying changes. The proposed amendments (i) remove a teacher's option to have a grievance heard before a fact-finding panel, (ii) permit a local school board to designate an impartial hearing officer from outside the school division to hear a teacher's grievance, (iii) eliminate probation as a form of discipline, and (iv) reduce the time in which a teacher who received a notice of dismissal has to request a hearing to 10 days.

Part I
Definitions

8VAC20-90-10. Definitions.

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

"Business day" means, in accordance with § 22.1-312 of the Code of Virginia, any day that the relevant school board office is open.

"Days" means calendar days unless a different meaning is clearly expressed in this procedure. Whenever any period of time fixed by this procedure shall expire the last day for performing an act required by this procedure falls on a Saturday, Sunday, or legal holiday, the period of time for taking action under this procedure shall be extended to the act may be performed on the next day if it that is not a Saturday, Sunday, or legal holiday.

"Dismissal" means the dismissal of any teacher within the term of such teacher's contract and the nonrenewal of a contract of a teacher on a continuing contract.

"Grievance" means, for the purpose of Part II (8VAC20-90-20 et seq.), a complaint or a dispute by a teacher relating to his employment, including but not necessarily limited to the application or interpretation of personnel policies, rules and regulations, ordinances, and statutes; acts of reprisal as a result against a teacher for filing or processing a grievance, or participating as a witness in any step, meeting, or hearing related to a grievance; or complaints of discrimination on the basis of race, color, creed, political affiliation, handicap, age, national origin, or sex. "Grievance" means, for the purposes of Part III (8VAC20-90-60 et seq.), a complaint or a dispute involving a teacher relating to his employment involving dismissal or placing on probation. The term "grievance" shall not include a complaint or dispute by a teacher relating to the establishment and revision of wages or salaries, position classifications or general benefits; suspension of a teacher or nonrenewal of the contract of a teacher who has not achieved continuing contract status; the establishment or contents of ordinances, statutes or personnel policies, procedures, rules and regulations; failure to promote; or discharge, layoff, or suspension from duties because of decrease in enrollment, decrease in a particular subject, enrollment in or abolition of a particular subject, or insufficient funding; hiring, transfer, assignment and retention of teachers within the school division; suspension from duties in emergencies; or the methods, means and personnel by which the school division's operations are to be carried on; or coaching or extracurricular activity sponsorship. While these management rights are reserved to the school board, failure to apply, where applicable, these rules, regulations, policies, or procedures as written or established by the school board is grievable.

"Hearing officer" means an impartial hearing officer from outside the school division who possesses some knowledge and expertise in public education and education law and who is capable of presiding over an administrative hearing.

"Personnel file" means, for the purposes of Part III (8VAC20-90-60 et seq.), any and all memoranda, entries or other documents included in the teacher's file as maintained in the central school administration office or in any file regarding the teacher maintained within a school in which the teacher serves.

"Probation" means a period not to exceed one year during which time it shall be the duty of the teacher to remedy those deficiencies which give rise to the probationary status.

"Teacher" or "teachers" means, for the purposes of Part II (8VAC20-90-20 et seq.), all employees of the school division involved in classroom instruction and all other full-time employees of the school division except those employees classified as supervising employees. "Teacher" means, for the purposes of Part III (8VAC20-90-60 et seq.), all regularly certified licensed professional public school personnel employed by any school division under a written contract as provided by § 22.1-302 of the Code of Virginia, by any school division as a teacher or as an assistant principal, principal, or supervisor of classroom teachers but excluding all superintendents as provided by § 22.1-294 of the Code of Virginia.

"Shall file," "shall respond in writing," or "shall serve written notice" means the document is either delivered personally to the grievant or office of the proper school board representative or is mailed by registered or certified mail, return receipt requested, and postmarked within the time limits prescribed by this procedure to the grievant or office of the proper school board representative.

"Supervisory employee" means any person having authority in the interest of the board (i) to hire, transfer, suspend, layoff, recall, promote, discharge, assign, reward, or discipline other employees; and (ii) to direct other employees; or (iii) to adjust the grievance of other employees; or (iv) to recommend any action set forth in clause (i), (ii), or (iii) above; provided that the authority to act as set forth in clause (i), (ii), (iii), or (iv) requires the exercise of independent judgment and is not merely routine and clerical in nature.

"Written grievance appeal" means a written or typed statement describing the event or action complained of, or the date of the event or action complained of, and a concise description of those policies, procedures rules, regulations, ordinances or statutes upon which the teacher bases his claim. The grievant shall specify what he expects to obtain through use of the grievance procedure. A statement written grievance appeal shall be written upon on forms prescribed by the Board of Education and supplied by the local school board.

Part II
Grievance Procedure

8VAC20-90-20. Purpose of Part II of this grievance procedure.

The purpose of Part II of the Procedure for Adjusting Grievances is to provide an orderly procedure for resolving disputes concerning the application, interpretation, or violation of any of the provisions of local school board policies, rules and regulations as they affect the work of teachers, other than dismissals or probation. An equitable solution of grievances should be secured at the most immediate administrative level. The procedure should not be construed as limiting the right of any teacher to discuss any matter of concern with any member of the school administration, nor should the procedure be construed to restrict any teacher's right to seek, or the school division administration's right to provide, review of complaints that are not included within the definition of a grievance. Nothing in this procedure shall be interpreted to limit a school board's exclusive final authority over the management and operation of the school division.

8VAC20-90-30. Grievance procedure.

Recognizing that grievances should be begun begin and should be settled promptly, a grievance must be initiated within 15 business days following either the event giving rise to the grievance, or within 15 business days following the time when the employee knew or reasonably should have known of its occurrence. Grievances shall be processed as follows:

1. Step 1 -- Informal. The first step shall be an informal conference between the teacher and his immediate supervisor (which may be the principal). The teacher shall state the nature of the grievance, and the immediate supervisor shall attempt to adjust the grievance. It is mandatory that the teacher present the grievance informally prior to proceeding to Step 2.

2. Step 2 -- Principal. If for any reason the grievance is not resolved informally in Step 1 to the satisfaction of the teacher, the teacher must perfect his grievance by filing said grievance in writing a written grievance appeal on the required form within 15 business days following the event giving rise to the grievance, or within 15 business days following the time when the employee knew or reasonably should have known of its occurrence, specifying on the form the specific relief expected. Regardless of the outcome of Step 1, if a written grievance appeal is not, without just cause, filed within the specified time, the grievance will be barred.

A meeting shall be held between the principal (or his designee or both) and the teacher (or his designee or both) within five business days of the receipt by the principal of the written grievance. At such meeting the teacher or other party involved, or both, shall be entitled to present appropriate witnesses and to be accompanied by a representative other than an attorney. The principal (or his designee or both) shall respond in writing within five business days following such meeting.

The principal may forward to the teacher within five days from the receipt of the written grievance a written request for more specific information regarding the grievance. The teacher shall file an answer thereto within 10 business days, and the meeting must then be held within five business days thereafter.

3. Step 3 -- Superintendent. If the grievance is not settled to the teacher's satisfaction in Step 2, the teacher can proceed to Step 3 by filing a written notice of appeal with the superintendent, accompanied by the original written grievance appeal form within five business days after receipt of the Step 2 answer (or the due date of such answer). A meeting shall then be held between the superintendent (or his designee or both) and the teacher (or his designee or both) at a mutually agreeable time within five business days. The superintendent or designee may make a written request for more specific information from the teacher, but only if such information was not requested in Step 2. The teacher shall file an answer to such request within 10 business days, and the meeting shall be held within five business days of the date on which the answer was received. At such meeting both the superintendent and the teacher shall be entitled to present witnesses and to be accompanied by a representative who may be an attorney. A representative may examine, cross-examine, question, and present evidence on behalf of a grievant or the superintendent without violating the provisions of § 54.1- 3904 of the Code of Virginia. If no settlement can be reached in said meeting, the superintendent (or his designee) shall respond in writing within five business days following such meeting. The superintendent or designee may make a written request for more specific information from the teacher, but only if such was not requested in Step 2. Such request shall be answered within 10 business days, and the meeting shall be held within five business days of the date on which the answer was received. If the grievance is not resolved to the satisfaction of the teacher in Step 3, the teacher may elect to have a hearing by a fact-finding panel, as provided in Step 4, or after giving proper notice may request a decision by the school board pursuant to Step 5 4.

4. Step 4 -- Fact-finding panel. In the event the grievance is not settled upon completion of Step 3, either the teacher or the school board may elect to have a hearing by a fact-finding panel prior to a decision by the school board, as provided in Step 4. If the teacher elects to proceed to Step 4, he must notify the superintendent in writing of the intention to request a fact-finding panel and enclose a copy of the original grievance form within five business days after receipt of a Step 3 answer (or the due date of such answer). If the school board elects to proceed to a fact-finding panel, the superintendent must serve written notice of the board's intention upon the grievant within 15 business days after the answer provided by Step 3.

a. Panel. Within five business days after the receipt by the division superintendent of the request for a fact-finding panel, the teacher and the division superintendent shall each select one panel member from among the employees of the school division other than an individual involved in any previous phase of the grievance procedure as a supervisor, witness, or representative. The two panel members so selected shall within five business days of their selection select a third impartial panel member.

b. Selection of impartial third member. In the event that both panel members are unable to agree upon a third panel member within five business days, both members of the panel shall request the chief judge of the circuit court having jurisdiction of the school division to furnish a list of five qualified and impartial individuals from which one individual shall be selected by the two members of the panel to serve as the third member. The individuals named by the chief judge may reside either within or outside the jurisdiction of the circuit court, be residents of the Commonwealth of Virginia, and in all cases shall possess some knowledge and expertise in public education and education law and shall be deemed by the judge capable of presiding over an administrative hearing. Within five business days after receipt by the two panel members of the list of fact finders nominated by the chief judge, the panel members shall meet to select the third panel member. Selection shall be made by alternately deleting names from the list until only one remains. The panel member selected by the teacher shall make the first deletion. The third impartial panel member shall chair the panel. No elected official shall serve as a panel member. Panel members shall not be parties to, or witnesses to, the matter grieved. With the agreement of the teacher's and division superintendent's panel members, the impartial panel member shall have the authority to conduct the hearing and make recommendations as set forth herein while acting as a hearing officer.

The Attorney General shall represent personally or through one of his assistants any third impartial panel member who shall be made a defendant in any civil action arising out of any matter connected with his duties as a panel member. If, in the opinion of the Attorney General, it is impracticable or uneconomical for such legal representation to be rendered by him or one of his assistants, he may employ special counsel for this purpose, whose compensation shall be fixed by the Attorney General and be paid out of the funds appropriated for the administration of the Department of Education.

c. Holding of hearing. The hearing shall be held by the panel within 30 business days from the date of the selection of the final panel member. The panel shall set the date, place, and time for the hearing and shall so notify the division superintendent and the teacher. The teacher and the division superintendent each may have present at the hearing and be represented at all stages by a representative or legal counsel.

d. Procedure for fact-finding panel.

(1) The panel shall determine the propriety of attendance at the hearing of persons not having a direct interest in the hearing, provided that, at the request of the teacher, the hearing shall be private.

(2) The panel may ask, at the beginning of the hearing, for statements from the division superintendent and the teacher clarifying the issues involved.

(3) The parties shall then present their claims and evidence. Witnesses may be questioned by the panel members, the teacher and the division superintendent. The panel may, at its discretion, vary this procedure, but shall afford full and equal opportunity to all parties to present any material or relevant evidence and shall afford the parties the right of cross-examination.

(4) The parties shall produce such additional evidence as the panel may deem necessary to an understanding and determination of the dispute. The panel shall be the judge of the relevancy and materiality of the evidence offered. All evidence shall be taken in the presence of the panel and of the parties.

(5) Exhibits offered by the teacher of the division superintendent may be received in evidence by the panel and, when so received, shall be marked and made a part of the record.

(6) The facts found and recommendations made by the panel shall be arrived at by a majority vote of the panel members.

(7) The hearing may be reopened by the panel, on its own motion or upon application of the teacher or the division superintendent, for good cause shown, to hear after-discovered evidence at any time before the panel's report is made.

(8) The panel shall make a written report which shall include its findings of fact and recommendations, and shall file it with the members of the school board, the division superintendent, and the teacher, not later than 30 business days after the completion of the hearing.

(9) A stenographic record or tape recording of the proceedings shall be taken. However, in proceedings concerning grievances not related to dismissal or probation, the recording may be dispensed with entirely by mutual consent of the parties. In such proceedings, if the recording is not dispensed with the two parties shall share equally the cost of the recording. If either party requests a transcript, that party shall bear the expense of its preparation.

In cases of dismissal or probation, a record or recording of the proceedings shall be made and preserved for a period of six months. If either the teacher or the school board requests that a transcript of the record or recording be made at any time prior to expiration of the six-month period, it shall be made and copies shall be furnished to both parties. The school board shall bear the expense of the recording and the transcription.

(10) The recommendations and findings of fact of the panel submitted to the school board shall be based exclusively upon the evidence presented to the panel at the hearing. No panel member shall conduct an independent investigation involving the matter grieved.

e. Expenses.

(1) The teacher shall bear his own expenses. The school board shall bear the expenses of the division superintendent. The expenses of the panel shall be borne one half by the school board and one half by the teacher.

(2) The parties shall set the per diem rate of the panel. If the parties are unable to agree on the per diem, it shall be fixed by the chief judge of the circuit court. No employee of the school division shall receive such per diem for service on a panel during his normal business hours if he receives his normal salary for the period of such service.

(3) Witnesses who are employees of the school board shall be granted release time if the hearing is held during the school day. The hearing shall be held at the school in which most witnesses work, if feasible.

f. Right to further hearings. Following a hearing by a fact-finding panel, the teacher shall not have the right to a further hearing by the school board as provided in subdivision 5 c of this section. The school board shall have the right to require a further hearing in any grievance proceeding as provided in subdivision 5 c of this section.

5. 4. Step 5 4 -- Decision by the school board.

a. If a teacher elects to proceed directly to a determination before request a decision by the school board as provided for in Step 5 3, he must notify the superintendent in writing of the intention to appeal directly to make the request of the board, of the grievance alleged, and the relief sought within five business days after receipt of the answer as required in Step 3 or the due date thereof. Upon receipt of such notice, the school board may elect to have a hearing before a fact-finding panel, as indicated in Step 4, by filing a written notice of such intention with the teacher within 10 business days of the deadline for the teacher's request for a determination by the school board the board may hold a hearing on the grievance, may elect to have the hearing conducted by a hearing officer appointed by the school board consistent with the procedures in § 22.1-311 of the Code of Virginia, or may make its determination on the basis of the written evidence presented by the teacher and the recommendation of the superintendent.

b. In the case of a hearing before a fact-finding panel, the school board shall give the grievant its written decision within 30 days after the school board receives both the transcript of such hearing, if any, and the panel's finding of fact and recommendations unless the school board proceeds to a hearing under subdivision 5 c of this section. The decision of the school board shall be reached after considering the transcript, if any; the findings of fact and recommendations of the panel; and such further evidence as the school board may receive at any further hearing which the school board elects to conduct.

c. In any case in which a hearing before a fact-finding panel is held in accordance with Step 4, the local school board may conduct a further hearing before such school board.

(1) The local school board shall initiate such hearing by sending written notice of its intention to the teacher and the division superintendent within 10 days after receipt by the board of the findings of fact and recommendations of the fact-finding panel and any transcript of the panel hearing. Such notice shall be provided upon forms to be prescribed by the Board of Education and shall specify each matter to be inquired into by the school board.

(2) In any case where such further hearing is held by a school board after a hearing before the fact-finding panel, the school board shall consider at such further hearing the transcript, if any; the findings and recommendations of the fact-finding panel; and such further evidence including, but not limited to, the testimony of those witnesses who have previously testified before the fact-finding panel as the school board deems may be appropriate or as may be offered on behalf of the grievant or the administration.

(3) The further hearing before the school board shall be set within 30 days of the initiation of such hearing, and the teacher must be given at least 15 days written notice of the date, place, and time of the hearing.

b. In any case in which the school board elects to hold a hearing or elects to have a hearing officer conduct the hearing, the hearing shall be set within 30 days of the school board's receipt of the notice required by subdivision 4 a of this section (Step 4a), and the teacher must be given at least 15 days' written notice of the date, time, and place of the hearing.

The teacher and the division superintendent may be represented by legal counsel or other representatives. The hearing before the school board shall be private, unless the teacher requests a public hearing. The school board or the hearing officer, as the case may be, shall establish the rules for the conduct of any the hearing before it. Such rules shall include the opportunity for the teacher and the division superintendent to make an opening statement and to present all material or relevant evidence, including the testimony of witnesses and the right of all parties or their representatives to cross-examine the witnesses. Witnesses may be questioned by the school board or the hearing officer.

The In the case of a hearing conducted by the school board, the school board's attorney, assistants, or representative, if he, or they, represented a participant in the prior proceedings, the grievant, the grievant's attorney, or representative and, notwithstanding the provisions of § 22.1-69 of the Code of Virginia, the superintendent shall be excluded from any executive session of the school board which that has as its purpose reaching a decision on the grievance. However, immediately after a decision has been made and publicly announced, as in favor of or not in favor of the grievant, the school board's attorney or representative, and the superintendent, may join the school board in executive session to assist in the writing of the decision.

A stenographic record or tape recording of the proceedings hearing shall be taken. However, in proceedings concerning grievances not related to dismissal or probation, the recording may be dispensed with entirely by mutual consent of the parties. In such proceedings, if If the recording is not dispensed with, the two parties shall share the cost of the recording equally, and if either party requests a transcript, that party shall bear the expense of its preparation.

In the case of dismissal or probation, a record or recording of the proceedings shall be made and preserved for a period of six months. If either the teacher or the school board requests that a transcript of the record or recording be made at any time prior to the expiration of the six-month period, it shall be made and copies shall be furnished to both parties. The school board shall bear the expense of the recording and the transcription.

c. In the event of a hearing conducted by a hearing officer, the recommendation of the hearing officer shall be based exclusively upon the evidence presented at the hearing. Upon the hearing officer's own motion or upon application by either party to the grievance, the hearing officer may reopen the hearing for the purpose of hearing after-discovered evidence upon a finding of good cause by the hearing officer at any time before his recommendation is due. The hearing officer shall transmit his written recommendation and a record or recording of the hearing to the school board as soon as practicable and no more than 10 business days after the hearing.

d. In the event of a hearing by a hearing officer, the school board may make its decision upon the record or recording of such hearing or the school board may elect to conduct a further hearing to receive additional evidence. The school board must hold such further hearing as soon as practicable and must give written notice of the time and place of such further hearing to the division superintendent and the teacher within 10 business days after the board received the record or recording of the initial hearing. The notice must specify each matter to be inquired into by the school board. The school board shall determine the procedure to be followed at such further hearing.

e. In the event of a hearing before the school board, the school board shall give the teacher its written decision as soon as practicable and no more than 30 days after the hearing. The decision of the school board shall be reached after considering the evidence and information presented at the school board hearing.

f. In the event of a hearing before a hearing officer followed by a further hearing by the school board, the school board shall give the teacher its written decision as soon as practicable and no more than 30 days after such further hearing. The decision of the school board shall be reached after considering the record or recording of the initial hearing, the recommendations of the hearing officer, and the evidence and information presented at the further hearing before the school board.

g. In the event of a hearing before a hearing officer in cases in which no further hearing is conducted by the school board, the school board shall give the teacher its written decision as soon as practicable and no more than 30 days after receiving the record or recording of the hearing. The decision of the school board shall be reached after considering the record or recording of the hearing and the recommendations of the hearing officer.

(4) The decision of the school board shall be based solely on the transcript, if any; the findings of fact and recommendations of the fact-finding panel; and any evidence relevant to the issues of the original grievance procedure at the school board hearing in the presence of each party. The school board shall give the grievant its written decision within 30 days after the completion of the hearing before the school board. In the event the school board's decision is at variance with the recommendations of the fact-finding panel, the school board's written decision shall include the rationale for the decision.

d. In any case where a hearing before a fact-finding panel is not held, the board may hold a separate hearing or may make its determination on the basis of the written evidence presented by the teacher and the recommendation of the superintendent.

e. h. The school board shall retain its exclusive final authority over matters concerning employment and the supervision of its personnel.

8VAC20-90-40. Grievability.

A. Initial determination of grievability. Decisions regarding whether a matter is grievable shall be made by the school board at the request of the division superintendent administration or grievant and such decision shall be made within 10 business days of such request. The school board shall reach its decision only after allowing the division superintendent administration and the grievant opportunity to present written or oral arguments regarding grievability. The decision as to whether the arguments shall be written or oral shall be at the discretion of the school board. Decisions shall be made within 10 business days of such request. Such determination of grievability shall be made subsequent to the reduction of the grievance to writing but prior to any panel or board hearing by the board or a hearing officer, or the right to such determination shall be deemed to have been waived. Failure of the school board to make such a determination within such a prescribed 10-business-day period shall entitle the grievant to advance to the next step as if the matter were grievable.

B. Appeal of determination on grievability.

1. Decisions of the school board may be appealed to the circuit court having jurisdiction in the school division for a hearing on the issue of grievability.

a. Proceedings for a review of the decision of the school board shall be instituted by filing a notice of appeal with the school board within 10 business days after the date of the decision and giving a copy thereof to all other parties.

b. Within 10 business days thereafter, the school board shall transmit to the clerk of the court to which the appeal is taken, a copy of its decision, a copy of the notice of appeal, and the exhibits. The failure of the school board to transmit the record within the time allowed shall not prejudice the rights of the grievant. The court may, on motion of the grievant, issue a writ of certiorari requiring the school board to transmit the records on or before a certain date.

c. Within 10 business days of receipt by the clerk of such record, the court, sitting without a jury, shall hear the appeal on the record transmitted by the school board and such additional evidence as may be necessary to resolve any controversy as to the correctness of the record. The court may, in its discretion, receive such other evidence as the ends of justice require.

d. The court may affirm the decision of the school board or may reverse or modify the decision. The decision of the court shall be rendered not later than 15 days from the date of the conclusion of the court's hearing.

Part III
Procedure for Dismissals or Placing on Probation

8VAC20-90-60. Dispute resolution.

This Part III of the Procedure for Adjusting Grievances adopted by the Board of Education in accordance with the statutory mandate of Article 3 (§ 22.1-306 et seq.) of Chapter 15 of Title 22.1 of the Code of Virginia and the Standards of Quality for school divisions, Chapter 13.1 (§ 22.1-253.13:1 et seq.) of Title 22.1 of the Code of Virginia, is to provide an orderly procedure for the expeditious resolution of disputes involving the dismissal or placing on probation of any teacher.

8VAC20-90-70. Procedure for dismissals or placing on probation.

A. Notice to teacher of recommendation for dismissal or placing on probation.

1. In the event a division superintendent determines to recommend dismissal of any teacher, or the placing on probation of a teacher on continuing contract, written notice shall be sent to the teacher on forms to be prescribed by the Board of Education notifying him of the proposed dismissal, or placing on probation, and informing the teacher that within 15 10 business days after receiving the notice, the teacher may request a hearing before the school board, or before a fact-finding panel as hereinafter set forth or, at the option of the school board, a hearing officer appointed by the school board, as provided in § 22.1-311 of the Code of Virginia.

2. During such 15-day 10-business-day period and thereafter until a hearing is held in accordance with the provisions herein, if one is requested by the teacher, the merits of the recommendation of the division superintendent shall not be considered, discussed, or acted upon by the school board except as provided for herein.

3. At the request of the teacher, the superintendent shall provide the reasons for the recommendation in writing or, if the teacher prefers, in a personal interview. In the event a teacher requests a hearing pursuant to § 22.1-311 or § 22.1-312 of the Code of Virginia, the division superintendent shall provide, within 10 days of the request, the teacher, or his representative, with the opportunity to inspect and copy his personnel file and all other documents relied upon in reaching the decision to recommend dismissal or probation. Within 10 days of the request of the division superintendent, the teacher, or his representative, shall provide the division superintendent with the opportunity to inspect and copy the documents to be offered in rebuttal to the decision to recommend dismissal or probation. The division superintendent and the teacher or his representative shall be under a continuing duty to disclose and produce any additional documents identified later that may be used in the respective parties' cases-in-chief. The cost of copying such documents shall be paid by the requesting party.

4. Upon a timely request for a hearing, the school board or, at the school board's option, a hearing officer appointed by the school board shall set a hearing within 15 days of the request and the teacher shall be given at least five days' written notice of the time and the place of the hearing.

B. Fact-finding panel. Within 15 days after the teacher receives the notice referred to in subdivision A 1 of this section, either the teacher, or the school board, by written notice to the other party upon a form to be prescribed by the Board of Education, may elect to have a hearing before a fact-finding panel prior to any decision by the school board.

1. Panel. Within five business days after the receipt by the division superintendent of the request for a fact-finding panel, the teacher and the division superintendent shall each select one panel member from among the employees of the school division other than an individual involved in the recommendation of dismissal or placing on probation as a supervisor, witness, or representative. The two panel members so selected shall within five business days of their selection select a third impartial panel member.

2. Selection of impartial third member. In the event that both panel members are unable to agree upon a third panel member within five business days, both members of the panel shall request the chief judge of the circuit court having jurisdiction of the school division to furnish a list of five qualified and impartial individuals from which list one individual shall be selected by the two members of the panel as the third member. The individuals named by the chief judge may reside either within or without the jurisdiction of the circuit court, be residents of the Commonwealth of Virginia, and in all cases shall possess some knowledge and expertise in public education and education law, and shall be deemed by the judge capable of presiding over an administrative hearing. Within five business days after receipt by the two panel members of the list of fact finders nominated by the chief judge, the panel members shall meet to select the third panel member. Selection shall be made by the panel members alternately deleting names from the list until only one remains with the panel member selected by the teacher to make the first deletion. The third impartial panel member shall chair the panel. No elected official shall serve as a panel member. Panel members shall not be parties to, or witnesses to, the matter grieved. With the agreement of the teacher's and division superintendent's panel members, the impartial panel member shall have the authority to conduct the hearing and make recommendations as set forth herein while acting as a hearing officer.

The Attorney General shall represent personally or through one of his assistants any third impartial panel member who shall be made a defendant in any civil action arising out of any matter connected with his duties as a panel member. If, in the opinion of the Attorney General, it is impracticable or uneconomical for such legal representation to be rendered by him or one of his assistants, he may employ special counsel for this purpose, whose compensation shall be fixed by the Attorney General and be paid out of the funds appropriated for the administration of the Department of Education.

3. Holding of hearing. The hearing shall be held by the panel within 30 calendar days from the date of the selection of the final panel member. The panel shall set the date, place, and time for the hearing and shall so notify the division superintendent and the teacher. The teacher and the division superintendent each may have present at the hearing and be represented at all stages by legal counsel or another representative.

4. Procedure for fact-finding panel.

a. The panel shall determine the propriety of attendance at the hearing of persons not having a direct interest in the hearing, provided that, at the request of the teacher, the hearing shall be private.

b. The panel may ask, at the beginning of the hearing, for statements from the division superintendent and the teacher (or their representative) clarifying the issues involved.

c. The parties shall then present their claims and evidence. Witnesses may be questioned by the panel members, the teacher and the division superintendent,. However, the panel may, at its discretion, vary this procedure but shall afford full and equal opportunity to all parties for presentation of any material or relevant evidence and shall afford the parties the right of cross-examination.

B. Procedure for hearing.

1. The hearing shall be conducted by the school board or, at the school board's option, a hearing officer appointed by the school board. The teacher and the division superintendent may be represented by legal counsel or other representatives. The hearing shall be private, unless the teacher requests a public hearing. The school board or hearing officer, as the case may be, shall establish the rules for the conduct of the hearing, and such rules shall include the opportunity for the teacher and the division superintendent to make an opening statement and to present all material or relevant evidence, including the testimony of witnesses, and the right of all parties to cross-examine the witnesses. Witnesses may be questioned by the school board or hearing officer.

d. 2. The parties shall produce such additional evidence as the panel school board or hearing officer may deem necessary to an understanding and determination of the dispute. The panel school board or hearing officer shall be determine the judge of relevancy and materiality of the evidence offered. All evidence shall be taken in the presence of the panel school board or hearing officer and of the parties.

e. 3. Exhibits offered by the teacher or the division superintendent may be received in evidence by the panel school board or hearing officer and, when so received, shall be marked and made a part of the record.

f. The facts found and recommendations made by the panel shall be arrived at by a majority vote of the panel members.

g. The recommendations and findings of fact of the panel shall be based exclusively upon the evidence presented to the panel at the hearing. No panel member shall conduct an independent investigation involving the matter grieved.

h. The hearing may be reopened by the panel at any time before the panel's report is made upon its own motion or upon application of the teacher or the division superintendent for good cause shown to hear after-discovered evidence.

i. The panel shall make a written report which shall include its findings of fact and recommendations and shall file it with the members of the school board, the division superintendent and the teacher, not later than 30 days after the completion of the hearing.

j. A stenographic record or tape recording of the proceedings shall be taken. However, in proceedings concerning grievances not related to dismissal or probation, the recording may be dispensed with entirely by mutual consent of the parties. In such proceedings, if the recording is not dispensed with, the two parties shall share the cost of the recording equally; if either party requests a transcript, that party shall bear the expense of its preparation.

In cases of dismissal or probation, a record or recording of the proceedings shall be made and preserved for a period of six months. If either the teacher or the school board requests that a transcript of the record or recording be made at any time prior to expiration of the six-month period, it shall be made and copies shall be furnished to both parties. The school board shall bear the expense of the recording and the transcription.

5. Expenses.

a. The teacher shall bear his own expenses. The school board shall bear the expenses of the division superintendent. The expenses of the panel shall be borne one half by the school board and one half by the teacher.

b. The parties shall set the per diem rate of the panel. If the parties are unable to agree on the per diem, it shall be fixed by the chief judge of the circuit court. No employee of the school division shall receive such per diem for service on a panel during his normal business hours if he receives his normal salary for the period of such service.

6. Right to further hearing. If the school board elects to have a hearing by a fact-finding panel on the dismissal or placing on probation of a teacher, the teacher shall have the right to a further hearing by the school board as provided in subsection C of this section. The school board shall have the right to require a further hearing as provided in subsection C also.

7. Witnesses. Witnesses who are employees of the school board shall be granted release time if the hearing is held during the school day. The hearing shall be held at the school in which most witnesses work, if feasible.

C. Hearing by school board.

1. After receipt of the notice of pending dismissal or placing on probation described in subdivision A 1 of this section, the teacher may request a hearing before the school board by delivering written notice to the division superintendent within 15 days from the receipt of notice from the superintendent. Subsequent to the hearing by a fact-finding panel under subsection B of this section, the teacher, as permitted by subdivision B 6 of this section, or the school board may request a school board hearing by written notice to the opposing party and the division superintendent within 10 business days after the receipt by the party initiating such hearing of the findings of fact and recommendations made by the fact-finding panel and the transcript of the panel hearing. Such notice shall be provided upon a form to be prescribed by the Board of Education and shall specify each matter to be inquired into by the school board.

2. In any case in which a further hearing is held by a school board after a hearing before the fact-finding panel, the school board shall consider at such further hearing the record, or transcript, if any, the findings of fact and recommendations made by the fact-finding panel and such further evidence, including, but not limited to, the testimony of those witnesses who have previously testified before the fact-finding panel as the school board deems may be appropriate or as may be offered on behalf of the teacher or the superintendent.

3. The school board hearing shall be set and conducted within 30 days of the receipt of the teacher's notice or the giving by the school board of its notice. The teacher shall be given at least 15 days written notice of the date, place, and time of the hearing and such notice shall also be provided to the division superintendent.

4. The teacher and the division superintendent may be represented by legal counsel or other representatives. The hearing before the school board shall be private, unless the teacher requests a public hearing. The school board shall establish the rules for the conduct of any hearing before it, and such rules shall include the opportunity for the teacher and the division superintendent to make an opening statement and to present all material or relevant evidence including the testimony of witnesses and the right of all parties to cross-examine the witnesses. Witnesses may be questioned by the school board. The school board may hear a recommendation for dismissal and make a determination whether to make a recommendation to the Board of Education regarding the teacher's license at the same hearing or hold a separate hearing for each action.

5. A record or recording of the proceedings shall be made and preserved for a period of six months. If either the teacher or the school board requests that a transcript of the record or recording be made at any time prior to expiration of the six-month period, it shall be made and copies shall be furnished to both parties. The board shall bear the expense of the recording and the transcription.

6. The school board shall give the teacher its written decision within 30 days after the completion of the hearing before the school board.

7. The decision by the school board shall be based on the transcript, the findings of the fact and recommendations made by the fact-finding panel, and any evidence relevant to the issues of the original grievance produced at the school board hearing in the presence of each party.

The school board's attorney, assistants, or representative, if he or they represented a participant in the prior proceedings, the grievant, the grievant's attorney, or representative and, notwithstanding the provisions of § 22.1-69 of the Code of Virginia, the superintendent shall be excluded from any executive session of the school board which has as its purpose reaching a decision on a grievance. However, immediately after a decision has been made and publicly announced, as in favor of or not in favor of the grievant, the school board's attorney or representative and the superintendent may join the school board in executive session to assist in the writing of the decision.

4. A stenographic record or tape recording of the proceedings shall be taken. The two parties shall share the cost of the recording equally. The record or recording of the proceedings shall be preserved for a period of six months. If the school board requests that a transcript of the record or recording be made at any time prior to expiration of the six-month period, it shall be made and copies shall be furnished to both parties. The school board shall bear the expense of the transcription.

5. The teacher shall bear his own expenses. The school board shall bear the expenses of the division superintendent and the hearing officer.

6. Witnesses who are employees of the school board shall be granted release time if the hearing is held during the school day. The hearing shall be held at the school in which most witnesses work, if feasible.

7. In the event of a hearing conducted by a hearing officer, the recommendation of the hearing officer shall be based exclusively upon the evidence presented at the hearing. Upon the hearing officer's own motion or upon application by the teacher or the division superintendent, the hearing officer may reopen the hearing for the purpose of hearing after-discovered evidence upon a finding of good cause by the hearing officer at any time before his recommendation is due. The hearing officer shall transmit his written recommendation and a record or recording of the hearing to the school board as soon as practicable and no more than 10 business days after the hearing.

8. In the event of a hearing by a hearing officer, the school board may make its decision upon the record or recording of such hearing or the school board may elect to conduct a further hearing to receive additional evidence. The school board must hold such further hearing as soon as practicable and must give written notice of the time and place of such further hearing to the division superintendent and the teacher within 10 business days after the board received the record or recording of the initial hearing. The notice must specify each matter to be inquired into by the school board. The school board shall determine the procedure to be followed at such further hearing.

D. C. School board determination.

1. In any case in which a hearing is held before a fact-finding panel but no further hearing before the school board is requested by either party, the school board shall give the teacher its written decision within 30 days after the school board receives both the transcript of such hearing and the panel's findings of the fact and recommendation. The decision of the school board shall be reached after considering the transcript, the findings of fact, and the recommendations made by the panel. In the event of a hearing before the school board, the school board shall give the teacher its written decision as soon as practicable and no more than 30 days after the hearing. The decision of the school board shall be reached after considering the evidence and information presented at the school board hearing.

2. In the event of a hearing before a hearing officer followed by a further hearing by the school board pursuant to subdivision B 8 of this section, the school board shall give the teacher its written decision as soon as practicable and no more than 30 days after such further hearing. The decision of the school board shall be reached after considering the record or recording of the initial hearing, the recommendations of the hearing officer, and the evidence and information presented at the further hearing before the school board.

3. In the event of a hearing before a hearing officer in cases in which no further hearing is conducted by the school board, the school board shall give the teacher its written decision as soon as practicable and no more than 30 days after receiving the record or recording of the hearing. The decision of the school board shall be reached after considering the record or recording of the hearing and the recommendations of the hearing officer.

2. 4. The school board may dismiss, or suspend, or place on probation a teacher upon a majority vote of a quorum of the school board. In the event the school board's decision is at variance with the recommendation of the fact-finding panel, the school board shall be required to conduct an additional hearing, which shall be public unless the teacher requests a private one. However, if the fact-finding hearing was held in private, the additional hearing shall be held in private. The hearing shall be conducted by the school board pursuant to subdivisions C 1 and 2 of this section, except that the grievant and the division superintendent shall be allowed to appear, to be represented, and to give testimony. However, the additional hearing shall not include examination and cross-examination of any other witnesses. The school board's written decision shall include the rationale for the decision. The school board's attorney, assistants, or representative, if he or they represented a participant in the prior proceedings; the grievant; the grievant's attorney or representative; and, notwithstanding the provisions of § 22.1-69 of the Code of Virginia, the superintendent shall be excluded from any executive session of the school board that has as its purpose reaching a decision on a grievance. However, immediately after a decision has been made and publicly announced, as in favor of or not in favor of the grievant, the school board's attorney or representative and the superintendent may join the school board in executive session to assist in the writing of the decision.

FORMS (8VAC20-90)

Statement of Grievance, eff. 2/05

Principal's Decision, eff. 2/05

Superintendent's Level, eff. 2/05

Request for Hearing (Decision to be Presented to Grievant), eff. 2/05

Notice of Proposed Dismissal or Proposed Placing on Probation, eff. 2/05

Request for Hearing (to be submitted to Superintendent), eff. 2/05.

Statement of Grievance (undated, filed 11/2015)

Principal's Decision (undated, filed 11/2015)

Superintendent's Decision (undated, filed 11/2015)

Request for Hearing (undated, filed 11/2015)

Notice of Proposed Dismissal (undated, filed 11/2015)

Title of Regulation: 9VAC5-40. Existing Stationary Sources (Rev. C09) (amending 9VAC5-40-7800; adding 9VAC5-40-8380 through 9VAC5-40-8480).

Statutory Authority: § 10.1-1308 of the Code of Virginia; §§ 110, 111, 123, 129, 171, 172, and 182 of the federal Clean Air Act (40 CFR Parts 51 and 60).

Effective Date: February 1, 2016.

Agency Contact: Gary Graham, Department of Environmental Quality, 629 East Main Street, P.O. Box 1105, Richmond, VA 23218, telephone (804) 698-4103, FAX (804) 698-4510, or email gary.graham@deq.virginia.gov.

Summary:

The regulation requires owners to limit emissions from offset lithographic printing operations and letterpress printing operations to the level necessary for the protection of public health and welfare and the attainment and maintenance of the air quality standards. The regulation applies to sources within the Northern Virginia Volatile Organic Compound Emissions Control Area and establishes standards, control techniques, and provisions for determining compliance. The regulation also includes provisions for visible emissions, fugitive dust, odor, toxic pollutants, compliance, test methods and procedures, monitoring, notification, registration, malfunctions, and permits.

Changes since publication of the proposed regulation include revising the conditions under which performance testing would be conducted, adding default retention factors and capture efficiencies, adding a provision to allow an exemption of a certain amount of cleaning materials, and correcting definitions and standards to conform to the new control techniques guidelines.

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.

Article 53
Emission Standards for Lithographic Printing Processes (Rule 4-53)

9VAC5-40-7800. Applicability and designation of affected facility.

A. Except as provided in subsections C, D, and E of this section, the affected facility to which the provisions of this article apply is each lithographic printing process which that uses a substrate other than a textile.

B. The provisions of this article apply only to sources of volatile organic compounds in volatile organic compound emissions control areas designated in 9VAC5-20-206.

C. Exempted from the provisions of this article are facilities offset lithographic printing operations in the Northern Virginia Volatile Organic Compound Emissions Control Area whose potential to emit is less than 10 tons per year of volatile organic compounds, provided the emission rates are determined in a manner acceptable to the board. All volatile organic compound emissions from printing inks, coatings, cleaning solutions, and fountain solutions shall be considered in applying the exemption levels specified in this subsection. Provisions applicable to offset lithographic printing operations in the Northern Virginia Volatile Organic Compound Emissions Control Area are provided in Article 56.1 [ of this part ] (9VAC5-40-8420 et seq.) [ of this part ].

D. Exempted from the provisions of this article are facilities in all volatile organic compound emissions control areas, other than the Northern Virginia Volatile Organic Compound Emissions Control Area, whose potential to emit is less than 100 tons per year of volatile organic compounds, provided the emission rates are determined in a manner acceptable to the board. All volatile organic compound emissions from printing inks, coatings, cleaning solutions, and fountain solutions shall be considered in applying the exemption levels specified in this subsection.

E. The provisions of this article do not apply to the following:

1. Printing processes used exclusively for determination of product quality and commercial acceptance provided:

a. The operation is not an integral part of the production process;

b. The emissions from all product quality printing processes do not exceed 400 pounds in any 30-day period; and

c. The exemption is approved by the board.

2. Photoprocessing, typesetting, or imagesetting equipment using water-based chemistry to develop silver halide images.

3. Platemaking equipment using water-based chemistry to remove unhardened image-producing material from an exposed plate.

4. Equipment used to make blueprints.

5. Any sheet-fed offset lithographic press with a cylinder width of 26 inches or less.

Article 56
Emission Standards for Letterpress Printing Operations in the Northern Virginia Volatile Organic Compound Emissions Control Area, 8-hour Ozone Standard (Rule 4-56)

9VAC5-40-8380. Applicability and designation of affected facility.

A. The affected facility to which the provisions of this article apply is any letterpress printing operation at a stationary source where the actual emissions of volatile organic compounds (VOCs) from all aspects of letterpress printing operations, including related cleaning activities, before the consideration of controls, are equal to or exceed 3.0 tons per 12-month rolling period.

B. The provisions of this article apply only to sources of VOCs located in the Northern Virginia VOC Emissions Control Area designated in subdivision 1 a of 9VAC5-20-206.

9VAC5-40-8382. Definitions.

A. For the purpose of applying this article in the context of the regulations for the control and abatement of air pollution and related uses, the words or terms shall have the meanings given them in subsection C of this section.

B. Unless otherwise required by context, all terms not defined in this section shall have the meanings given them in 9VAC5-170 (Regulation for General Administration), 9VAC5-10 (General Definitions), or commonly ascribed to them by recognized authorities, in that order of priority.

C. Terms defined.

"Cleaning materials" means any washes, cleaners, solvents, or rejuvenators that are used to remove excess printing inks, oils, and residual paper from a press, press equipment, or press parts, or used to remove dried ink from areas around a press. Cleaning materials include solvents and cleaners used for manual cleaning, and cleaning solutions used by automatic cleaning systems such as roller wash and type wash. Cleaning materials do not include cleaners used for cleaning electronic components of a press, pre-press cleaning operations (e.g., platemaking), post-press cleaning operations (e.g., binding), cleaning supplies such as detergents used to clean the floor (other than to remove dried ink from areas around a press), and cleaning performed in parts washers and cold cleaners subject to Article 47 (9VAC5-40-6820 et seq.) of Part II of 9VAC5-40 (Existing Stationary Sources).

"Composite partial vapor pressure" means the sum of the partial pressures of the compounds defined as volatile organic compounds. Composite partial vapor pressure is calculated as follows:

where:

"First installation date" means the date that a control device is first installed for the purpose of controlling emissions. The first installation date does not change if the control device is later moved to a new location or installed on a different press.

"Heatset" means a printing process in which heat from a dryer is used to evaporate ink oils from the substrate.

"Letterpress printing" means a printing process in which the image area is raised relative to the nonimage area and paste ink is transferred to the substrate directly from the image surface.

"Letterpress printing operation" means one or more [ letterpress ] printing processes employing letterpress printing on [ letterpress ] printing presses and the related processes necessary to directly support the operation of those presses including, but not limited to, cleaning, pre-press, and post-press operations.

"Non-heatset" means a printing process in which the printing inks are set and dried by absorption or oxidation rather than heat. For the purposes of this article, UV-cured and electron beam-cured inks are considered non-heatset.

"Press" means a printing production assembly composed of one or more units to produce a printed substrate (sheet or web).

"Printing" means a photomechanical process in which a transfer of text, designs, and images occurs through contact of an image carrier with a substrate.

"Printing process" means any operation or system wherein printing ink or a combination of printing ink and surface coating is applied, dried, or cured and that is subject to the same emission standard. A printing process may include any equipment that applies, conveys, dries, or cures inks or surface coatings, including, but not limited to, flow coaters, flashoff areas, [ air presses, digital output devices, heaters, ] dryers, drying areas, and ovens.

"Sheet-fed" means a printing process in which individual sheets of substrate are fed into the press sequentially.

"Theoretical potential to emit" means for the purposes of this article the maximum capacity of a letterpress printing process to emit VOC and shall be based on emissions at design capacity or maximum production and maximum operating hours (8,760 hours/year) before add-on controls, unless the [ heatset web offset lithographic letterpress ] printing process is subject to state and federally enforceable permit conditions that limit production rates or hours of operation.

"12-month rolling period" means a period that is determined monthly and consists of the previous 12 consecutive calendar months.

"Unit" means [ , for the purposes of this article, ] the smallest complete printing component, composed of an inking [ and dampening ] system, of a [ letterpress ] printing press.

"VOC" means volatile organic compound.

"Web" means a continuous roll of printing substrate.

9VAC5-40-8384. Standard for volatile organic compounds.

A. No owner or other person shall use or permit the use of any letterpress printing press, letterpress printing process, or other letterpress printing operation that is subject to this article unless that press, process, or operation meets the requirements of this section.

B. The following provisions apply to each dryer on each heatset web letterpress printing process, except that these provisions do not apply to (i) any heatset web letterpress printing process with a theoretical potential to emit less than 25 tons per year of VOC [ (petroleum ink oil) ] from the dryer, prior to controls; (ii) any heatset web letterpress printing process used exclusively for book printing; or (iii) any heatset web letterpress printing process with a maximum web width of 22 inches or less. These provisions also do not apply to non-heatset web letterpress printing processes or to sheet-fed letterpress printing processes.

1. VOC emissions from the heatset web letterpress printing process dryer shall be controlled as follows:

a. The dryer shall operate at a lower air pressure than the pressroom air pressure at all times when the printing process is operating;

b. Exhaust air from the dryer shall be collected and sent to a control device that operates at all times when the printing process is operating.

c. For a control device whose first installation date is prior to [ (insert effective date of this article) February 1, 2016 ], the control device shall reduce VOC emissions in the dryer air exhaust by at least 90%.

d. For a control device whose first installation date is on or after [ (insert effective date of this article) February 1, 2016 ], the control device shall reduce VOC emissions in the dryer air exhaust by at least 95%.

2. Where the heatset web letterpress printing process control device inlet VOC concentration is too low to achieve the control device efficiency requirements specified in subdivisions 1 c and 1 d of this subsection or there is no identifiable measurable inlet, the control device shall reduce the VOC concentration of the heatset web letterpress printing process dryer exhaust air to 20 parts per million volume (ppmv) or less, as hexane on a dry basis.

3. Federally enforceable limitations on (i) the VOC [ (petroleum ink oil) ] content of inks and coatings applied [ prior to the dryer ], (ii) the total amounts of inks and coatings applied, (iii) the press application rates of inks and coatings, or (iv) the hours of press operation may be used to meet the 25 ton per year exception to this subsection.

C. Cleaning materials used at each letterpress printing operation shall meet one of the following limits, as applied [ , except that 110 gallons of cleaning materials that meet neither limit may be used per 12-month rolling period ]:

1. A VOC content of 70% by weight; or

2. A composite vapor pressure of 10 mm Hg at 20°C.

[ The use of cleaning materials not meeting the limits in subdivision 1 or 2 of this subsection is permitted provided that the quantity of cleaning material used does not exceed 110 gallons over any 12-month rolling period. ]

D. The following work practices shall be implemented:

1. Cleaning materials, inks, and coatings containing VOCs shall be kept in closed containers at all times unless filling, draining, or performing cleaning operations.

2. Shop towels, sponges, and other manual cleaning aids (i) that have been used for picking up excess ink and other coatings containing VOCs or (ii) that have been used with cleaning materials containing VOCs shall be kept in closed containers.

3. Spills of cleaning materials, fountain solution, inks, varnishes, and other coatings containing VOCs shall be minimized and shall be cleaned up promptly.

9VAC5-40-8386. Standard for visible emissions.

The provisions of Article 1 (9VAC5-40-60 et seq.) of Part II of 9VAC5-40 (Existing Stationary Sources) apply.

9VAC5-40-8388. Standard for fugitive dust/emissions.

The provisions of Article 1 (9VAC5-40-60 et seq.) of Part II of 9VAC5-40 (Existing Stationary Sources) apply.

9VAC5-40-8390. Standard for odor.

The provisions of Article 2 (9VAC5-40-130 et seq.) of Part II of 9VAC5-40 (Existing Stationary Sources) apply.

9VAC5-40-8394. Standard for toxic pollutants.

The provisions of Article 4 (9VAC5-60-200 et seq.) of Part II of 9VAC5-60 (Hazardous Air Pollutant Sources) apply.

9VAC5-40-8396. Compliance.

A. The provisions of 9VAC5-40-20 (Compliance) apply.

B. [ An If requested by the board, an ] emission test of the control device installed on a heatset web letterpress printing process dryer shall be performed to demonstrate compliance with the provisions of 9VAC5-40-8384 B [ and 9VAC5-40-8398 ]. The negative dryer pressure shall be established during the initial test using an airflow direction indicator, such as a smoke stick or aluminum ribbons, or a differential pressure gauge. [ The board may accept the results of an emission test conducted prior to February 1, 2016, if the owner or operator provides information and data that demonstrate that the test demonstrated compliance with the provisions of 9VAC5-40-8384 B. ]

C. [ Once initial compliance has been demonstrated with the heatset web letterpress printing process dryer control requirements of 9VAC5-40-8384 B through performance testing of an catalytic or thermal oxidation control device, continuing Continuing ] compliance with the heatset web letterpress printing process dryer control requirements in 9VAC5-40-8384 B shall be demonstrated for the catalytic or thermal oxidation control device by monitoring the control device in accordance with 9VAC5-40-8410 B. The owner shall maintain the [ 3-hour three-hour ] average of the monitored temperature at a temperature no less than 50°F below the [ 3-hour three-hour ] average temperature that was recorded during the most recent performance test during which compliance was demonstrated. [ In the absence of performance test results acceptable to the board that provide dryer control device temperatures that demonstrate continuing compliance with the requirements in 9VAC5-40-8384 B, control device temperatures that demonstrate compliance with manufacturer recommendations may be considered by the board to demonstrate compliance with heatset web offset letterpress printing process dryer control requirements in 9VAC5-40-8384 B.

D. A portion of the volatile organic compounds contained in inks and cleaning solution is retained in the printed web and in the shop towels used for cleaning. When applicable, the following retention factors may be used in determining volatile organic compounds emissions from letterpress printing operations:

1. A 20% volatile organic compound retention factor may be used for petroleum ink oils contained in heatset inks that are printed on absorptive substrates, meaning that 80% of the VOC (petroleum ink oil) in the ink is emitted during the printing process and is available for capture and control by an add-on pollution control device.

2. A 100% volatile organic compound retention factor may be used for vegetable ink oils contained in heatset inks that are printed on absorptive substrates, meaning that none of the VOC (vegetable ink oil) in the ink is emitted during the printing process and available for capture and control by an add-on pollution control device.

3. A 95% volatile organic compound retention factor may be used for petroleum ink oils contained in sheet-fed and non-heatset web inks printed on absorptive substrates, meaning that 5.0% of the VOC (petroleum ink oil) in the ink is emitted during the printing process.

4. A 100% volatile organic compound retention factor may be used for vegetable ink oils contained in sheet-fed and non-heatset web inks printed on absorptive substrates, meaning that none of the VOC (vegetable ink oil) in the ink is emitted during the printing process.

5. A 50% volatile organic compound retention factor may be used for cleaning solution VOC in shop towels for those cleaning solutions with a volatile organic compounds composite vapor pressure of no more than 10 millimeters of mercury (Hg) at 20°C (68°F) provided that the cleaning materials and used shop towels are kept in closed containers.

E. A portion of the volatile organic compounds contained in inks is captured for control by add-on air pollution control equipment. When applicable, the following capture efficiencies may be used in determining volatile organic compounds emissions from letterpress printing operations:

1. A 100% volatile organic compound capture efficiency may be used for VOC (petroleum ink oils) from oil-based paste inks and oil-based paste varnishes (coatings) when the dryer is demonstrated to be operating at negative pressure relative to the surrounding pressroom.

2. Conventional letterpress inks and varnishes are paste-type materials. If other types of inks or coating materials are used on a letterpress press (e.g., fluid inks or coatings), capture efficiency testing shall be conducted for the VOC from these other materials if the printer wants to take into account the effect that the dryer controls have on VOC emissions from these other types of inks or coatings. ]

9VAC5-40-8398. Compliance schedule.

The owner shall comply with the provisions of this article as expeditiously as possible but in no case later than [ (insert a date corresponding to the first day of the 12th month after the effective date of this article) February 1, 2017 ].

9VAC5-40-8400. Test methods and procedures.

A. The provisions of 9VAC5-40-30 (Emission testing) apply.

B. The following EPA test methods shall be used to demonstrate compliance with the heatset web letterpress printing process dryer control device control requirements in 9VAC5-40-8384 B.

1. Reference Method 1 or 1A, as appropriate, shall be used to select the sampling sites.

2. Reference Method 2, 2A, 2C, or 2D, as appropriate, shall be used to determine the velocity and volumetric flow rate of the exhaust stream.

3. Reference Method 3 or 3A, as appropriate, shall be used to determine the concentration of O₂ and CO₂.

4. Reference Method 4 shall be used to determine moisture content.

5. Reference Methods 18, 25, or 25A shall be used to determine the VOC concentration of the dryer exhaust stream entering and exiting the control device, unless the alternate limit in 9VAC5-40-8384 B 2 is being met, in which case only the VOC concentration of the dryer exhaust control device outlet shall be determined.

6. Reference Method 25A shall be used to determine the dryer exhaust control device inlet and outlet VOC concentrations when the control device outlet concentration is less than 50 [ ppmv parts per million volume (ppmv) ] VOC as carbon.

7. If the control device is an oxidizer, the combustion chamber temperature or catalyst bed inlet temperature corresponding to destruction efficiencies that meet the requirements of 9VAC5-40-8384 B shall be recorded.

C. The VOC content of as-applied inks, coatings, and cleaning materials shall be determined using Reference Method 24.

1. The analysis of as-supplied materials may be performed by the manufacturer or the supplier. Formulation information from the manufacturer may be used in lieu of Reference Method 24 analysis unless the board or the owner has reason to believe that the formulation information provided by the manufacturer is inaccurate.

2. The owner may use VOC content information provided by the manufacturer or supplier, such as the container label, the product data sheet, or the [ MSDS sheet Safety Data Sheet (SDS) ] to document the VOC content of the as-supplied material.

3. If cleaning materials are diluted by the owner prior to use, a calculation that combines the as-supplied VOC content information provided by the manufacturer or supplier, the VOC content of the diluent, and the proportions in which they are mixed may be used to make a determination of VOC content of the as-applied cleaning material in lieu of Reference Method 24.

4. The owner shall conduct Reference Method 24 testing of any as-applied cleaning material used for letterpress printing operations at any time at the board's request. The owner shall be prepared to sample as-applied fountain solution or cleaning materials at all times.

D. The VOC composite partial vapor pressure of cleaning solutions shall be determined using the formula provided in 9VAC5-40-8382 C or by an appropriate test method approved by the board.

1. The determination VOC composite partial vapor pressure for as-supplied cleaning solutions may be performed by the manufacturer or the supplier. The determination of as-applied composite vapor pressure based upon the manufacturer's instructions for dilution may be performed by the manufacturer or supplier.

2. The owner may use VOC composite partial vapor pressure information provided by the manufacturer or supplier, such as the container label, the product data sheet, or the [ Material Safety Data Sheet (MSDS) Safety Data Sheet (SDS) ] to document the VOC composite partial vapor pressure of the as-supplied or as-applied cleaning materials.

3. The following provisions apply to the determination of VOC composite partial vapor pressure for cleaning materials that are diluted by the owner prior to use:

a. If the dilution is made according to the manufacturer's instructions, the VOC composite partial vapor pressure for the as-applied cleaning material provided by the manufacturer or supplier may be used.

b. If a dilution is made and an as-applied VOC composite partial vapor pressure has not been provided by the manufacturer or supplier, or if the dilution is not made according to the manufacturer's instructions, then the owner shall determine the VOC composite partial vapor pressure using the calculation method provided in 9VAC5-40-8382 C or by an appropriate test method approved by the board.

4. The owner shall conduct testing of any as-applied cleaning materials used for letterpress printing operations at any time at the board's request. The owner shall be prepared to sample as-applied cleaning materials at all times.

9VAC5-40-8410. Monitoring.

A. The provisions of 9VAC5-40-40 (Monitoring) apply.

B. Periodic monitoring of letterpress printing operations shall be conducted as follows:

1. The temperature of a catalytic or thermal oxidation control device shall be monitored at least once every 15 minutes while the printing process is operating, and that temperature shall be recorded by an analog or digital recording device.

a. For a catalytic oxidizer, the dryer exhaust temperature upstream of the catalyst bed shall be monitored and recorded.

b. For a thermal oxidizer, the combustion chamber temperature of the oxidizer shall be monitored and recorded.

2. Catalyst bed material in a catalytic oxidation control device shall be inspected annually for general catalyst condition and any signs of potential catalyst depletion. Sampling and evaluation of the catalyst bed material shall be conducted whenever the results of the inspection indicate signs of potential catalyst depletion or poor catalyst condition based on manufacturer's recommendations, but not less than once per year.

3. If a heatset web letterpress printing process is interlocked to ensure that the control device is operating and airflow is present when the printing process is operating, then periodic monitoring of dryer air flow is not required. If no interlock is present, then the printing process dryer air flow shall be verified and recorded once per operating day.

9VAC5-40-8412. Notification, records, and reporting.

The provisions of 9VAC5-40-50 (Notification, records and reporting) apply.

9VAC5-40-8414. Registration.

The provisions of 9VAC5-20-160 (Registration) apply.

9VAC5-40-8416. Facility and control equipment maintenance or malfunction.

The provisions of 9VAC5-20-180 (Facility and control equipment maintenance or malfunction) apply.

9VAC5-40-8418. Permits.

A permit may be required prior to beginning any of the activities specified [ below in this section ] if the provisions of 9VAC5-50 (New and Modified Stationary Sources) and 9VAC5-80 (Permits for Stationary Sources) apply. Owners contemplating such action should review those provisions and contact the appropriate regional office for guidance on whether those provisions apply.

1. Construction of a facility.

2. Reconstruction (replacement of more than half) of a facility.

3. Modification (any physical change to equipment) of a facility.

4. Relocation of a facility.

5. Reactivation (re-startup) of a facility.

6. Operation of a facility.

Article 56.1
Emission Standards for Offset Lithographic Printing Operations in the Northern Virginia Volatile Organic Compound Emissions Control Area, 8-hour Ozone Standard (Rule 4-56.1)

9VAC5-40-8420. Applicability and designation of affected facility.

A. The affected facility to which the provisions of this article apply is any offset lithographic printing operation at a stationary source where the actual emissions of volatile organic compounds (VOCs) from all aspects of offset lithographic printing operations, including related cleaning activities, before the consideration of controls are equal to or exceed 3.0 tons per 12-month rolling period.

B. The provisions of this article apply only to sources of VOCs located in the Northern Virginia VOC Emissions Control Area designated in subdivision 1 a of 9VAC5-20-206.

9VAC5-40-8422. Definitions.

A. For the purpose of applying this article in the context of the regulations for the control and abatement of air pollution and related uses, the words or terms shall have the meanings given them in subsection C of this section.

B. Unless otherwise required by context, all terms not defined in this section shall have the meanings given them in 9VAC5-170 (Regulation for General Administration), 9VAC5-10 (General Definitions), or commonly ascribed to them by recognized authorities, in that order of priority.

C. Terms defined.

"Alcohol" means any of the following compounds when used as a fountain solution additive: ethanol, n-propanol, and isopropanol.

"Alcohol substitute" means any nonalcohol additive that contains volatile organic compounds and is used in the fountain solution.

"Batch" means a supply of fountain solution [ or cleaning solution ] that is prepared and used without alteration until completely used or removed from the printing process.

"Cleaning materials" means any washes, cleaners, solvents, or rejuvenators that are used to remove (i) excess printing inks, oils, and residual paper from a press, press equipment, or press parts or (ii) dried ink from areas around a press. Cleaning materials include solvents and cleaners used for manual cleaning and cleaning solutions used by automatic cleaning systems such as blanket wash, plate cleaner, metering roller cleaner, impression cylinder washes, rubber rejuvenators, and roller wash. Cleaning materials do not include cleaners used for cleaning electronic components of a press, pre-press cleaning operations (e.g., platemaking), post-press cleaning operations (e.g., binding), cleaning supplies such as detergents used to clean the floor (other than to remove dried ink from areas around a press), and cleaning performed in parts washers and cold cleaners subject to Article 47 (9VAC5-40-6820 et seq.) of Part II of 9VAC5-40 (Existing Stationary Sources).

"Composite partial vapor pressure" means the sum of the partial pressures of the compounds defined as volatile organic compounds. Composite partial vapor pressure is calculated as follows:

where:

"First installation date" means the date that a control device is first installed for the purpose of controlling emissions. The first installation date does not change if the control device is later moved to a new location or installed on a different press.

"Fountain solution" means any mixture of water, volatile and nonvolatile chemicals, and additives applied to a lithographic plate to repel ink from the nonimage area on the plate.

"Heatset" means a printing process in which heat from a dryer is used to evaporate ink oils from the substrate.

"Heatset web offset lithographic printing dryer" means the dryer or dryers installed as part of a heatset web offset lithographic printing process that dries [ or cures ] inks or surface coatings.

"Lithographic printing" means a planographic printing process in which the image and nonimage areas are chemically differentiated with the image area being oil receptive and the nonimage area being water receptive. This process differs from other printing processes, where the image is a raised or recessed surface.

"Non-heatset" means a printing process in which the printing inks are set and dried by absorption or oxidation rather than heat. For the purposes of this article, UV-cured and electron beam-cured inks are considered non-heatset.

"Offset lithographic printing" means a printing process that transfers the ink film from the lithographic plate to an intermediary surface (blanket), which, in turn, transfers the ink film to the substrate.

"Offset lithographic printing operation" means one or more printing processes employing offset lithographic printing on [ offset lithographic ] printing presses and includes the related processes necessary to directly support the operation of those offset lithographic printing processes including, but not limited to, pre-press and post-press operations. Varnishes, glues, and other coatings that are applied by an offset lithographic printing process are part of offset lithographic printing operations and are not considered as a separate process (e.g., paper coating).

"Press" means a printing production assembly composed of one or more units to produce a printed substrate (sheet or web).

"Printing" means a photomechanical process in which a transfer of text, designs, and images occurs through contact of an image carrier with a substrate.

"Printing process" means any operation or system wherein printing ink or a combination of printing ink and surface coating is applied, dried, or cured and that is subject to the same emission standard. A printing process may include any equipment that applies, conveys, dries, or cures inks or surface coatings, including, but not limited to, flow coaters, flashoff areas, [ air presses, digital output devices, fountain solutions, heaters, ] dryers, drying areas, and ovens.

"Sheet-fed" means a printing process in which individual sheets of substrate are fed into the press sequentially.

"Theoretical potential to emit" means for the purposes of this article the maximum capacity of a heatset web offset lithographic printing process to emit VOC and shall be based on emissions at design capacity or maximum production and maximum operating hours (8,760 hours/year) before add-on controls, unless the heatset web offset lithographic printing process is subject to state and federally enforceable permit conditions that limit production rates or hours of operation.

"12-month rolling period" means a period that is determined monthly and consists of the previous 12 consecutive calendar months.

"Unit" means the smallest complete printing component, composed of an inking [ and dampening ] system, of a printing press.

"VOC" means volatile organic compound.

"Web" means a continuous roll of printing substrate.

9VAC5-40-8424. Standard for volatile organic compounds.

A. No owner or other person shall use or permit the use of any offset lithographic printing press, offset lithographic printing process, or other offset lithographic printing operation that is subject to this article unless that press, process, or operation meets the requirements of this section.

B. Except as provided in subdivision 3 of this subsection, the following provisions apply to each heatset offset lithographic printing process at a facility whose potential to emit is greater than or equal to 10 tons per year of VOC, provided that the emission rates are determined in a manner acceptable to the board. All VOC emissions from printing inks, coatings, cleaning solutions, and fountain solutions shall be considered in determining the potential to emit for this subsection.

1. VOC emissions from the heatset web offset lithographic printing process dryer shall be controlled as follows:

a. The dryer shall operate at a lower air pressure than the pressroom air pressure at all times when the printing process is operating.

b. Exhaust air from the dryer shall be collected and sent to a control device that operates at all times when the printing process is operating.

c. The control device shall reduce VOC emissions in the dryer air exhaust by at least 90%.

2. Where the heatset web offset lithographic printing process control device inlet VOC concentration is too low to achieve the control device efficiency requirements specified in [ subdivisions subdivision ] 1 c of this subsection or there is no identifiable measurable inlet, the control device shall reduce the VOC concentration of the heatset web offset lithographic printing process dryer exhaust air to 50 parts per million volume (ppmv) or less, as carbon (minus methane and ethane).

3. The provisions in subdivisions 1 and 2 of this subsection do not apply to the following:

a. Any heatset web offset lithographic printing process with a theoretical potential to emit of 25 tons per year of VOC [ (petroleum ink oil) ] or more from the heatset web offset lithographic printing dryer. VOC standards for heatset web offset lithographic printing process with a theoretical potential to emit of 25 tons per year of VOC [ (petroleum ink oil) ] or more are provided in subsection C of this section.

b. Printing processes used exclusively for determination of product quality and commercial acceptance provided:

(1) The operation is not an integral part of the production process;

(2) The emissions from all product quality printing processes do not exceed 400 pounds in any 30-day period; and

(3) The exemption is approved by the board.

c. Photoprocessing, typesetting, or imagesetting equipment using water-based chemistry to develop silver halide images.

d. Platemaking equipment using water-based chemistry to remove unhardened image-producing material from an exposed plate.

e. Equipment used to make blueprints.

f. Any sheet-fed offset lithographic press with a cylinder width of 26 inches or less.

C. Except as provided in subdivisions [ 3, ] 4 [ , ] and 5 of this subsection, the following provisions apply to each heatset web offset lithographic printing process with a theoretical potential to emit of 25 tons per year of VOC [ (petroleum ink oil) ] or more from the dryer. These provisions do not apply to non-heatset web offset lithographic printing processes or to sheet-fed offset lithographic printing processes.

1. VOC emissions from the heatset web offset lithographic printing process dryer shall be controlled as follows:

a. The dryer shall operate at a lower air pressure than the pressroom air pressure at all times when the printing process is operating.

b. Exhaust air from the dryer shall be collected and sent to a control device that operates at all times when the printing process is operating.

c. For a control device whose first installation date is prior to [ (insert effective date of this article) February 1, 2016 ], the control device shall reduce VOC emissions in the dryer air exhaust by at least 90%.

d. For a control device whose first installation date is on or after [ (insert effective date of this article) February 1, 2016 ], the control device shall reduce VOC emissions in the dryer air exhaust by at least 95%.

2. Where the heatset web offset lithographic printing process control device inlet VOC concentration is too low to achieve the control device efficiency requirements specified in subdivisions 1 c and 1 d of this subsection or there is no identifiable measurable inlet, the control device shall reduce the VOC concentration of the heatset web offset lithographic printing process dryer exhaust air to 20 parts per million volume (ppmv) or less, as hexane on a dry basis.

3. Federally enforceable limitations on (i) the VOC [ (petroleum ink oil) ] content of inks, varnishes, and other coatings applied [ prior to the dryer ]; (ii) the total amounts of inks, varnishes, and other coatings applied; (iii) the press application rates of inks, varnishes, and other coatings; or (iv) the hours of press operation may be used to meet the 25 ton per year exception to this subsection.

4. The provisions of subdivisions 1 and 2 of this subsection do not apply to (i) any heatset web offset lithographic printing process constructed on or after [ (insert effective date of this article) February 1, 2016, ] and used exclusively for book printing or (ii) any heatset web offset lithographic printing process constructed on or after [ (insert effective date of this article) February 1, 2016, ] with a maximum web width of 22 inches or less.

5. The heatset web offset lithographic printing process dryer control device provisions of subdivision 1 d of this subsection do not apply to (i) any heatset web offset lithographic printing process used exclusively for book printing; or (ii) any heatset web offset lithographic printing process with a maximum web width of 22 inches or less.

D. The following provisions shall apply to fountain solution applied to each offset lithographic printing press, except that these provisions shall not apply to (i) sheet-fed offset lithographic printing processes with a sheet size of 11 inches by 17 inches or smaller or (ii) sheet-fed offset lithographic printing processes with a total fountain solution reservoir of less than one gallon.

1. For each heatset web press:

a. When the fountain solution contains alcohol:

(1) The fountain solution, as applied, shall contain no more than 1.6% volatile organic compounds by weight; or

(2) The temperature of the fountain solution shall be maintained at or below 60°F and the fountain solution, as applied, shall contain no more than 3.0% VOCs by weight; or

b. When the fountain solution contains no alcohol, the fountain solution, as applied, shall contain no more than 5.0% VOCs by weight.

2. For each non-heatset web press, the fountain solution, as applied, shall contain no alcohol and shall contain no more than 5.0% VOCs by weight.

3. For each sheet-fed press:

a. The fountain solution, as applied, shall contain no more than 5.0% VOCs by weight; or

b. The temperature of the fountain solution shall be maintained at or below 60°F and the fountain solution, as applied, shall contain no more than 8.5% VOCs by weight.

E. Cleaning materials used at each offset lithographic printing operation shall meet one of the following limits, as applied:

1. A VOC content of 30% by weight; or

2. A composite vapor pressure of 10 mm Hg at 20°C (68°F).

[ The use of cleaning materials not meeting the limits in subdivision 1 or 2 of this subsection is permitted provided that the quantity of cleaning material used does not exceed 110 gallons over any 12-month rolling period. ]

F. The following work practices shall be implemented.

1. Cleaning materials, fountain solution, inks, varnishes, and coatings containing VOCs shall be kept in closed containers at all times unless filling, draining, or performing cleaning operations.

2. Shop towels, sponges, and other manual cleaning aids that (i) have been used for picking up excess ink, fountain solution, varnishes, and other coatings containing VOCs or (ii) have been used with cleaning materials containing VOCs shall be kept in closed containers.

3. Spills of cleaning materials, fountain solution, inks, varnishes, and other coatings containing VOCs shall be minimized and shall be cleaned up promptly.

9VAC5-40-8426. Standard for visible emissions.

The provisions of Article 1 (9VAC5-40-60 et seq.) of Part II of 9VAC5-40 (Existing Stationary Sources) apply.

9VAC5-40-8428. Standard for fugitive dust/emissions.

The provisions of Article 1 (9VAC5-40-60 et seq.) of Part II of 9VAC5-40 (Existing Stationary Sources) apply.

9VAC5-40-8430. Standard for odor.

The provisions of Article 2 (9VAC5-40-130 et seq.) of Part II of 9VAC5-40 (Existing Stationary Sources) apply.

9VAC5-40-8432. Standard for toxic pollutants.

The provisions of Article 4 (9VAC5-60-200 et seq.) of Part II of 9VAC5-60 (Hazardous Air Pollutant Sources) apply.

9VAC5-40-8434. Compliance.

A. The provisions of 9VAC5-40-20 (Compliance) apply.

B. [ An If requested by the board, an ] emission test of the control device installed on a heatset web offset lithographic printing process dryer shall be performed to demonstrate compliance with the provisions of 9VAC5-40-8424 B and C [ and 9VAC5-40-8436 ]. The negative dryer pressure shall be established during the initial test using an airflow direction indicator, such as a smoke stick or aluminum ribbons, or a differential pressure gauge. [ The board may accept the results of an emission test conducted prior to the compliance date specified in 9VAC5-40-8436 if the owner or operator provides information and data that demonstrate that the test demonstrated compliance with the provisions of 9VAC5-40-8424 B and C. ]

C. [ Once initial compliance has been demonstrated with the heatset web offset lithographic printing process dryer control requirements of 9VAC5-40-8424 B and C through performance testing of an catalytic or thermal oxidation control device, continuing Continuing ] compliance with the heatset web offset lithographic printing process dryer control requirements in 9VAC5-40-8424 B and C shall be demonstrated for the catalytic or thermal oxidation control device by monitoring the control device in accordance with 9VAC5-40-8440 B 3, B 4, and B 5. The owner shall maintain the [ 3-hour three-hour ] average of the monitored temperature at a temperature no less than 50°F below the [ 3-hour three-hour ] average temperature that was recorded during the most recent performance test during which compliance was demonstrated. [ In the absence of performance test results acceptable to the board that provide dryer control device temperatures that demonstrate continuing compliance with the requirements in 9VAC5-40-8424 B and C, control device temperatures that demonstrate compliance with manufacturer recommendations may be considered by the board to demonstrate compliance with heatset web offset lithographic printing process dryer control requirements in 9VAC5-40-8424 B and C.

D. A portion of the volatile organic compounds contained in inks and cleaning solution is retained in the printed web and in the shop towels used for cleaning. When applicable, the following retention factors may be used in determining volatile organic compounds emissions from offset lithographic printing operations:

1. A 20% volatile organic compound retention factor may be used for petroleum ink oils contained in heatset inks that are printed on absorptive substrates, meaning that 80% of the VOC (petroleum ink oil) in the ink is emitted during the printing process and is available for capture and control by an add-on pollution control device.

2. A 100% volatile organic compound retention factor may be used for vegetable ink oils contained in heatset inks that are printed on absorptive substrates, meaning that none of the VOC (vegetable ink oil) in the ink is emitted during the printing process and available for capture and control by an add-on pollution control device.

3. A 95% volatile organic compound retention factor may be used for petroleum ink oils contained in sheet-fed and non-heatset web inks printed on absorptive substrates, meaning that 5.0% of the VOC (petroleum ink oil) in the ink is emitted during the printing process.

4. A 100% volatile organic compound retention factor may be used for vegetable ink oils contained in sheet-fed and non-heatset web inks printed on absorptive substrates, meaning that none of the VOC (vegetable ink oil) in the ink is emitted during the printing process.

5. A 50% volatile organic compound retention factor may be used for cleaning solution VOC in shop towels for those cleaning solutions with a volatile organic compounds composite vapor pressure of no more than 10 millimeters of mercury (Hg) at 20°C (68°F) provided that the cleaning materials and used shop towels are kept in closed containers.

E. A portion of the volatile organic compounds contained in inks, fountain solutions, and automatic blanket washes is captured for control by add-on air pollution control equipment. When applicable, the following capture efficiencies may be used in determining volatile organic compounds emissions from offset lithographic printing operations:

1. A 40% volatile organic compound capture efficiency may be used for automatic blanket washing when the VOC composite vapor pressure of the cleaning material is less than 10 millimeters of mercury (Hg).

2. A 70% volatile organic compound capture efficiency may be used for alcohol substitutes in fountain solutions.

3. A 100% volatile organic compound capture efficiency may be used for VOC (petroleum ink oils) from oil-based paste inks and oil-based paste varnishes (coatings) when the dryer is demonstrated to be operating at negative pressure relative to the surrounding pressroom.

4. Conventional heatset lithographic inks and varnishes are paste-type materials. If other types of inks or coating materials are used on a heatset lithographic press (e.g., fluid inks or coatings), capture efficiency testing shall be conducted for the VOC from these other materials if the printer wants to take into account the effect that the dryer controls have on VOC emissions from these other types of inks or coatings. ]

9VAC5-40-8436. Compliance schedule.

The owner shall comply with the provisions of this article as expeditiously as possible but in no case later than [ (insert a date corresponding to the first day of the 12th month after the effective date of this article) February 1, 2017 ].

9VAC5-40-8438. Test methods and procedures.

A. The provisions of 9VAC5-40-30 (Emission testing) apply.

B. The following EPA test methods shall be used to demonstrate compliance with the heatset web offset lithographic printing process dryer control device control requirements in 9VAC5-40-8424 B and C.

1. Reference Method 1 or 1A, as appropriate, shall be used to select the sampling sites.

2. Reference Method 2, 2A, 2C, or 2D, as appropriate, shall be used to determine the velocity and volumetric flow rate of the exhaust stream.

3. Reference Method 3 or 3A, as appropriate, shall be used to determine the concentration of O₂ and CO₂.

4. Reference Method 4 shall be used to determine moisture content.

5. Reference Methods 18, 25, or 25A shall be used to determine the VOC concentration of the dryer exhaust stream entering and exiting the control device, unless the alternate limit in 9VAC5-40-8424 B 2 or C 2 is being met, in which case only the VOC concentration of the dryer exhaust control device outlet shall be determined.

6. Reference Method 25A shall be used to determine the dryer exhaust control device inlet and outlet VOC concentrations when the control device outlet concentration is less than 50 [ ppmv parts per million volume (ppmv) ] VOC as carbon.

7. If the control device is an oxidizer, the combustion chamber temperature or catalyst bed inlet temperature corresponding to destruction efficiencies that meet the requirements of 9VAC5-40-8424 B or C, as appropriate, shall be recorded.

C. The VOC content of as-applied inks, varnishes and other coatings, fountain solutions, and cleaning materials shall be determined using Reference Method 24.

1. The analysis of as-supplied materials may be performed by the manufacturer or the supplier. Formulation information from the manufacturer may be used in lieu of Reference Method 24 analysis unless the board or the owner has reason to believe that the formulation information provided by the manufacturer is inaccurate.

2. The owner may use VOC content information provided by the manufacturer or supplier, such as the container label, the product data sheet, or the [ MSDS sheet Safety Data Sheet (SDS) ] to document the VOC content of the as-supplied material.

3. If fountain solution or cleaning materials are diluted by the owner prior to use, a calculation that combines the as-supplied VOC content information provided by the manufacturer or supplier, the VOC content of the diluent, and the proportions in which they are mixed may be used to make a determination of VOC content of the as-applied fountain solution or cleaning material in lieu of Reference Method 24.

4. The owner shall conduct Reference Method 24 testing of any as-applied fountain solution or cleaning material used for offset lithographic printing operations at any time at the board's request. The owner shall be prepared to sample as-applied fountain solution or cleaning materials at all times.

D. A thermometer or other temperature detection device capable of reading the temperature of the fountain solution to within 0.5°F shall be used to determine compliance with fountain solution temperature requirements in 9VAC5-40-8424 D.

E. The VOC composite partial vapor pressure of cleaning solutions shall be determined using the formula provided in 9VAC5-40-8422 C or by an appropriate test method approved by the board.

1. The determination VOC composite partial vapor pressure for as-supplied cleaning solutions may be performed by the manufacturer or the supplier. The determination of as-applied composite vapor pressure based upon the manufacturer's instructions for dilution may be performed by the manufacturer or supplier.

2. The owner may use VOC composite partial vapor pressure information provided by the manufacturer or supplier, such as the container label, the product data sheet, or the [ Material Safety Data Sheet (MSDS) Safety Data Sheet (SDS) ], to document the VOC composite partial vapor pressure of the as-supplied or as-applied cleaning materials.

3. The following provisions apply to the determination of VOC composite partial vapor pressure for cleaning materials that are diluted by the owner prior to use:

a. If the dilution is made according to the manufacturer's instructions, the VOC composite partial vapor pressure for the as-applied cleaning material provided by the manufacturer or supplier may be used.

b. If a dilution is made and an as-applied VOC composite partial vapor pressure has not been provided by the manufacturer or supplier, or if the dilution is not made according to the manufacturer's instructions, then the owner shall determine the VOC composite partial vapor pressure using the calculation method provided in 9VAC5-40-8422 C.

4. The owner shall conduct testing of any as-applied cleaning materials used for offset lithographic printing operations at any time at the board's request. The owner shall be prepared to sample as-applied cleaning materials at all times.

9VAC5-40-8440. Monitoring.

A. The provisions of 9VAC5-40-40 (Monitoring) apply.

B. Periodic monitoring of offset lithographic printing operations shall be conducted as follows:

1. The alcohol concentration of offset lithographic printing process fountain solution shall be monitored with a hydrometer, equipped with temperature correction or with readings adjusted for temperature, and recorded at least once per shift or once per batch, whichever is longer. A standard solution shall be used to calibrate the hydrometer for the type of alcohol used in the fountain.

2. The temperature of refrigerated fountain solution shall be measured at the recirculating tank at least once per operating day.

3. The temperature of a catalytic or thermal oxidation control device shall be monitored at least once every 15 minutes while the printing process is operating, and that temperature shall be recorded by an analog or digital recording device.

a. For a catalytic oxidizer, the dryer exhaust temperature upstream of the catalyst bed shall be monitored and recorded.

b. For a thermal oxidizer, the combustion chamber temperature of the oxidizer shall be monitored and recorded.

4. Catalyst bed material in a catalytic oxidation control device shall be inspected annually for general catalyst condition and any signs of potential catalyst depletion. Sampling and evaluation of the catalyst bed material shall be conducted whenever the results of the inspection indicate signs of potential catalyst depletion or poor catalyst condition based on manufacturer's recommendations, but not less than once per year.

5. If a heatset web offset lithographic printing process is interlocked to ensure that the control device is operating and airflow is present when the printing process is operating, then periodic monitoring of dryer air flow is not required. If no interlock is present, then the printing process dryer air flow shall be verified and recorded once per operating day.

9VAC5-40-8450. Notification, records, and reporting.

The provisions of 9VAC5-40-50 (Notification, records, and reporting) apply.

9VAC5-40-8460. Registration.

The provisions of 9VAC5-20-160 (Registration) apply.

9VAC5-40-8470. Facility and control equipment maintenance or malfunction.

The provisions of 9VAC5-20-180 (Facility and control equipment maintenance or malfunction) apply.

9VAC5-40-8480. Permits.

A permit may be required prior to beginning any of the activities specified [ below in this section ] if the provisions of 9VAC5-50 (New and Modified Stationary Sources) and 9VAC5-80 (Permits for Stationary Sources) apply. Owners contemplating such action should review those provisions and contact the appropriate regional office for guidance on whether those provisions apply.

1. Construction of a facility.

2. Reconstruction (replacement of more than half) of a facility.

3. Modification (any physical change to equipment) of a facility.

4. Relocation of a facility.

5. Reactivation (re-startup) of a facility.

6. Operation of a facility.

Titles of Regulations: 9VAC5-20. General Provisions (Rev. E09) (amending 9VAC5-20-21).

9VAC5-40. Existing Stationary Sources (Rev. E09) (amending 9VAC5-40-4760; adding 9VAC5-40-8810 through 9VAC5-40-8950).

Statutory Authority: § 10.1-1308 of the Code of Virginia; §§ 110, 111, 123, 129, 171, 172, and 182 of the federal Clean Air Act (40 CFR Parts 51 and 60).

Effective Date: February 1, 2016.

Agency Contact: Mary E. Major, Department of Environmental Quality, 629 East Main Street, P.O. Box 1105, Richmond, VA 23218, telephone (804) 698-4423, FAX (804) 698-4510, or email mary.major@deq.virginia.gov.

Summary:

The regulation requires owners to limit emissions of air pollution from miscellaneous metal and plastic parts coating operations to the level necessary for the protection of public health and welfare and the attainment and maintenance of the air quality standards. The regulation applies to sources within the Northern Virginia Volatile Organic Compound Emissions Control Area and establishes standards, control techniques, and provisions for determining compliance. The regulation also includes provisions for visible emissions, fugitive dust, odor, toxic pollutants, compliance, test methods and procedures, monitoring, notification, registration, malfunctions, and permits.

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.

9VAC5-20-21. Documents incorporated by reference.

A. The Administrative Process Act and Virginia Register Act provide that state regulations may incorporate documents by reference. Throughout these regulations, documents of the types specified below have been incorporated by reference.

1. United States Code.

2. Code of Virginia.

3. Code of Federal Regulations.

4. Federal Register.

5. Technical and scientific reference documents.

Additional information on key federal regulations and nonstatutory documents incorporated by reference and their availability may be found in subsection E of this section.

B. Any reference in these regulations to any provision of the Code of Federal Regulations (CFR) shall be considered as the adoption by reference of that provision. The specific version of the provision adopted by reference shall be that contained in the CFR (2014) in effect July 1, 2014. In making reference to the Code of Federal Regulations, 40 CFR Part 35 means Part 35 of Title 40 of the Code of Federal Regulations; 40 CFR 35.20 means § 35.20 in Part 35 of Title 40 of the Code of Federal Regulations.

C. Failure to include in this section any document referenced in the regulations shall not invalidate the applicability of the referenced document.

D. Copies of materials incorporated by reference in this section may be examined by the public at the central office of the Department of Environmental Quality, Eighth Floor, 629 East Main Street, Richmond, Virginia, between 8:30 a.m. and 4:30 p.m. of each business day.

E. Information on federal regulations and nonstatutory documents incorporated by reference and their availability may be found below in this subsection.

1. Code of Federal Regulations.

a. The provisions specified below from the Code of Federal Regulations (CFR) are incorporated herein by reference.

(1) 40 CFR Part 50 -- National Primary and Secondary Ambient Air Quality Standards.

(a) Appendix A-1 -- Reference Measurement Principle and Calibration Procedure for the Measurement of Sulfur Dioxide in the Atmosphere (Ultraviolet Fluorescence Method).

(b) Appendix A-2 -- Reference Method for the Determination of Sulfur Dioxide in the Atmosphere (Pararosaniline Method).

(c) Appendix B -- Reference Method for the Determination of Suspended Particulate Matter in the Atmosphere (High-Volume Method).

(d) Appendix C -- Measurement Principle and Calibration Procedure for the Continuous Measurement of Carbon Monoxide in the Atmosphere (Non-Dispersive Infrared Photometry).

(e) Appendix D -- Measurement Principle and Calibration Procedure for the Measurement of Ozone in the Atmosphere.

(f) Appendix E -- Reserved.

(g) Appendix F -- Measurement Principle and Calibration Procedure for the Measurement of Nitrogen Dioxide in the Atmosphere (Gas Phase Chemiluminescence).

(h) Appendix G -- Reference Method for the Determination of Lead in Suspended Particulate Matter Collected from Ambient Air.

(i) Appendix H -- Interpretation of the National Ambient Air Quality Standards for Ozone.

(j) Appendix I -- Interpretation of the 8-Hour Primary and Secondary National Ambient Air Quality Standards for Ozone.

(k) Appendix J -- Reference Method for the Determination of Particulate Matter as PM₁₀ in the Atmosphere.

(l) Appendix K -- Interpretation of the National Ambient Air Quality Standards for Particulate Matter.

(m) Appendix L -- Reference Method for the Determination of Fine Particulate Matter as PM_2.5 in the Atmosphere.

(n) Appendix M -- Reserved.

(o) Appendix N -- Interpretation of the National Ambient Air Quality Standards for PM_2.5.

(p) Appendix O -- Reference Method for the Determination of Coarse Particulate Matter as PM in the Atmosphere.

(q) Appendix P -- Interpretation of the Primary and Secondary National Ambient Air Quality Standards for Ozone.

(r) Appendix Q -- Reference Method for the Determination of Lead in Suspended Particulate Matter as PM₁₀ Collected from Ambient Air.

(s) Appendix R -- Interpretation of the National Ambient Air Quality Standards for Lead.

(t) Appendix S -- Interpretation of the Primary National Ambient Air Quality Standards for Oxides of Nitrogen (Nitrogen Dioxide).

(u) Appendix T -- Interpretation of the Primary National Ambient Air Quality Standards for Oxides of Sulfur (Sulfur Dioxide).

(2) 40 CFR Part 51 -- Requirements for Preparation, Adoption, and Submittal of Implementation Plans.

(a) Appendix M -- Recommended Test Methods for State Implementation Plans.

(b) Appendix S -- Emission Offset Interpretive Ruling.

(c) Appendix W -- Guideline on Air Quality Models (Revised).

(d) Appendix Y -- Guidelines for BART Determinations Under the Regional Haze Rule.

(3) 40 CFR Part 55 -- Outer Continental Shelf Air Regulations.

(4) 40 CFR Part 58 -- Ambient Air Quality Surveillance.

Appendix A -- Quality Assurance Requirements for SLAMS, SPMs and PSD Air Monitoring.

(5) 40 CFR Part 59 -- National Volatile Organic Compound Emission Standards for Consumer and Commercial Products.

(a) Subpart C -- National Volatile Organic Compound Emission Standards for Consumer Products.

(b) Subpart D -- National Volatile Organic Compound Emission Standards for Architectural Coatings, Appendix A -- Determination of Volatile Matter Content of Methacrylate Multicomponent Coatings Used as Traffic Marking Coatings.

(6) 40 CFR Part 60 -- Standards of Performance for New Stationary Sources.

The specific provisions of 40 CFR Part 60 incorporated by reference are found in Article 5 (9VAC5-50-400 et seq.) of Part II of 9VAC5-50 (New and Modified Sources).

(7) 40 CFR Part 61 -- National Emission Standards for Hazardous Air Pollutants.

The specific provisions of 40 CFR Part 61 incorporated by reference are found in Article 1 (9VAC5-60-60 et seq.) of Part II of 9VAC5-60 (Hazardous Air Pollutant Sources).

(8) 40 CFR Part 63 -- National Emission Standards for Hazardous Air Pollutants for Source Categories.

The specific provisions of 40 CFR Part 63 incorporated by reference are found in Article 2 (9VAC5-60-90 et seq.) of Part II of 9VAC5-60 (Hazardous Air Pollutant Sources).

(9) 40 CFR Part 64 -- Compliance Assurance Monitoring.

(10) 40 CFR Part 72 -- Permits Regulation.

(11) 40 CFR Part 73 -- Sulfur Dioxide Allowance System.

(12) 40 CFR Part 74 -- Sulfur Dioxide Opt-Ins.

(13) 40 CFR Part 75 -- Continuous Emission Monitoring.

(14) 40 CFR Part 76 -- Acid Rain Nitrogen Oxides Emission Reduction Program.

(15) 40 CFR Part 77 -- Excess Emissions.

(16) 40 CFR Part 78 -- Appeal Procedures for Acid Rain Program.

(17) 40 CFR Part 152 Subpart I -- Classification of Pesticides.

(18) 49 CFR Part 172 -- Hazardous Materials Table. Special Provisions, Hazardous Materials Communications, Emergency Response Information, and Training Requirements, Subpart E, Labeling.

(19) 29 CFR Part 1926 Subpart F -- Fire Protection and Prevention.

b. Copies may be obtained from: Superintendent of Documents, P.O. Box 371954, Pittsburgh, Pennsylvania 15250-7954; phone (202) 783-3238.

2. U.S. Environmental Protection Agency.

a. The following documents from the U.S. Environmental Protection Agency are incorporated herein by reference:

(1) Reich Test, Atmospheric Emissions from Sulfuric Acid Manufacturing Processes, Public Health Service Publication No. PB82250721, 1980.

(2) Compilation of Air Pollutant Emission Factors (AP-42). Volume I: Stationary and Area Sources, stock number 055-000-00500-1, 1995; Supplement A, stock number 055-000-00551-6, 1996; Supplement B, stock number 055-000-00565, 1997; Supplement C, stock number 055-000-00587-7, 1997; Supplement D, 1998; Supplement E, 1999.

(3) "Guidelines for Determining Capture Efficiency" (GD-35), Emissions Monitoring and Analysis Division, Office of Air Quality Planning and Standards, January 9, 1995.

b. Copies of the document identified in subdivision E 2 a (1) of this [ subdivision section ], and Volume I and Supplements A through C of the document identified in subdivision E 2 a (2) of this [ subdivision section ], may be obtained from: U.S. Department of Commerce, National Technical Information Service, 5285 Port Royal Road, Springfield, Virginia 22161; phone 1-800-553-6847. Copies of Supplements D and E of the document identified in subdivision E 2 a (2) of this [ subdivision section ] may be obtained online from EPA's Technology Transfer Network at http://www.epa.gov/ttn/index.html. Copies of the document identified in subdivision E 2 a (3) of this [ subdivision section ] are only available online from EPA's Technology Transfer Network at http://www.epa.gov/ttn/emc/guidlnd.html.

3. U.S. government.

a. The following document from the U.S. government is incorporated herein by reference: Standard Industrial Classification Manual, 1987 (U.S. Government Printing Office stock number 041-001-00-314-2).

b. Copies may be obtained from: Superintendent of Documents, P.O. Box 371954, Pittsburgh, Pennsylvania 15250-7954; phone (202) 512-1800.

4. American Society for Testing and Materials (ASTM).

a. The documents specified below from the American Society for Testing and Materials are incorporated herein by reference.

(1) D323-99a, "Standard Test Method for Vapor Pressure of Petroleum Products (Reid Method)."

(2) D97-96a, "Standard Test Method for Pour Point of Petroleum Products."

(3) D129-00, "Standard Test Method for Sulfur in Petroleum Products (General Bomb Method)."

(4) D388-99, "Standard Classification of Coals by Rank."

(5) D396-98, "Standard Specification for Fuel Oils."

(6) D975-98b, "Standard Specification for Diesel Fuel Oils."

(7) D1072-90(1999), "Standard Test Method for Total Sulfur in Fuel Gases."

(8) D1265-97, "Standard Practice for Sampling Liquefied Petroleum (LP) Gases (Manual Method)."

(9) D2622-98, "Standard Test Method for Sulfur in Petroleum Products by Wavelength Dispersive X-Ray Fluorescence Spectrometry."

(10) D4057-95(2000), "Standard Practice for Manual Sampling of Petroleum and Petroleum Products."

(11) D4294-98, "Standard Test Method for Sulfur in Petroleum and Petroleum Products by Energy-Dispersive X-Ray Fluorescence Spectroscopy."

(12) D523-89, "Standard Test Method for Specular Gloss" (1999).

(13) D1613-02, "Standard Test Method for Acidity in Volatile Solvents and Chemical Intermediates Used in Paint, Varnish, Lacquer and Related Products" (2002).

(14) D1640-95, "Standard Test Methods for Drying, Curing, or Film Formation of Organic Coatings at Room Temperature" (1999).

(15) E119-00a, "Standard Test Methods for Fire Tests of Building Construction Materials" (2000).

(16) E84-01, "Standard Test Method for Surface Burning Characteristics of Building Construction Materials" (2001).

(17) D4214-98, "Standard Test Methods for Evaluating the Degree of Chalking of Exterior Paint Films" (1998).

(18) D86-04b, "Standard Test Method for Distillation of Petroleum Products at Atmospheric Pressure" (2004).

(19) D4359-90, "Standard Test Method for Determining Whether a Material is a Liquid or a Solid" (reapproved 2000).

(20) E260-96, "Standard Practice for Packed Column Gas Chromatography" (reapproved 2001).

(21) D3912-95, "Standard Test Method for Chemical Resistance of Coatings Used in Light-Water Nuclear Power Plants" (reapproved 2001).

(22) D4082-02, "Standard Test Method for Effects of Gamma Radiation on Coatings for Use in Light-Water Nuclear Power Plants."

(23) F852-99, "Standard Specification for Portable Gasoline Containers for Consumer Use" (reapproved 2006).

(24) F976-02, "Standard Specification for Portable Kerosine and Diesel Containers for Consumer Use."

(25) D4457-02, "Standard Test Method for Determination of Dichloromethane and 1,1,1-Trichloroethane in Paints and Coatings by Direct Injection into a Gas Chromatograph" (reapproved 2008).

(26) D3792-05, "Standard Test Method for Water Content of Coatings by Direct Injection Into a Gas Chromatograph."

(27) D2879-97, "Standard Test Method for Vapor Pressure-Temperature Relationship and Initial Decomposition Temperature of Liquids by Isoteniscope" (reapproved 2007).

b. Copies may be obtained from: American Society for Testing Materials, 100 Barr Harbor Drive, West Conshohocken, Pennsylvania 19428-2959; phone (610) 832-9585.

5. American Petroleum Institute (API).

a. The following document from the American Petroleum Institute is incorporated herein by reference: Evaporative Loss from Floating Roof Tanks, API MPMS Chapter 19, April 1, 1997.

b. Copies may be obtained from: American Petroleum Institute, 1220 L Street, Northwest, Washington, D.C. 20005; phone (202) 682-8000.

6. American Conference of Governmental Industrial Hygienists (ACGIH).

a. The following document from the ACGIH is incorporated herein by reference: 1991-1992 Threshold Limit Values for Chemical Substances and Physical Agents and Biological Exposure Indices (ACGIH Handbook).

b. Copies may be obtained from: ACGIH, 1330 Kemper Meadow Drive, Suite 600, Cincinnati, Ohio 45240; phone (513) 742-2020.

7. National Fire Prevention Association (NFPA).

a. The documents specified below from the National Fire Prevention Association are incorporated herein by reference.

(1) NFPA 385, Standard for Tank Vehicles for Flammable and Combustible Liquids, 2000 Edition.

(2) NFPA 30, Flammable and Combustible Liquids Code, 2000 Edition.

(3) NFPA 30A, Code for Motor Fuel Dispensing Facilities and Repair Garages, 2000 Edition.

b. Copies may be obtained from the National Fire Prevention Association, One Batterymarch Park, P.O. Box 9101, Quincy, Massachusetts 02269-9101; phone (617) 770-3000.

8. American Society of Mechanical Engineers (ASME).

a. The documents specified below from the American Society of Mechanical Engineers are incorporated herein by reference.

(1) ASME Power Test Codes: Test Code for Steam Generating Units, Power Test Code 4.1-1964 (R1991).

(2) ASME Interim Supplement 19.5 on Instruments and Apparatus: Application, Part II of Fluid Meters, 6th edition (1971).

(3) Standard for the Qualification and Certification of Resource Recovery Facility Operators, ASME QRO-1-1994.

b. Copies may be obtained from the American Society of Mechanical Engineers, Three Park Avenue, New York, New York 10016; phone (800) 843-2763.

9. American Hospital Association (AHA).

a. The following document from the American Hospital Association is incorporated herein by reference: An Ounce of Prevention: Waste Reduction Strategies for Health Care Facilities, AHA Catalog no. W5-057007, 1993.

b. Copies may be obtained from: American Hospital Association, One North Franklin, Chicago, IL 60606; phone (800) 242-2626.

10. Bay Area Air Quality Management District (BAAQMD).

a. The following documents from the Bay Area Air Quality Management District are incorporated herein by reference:

(1) Method 41, "Determination of Volatile Organic Compounds in Solvent-Based Coatings and Related Materials Containing Parachlorobenzotrifluoride" (December 20, 1995).

(2) Method 43, "Determination of Volatile Methylsiloxanes in Solvent-Based Coatings, Inks, and Related Materials" (November 6, 1996).

b. Copies may be obtained from: Bay Area Air Quality Management District, 939 Ellis Street, San Francisco, CA 94109, phone (415) 771-6000.

11. South Coast Air Quality Management District (SCAQMD).

a. The following documents from the South Coast Air Quality Management District are incorporated herein by reference:

(1) Method 303-91, "Determination of Exempt Compounds," in Manual SSMLLABM, "Laboratory Methods of Analysis for Enforcement Samples" (1996).

(2) Method 318-95, "Determination of Weight Percent Elemental Metal in Coatings by X-Ray Diffraction," in Manual SSMLLABM, "Laboratory Methods of Analysis for Enforcement Samples" (1996).

(3) Rule 1174 Ignition Method Compliance Certification Protocol (February 28, 1991).

(4) Method 304-91, "Determination of Volatile Organic Compounds (VOC) in Various Materials," in Manual SSMLLABM, "Laboratory Methods of Analysis for Enforcement Samples" (1996).

(5) Method 316A-92, "Determination of Volatile Organic Compounds (VOC) in Materials Used for Pipes and Fittings" in Manual SSMLLABM, "Laboratory Methods of Analysis for Enforcement Samples" (1996).

(6) "General Test Method for Determining Solvent Losses from Spray Gun Cleaning Systems," October 3, 1989.

b. Copies may be obtained from: South Coast Air Quality Management District, 21865 E. Copley Drive, Diamond Bar, CA 91765, phone (909) 396-2000.

12. California Air Resources Board (CARB).

a. The following documents from the California Air Resources Board are incorporated herein by reference:

(1) Test Method 510, "Automatic Shut-Off Test Procedure for Spill-Proof Systems and Spill-Proof Spouts" (July 6, 2000).

(2) Test Method 511, "Automatic Closure Test Procedure for Spill-Proof Systems and Spill-Proof Spouts" (July 6, 2000).

(3) Method 100, "Procedures for Continuous Gaseous Emission Stack Sampling" (July 28, 1997).

(4) Test Method 513, "Determination of Permeation Rate for Spill-Proof Systems" (July 6, 2000).

(5) Method 310, "Determination of Volatile Organic Compounds (VOC) in Consumer Products and Reactive Organic Compounds in Aerosol Coating Products (Including Appendices A and B)" (May 5, 2005).

(6) California Code of Regulations, Title 17, Division 3, Chapter 1, Subchapter 8.5, Article 1, § 94503.5 (2003).

(7) California Code of Regulations, Title 17, Division 3, Chapter 1, Subchapter 8.5, Article 2, §§ 94509 and 94511 (2003).

(8) California Code of Regulations, Title 17, Division 3, Chapter 1, Subchapter 8.5, Article 4, §§ 94540-94555 (2003).

(9) "Certification Procedure 501 for Portable Fuel Containers and Spill-Proof Spouts, CP-501" (July 26, 2006).

(10) "Test Procedure for Determining Integrity of Spill-Proof Spouts and Spill-Proof Systems, TP-501" (July 26, 2006).

(11) "Test Procedure for Determining Diurnal Emissions from Portable Fuel Containers, TP-502" (July 26, 2006).

b. Copies may be obtained from: California Air Resources Board, P.O. Box 2815, Sacramento, CA 95812, phone (906) 322-3260 or (906) 322-2990.

13. American Architectural Manufacturers Association.

a. The following documents from the American Architectural Manufacturers Association are incorporated herein by reference:

(1) Voluntary Specification 2604-02, "Performance Requirements and Test Procedures for High Performance Organic Coatings on Aluminum Extrusions and Panels" (2002).

(2) Voluntary Specification 2605-02, "Performance Requirements and Test Procedures for Superior Performing Organic Coatings on Aluminum Extrusions and Panels" (2002).

b. Copies may be obtained from: American Architectural Manufacturers Association, 1827 Walden Office Square, Suite 550, Schaumburg, IL 60173, phone (847) 303-5664.

14. American Furniture Manufacturers Association.

a. The following document from the American Furniture Manufacturers Association is incorporated herein by reference: Joint Industry Fabrics Standards Committee, Woven and Knit Residential Upholstery Fabric Standards and Guidelines (January 2001).

b. Copies may be obtained from: American Furniture Manufacturers Association, P.O. Box HP-7, High Point, NC 27261; phone (336) 884-5000.

15. American Architectural Manufacturers Association [ (AAMA) ].

a. The following documents from the American Architectural Manufacturers Association are incorporated herein by reference:

(1) Voluntary Specification, Performance Requirements and Test Procedures for High Performance Organic Coatings on Aluminum Extrusions and Panels, publication number AAMA 2604-05.

(2) Voluntary Specification, Performance Requirements and Test Procedures for Superior Performing Organic Coatings on Aluminum Extrusions and Panels, publication number AAMA 2605-05.

b. Copies may be obtained from: American Architectural Manufacturers Association, 1827 Walden Office Square, Suite 550, Schaumburg, IL 60173-4268; phone 847-303-5774.

Article 34
Emission Standards for Miscellaneous Metal Parts and Products Coating Application Systems (Rule 4-34)

9VAC5-40-4760. Applicability and designation of affected facility.

A. Except as provided in subsections C and D of this section, the affected facility to which the provisions of this article apply is each miscellaneous metal parts and products coating application system.

B. The provisions of this article apply only to sources of volatile organic compounds in volatile organic compound emissions control areas designated in 9VAC5-20-206. [ After (insert date one year from effective date of this article) they do On and after February 1, 2017, this article does not apply to sources in the Northern Virginia Volatile Organic Compound Emissions Control Area designated in 9VAC5-20-206. These sources are subject to Article 59 (9VAC5-40-8810 et seq.) of this part.

C. Exempted from the provisions of this article are coating plants whose emissions of volatile organic compounds are not more than 2.7 tons per year, 15 pounds per day and three pounds per hour, based on the actual emission rate. All volatile organic compound emissions from purging or washing solvents shall be considered in applying the exemption levels specified in this subsection.

D. The provisions of this article do not apply to the following:

1. Coating application systems used exclusively for determination of product quality and commercial acceptance provided:

a. The operation is not an integral part of the production process;

b. The emissions from all product quality coating application systems do not exceed 400 pounds in any 30 day period; and

c. The exemption is approved by the board.

2. Vehicle refinishing operations.

3. Vehicle customized coating operations, if production is less than 20 vehicles per day.

4. Fully assembled aircraft and marine vessel exterior coating operations.

Article 59
Emission Standards for Miscellaneous Metal Parts and Products Coating Application Systems in the Northern Virginia Volatile Organic Compound Emissions Control Area, 8-hour Ozone Standard (Rule 4-59)

9VAC5-40-8810. Applicability and designation of affected facility.

A. Except as provided in subsections C [ and D through H ] of this section, the affected facility to which the provisions of this article apply is each miscellaneous metal product and plastic parts surface coating operation at a facility where the total actual emissions of volatile organic compounds (VOCs) from all miscellaneous metal product and plastic parts surface coating operations, including related cleaning activities, at that facility are equal to or exceed 6.8 kilograms per day (15 pounds per day), or an equivalent level of 2.7 tons per 12-month rolling period, before consideration of controls.

B. The provisions of this article apply only to affected facilities located in the Northern Virginia VOC Emissions Control Area designated in subdivision 1 a of 9VAC5-20-206.

C. Facilities that coat bodies or body parts for new heavier vehicles (including all vehicles that meet the definition of the term "other motor vehicles" as defined in 40 CFR 63.3176 of the National Emission Standards for Surface Coating of Automobile and Light-Duty Trucks) may, in lieu of complying with the provisions of this article, opt to comply with Article 28 (Emission Standards for Automobile [ And and ] Light Duty Truck Coating Application Systems, 9VAC5-40-3860 et seq.) of 9VAC5-40 (Existing Stationary Sources).

D. The provisions of this article do not apply to the following:

1. Miscellaneous metal product and plastic parts surface coating operations subject to Article 26 ([ Emissions Standards for ] Large Appliance [ Coatings Coating Application Systems ], 9VAC5-40-3560 et seq.), Article 27 (Emission Standards for Magnet Wire Coating Application Systems, 9VAC5-40-3710 et seq.), Article 29 (Emission Standards for Can Coating Application Systems, 9VAC5-40-4010 et seq.), Article 30 (Emission Standards for Metal Coil Coating Application Systems, 9VAC5-40-4160), Article 31 (Emission Standards for Paper and Fabric Coating Application Systems, 9VAC5-40-4310), Article 33 ([ Emissions Standards for ] Metal Furniture Coating Application Systems, 9VAC5-40-4610 et seq.), and Article 48 (Emission Standards for Mobile Equipment Repair and Refinishing Operations, 9VAC5-40-6970 et seq.) of 9VAC5-40 (Existing Stationary Sources); and Article 5 (Emission Standards for Architectural and Industrial Maintenance Coatings, 9VAC5-45-520 et seq.) of 9VAC5-45 (Consumer and Commercial Products).

2. Coating application systems used exclusively for determination of product quality and coatings that are applied to test panels and coupons as part of research and development, quality control, or performance testing activities at paint research or manufacturing facilities.

3. Coatings applied using a handheld, pressurized, nonrefillable container that expels coatings from the container in a finely divided spray when a valve on the container is depressed.

4. Miscellaneous metal product and plastic parts surface coating operations associated with the following product categories or processes: aerospace coatings; wood furniture coatings; fiberglass boat manufacturing materials; and paper, film, and foil coatings not otherwise regulated under Article 31 (Emission Standards [ For for ] Paper and Fabric Coating Application Systems, 9VAC5-40-4310) of 9VAC5-40 (Existing Stationary Sources).

[ 5. Recommended VOC limits and application methods do not apply to aerosol coating products or powder coatings.

E. For metal coatings:

1. Recommended work practices still apply; however, the VOC limits and application methods for provisions of this article do not apply to the following:

a. Stencil coatings;

b. Safety-indicating coatings;

c Solid-film lubricants;

d. Electric-insulating and thermal conducting coatings;

e. Magnetic data storage disk coatings; and

f. Plastic extruded onto metal parts to form a coating.

2. Recommended VOC limits and work practices still apply to these coatings and coating operations; however, the application methods for provisions of this article do not apply to the following:

a. Touch-up coatings;

b. Repair coatings; and

c. Textured finishes.

F. For plastic coatings:

1. Recommended application and work practices still apply to these coatings and coating operations; however, the VOC limits for provisions of this article do not apply to the following:

a. Touch-up and repair coatings;

b. Stencil coatings applied on clear or transparent substrates;

c. Clear or translucent coatings;

d. Coatings applied at a paint manufacturing facility while conducting performance tests on the coatings;

e. Any individual coating category used in volumes less than 50 gallons in any one year, if substitute complaint coatings are not available, provided that the total usage of all such coatings does not exceed 200 gallons per year, per facility;

f. Reflective coating applied to highway cones;

g. Mask coatings that are less than 0.5 millimeter thick (dried) and the area coated is less than 25 square inches;

h. EMI/RF shielding coatings; and

i. Heparin-benzalkonium chloride (HBAC)-contained coatings applied to medical devices, provided that the total usage of all such coatings does not exceed 100 gallons per year, per facility.

2. The application methods for provisions of this article do not apply to airbrush methods using five gallons or less per year of coating; however, VOC limits and work practices do apply.

G. For automotive/transportation and business machine plastic part coatings:

1. The VOC limits for provisions of this article do not apply to the following:

a. Texture coatings;

b. Vacuum metalizing coatings;

c. Gloss reducers;

d. Texture topcoats;

e. Adhesion primers;

f. Electrostatic preparation coatings;

g. Resist coatings; and

h. Stencil coatings.

2. Recommended application and work practices still apply to these coatings and coating operations.

H. For pleasure craft surface coating operations, VOC limits and work practices do apply to extreme high gloss coatings; however, recommended application methods do not apply. ]

9VAC5-40-8820. Definitions.

A. For the purpose of this article and subsequent amendments or any orders issued by the board, the words or terms shall have the meaning given them in subsection C of this section.

B. As used in this article, all terms not defined here shall have the meaning given them in 9VAC5-10 (General Definitions), unless otherwise required by context.

C. Terms defined.

"Aerospace coatings" means materials that are applied to the surface of an aerospace vehicle or component to form a decorative, protective, or functional solid film, or the solid film itself at a facility that produces, reworks, or repairs in any amount any commercial, civil, or military aerospace vehicle or component.

"Air-dried coating" means:

1. For general use, a coating that is cured at a temperature below 90°C (194°F).

2. For automotive/transportation and business machine use, a coating that is dried by the use of air or forced warm air at temperatures up to 90°C (194°F).

"Antifoulant coating" means any coating applied to the underwater portion of a pleasure craft to prevent or reduce the attachment of biological organisms, and registered with the U.S. Environmental Protection Agency (EPA) as a pesticide under the Federal Insecticide, Fungicide, and Rodenticide Act (7 USC § 136).

[ "Antifouling sealer/tie coat" means any coating applied over biocidal antifouling coating for the purpose of preventing release of biocides into the environment or to promote adhesion between an antifouling and a primer or other antifoulings. ]

"Baked coating" means a coating that is cured at a temperature at or above 90°C (194°F).

[ "Biocide" means a chemical substance or microorganism that can deter, render harmless, or exert a controlling effect on any harmful organism by chemical or biological means. ]

"Black automotive coating" means a coating that meets both of the following criteria: (i) maximum lightness of 23 units and (ii) saturation of less than 2.8, where saturation equals the square root of A² + B². These criteria are based on Cielab color space, 0/45 geometry. For spherical geometry, specular included, maximum lightness is 33 units.

"Business machine" means a device that uses electronic or mechanical methods to process information, perform calculations, print or copy information, or convert sound into electrical impulses for transmission, including devices listed in [ Standard Industrial Classification numbers 3572, 3573, 3574, 3579, and 3661 and photocopy machines, a subcategory of Standard Industrial Classification number 3861 National American Industry Classification System (NAICS) codes 333318, 334111, 339940, 334112, 334118, 334210, 334418, 334519, 334613, and photocopying equipment in 333316 ].

"Camouflage coating" means a coating used, principally by the military, to conceal equipment from detection.

"Clear coating" means:

1. For general use, a colorless coating that contains binders, but no pigment, and is formulated to form a transparent film.

2. For automotive/transportation and business machine use, a coating that lacks color and opacity or is transparent and that uses the undercoat as a reflectant base or undertone color.

"Coating unit" means a series of one or more coating applicators and any associated drying area or oven wherein a coating is applied, dried, or cured. A coating unit ends at the point where the coating is dried or cured, or prior to any subsequent application of a different coating. It is not necessary for a coating unit to have an oven or flash-off area.

"Drum" means any cylindrical metal shipping container larger than 12 gallons capacity but no larger than 110 gallons capacity.

"Electric dissipating coating" means a coating that rapidly dissipates a high-voltage electric charge.

"Electric-insulating varnish" means a nonconvertible-type coating applied to electric motors, components of electric motors, or power transformers to provide electrical, mechanical, and environmental protection or resistance.

[ "EMF/RFI shielding" means a coating used on electrical or electronic equipment to provide shielding against electromagnetic interference, radio frequency interference, or static discharge. ]

"Etching filler" means a coating that contains less than 23% solids by weight and at least 0.5% acid by weight and is used instead of applying a pretreatment coating followed by a primer.

"Extreme high-gloss coating" means:

1. For general use, a coating that when tested by the American Society for Testing and Materials (ASTM) Standard Test Method for Specular Gloss (see 9VAC5-20-21) shows a reflectance of 75 or more on a 60° meter.

2. For pleasure craft surface coating, any coating that achieves at least 95% reflectance on a 60° meter when tested by ASTM Standard Test Method for Specular Gloss (see 9VAC5-20-21).

"Extreme performance coating" means a coating used on a metal or plastic surface where the coated surface is, in its intended use, subject to the following:

1. Chronic exposure to corrosive, caustic, or acidic agents, chemicals, chemical fumes, chemical mixtures, or solutions;

2. Repeated exposure to temperatures in excess of 250°F; or

3. Repeated heavy abrasion, including mechanical wear and repeated scrubbing with industrial grade solvents, cleansers, or scouring agents.

Extreme performance coatings include, but are not limited to, coatings applied to locomotives, railroad cars, farm machinery, and heavy duty trucks.

"Fiberglass boat manufacturing materials" means materials utilized at facilities that manufacture hulls or decks of boats from fiberglass or build molds to make fiberglass boat hulls or decks. Fiberglass boat manufacturing materials are not materials used at facilities that manufacture solely parts of boats (i.e., hatches, seats, or lockers) or boat trailers, but do not (i) manufacture hulls or decks of boats from fiberglass or (ii) build molds to make fiberglass boat hulls or decks.

"Finish primer/surfacer" means a coating applied with a wet film thickness of less than 10 mils prior to the application of a topcoat for purposes of providing corrosion resistance, adhesion of subsequent coatings, a moisture barrier, or promotion of a uniform surface necessary for filling in surface imperfections.

"Flexible coating" means any coating that is required to comply with engineering specifications for impact resistance, mandrel bend, or elongation as defined by the original equipment manufacturer.

"Fog coat" means a coating that is applied to a plastic part for the purpose of color matching without masking a molded-in texture. A fog coat shall not be applied at a thickness of more than 0.5 mils of coating solids.

"Heat-resistant coating" means a coating that must withstand a temperature of at least 400°F during normal use.

"High bake coating" means a coating that is designed to cure only at temperatures of more than 90°C (194°F).

"High build primer/surfacer" means a coating applied with a wet film thickness of 10 mils or more prior to the application of a topcoat for purposes of providing corrosion resistance, adhesion of subsequent coatings, or a moisture barrier, or promoting a uniform surface necessary for filling in surface imperfections.

"High gloss" means any coating that achieves at least 85% reflectance on a 60° meter when tested by ASTM Standard Test Method for Specular Gloss (see 9VAC5-20-21).

"High performance architectural coating" means a coating used to protect architectural subsections and that meets the requirements of the Architectural Aluminum Manufacturer Association's publication number AAMA 2604-05 (Voluntary Specification, Performance Requirements and Test Procedures for High Performance Organic Coatings on Aluminum Extrusions and Panels) or 2605-05 (Voluntary Specification, Performance Requirements and Test Procedures for Superior Performing Organic Coatings on Aluminum Extrusions and Panels).

"High temperature coating" means a coating that is certified to withstand a temperature of 1000°F for 24 hours.

"Metallic coating" means a coating that contains more than [ 5 five ] grams of metal particles per liter of coating as applied. "Metal particles" are pieces of a pure elemental metal or a combination of elemental metals.

"Military specification coating" means a coating that has a formulation approved by a United States military agency for use on military equipment.

"Miscellaneous metal parts and products" means a varied range of metal and plastic parts and products that are constructed either entirely or partially from metal or plastic. These miscellaneous metal products and plastic parts include, but are not limited to, metal and plastic components of the following types of products as well as the products themselves: fabricated metal products, molded plastic parts, small and large farm machinery, commercial and industrial machinery and equipment, automotive or transportation equipment, interior or exterior automotive parts, construction equipment, motor vehicle accessories, bicycles and sporting goods, toys, recreational vehicles, pleasure craft (recreational boats), extruded aluminum structural components, railroad cars, heavier vehicles (as defined in 40 CFR 63.3176), lawn and garden equipment, business machines, laboratory and medical equipment, electronic equipment, steel drums, metal pipes, and numerous other industrial and household products.

"Miscellaneous metal product and plastic parts coating" means coatings that include paints, sealants, caulks, inks, and maskants (decorative, protective, or functional materials that consist only of protective oils for metal, acids, bases, or any combination of these substances are not considered miscellaneous metal or plastic part coatings). The paints include several categories of primers, topcoats, and specialty coatings, typically defined by the coating's function. The types of coating technologies used by miscellaneous metal product and plastic part surface coating facilities include higher solids, waterborne, and powder coatings, as well as conventional solvent-borne coatings. Decorative, protective, or functional materials that consist only of protective oils for metal, acids, bases, or any combination of these substances are not considered miscellaneous metal or plastic part coatings.

"Miscellaneous metal product and plastic parts surface coating operation" means the application of surface coatings by the manufacturer of miscellaneous metal and plastic parts to the parts it produces, and by facilities that perform surface coating of miscellaneous metal and plastic parts on a contract basis.

"Mold seal coating" means the initial coating applied to a new mold or a repaired mold to provide a smooth surface that, when coated with a mold release coating, prevents products from sticking to the mold.

"Motor vehicle bedliner" means a multi-component coating, used at a facility that is not an automobile or light-duty truck assembly coating facility, applied to a cargo bed after the application of topcoat to provide additional durability and chip resistance.

"Motor vehicle cavity wax" means a coating, used at a facility that is not an automobile or light-duty truck assembly coating facility, applied into the cavities of the vehicle primarily for the purpose of enhancing corrosion protection.

"Motor vehicle deadener" means a coating, used at a facility that is not an automobile or light-duty truck assembly coating facility, applied to selected vehicle surfaces primarily for the purpose of reducing the sound of road noise in the passenger compartment.

"Motor vehicle gasket/sealing material" means a fluid, used at a facility that is not an automobile or light-duty truck assembly coating facility, applied to coat a gasket or replace and perform the same function as a gasket. Automobile and light-duty truck gasket/gasket sealing material includes room temperature vulcanization (RTV) seal material.

"Motor vehicle lubricating wax/compound" means a protective lubricating material, used at a facility that is not an automobile or light-duty truck assembly coating facility, applied to vehicle hubs and hinges.

"Motor vehicle sealer" means a high viscosity material, used at a facility that is not an automobile or light-duty truck assembly coating facility, generally, but not always, applied in the paint shop after the body has received an electrodeposition primer coating and before the application of subsequent coatings (e.g., primer-surfacer). The primary purpose of automobile and light-duty truck sealer is to fill body joints completely so that there is no intrusion of water, gases or corrosive materials into the passenger area of the body compartment. Such materials are also referred to as sealant, sealant primer, or caulk.

"Motor vehicle trunk interior coating" means a coating, used at a facility that is not an automobile or light-duty truck assembly coating facility, applied to the trunk interior to provide chip protection.

"Motor vehicle underbody coating" means a coating, used at a facility that is not an automobile or light-duty truck assembly coating facility, applied to the undercarriage or firewall to prevent corrosion [ and/or or ] provide chip protection.

"Multi-colored coating" means a coating that exhibits more than one color when applied, and which is packaged in a single container and applied in a single coat.

"Multi-component coating" means a coating requiring the addition of a separate reactive resin, commonly known as a catalyst or hardener, before application to form an acceptable dry film.

"One-component coating" means a coating that is ready for application as it comes out of its container to form an acceptable dry film. A thinner, necessary to reduce the viscosity, is not considered a component.

"Optical coating" means a coating applied to an optical lens.

"Pan-backing coating" means a coating applied to the surface of pots, pans, or other cooking implements that are exposed directly to a flame or other heating elements.

"Paper, film, and foil coating" means coating that is applied to paper, film, or foil surfaces in the manufacturing of several major product types for the following industry sectors: pressure sensitive tape and labels (including fabric coated for use in pressure sensitive tapes and labels); photographic film; industrial and decorative laminates; abrasive products (including fabric coated for use in abrasive products); and flexible packaging (including coating of nonwoven polymer substrates for use in flexible packaging). Paper and film coating also includes coatings applied during miscellaneous coating operations for several products including: corrugated and solid fiber boxes; die-cut paper paperboard, and cardboard; converted paper and paperboard not elsewhere classified; folding paperboard boxes, including sanitary boxes; manifold business forms and related products; plastic aseptic packaging; and carbon paper and inked ribbons.

"Pleasure craft" means vessels that are manufactured or operated primarily for recreational purposes, or leased, rented, or chartered to a person or business for recreational purposes. The owner of such vessels shall be responsible for certifying that the intended use is for recreational purposes.

"Pleasure craft coating" means any marine coating, except unsaturated polyester resin (fiberglass) coatings, applied by brush, spray, roller, or other means to a pleasure craft.

"Prefabricated architectural component coatings" means coatings applied to metal parts and products that are to be used as an architectural structure.

"Pretreatment coating" means a coating that contains no more than 12% solids by weight, and at least 0.5% acid, by weight, is used to provide surface etching, and is applied directly to metal surfaces to provide corrosion resistance, adhesion, and ease of stripping.

"Pretreatment wash primer" means a coating that contains no more than 12% solids, by weight, and at least 0.5% acids, by weight; is used to provide surface etching; and is applied directly to fiberglass and metal surfaces to provide corrosion resistance and adhesion of subsequent coatings.

"Red automotive coating" means a coating that meets all of the following criteria:

1. Yellow limit: the hue of hostaperm scarlet.

2. Blue limit: the hue of monastral red-violet.

3. Lightness limit for metallics: 35% aluminum flake.

4. Lightness limit for solids: 50% titanium dioxide white.

5. Solid reds: hue angle of -11 to 38 degrees and maximum lightness of 23 to 45 units.

6. Metallic reds: hue angle of -16 to 35 degrees and maximum lightness of 28 to 45 units.

These criteria are based on Cielab color space, 0/45 geometry. For spherical geometry, specular included, the upper limit is 49 units. The maximum lightness varies as the hue moves from violet to orange. This is a natural consequence of the strength of the colorants, and real colors show this effect.

"Repair coating" means a coating used to re-coat portions of a previously coated product that has sustained mechanical damage to the coating following normal coating operations.

"Shock-free coating" means a coating applied to electrical components to protect the user from electric shock. The coating has characteristics of being of low capacitance and high resistance, and having resistance to breaking down under high voltage.

"Silicone release coating" means any coating that contains silicone resin and is intended to prevent food from sticking to metal surfaces such as baking pans.

"Solar-absorbent coating" means a coating that has as its prime purpose the absorption of solar radiation.

"Texture coating" means a coating that is applied to a plastic part that, in its finished form, consists of discrete raised spots of the coating.

"Topcoat" means any final coating applied to the interior or exterior of a pleasure craft.

"Touchup coating" means a coating used to cover minor coating imperfections appearing after the main coating operation.

"Vacuum-metalizing coating" means:

1. For general use, the undercoat applied to the substrate on which the metal is deposited or the overcoat applied directly to the metal film. Vacuum metalizing/physical vapor deposition (PVD) is the process whereby metal is vaporized and deposited on a substrate in a vacuum chamber.

2. For automotive/transportation and business machine use, topcoats and basecoats that are used in the vacuum-metalizing process.

"VOC" means volatile organic compound.

"Wood furniture coatings" means protective, decorative, or functional films applied in thin layers to a surface used in the manufacture of wood furniture or wood furniture components. Such coatings include, but are not limited to, paints, topcoats, varnishes, sealers, stains, washcoats, basecoats, enamels, inks, and temporary protective coatings.

9VAC5-40-8830. Standard for volatile organic compounds.

A. No owner or other person shall cause or permit the discharge into the atmosphere from a coating application system any volatile organic compound in excess of the limits contained in Tables 4-59A through 4-59E. The VOC content limits are mass VOC per gallon of coating less water and exempt solvents and are based on low-VOC coatings. If more than one emission limitation in this subsection applies to a specific coating, then the least-stringent emission limitation shall be applied.

Title of Regulation: 9VAC5-40. Existing Stationary Sources (Rev. D09) (adding 9VAC5-40-8510 through 9VAC5-40-8800).

Statutory Authority: § 10.1-1308 of the Code of Virginia; §§ 110, 111, 123, 129, 171, 172, and 182 of the federal Clean Air Act (40 CFR Parts 51 and 60).

Effective Date: February 1, 2016.

Agency Contact: Karen G. Sabasteanski, Department of Environmental Quality, 629 East Main Street, P.O. Box 1105, Richmond, VA 23218, telephone (804) 698-4426, FAX (804) 698-4510, or email karen.sabasteanski@deq.virginia.gov.

Summary:

The regulation requires owners to limit emissions of air pollution from industrial solvent cleaning operations and miscellaneous industrial adhesive application processes to the level necessary for the protection of public health and welfare and the attainment and maintenance of the air quality standards. The regulation applies to sources within the Northern Virginia Volatile Organic Compound Emissions Control Area and establishes standards, control techniques, and provisions for determining compliance. The regulation includes provisions for visible emissions, fugitive dust, odor, toxic pollutants, compliance, test methods and procedures, monitoring, notification, registration, malfunctions, and permits. The final amendments add an alternative work practices procedure and an alternative standard for coatings, inks, adhesives, and resin manufacturing operations.

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.

Article 57
Emission Standards for Industrial Solvent Cleaning Operations in the Northern Virginia Volatile Organic Compound Emissions Control Area, 8-hour Ozone Standard (Rule 4-57)

9VAC5-40-8510. Applicability and designation of affected facility.

A. Except as provided in subsections C and D of this section, the affected facility to which the provisions of this article apply is each facility that uses organic solvent for cleaning unit operations such as mixing vessels (tanks), spray booths, and parts cleaners and that emits, before consideration of controls, at least 6.8 kilograms per day (15 pounds per day) of volatile organic compounds (VOCs). Such operations include, but are not limited to, spray gun cleaning, spray booth cleaning, large manufactured components cleaning, parts cleaning, equipment cleaning, line cleaning, floor cleaning, tank cleaning, and small manufactured components cleaning.

B. The provisions of this article apply only to affected facilities located in the Northern Virginia VOC Emissions Control Area designated in subdivision 1 a of 9VAC5-20-206.

C. Exempted from the provisions of this article are solvent cleaning operations (i) for cleaning of electrical and electronic components; (ii) for cleaning of high precision optics and cleaning of cotton swabs to remove cottonseed oil before cleaning of high precision optics; (iii) for cleaning of numismatic dies; (iv) for cleaning of resin, coating, ink, and adhesive mixing, molding, and application equipment; (v) in research and development laboratories; (vi) in manufacturing medical devices or pharmaceutical products; (vii) related to performance or quality assurance testing of coatings, inks, or adhesives.

D. The provisions of this article do not apply to the following:

1. Surface preparation and solvent cleaning operations associated with the surface coating, application of adhesive, sealants and their primers or printing operations subject to Article 26 (Large Appliance Coatings, 9VAC5-40-3560 et seq.), Article 28 (Automobile and Light Duty Truck Coating Applications, 9VAC5-40-3860 et seq.), Article 33 (Metal Furniture Coating Application Systems, 9VAC5-40-4610 et seq.), Article 34 (Miscellaneous Metal Parts/Products Coating Application, 9VAC5-40-4760), Article 35 (Flatwood Paneling Coating Application Systems, 9VAC5-40-4910 et seq.), Article 53 (Lithographic Printing Processes, 9VAC5-40-7800 et seq.), Article 56 (Letterpress Printing Operations, 9VAC5-40-8380 et seq.), Article 56.1 (Lithographic Printing Operations, 9VAC5-40-8420 et seq.), Article 58 (Miscellaneous Industrial Adhesive Application Processes, 9VAC5-40-8660 et seq.), and Article 59 (Miscellaneous Metal Parts and Products Coating Application Systems, 9VAC5-40-8810 et seq.) of 9VAC5-40 (Existing Stationary Sources).

2. The use of janitorial supplies used for cleaning offices, bathrooms, or other similar areas.

3. Stripping of cured inks, coatings, and adhesives.

4. Surface preparation and solvent cleaning operations associated with the surface coating, application of adhesive, sealants and their primers, or printing operations of the following product categories or processes: aerospace coatings, wood furniture coatings, shipbuilding and repair coatings, flexible packaging printing materials, paper film and foil coating, plastic parts coating, and fiberglass boat manufacturing materials.

5. Solvent metal cleaning operations subject to Article 47 (Emission Standards for Solvent Metal Cleaning Operations in the Northern Virginia Volatile Organic Compound Emissions Control Area, 9VAC5-40-6820 et seq.) of 9VAC5-40 (Existing Stationary Sources).

[ 6. The use of cleaning solvent in a digital printing operation in which an electronic output device transfers variable data, in the form of an image, from a computer to a substrate. ]

9VAC5-40-8520. Definitions.

A. For the purpose of applying this article in the context of the regulations for the control and abatement of air pollution and related uses, the words or terms shall have the meanings given them in subsection C of this section.

B. Unless otherwise required by context, all terms not defined in this section shall have the meanings given them in 9VAC5-170 (Regulation for General Administration), 9VAC5-10 (General Definitions), or commonly ascribed to them by recognized authorities, in that order of priority.

C. Terms defined.

"Aerospace coatings" means materials that are applied to the surface of an aerospace vehicle or component to form a decorative, protective, or functional solid film, or the solid film itself at a facility that produces, reworks, or repairs in any amount any commercial, civil, or military aerospace vehicle or component.

"Electrical and electronic components" means components and assemblies of components that generate, convert, transmit, or modify electrical energy. Electrical and electronic components include, but are not limited to, wires, windings, stators, rotors, magnets, contacts, relays, printed circuit boards, printed wire assemblies, wiring boards, integrated circuits, resistors, capacitors, and transistors but does not include the cabinets in which electrical and electronic components are housed.

"Fiberglass boat manufacturing materials" means materials utilized at facilities that manufacture hulls or decks of boats from fiberglass or build molds to make fiberglass boat hulls or decks. Fiberglass boat manufacturing materials are not materials used at facilities that manufacture solely parts of boats (such as hatches, seats, or lockers) or boat trailers, but do not (i) manufacture hulls or decks of boats from fiberglass or (ii) build molds to make fiberglass boat hulls or decks.

"Flexible packaging printing materials" means materials used in the manufacture of any package or part of a package the shape of which can be readily changed. Flexible packaging includes, but is not limited to, bags, pouches, liners, and wraps utilizing paper, plastic, film, aluminum foil, metalized or coated paper or film, or any combination of these materials.

"High precision optics" means an optical element used in an electro-optical device and is designed to sense, detect, or transmit light energy, including specific wavelengths of light energy and changes in light energy levels.

"Industrial cleaning solvents" means products used to remove contaminants such as adhesives, inks, paint, dirt, soil, oil, and grease from parts, products, tools, machinery, equipment, vessels, floors, walls, and other work production related work areas for reasons such as safety, operability, and to avoid product contamination. The cleaning solvents used in these operations may be generally available bulk solvents that are used for a multitude of applications in addition to cleaning, such as for paint thinner, or as an ingredient used in the manufacture of a coating, such as paint.

"Medical device" means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar article, including any component or accessory that is (i) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of diseases; or (ii) intended to affect the structure or any function of the body.

"Paper, film, and foil coating" means coating that is applied to paper, film, or foil surfaces in the manufacturing of several major product types for the following industry sectors: pressure sensitive tape and labels (including fabric coated for use in pressure sensitive tapes and labels); photographic film; industrial and decorative laminates; abrasive products (including fabric coated for use in abrasive products); and flexible packaging (including coating of nonwoven polymer substrates for use in flexible packaging). Paper and film coating also includes coatings applied during miscellaneous coating operations for several products including: corrugated and solid fiber boxes; die-cut paper paperboard, and cardboard; converted paper and paperboard not elsewhere classified; folding paperboard boxes, including sanitary boxes; manifold business forms and related products; plastic aseptic packaging; and carbon paper and inked ribbons.

"Pharmaceutical product" means a preparation or compound, which includes any drug, analgesic, decongestant, antihistamine, cough suppressant, vitamin, mineral or herb supplement intended for human or animal consumption and used to cure, mitigate or treat disease or improve or enhance health.

"Plastic parts coating" means a coating that is applied to the surfaces of a varied range of plastic parts and products. Such parts or products are constructed either entirely or partially from metal or plastic. These parts include, but are not limited to, metal and plastic components of the following types of products as well as the products themselves: fabricated metal products, molded plastic parts, small and large farm machinery, commercial and industrial machinery and equipment, automotive or transportation equipment, interior or exterior automotive parts, construction equipment, motor vehicle accessories, bicycles and sporting goods, toys, recreational vehicles, pleasure craft (recreational boats), extruded aluminum structural components, railroad cars, heavier vehicles, lawn and garden equipment, business machines, laboratory and medical equipment, electronic equipment, steel drums, metal pipes, and numerous other industrial and household products.

"Shipbuilding and repair coating" means material that can be applied as a thin layer to a substrate and which cures to form a continuous solid film, and is used in the building, repair, repainting, converting, or alteration of ships.

"Solvent cleaning operation" means the employment of industrial cleaning solvents to remove loosely held uncured adhesives, uncured inks, uncured coatings, and contaminants [ , ] which include, but are not limited to, dirt, soil, and grease [ , ] from parts, products, tools, machinery, equipment, and general work areas and includes but is not limited to activities such as wipe cleaning, solvent flushing, or spraying [ and each. Each ] distinct method of cleaning in a cleaning process, which consists of a series of cleaning methods, [ shall ] constitute a separate solvent cleaning operation.

"Solvent flushing" means the use of a solvent to remove uncured adhesives, uncured inks, uncured coatings, or contaminants from the internal surfaces and passages of the equipment by flushing solvent through the equipment.

"Surface preparation" means the cleaning of surfaces prior to coating, further treatment, sale, or intended use.

"VOC" means volatile organic compound.

"Wipe cleaning" means the method of cleaning a surface by physically rubbing it with a material such as a rag, paper, sponge, or a cotton swab moistened with a solvent.

"Wood furniture coatings" means protective, decorative, or functional films applied in thin layers to a surface used in the manufacture of wood furniture or wood furniture components. Such coatings include, but are not limited to, paints, topcoats, varnishes, sealers, stains, washcoats, basecoats, enamels, inks, and temporary protective coatings.

9VAC5-40-8530. Standard for volatile organic compounds.

A. No owner or other person shall cause or permit to be discharged into the atmosphere any VOC emissions from any solvent cleaning operation employing industrial cleaning solvents in excess of both of the following limits:

1. A VOC content limit of 50 grams per liter (0.42 pounds per gallon) of industrial cleaning solvent shall apply unless emissions are controlled by an emission control system with an overall control efficiency of at least 85%; and

2. A composite vapor pressure limit of [ 8 eight ] millimeters of mercury at 20°C.

B. VOC emissions from the use, handling, storage, and disposal of industrial cleaning solvents and shop towels shall be controlled by the following work practices:

1. Open containers and used applicators shall be covered.

2. Air circulation around cleaning operations shall be minimized.

3. Used solvent and shop towels shall be disposed of properly.

4. Equipment practices that minimize emissions (including but not limited to keeping arts cleaners covered and maintaining cleaning equipment to repair solvent leaks) shall be implemented.

[ C. In lieu of complying with the requirements of subsections A and B of this section, a manufacturer of coatings, inks, resin, or adhesives may comply with the following requirements:

1. Clean portable or stationary mixing vats, high dispersion mills, grinding mills, tote tanks, and roller mills by one or more of the following methods:

a. Use a cleaning solvent that either contains less than 1.67 pounds per gallon of VOC or has a composite vapor pressure no more than eight mmHg at 20°C;

b. Comply with the following work practices:

(1) Equipment being cleaned shall be maintained leak free;

(2) VOC-containing cleaning materials shall be drained from the cleaned equipment upon completion of cleaning;

(3) VOC-containing cleaning materials, including waste solvent, shall not be stored or disposed of in such a manner that will cause or allow evaporation into the atmosphere; and

(4) All VOC-containing cleaning materials shall be stored in closed containers.

c. Collect and vent the emissions from equipment cleaning to a VOC emission control system that has an overall capture and control efficiency of at least 80%, by weight, for the VOC emissions. Where such reduction is achieved by incineration, at least 90% of the organic carbon shall be oxidized to carbon dioxide.

d. Use organic solvents other than those allowed in subdivision 1 a of this subsection provided no more than 60 gallons of fresh solvent shall be used per month. Organic solvent that is reused or recycled (either on site or off site) for further use in equipment cleaning or the manufacture of coating, ink, or adhesive shall not be included in this limit. All VOC-containing cleaning materials shall be stored in closed containers.

2. When using solvent for wipe cleaning, the owner shall not (i) use open containers for the storage or disposal of cloth or paper impregnated with organic compounds that is used for cleanup, or coating, ink, or adhesive removal and (ii) store spent or fresh organic compounds to be used for cleanup or coating, ink, resin, or adhesive removal in open containers.

3. Any manufacturer of coatings, inks, resin, or adhesives that complies with subdivision 1 d of this subsection shall record the following information each month for each cleaning material and shall maintain the information at the facility for a period of five years: (i) the total volume of fresh cleaning solvent material used for equipment cleaning and (ii) the total volume of cleaning solvent material recovered for either on-site or off-site recycling.

D. The control requirements for screen printing shall be either use of solvent technology at 4.2 pounds of VOC per gallon, or the use of a product with a vapor pressure of eight mm Hg. ]

9VAC5-40-8540. Standard for visible emissions.

The provisions of Article 1 (9VAC5-40-60 et seq.) of Part II of 9VAC5-40 (Existing Stationary Sources) apply.

9VAC5-40-8550. Standard for fugitive dust/emissions.

The provisions of Article 1 (9VAC5-40-60 et seq.) of Part II of 9VAC5-40 (Existing Stationary Sources) apply.

9VAC5-40-8560. Standard for odor.

The provisions of Article 2 (9VAC5-40-130 et seq.) of Part II of 9VAC-40 (Existing Stationary Sources) apply.

9VAC5-40-8570. Standard for toxic pollutants.

The provisions of Article 4 (9VAC5-60-200 et seq.) of Part II of 9VAC5-60 (Hazardous Air Pollutant Sources) apply.

9VAC5-40-8580. Compliance.

The provisions of 9VAC5-40-20 (Compliance) apply.

9VAC5-40-8590. Compliance schedule.

The owner shall comply with the provisions of this article as expeditiously as possible but in no case later than [ (insert date one year after the effective date of this article) February 1, 2017 ].

9VAC5-40-8600. Test methods and procedures.

A. The provisions of 9VAC5-40-30 (Emission testing) apply.

B. The composite vapor pressure of organic compounds in cleaning materials shall be determined by quantifying the amount of each compound in the blend using ASTM "Standard Practice for Packed Column Gas Chromatography" for organics and ASTM "Standard Test Method for Water Content of Coatings by Direct Injection Into a Gas Chromatograph" for water content (see 9VAC5-20-21), as applicable, and the following equation:

where:

Ppc = VOC composite partial pressure at 20ºC, in mm Hg.

Wi = Weight of the "i"th VOC compound, in grams, as determined by

ASTM "Standard Practice for Packed Column Gas Chromatography" (see 9VAC5-20-

21).

Ww = Weight of water, in grams as determined by ASTM "Standard Test

Method for Water Content of Coatings by Direct Injection Into a Gas Chromatograph"

(see 9VAC5-20-21).

We = Weight of the "i"th exempt compound, in grams, as determined by

ASTM "Standard Practice for Packed Column Gas Chromatography" (see 9VAC5-20-21).

Mwi = Molecular weight of the "i"th VOC compound, in grams per g-mole,

as given in chemical reference literature.

Mww = Molecular weight of water, 18 grams per g-mole.

Mwe = Molecular weight of the "i"th exempt compound, in grams per g-mole,

as given in chemical reference literature.

VPi = Vapor pressure of the "i"th VOC compound at 20ºC, in mm Hg, as determined by subsection C of this section.

C. The vapor pressure of each single component compound may be determined from ASTM "Standard Test Method for Vapor Pressure-Temperature Relationship and Initial Decomposition Temperature of Liquids by Isoteniscope" (see 9VAC5-20-21), from chemical reference literature, or from additional sources acceptable to the board.

9VAC5-40-8610. Monitoring.

The provisions of 9VAC5-40-40 (Monitoring) apply.

9VAC5-40-8620. Notification, records, and reporting.

The provisions of 9VAC5-40-50 (Notification, records and reporting) apply.

9VAC5-40-8630. Registration.

The provisions of 9VAC5-20-160 (Registration) apply.

9VAC5-40-8640. Facility and control equipment maintenance or malfunction.

The provisions of 9VAC5-20-180 (Facility and control equipment maintenance or malfunction) apply.

9VAC5-40-8650. Permits.

A permit may be required prior to beginning any of the activities specified below if the provisions of 9VAC5-50 (New and Modified Stationary Sources) and 9VAC5-80 (Permits for Stationary Sources) apply. Owners contemplating such action should review those provisions and contact the appropriate regional office for guidance on whether those provisions apply.

1. Construction of a facility.

2. Reconstruction (replacement of more than half) of a facility.

3. Modification (any physical change to equipment) of a facility.

4. Relocation of a facility.

5. Reactivation (re-startup) of a facility.

6. Operation of a facility.

Article 58
Emission Standards for Miscellaneous Industrial Adhesive Application Processes in the Northern Virginia Volatile Organic Compound Emissions Control Area, 8-hour Ozone Standard (Rule 4-58)

9VAC5-40-8660. Applicability and designation of affected facility.

A. Except as provided in subsection C of this section, the affected facility to which the provisions of this article apply is each miscellaneous industrial adhesive application process at a facility where the total actual volatile organic compound (VOC) emissions from all miscellaneous industrial adhesive application processes, including related cleaning activities and related application of adhesive primers, are, before consideration of controls, either (i) equal to or exceed 6.8 kilograms per day (15 pounds per day) or (ii) [ 3 three ] tons per 12-month rolling period.

B. The provisions of this article apply only to sources of VOCs located in the Northern Virginia VOC Emissions Control Area designated in 9VAC5-20-206 1 a.

C. The provisions of this article do not apply to the following.

1. Miscellaneous industrial adhesive application process operations subject to Article 6 (Rubber Tire Manufacturing Operations, 9VAC5-40-5810 et seq.), Article 26 (Large Appliance Coatings, 9VAC5-40-3560 et seq.), Article 28 (Automobile and Light Duty Truck Coating Applications, 9VAC5-40-3860 et seq.), Article 30 (Metal Coil Coating Application Systems, 9VAC5-40-4160 et seq.), Article 31 (Paper and Fabric Coating Application Systems, 9VAC5-40-4310 et seq.) Article 33 (Metal Furniture Coating Application Systems, 9VAC5-40-4610 et seq.), Article 35 (Flatwood Paneling Coating Application Systems, 9VAC5-40-4910 et seq.), Article 53 (Lithographic Printing Processes, 9VAC5-40-7800 et seq.), Article 56 (Letterpress Printing Operations, 9VAC5-40-8380 et seq.), Article 56.1 (Lithographic Printing Operations, 9VAC5-40-8420 et seq.), and Article 57 (Industrial Solvent Cleaning Operations, 9VAC5-40-8510 et seq.) of 9VAC5-40 (Existing Stationary Sources).

2. Miscellaneous industrial adhesive application process operations associated with the following product categories or processes: aerospace coatings, flexible packaging printing materials, paper film and foil coating, and fiberglass boat manufacturing materials.

D. The provisions of Article 6 (Emission Standards for Adhesives and Sealants, 9VAC5-45-620 et seq.) of 9VAC5-45 (Consumer and Commercial Products) may apply. In the case of a conflict between these articles, the more restrictive provisions shall apply.

9VAC5-40-8670. Definitions.

A. For the purpose of applying this article in the context of the regulations for the control and abatement of air pollution and related uses, the words or terms shall have the meanings given them in subsection C of this section.

B. Unless otherwise required by context, all terms not defined in this section shall have the meanings given them in 9VAC5-170 (Regulation for General Administration), 9VAC5-10 (General Definitions), or commonly ascribed to them by recognized authorities, in that order of priority.

C. Terms defined.

"ABS welding" means any process to weld acrylonitrile-butadiene-styrene pipe.

"Adhesive" means any chemical substance that is applied for the purpose of bonding two surfaces together other than by mechanical means.

"Adhesive primer" means any product intended by the manufacturer for application to a substrate, prior to the application of an adhesive, to provide a bonding surface.

"Aerosol adhesive or adhesive primer" means an adhesive or adhesive primer packaged as an aerosol product in which the spray mechanism is permanently housed in a nonrefillable can designed for handheld application without the need for ancillary hoses or spray equipment.

"Aerospace coatings" means materials that are applied to the surface of an aerospace vehicle or component to form a decorative, protective, or functional solid film, or the solid film itself at a facility that produces, reworks, or repairs in any amount any commercial, civil, or military aerospace vehicle or component.

"Application process" means a series of one or more adhesive applicators and any associated drying area or oven in which an adhesive is applied, dried, or cured. An application process ends at the point where the adhesive is dried or cured, or prior to any subsequent application of a different adhesive. It is not necessary for an application process to have an oven or flash-off area.

"Ceramic tile installation adhesive" means any adhesive intended by the manufacturer for use in the installation of ceramic tiles.

"Chlorinated polyvinyl chloride plastic" or "CPVC plastic welding" means a polymer of the vinyl chloride monomer that contains 67% chlorine and is normally identified with a CPVC marking.

"Chlorinated polyvinyl chloride welding" or "CPVC welding" means an adhesive labeled for welding of chlorinated polyvinyl chloride plastic.

"Cleaning activities" means activities other than surface preparation and priming that use cleaning materials to remove adhesive residue or other unwanted materials from equipment related to application operations, as well as the cleaning of spray guns, transfer lines (such as tubing or piping), tanks, and the interior of spray booths.

"Contact adhesive" means an adhesive that (i) is designed for application to both surfaces to be bonded together, (ii) is allowed to dry before the two surfaces are placed in contact with each other, (iii) forms an immediate bond that is impossible, or difficult, to reposition after both adhesive-coated surfaces are placed in contact with each other, and (iv) does not need sustained pressure or clamping of surfaces after the adhesive-coated surfaces have been brought together using sufficient momentary pressure to establish full contact between both surfaces. Contact adhesive does not include rubber cements that are primarily intended for use on paper substrates or vulcanizing fluids that are designed and labeled for tire repair only.

"Cove base" means a flooring trim unit, generally made of vinyl or rubber, having a concave radius on one edge and a convex radius on the opposite edge that is used in forming a junction between the bottom wall course and the floor or to form an inside corner.

"Cove base installation adhesive" means any adhesive intended by the manufacturer to be used for the installation of cove base or wall base on a wall or vertical surface at floor level.

"Cyanoacrylate adhesive" means any adhesive with a cyanoacrylate content of at least 95% by weight.

"Fiberglass boat manufacturing facility" means a facility that manufactures hulls or decks of boats from fiberglass or builds molds to make fiberglass boat hulls or decks and does not include a facility that solely manufactures parts of boats (such as hatches, seats, or lockers) or boat trailers, that is, which does not also manufacture hulls or decks of boats from fiberglass or builds molds to make fiberglass boat hulls or decks.

"Fiberglass boat manufacturing materials" means materials utilized at fiberglass boat manufacturing facilities to manufacture hulls or decks of boats from fiberglass, and parts of boats (such as hatches, seats, or lockers), or to build molds to make fiberglass boat hulls or decks.

"Flexible packaging printing materials" means materials used in the manufacture of any package or part of a package the shape of which can be readily changed. Flexible packaging includes, but is not limited to, bags, pouches, liners, and wraps utilizing paper, plastic, film, aluminum foil, metalized or coated paper or film, or any combination of these materials.

"Flexible vinyl" means nonrigid polyvinyl chloride plastic with a 5.0% by weight plasticizer content.

"Indoor floor covering installation adhesive" means any adhesive intended by the manufacturer for use in the installation of wood flooring, carpet, resilient tile, vinyl tile, vinyl backed carpet, resilient sheet and roll, or artificial grass. Adhesives used to install ceramic tile and perimeter bonded sheet flooring with vinyl backing onto a nonporous substrate, such as flexible vinyl, are excluded from this category.

"Industrial adhesives" means adhesives used for joining surfaces in assembly and construction of a large variety of products. Adhesives may be generally classified as solution/waterborne, solvent-borne, solventless or solid (such as hot melt adhesives), pressure sensitive, hot-melt, or reactive (such as epoxy adhesives and ultraviolet-curable adhesives). Adhesives may also be generally classified according to whether they are structural or nonstructural. Structural adhesives are commonly used in industrial assembly processes and are designed to maintain product structural integrity.

"Medical equipment manufacturing" means the manufacture of medical devices, such as, but not limited to, catheters, heart valves, blood cardioplegia machines, tracheostomy tubes, blood oxygenators, and cardiatory reservoirs.

"Metal to urethane/rubber molding or casting adhesive" means any adhesive intended by the manufacturer to bond metal to high density or elastomeric urethane or molded rubber materials, in heater molding or casting processes, to fabricate products such as rollers for computer printers or other paper handling equipment.

"Motor vehicle adhesive" means an adhesive, including glass bonding adhesive, used at a facility that is not an automobile or light-duty truck assembly coating facility, applied for the purpose of bonding two vehicle surfaces together without regard to the substrates involved.

"Motor vehicle glass bonding primer" means a primer, used at a facility that is not an automobile or light-duty truck assembly coating facility, applied to windshield or other glass, or to body openings, to prepare the glass or body opening for the application of glass bonding adhesives or the installation of adhesive bonded glass. Motor vehicle glass bonding primer includes glass bonding/cleaning primers that perform both functions (cleaning and priming of the windshield or other glass, or body openings) prior to the application of adhesive or the installation of adhesive bonded glass.

"Motor vehicle weatherstrip adhesive" means an adhesive, used at a facility that is not an automobile or light-duty truck assembly coating facility, applied to weatherstripping materials for the purpose of bonding the weatherstrip material to the surface of the vehicle.

"Multipurpose construction adhesive" means any adhesive intended by the manufacturer for use in the installation or repair of various construction materials, including but not limited to drywall, subfloor, panel, fiberglass reinforced plastic (FRP), ceiling tile, and acoustical tile.

"Outdoor floor covering installation adhesive" means any adhesive intended by the manufacturer for use in the installation of floor covering that is not in an enclosure and that is exposed to ambient weather conditions during normal use.

"Paper, film, and foil coating" means coating that is applied to paper, film, or foil surfaces in the manufacturing of several major product types for the following industry sectors: pressure sensitive tape and labels (including fabric coated for use in pressure sensitive tapes and labels); photographic film; industrial and decorative laminates; abrasive products (including fabric coated for use in abrasive products); and flexible packaging (including coating of nonwoven polymer substrates for use in flexible packaging). Paper and film coating also includes coatings applied during miscellaneous coating operations for several products including: corrugated and solid fiber boxes; die-cut paper paperboard, and cardboard; converted paper and paperboard not elsewhere classified; folding paperboard boxes, including sanitary boxes; manifold business forms and related products; plastic aseptic packaging; and carbon paper and inked ribbons.

"Perimeter bonded sheet flooring installation" means the installation of sheet flooring with vinyl backing onto a nonporous substrate using an adhesive designed to be applied only to a strip of up to four inches wide around the perimeter of the sheet flooring.

"Plastic" means a synthetic material chemically formed by the polymerization of organic (carbon-based) substances. Plastics are usually compounded with modifiers, extenders, and/or reinforcers and are capable of being molded, extruded, cast into various shapes and films or drawn into filaments.

"Plastic solvent welding adhesive" means any adhesive intended by the manufacturer for use to dissolve the surface of plastic to form a bond between mating surfaces.

"Plastic solvent welding adhesive primer" means any primer intended by the manufacturer for use to prepare plastic substrates prior to bonding or welding.

"Polyvinyl chloride plastic" or "PVC" means a polymer of the chlorinated vinyl monomer that contains 57% chlorine.

"Polyvinyl chloride welding adhesive" or "PVC welding adhesive" means any adhesive intended by the manufacturer for use in the welding of PVC plastic pipe.

"Porous material" means a substance that has tiny openings, often microscopic, in which fluids may be absorbed or discharged, including, but not limited to, paper and corrugated paperboard. For the purposes of this article, porous materialdoes not include wood.

"Reactive adhesive" means adhesive systems composed, in part, of volatile monomers that react during the adhesive curing reaction, and, as a result, do not evolve from the film during use. These volatile components instead become integral parts of the adhesive through chemical reaction. At least 70% of the liquid components of the system, excluding water, react during the process.

"Reinforced plastic composite" means a composite material consisting of plastic reinforced with fibers.

"Rubber" means any natural or manufactured rubber substrate, including but not limited to, styrene-butadiene rubber, polychloroprene (neoprene), butyl rubber, nitrile rubber, chlorosulfonated polyethylene, and ethylene propylene diene terpolymer.

"Sheet rubber lining installation" means the process of applying sheet rubber liners by hand to metal or plastic substrates to protect the underlying substrate from corrosion or abrasion. These operations also include laminating sheet rubber to fabric by hand.

"Single-ply roof membrane" means a prefabricated single sheet of rubber, normally ethylene-propylenediene terpolymer, that is field-applied to a building roof using one layer of membrane material. For the purposes of this article, single-ply roof membrane does not include membranes prefabricated from ethylene-propylenediene monomer (EPDM).

"Single-ply roof membrane adhesive primer" means any primer labeled for use to clean and promote adhesion of the single-ply roof membrane seams or splices prior to bonding.

"Single-ply roof membrane installation and repair adhesive" means any adhesive labeled for use in the installation or repair of single-ply roof membrane. Installation includes, as a minimum, attaching the edge of the membrane to the edge of the roof and applying flashings to vents, pipes, and ducts that protrude through the membrane. Repair includes gluing the edges of torn membrane together, attaching a patch over a hole and reapplying flashings to vents, pipes, or ducts installed through the membrane.

"Structural glazing" means a process that includes the application of adhesive to bond glass, ceramic, metal, stone, or composite panels to exterior building frames.

"Thin metal laminating adhesive" means any adhesive intended by the manufacturer for use in bonding multiple layers of metal to metal or metal to plastic in the production of electronic or magnetic components in which the thickness of the bond line or lines is less than 0.25 mils.

"Tire repair" means a process that includes expanding a hole, tear, fissure, or blemish in a tire casing by grinding, gouging, or applying adhesive and filling the hole or crevice with rubber.

"Undersea-based weapons systems components" means the fabrication of parts, assembly of parts or completed units of any portion of a missile launching system used on undersea ships.

"VOC" means volatile organic compound.

"Waterproof resorcinol glue" means a two-part resorcinol-resin-based adhesive designed for applications where the bond line must be resistant to conditions of continuous immersion in fresh or salt water.

9VAC5-40-8680. Standard for volatile organic compounds.

A. No owner or other person shall perform miscellaneous industrial adhesive application processes in excess of the following limits.

1. Facilities opting to meet specific emissions limits in lieu of the control efficiency in subdivision 2 of this subsection shall meet the applicable emissions limits in Table 4-58A.

a. The VOC content limits in Table 4-58A for adhesives applied to particular substrates shall apply as follows:

(1) If an owner or other person uses an adhesive or sealant subject to a specific VOC content limit for such adhesive or sealant in Table 4-58A, such specific limit is applicable rather than an adhesive-to-substrate limit.

(2) If an adhesive is used to bond dissimilar substrates together, the applicable substrate category with the highest VOC content shall be the limit for such use.

b. The emission limits in Table 4-58A shall be met by averaging the VOC content of materials used on a single application process unit for each day (i.e., daily within-application process unit averaging). Cross-application process unit averaging (i.e., averaging across multiple application units) shall not be used to determine these emission limits.

c. VOC content shall be determined as follows:

(1) For adhesives that are not reactive adhesives, VOC content shall be determined using Reference Method 24.

(2) For reactive adhesives, VOC content shall be determined using the procedure for reactive adhesives in Appendix A of subpart PPPP of 40 CFR Part 63.

(3) As an alternative to the methods in subdivisions (1) and (2) of this subdivision A 1 c, the manufacturer's formulation data may be used. If there is a disagreement between manufacturer's formulation data and the results of a subsequent test, the test method results shall be used unless the facility can demonstrate to the board's satisfaction that the manufacturer's formulation data are correct.

2. Facilities opting to meet a control efficiency in lieu of the specific emission limits in subdivision 1 of this subsection shall meet an overall control efficiency of 85%.

3. The following materials shall not be subject to the limits and controls found in subdivisions 1 and 2 of this subsection but shall be subject to the work practices found in subdivision B 3 of this section:

a. Adhesives or adhesive primers being tested or evaluated in any research and development, quality assurance, or analytical laboratory.

b. Adhesives or adhesive primers used in the assembly, repair, or manufacture of aerospace or undersea-based weapon systems.

c. Adhesives or adhesive primers used in medical equipment manufacturing operations.

d. Cyanoacrylate adhesive application processes.

e. Application of aerosol adhesives and adhesive primers applied with a handheld, disposable can that is pressured and that dispenses an adhesive or adhesive primer by means of a propellant. Aerosol adhesives are regulated by VOC Emission Standards for Consumer Products, subpart C of 40 CFR Part 59. Aerosol adhesive primers are regulated as "primers" under VOC Emission Standards for Aerosol Coatings, subpart E of 40 CFR Part 59.

f. Processes using polyester bonding putties to assemble fiberglass parts at fiberglass boat manufacturing facilities and at other reinforced plastic composite manufacturing facilities.

g. Processes using adhesives and adhesive primers that are supplied by the manufacturer in containers with a net volume of 16 ounces or less, or a net weight of one pound or less.

h. Cleaning materials.

B. The owner of a facility subject to this article shall implement the following control options as applicable:

1. A facility using low-VOC adhesives or adhesive primers shall use one of the following application methods:

a. Electrostatic spray;

b. HVLP spray;

c. Flow coat;

d. Roll coat or hand application, including nonspray application methods similar to hand or mechanically powered caulking gun, brush, or direct hand application;

e. Dip coat, including electrodeposition;

f. Airless spray;

g. Air-assisted airless spray; or

h. Other adhesive application method capable of achieving a transfer efficiency equivalent to or better than that achieved by HVLP spraying.

2. A facility with product performance requirements or other needs that dictate the use of higher-VOC materials than those that would meet the emission limits in Table 4-58A shall either (i) use add-on control equipment with an overall control efficiency of 85% or (ii) use a combination of adhesives and add-on control equipment on an application process unit to meet the emission limits in Table 4-58A. Add-on devices may include oxidizers, adsorbers, absorbers, and concentrators.

3. The following work practices for the application of adhesives, adhesive primers, and process-related waste materials, shall be used:

a. All VOC-containing adhesives, adhesive primers, and process-related waste materials shall be stored in closed containers.

b. Mixing and storage containers used for VOC-containing adhesives, adhesive primers, and process-related waste materials shall be kept closed at all times except when these materials are being deposited or removed.

c. Spills of VOC-containing adhesives, adhesive primers, and process-related waste materials shall be minimized.

d. VOC-containing adhesives, adhesive primers, and process-related waste materials shall be conveyed from one location to another in closed containers or pipes.

4. The following work practices for cleaning activities shall be used:

a. All VOC-containing cleaning materials and used shop towels shall be stored in closed containers.

b. Storage containers used for VOC-containing cleaning materials shall be kept closed at all times except when these materials are deposited or removed.

c. Spills of VOC-containing cleaning materials shall be minimized.

d. VOC-containing cleaning materials shall be conveyed from one location to another in closed containers or pipes.

e. VOC emissions from cleaning of application, storage, mixing, and conveying equipment shall be minimized by performing equipment cleaning without atomizing the cleaning solvent and by capturing all spent solvent in closed containers.

5. The application of adhesives and adhesive primers applied with a handheld, disposable can that is pressured and that dispenses an adhesive or adhesive primer by means of a propellant shall not be subject to the application method limits and controls found in subdivisions 1, 2, and 4 of this subsection but shall be subject to the work practices found in subdivisions 3 and 4 of this subsection.

9VAC5-40-8690. Standard for visible emissions.

The provisions of Article 1 (9VAC5-40-60 et seq.) of Part II of 9VAC5-40 (Existing Stationary Sources) apply.

9VAC5-40-8700. Standard for fugitive dust/emissions.

The provisions of Article 1 (9VAC5-40-60 et seq.) of Part II of 9VAC5-40 (Existing Stationary Sources) apply.

9VAC5-40-8710. Standard for odor.

The provisions of Article 2 (9VAC5-40-130 et seq.) of Part II of 9VAC-40 (Existing Stationary Sources) apply.

9VAC5-40-8720. Standard for toxic pollutants.

The provisions of Article 4 (9VAC5-60-200 et seq.) of Part II of 9VAC5-60 (Hazardous Air Pollutant Sources) apply.

9VAC5-40-8730. Compliance.

A. The provisions of 9VAC5-40-20 (Compliance) apply.

B. The emission standards in 9VAC5-40-4330 apply to coating by coating or to the volume weighted average of coatings where the coatings are used on a single coating application system and the coatings are the same type or perform the same function. Such averaging shall not exceed 24 hours.

C. Compliance determinations for control technologies not based on compliant coatings (i.e., coating formulation alone) shall be based on the applicable standard in terms of pounds of VOCs per gallon solids or pounds of VOCs per gallon solids applied according to the applicable procedure in 9VAC5-20-121. Compliance may also be based on transfer efficiency greater than the baseline transfer efficiency of 9VAC5-40-8680 B if demonstrated by methods acceptable to the board according to the applicable procedure in 9VAC5-20-121.

9VAC5-40-8740. Compliance schedule.

The owner shall comply with the provisions of this article as expeditiously as possible but in no case later than [ (insert date one year after the effective date of this article) February 1, 2017].

9VAC5-40-8750. Test methods and procedures.

The provisions of 9VAC5-40-30 (Emission testing) apply.

9VAC5-40-8760. Monitoring.

The provisions of 9VAC5-40-40 (Monitoring) apply.

9VAC5-40-8770. Notification, records, and reporting.

The provisions of 9VAC5-40-50 (Notification, records and reporting) apply.

9VAC5-40-8780. Registration.

The provisions of 9VAC5-20-160 (Registration) apply.

9VAC5-40-8790. Facility and control equipment maintenance or malfunction.

The provisions of 9VAC5-20-180 (Facility and control equipment maintenance or malfunction) apply.

9VAC5-40-8800. Permits.

A permit may be required prior to beginning any of the activities specified in this section if the provisions of 9VAC5-50 (New and Modified Stationary Sources) and 9VAC5-80 (Permits for Stationary Sources) apply. Owners contemplating such action should review those provisions and contact the appropriate regional office for guidance on whether those provisions apply.

1. Construction of a facility.

2. Reconstruction (replacement of more than half) of a facility.

3. Modification (any physical change to equipment) of a facility.

4. Relocation of a facility.

5. Reactivation (re-startup) of a facility.

6. Operation of a facility.

Title of Regulation: 12VAC5-110. Regulations for the Immunization of School Children (amending 12VAC5-110-10, 12VAC5-110-70, 12VAC5-110-80, 12VAC5-110-90).

Statutory Authority: §§ 22.1-271.2, 32.1-12, and 32.1-46 of the Code of Virginia.

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: December 30, 2015.

Effective Date: January 14, 2016.

Agency Contact: James Farrell, Director, Division of Immunization, Department of Health, 109 Governor Street, Richmond, VA 23219, telephone (804) 864-8055, or email james.farrell@vdh.virginia.gov.

Basis: Sections 22.1-271.2 and 32.1-46 of the Code of Virginia provide the State Board of Health with the authority to promulgate regulations regarding immunization of school children.

Purpose: Regulations are necessary to ensure children are protected to the extent possible from vaccine-preventable diseases and to protect indirectly the health of all Virginians. Recent periodic review of existing regulations identified language that is unclear or should be modified to address technological changes.

Rationale for Using Fast-Track Process: While some changes are the result of comments received during the periodic review process, additional changes are suggested to clarify issues that have been identified since the most recent amendments were enacted. None of the suggested changes will change any currently required immunizations or result in significant changes to current practice.

Substance: Amendments to the current regulations (i) update and clarify definitions; (ii) remove references to outdated versions of forms and ACIP schedules; (iii) clarify that a printout of an electronic record can be accepted without the signature of a nurse or physician; (iv) clarify that pneumococcal conjugate vaccine is not required for children enrolling in kindergarten; (v) clarify how long after the fourth birthday is allowable for those vaccines that are required to be administered on or after the fourth birthday; (vi) add mumps to the list of diseases for which demonstration of immunity is acceptable; (vii) clarify that the certificate of religious exemption must be notarized; and (viii) update responsibilities of admitting officials.

Issues: The primary advantages to the agency and the public are that current regulations ensure that children are appropriately protected to the extent possible from vaccine-preventable diseases. This also indirectly protects the health of all citizens of Virginia. Proposed changes should help clarify and simplify processes for providing and documenting immunizations required for school attendance. No disadvantages to the public or the Commonwealth are anticipated.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The State Board of Health (Board) proposes to:

• Add mumps to the list of diseases for which demonstration of immunity is acceptable in lieu of a vaccine shot;

• Reduce from 30 days to 10 days the time that the admitting official from the school that a student has left must send immunization records and academic records to the student's new school;

• Update and clarify definitions;

• Remove references to outdated versions of forms and U.S. Center for Disease Control and Prevention Advisory Committee on Immunization Practices (CDC-ACIP) schedules;

• Clarify that a printout of an electronic record can be accepted without the signature of a nurse or physician;

• Clarify that pneumococcal conjugate vaccine is not required for children enrolling in kindergarten;

• Clarify how long after the fourth birthday is allowable for those vaccines that are required to be administered on or after the fourth birthday; and

• Clarify that the certificate of religious exemption must be notarized.

Result of Analysis. The benefits likely exceed the costs for all proposed changes.

Estimated Economic Impact. The proposed updating of definitions and the various proposed language amendments to clarify current requirements will enable readers of the regulation to more accurately understand requirements in practice. Thus these proposed amendments will likely produce a small net benefit.

The CDC-ACIP has found that children who have demonstrated existing immunity to mumps are safe to be considered adequately immunized for the disease. Consequently the Board proposes to exempt students who have documentation of antibodies against mumps from the requirement for the mumps immunization shot. In order to prove immunity the child would need to have blood drawn. So for those families who choose to prove immunity rather than have the mumps shot, it will not likely significantly affect cost in time or dollars but does provide an additional option for those who wish to avoid additional vaccines. Thus, this proposed amendment will create a net benefit.

Under the current regulations, the admitting official of the school from which a student is transferring must send the student's immunization records or a copy thereof, along with his permanent academic or scholastic records, to the admitting official of the school to which the student is transferring within 30 days of the transfer to the new school. The Board proposes to shorten the required time within which to send the records to 10 days. The proposed reduction in time is intended to help reduce the potential for delays in enrollment for transferring students.¹

There are no official requirements concerning notifying the old school when a student seeks to enroll in a new school.² Nevertheless, according to the Department of Education the admitting officials of the schools from which students transfer have been notified in sufficient time in practice. The 30-day deadline has been consistently met, but taking upwards of 30 days to send immunization records has in some cases delayed students' enrollment in their new school. To the extent that reducing from 30 days to 10 days the time that the admitting official from the school that a student has left must send immunization records and academic records to the student's new school would reduce enrollment delays, the proposed amendment has the potential to produce significant benefit.

In order for the proposed amendment to make a significant difference in practice, the admitting officials of the old schools will need to be notified of the student's attempt at new enrollment quickly. There are no explicit penalties for failure to meet either the 30-day or 10-day deadline; presumably admitting officials will seek to meet the deadline in effect in order to help the student in question.

Businesses and Entities Affected. The proposed regulations pertain to approximately 4200 private health care providers,³ 135 public health clinics,⁴ admitting officials at schools within the Commonwealth's 132 school districts, and students.

Localities Particularly Affected. The proposed amendments do not disproportionately affect particular localities.

Projected Impact on Employment. The proposed amendments will not significantly affect employment.

Effects on the Use and Value of Private Property. The proposed amendments will not significantly affect the use and value of private property.

Small Businesses: Costs and Other Effects. The proposed amendments will not significantly affect costs for small businesses.

Small Businesses: Alternative Method that Minimizes Adverse Impact. The proposed amendments will not adversely affect small businesses.

Real Estate Development Costs. The proposed amendments will not affect real estate development costs.

_______________________________

¹ Source: Virginia Department of Education

² Ibid

³ Data source: Virginia Department of Health

⁴ Ibid

Agency's Response to Economic Impact Analysis: The Department of Health concurs with the Department of Planning and Budget's economic impact analysis of 12VAC5-110.

Summary:

The amendments (i) update and clarify definitions; (ii) update the version of the U.S. Center for Disease Control and Prevention Advisory Committee on Immunization Practices schedules that is incorporated by reference; (iii) clarify that a printout of an electronic record can be accepted without the signature of a nurse or physician; (iv) clarify that pneumococcal conjugate vaccine is not required for children enrolling in kindergarten; (v) clarify how long after the fourth birthday is allowable for those vaccines that are required to be administered on or after the fourth birthday; (vi) add mumps to the list of diseases for which demonstration of immunity is acceptable; (vii) clarify that the certificate of religious exemption must be notarized; and (viii) update responsibilities of admitting officials.

Part I
Definitions

12VAC5-110-10. Definitions.

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

"Adequate immunization" means the immunization requirements prescribed under 12VAC5-110-70.

"Admit" or "admission" means the official enrollment or reenrollment for attendance at any grade level, whether full-time or part-time, of any student by any school.

"Admitting official" means the school principal or his designated representative if a public school; if a nonpublic school or child care center, the principal, headmaster or director of the school or center.

"Board" means the State Board of Health.

"Commissioner" means the State Health Commissioner.

"Compliance" means the completion of the immunization requirements prescribed under 12VAC5-110-70.

"Conditional enrollment" means the enrollment of a student for a period of 90 days contingent upon the student having received at least one dose of each of the required vaccines and the student possessing a plan, from a physician or local health department, for completing his immunization requirements within the ensuing 90 calendar days. If the student requires more than two doses of hepatitis B vaccine, the conditional enrollment period, for hepatitis B vaccine only, shall be 180 calendar days.

"Documentary proof" means an appropriately completed copy of the most current version of Form MCH 213F 213G signed by a physician or his designee, registered nurse, or an official of a local health department. A copy of the immunization record signed or stamped by a physician or his designee, registered nurse, or an official of a local health department indicating the dates of administration including month, day, and year of the required vaccines, shall be acceptable in lieu of recording these dates on Form MCH 213F 213G, as long as the record is attached to Form MCH 213F 213G and the remainder of Form MCH 213F 213G has been appropriately completed. A printout of an immunization record from the provider's electronic health record can be accepted without a signature or stamp. For a new student transferring from an out-of-state school, any immunization record, which contains the exact date (month/day/year) of administration of each of the required doses of vaccines, is signed by a physician or his designee or registered nurse, and complies fully with the requirements prescribed under 12VAC5-110-70 shall be acceptable.

"Immunization" means the administration of a product licensed by the FDA to confer protection against one or more specific pathogens.

"Immunization schedule" schedules" means the schedule 2015 Recommended Immunization Schedules for Persons Aged 0 through 18 Years developed and published by the Centers for Disease Control and Prevention (CDC), the Advisory Committee on Immunization Practices (ACIP), the American Academy of Pediatrics (AAP), and the American Academy of Family Physicians (AAFP).

"Physician" means any person licensed to practice medicine in any of the 50 states or the District of Columbia.

"School" means:

1. Any public school from kindergarten through grade 12 operated under the authority of any locality within this Commonwealth;

2. Any private or religious school that offers instruction at any level or grade from kindergarten through grade 12;

3. Any private or religious nursery school or preschool, or any private or religious child care center required to be licensed by this Commonwealth;

4. Any preschool classes or Head Start classes operated by the school divisions within this Commonwealth; and

5. Any family day home or developmental center.

"Student" means any person who seeks admission to a school, or for whom admission to a school is sought by a parent or guardian, and who will not have attained the age of 20 years by the start of the school term for which admission is sought.

"Twelve months of age" means the 365th day following the date of birth. For the purpose of evaluating records, vaccines administered up to four days prior to the first birthday (361 days following the date of birth) will be considered valid.

Part III
Immunization Requirements

12VAC5-110-70. Immunization requirements.

Every student enrolling in a school shall provide documentary proof of adequate immunization with the prescribed number of doses of each of the vaccines and toxoids listed in the following subdivisions, as appropriate for his age according to the immunization schedule schedules. Spacing, minimum ages, and minimum intervals shall be in accordance with the immunization schedule schedules. A copy of every student's immunization record shall be on file in his school record.

1. Diphtheria Toxoid. A minimum of four properly spaced doses of diphtheria toxoid. One dose shall be administered on or after the fourth birthday and prior to entering kindergarten.

2. Tetanus Toxoid. A minimum of four properly spaced doses of tetanus toxoid. One dose shall be administered on or after the fourth birthday and prior to entering kindergarten.

3. Acellular Pertussis Vaccine. A minimum of four properly spaced doses of acellular pertussis vaccine. One dose shall be administered on or after the fourth birthday. A booster dose shall be administered prior to entering the sixth grade.

4. Poliomyelitis Vaccine. A minimum of four doses of poliomyelitis vaccine with one dose administered on or after the fourth birthday and prior to entering kindergarten.

5. Measles (Rubeola) Vaccine. One dose of live measles vaccine administered at age 12 months or older, and a second dose administered prior to entering kindergarten.

6. Rubella Vaccine. A minimum of one dose of rubella virus vaccine administered at age 12 months or older.

7. Mumps Vaccine. One dose of mumps virus vaccine administered at age 12 months or older and a second dose administered prior to entering kindergarten.

8. Haemophilus Influenzae Type b (Hib) Vaccine. A complete series of Hib vaccine (i.e., up to a maximum of four doses of vaccine as appropriate for the age of the child and the age at which the immunization series was initiated). The number of doses administered shall be in accordance with current immunization schedule recommendations. Attestation by the physician or his designee, registered nurse, or an official of a local health department on that portion of Form MCH 213G pertaining to Hib vaccine shall mean that the child has satisfied the requirements of this section. This section shall not apply to children older than 60 months of age or for admission to any grade level, kindergarten through grade 12.

9. Hepatitis B Vaccine. A minimum of three doses of hepatitis B vaccine for all children. The FDA has approved a two-dose schedule only for adolescents 11 through 15 years of age and only when the Merck brand (RECOMBIVAX HB) Adult Formulation Hepatitis B vaccine is used. The two RECOMBIVAX HB adult doses must be separated by a minimum of four months. The two dose schedule using the adult formulation must be clearly documented in the Hepatitis B section on Form MCH 213G.

10. Varicella (Chickenpox) Vaccine. All children born on and after January 1, 1997, shall be required to have one dose of chickenpox vaccine on or after 12 months of age and a second dose administered prior to entering kindergarten.

11. Pneumococcal Conjugate Vaccine (PCV). A complete series of PCV (i.e., up to a maximum of four doses of vaccine as appropriate for the age of the child and the age at which the immunization series was initiated). The number of doses administered shall be in accordance with current immunization schedule recommendations. Attestation by the physician or his designee, registered nurse, or an official of a local health department on that portion of Form MCH 213G pertaining to PCV vaccine shall mean that the child has satisfied the requirements of this section. This section shall not apply to children older than 60 months of age or for admission to any grade level, kindergarten through grade 12.

12. Human Papillomavirus (HPV) Vaccine. Three doses of properly spaced HPV vaccine for females, effective October 1, 2008. The first dose shall be administered before the child enters the sixth grade.

12VAC5-110-80. Exemptions from immunization requirements.

A. Religious and medical exemptions. No certificate of immunization shall be required of any student for admission to school if:

1. The student or his parent or guardian submits a notarized Certificate of Religious Exemption (Form CRE 1), to the admitting official of the school to which the student is seeking admission. Form CRE 1 is an affidavit stating that the administration of immunizing agents conflicts with the student's religious tenets or practices. The form is available on the Division of Immunization website at http://www.vdh.virginia.gov//Epidemiology/Immunization/requirements.htm; or

2. The school has written certification on either of the documents specified under "documentary proof" in 12VAC5-110-10 from a physician, registered nurse, or a local health department that one or more of the required immunizations may be detrimental to the student's health. Such certification of medical exemption shall specify the nature and probable duration of the medical condition or circumstance that contraindicates immunization.

3. Upon the identification of an outbreak, potential epidemic, or epidemic of a vaccine-preventable disease in a public or private school, the commissioner has the authority to require the exclusion from such school of all children who are not immunized against that disease.

B. Demonstration of existing immunity. The demonstration in a student of antibodies against rubeola mumps, measles, rubella, or varicella in sufficient quantity to ensure protection of that student against that disease, shall render that student exempt from the immunization requirements contained in 12VAC5-110-70 for the disease in question. Such protection should be demonstrated by means of a serological testing method appropriate for measuring protective antibodies against rubeola mumps, measles, rubella, or varicella respectively. Reliable history of chickenpox disease diagnosed or verified by a health care provider shall render students exempt from varicella requirements.

C. HPV vaccine. Because the human papillomavirus is not communicable in a school setting, a parent or guardian, at the parent's or guardian's sole discretion, may elect for the parent's or guardian's child not to receive the HPV vaccine, after having reviewed materials describing the link between the human papillomavirus and cervical cancer approved for such use by the board.

Part IV
Procedures and Responsibilities

12VAC5-110-90. Responsibilities of admitting officials.

A. Procedures for determining the immunization status of students. Each admitting official or his designee shall review, before the first day of each school year, the school medical record of every new student seeking admission to his school, and that of every student enrolling in grade six for compliance with the requirements prescribed in 12VAC5-110-70. Such review shall determine into which one of the following categories each student falls:

1. Students whose immunizations are adequately documented and complete in conformance with 12VAC5-110-70. Students with documentation of existing immunity to mumps, measles, rubella, or varicella as defined in 12VAC5-110-80 B shall be considered to be adequately immunized for such disease.

2. Students who are exempt from the immunization requirements of 12VAC5-110-70 because of medical contraindications or religious beliefs provided for by 12VAC5-110-80.

3. Students whose immunizations are inadequate according to the requirements of 12VAC5-110-70.

4. Students without any documentation of having been adequately immunized.

B. Notification of deficiencies. Upon identification of the students described in subdivisions A 3 and 4 of this section, the admitting official shall notify the parent or guardian of the student:

1. That there is no, or insufficient, documentary proof of adequate immunization in the student's school records.

2. That the student cannot be admitted to school unless he has documentary proof that he is exempted from immunization requirements pursuant to 12VAC5-110-70.

3. That the student may be immunized and receive certification by a licensed physician, registered nurse, or an official of a local health department.

4. How to contact the local health department to receive the necessary immunizations.

C. Conditional enrollment. Any student whose immunizations are incomplete may be admitted conditionally if that student provides documentary proof at the time of enrollment of having received at least one dose of the required immunizations accompanied by a schedule for completion of the required doses within 90 calendar days, during which time that student shall complete the immunizations required under 12VAC5-110-70. If the student requires more than two doses of hepatitis B vaccine, the conditional enrollment period, for hepatitis B vaccine only, shall be 180 calendar days. If a student is a homeless child or youth and does not have documentary proof of necessary immunizations or has incomplete immunizations and is not exempted from immunization as described in 12VAC5-110-80, the school administrator shall immediately admit such student and shall immediately refer the student to the local school division liaison, who shall assist in obtaining the documentary proof of, or completing, immunizations. The admitting official should examine the records of any conditionally enrolled student at regular intervals to ensure that such a student remains on schedule with his plan of completion.

D. Exclusion. The admitting official shall, at the end of the conditional enrollment period, exclude any student who is not in compliance with the immunization requirements under 12VAC5-110-70 and who has not been granted an exemption under 12VAC5-110-80 until that student provides documentary proof that his immunization schedule has been completed, unless documentary proof that a medical contraindication developed during the conditional enrollment period is submitted.

E. Transfer of records. The admitting official of every school shall be responsible for sending a student's immunization records or a copy thereof, along with his permanent academic or scholastic records, to the admitting official of the school to which a student is transferring within 30 10 days of his transfer to the new school.

F. Report of student immunization status. Each admitting official shall, within 30 days of the beginning of each school year or entrance of a student, or by October 15 of each school year, file with the State Health Department through the health department for his locality, a report summarizing the immunization status of the students in his school as of the first day of school. This report shall be filed using the web-enabled reporting system or on the most current version of Form SIS 1, the Student Immunization Status Report, and shall contain the number of students admitted to that school with documentary proof of immunization, the number of students who have been admitted with a medical or religious exemption and the number of students who have been conditionally admitted. The report for students entering the sixth grade shall include the number with a booster dose of tetanus, diphtheria, or pertussis containing vaccine within the last five years.

G. Each admitting official shall ensure that the parent or guardian of a female to be enrolled in the sixth grade receives educational materials describing the link between the human papillomavirus and cervical cancer. Materials shall be approved by the board and provided to the parent or guardian prior to the child's enrollment in the sixth grade.

FORMS (12VAC5-110)

Certificate of Religious Exemption, CRE-1 (rev. 00/1992)

School Entrance Health Form, Health Information Form/Comprehensive Physical Examination Report/Certification of Immunization, MCH 213G (rev. 3/2014)

Student Immunization Status Report, Form SIS 3 (School) (rev. 5/2009)

DOCUMENTS INCORPORATED BY REFERENCE (12VAC5-110)

2010 Recommended Immunization Schedule for Persons Aged 0 through 6 Years, U.S. Department of Health and Human Services.

2010 Recommended Immunization Schedule for Persons Aged 7 through 18 Years, U.S. Department of Health and Human Services.

2015 Recommended Immunization Schedules for Persons Aged 0 through 18 Years, Centers for Disease Control and Prevention, U.S. Department of Health and Human Services, effective January 1, 2015

Title of Regulation: 12VAC5-410. Regulations for the Licensure of Hospitals in Virginia (amending 12VAC5-410-260).

Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: December 30, 2015.

Effective Date: January 14, 2016.

Agency Contact: Susan Puglisi, Policy Analyst, Department of Health, 9960 Mayland Drive, Richmond, VA 23233, telephone (804) 367-2157, FAX (804) 527-4502, or email susan.puglisi@vdh.virginia.gov.

Basis: The regulation is promulgated under the authority of §§ 32.1-12 and 32.1-127 of the Code of Virginia. Section 32.1-12 grants the board the legal authority "to make, adopt, promulgate, and enforce such regulations necessary to carry out the provisions of Title 32.1 of the Code." Section 32.1-127 of the Code of Virginia directs the board to promulgate regulations with minimum standards for the construction and maintenance of hospitals, the operation, staffing and equipping of hospitals, qualifications and training of staff of hospitals, conditions under which a hospital may provide medical and nursing services to patients in their places of residence, and policies related to infection prevention, disaster preparedness, and facility security.

Purpose: The federal Centers for Medicare and Medicaid Services (CMS) issued a final rule on May 12, 2014, that enables a qualified dietitian or qualified nutrition professional to become privileged to independently order both standard and therapeutic diets within the hospital and critical access hospital settings. According to the CMS rule, hospitals will have the flexibility to either (i) appoint registered dieticians to the medical staff and grant them specific nutritional ordering privileges or (ii) authorize ordering privileges without appointment to the medical staff through the hospital’s appropriate medical staff rules, regulations, and bylaws. This rule change became effective on July 11, 2014. 12VAC5-410-260 is currently written in a manner that is more restrictive than the federal regulations because it only allows registered dietitians to write independent nutrition orders in hospitals if they are appointed to the medical staff. This regulatory action will amend the regulations to remove restrictions that are more stringent than federal law. This regulatory action will protect the health and welfare of Virginians by ensuring that patients within a hospital setting are able to obtain the proper standard and therapeutic diets within the Commonwealth.

Rationale for Using Fast-Track Process: These amendments simply ensure that the Commonwealth's regulations are not more restrictive than federal regulations. These amendments have also been prepared with input from the Virginia Academy of Nutrition and Dietetics. Therefore, the department does not expect that this regulatory action will be controversial.

Substance: Amendments to 12VAC5-410-260 remove the requirement that all patient diets be ordered in writing by a member of the medical staff; allow practitioners responsible for the care of the patient, or dietitians authorized by the medical staff, to order patient diets; and allow a hospital or medical staff to privilege qualified dietitians to prescribe diets and order tests to determine appropriate diets for the patient and specify that therapeutic diets include the provision of enteral and parenteral nutrition.

Issues: The primary advantage to the agency, the Commonwealth, and the public of the proposed regulatory action will be less burdensome regulations. The proposed regulatory action will also lead to greater access to well-rounded patient care. There are no known disadvantages to the agency, the Commonwealth, or the public.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The federal Centers for Medicare and Medicaid Services (CMS) issued a final rule on May 12, 2014, which enables a qualified dietitian or qualified nutrition professional to become privileged to independently order both standard and therapeutic diets within the hospital and critical access hospital settings. This rule change became effective on July 11, 2014. The State Board of Health (Board) proposes to amend this regulation to reflect this change.

Result of Analysis. The benefits likely exceed the costs for all proposed changes.

Estimated Economic Impact. The current regulation requires that all patient diets be ordered in writing by a member of the medical staff. The Board proposes to amend this requirement to state that all patient diets be ordered in writing by a practitioner responsible for the care of the patient or by a dietitian as authorized by the medical staff. The proposed new language will permit medical staff to use their time more efficiently. Permitting a qualified dietician authorized by the medical staff to do the ordering will enable the medical staff to spend the time they otherwise would have spent on the ordering of diets on other productive health care tasks such as diagnosing and treating patients, etc.

Businesses and Entities Affected. The proposed amendments affect qualified dietitians, the 106 licensed hospitals and critical access hospitals within the Commonwealth, and patients served by hospitals throughout Virginia.

Localities Particularly Affected. The proposed amendments do not disproportionately affect particular localities.

Projected Impact on Employment. The proposal to permit authorized dieticians not on the medical staff to order both standard and therapeutic diets within the hospital may encourage hospitals to employ more dieticians for this purpose.

Effects on the Use and Value of Private Property. The proposed amendments are unlikely to significantly affect the use and value of private property.

Real Estate Development Costs. The proposed amendments do not affect real estate development costs.

Small Businesses:

Definition. Pursuant to § 2.2-4007.04 of the Code of Virginia, small business is defined as "a business entity, including its affiliates, that (i) is independently owned and operated and (ii) employs fewer than 500 full-time employees or has gross annual sales of less than $6 million."

Costs and Other Effects. The proposed amendments are unlikely to significantly affect small businesses.

Alternative Method that Minimizes Adverse Impact. The proposed amendments will not adversely affect small businesses.

Adverse Impacts:

Businesses: The proposed amendments will not adversely affect businesses.

Localities: The proposed amendments will not adversely affect localities.

Other Entities: The proposed amendments will not adversely affect other entities.

Agency's Response to Economic Impact Analysis: The Department of Health concurs with the Department of Planning and Budget's economic impact analysis.

Summary:

The amendments (i) remove the requirement that all patient diets be ordered in writing by a member of the medical staff; (ii) add language allowing practitioners responsible for the care of the patient, or dietitians authorized by the medical staff, to order patient diets; and (iii) allow a hospital or medical staff to privilege qualified dietitians to prescribe diets and order tests to determine appropriate diets for the patient and specify that therapeutic diets include the provision of enteral and parenteral nutrition.

12VAC5-410-260. Dietary service.

A. Each hospital shall maintain a dietary service directed by a full-time person, qualified as allowed in 12VAC5-421.

B. Each hospital shall have at least one dietitian, meeting the criteria of § 54.1-2731 of the Code of Virginia, employed on either a full-time, part-time or on a consultative basis, to direct nutritional aspects of patient care and to advise on food preparation and service.

C. Space, equipment and supplies shall be provided for the efficient, safe and sanitary receiving, storage, refrigeration, preparation and serving of food.

D. The hospital food service operation shall comply with applicable standards in 12VAC5-421.

E. A diet manual, approved by the medical staff shall be maintained by the dietary service. Diets served to patients shall comply with the principles set forth in the diet manual.

F. All patient diets shall be ordered in writing by a member of the medical staff, including therapeutic diets, shall be ordered in writing by a practitioner, or by a dietitian as authorized by the medical staff, responsible for the care of the patient.

1. Hospitals and their medical staffs may grant privileges to dietitians meeting the criteria of § 54.1-2731 of the Code of Virginia to order patient diets, including therapeutic diets, and to order laboratory tests to help determine appropriate diets for the patient.

2. Therapeutic diets include the provision of enteral and parenteral nutrition.

G. Pertinent observations and information relative to the special diets and to dietetic treatment shall be recorded in the patient's medical record.

H. A hospital contracting for food service shall require, as part of the contract, that the contractor comply with the provisions of this section.

Title of Regulation: 12VAC5-540. Rules and Regulations for the Identification of Medically Underserved Areas in Virginia (amending 12VAC5-540-10, 12VAC5-540-20, 12VAC5-540-30, 12VAC5-540-40).

Statutory Authority: §§ 32.1-12 and 32.1-122.5 of the Code of Virginia.

Effective Date: December 30, 2015.

Agency Contact: Kenneth Studer, Department of Health, 109 Governor Street, Richmond, VA 23219, telephone (804) 864-7428, or email ken.studer@vdh.virginia.gov.

Summary:

The amendments (i) automatically designate the state facilities operated by the Departments of Corrections, Juvenile Justice, and Behavioral Health and Developmental Services as Virginia medically underserved areas; and (ii) remove outdated information regarding scholarship programs that are affected by the designation.

Summary of Public Comments and Agency's Response: No public comments were received by the promulgating agency.

Part I
General Information

12VAC5-540-10. Authority.

In accordance with the provisions of § 32.1-122.5 of the Code of Virginia, the State Board of Health is required to establish criteria for determining medically underserved areas within the Commonwealth and include in these criteria the need for medical care services in the state facilities operated by the Departments of Corrections, Juvenile Justice, and Behavioral Health and Developmental Services. The criteria are required to be quantifiable measures, sensitive to the unique characteristics of urban and rural jurisdictions.

12VAC5-540-20. Purpose.

The purpose of identifying medically underserved areas within the Commonwealth is to establish geographic areas in need of additional primary health care services. These areas may be selected by trained primary care physicians and other health professionals as practice sites in fulfillment of obligations that the physicians and other health professionals accepted in return for medical training and scholarship grant assistance. Each year of practice in a medically underserved area satisfies the repayment requirement of a year of scholarship support from the Virginia Medical Scholarship Program. Additionally, these medically underserved areas will be eligible locations for practicing primary care physicians and other health professionals participating in the state or federal physician loan repayment programs. Further, these medically underserved areas may become eligible for assistance, state or federal, to establish primary care medical centers.

Part II
Designating Medically Underserved Areas

12VAC5-540-30. Criteria for determining medically underserved areas.

The following [ five ] criteria, as available, and as indicated, shall be used to evaluate and identify medically underserved areas throughout the Commonwealth of Virginia [ and the criteria shall be applied at a minimum five-year interval using the most recent data available to update the designations ]:

1. Percentage of population with income at or below 100% of the federal poverty level. The source for these data shall be the most recent available publication of the Bureau of the Census of the U.S. Department of Commerce [ or appropriate intercensorial estimates of poverty accepted by the Health Resources and Services Administration Shortage Designation Branch for federal health professional shortage area and medically underserved area designations ].

2. Percentage of population that is 65 years of age or older. The source for these data shall be the [ Bureau of the Census of the U.S. Department of Commerce, or the latest estimates from the Weldon Cooper Center for Public Service at the University of Virginia, or the ] Economic Services Division of the Virginia Employment Commission.

3. The primary care physician to population ratio. The source for these data shall be the [ Department of Family Practice of the Medical College of Virginia of Virginia Commonwealth University Virginia Department of Health Professions, or Board of Medicine physician profile database. Primary care physicians are defined as board certified or self-designated generalist practitioners who practice family medicine, pediatrics, internal medicine, or obstetrics/gynecology ].

4. The four-year aggregate infant mortality rate. The source for these data shall be the [ Center most recent four-year infant mortality data for each jurisdiction from the Division ] of Health Statistics of the Virginia Department of Health.

5. The most recent [ annual seasonally adjusted quarterly ] civilian unemployment rate [ for each jurisdiction ]. The source for these data shall be [ the ] Information Services Division of the Virginia Employment Commission.

[ 6. Medical care services in state facilities operated by the Departments of Corrections, Juvenile Justice, and Behavioral Health and Developmental Services shall be deemed Virginia medically underserved areas. ]

12VAC5-540-40. Application of the criteria.

A. Determining medically underserved cities and counties. The criteria enumerated in 12VAC5-540-30 shall be used to construct a numerical index by which the relative degree of medical underservice shall be calculated for each city and county within the Commonwealth. Observations for each of the five criteria will be listed for each Virginia city and county. An interval scale will be used to assign a particular value to each observation. This will be done for each of the five criteria. Each interval scale will consist of four ranges or outcomes of observations. The ranges will be numerically equal. The four ranges will be labeled as Level 1, Level 2, Level 3, and Level 4. The numerical difference between the ranges will be established beginning with the Level 2 range.

The Level 2 range shall have the statewide average for each respective criterion, except the population to primary care physician ratio, as its upper limit. The Level 2 upper limit for the primary care physician to population ratio is established by dividing the difference between the Level 4 upper limit for this criterion and the Level 1 upper limit by two. Each observation which is equal to or less than the Level 2 upper limit, but greater than the Level 1 upper limit, will be assigned a numerical value of two.

The Level 1 range shall have an upper limit which is the quotient of the statewide average divided by two. For the ratio of population to primary care physician criterion, the upper limit of Level 1 shall be the ratio 2500:1 as recommended by the American Academy of Family Physicians. Each observation that is equal to or less than the Level 1 upper limit will be assigned a numerical value of one.

The Level 3 range shall have an upper limit that is equal to the sum of the upper limit of the Level 1 range and the upper limit of the Level 2 range. For the ratio of population to primary care physician criterion, the upper limit of level 3 shall be established at 3500:1, the federal standard for designating health manpower shortage areas. Each observation that is equal to or less than the Level 3 upper limit will be assigned a numerical value of three.

The Level 4 range will include any observation greater than the upper limit of Level 3 range. Each observation in the Level 4 range will be assigned a numerical value of four.

The values for each of the ranges of the five criteria will be summed for each Virginia city and county. Each Virginia city and county will have an assigned value of five or greater, to a maximum of 20. A statewide average value will be determined by summing the total city and county values and dividing by the number of cities and counties. Any city or county assigned a value that is greater than the statewide average value shall be considered medically underserved. The application of criteria for determining medically underserved cities and counties shall be performed annually and published by the board.

B. Determining medically underserved areas within cities and counties. Geographic subsections of cities or counties may be designated as medically underserved areas when the entire city or county is not eligible if the subsection has: (i) a population to primary care physician ratio equal to or greater than 3500:1; and (ii) a population whose rate of poverty is greater than the statewide average poverty rate; and (iii) a minimum population of 3,500 persons residing in a contiguous, identifiable, geographic area. The board shall from time to time, on petition of any person, or as a result of its own decision, apply criteria for determining medically underserved subareas of cities and counties. Once determined to be medically underserved, any subarea of a city or county shall appear on the next list of medically underserved areas published by the board. Areas which qualify as medically underserved areas under 12VAC5-540-40 A and that are within Standard Metropolitan Areas as defined by the U.S. Department of Commerce, must also qualify under this section for purposes of placement of health professionals.

[ C. Medical care services in state facilities operated by the Departments of Corrections, Juvenile Justice, and Behavioral Health and Developmental Services will be deemed Virginia medically underserved areas. ]

Title of Regulation: 12VAC30-120. Waivered Services (adding 12VAC30-120-927).

Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396.

Effective Date: December 30, 2015.

Agency Contact: Melissa Fritzman, Project Manager, Division of Long Term Care Services, Department of Medical Assistance Services, 600 East Broad Street, Suite 1300, Richmond, VA 23219, telephone (804) 225-4206, FAX (804) 612-0040, or email melissa.fritzman@dmas.virginia.gov.

Summary:

This regulatory action adopts a new section to establish criteria for approval of personal care service hours that exceed the maximum allowed limit of 56 hours per week. This action is required by Item 297 CCCCC of Chapter 890 of the 2011 Acts of Assembly and only affects the Elderly or Disabled with Consumer Direction Waiver.

Summary of Public Comments and Agency's Response: No public comments were received by the promulgating agency.

12VAC30-120-927. Exception criteria for personal care services.

DMAS shall apply the following criteria to individuals who request approval of personal care hours in excess of the maximum allowed 56 hours per week. [ The In order to qualify for personal care hours in excess of 56 hours per week, the ] waiver individual shall:

1. Presently have a minimum level of care of B (the waiver individual has a composite activities of daily living (ADL) score between seven and 12 and has a medical nursing need) or C (the waiver individual has a composite ADL score of nine or higher and has a skilled medical nursing need).

2. In addition to meeting the requirements set out in subdivision 1 of this [ subsection section ], the individual shall have [ at least ] one [ or more ] of the following:

a. Documentation of dependencies in all of the following activities of daily living: bathing, dressing, transferring, toileting, and eating/feeding, as defined by the current preadmission screening criteria (submitted to the service authorization contractor via DMAS-99);

b. Documentation of dependencies in both behavior and orientation as defined by the current preadmission screening criteria (submitted to the service authorization contractor via DMAS-99); or

c. Documentation from the local department of social services that the individual has an open case (as described in subdivisions c (1) and c (2) of this subdivision [ 2 ] ) with either Adult Protective Services (APS) or Child Protective Services (CPS) and is [ therefore ] in need of additional services beyond the maximum allowed 56 hours per week. Documentation can be in the form of a phone log contact or any other documentation supplied (submitted to the service authorization contractor via attestation).

(1) For APS an open case is defined as a substantiated APS case with a disposition of needs protective services and the adult accepts the needed services.

(2) For CPS an open case is defined as being open to CPS investigation if it is both founded by the investigation and the completed family assessment documents the case with moderate or high risk.

Title of Regulation: 12VAC30-141. Family Access to Medical Insurance Security Plan (amending 12VAC30-141-100, 12VAC30-141-120).

Statutory Authority: §§ 32.1-325 and 32.1-351 of the Code of Virginia; 42 USC § 1396 et seq.

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: January 29, 2016.

Agency Contact: Victoria Simmons, Regulatory Coordinator, Department of Medical Assistance Services, 600 East Broad Street, Suite 1300, Richmond, VA 23219, telephone (804) 371-6043, FAX (804) 786-1680, TTY (800) 343-0634, or email victoria.simmons@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 State Plan for Medical Assistance and directs that such plan include a provision for the Family Access to Medical Insurance Security (FAMIS) program. Section 32.1-324 of the Code of Virginia authorizes the Director of the Department of Medical Assistance Services (DMAS) to administer and amend the State Plan for Medical Assistance when the board is not in session, subject to such rules and regulations as may be prescribed by the board. Section 32.1-351 of the Code of Virginia authorizes DMAS or the director, as the case may be, to develop and submit to the federal Secretary of Health and Human Services an amended Title XXI plan for the Family Access to Medical Insurance Security Plan, and revise such plan and promulgate regulations as may be necessary.

Section 2105 of the Social Security Act (42 USC § 1397ee) provides governing authority for payments for services. The Patient Protection and Affordable Care Act (PPACA) (2010) permits states to extend eligibility in the Children's Health Insurance Program (CHIP) to children of state employees who are otherwise eligible under the state child health plan, known in Virginia as FAMIS. A critical issue reported to the Governor by the agency's director is the denial of access for the children of Virginia state employees to the FAMIS program. Virginia's workforce includes a significant number of lower income employees. Last year, more than 9,600 full-time state employees qualified for the Earned Income Tax Credit, a federal tax subsidy for lower-income working families. Full-time state employees may cover their dependent children through their employee health insurance, but for many families this is not an affordable option. Employees who choose this option face an increase in their insurance premium contributions of approximately $100 to $200 per month. Even with the most comprehensive coverage, employees must also pay co-pays of up to $40 for doctor visits. These health care premiums and cost sharing represent a significant reduction in take home pay for many state workers. Some may be forced to opt for employee-only coverage, thereby leaving their children with no health insurance; others may struggle to pay for rent or other necessities because of the additional cost for their children's insurance. This reduced access to covered medical services creates increased health risks for the children of Virginia state workers.

Current DMAS regulations exclude state employees from FAMIS eligibility. DMAS now seeks to remove this barrier to the FAMIS program and open up low-cost comprehensive health care coverage for the dependent children of Virginia state employees. This rule change will only affect state employees who are qualified for employer-sponsored health insurance; wage employees are not eligible to receive a state contribution toward the cost of their health coverage.

Purpose: The proposed regulatory action is intended to remove a barrier (i.e., high out-of-pocket costs) to access to health care services for more lower-income families.

At this time, a child who is a member of a family that is eligible for subsidized coverage under any Virginia state employee health insurance plan is not eligible for FAMIS. This policy was originally enacted to be compliant with § 2110(b)(2)(B) of the Social Security Act, which categorically excluded dependents of state employees in the definition of a "targeted low-income child."

Virginia's state employee health benefit policies do not allow adding or dropping dependents to coverage outside of the open enrollment period for the new plan year beginning annually July 1, except in the case of certain qualifying events. Eligibility for Medicaid has been such a qualifying event. Children in very low-income families (at or less than 143% federal poverty level (FPL)) are already eligible for Medicaid; those who are dependents of state employees can, under current rules, be dropped from state-subsidized coverage and enroll in Medicaid. The new rules will allow children in families with income between 144% and 200% FPL to move from state-subsidized coverage and enroll in FAMIS.

The children of working families who cannot afford insurance due to out-of-pocket costs suffer from lack of access to health care. While state employees may cover their dependent children through their employee health insurance, for many low-income families this is not an affordable option due to premium contributions, copayments, and deductibles that can add up to a substantial proportion of earned income. This regulatory action will allow children of state employees who are otherwise eligible (e.g., by virtue of family income, residency) to be enrolled for health coverage under the FAMIS Plan. The action will remove the current exclusion of such children from enrollment. This will allow employees of the Commonwealth to be treated the same as other families with access to employer-sponsored health insurance who by current policy may apply for coverage under FAMIS.

As a result of this regulatory action, more lower-income families will be able to obtain insurance coverage for preventive services and necessary medical care for their children. This regulatory action is essential to protect the health, safety, and welfare of these affected individuals by providing an opportunity to access high quality health care services that they may otherwise not be able to afford.

Substance: The intent of this action is to align Virginia policy with changes in federal laws and in doing so to offer more options for health care coverage to more children in lower-income families.

The proposed regulatory action allows state employees to enroll their otherwise-eligible dependent children in the FAMIS plan by removing the language that prohibits such enrollment. Since emergency regulations went into effect in January 2015, state employees who do not currently cover their dependent children on their health benefits have been able to enroll their dependent children in FAMIS if all eligibility standards are met. DMAS and the Department of Human Resources Management (DHRM) are implementing communication strategies to include agency website postings of a fact sheet, electronic newsletters to state benefit administrators, inclusion in the annual notice to all state employees about premium assistance, and the state employee open enrollment newsletter for 2015. It is estimated that 5.0% of the eligible state workforce will be impacted by this change, with a resulting 5,000 children enrolled in FAMIS

Issues: The primary advantage of this proposed action to the public is that more low-income working families will have access to the FAMIS program, with significantly reduced out-of-pocket expenses for health care. This will result in more disposable income for such families to cover their basic necessities or other discretionary expenses. Businesses that offer health insurance to their employees may see a reduction in their health insurance costs if any of their employees have a spouse employed by the state and their eligible children can be enrolled in FAMIS. The primary disadvantage for families is the administrative process of dropping a child from state-sponsored insurance during the open enrollment period (if already covered) and having to apply for FAMIS.

The primary advantage to the Commonwealth is cost savings associated with the state employee health benefit plan. Those employees who currently cover their children on the state health plan could reduce their benefit option to that of an employee only, or employee plus spouse, thus reducing the state's share of premium for family coverage. Since the state employee health plan is self-insured, the actual costs of claims incurred for children covered under the plan would generate additional savings if those children were enrolled in FAMIS. According to DHRM staff, the state health plan's actuary estimates that the reduced cost to the state employee health plan for each child up to age 19 years (i.e., the FAMIS age limit) who leaves the plan averages $2,877. The employer's average share (both general and nongeneral funds) of this amount is $2,418.

Therefore, if 100 children leave the state plan for FAMIS coverage, the savings to the plan is projected to be $287,700, and the employer's share is estimated to be $241,800. DHRM notes that it has no reliable way to predict how many children will leave the health plan for FAMIS coverage. DHRM also cannot predict the specific health status or age of the children who leave, so actual savings may vary from this estimate.

Another advantage to the Commonwealth is reduction of the social and economic costs associated with reducing the number of uninsured children. It is estimated that about 100,000 children remain uninsured in Virginia. This regulatory action aims to reduce that number by 5.0%. DMAS does not anticipate any disadvantages to the public, the agency, or the Commonwealth. The proposed regulatory action fulfills the intent of Governor McAuliffe's A Healthy Virginia Plan to allow FAMIS coverage for children of state employees. It also has the potential to be considered a positive benefit for many state employees that may aid in workforce satisfaction and retention.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The proposed changes remove the current exclusion in regulations and allow low-income state employees, whose children are otherwise eligible for Family Access to Medical Insurance Security Plan, to be enrolled in the program.

Result of Analysis. The benefits likely exceed the costs for all proposed changes.

Estimated Economic Impact. These regulations establish rules for implementation and oversight of the state's Children's Health Insurance Program (CHIP), known in Virginia as the Family Access to Medical Insurance Security (FAMIS) plan. In the past, the federal government prohibited eligibility of children of state employees for FAMIS under section 2110(b)(2)(B) of the Social Security Act which categorically excluded dependents of state employees in the definition of a "targeted low-income child." However, the federal Patient Protection and Affordable Care Act (PPACA) enacted in 2010 permitted states to extend eligibility in CHIP to children of state employees who are otherwise eligible under FAMIS. The proposed changes remove the current exclusion in regulations and allow low-income state employees, whose children are otherwise eligible for FAMIS, to be enrolled in the program.

According to the Department of Human Resource Management (DHRM), last year, more than 9,600 full-time state employees qualified for the Earned Income Tax Credit, a federal tax subsidy for lower-income working families. Full-time state employees may cover their dependent children through their employee health insurance, but for many families this is not an affordable option. Employees who choose this option face an increase in their insurance premium contributions of approximately $100 to $200 per month. Even with the most comprehensive coverage, employees must also pay co-pays of up to $40 for doctor visits and must pay deductibles. These health care premiums and cost sharing represent a significant reduction in take home pay for many state workers. Some are forced to opt for employee-only coverage, thereby leaving their children with no health insurance; others may struggle to pay for rent or other necessities because of the additional cost for their children's insurance. This reduced access to covered medical services creates increased health risks for the children of Virginia state workers.

In light of this situation, the Governor charged the Secretary of Health and Human Resources to create a plan to provide Virginians with greater access to health care for uninsured citizens. As a result, the Department of Medical Assistance Services (DMAS) developed and promulgated emergency regulations that became effective on January 1, 2015. The proposed changes will permanently implement the emergency regulations currently in effect.

The new rules allow children in families with income between 144% and 200% federal poverty level who are currently not covered under their parent's state-subsidized plan to enroll in FAMIS.¹ Similarly, if the children are currently covered under their parent's state-subsidized plan, they are allowed to drop their current coverage and enroll in FAMIS. This change allows employees of the Commonwealth to be treated the same as other families with access to employer-sponsored health insurance who by current policy may apply for coverage under FAMIS. It is estimated that five percent of the state workforce eligible for insurance will be impacted by this change, with a resulting 5,000 children enrolled in FAMIS.

The economic effects of the proposed changes are different depending on whether the affected children are currently covered under their parent's policy or not. For state employees currently covering their children, a reduction in out-of-pocket expenses for health care is expected. This will result in more disposable income for such families to cover their basic necessities or other discretionary expenses. According to DMAS, most of the new enrollment in FAMIS is expected to be in this category (i.e., children dropping their existing coverage). For state employees who are not currently covering their children, some reduction in out-of-pocket expenses may also be expected. Such families may be paying out of pocket expenses for emergency or nonemergency services for their uninsured children. A reduction in out of pocket expenses will also result in more disposable income for such families to cover their basic necessities or other discretionary expenses. The primary disadvantage for affected families is the administrative process of having to apply for FAMIS and/or dropping their child from state sponsored insurance during the open enrollment period.

In addition to the savings to the employees, the primary advantage to the Commonwealth is cost savings associated with the state employee health benefit plan. Employees who currently cover their children on the state health plan could reduce their benefit option to that of an employee only, or employee plus spouse, thus reducing the state's share of premium for family coverage. Since the state employee health plan is self-insured, the actual costs of claims incurred for children covered under the plan would generate additional savings if those children were enrolled in FAMIS instead. According to DHRM, the state health plan's actuary estimates that the reduced cost to the state employee health plan for each child up to age 19 (i.e., the FAMIS age limit) who leaves the plan averages $2,877 per year. The employer's average share (both general and nongeneral funds) of this amount is $2,418 per year. Similarly, the Commonwealth may also experience a reduction in uncompensated health care costs for currently uninsured children of state employees.

Similar to the benefits to the Commonwealth, businesses that offer health insurance to their employees also stand to see a reduction in their health insurance costs if any of their employees have a spouse employed by the state and can enroll their eligible children in FAMIS.

The proposed changes may also affect health care providers. Currently, state health plan and FAMIS utilizes several provider networks. If coverage under the state health plan is dropped, affected children may start receiving services from a different provider participating in FAMIS. However, there is significant overlap between providers in state health plan networks and providers in FAMIS networks. Thus, affected children may be able to continue to receive their health care from the same providers. Likewise, a reduction in uninsured children of state employees would also reduce utilization of uncompensated health care services provided and increase utilization of providers in FAMIS.

While the Commonwealth will experience savings due to reduced employer contributions toward family coverage on the state health plan or reduced uncompensated care costs, some of these savings will be offset due to the state's share of FAMIS costs for additional children. Based on 250 new children expected to be enrolled in FAMIS in fiscal year (FY) 2015 and 5,000 new children expected in FY 2016 and thereafter, DMAS estimates $255,687 increase in total FAMIS expenditures ($89,490 in general funds, $166,196 in federal funds) in FY 2015, $12.9 million increase in total FAMIS expenditures ($2.3 million in general funds, $10.6 million in federal funds) in FY 2016, and $13.6 million increase in total FAMIS expenditures ($1.6 million in general funds, $12 million in federal funds) in FY 2017.

The average cost per FAMIS child is estimated to be $2,454 in FY 2015 ($859 in general funds due to 65% federal match and $1,595 in federal funds), is estimated to be $2,580 in FY 2016 ($458 in general funds due to 82.25% federal match and $2,122 in federal funds), and is estimated to be $2,724 in FY 2017 ($327 in general funds due to 88% federal match and $2,397 in federal funds). Given that the Commonwealth is expected to save $2,418 per child whose family drops their coverage under the state employee health plan, significant net savings to the Commonwealth are expected.

In general, most of the Commonwealth's net savings will be replaced by federal funds and consequently increase inflow of federal funds coming into Virginia. An increase in federal funds would contribute to the Commonwealth's overall economy.

Businesses and Entities Affected. Under the proposed changes, approximately 250 new children are expected to be enrolled in FAMIS in FY 2015 and 5,000 new children are expected in FY 2016 and thereafter. Most of the new enrollment in FAMIS is expected to be from children dropping their existing coverage.

The proposed changes are also expected to shift utilization of services from providers in state health plan or from providers of other health plans offered to the children of state employees to the providers participating in FAMIS.

The primary affected entity is the Commonwealth of Virginia as it will see a significant reduction in its contributions to the state employee health plan and a relatively small increase in expenditures in FAMIS due to significant federal funding, therefore experiencing significant net savings.

Localities Particularly Affected. The proposed amendment does not disproportionately affect particular localities.

Projected Impact on Employment. The proposed amendments may reduce demand for labor by providers in the state health plan or by providers of other health plans offered to the children of state employees and increase the demand for labor by the providers participating in FAMIS. However, DMAS indicates that there is a significant overlap between the providers in the state health plan and in FAMIS.

Effects on the Use and Value of Private Property. The proposed amendments are unlikely to significantly affect the use and value of private property.

Real Estate Development Costs. The proposed amendments are unlikely to significantly affect real estate development costs.

Small Businesses.²

Costs and Other Effects. The proposed amendments may affect health care providers who are currently providing services to affected children and who will be providing services through FAMIS as discussed above. The majority of these providers are believed to be small businesses.

Alternative Method that Minimizes Adverse Impact. There is no known alternative method that would minimize the potential adverse impact on providers who are currently providing services to affected children while accomplishing the same goals.

Adverse Impacts:

Businesses: The proposed amendments may have an adverse impact on health care networks currently utilized by the state health plan which are not believed to be small businesses. However, some of these networks also participate in FAMIS and may continue to provide services to majority of the same children affected by the proposed changes.

Localities: The proposed amendments will not adversely affect localities.

Other Entities: The proposed amendments will not adversely affect other entities.

____________________________________

¹ Children in very low-income families (at or less than 143% federal poverty level) are already eligible for Medicaid; those who are dependents of state employees can, under the current rules, be dropped from state-subsidized coverage and enroll in Medicaid.

² Pursuant to § 2.2-4007.04 of the Code of Virginia, small business is defined as "a business entity, including its affiliates, that (i) is independently owned and operated and (ii) employs fewer than 500 full-time employees or has gross annual sales of less than $6 million."

Agency's Response to Economic Impact Analysis: The agency has reviewed the economic impact analysis prepared by the Department of Planning and Budget regarding the regulations concerning FAMIS Eligibility for Children of State Employees. The agency raises no issues with this analysis.

Summary:

The proposed amendments remove the exclusion of otherwise eligible, by income and residency, state employees, who have access to subsidized health insurance coverage, from enrolling their dependent children in the Family Access to Medical Insurance Security (FAMIS) Plan and allow low-income state employees, whose children are eligible for the FAMIS Plan, to be enrolled in the program.

Part III
Eligibility Determination and Application Requirements

12VAC30-141-100. Eligibility requirements.

A. This section shall be used to determine eligibility of children for FAMIS.

B. FAMIS shall be in effect statewide.

C. Eligible children must:

1. Be determined ineligible for Medicaid by a local department of social services or be screened by the FAMIS central processing unit and determined not Medicaid likely;

2. Be under 19 years of age;

3. Be residents of the Commonwealth;

4. Be either U.S. citizens, U.S. nationals or qualified noncitizens;

5. Be uninsured, that is, not have comprehensive health insurance coverage; and

6. Not be a member of a family eligible for subsidized dependent coverage, as defined in 42 CFR 457.310(c)(1)(ii) under any Virginia state employee health insurance plan on the basis of the family member's employment with a state agency; and

7. 6. Not be an inpatient in an institution for mental diseases (IMD), or an inmate in a public institution that is not a medical facility.

D. Income.

1. Screening. All child health insurance applications received at the FAMIS central processing unit must be screened to identify applicants who are potentially eligible for Medicaid. Children screened and found potentially eligible for Medicaid cannot be enrolled in FAMIS until there has been a finding of ineligibility for Medicaid. Children who do not appear to be eligible for Medicaid shall have their eligibility for FAMIS determined. Children determined to be eligible for FAMIS will be enrolled in the FAMIS program. Child health insurance applications received at a local department of social services shall have a full Medicaid eligibility determination completed. Children determined to be ineligible for Medicaid due to excess income will have their eligibility for FAMIS determined. If a child is found to be eligible for FAMIS, the local department of social services will enroll the child in the FAMIS program.

2. Standards. Income standards for FAMIS are based on a comparison of countable income to 200% of the federal poverty level for the family size, as defined in the State Plan for Title XXI as approved by the Centers for Medicare & Medicaid Services. Children who have income at or below 200% of the federal poverty level, but are ineligible for Medicaid due to excess income, will be income eligible to participate in FAMIS.

3. Grandfathered CMSIP children. Children who were enrolled in the Children's Medical Security Insurance Plan at the time of conversion from CMSIP to FAMIS and whose eligibility determination was based on the requirements of CMSIP shall continue to have their income eligibility determined using the CMSIP income methodology. If their income exceeds the FAMIS standard, income eligibility will be based on countable income using the same income methodologies applied under the Virginia State Plan for Medical Assistance for children as set forth in 12VAC30-40-90. Income that would be excluded when determining Medicaid eligibility will be excluded when determining countable income for the former CMSIP children. Use of the Medicaid income methodologies shall only be applied in determining the financial eligibility of former CMSIP children for FAMIS and for only as long as the children meet the income eligibility requirements for CMSIP. When a former CMSIP child is determined to be ineligible for FAMIS, these former CMSIP income methodologies shall no longer apply and income eligibility will be based on the FAMIS income standards.

4. Spenddown. Deduction of incurred medical expenses from countable income (spenddown) shall not apply in FAMIS. If the family income exceeds the income limits described in this section, the individual shall be ineligible for FAMIS regardless of the amount of any incurred medical expenses.

E. Residency. The requirements for residency, as set forth in 42 CFR 435.403, will be used when determining whether a child is a resident of Virginia for purposes of eligibility for FAMIS. A child who is not emancipated and is temporarily living away from home is considered living with his parents, adult relative caretaker, legal guardian, or person having legal custody if the absence is temporary and the child intends to return to the home when the purpose of the absence (such as education, medical care, rehabilitation, vacation, visit) is completed.

F. U.S. citizen or nationality. Upon signing the declaration of citizenship or nationality required by § 1137(d) of the Social Security Act, the applicant or recipient is required under § 2105(c)(9) to furnish satisfactory documentary evidence of U.S. citizenship or nationality and documentation of personal identity unless citizenship or nationality has been verified by the Commissioner of Social Security or unless otherwise exempt.

G. Qualified noncitizen. The requirements for qualified aliens set out in Public Law 104-193, as amended, and the requirements for noncitizens set out in subdivisions 3 b, c, and e of 12VAC30-40-10 will be used when determining whether a child is a qualified noncitizen for purposes of FAMIS eligibility.

H. Coverage under other health plans.

1. Any child covered under a group health plan or under health insurance coverage, as defined in § 2791 of the Public Health Services Act (42 USC § 300gg-91(a) and (b)(1)), shall not be eligible for FAMIS.

2. No substitution for private insurance.

a. Only uninsured children shall be eligible for FAMIS. A child is not considered to be insured if the health insurance plan covering the child does not have a network of providers in the area where the child resides. Each application for child health insurance shall include an inquiry about health insurance. Each redetermination of eligibility shall also document inquiry about current health insurance.

b. Health insurance does not include Medicare, Medicaid, FAMIS, or insurance for which DMAS paid premiums under Title XIX through the Health Insurance Premium Payment (HIPP) Program or under Title XXI through the SCHIP premium assistance program.

I. Eligibility of newborns. If a child otherwise eligible for FAMIS is born within the three months prior to the month in which a signed application is received, the eligibility for coverage is effective retroactive to the child's date of birth if the child would have met all eligibility criteria during that time. A child born to a mother who is enrolled in FAMIS, under either the XXI Plan or a related waiver (such as FAMIS MOMS), on the date of the child's birth shall be deemed eligible for FAMIS for one year from birth unless the child is otherwise eligible for Medicaid.

12VAC30-141-120. Children ineligible for FAMIS.

A. If a child is:

1. Eligible for Medicaid, or would be eligible if he applied for Medicaid, he shall be ineligible for coverage under FAMIS. A child found through the screening process to be potentially eligible for Medicaid but who fails to complete the Medicaid application process for any reason, cannot be enrolled in FAMIS;

2. A member of a family eligible for coverage under any Virginia state employee health insurance plan, he shall be ineligible for FAMIS;

3. 2. An inmate of a public institution as defined in 42 CFR 435.1009, he shall be ineligible for FAMIS; or

4. 3. An inpatient in an institution for mental disease (IMD) as defined in 42 CFR 435.1010, he shall be ineligible for FAMIS.

B. If a child's parent or other authorized representative does not meet the requirements of assignment of rights to benefits or requirements of cooperation with the agency in identifying and providing information to assist the Commonwealth in pursuing any liable third party, the child shall be ineligible for FAMIS.

C. If a child, if age 18, or if under age 18, a parent, adult relative caretaker, guardian, or legal custodian obtained benefits for a child or children who would otherwise be ineligible by willfully misrepresenting material facts on the application or failing to report changes, the child or children for whom the application is made shall be ineligible for FAMIS. The child, if age 18, or if under age 18, the parent, adult relative caretaker, guardian, or legal custodian who signed the application shall be liable for repayment of the cost of all benefits issued as the result of the misrepresentation.

Title of Regulation: 14VAC5-216. Rules Governing Internal Appeal and External Review (amending 14VAC5-216-10, 14VAC5-216-20, 14VAC5-216-40, 14VAC5-216-50; adding 14VAC5-216-65).

Statutory Authority: §§ 12.1-13 and 38.2-223 of the Code of Virginia.

Public Hearing Information: A public hearing will be held upon request.

Public Comment Deadline: December 18, 2015.

Agency Contact: Tom Bridenstine, Bureau of Insurance Manager, Life and Health Division, Bureau of Insurance, State Corporation Commission, P.O. Box 1157, Richmond, VA 23218, telephone (804) 371-9746, FAX (804) 371-9944, or email tom.bridenstine@scc.virginia.gov.

Summary:

The proposed amendments (i) define an "exception request" for an enrollee to obtain a prescription drug that is not on a health carrier's closed formulary; (ii) describe the requirements for the exception request process, which enhances and further clarifies the process identified in subdivisions B 2 and B 3 of § 38.2-3407.9:01 of the Code of Virginia and is in accordance with 45 CFR 156.122(c); and (iii) provide further clarification to an existing provision in the urgent care appeals section.

AT RICHMOND, NOVEMBER 9, 2015

COMMONWEALTH OF VIRGINIA, ex rel.

STATE CORPORATION COMMISSION

CASE NO. INS-2015-00184

Ex Parte: In the matter of Amending Rules
Governing Internal Appeal and External Review

ORDER TO TAKE NOTICE

Section 12.1-13 of the Code of Virginia ("Code") provides that the State Corporation Commission ("Commission") shall have the power to promulgate rules and regulations in the enforcement and administration of all laws within its jurisdiction, and § 38.2-223 of the Code provides that the Commission may issue any rules and regulations necessary or appropriate for the administration and enforcement of Title 38.2 of the Code.

The rules and regulations issued by the Commission pursuant to § 38.2-223 of the Code are set forth in Title 14 of the Virginia Administrative Code. A copy may also be found at the Commission's website: http://www.scc.virginia.gov/boi/laws.aspx.

The Bureau of Insurance ("Bureau") has submitted to the Commission a proposal to amend certain sections found in Chapter 216 of Title 14 of the Virginia Administrative Code entitled "Rules Governing Internal Appeal and External Review" ("Rules"), which are set out at 14 VAC 5-216-10, 14 VAC 5-216-20, 14 VAC 5-216-40, and 14 VAC 5-216-50, and establish a new section at 14 VAC 5-216-65.

The amendments and the new section are necessary to define an "exception request" for an enrollee to obtain a prescription drug that is not on a health carrier's closed formulary and to describe the requirements for the exception request process that will enhance and further clarify the process identified in § 38.2-3407.9:01 B 2 and 3 of the Code. The amendments also provide further clarification to the urgent care appeals section.

NOW THE COMMISSION is of the opinion that the proposed amendments to 14 VAC 5-216-10, 14 VAC 5-216-20, 14 VAC 5-216-40, and 14 VAC 5-216-50 and the new section at 14 VAC 5-216-65, as submitted by the Bureau, should be considered for adoption.

Accordingly, IT IS ORDERED THAT:

(1) The proposed amendments to the "Rules Governing Internal Appeal and External Review," which amend the Rules at 14 VAC 5-216-10, 14 VAC 5-216-20, 14 VAC 5-216-40, and 14 VAC 5-216-50 and establish a new section at 14 VAC 5-216-65, are attached hereto and made a part hereof.

(2) All interested persons who desire to comment in support of or in opposition to, or request a hearing to consider the proposed amendments and new section, shall file such comments or hearing request on or before December 18, 2015, with Joel H. Peck, Clerk, State Corporation Commission, c/o Document Control Center, P.O. Box 2118, Richmond, Virginia 23218. Interested persons desiring to submit comments electronically may do so by following the instructions at the Commission's website: http://www.scc.virginia.gov/case. All comments shall refer to Case No. INS-2015-00184.

(3) If no written request for a hearing on the proposal to amend and establish new Rules as outlined in this Order is received on or before December 18, 2015, the Commission, upon consideration of any comments submitted in support of or in opposition to the proposal, may adopt the Rules as submitted by the Bureau.

(4) The Bureau forthwith shall provide notice of the proposal to amend and establish new Rules by sending, by e-mail or U.S. mail, a copy of this Order, together with the proposal, to all insurers, health maintenance organizations and health services plans licensed in Virginia to sell accident and sickness insurance, and to all interested persons.

(5) The Commission's Division of Information Resources forthwith shall cause a copy of this Order, together with the proposal to amend and establish new Rules, to be forwarded to the Virginia Registrar of Regulations for appropriate publication in the Virginia Register of Regulations.

(6) The Commission's Division of Information Resources shall make available this Order and the attached proposal on the Commission's website: http://www.scc.virginia.gov/case.

(7) The Bureau shall file with the Clerk of the Commission an affidavit of compliance with the notice requirements of Ordering Paragraph (4).

(8) This matter is continued.

AN ATTESTED COPY hereof shall be sent by the Clerk of the Commission to: Kiva B. Pierce, Assistant Attorney General, Division of Consumer Counsel, Office of the Attorney General, 900 East Main Street, Second Floor, Richmond, Virginia 23219; and a copy hereof shall be delivered to the Commission's Office of General Counsel and the Bureau of Insurance in care of Deputy Commissioner Althelia P. Battle.

Part I
General

14VAC5-216-10. Scope and purpose.

A. This chapter shall apply to all health carriers, except that the provisions of this chapter shall not apply to a policy or certificate that provides coverage only for a specified disease, specified accident or accident-only coverage; credit; disability income; hospital indemnity; long-term care; dental, vision care, or any other limited supplemental benefit or to a Medicare supplement policy of insurance; coverage under a plan through Medicare, Medicaid, or the federal employees health benefits program; self-insured plans except that a self-insured employee welfare benefit plan may elect to use the state external review process; any coverage issued under Chapter 55 of Title 10 of the U.S. Code (TRICARE), and any coverage issued as supplemental to that coverage; any coverage issued as supplemental to liability insurance, workers' compensation or similar insurance; and automobile medical payment insurance or any insurance under which benefits are payable with or without regard to fault, whether written on a group or individual basis.

B. The purpose of this chapter is to set forth rules to carry out the provisions of Chapter 35.1 (§ 38.2-3556 et seq.) of Title 38.2 of the Code of Virginia as well as federal law to provide a health carrier with guidelines to assist with establishing a procedure for an internal appeals process under which there will be a full and fair review of any adverse benefit determination. This chapter also sets forth requirements for the external review process.

C. This chapter shall apply to any adverse benefit determination made on or after July 1, 2011, by any health carrier for a grandfathered or non-grandfathered health benefit plan, as defined by the PPACA.

D. This chapter also sets forth requirements for an exception request for plan years beginning on or after January 1, 2016.

14VAC5-216-20. Definitions.

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

"Adverse benefit determination" in the context of the internal appeals process means (i) a determination by a health carrier or its designee utilization review entity that, based on the information provided, a request for, a benefit under the health carrier's health benefit plan upon application of any utilization review technique does not meet the health carrier's requirements for medical necessity, appropriateness, health care setting, level of care, or effectiveness or is determined to be experimental or investigational and the requested benefit is therefore denied, reduced, or terminated or payment is not provided or made, in whole or in part, for the requested benefit; (ii) the denial, reduction, or termination of, or failure to provide or make payment in whole or in part for, a benefit based on a determination by a health carrier or its designee utilization review entity of a covered person's eligibility to participate in the health carrier's health benefit plan; (iii) any review determination that denies, reduces, or terminates or fails to provide or make payment, in whole or in part, for a benefit; (iv) a rescission of coverage determination as defined in § 38.2-3438 of the Code of Virginia; or (v) any decision to deny individual coverage in an initial eligibility determination.

"Adverse determination" in the context of external review means a determination by a health carrier or its designee utilization review entity that an admission, availability of care, continued stay, or other health care service that is a covered benefit has been reviewed and, based upon the information provided, does not meet the health carrier's requirements for medical necessity, appropriateness, health care setting, level of care, or effectiveness or is determined to be experimental or investigational and the requested service or payment for the service is therefore denied, reduced, or terminated.

"Authorized representative" means (i) a person to whom a covered person has given express written consent to represent the covered person; (ii) a person authorized by law to provide substituted consent for a covered person; (iii) a family member of a covered person or the covered person's treating health care professional when the covered person is unable to provide consent; (iv) a health care professional when the covered person's health benefit plan requires that a request for a benefit under the plan be initiated by the health care professional; or (v) in the case of an urgent care internal appeal, a health care professional with knowledge of the covered person's medical condition.

"Clinical peer reviewer" means a practicing health care professional who holds a nonrestricted license in a state, district, or territory of the United States and in the same or similar specialty as typically manages the medical condition, procedure, or treatment under appeal.

"Commission" means the State Corporation Commission.

"Concurrent review" means utilization review conducted during a patient's stay or course of treatment in a facility, the office of a health care professional, or other inpatient or outpatient health care setting.

"Covered person" means a policyholder, subscriber, enrollee, or other individual participating in a health benefit plan. For purposes of this chapter with respect to the administration of appeals, references to a covered person include a covered person's authorized representative, if any.

"Emergency services" means those health care services that are rendered after the sudden onset of a medical condition that manifests itself by symptoms of sufficient severity, including severe pain, that the absence of immediate medical attention could reasonably be expected by a prudent layperson who possesses an average knowledge of health and medicine to result in (i) serious jeopardy to the mental or physical health of the individual, (ii) danger of serious impairment of the individual's bodily functions, (iii) serious dysfunction of any of the individual's bodily organs, or (iv) in the case of a pregnant woman, serious jeopardy to the health of the fetus.

"Exception request" means a process that allows a covered person, authorized representative, or prescribing physician (or other prescriber, as appropriate) to request and gain access to clinically appropriate drugs not otherwise covered by a health benefit plan.

"Final adverse determination" means an adverse determination involving a covered benefit that has been upheld by a health carrier, or its designee utilization review entity, at the completion of the health carrier's internal appeal process.

"Group health plan" means an employee welfare benefit plan (as defined in the Employee Retirement Income Security Act of 1974 (29 USC § 1002(1)), to the extent that the plan provides medical care and including items and services paid for as medical care to employees or their dependents (as defined under the terms of the plan) directly or through insurance, reimbursement, or otherwise.

"Health benefit plan" means a policy, contract, certificate, or agreement offered or issued by a health carrier to provide, deliver, arrange for, pay for, or reimburse any of the costs of health care services. "Health benefit plan" does not include accident only, credit, or disability insurance; coverage of Medicare services or federal employee health plans pursuant to contracts with the United States government; Medicare supplement or long-term care insurance; Medicaid coverage; dental only or vision only insurance; specified disease insurance; hospital indemnity coverage; limited benefit health coverage; coverage issued as a supplement to liability insurance; insurance arising out of a workers' compensation or similar law; automobile medical payment insurance; medical expense and loss of income benefits; or insurance under which benefits are payable with or without regard to fault and that is statutorily required to be contained in any liability insurance policy or equivalent self-insurance.

"Health care professional" means a physician or other health care practitioner licensed, accredited, or certified to perform specified health care services consistent with the laws of the Commonwealth.

"Health carrier" means an entity, subject to the insurance laws and regulations of the Commonwealth or subject to the jurisdiction of the commission, that contracts or offers to contract to provide, deliver, arrange for, pay for, or reimburse any of the costs of health care services, including an accident and sickness insurance company, a health maintenance organization, a nonprofit hospital and health service corporation, or a nonstock corporation offering or administering a health services plan, a hospital services plan, or a medical or surgical services plan, or any other entity providing a plan of health insurance, health benefits, or health care services except as excluded under § 38.2-3557 of the Code of Virginia.

"Independent review organization" means an entity that conducts independent external reviews of adverse determinations and final adverse determinations, as well as alleged violations of 14VAC5-216-30 through 14VAC5-216-70 pertaining to internal appeal.

"PPACA" means the Patient Protection and Affordable Care Act (P.L. 111-148), as amended by the Health Care and Education Reconciliation Act of 2010 (P.L. 111-152).

"Pre-service claim" means a claim for a benefit under a health benefit plan that requires approval of the benefit in whole or in part, in advance of obtaining the service or treatment.

"Post-service claim" means a claim for a benefit under a health benefit plan that is not a pre-service claim, or the service or treatment has been provided to the covered person.

"Self-insured plan" means an "employee welfare benefit plan" that has the meaning set forth in the Employee Retirement Income Security Act of 1974, 29 USC § 1002(1).

"Urgent care appeal" means an appeal for medical care or treatment with respect to which the application of the time periods for making non-urgent care determinations (i) could seriously jeopardize the life or health of the covered person or the ability of the covered person to regain maximum function; or (ii) in the opinion of the treating health care professional with knowledge of the covered person's medical condition, would subject the covered person to severe pain that cannot be adequately managed without the care or treatment that is the subject of the appeal. An urgent care appeal shall not be available for any post-service claim or retrospective adverse benefit determination.

"Utilization review" means a set of formal techniques designed to monitor the use of or evaluate the clinical necessity, appropriateness, efficacy, or efficiency of health care services, procedures or settings. Techniques may include ambulatory review, prospective review, second opinion, certification, concurrent review, case management, discharge planning, or retrospective review.

14VAC5-216-40. Minimum appeal requirements.

A. Each covered person shall be entitled to a full and fair review of an adverse benefit determination. Within 180 days after the date of receipt of a notice of an adverse benefit determination, a covered person may file an appeal with the health carrier. A health carrier may designate a utilization review entity to coordinate the review. For purposes of this chapter, "health carrier" may also mean its designated utilization review entity.

B. The health carrier shall conduct the appeal in a manner to ensure the independence and impartiality of the individuals involved in reviewing the appeal. In ensuring the independence and impartiality of such individuals, the health carrier shall not make decisions regarding hiring, compensation, termination, promotion, or other similar matters based upon the likelihood that an individual will support the denial of benefits.

C. 1. In deciding an appeal of any adverse benefit determination that is based in whole or in part on a medical judgment, including determinations with regard to whether a particular treatment, drug, or other service is experimental, investigational, or not medically necessary or appropriate, the health carrier shall designate a clinical peer reviewer to review the appeal. The clinical peer reviewer shall not have been involved in any previous adverse benefit determination with respect to the claim.

2. A reviewer of any other type of adverse benefit determination shall be an appropriate person designated by the health carrier. The reviewer of the appeal shall not be the individual who made any previous adverse benefit determination of the subject appeal nor the subordinate of such individual and shall not defer to any prior adverse benefit determination.

D. A full and fair review shall also provide for:

1. The covered person to have an opportunity to submit written comments, documents, records, and other information relating to the appeal for the reviewer or reviewers to consider when reviewing the appeal.

2. Upon request to the health carrier, the covered person to have reasonable access to and free of charge copies of all documents, records, and other information relevant to the covered person's request for benefits. This information shall be provided to the covered person as soon as practicable.

3. An appeal process that takes into account all comments, documents, records, and other information submitted by the covered person relating to the appeal, without regard to whether such information was submitted or considered in the initial benefit determination.

4. The identification of medical or vocational experts whose advice was obtained on behalf of the health benefit plan carrier in connection with a covered person's adverse benefit determination, without regard to whether the advice was relied upon in making the benefit determination.

5. An urgent care appeal process.

6. Prior to issuing a final adverse benefit determination, the health carrier to provide free of charge to the covered person any new or additional evidence relied upon or generated by the health carrier or at the direction of the health carrier, in connection with the internal appeal sufficiently in advance of the date the determination is required to be provided to permit the covered person a reasonable opportunity to respond prior to that date.

E. A health carrier shall notify the covered person of the final benefit determination within a reasonable period of time appropriate to the medical circumstances, but not later than the timeframes established in subdivisions 1 and 2 of this subsection.

1. If an internal appeal involves a pre-service claim review request, the health carrier shall notify the covered person of its decision within 30 days after receipt of the appeal. A health carrier may provide a second level of internal appeal for group health plans only, provided that a maximum of 15 days is allowed for a benefit determination and notification from each level of the appeal.

2. If an internal appeal involves a post-service claim review request, the health carrier shall notify the covered person of its decision within 60 days after receipt of the appeal. A health carrier may provide a second level of internal appeal for group health plans only, provided that a maximum of 30 days is allowed for a benefit determination and notification from each level of the appeal.

14VAC5-216-50. Urgent care appeals.

A. The health carrier shall notify the covered person of its initial benefit determination as soon as possible taking into account medical exigencies, but not later than 72 hours after receipt of the request, unless the covered person fails to provide sufficient information to determine whether, or to what extent, benefits are covered or payable under the health benefit plan. In the case of such failure, the health carrier shall notify the covered person as soon as possible, but not later than 24 hours after receipt of the request, of the specific information necessary to complete the claim. The covered person shall be afforded a reasonable amount of time, taking into account the circumstances, but not less than 48 hours to provide the specified information. The health carrier shall notify the covered person of its benefit determination not later than 48 hours after the earlier of (i) its receipt of the specified information or (ii) the end of the period afforded to the covered person to provide the specified additional information.

B. The notification of an urgent care adverse benefit determination that is based on a medical necessity, appropriateness, health care setting, level of care, effectiveness, experimental or investigational service or treatment, or similar exclusion or limit, shall include a description of the health carrier's urgent care appeal process including any time limits applicable to those procedures and the availability of and procedures for an expedited external review.

C. Upon receipt of an adverse benefit determination, a covered person may submit a request for an urgent care appeal either orally or in writing to the health carrier. Any appeal request made under this section by a treating health care professional shall be handled as an urgent care appeal. If such request is made by the covered person and not the treating health care professional, an individual acting on behalf of the health carrier shall apply the judgment of a prudent layperson who possesses an average knowledge of health and medicine to determine whether the appeal meets urgent care requirements.

D. All necessary information, including the benefit determination on appeal, shall be transmitted between the health carrier and the covered person by telephone, facsimile, or the most expeditious method available.

E. The health carrier shall notify the covered person and the treating health care professional of its benefit determination as soon as possible, taking into account the medical exigencies, but not later than 72 hours after receipt of an urgent care appeal.

14VAC5-216-65. Exception request for prescription drugs.

A. For plan years beginning on or after January 1, 2016, notwithstanding any other provision of this chapter, a health carrier shall have a process in place that allows for a covered person or his prescribing physician (or other prescriber) to request and gain access to clinically appropriate drugs not otherwise covered by the health benefit plan, known as an exception request, in accordance with the requirements of 45 CFR §156.122 (c).

1. A standard exception request shall be reviewed and a coverage determination provided to the covered person and prescribing physician no later than the earlier of one business day or 72 hours following receipt of the request.

2. An expedited exception request may be made when exigent circumstances exist. Exigent circumstances exist when the covered person is suffering from a health condition that may seriously jeopardize the covered person's life, health, or ability to regain maximum function or when the covered person is undergoing a current course of treatment using a nonformulary drug. An expedited exception request shall be reviewed and a coverage determination provided to the covered person and prescribing physician no later than 24 hours following receipt of the request.

3. If a health carrier denies coverage as a result of a standard exception request or an expedited exception request, the covered person or prescribing physician may submit an external exception request to the health carrier, requiring that the original exception request and subsequent denial be reviewed by an independent review organization. Such request shall be reviewed and a coverage determination provided to the covered person and prescribing physician no later than 72 hours following receipt of the request if the original request was a standard exception request, or 24 hours following receipt of the request if the original request was an expedited exception request.

B. The health carrier shall provide the nonformulary drug or drugs for the duration of the prescription (including refills) if coverage is granted under a standard exception request, or for the duration of the exigency if coverage is granted under an expedited exception request, including those granted through an external exception request. Coverage for each drug approved by an exception request shall be applied as if the drug was part of the prescription formulary.

C. A health carrier shall contract with at least one accredited independent review organization to conduct reviews in accordance with the requirements of subdivision A 3 of this section.

Title of Regulation: 14VAC5-395. Rules Governing Settlement Agents (amending 14VAC5-395-10, 14VAC5-395-20, 14VAC5-395-30 through 14VAC5-395-80; adding 14VAC5-395-75, 14VAC5-395-100; repealing 14VAC5-395-25).

Statutory Authority: §§ 12.1-13 and 55-525.28 of the Code of Virginia.

Public Hearing Information: A public hearing will be scheduled upon request.

Public Comment Deadline: December 31, 2015.

Agency Contact: Chuck F. Myers, Supervisor of RESA Investigation Unit, Bureau of Insurance, State Corporation Commission, P.O. Box 1157, Richmond, VA 23218, telephone (804) 371-9619, FAX (804) 371-5661, or email chuck.myers@scc.virginia.gov.

Summary:

The proposed amendments (i) define various terms, including "designated licensed producer," "escrow, closing, or settlement services," and "settlement agent"; (ii) add reporting requirements for settlement agents; (iii) clarify registration, appointments, and the use of title insurance agent independent contractors; (iv) add requirements regarding escrow accounts; (v) require that settlement agents and former settlement agents maintain contact information with the Bureau of Insurance; and (vi) make various other technical and clarifying amendments.

AT RICHMOND, NOVEMBER 9, 2015

COMMONWEALTH OF VIRGINIA, ex rel.

STATE CORPORATION COMMISSION

CASE NO. INS-2015-00170

Ex Parte: In re: Rules Governing Settlement Agents

ORDER TO TAKE NOTICE

Section 55-525.28 of the Code of Virginia provides that the State Corporation Commission ("Commission") may adopt such regulations as it deems appropriate to effect the purposes of Chapter 27.3 (§ 55-525.16 et seq.) of Title 55 of the Code of Virginia. The Commission's regulations governing title insurance agents, title insurance agencies and title insurance companies providing escrow, closing or settlement services involving real property located in Virginia ("settlement agents") are set forth in Chapter 395 of Title 14 of the Virginia Administrative Code ("Chapter 395").

The Bureau of Insurance ("Bureau") has submitted to the Commission proposed amendments to Chapter 395. The amendments to the regulations are being proposed to address changes in business practices, technology, and federal law, and include various technical and other clarifying changes. A copy of the regulations may also be found at the Commission's website: http://www.scc.virginia.gov/boi/laws.aspx.

NOW THE COMMISSION, based on the information supplied by the Bureau, is of the opinion and finds that the proposed regulations should be considered for adoption with a proposed effective date of February 1, 2016.

Accordingly, IT IS ORDERED THAT:

(1) The proposed regulations are appended hereto and made a part of the record herein.

(2) Comments or requests for a hearing on the proposed regulations must be submitted in writing to Joel H. Peck, Clerk, State Corporation Commission, c/o Document Control Center, P.O. Box 2118, Richmond, Virginia 23218, on or before December 31, 2015. Requests for a hearing shall state why a hearing is necessary and why the issues cannot be adequately addressed in written comments. All correspondence shall contain a reference to Case No. INS-2015-00170. Interested persons desiring to submit comments or request a hearing electronically may do so by following the instructions available at the Commission's website: http://www.scc.virginia.gov/case.

(3) This Order and the attached proposed regulations shall be posted on the Commission's website at http://www.scc.virginia.gov/case.

(4) The Commission's Division of Information Resources shall provide a copy of this Order, including a copy of the attached proposed regulations, to the Virginia Registrar of Regulations for publication in the Virginia Register of Regulations.

(5) The Bureau shall forthwith send by e-mail or U.S. mail a copy of this Order, together with a copy of the proposed regulations, to all licensed and registered title insurance agents, title insurance agencies and title insurance companies providing escrow, closing or settlement services involving real property located in Virginia, and such other interested parties as the Bureau may designate.

(6) The Bureau shall file with the Clerk of the Commission an affidavit of compliance

with the notice requirements of Ordering Paragraph (5).

(7) This matter is continued.

AN ATTESTED COPY hereof shall be sent by the Clerk of the Commission to: Kiva B. Pierce, Assistant Attorney General, Division of Consumer Counsel, Office of the Attorney General, 900 East Main Street, Second Floor, Richmond, Virginia 23219; and a copy hereof shall be delivered to the Commission's Office of General Counsel and the Bureau of Insurance in care of Deputy Commissioner Brian P. Gaudiose.

14VAC5-395-10. Purpose Applicability.

A. The purpose of this This chapter is to implement implements Chapter 27.3 (§ 55-525.16 et seq.) of Title 55 of the Code of Virginia B. This chapter and applies to all title insurance agents, title insurance agencies, and title insurance companies providing escrow, closing, or settlement services involving the purchase of or lending on the security of any real estate containing not more than four residential dwelling units property in the Commonwealth of Virginia.

C. The Bureau of Insurance shall issue the necessary forms to carry out the provisions of Chapter 27.3 (§ 55-525.16 et seq.) of Title 55 of the Code of Virginia and this chapter.

14VAC5-395-20. Definitions.

Unless otherwise defined herein, all The following words and terms when used in this chapter shall have the meaning as set forth in Chapter 27.3 (§ 55-525.16 et seq.) of Title 55 of the Code of Virginia following meanings unless the context clearly indicates otherwise:

"Agent" or "insurance agent" shall have the same meaning as set forth in § 38.2-1800 of the Code of Virginia means an individual or business entity that sells, solicits, or negotiates contracts of insurance or annuity in the Commonwealth.

"Bureau" means the State Corporation Commission Bureau of Insurance.

"Business entity" means a partnership, limited partnership, limited liability company, corporation, or other legal entity other than a sole proprietorship.

"Designated licensed producer" means an individual who (i) possesses a valid Virginia title license to sell, solicit, or negotiate contracts of insurance or annuity in the Commonwealth; (ii) is appointed; (iii) is an employee of the business entity; and (iv) is responsible for the business entity's compliance with the insurance laws, rules, and regulations of this Commonwealth.

"Employee" means an individual (i) whose manner and means of performance of work are subject to the right of control of, or are controlled by, a business entity and (ii) whose compensation for federal income tax purposes is reported, or required to be reported, on a W-2 form issued by the controlling business entity.

"Escrow, closing, or settlement services" means the administrative and clerical services required to carry out the terms of contracts affecting real estate. These services include (i) placing orders for title insurance; (ii) receiving and issuing receipts for money received from the parties; (iii) ordering loan checks and payoffs; (iv) ordering surveys and inspections; (v) preparing settlement statements or Closing Disclosure forms; (vi) determining that all closing documents conform to the parties' contract requirements; (vii) setting the closing appointment; (viii) following up with the parties to ensure that the transaction progresses to closing; (ix) ascertaining that the lenders' instructions have been satisfied; (x) conducting a closing conference at which the documents are executed; (xi) receiving and disbursing funds; (xii) completing form documents and instruments selected by and in accordance with instructions of the parties to the transaction; (xiii) handling or arranging for the recording of documents; (xiv) sending recorded documents to the lender; (xv) sending the recorded deed and the title policy to the buyer; and (xvi) reporting federal income tax information for the real estate sale to the Internal Revenue Service.

"Lay real estate settlement agent" means a person who (i) is not licensed as an attorney under Chapter 39 (§ 54.1-3900 et seq.) of Title 54.1 of the Code of Virginia, (ii) is not a party to the real estate transaction, (iii) provides escrow, closing or settlement services in connection with a transaction related to any real estate in this Commonwealth, and (iv) is listed as the settlement agent on the settlement statement or Closing Disclosure for such the transaction.

"Settlement agent" shall have the same meaning as set forth in § 55-525.16 of the Code of Virginia means any title insurance agent, title insurance agency, title insurance company, or person, other than a party to the real estate transaction, who provides escrow, closing, or settlement services in connection with a transaction related to real estate in the Commonwealth and who is listed as the settlement agent on the settlement statement or Closing Disclosure for the transaction. Any person, other than a party to the transaction, who conducts the settlement conference and receives or handles money shall be deemed a "settlement agent" subject to the applicable requirements of Chapter 27.3 (§ 55-525.16 et seq.) of the Code of Virginia and this chapter.

"Title insurance agency" means a business entity licensed in this Commonwealth as a title insurance agent.

"Title insurance agent" shall have the same meaning as set forth in § 38.2-1800 of the Code of Virginia.

"Title insurance agency" or "title insurance agent" means any individual or business entity licensed in the Commonwealth, pursuant to Chapter 18 (§ 38.2-1800 et seq.) of Title 38.2 of the Code of Virginia, as a title insurance agent and appointed by a title insurance company licensed in the Commonwealth who shall perform all of the following services (for which liability arises) relevant to the issuance of title insurance policies, subject to the underwriting directives and guidelines of the agent's title insurance company. These services shall include (i) the evaluation of the title search to determine the insurability of the title; (ii) a determination of whether or not underwriting objections have been cleared; (iii) the actual issuance of a title commitment or binder and endorsements; and (iv) the actual issuance of the policy or policies and endorsements on behalf of the title insurance company. A title insurance agent holding funds in escrow shall promptly deposit the funds in a trust account in a financial institution authorized to do business in this Commonwealth. This trust account shall be separate from all other accounts held by the agent.

"Title insurance company" means any company licensed to transact, or transacting, title insurance in this Commonwealth.

14VAC5-395-25. Lay real estate settlement agents. (Repealed.)

Notwithstanding any provision of this chapter to the contrary, and pursuant to § 55-525.18 of the Code of Virginia, a lay real estate settlement agent shall be required to comply with the provisions of this chapter, except as specifically set forth in 14VAC5-395-60.

14VAC5-395-30. Registration.

A. Every title insurance agent, title insurance agency and title insurance company that acts as a settlement agent shall be required to be registered register with the bureau in accordance with the provisions of § 55-525.30 of the Code of Virginia.

B. At the time of application for registration, a settlement agent shall provide to the bureau (i) its certificate of authorization or charter of a domestic limited liability company or corporation, or certificate of registration or certificate of authority of a foreign limited liability company or corporation, as applicable; (ii) an original surety bond; and (iii) a designated licensed producer.

C. Within 30 days of registration a settlement agent shall furnish to the bureau:

1. Legal name;

2. Any fictitious names;

3. Principal place of business address;

4. Addresses of all other business locations;

5. Telephone numbers;

6. Escrow account numbers and financial institution addresses;

7. Employee and independent contractor list;

8. Website or websites;

9. Affiliated entities; and

10. Such other information as the bureau may require.

14VAC5-395-40. Insurance and bonding requirements.

A. At the time of registration, every title insurance agent and title insurance agency acting as a settlement agent shall file a certification on a form prescribed by the bureau, that the settlement agent has, and thereafter shall keep in force for as long as they are acting as a settlement agent, the following:

1. An errors and omissions insurance policy providing limits of at least $250,000 per occurrence or per claim and issued by an insurer authorized to do business in the Commonwealth of Virginia. A deductible is permitted but shall not hinder or delay the payment of a claim.

2. A blanket fidelity bond or employee dishonesty insurance policy covering persons employed by the settlement agent providing limits of at least $100,000 per occurrence or per claim and issued by an insurer authorized to do business in the Commonwealth of Virginia. Settlement agents that have no employees except the owners, partners, shareholders, or members may request apply for a waiver of this requirement on their certification form.

B. Every title insurance agent and title insurance agency that acts as a settlement agent in the Commonwealth of Virginia shall file an original surety bond in an amount not less than $200,000 on a form prescribed by the bureau at the time of application for registration and, if such bond is canceled, at the time a replacement bond is issued.

14VAC5-395-50. Audits.

A. Every title insurance agent and title insurance agency that acts as a settlement agent in the Commonwealth of Virginia shall, at its expense, have an audit of its escrow accounts conducted by an independent certified public accountant at least once each consecutive 12-month period. The audit month shall be prescribed by the bureau. Such audit shall conform with the standards established by the American Institute of Certified Public Accountants, Statement on Auditing AICPA Professional Standards, Volume 1, as of June 1, 2015, Special Reports Considerations - Audits of Single Financial Statements and Specific Elements, Accounts, or Items of a Financial Statement, and shall be filed by the settlement agent with the bureau no later than 60 days after the date on which the audit is completed. A title insurance company shall be subject to the requirements of this subsection unless such company's financial statements are audited annually by an independent certified public accountant.

B. Every title insurance agent or title insurance agency acting as a settlement agent shall file a copy of its audit report with each title insurance company it represents.

C. In lieu of an audit conducted by a certified public accountant, a title insurance agent or title insurance agency acting as a settlement agent shall allow each title insurance company for which it has an appointment to conduct an analysis of its escrow accounts at least once each consecutive 12-month period. The form of such the analysis and the analysis month shall be prescribed by the bureau. The title insurance company shall submit a copy of its analysis to the bureau no later than 60 days after the date on which the analysis is completed. With the consent of the title insurance agent or agency, a title insurance company may share the results of its analysis with other title insurance companies that will accept the same in lieu of conducting a separate analysis.

D. Every settlement agent shall (i) make a good faith effort to disburse funds in its possession and return the funds to the rightful owner; (ii) escheat unclaimed funds yearly to the Virginia Department of the Treasury; and (iii) comply with The Uniform Disposition of Unclaimed Property Act (§ 55-210.1 et seq.) of Title 55 of the Code of Virginia.

E. A settlement agent shall complete and file a close-out audit with the bureau in conformance with this chapter and the bureau's instructions within 180 days from the date the settlement agent ceases conducting settlements.

14VAC5-395-60. Separate fiduciary trust account.

A. Every title insurance agent, title insurance agency and title insurance company that acts as a settlement agent in the Commonwealth of Virginia shall maintain a separate fiduciary trust account for the purpose of handling funds received in connection with escrow, closing, or settlement services involving real estate located only in this Commonwealth. No other funds may be included in this escrow account except funds deposited to guarantee the adequacy of the account. Such trust account shall be with a financial institution authorized to do business in the Commonwealth of Virginia.

B. If the agent, agency, or company acting as a lay real estate settlement agent provides escrow, closing, or settlement services in transactions involving multiple parcels or tracts of real estate and any one of those tracts or parcels is located wholly or partially outside of this Commonwealth, that the settlement agent, agency, or company shall maintain another separate fiduciary trust account for the purpose of handling funds received in connection with such transactions.

C. A settlement agent may utilize a general escrow account for the purpose of receiving funds in connection with an escrow, closing, or settlement involving real estate located in the Commonwealth, provided that the settlement agent (i) handles the funds in a fiduciary capacity and (ii) deposits the funds in a separate fiduciary trust account in compliance with subsection A of this section no later than the close of the second business day after receipt of the funds.

14VAC5-395-70. Access to records Reporting requirements.

A. Every title insurance agent, title insurance agency and title insurance company that acts as a settlement agent in the Commonwealth of Virginia shall make all escrow, closing, or settlement records available promptly upon request for examination by the bureau without notice during normal business hours.

B. A settlement agent shall maintain documentation that supports all entries on the settlement statement or Closing Disclosure.

C. A settlement agent shall promptly respond to a bureau request for books, records, documentation, or other information in connection with the bureau's investigation, enforcement, or examination of the settlement agent's compliance with applicable laws and regulations. If no time period is specified by the bureau, a written response as well as any requested books, records, documentation, or information shall be delivered by the settlement agent to the bureau not later than 30 days from the date of such request.

D. Within 30 days following the occurrence of any of the following events, a settlement agent shall report to the bureau if:

1. Any bankruptcy, reorganization, or receivership proceedings are filed by or against the settlement agent.

2. Any local, state, or federal governmental authority institutes revocation, suspension, or other formal administrative, regulatory, or enforcement proceedings against the settlement agent.

3. Any local, state, or federal governmental authority (i) revokes or suspends the settlement agent's registration, license, or other license for a similar business; (ii) takes formal administrative, regulatory, or enforcement action against the settlement agent relating to its business; or (iii) takes any other action against the settlement agent relating to its business where the total amount of restitution or other payment from the settlement agent exceeds $2,500.

4. Based on allegations by any local, state, or federal governmental authority that the settlement agent violated any law or regulation applicable to the conduct of its licensed business, the settlement agent enters into, or otherwise agrees to the entry of, a settlement or consent order, decree, or agreement with or by such governmental authority.

5. The settlement agent surrenders its license in another state in lieu of threatened or pending license revocation; license suspension; or other administrative, regulatory, or enforcement action.

6. The settlement agent is denied a license in another state.

7. The settlement agent or any of its members, partners, directors, officers, principals, employees, or independent contractors is indicted or convicted of a felony.

8. Any funds held by the settlement agent are (i) seized by or on behalf of any court or governmental instrumentality or (ii) forfeited to or on behalf of any court or governmental instrumentality.

E. A settlement agent shall immediately notify the bureau following the loss of (i) a designated licensed producer, (ii) required insurance coverage, or (iii) required bond coverage.

F. A settlement agent or former settlement agent shall provide the following information to the bureau within 10 days after such person's license is surrendered, terminated, suspended, or revoked or has lapsed by operation of law, or the licensed and registered business is otherwise closed: (i) the names, addresses, telephone numbers, fax numbers, and email addresses of a designated contact person; (ii) the location of the settlement agent's or former settlement agent's records; and (iii) any additional information that the bureau may reasonably require. A settlement agent or former settlement agent shall maintain current information with the bureau until all escrow funds are disbursed and all title policies are issued.

G. Sixty days prior to ceasing business, a settlement agent shall provide notice to the bureau of its intent to cease conducting settlements and the anticipated date of business termination.

H. The reports required by this section shall be in the format and contain such additional information as the bureau may reasonably require. The bureau may also require additional reports that it deems necessary.

14VAC5-395-75. Operating requirements.

A settlement agent shall comply with the following requirements:

1. A settlement agent shall continuously maintain the requirements and standards for licensure and registration.

2. A settlement agent shall reconcile its escrow accounts monthly.

3. A settlement agent shall not provide any information to the bureau or a consumer that is false, misleading, or deceptive.

4. A settlement agent shall not charge duplicative or inflated fees for escrow, closing, or settlement services.

5. A settlement agent shall not engage in any activity that directly or indirectly results in an evasion of the provisions of Chapter 27.3 (§ 55-525.16 et seq.) of the Code of Virginia or this chapter.

6. Any person, other than a party to the transaction, who conducts the settlement conference and receives or handles money, including possessing wire transfer authority, shall be properly licensed and shall be deemed a "settlement agent" subject to the applicable requirements of Chapter 27.3 and this chapter.

7. A designated licensed producer shall be appointed by the same title insurance company as its employer settlement agent.

8. A settlement agent may not use or accept the services of a title insurance agent independent contractor unless the title insurance agent independent contractor (i) holds a title insurance license, (ii) is appointed, (iii) is registered, and (iv) maintains the insurance or bond coverages required by Chapter 27.3 and this chapter.

9. A settlement agent that uses the services of a title insurance agent independent contractor shall be (i) the legal principal of the title insurance agent independent contractor and (ii) liable for all actions of the title insurance agent independent contractor, including unintentional conduct, that occurs during the period services are utilized.

10. A former settlement agent shall remain subject to the provisions of Chapter 27.3 and this chapter in connection with all settlements that the settlement agent performed while licensed and registered, notwithstanding the occurrence of any of the following events:

a. The settlement agent's license is surrendered, terminated, suspended, or revoked or has lapsed by operation of law; or

b. The settlement agent ceases conducting settlements.

11. If a settlement agent or former settlement agent disposes of records containing a consumer's personal financial information or copies of a consumer's identification documents, such records and copies shall be disposed of in a secure manner.

14VAC5-395-80. Violations Enforcement.

Any violation of Failure to comply with any provision of Chapter 27.3 (§ 55-525.16 et seq. of the Code of Virginia) or this chapter shall be punished as provided for in Chapter 27.3 (§ 55-525.16 et seq.) of Title 55 of the Code of Virginia may result in penalties, license revocation or suspension, the entry of a cease and desist order, restitution, or other enforcement action.

14VAC5-395-100. Commission authority.

The commission may, at its discretion, waive or grant exceptions to any provision of this chapter for good cause shown.

FORMS (14VAC5-395)

Settlement Agent Official Registration Form for a Title Agent (eff. 3/2012)

Settlement Agent Official Registration Form for Licensed Title Insurance Company or Agency (eff. 3/2012)

Title Settlement Agency/Agency Financial Responsibility Certification (undated, filed 11/2015)

Waiver of Blanket Fidelity Bond or Employee Dishonesty Insurance Policy for Title Insurance Settlement Agents (undated, filed 11/2015)

Bond for Title Insurance Settlement Agent (undated, filed 11/2015)

Standard Report of Escrow Accounts Maintained by Title Insurance Agents (eff. 10/2010)

DOCUMENTS INCORPORATED BY REFERENCE (14VAC5-395)

Statement on Auditing Standards, Special Reports, July 1, 1989, American Institute of Certified Public Accountants.

AICPA Professional Standards, Volume 1, as of June 1, 2015, American Institute of Certified Public Accountants, New York, New York 10036-8775, http://www.aicpa.org

AICPA Professional Standards, Volume 2, as of June 1, 2015, American Institute of Certified Public Accountants, New York, New York 10036-8775, http://www.aicpa.org

Titles of Regulations: 16VAC25-140. Virginia Confined Space Standard for the Construction Industry (repealing 16VAC25-140-10 through 16VAC25-140-90, Appendix A, Appendix B).

16VAC25-150. Underground Construction, Construction Industry (repealing 16VAC25-150-10).

16VAC25-170. Virginia Excavation Standard, Construction Industry (29 CFR 1926.650 - 1926.652) (repealing 16VAC25-170-10, 16VAC25-170-20, 16VAC25-170-30).

16VAC25-175. Federal Identical Construction Industry Standards (amending 16VAC25-175-1926.953, 16VAC25-175-1926.968, 16VAC25-175-1926.1200 through 16VAC25-175-1926.1213; adding 16VAC25-175-1926.650, 16VAC25-175-1926.651, 16VAC25-175-1926.652, 16VAC25-175-1926.800; repealing 16VAC25-175-1926.21).

Statutory Authority: § 40.1-22 of the Code of Virginia.

Effective Date: January 1, 2016.

Agency Contact: John Crisanti, Policy and Planning Manager, Department of Labor and Industry, Main Street Centre, 600 East Main Street, Richmond, VA 23219, telephone (804) 786-4300, or email crisanti.john@dol.gov.

Summary:

In a final rule, federal Occupational Safety & Health Administration (OSHA) adopted a new construction standard on confined spaces in construction, Subpart AA (29 CFR 1926.1200 through 29 CFR 1926.1213), and revisions to related provisions (29 CFR 1926.21, 29 CFR 1926.953, and 29 CFR 1926.968). Subpart AA replaces OSHA's current one training requirement for confined space work with a comprehensive standard that includes a permit program designed to protect employees from exposure to many hazards associated with work in confined spaces, including atmospheric and physical hazards. The final rule is similar in content and organization to the general industry confined space standard, but also incorporates several provisions from the proposed rule to address construction-specific hazards, accounts for advancements in technology, and improves enforceability of the requirements. This action incorporates these changes into the Virginia standard. The new OSHA final rule provides comprehensive and uniform levels of worker protection across industries that previously were lacking in the federal regulations but had been addressed in 16VAC25-140, Virginia Confined Space Standard for the Construction Industry, a Virginia unique regulation. Since 16VAC25-140 is no longer necessary, the board is repealing it as part of this regulatory action.

The OSHA final rule does not apply to excavation or underground construction, which are covered by existing federal regulations. Therefore, the board adopted the existing federal identical regulations for the Excavation Standard (29 CFR 1926.650, 1926.651, and 1926.652) and the Underground Construction Standard (29 CFR 1926.800) and repealed the Virginia unique standards 16VAC25-150, Underground Construction, Construction Industry, and 16VAC25-170, Virginia Excavation Standard, Construction Industry.

Note on Incorporation by Reference: Pursuant to § 2.2-4103 of the Code of Virginia, 29 CFR Part 1926 (Construction Industry Standards) is declared a document generally available to the public and appropriate for incorporation by reference. For this reason this document will not be printed in the Virginia Register of Regulations. A copy of this document is available for inspection at the Department of Labor and Industry, Main Street Centre, 600 East Main Street, Richmond, Virginia 23219, and in the office of the Registrar of Regulations, General Assembly Building, 9th and Broad Streets, Richmond, Virginia 23219.

Statement of Final Agency Action: On October 29, 2015, the Safety and Health Codes Board adopted federal OSHA's Final Rule for Confined Spaces in Construction, as published in 80 FR 25365 through 80 FR 25526 on May 4, 2015, with an effective date of August 3, 2015.

Federal Terms and State Equivalents: When the regulations as set forth in the revised final rule for the Construction Industry Standards are applied to the Commissioner of the Department of Labor and Industry or to Virginia employers, the following federal terms shall be considered to read as follows:

Title of Regulation: 18VAC30-20. Regulations Governing the Practice of Audiology and Speech-Language Pathology (amending 18VAC30-20-240).

Statutory Authority: § 54.1-2400 of the Code of Virginia.

Public Hearing Information:

December 11, 2015 - 8:40 a.m. - Department of Health Professions, Perimeter Center, 9960 Mayland Drive, Conference Center, 2nd Floor, Richmond, VA

Public Comment Deadline: January 29, 2016.

Agency Contact: Leslie L. Knachel, 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 leslie.knachel@dhp.virginia.gov.

Basis: Section 54.1-2400 of the Code of Virginia provides the Board of Audiology and Speech-Language Pathology the authority to promulgate regulations that are reasonable and necessary to administer effectively the regulatory system. Authority for the board to adopt regulations for a person practicing as an assistant speech-language pathologist (SLPA) is found in the amendment to § 54.1-2600 of the Code of Virginia in Chapter 661 of the 2014 Acts of the Assembly.

Purpose: Chapter 661 of the 2014 Acts of Assembly authorizes a person "who has met the qualifications prescribed by the Board" to practice as an assistant speech-language pathologist under the supervision of a licensed speech-language pathologist. The purpose of the proposed regulatory action is to set out the qualifications for such a person, the scope of his practice, and the responsibilities of the licensed supervisor.

The practice of speech-language pathology includes "facilitating development and maintenance of human communication through programs of screening, identifying, assessing and interpreting, diagnosing, habilitating and rehabilitating speech-language disorders" (§ 54.1-2600 of the Code of Virginia). Unlicensed assistants may be utilized to extend but not replace the practice of a licensed SLP. The American Speech-Language-Hearing Association white paper on the scope of practice for assistants states: "The decision to shift responsibility for implementation of the more repetitive, mechanical, or routine clinical activities to SLPA's should be made only by qualified professionals and only when the quality of care and level of professionalism will not be compromised." The proposed regulatory action for the establishment of assistant competency and scope of practice is essential to ensure the quality and continuity of care under the legal and professional responsibility of a licensed SLP to protect the health and safety of clients receiving speech-language services.

Substance: Current regulations in 18VAC30-20-240 specify that a licensed speech-language pathologist shall provide documented supervision to unlicensed assistants, shall be held fully responsible for his performance and activities, and shall ensure that he performs only those activities that do not constitute the practice of speech-language pathology and that are commensurate with his level of training. Further, regulations provide that the identity of the unlicensed assistant shall be disclosed to the client prior to treatment and shall be made a part of the client's file.

Amendments to set out the qualifications of an assistant speech-language pathologist to include a bachelor's degree or associate's degree and specific training as necessary to be determined by the supervising SLP. Minimal competency in performance must be documented before the supervising SLP can assign tasks to the assistant. After demonstration of competency, the assistant may perform duties planned, designed, and supervised by a licensed SLP. Regulations specify which duties are appropriate to the practice of an assistant and which would constitute licensed practice of an SLP and therefore are not to be performed by an unlicensed assistant. Generally speaking, activities that require assessment and professional judgment in speech-language pathology are not appropriate for delegation to an assistant. Finally, regulations specify the supervisory responsibilities of the licensed SLP for the activities of the assistant, the number of assistants who may be supervised, the frequency with which there must be on-site supervision of assistants, and the frequency with which the licensed SLP must personally see and evaluate the client. Ultimate responsibility for the client and the outcomes of his care and treatment remains with the licensed SLP.

Issues: The primary advantage to the public is minimal qualifications for unlicensed assistants who are providing direct services to clients and clearer specifications about the appropriate role of an assistant and responsibility of a supervisor. There are no disadvantages as persons receiving services are better protected by proposed regulations.

There are no real advantages and disadvantages to the agency or the Commonwealth, except greater clarity and specification in regulation to reduce ambiguity for licensees.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. Pursuant to Chapter 661 of the 2014 Acts of the Assembly, the Board of Audiology and Speech-Language Pathology proposes to amend its regulation to clarify rules for supervising unlicensed assistants and to set education and/or experience requirements that assistants must have in order for licensed speech-language pathologists to be able to hire or supervise them.

Result of Analysis. Benefits may outweigh costs for some of these proposed regulatory changes. For one regulatory change, there is insufficient information to ascertain whether benefits will outweigh costs. For one regulatory change, costs likely outweigh benefits.

Estimated Economic Impact. Current regulation requires licensed audiologists and licensed speech-language pathologists to provide documented supervision to their unlicensed assistants. Licensed audiologists and licensed speech-language pathologists are currently responsible for ensuring that assistants do not perform tasks that would constitute the practice of audiology or speech-language pathology¹ and must also ensure that assistants only perform tasks for which they have been trained.

In 2014, the General Assembly passed legislation, which reads "A person who has met the qualifications prescribed by the Board may practice as an assistant speech-language pathologist and may perform duties not otherwise restricted to the practice of a speech-language pathologist under the supervision of a speech-language pathologist."

Pursuant to this legislation, the Board now proposes to amend its regulation 1) so that rules for audiologists and speech-language pathologists are separate (with rules for audiologist supervision of assistants remaining unchanged), 2) to clarify the rules for supervision of assistants, 3) to specify which duties a speech-language pathologist assistant can perform and which would constitute the practice of speech-language pathology and 4) to set education requirements for those assistants. Most of the amendments that will clarify the rules for supervision and the duties that assistants may perform are not new but instead will formally delineate current practice in this regulation. Board staff reports, for instance, that the requirement for speech-language pathologists to provide on-site supervision of at least two assistant lead client sessions every 30 days and to directly provide at least one client session every 30 days is reported to be current practice in the field and is also required for CMS (Centers for Medicare and Medicaid Services) reimbursement for services. Clarifying changes such as these are unlikely to increase costs for any affected entity but will provide the benefit of greater understanding for the rules of supervision and provision of client services. Benefits will outweigh costs for these clarifying changes.

The Board newly proposes to limit the number of assistants that a speech-language pathologist may supervise at any time to two. Board staff reports that this limit is being imposed at the request of the Virginia Department of Education (VDOE) and of the speech-language pathologists that provided comment on the proposed regulation. To the extent that some speech-language pathologists may be currently supervising more than two assistants without compromising patient care, this change will likely adversely affect them as it will limit the number of clients they may serve. There is insufficient information available, however, to ascertain whether any benefits to clients that may accrue on account of speech-language pathologists being limited to two assistants will outweigh any adverse impacts to the speech-language pathologists themselves.

Board staff reports that the Board convened a Regulatory Advisory Panel (RAP) committee to provide subject matter expertise in developing the proposed regulation. This committee agreed that the responsibility for the training of assistants and for their practice belongs to the supervising speech-language pathologist. Board staff reports that the committee considered just requiring that assistants complete documented training with a licensed speech-language pathologist in topics that would allow them to complete assigned duties competently. By count, 7 of the 15 comments received at the NOIRA stage of this action suggested that assistants be required to have a bachelor's degree (one suggested that they be required to complete education specific to speech-language disorders). With that feedback the Board now proposes to require that assistants who are supervised by speech-language pathologists either 1) have been employed as an assistant in a U.S. jurisdiction at some time in the five years preceding the effective date of this proposed regulation or 2) have a bachelor's or associate's degree in any field and documented training by a speech-language pathologist. Board staff reports that the Board is not proposing formal education specifically in speech-language pathology because there are no associate's or bachelor's level programs in speech language pathology in the Commonwealth. Board staff further reports that there are several bachelors' programs in communication sciences and disorders in the Commonwealth: at Longwood University, the University of Virginia, James Madison University (JMU), Radford University, Old Dominion University (ODU), Hampton University and Norfolk State University.

These education requirements will likely cost new assistant speech-language pathologists entering the field after this proposed regulation becomes effective at least $20,000 for a two year associate's degree to many more tens of thousands of dollars for a bachelor's degree at a traditional four year university. The bachelors' programs in communications sciences and disorders reported by Board staff, and for which DPB could find cost information, would cost between $48,384 at ODU to $98,000 at JMU for a four year degree. These greatly increased costs to enter the field will likely limit the number of individuals able to work as assistant speech-language pathologists. This, in turn, will likely increase costs for local school districts and health care institutions that hire the majority of speech-language pathologists that will be competing to hire from a smaller pool of approved assistants. Speech language pathologists who work in private practice will also see increased costs, or a decreased client capacity with fewer assistants. These education requirements will also put future assistants at a competitive disadvantage when compared to assistants now working as they will have paid much more to enter the field which will not be as remunerative for them once they account for the financial outlay of required formal education. It is also likely hard to justify this education requirement when 1) there is likely little nexus between requiring just any degree and competent practice as an assistant and 2) there is no suggestion that current assistants are practicing incompetently with training from their supervising speech-language pathologist. Without some evidence that current assistant practice is suffering from issues that formal education would specifically address, all affected entities, including clients, would likely benefit from amending the proposed regulation to eliminate the requirement for formal higher education. Costs likely outweigh benefits for this proposed change.

Businesses and Entities Affected. Board staff reports that this proposed regulation will affect all speech-language pathologists in the Commonwealth as well as any assistants that they supervise. The Board currently licenses 3,662 speech-language pathologists but Board staff does not know how many individuals are employed as speech-language pathologist assistants. According to the Department of Health Profession's Healthcare Workforce Data Center, as of 2013 approximately 14% of speech-language pathologists worked in private practice and so would likely qualify as small businesses. All other speech-language pathologists work for either large health care institutions or school systems.

Localities Particularly Affected. New education requirements for speech-language pathologist assistants will require a bachelor's or associate's degree of assistants hired for the first time to do this job after the effective date of this proposed regulation. Local school systems that have not been requiring this level of education in the assistants that they hire will likely have a smaller pool of individuals to hire from and may have to pay more to secure the services of these individuals.

Projected Impact on Employment. This regulatory action will likely decrease the number of individuals who may be hired as speech-language pathologists.

Effects on the Use and Value of Private Property. To the extent that this regulatory action raises the cost of hiring speech-language pathology assistants, private practice speech-language pathologists as well as large health institutions may either choose to hire fewer assistants (thus somewhat limiting the number of clients they may serve) or may have to cover increased salary costs. Both of these responses to increased costs would tend to slightly decrease profits.

Small Businesses: Costs and Other Effects. Private practice speech-language pathologists may experience increased employment costs for hiring assistants once assistants are required to have a bachelor's or associate's degree.

Small Businesses: Alternative Method that Minimizes Adverse Impact. Absent some evidence that current speech-language pathologist assistants are practicing in ways that would raise competency issues that are best addressed by the formal education requirements in this proposed regulation, speech-language pathologists, their assistants and their clients will likely benefit from eliminating those requirements and allowing speech-language pathologists to provide training in the specific tasks that they plan to assign their assistants.

Real Estate Development Costs. This regulatory action will likely have no effect on real estate development costs in the Commonwealth.

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¹ Assistants may not 1) hold themselves out as being an audiologist or speech-language pathologist, 2) perform any tests or evaluations, 3) perform procedures that require professional clinical skills, 4) interpret results of tests or evaluations or provide interpretive information on client status or services, 5) participate in conferences or meetings without the presence of their supervisor or 6) write, develop or modify client treatment plans.

Agency's Response to Economic Impact Analysis: The Board of Audiology and Speech-Language Pathology does not concur with the analysis of the Department of Planning and Budget (DPB) on 18VAC30-20, Regulations Governing the Practice of Audiology and Speech-Language, relating to its assertions about the unnecessary burden of requiring an associate's degree or bachelor's degree for persons working as speech-language pathology assistants.

At its meeting on June 11, 2015, the board considered the economic impact analysis prepared by DPB and chose to retain its original proposal for the following reasons:

1) While an assistant will perform activities as directed and supervised by a licensed speech-language pathologist (SLP), he will be providing significant services to clients, often with children or the elderly. The assistant must have the knowledge and skills to assist with screenings, assist with assessments, follow a treatment plan and document results, assist with programming devices and in training the client on such devices, and document performance and report to the SLP. Members concurred that a post-secondary level of education was essential for the core knowledge and skills to train an assistant for safe, competent practice. Much in the same way a basic baccalaureate degree is necessary to secure admission in graduate programs, the board believes an associate's or bachelor's degree should be the foundational educational level for an assistant who will then receive special training in speech-language pathology duties.

2) By setting the qualification at the associate or bachelor level, the regulation may open opportunities for persons who hold those degrees but do not have specialized training and experience that qualifies them for employment.

3) It is not accurate to state that there are no bachelor's level programs in speech-language pathology or communication disorders. The agency background document has been revised to clarify that such programs and degrees are available and do graduate several hundred persons each year.

4) Current capacity for hiring bachelor's degree persons should be more than adequate to meet demand. A master's degree is required for licensure as an SLP. Recent information from masters-level programs in speech-language pathology or communication-speech disorders in Virginia indicates that there are significantly more applicants with bachelor's degrees than slots in graduate programs. At James Madison University, there were 249 applications for the online program, and 20 were admitted; there were 349 applications for the on-campus program; 22 were admitted. At Longwood University, there were 240 applications, 50 were admitted with intent of securing a class of 22. At the University of Virginia, there were 300 applicants for 25 available seats. It is apparent that there are several hundred graduates who have an interest in speech-language disorders who do not qualify for licensure but would benefit from the opportunity to be hired as an assistant and gain valuable knowledge and experience to possibly help secure a position in a graduate program.

5) According to the Speech-Language Hearing Association of Virginia and the members of the Ad Hoc Committee and the board, speech-language pathologists who work in private practices do not currently hire persons as SLP assistants who have less than a bachelor's degree, so it is not accurate to state there they will see increased costs or a decreased client capacity.

6) The economic impact analysis stated that the Assistant Attorney General advised the board that it must include a requirement for "formal education." In fact, the Assistant Attorney General advised that the law specified that the board must set "qualifications" for an assistant speech-language pathologist and that allowing them to be trained on the job was not necessarily a qualification for practice.

7) Finally, there were six persons who commented on the Notice of Intended Regulatory Action that a bachelor's degree in speech-language or communication disorders should be the minimum qualification for an assistant SLP; two others stated that the minimum qualification should be a bachelor of arts degree or a bachelor of sciences degree.

Summary:

The proposed regulations for the supervision of unlicensed assistants include the (i) responsibility of the licensed speech-language pathologist for the training and assignment of duties of an assistant, (ii) qualifications of an assistant, (iii) duties that may be performed by an assistant, (iv) scope of practice of a speech-language pathologist that may not be delegated to an assistant, (v) the level and limitation on supervision of assistants, and (vi) the obligation of the licensee to provide the necessary level of supervision to ensure quality of care, including on-site observation of at least two client sessions for each assistant every 30 days and direct delivery of service to each client at least every 30 days.

18VAC30-20-240. Supervisory responsibilities; supervision of unlicensed assistants.

A. Responsibility of a licensee.

1. A licensed audiologist and speech-language pathologist shall provide documented supervision to who supervises unlicensed assistants shall document such supervision, shall be held fully responsible for their performance and activities, and shall ensure that they perform only those activities which that do not constitute the practice of audiology or speech-language pathology and which that are commensurate with their level of training.

2. A licensed speech-language pathologist who supervises unlicensed assistants shall document such supervision, shall be held fully responsible for their performance and activities, and shall ensure that they perform only those activities that do not constitute the practice of speech-language pathology and that are commensurate with their level of training.

a. A speech-language pathologist shall not supervise an assistant without the speech-language pathologist's knowledge and consent by the assistant and the licensee documented prior to assumption of supervisory responsibilities.

b. The frequency in which the speech-language pathologist personally delivers treatment or services to a client who is receiving some services from an assistant shall be up to the professional judgment of the speech-language pathologist and shall be determined by the treatment needs of the client, the type of services being provided, and the setting in which the client is being served, but shall occur at least every 30 days.

B. 3. The identity of the unlicensed assistant shall be disclosed to the client prior to treatment and shall be made a part of the client's file.

B. Qualifications of a speech-language pathologist assistant.

1. A person acting as a speech-language pathologist assistant shall have:

a. A bachelor's degree or associate's degree and documented training by a licensed speech-language pathologist in topics related to the client population to be served; or

b. Employment as a speech-language pathologist assistant in a United States jurisdiction within the last five years preceding (the effective date of the regulations).

2. A speech-language pathologist supervising an assistant shall be responsible for determining that the knowledge, skills, and clinical experience of the assistant are sufficient to ensure competency to perform all tasks to which the assistant is assigned. The speech-language pathologist shall document competency after training and direct observation of the assistant's performance of such tasks, and a record of skills and competencies shall be maintained.

C. Scope of practice of a speech-language pathologist assistant. After demonstration and documentation of competency for the duties to be assigned, an assistant shall only engage in those duties planned, designed, and supervised by a licensed speech-language pathologist, to include the following:

1. Assist with speech, language, and hearing screenings without clinical interpretation of results.

2. Assist during assessment of a client exclusive of administration or interpretation.

3. Perform activities for each session that are routine and do not require professional judgment, in accordance with a plan developed and directed by the speech-language pathologist who retains the professional responsibility for the client.

4. Document a client's performance and report information to the supervising speech-language pathologist.

5. Assist with programming augmentative and alternative communication devices and assist the client in repetitive use of such devices.

6. Sign or initial informal treatment notes and, upon request, co-sign formal documents with the supervising speech-language pathologist.

7. Engage in the following activities:

a. Preparing materials;

b. Scheduling appointments and activities;

c. Preparing charts, records, or graphs and performing other clerical duties;

d. Performing checks and maintenance of equipment; and

e. Assisting a client with transitioning to and from therapy sessions.

8. Perform duties not otherwise restricted to the practice of speech-language pathology.

D. A speech-language pathologist assistant shall not engage in the practice of speech-language pathology, including the following:

1. Represent himself as a speech-language pathologist.

2. Perform standardized or nonstandardized diagnostic tests or formal or informal evaluations.

3. Perform procedures that require a professional level of clinical acumen and technical skill.

4. Tabulate or interpret results and observations of feeding and swallowing evaluations or screenings performed by a speech-language pathologist.

5. Participate in formal conferences or meetings without the presence of the supervising speech-language pathologist.

6. Provide interpretative information to the client, the family of the client, or others regarding the client's status or service.

7. Write, develop, or modify a client's treatment plan.

8. Assist in or provide services as specified in subsection C of this section unless directed by the supervising speech-language pathologist.

9. Sign any formal documents in lieu of the supervising speech-language pathologist.

10. Select a client for service or discharge a client from service.

11. Make a decision on the need for additional services or make referrals for service.

12. Disclose clinical or confidential information either orally or in writing to anyone other than the supervising speech-language pathologist, unless mandated by law or authorized by the supervising speech-language pathologist.

13. Develop or determine the swallowing or feeding strategies or precautions for a client or provide feeding or swallowing treatment.

E. Supervision of an assistant in speech-language pathology.

1. The practice of an assistant shall only be supervised by a speech-language pathologist who retains full legal and ethical responsibility for the client. A speech-language pathologist shall only supervise the equivalent of two full-time assistants.

2. The speech-language pathologist shall provide the level of supervision to the speech-language pathologist assistant necessary to ensure quality of care to include on-site supervision of at least two client sessions for each assistant being supervised every 30 days to directly observe and evaluate the performance of the assistant. The speech-language pathologist shall document such on-site observation and evaluation in the client record for each session.

Title of Regulation: 18VAC30-20. Regulations Governing the Practice of Audiology and Speech-Language Pathology (amending 18VAC30-20-10; adding 18VAC30-20-241).

Statutory Authority: § 54.1-2400 of the Code of Virginia.

Public Hearing Information:

December 11, 2015 - 8:45 a.m. - Department of Health Professions, Perimeter Center, 9960 Mayland Drive, Conference Center, 2nd Floor, Richmond, VA

Public Comment Deadline: January 29, 2016.

Agency Contact: Leslie L. Knachel, 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 leslie.knachel@dhp.virginia.gov.

Basis: Regulations Governing the Practice of Audiology and Speech-Language Pathology (18VAC30-20) are promulgated under the general authority of subdivision 6 of § 54.1-2400 of the Code of Virginia, which provides the Board of Audiology and Speech-Language Pathology the authority to promulgate regulations to administer the regulatory system.

Authority for the board to adopt regulations for limited cerumen management in the practice of audiology is pursuant to Chapter 327 of the 2014 Acts of Assembly.

Purpose: Since cerumen management is a more advanced skill in the practice of audiology, requiring additional knowledge and training, regulations specify the education and specific training necessary to perform it on patients. Additionally, audiologists must know the contraindications for performance by an audiologist and the conditions that require referral to a medical doctor. The goal of the amended regulation is to provide a framework for safe practice in an advanced procedure that prior to 2014 was not recognized in Virginia as being within the scope of practice of an audiologist. By the change in law and regulation, the practice is expanded to include limited cerumen management, but the qualifications for such practice and the limitations of practice by an audiologist are essential to protect patients.

If an audiologist does not have the clinical knowledge and skills or if he attempts to perform cerumen management on a patient beyond his scope of practice or in spite of contraindications, he can do serious damage to a patient's ear. If an audiologist is adequately trained and practices according to the standard of care and the board's regulation, the public's health and safety should be protected.

Substance: 18VAC30-20-10 is amended to include a definition for "limited cerumen management."

18VAC30-20-241 is a new section, in which subsection A sets out the basic educational qualification for performance of cerumen management, subsection B sets out the training an audiologist must satisfactorily complete to perform cerumen management and specifies that documentation of such training must be maintained, subsection C sets out the contraindications for performance of cerumen management, and subsection D provides that an audiologist performing cerumen management shall obtain informed written consent of the patient or legally responsible adult and maintain documentation of such consent and the procedure performed in the patient record. It also specifies that the audiologist shall refer patients to a physician if they exhibit contraindications or experience any complication, such as dizziness, during the procedure.

Issues: There are no disadvantages to the public. With the passage of Chapter 327 of the 2014 Acts of Assembly, it is clear that cerumen management of a limited nature is within the scope of practice of audiologists who have been specially trained in the procedure. Proposed regulations protect patients by specifying the necessary training and the medical conditions and situations in which it is not appropriate for a patient to have cerumen removed by an audiologist. There are no particular advantages or disadvantages to the agency or the Commonwealth.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The proposed regulation provides a regulatory framework for practice in cerumen management, which was not recognized in Virginia as being within the scope of practice of an audiologist before 2014.

Result of Analysis. The benefits likely exceed the costs for all proposed changes.

Estimated Economic Impact. Prior to 2014, Virginia law and regulations did not address cerumen (commonly known as ear wax) management within the scope of practice of an audiologist though various forms of it were practiced by some audiologists to various extents. Cerumen management involves identification and removal of cerumen from the ear canal. According to the Board of Audiology and Speech-Language Pathology (Board), if an audiologist does not have the clinical knowledge and skills or if he attempts to perform cerumen management on a patient beyond his or her scope of practice or in spite of contraindications, he or she can do serious damage to a patient's ear.

In order to address potential health and safety concerns, Chapter 327 of the 2014 Acts of the Assembly (HB500) added "limited cerumen management" to the scope of audiology practice and directed the Board to establish criteria for its practice. Pursuant to the legislative mandate, the Board promulgated emergency regulations, which became effective on December 29, 2014. The proposed regulation will replace the emergency regulation permanently.

With this action, the Board proposes to define "limited cerumen management" as the identification and removal of cerumen from the cartilaginous outer one-third portion of the external auditory canal. The Board also proposes to allow the practice of limited cerumen management by only those audiologists i) who are a graduate of an accredited doctoral program in audiology that included didactic education and supervised clinical experience in cerumen management, or ii) who completed an approved course or workshop in cerumen management. Furthermore, the Board sets out the contraindications to identify cases when the procedure shall not be performed, but the patient be referred to a physician; requires audiologists to obtain written consent of the patient or legally responsible adult; and maintain documentation. The proposed rules do not require audiologists to submit evidence of training and education, or consent documents to the Board, but instead require the evidence be available when and if the Department of Health Professions investigates a complaint.

The proposed training and education could occur within a practice under direct supervision. Training courses are also being developed by the state and national professional associations specifically for cerumen management. Parts of the training may be done online, but certain parts of the training must be done in-person with an audiologist who is already qualified or with a physician. The cost of the training and education may vary. The Speech-Language Hearing Association of Virginia is currently offering a one-day training in September 2015 at a cost of $230 for members and $300 for non-members. However, since the proposed regulation applies only if an audiologist wishes to perform limited cerumen management and if an audiologist chooses to obtain education and training to perform it, we can reliably infer that the anticipated benefits likely exceed compliance costs to him or her in terms of time, travel, and training fees.

Other benefits of the proposed regulation include: explicitly allowing qualified audiologists to perform cerumen management on a limited basis and possibly avoiding an extra visit to a physician’s office for limited cerumen management, establishing what the allowed scope of cerumen management by an audiologist is, establishing under what circumstances it may or may not be performed, and consequently providing a greater degree of patient health and safety compared to its practice without any standards.

While the proposed regulation is expected to be beneficial, the magnitude of benefits may be relatively small. As mentioned above, prior to 2014, various forms of cerumen management had been performed by some audiologist to various extents. The Board is unaware of any complaints or investigations related to practice of cerumen management when there was no regulatory framework on cerumen management by audiologists.

Businesses and Entities Affected. The proposed rules affect audiologists who want to include limited cerumen management in their practice. Currently, there are 517 licensed audiologists in Virginia, but the Board does not know how many of them are currently practicing cerumen management and how many may choose to perform this procedure in the future.

Localities Particularly Affected. The proposed changes apply throughout the Commonwealth.

Projected Impact on Employment. The proposed amendments are unlikely to affect employment.

Effects on the Use and Value of Private Property. The proposed rules are not anticipated to affect the use and value of private property.

Real Estate Development Costs. The proposed amendments are unlikely to affect real estate development costs.

Small Businesses:

Definition. Pursuant to § 2.2-4007.04 of the Code of Virginia, small business is defined as "a business entity, including its affiliates, that (i) is independently owned and operated and (ii) employs fewer than 500 full-time employees or has gross annual sales of less than $6 million."

Costs and Other Effects. The proposed rules introduce compliance costs to audiologists in terms of time, travel, and course fees to obtain training and education only if the audiologist does not have the appropriate training and education and he or she chooses to perform limited cerumen management and he or she would have performed it without obtaining the appropriate training and education if there were no regulations. However, it is highly unlikely that an audiologist would have performed a procedure that he or she is not trained and educated in for liability reasons. Thus, the compliance costs are likely negligible.

Alternative Method that Minimizes Adverse Impact. The adverse impact on audiologists is likely negligible as discussed above.

Adverse Impacts:

Businesses: The proposed regulation is not anticipated to adversely impact non-small businesses.

Localities: The proposed amendments will not adversely affect localities.

Other Entities: No other entities are anticipated to be adversely affected.

Agency's Response to Economic Impact Analysis: The Board of Audiology and Speech-Language Pathology concurs with the economic impact analysis of the Department of Planning and Budget.

Summary:

Pursuant to Chapter 327 of the 2014 Acts of Assembly, the proposed action provides a framework for safe practice of limited cerumen management by an audiologist including (i) a definition of "limited cerumen management," (ii) the education and specific training necessary to perform limited cerumen management on patients, (iii) the contraindications for performance by an audiologist of limited cerumen management on patients, and (iv) the conditions that require referral to a medical doctor.

Part I
General Provisions

18VAC30-20-10. Definitions.

A. The words and terms "audiologist," "board," "practice of audiology," "practice of speech-language pathology," "speech-language disorders," and "speech-language pathologist" when used in this chapter shall have the meanings ascribed to them in § 54.1-2600 of the Code of Virginia.

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

"Contact hour" means 60 minutes of time spent in continuing learning activities.

"Limited cerumen management" means the identification and removal of cerumen from the cartilaginous outer one-third portion of the external auditory canal in accordance with minimum standards and procedures set forth in this chapter.

"School speech-language pathologist" means a person licensed pursuant to § 54.1-2603 of the Code of Virginia to provide speech-language pathology services solely in public school divisions.

"Supervision" means that the audiologist or speech-language pathologist is responsible for the entire service being rendered or activity being performed, is available for consultation, and is providing regular monitoring and documentation of clinical activities and competencies of the person being supervised.

"Type 1" means continuing learning activities that must be offered by an accredited sponsor or organization as specified in 18VAC30-20-300.

"Type 2" means continuing learning activities that may or may not be approved by an accredited sponsor or organization but shall be activities considered by the learner to be beneficial to practice or to continuing learning. In Type 2 activities, licensees document their own participation on the Continued Competency Activity and Assessment Form and are considered self-learning activities.

18VAC30-20-241. Limited cerumen management.

A. In order for an audiologist to perform limited cerumen management, he shall:

1. Be a graduate of a doctoral program in audiology that is accredited by the Council on Academic Accreditation of the American Speech-Language-Hearing Association or other accrediting body recognized by the board and that included didactic education and supervised clinical experience in cerumen management as specified in subsection B of this section; or

2. Complete a course or workshop in cerumen management that provides training as specified in subsection B of this section and that is approved by the American Speech-Language Hearing Association or the American Academy of Audiology.

B. An audiologist shall maintain documentation evidencing satisfactory completion of training in cerumen management to include the following:

1. Recognizing the presence of preexisting contraindications that necessitate referral to a physician;

2. Recognizing patient distress and appropriate action to take if complications are encountered;

3. Use of infection control precautions;

4. Procedures for removal of cerumen, including cerumen loop, gentle water irrigation, suction, and the use of material for softening;

5. Observation of each type of cerumen management procedure performed by a qualified audiologist or physician; and

6. Successful performance, under direct supervision by an audiologist qualified to perform cerumen management or a physician, of each type of cerumen management procedure.

C. An audiologist shall not perform cerumen management on a patient who has any of the following preexisting contraindications:

1. A perforated tympanic membrane;

2. Inflammation, tenderness, drainage, or open wounds or traces of blood in the external ear canal;

3. History of ear surgery that results in distortion of the external ear canal;

4. HIV infection or bleeding disorders;

5. Actual or suspected foreign body in the ear, excluding hearing aid components that are located in the lateral one-third portion of the ear canal;

6. Stenosis or bony exostosis of the ear canal; or

7. Cerumen impaction that totally occludes the visualization of the tympanic membrane.

D. An audiologist performing cerumen management shall:

1. Obtain informed written consent of the patient or legally responsible adult and maintain documentation of such consent and the procedure performed in the patient record.

2. Refer patients to a physician if they exhibit contraindications or experience any complication, such as dizziness, during the procedure.

Title of Regulation: 18VAC85-120. Regulations Governing the Licensure of Athletic Trainers (amending 18VAC85-120-10).

Statutory Authority: §§ 54.1-2400 and 54.1-2957.4 of the Code of Virginia.

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: December 30, 2015.

Effective Date: January 15, 2016.

Agency Contact: William L. Harp, M.D., Executive Director, Board of Medicine, 9960 Mayland Drive, Suite 300, Richmond, VA 23233, telephone (804) 367-4558, FAX (804) 527-4429, or email william.harp@dhp.virginia.gov.

Basis: Section 54.1-2400 of the Code of Virginia provides the Board of Medicine the authority to promulgate regulations that are reasonable and necessary to administer effectively the regulatory system.

The specific legal authority to promulgate regulations for licensure is found in § 54.1-2957.4 of the Code of Virginia.

Purpose: The purpose of the amended regulation is to define a "student athletic trainer" so there is no confusion between the activities of a person enrolled in an athletic training educational program at the bachelor's or master's degree level and a person who is a high school student who is acting as an aide to the athletic director or a coach. The student athletic trainer is permitted to perform tasks within the scope of a licensee provided he is appropriately trained and supervised in accordance with the provisions of 18VAC85-120-130 B. However, using a high school aide who does not have the educational background and skills to perform such tasks is potentially dangerous to the health and safety of student athletes. Therefore, it is necessary to define the term "student athletic trainer" to ensure that there is no confusion about the application of the regulation.

Rationale for Using Fast-Track Process: There is no controversy in the adoption of this amendment; it is clarifying in nature and may prevent a misunderstanding of the regulations.

Substance: The amended regulation will define a "student athletic trainer" as a person enrolled in an accredited bachelor's or master's level educational program in athletic training.

Issues: The primary advantage to the public is clarity in the regulation so that a high school student is not allowed to practice as a "student athletic trainer" in the performance of tasks that should be reserved for persons enrolled in an athletic training program on the college or university level. There are no disadvantages to the public.

There are no advantages or disadvantages to the agency or the Commonwealth.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The Board of Medicine (Board) proposes to add a definition for student athletic trainer to its regulation that sets rules for the licensing of athletic trainers.

Result of Analysis. The benefits likely exceed the costs for this proposed regulation.

Estimated Economic Impact. Currently, this regulation contains rules for student athletic trainers but does not contain a definition of what a student athletic trainer is. The Board now proposes to define a student athletic trainer as "a person enrolled in an accredited bachelor's or master's level educational program in athletic training." No entities are likely to incur costs on account of this change. To the extent that adding this definition clarifies the Board's rules, individuals who are seeking to understand these rules will benefit.

Businesses and Entities Affected. This proposed change will affect all student athletic trainers as well as any other individuals who might read this regulation.

Localities Particularly Affected. This proposed change will not particularly affect any locality in the Commonwealth.

Projected Impact on Employment. This proposed change will likely not affect employment in the Commonwealth.

Effects on the Use and Value of Private Property. This proposed change will likely have no impact on the use or value of private property.

Real Estate Development Costs. This proposed change will likely not affect real estate development costs.

Small Businesses:

Definition. Pursuant to § 2.2-4007.04 of the Code of Virginia, small business is defined as "a business entity, including its affiliates, that (i) is independently owned and operated and (ii) employs fewer than 500 full-time employees or has gross annual sales of less than $6 million."

Costs and Other Effects. No small businesses will incur costs on account of this regulatory change.

Alternative Method that Minimizes Adverse Impact. No small businesses will incur costs on account of this regulatory change.

Adverse Impacts:

Businesses: This proposed change is unlikely to adversely impact any business in the Commonwealth.

Localities: This proposed change is unlikely to adversely impact localities.

Other Entities: This proposed change is unlikely to adversely impact any other entities in the Commonwealth.

Agency's Response to Economic Impact Analysis: The Board of Medicine concurs with the analysis of the Department of Planning and Budget.

Summary:

The amendment clarifies that the term "student athletic trainer" as used in the regulation means a person enrolled in an accredited bachelor's or master's level education program in athletic training.

Part I
General Provisions

18VAC85-120-10. Definitions.

In addition to words and terms defined in § 54.1-2900 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:

"Advisory board" means the Advisory Board on Athletic Training to the board as specified in § 54.1-2957.5 of the Code of Virginia.

"Athletic trainer" means a person licensed by the Virginia Board of Medicine to engage in the practice of athletic training as defined in § 54.1-2900 of the Code of Virginia.

"Board" means the Virginia Board of Medicine.

"NATABOC" means the National Athletic Trainers' Association Board of Certification.

"Student athletic trainer" means a person enrolled in an accredited bachelor's or master's level educational program in athletic training.

Title of Regulation: 18VAC85-50. Regulations Governing the Practice of Physician Assistants (amending 18VAC85-50-160).

Statutory Authority: §§ 54.1-2400 and 54.1-2952.1 of the Code of Virginia.

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: December 30, 2015.

Effective Date: January 15, 2016.

Agency Contact: William L. Harp, M.D., Executive Director, Board of Medicine, 9960 Mayland Drive, Suite 300, Richmond, VA 23233, telephone (804) 367-4558, FAX (804) 527-4429, or email william.harp@dhp.virginia.gov.

Basis: Section 54.1-2400 of the Code of Virginia provides the Board of Medicine the authority to promulgate regulations that are reasonable and necessary to administer effectively the regulatory system. Section 54.1-2952.1 of the Code of Virginia authorizes the Board of Medicine, in consultation with the Board of Pharmacy, to promulgate regulations governing the prescriptive authority of physician assistants.

Purpose: The purpose of the amendment is to modify a regulation that is considered burdensome by physician assistants. Facilitating prescribing practice by physician assistants, under the supervision of a physician, will enhance efficiency and access to patient care. Since disclosures about the supervising physician and the licensure of the physician assistant remain in regulation, the amendment to the regulation will not lessen protection for the health and safety of the patient.

Rationale for Using Fast-Track Process: There is no controversy in the adoption of this amendment; it is recommended by physician assistants and the supervising physicians with whom they work.

Substance: The amended regulation will eliminate the requirement for the name of the supervising physician on a prescription written by a physician assistant if the assistant is writing a prescription for a Schedule VI drug. The physician's name on the prescription will continue to be required if the assistant is writing a prescription for Schedule II through V drugs. Amendments also will clarify how the physician assistant can comply with the disclosure requirement specified in § 54.1-2952.1 of the Code of Virginia.

Issues: The primary advantage to the public is facilitation of prescribing by physician assistants for greater efficiency and access. There are no disadvantages to the public. There are no advantages or disadvantages to the agency or the Commonwealth.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. As a result of a recommendation from the Advisory Board on Physician Assistants, the Board of Medicine (Board) proposes to eliminate the requirement for the signature of a supervising physician or podiatrist on prescriptions for Schedule VI drugs written by physician assistants.

Result of Analysis. There is insufficient information to ascertain if benefits will outweigh costs for this regulatory action.

Estimated Economic Impact. Current law requires that physician assistants practice under a written supervisory agreement with a licensed physician or podiatrist "which provides for the direction and supervision by the licensee of the prescriptive practices of the assistant. Such agreement must contain the controlled substances that the physician assistant is or is not authorized to prescribe and may restrict such prescriptive authority as deemed appropriate by the physician or podiatrist providing direction and supervision." As part of that supervision, physician assistants are required to have their supervising physician's or podiatrist's name on all prescriptions that they write whatever the Schedule the prescribed drugs might be in. In February of 2015, the Board considered a recommendation from the Advisory Board on Physician Assistants to eliminate the requirement that a supervising physician's or podiatrist's name be on prescriptions for all Schedule drugs (Schedules II through VI) written by physician assistants as this requirement was seen as unnecessarily burdensome. The Board decided at its meeting on June 18, 2015, to eliminate the requirement for the signature of a supervising physician or podiatrist on prescriptions for Schedule VI drugs but to retain that requirement for prescriptions of Schedule II through V drugs.

Board staff reports that the Board chose to amend this regulation in the way they did because the current system for electronic prescriptions used in the Commonwealth only has a place for two names (the prescribing physician assistant and the supervising physician or podiatrist) on prescriptions for Schedule II through V drugs that fall under the federal Controlled Substances Act. Board staff reports that this change will make it easier for physician assistants to write electronic prescriptions for Schedule VI drugs which are not controlled under federal law but are controlled under Virginia Code. To the extent that physician assistants currently write paper prescriptions for Schedule VI drugs when an electronic prescription sent directly to the pharmacy would allow the patient to avoid spending time and gas to physically pick up their prescription, this change will likely benefit both physician assistants and patients.

Schedule VI drugs include topical anesthetics, and topical and oral anti-allergy drugs (including antihistamines and mast cell stabilizers), anti-fungals, anti-glaucoma drugs, anti-infective drugs (including antibiotics and antivirals) and anti-inflammatory drugs (including steroids like prednisone and Solu-Medrol). While these drugs are not addictive or as potentially dangerous as drugs in Schedules II through V, they can still be dangerous if prescribed incorrectly or for too long. Steroids, for instance, can induce Cushing's Syndrome in individuals who take them long term. Although Board staff reports that physician assistants have other requirements to disclose the name of their supervising physician that will likely protect patient health, removing the supervising physician's or podiatrist's name from Schedule VI drug prescriptions may decrease the ability of outside entities like pharmacists, who are not privy to information about the physician assistant's supervisor outside of the information explicitly contained on a prescription, to report potential contra-indications and problematic prescriptive practices directly to that supervisor. Without knowing either the magnitude of time savings for physician assistants and patients due to easier electronic prescribing or the potential magnitude of any possible harm that may arise from this change, it is not possible to say if benefits will outweigh costs for this regulatory change.

Businesses and Entities Affected. This regulatory change will affect all physician assistants as well as the patients who see them. Board staff reports that there are currently 3,058 individuals who are licensed as physician assistants in the Commonwealth.

Localities Particularly Affected. This proposed change will not particularly affect any locality in the Commonwealth.

Projected Impact on Employment. This proposed change is unlikely to impact employment in the Commonwealth.

Effects on the Use and Value of Private Property. This proposed change will likely have no impact on the use or value of private property.

Real Estate Development Costs. This proposed change will likely not affect real estate development costs.

Small Businesses:

Definition. Pursuant to § 2.2-4007.04 of the Code of Virginia, small business is defined as "a business entity, including its affiliates, that (i) is independently owned and operated and (ii) employs fewer than 500 full-time employees or has gross annual sales of less than $6 million."

Costs and Other Effects. No small businesses will incur costs on account of this regulatory change.

Alternative Method that Minimizes Adverse Impact. No small businesses will incur costs on account of this regulatory change.

Adverse Impacts:

Businesses: This proposed change is unlikely to adversely impact any business in the Commonwealth.

Localities: This proposed change is unlikely to adversely impact localities.

Other Entities: This proposed change may adversely affect patients prescribed Schedule VI drugs if pharmacists are less likely or able to contact supervising physicians when problems with those prescriptions arise and contacting the prescribing physician assistant does not yield corrective action.

Agency's Response to Economic Impact Analysis: In the adoption of a fast-track regulation, the Board of Medicine does not concur with the statement of the Department of Planning and Budget that "removing the supervising physician's or podiatrist's name from Schedule VI drug prescriptions may decrease the ability of outside entities like pharmacists, who are not privy to information about the physician assistant's supervisor outside of the information explicitly contained on a prescription, to report potential contra-indications and problematic prescriptive practices directly to that supervisor." Pharmacists will have access to that information through the national provider number on each prescription. Additionally, nurse practitioners are not required to list the physician with whom they have a practice agreement on any prescription in Schedules II through VI.

Summary:

The amendments (i) eliminate the requirement for the supervising physician's name to appear on a prescription written by a physician assistant for a Schedule VI drug and (ii) and clarify how a physician assistant may comply with the requirement to disclose to a patient that he is a licensed physician assistant.

18VAC85-50-160. Disclosure.

A. Each prescription for a Schedule II through V drug shall bear the name of the supervising physician and of the physician assistant.

B. The physician assistant shall disclose to the patient that he is a licensed physician assistant, and also the name, address and telephone number of the supervising physician. Such disclosure may shall either be included on the prescription pad or may be given in writing to the patient.

Title of Regulation: 18VAC85-20. Regulations Governing the Practice of Medicine, Osteopathic Medicine, Podiatry, and Chiropractic (amending 18VAC85-20-320, 18VAC85-20-340, 18VAC85-20-350, 18VAC85-20-370, 18VAC85-20-380).

Statutory Authority: §§ 54.1-2400 and 54.1-2912.1 of the Code of Virginia.

Public Hearing Information:

December 4, 2015 - 8:30 a.m. - Perimeter Center, 9960 Mayland Drive, Suite 201, Richmond, VA 23233-1463

Public Comment Deadline: January 29, 2016.

Agency Contact: William L. Harp, M.D., Executive Director, Board of Medicine, 9960 Mayland Drive, Suite 300, Richmond, VA 23233-1463, telephone (804) 367-4558, FAX (804) 527-4429, or email william.harp@dhp.virginia.gov.

Basis: Section 54.1-2400 of the Code of Virginia provides the Board of Medicine the authority to promulgate regulations to administer the regulatory system. Specific authority for regulation of office-based anesthesia is found in § 54.1-2912.1 of the Code of Virginia.

Purpose: A Notice of Intended Regulatory Action was approved by the Board of Medicine on October 16, 2014, in response to a petition for rulemaking from the Medical Society of Virginia. The intent of the board is to address the need for additional public protection in the administration of office-based anesthesia. As more medical and surgical procedures are being performed in office-based settings, there is a greater need for standards in the administration of anesthesia to address possible consequences that could result in an emergency transport to a hospital and even in the death of a patient. Therefore, changes are recommended in the applicability of requirements for office-based anesthesia, documentation of complications, duration of such a procedure, informed consent by patient of the anesthesia plan, discharge planning, and emergency transfer protocols. The board adopted regulatory changes as necessary to protect the health and safety of patients who undergo procedures in office-based settings.

Substance: Amendments to the requirements for office-based anesthesia are adopted to (i) include the administration of 300 milligrams or more of lidocaine under the applicability of the requirements; (ii) ensure that the patient has adequate information in giving informed consent, including knowledge about whether the physician is board certified or board eligible; (iii) require documentation of complications during surgery or recovery; (iv) set a time limit on procedures that may be performed in an office; (v) specify the availability of a hospital to which a patient may be transferred; and (vi) specify that the anesthesia provider or the doctor supervising the anesthesia must give the order for discharge.

Issues: The primary advantage to the public is greater protection for office-based procedures requiring moderate sedation or anesthesia and more information about the physician, the plan for anesthesia and expectations for discharge. There are no disadvantages to the public. There are no advantages or disadvantages to the agency or the Commonwealth. This proposal was carefully negotiated with specialty groups of physicians to ensure that the central issue remained public protection but qualified providers were not excluded.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. In response to a petition for rulemaking from the Medical Society of Virginia, the Board of Medicine (Board) proposes to amend its requirements for office-based anesthesia to: 1) define the administration of 300 milligrams or more of lidocaine (or equivalent doses of local anesthetics) as moderate sedation that is subject to the requirements of this regulation, 2) limit the duration of a procedure that include sedation that falls under the requirements of this regulation to last no longer than four hours if the anesthesia is not administered by an anesthesiologist or a certified registered nurse anesthetist or eight hours if anesthesia is administered by one of these entities and 3) define "reasonable proximity" for the safe transfer of patients to a hospital in case of an emergency as "accessible within 30 minutes of the office." The Board also proposes several clarifying changes that will likely not affect costs.

Result of Analysis. There is insufficient information to ascertain whether benefits will outweigh costs for one proposed substantive change. Benefits likely outweigh costs for all proposed clarifying changes and the two other proposed substantive changes.

Estimated Economic Impact. Current regulation applies to "the administration of moderate sedation/conscience sedation, deep sedation, general anesthesia or regional anesthesia consisting of a major conductive block" in an office setting. On the recommendation of the Medical Society of Virginia, and particularly plastic surgeons that are part of that group, the Board proposes to also require that any procedure that involves the administration of 300 milligrams or more of lidocaine (or equivalent doses of local anesthesia) be subject to this regulation. This would mean that doctors who choose to use lidocaine or other local anesthetics in the described dosages as a part of an office surgery or procedure would newly have to follow all the requirements laid out in this regulation including: ensuring a pre-anesthetic check-up is performed, developing an anesthesia plan and having written protocols for office-based anesthesia, procedure selection and patient evaluation. Doctors' offices where such procedures are performed would also newly be required to be within reasonable proximity of a licensed general hospital capable of providing necessary emergency services (within 30 minutes' drive, according to the proposed regulation).

This new requirement will likely increase costs (or decrease revenue) for doctors who perform office-based procedures or surgeries under lidocaine or other local anesthetics; these doctors will either incur additional bookkeeping and other time costs for any procedure that requires these local anesthetics, have to stop performing those procedures if they know or suspect that the patient will require 300 milligrams or more of lidocaine (or equivalent for other local anesthetics) or will have to switch to other, presumably less optimal, forms of anesthesia. Specifically, doctors will definitely incur additional costs that accrue on a per patient basis (such as time spent either performing pre-anesthesia checkups or ensuring that such checkups have been performed) but will only incur time and other costs for writing and keeping required protocols if they only perform in-office surgeries that are currently exempt from this regulation but will not be exempt under the proposed regulation. Doctors who now only perform surgery and procedures requiring minor, local or topical anesthesia and whose offices are more than 30 minutes from a hospital would either have to move offices, switch to using other, presumably less optimal, anesthesia or stop performing the surgeries they now offer altogether. Affected patients will likely also incur costs on account of pre-anesthesia checkup requirements as well as other requirements that would extend the time and doctor resources required to care for them.

Research indicates that lidocaine is given in doses that vary according to the weight of the patient. Specifically, Drugs.com¹ reports that the usual adult dose for lidocaine used as a local anesthetic "varies with procedure, degree of anesthesia needed, vascularity of tissue, duration of anesthesia required and physical condition of (the) patient" but can go up to a maximum dosage of 4.5 milligrams per kilogram of weight not more than every two hours. The website for the University of Iowa Healthcare System² reports that the maximum safe dosage of lidocaine without epinephrine for pediatric patients is 4 milligrams per kilogram of weight. This means that for adults, any procedure involving administration of the maximum safe dosage of lidocaine for patients weighing more than approximately 147 lbs.³ would automatically fall under the more stringent rules for moderate or deep sedation or general anesthesia even if that patient is in excellent general health and would otherwise not need the heightened scrutiny and care plans required under this regulation.

In addition to disproportionately affecting patients that weigh more than 147 pounds, this requirement may have a disproportionate adverse impact on patients that live in rural parts of Virginia that do not have a local hospital within 30 minutes. Patients that now can have minor procedures or surgeries involving lidocaine (300 milligrams of more) in a local doctor's office would, under the proposed requirement, have to incur travel expenses, and possibly higher medical costs to have that procedure or surgery done either at a hospital or at a non-local doctor's office that is close enough to a hospital to meet the requirements of this regulation. All of these potential costs would have to be measured against the possible benefits to patients of limiting the absolute amount of lidocaine that can be used in a procedure without enhanced requirements kicking in. There is currently insufficient information on the magnitude of potential benefits that may accrue on account of this change to ascertain whether benefits will outweigh costs.

Current regulation does not set a limit on the duration of in-office surgeries using moderate sedation/conscience sedation, deep sedation, general anesthesia or regional anesthesia consisting of a major conductive blocks but only requires that such surgeries be "of a duration and degree of complexity that will permit the patient to recover and be discharged from the facility in less than 24 hours." The Board now proposes to specify that surgeries occurring under the auspices of this regulation may last no longer than four hours if the anesthesia is not administered by an anesthesiologist or a certified registered nurse anesthetist or eight hours if anesthesia is administered by one of these entities. Because research indicates⁴ that the odds of a whole host of potential side effects and adverse outcomes increase as the length of time spent under anesthesia increases, patients will likely benefit from this restriction. Patient benefits will likely outweigh any costs doctors incur for not being able to perform surgeries over four (or eight) hours in their offices.

Current regulation requires that doctors who perform in-office surgery using moderate sedation/conscience sedation, deep sedation, general anesthesia or regional anesthesia consisting of a major conductive blocks be able to transfer their patients to a hospital in "reasonable proximity" to their office. The Board now proposes to specify that reasonable proximity is within 30 minutes of the doctor's office. Although the actual specified time is new, it is likely that the Board already enforced this provision using the same or similar time limits. In any case, all affected entities in both the regulated and regulating community will likely benefit from the additional certainty that this change will bring.

Businesses and Entities Affected. Board staff reports that these changes will potentially affect all Board licensed doctors of medicine, osteopathy and podiatry that perform surgeries in their offices as well as all of these doctors' patients.

Localities Particularly Affected. Rural communities that are not in close proximity to a hospital will be disproportionately affected by these proposed changes.

Projected Impact on Employment. These proposed changes may moderately decrease employment in doctors' offices that currently are not subject to these regulations but will become subject to them on account of the proposed changes.

Effects on the Use and Value of Private Property. The value of some medical, osteopathic or podiatric practices may decrease if they incur costs on account of these proposed changes.

Real Estate Development Costs. These proposed changes will likely not affect real estate development costs.

Small Businesses:

Definition. Pursuant to § 2.2-4007.04 of the Code of Virginia, small business is defined as "a business entity, including its affiliates, that (i) is independently owned and operated and (ii) employs fewer than 500 full-time employees or has gross annual sales of less than $6 million."

Costs and Other Effects. Small business doctors will likely incur additional costs that accrue on a per patient basis (such as time spent either performing pre-anesthesia checkups or ensuring that such checkups have been performed) but will only incur time and other costs for writing and keeping required protocols if they only perform in-office surgeries that are currently exempt from this regulation but will not be exempt under the proposed regulation. Doctors who now only perform surgery and procedures requiring minor, local or topical anesthesia and whose offices are more than 30 minutes from a hospital would either have to move offices, switch to using other, presumably less optimal, anesthesia or stop performing the surgeries they now offer altogether.

Alternative Method that Minimizes Adverse Impact. Doctors and their patients would incur fewer costs if lidocaine standards were written so that any imposed limit on the amount of lidocaine is evidence based and varies directly with the weight of the patient as that appears to be the way lidocaine is administered.

Adverse Impacts:

Businesses: Doctors who own their practices will likely incur additional costs that accrue on a per patient basis (such as time spent either performing pre-anesthesia checkups or ensuring that such checkups have been performed) but will only incur time and other costs for writing and keeping required protocols if they only perform in-office surgeries that are currently exempt from this regulation but will not be exempt under the proposed regulation. Doctors who now only perform surgery and procedures requiring minor, local or topical anesthesia and whose offices are more than 30 minutes from a hospital would either have to move offices, switch to using other, presumably less optimal, anesthesia or stop performing the surgeries they now offer altogether.

Localities: Rural localities that currently do not have a hospital in close proximity (as defined by this proposed regulation) may see a disproportionate adverse impact on the availability of minor out-patient surgical services offered.

Other Entities: The proposed changing categorization of lidocaine in doses at or over 300 milligrams (or like amounts of other local anesthetics) may have a disproportionate adverse impact on patients that live in rural parts of Virginia who do not have a local hospital within 30 minutes. Patients who now can have minor procedures or surgeries involving lidocaine (300 milligrams of more) in a local doctor's office would, under the proposed requirement, have to incur travel expenses and possibly higher medical costs to have that procedure or surgery done either at a hospital or at a non-local doctor's office that is close enough to a hospital to meet the requirements of this regulation.

_____________________________________________

¹http://www.drugs.com/dosage/lidocaine.html

²https://wiki.uiowa.edu/display/protocols/Maximum+Recommended+Doses+and+Duration+of+Local+Anesthetics

³300/4.5= 66.6666666667 kilograms which is just shy of 147 pounds.

⁴See, for instance, "Duration of General Anesthesia and Surgical Outcome": Yoho, Robert, et al. (http://www.dryoho.com/dr-yoho/clinical/duration_anesthesia.pdf). This study notes that research found the odds of patient death, post-operative nausea and vomiting, venous thromboemboli, post-operative surgical site S. aureus infection, post-operative core hypothermia and cardiopulmonary complication increased either as time under anesthesia increased or in surgeries over a certain duration (in this study, either two or three hours).

Agency's Response to Economic Impact Analysis: The Board of Medicine submits the following response to the analysis of the Department of Planning and Budget (DPB) of amendments to 18VAC85-20, Regulations Governing the Practice of Medicine, Osteopathic Medicine, Podiatry and Chiropractic, relating to rules for office-based anesthesia.

As the petitioner for the proposed regulations, the Medical Society of Virginia (MSV) was asked to comment on the DPB analysis. The board concurs with the comments listed below:

MSV agrees with the DBP analysis that "Benefits likely outweigh costs for all proposed clarifying changes and two other proposed substantive changes.

As to DPB's analysis of what we presume they are referring to as "one proposed substantive change," we do concur that the ability to accurately quantify whether or not the benefits exceed the costs is not a precise calculation. However, several of the items noted by the DPB analysis as potentially increasing costs may indeed already be part of a physician's routine standard of care. For example, a pre-anesthetic check-up, an anesthesia plan, and written protocols for office-based anesthesia, procedure selection, and patient evaluation are accepted, specialty developed standards of care for physicians routinely performing these procedures. Though the proposed regulations may increase costs for those physicians not currently following these standards, we believe that number to be relatively limited, that some may elect to do this voluntarily, but that for those who choose not to follow accepted quality and safety standards, appropriate regulations may create the added incentive needed for proper patient care.

The analysis also suggests that "Doctors who now only perform surgery and procedures requiring minor, local or topical anesthesia, and whose offices are more than 30 minutes from a hospital would either have to move offices, switch to using other, presumably less optimal anesthesia or stop performing the surgeries they now offer altogether" and therefore would incur higher costs or less revenue. It is the MSV's understanding that doctors only performing surgery that involves the administration of topical anesthesia, local anesthesia, minor conductive blocks, or minimal sedation/anxiolysis that do not result in alteration of consciousness beyond minimal pre-operative tranquilization are not subject to these regulations. (See 18VAC85-20-320 A 1 - Applicability of requirements for office-based anesthesia). Therefore, additional costs would not be incurred.

In addition, the DPB analysis discusses the application of the 300 milligrams or more of lidocaine as the base threshold for complying with these regulations and the extent to which it would apply based upon a dosage to weight ratio. The MSV work group that developed these proposed regulations consisted of board certified physicians from several specialties, including family practice, plastic surgery, orthopedics, and pediatrics. The 300 milligrams dosage was chosen for these proposed regulations in order to provide for an amount that was easily understood, measurable, applicable across the board, and recognized by other states with comparable regulations on office-based anesthesia. Further, the use of 300 mg or more of lidocaine for certain prolonged invasive procedures when it is not used primarily as a local anesthetic is not always the best practice and will signal to the physician that an alternative, more appropriate anesthetic agent should be used. Guidelines and trigger warnings like these can be readily captured in written protocols for office-based anesthesia, leading to better and safer quality of care.

Summary:

The proposed amendments (i) define the administration of 300 milligrams or more of lidocaine as moderate sedation, (ii) address informed consent by patients, including knowledge about whether the physician is board certified or board eligible, (iii) require documentation of complications during surgery or recovery, (iv) establish a time limit on procedures that may be performed in an office, (v) address proximity to a hospital to which a patient may be transferred, and (vi) specify that the anesthesia provider or the doctor supervising the anesthesia must give the order for discharge.

18VAC85-20-320. General provisions.

A. Applicability of requirements for office-based anesthesia.

1. The administration of topical anesthesia, local anesthesia, minor conductive blocks, or minimal sedation/anxiolysis, not involving a drug-induced alteration of consciousness other than minimal preoperative tranquilization, is not subject to the requirements for office-based anesthesia in this part. A health care practitioner administering such agents shall adhere to an accepted standard of care as appropriate to the level of anesthesia or sedation, including evaluation, drug selection, administration, and management of complications.

2. The administration of moderate sedation/conscious sedation, deep sedation, general anesthesia, or regional anesthesia consisting of a major conductive block are subject to these requirements for office-based anesthesia in this part. The administration of 300 milligrams or more of lidocaine or equivalent doses of local anesthetics shall be deemed to be subject to these requirements for office-based anesthesia in this part.

3. Levels of anesthesia or sedation referred to in this chapter shall relate to the level of anesthesia or sedation intended and documented by the practitioner in the preoperative anesthesia plan.

B. A doctor of medicine, osteopathic medicine, or podiatry administering office-based anesthesia or supervising such administration shall:

1. Perform a preanesthetic evaluation and examination or ensure that it has been performed;

2. Develop the anesthesia plan or ensure that it has been developed;

3. Ensure that the anesthesia plan has been discussed with the patient or responsible party preoperatively and informed consent has been obtained;

4. Ensure patient assessment and monitoring through the pre-, peri- preprocedure, periprocedure, and post-procedure phases, addressing not only physical and functional status, but also physiological and cognitive status;

5. Ensure provision of indicated post-anesthesia care; and

6. Remain physically present or immediately available, as appropriate, to manage complications and emergencies until discharge criteria have been met; and

7. Document any complications occurring during surgery or during recovery in the medical record.

C. All written policies, procedures, and protocols required for office-based anesthesia shall be maintained and available for inspection at the facility.

18VAC85-20-340. Procedure/anesthesia selection and patient evaluation.

A. A written protocol shall be developed and followed for procedure selection to include but not be limited to:

1. The doctor providing or supervising the anesthesia shall ensure that the procedure to be undertaken is within the scope of practice of the health care practitioners and the capabilities of the facility.

2. The procedure or combined procedures shall be of a duration and degree of complexity that shall not exceed four hours and that will permit the patient to recover and be discharged from the facility in less than 24 hours. The procedure or combined procedures may be extended for up to eight hours if the anesthesia is provided by an anesthesiologist or a certified registered nurse anesthesist.

3. The level of anesthesia used shall be appropriate for the patient, the surgical procedure, the clinical setting, the education and training of the personnel, and the equipment available. The choice of specific anesthesia agents and techniques shall focus on providing an anesthetic that will be effective, and appropriate and will address the specific needs of patients while also ensuring rapid recovery to normal function with maximum efforts to control post-operative pain, nausea, or other side effects.

B. A written protocol shall be developed for patient evaluation to include but not be limited to:

1. The preoperative anesthesia evaluation of a patient shall be performed by the health care practitioner administering the anesthesia or supervising the administration of anesthesia. It shall consist of performing an appropriate history and physical examination, determining the patient's physical status classification, developing a plan of anesthesia care, acquainting the patient or the responsible individual with the proposed plan, and discussing the risks and benefits.

2. The condition of the patient, specific morbidities that complicate anesthetic management, the specific intrinsic risks involved, and the nature of the planned procedure shall be considered in evaluating a patient for office-based anesthesia.

3. Patients who have pre-existing medical or other conditions that may be of particular risk for complications shall be referred to a facility appropriate for the procedure and administration of anesthesia. Nothing relieves the licensed health care practitioner of the responsibility to make a medical determination of the appropriate surgical facility or setting.

C. Office-based anesthesia shall only be provided for patients in physical status classifications for Classes I, II and III. Patients in Classes IV and V shall not be provided anesthesia in an office-based setting.

18VAC85-20-350. Informed consent.

A. Prior to administration, the anesthesia plan shall be discussed with the patient or responsible party by the health care practitioner administering the anesthesia or supervising the administration of anesthesia. Informed consent for the nature and objectives of the anesthesia planned shall be in writing and obtained from the patient or responsible party before the procedure is performed. Such consent shall include a discussion of discharge planning and what care or assistance the patient is expected to require after discharge. Informed consent shall only be obtained after a discussion of the risks, benefits, and alternatives, contain the name of the anesthesia provider, and be documented in the medical record.

B. The surgical consent forms shall be executed by the patient or the responsible party and shall contain a statement that the doctor performing the surgery is board certified or board eligible by one of the American Board of Medical Specialties boards, the Bureau of Osteopathic Specialists of the American Osteopathic Association, or the American Board of Foot and Ankle Surgery. The forms shall either list which board or contain a statement that doctor performing the surgery is not board certified or board eligible.

C. The surgical consent forms shall indicate whether the surgery is elective or medically necessary. If a consent is obtained in an emergency, the surgical consent form shall indicate the nature of the emergency.

18VAC85-20-370. Emergency and transfer protocols.

A. There shall be written protocols for handling emergency situations, including medical emergencies and internal and external disasters. All personnel shall be appropriately trained in and regularly review the protocols and the equipment and procedures for handing handling emergencies.

B. There shall be written protocols for the timely and safe transfer of patients to a prespecified hospital or hospitals within a reasonable proximity. For purposes of this section, "reasonable proximity" shall mean that a licensed general hospital capable of providing necessary services is normally accessible within 30 minutes of the office. There shall be a written or electronic transfer agreement with such hospital or hospitals.

18VAC85-20-380. Discharge policies and procedures.

A. There shall be written policies and procedures outlining discharge criteria. Such criteria shall include stable vital signs, responsiveness and orientation, ability to move voluntarily, controlled pain, and minimal nausea and vomiting.

B. Discharge from anesthesia care is the responsibility of the health care practitioner providing or the doctor supervising the anesthesia care and shall only occur when patients have:

1. The patient has met specific physician-defined criteria; and

2. The health care practitioner providing or the doctor supervising the anesthetic care has given the order for discharge.

C. Written instructions and an emergency phone number shall be provided to the patient. Patients shall be discharged with a responsible individual who has been instructed with regard to the patient's care.

D. At least one person trained in advanced resuscitative techniques shall be immediately available until all patients are discharged.