The Virginia Register OF
REGULATIONS is an official state publication issued every other week
throughout the year. Indexes are published quarterly, and are cumulative for
the year. The Virginia Register has several functions. The new and
amended sections of regulations, both as proposed and as finally adopted, are
required by law to be published in the Virginia Register. In addition,
the Virginia Register is a source of other information about state
government, including petitions for rulemaking, emergency regulations,
executive orders issued by the Governor, and notices of public hearings on
regulations.
ADOPTION,
AMENDMENT, AND REPEAL OF REGULATIONS
An
agency wishing to adopt, amend, or repeal regulations must first publish in the
Virginia Register a notice of intended regulatory action; a basis,
purpose, substance and issues statement; an economic impact analysis prepared
by the Department of Planning and Budget; the agency’s response to the economic
impact analysis; a summary; a notice giving the public an opportunity to
comment on the proposal; and the text of the proposed regulation.
Following
publication of the proposal in the Virginia Register, the promulgating agency
receives public comments for a minimum of 60 days. The Governor reviews the
proposed regulation to determine if it is necessary to protect the public
health, safety and welfare, and if it is clearly written and easily
understandable. If the Governor chooses to comment on the proposed regulation,
his comments must be transmitted to the agency and the Registrar no later than
15 days following the completion of the 60-day public comment period. The
Governor’s comments, if any, will be published in the Virginia Register.
Not less than 15 days following the completion of the 60-day public comment
period, the agency may adopt the proposed regulation.
The
Joint Commission on Administrative Rules (JCAR) or the appropriate standing
committee of each house of the General Assembly may meet during the
promulgation or final adoption process and file an objection with the Registrar
and the promulgating agency. The objection will be published in the Virginia
Register. Within 21 days after receipt by the agency of a legislative
objection, the agency shall file a response with the Registrar, the objecting
legislative body, and the Governor.
When
final action is taken, the agency again publishes the text of the regulation as
adopted, highlighting all changes made to the proposed regulation and
explaining any substantial changes made since publication of the proposal. A
30-day final adoption period begins upon final publication in the Virginia
Register.
The
Governor may review the final regulation during this time and, if he objects,
forward his objection to the Registrar and the agency. In addition to or in
lieu of filing a formal objection, the Governor may suspend the effective date
of a portion or all of a regulation until the end of the next regular General
Assembly session by issuing a directive signed by a majority of the members of
the appropriate legislative body and the Governor. The Governor’s objection or
suspension of the regulation, or both, will be published in the Virginia
Register. If the Governor finds that changes made to the proposed
regulation have substantial impact, he may require the agency to provide an
additional 30-day public comment period on the changes. Notice of the
additional public comment period required by the Governor will be published in
the Virginia Register.
The
agency shall suspend the regulatory process for 30 days when it receives
requests from 25 or more individuals to solicit additional public comment,
unless the agency determines that the changes have minor or inconsequential
impact.
A
regulation becomes effective at the conclusion of the 30-day final adoption
period, or at any other later date specified by the promulgating agency, unless
(i) a legislative objection has been filed, in which event the regulation,
unless withdrawn, becomes effective on the date specified, which shall be after
the expiration of the 21-day objection period; (ii) the Governor exercises his
authority to require the agency to provide for additional public comment, in
which event the regulation, unless withdrawn, becomes effective on the date
specified, which shall be after the expiration of the period for which the
Governor has provided for additional public comment; (iii) the Governor and the
General Assembly exercise their authority to suspend the effective date of a
regulation until the end of the next regular legislative session; or (iv) the
agency suspends the regulatory process, in which event the regulation, unless
withdrawn, becomes effective on the date specified, which shall be after the
expiration of the 30-day public comment period and no earlier than 15 days from
publication of the readopted action.
A
regulatory action may be withdrawn by the promulgating agency at any time
before the regulation becomes final.
FAST-TRACK
RULEMAKING PROCESS
Section
2.2-4012.1 of the Code of Virginia provides an exemption from certain
provisions of the Administrative Process Act for agency regulations deemed by
the Governor to be noncontroversial.  To use this process, Governor's
concurrence is required and advance notice must be provided to certain
legislative committees.  Fast-track regulations will become effective on the
date noted in the regulatory action if no objections to using the process are
filed in accordance with § 2.2-4012.1.
EMERGENCY
REGULATIONS
Pursuant
to § 2.2-4011 of the Code of Virginia, an agency, upon consultation
with the Attorney General, and at the discretion of the Governor, may adopt
emergency regulations that are necessitated by an emergency situation. An
agency may also adopt an emergency regulation when Virginia statutory law or
the appropriation act or federal law or federal regulation requires that a
regulation be effective in 280 days or less from its enactment. The emergency regulation becomes operative upon its
adoption and filing with the Registrar of Regulations, unless a later date is
specified. Emergency regulations are limited to no more than 18 months in
duration; however, may be extended for six months under certain circumstances
as provided for in § 2.2-4011 D. Emergency regulations are published as
soon as possible in the Register.
During
the time the emergency status is in effect, the agency may proceed with the
adoption of permanent regulations through the usual procedures. To begin
promulgating the replacement regulation, the agency must (i) file the Notice of
Intended Regulatory Action with the Registrar within 60 days of the effective
date of the emergency regulation and (ii) file the proposed regulation with the
Registrar within 180 days of the effective date of the emergency regulation. If
the agency chooses not to adopt the regulations, the emergency status ends when
the prescribed time limit expires.
STATEMENT
The
foregoing constitutes a generalized statement of the procedures to be followed.
For specific statutory language, it is suggested that Article 2 (§ 2.2-4006
et seq.) of Chapter 40 of Title 2.2 of the Code of Virginia be examined
carefully.
CITATION
TO THE VIRGINIA REGISTER
The Virginia
Register is cited by volume, issue, page number, and date. 34:8 VA.R.
763-832 December 11, 2017, refers to Volume 34, Issue 8, pages 763 through
832 of the Virginia Register issued on 
December 11, 2017.
The
Virginia Register of Regulations is
published pursuant to Article 6 (§ 2.2-4031 et seq.) of Chapter 40 of
Title 2.2 of the Code of Virginia. 
Members
of the Virginia Code Commission: John
S. Edwards, Chair; James A. "Jay" Leftwich, Vice Chair;
Ryan T. McDougle; Rita Davis; Leslie L. Lilley; E.M. Miller,
Jr.; Thomas M. Moncure, Jr.; Christopher R. Nolen; Charles S. Sharp; Samuel T.
Towell; Malfourd W. Trumbo; Mark J. Vucci.
Staff
of the Virginia Register: Karen
Perrine, Registrar of Regulations; Anne Bloomsburg, Assistant
Registrar; Nikki Clemons, Regulations Analyst; Rhonda Dyer,
Publications Assistant; Terri Edwards, Senior Operations Staff
Assistant.
 
 
                                                        PUBLICATION SCHEDULE AND DEADLINES
Vol. 35 Iss. 20 - May 27, 2019
June 2019 through August 2020
 
  | Volume: Issue | Material Submitted By Noon* | Will Be Published On | 
 
  | 35:22 | June 5, 2019 | June 24, 2019 | 
 
  | 35:23 | June 19, 2019 | July 8, 2019 | 
 
  | 35:24 | July 3, 2019 | July 22, 2019 | 
 
  | 35:25 | July 17, 2019 | August 5, 2019 | 
 
  | 35:26 | July 31, 2019 | August 19, 2019 | 
 
  | 36:1 | August 14, 2019 | September 2, 2019 | 
 
  | 36:2 | August 28, 2019 | September 16, 2019 | 
 
  | 36:3 | September 11, 2019 | September 30, 2019 | 
 
  | 36:4 | September 25, 2019 | October 14, 2019 | 
 
  | 36:5 | October 9, 2019 | October 28, 2019 | 
 
  | 36:6 | October 23, 2019 | November 11, 2019 | 
 
  | 36:7 | November 6, 2019 | November 25, 2019 | 
 
  | 36:8 | November 18, 2019 (Monday) | December 9, 2019 | 
 
  | 36:9 | December 4, 2019 | December 23, 2019 | 
 
  | 36:10 | December 18, 2019 | January 6, 2020 | 
 
  | 36:11 | January 1, 2020 | January 20, 2020 | 
 
  | 36:12 | January 15, 2020 | February 3, 2020 | 
 
  | 36:13 | January 29, 2020 | February 17, 2020 | 
 
  | 36:14 | February 12. 2020 | March 2, 2020 | 
 
  | 36:15 | February 26, 2020 | March 16, 2020 | 
 
  | 36:16 | March 11, 2020 | March 30, 2020 | 
 
  | 36:17 | March 25, 2020 | April 13, 2020 | 
 
  | 36:18 | April 8, 2020 | April 27, 2020 | 
 
  | 36:19 | April 22. 2020 | May 11, 2020 | 
 
  | 36:20 | May 6, 2020 | May 25, 2020 | 
 
  | 36:21 | May 20, 2020 | June 8, 2020 | 
 
  | 36:22 | June 3, 2020 | June 22, 2020 | 
 
  | 36:23 | June 17, 2020 | July 6, 2020 | 
 
  | 36:24 | July 1, 2020 | July 20, 2020 | 
 
  | 36:25 | July 15, 2020 | August 3, 2020 | 
*Filing deadlines are Wednesdays
unless otherwise specified.
 
   
                                                        
                                                        
                                                        NOTICES OF INTENDED REGULATORY ACTION
Vol. 35 Iss. 20 - May 27, 2019
TITLE 9. ENVIRONMENT
Small Renewable Energy Projects (Solar) Permit Regulation by Rule
Notice of Intended Regulatory Action
 
 Notice is hereby given in accordance with § 2.2-4007.01 of the
 Code of Virginia that the Department of Environmental Quality (DEQ) intends to
 consider amending 9VAC15-60, Small Renewable Energy Projects (Solar) Permit
 Regulation by Rule, which establishes criteria, procedures, and
 permit requirements as required by § 10.1-1197.5 et seq. of the Code of
 Virginia for solar energy projects of 150 megawatts or fewer. The purpose
 of the proposed action is to clarify specific definitions, establish clear
 timeframes for data submittals and recordkeeping activities, provide clarity
 for natural and cultural resource studies, clarify the public participation procedures,
 and address the fee structure to adequately fund the program. The goals of the
 proposed action are to clarify the requirements for applicants, operators, and
 permitted facilities; improve permitting procedures; and streamline the
 regulations for ease of use while still protecting natural resources and human
 health. 
 
 In addition, pursuant to Executive Order 14 (as amended July
 16, 2018) and § 2.2-4007.1 of the Code of Virginia, DEQ is conducting a
 periodic review and small business impact review of this regulation to
 determine whether this regulation should be terminated, amended, or retained in
 its current form. Public comment is sought on the review of any issue relating
 to this regulation, including whether the regulation (i) is necessary for the
 protection of public health, safety, and welfare or for the economical
 performance of important governmental functions; (ii) minimizes the economic
 impact on small businesses in a manner consistent with the stated objectives of
 applicable law; (iii) is designed to achieve its intended objective in the most
 efficient, cost-effective manner; (iv) is clearly written and easily
 understandable; (v) overlaps, duplicates, or conflicts with federal or state
 law or regulation; and (vi) is impacted by changes in technology, economic
 conditions, or other factors in the area affected by the regulation since the
 last review.
 
 The agency does not intend to hold a public hearing on the
 proposed action after publication in the Virginia Register. 
 
 Statutory Authority: § 10.1-1197.6 of the Code of
 Virginia.
 
 Public Comment Deadline: June 26, 2019.
 
 Agency Contact: Mary E. Major, Department of
 Environmental Quality, 1111 East Main Street, Suite 1400, P.O. Box 1105,
 Richmond, VA 23218, telephone (804) 698-4423, FAX (804) 698-4510, or email
 mary.major@deq.virginia.gov.
 
 VA.R. Doc. No. R19-5818; Filed May 6, 2019, 7:43 a.m. 
TITLE 9. ENVIRONMENT
Regulated Medical Waste Management Regulations
Notice of Intended Regulatory Action
 
 Notice is hereby given in accordance with § 2.2-4007.01 of
 the Code of Virginia that the Virginia Waste Management Board intends to
 consider amending 9VAC20-120, Regulated Medical Waste Management Regulations.
 The purpose of the proposed action is to modernize the standards for general
 handling and treatment of regulated medical waste based on current industry
 best management practices. The goals of the proposed action are to clarify the
 requirements for generators and permitted facilities, improve permitting
 procedures, and streamline the regulations for ease of use while still
 protecting natural resources and human health. 
 
 In addition, pursuant to Executive Order 17 (2014) and
 § 2.2-4007.1 of the Code of Virginia, the agency is conducting a periodic
 review and small business impact review of this regulation to determine whether
 this regulation should be terminated, amended, or retained in its current form.
 Public comment is sought on the review of any issue relating to this
 regulation, including whether the regulation (i) is necessary for the
 protection of public health, safety, and welfare or for the economical
 performance of important governmental functions; (ii) minimizes the economic
 impact on small businesses in a manner consistent with the stated objectives of
 applicable law; (iii) is designed to achieve its intended objective in the most
 efficient, cost-effective manner; (iv) is clearly written and easily
 understandable; (v) overlaps, duplicates, or conflicts with federal or state
 law or regulation; and (vi) is impacted by changes in technology, economic
 conditions, or other factors in the area affected by the regulation since the
 last review.
 
 The agency does not intend to hold a public hearing on the
 proposed action after publication in the Virginia Register. 
 
 Statutory Authority: § 10.1-1402 of the Code of
 Virginia; 42 USC § 6941 et seq.; 40 CFR Part 257.
 
 Public Comment Deadline: June 26, 2019.
 
 Agency Contact: Debra A. Harris, Planning and Policy
 Specialist, Department of Environmental Quality, P.O. Box 1105, Richmond, VA
 23218, telephone (804) 698-4209, FAX (804) 698-4019, or email debra.harris@deq.virginia.gov.
 
 VA.R. Doc. No. R19-5395; Filed May 6, 2019, 7:49 a.m. 
TITLE 12. HEALTH
 Regulations Governing Virginia Newborn Screening Services
Notice of Intended Regulatory Action
 
 Notice is hereby given in accordance with § 2.2-4007.01 of the
 Code of Virginia that the State Board of Health intends to consider amending 12VAC5-71,
 Regulations Governing Virginia Newborn Screening Services. The purpose of
 the proposed action is to amend the existing newborn screening regulation to
 add spinal muscular atrophy (SMA) and X-linked adrenoleukodystrophy (X-ALD) to
 the newborn screening panel. SMA is a genetic disorder that is estimated to
 occur in approximately 9.1 out of every 100,000 live births. X-ALD is a genetic
 disorder that is estimated to occur in approximately six out of every 100,000
 live births. Treatment for both X-ALD and SMA is available if detected early.
 Screening is necessary as these disorders cannot be detected at birth through
 physical examinations. The addition of SMA and X-ALD to the newborn screening
 panel has been recommended by the Virginia Genetics Advisory Committee. On the
 national level, these disorders have been added to the core panel of 35 genetic
 disorders included in the Recommended Uniform Screening Panel of the U.S.
 Secretary of Health and Human Services Advisory Committee on Heritable
 Disorders in Newborns and Children.
 
 The agency does not intend to hold a public hearing on the
 proposed action after publication in the Virginia Register. 
 
 Statutory Authority: §§ 32.1-12 and 32.1-67 of the
 Code of Virginia.
 
 Public Comment Deadline: June 27, 2019.
 
 Agency Contact: Joseph Hilbert, Deputy Commissioner,
 Governmental and Regulatory Affairs, Virginia Department of Health, 109
 Governor Street, Richmond, VA 23219, telephone (804) 864-7001, FAX (804)
 864-7022, or email joe.hilbert@vdh.virginia.gov.
 
 VA.R. Doc. No. R19-5996; Filed May 2, 2019, 4:49 p.m. 
TITLE 12. HEALTH
Regulations for Alternative Onsite Sewage Systems
Notice of Intended Regulatory Action
 
 Notice is hereby given in accordance with § 2.2-4007.01 of
 the Code of Virginia that the State Board of Health intends to consider
 amending 12VAC5-613, Regulations for Alternative Onsite Sewage Systems.
 The purpose of the proposed action is to review the entire regulation for
 necessary modifications, clarifications, and updates to provisions, including
 provisions relating to the general approval process for manufacturers of
 alternative onsite sewage systems (AOSS), performance requirements of the AOSS,
 and sampling requirements for owners. Other amendments may be proposed based on
 comments from the periodic review conducted in 2016, on feedback from the
 technical advisory committees and from the general public, and as authorized by
 the Code of Virginia.
 
 This Notice of Intended Regulatory Action serves as the report
 of the findings of the regulatory review pursuant to § 2.2-4007.1 of the
 Code of Virginia.
 
 The agency does not intend to hold a public hearing on the
 proposed action after publication in the Virginia Register. 
 
 Statutory Authority: §§ 32.1-12 and 32.1-164 of the
 Code of Virginia.
 
 Public Comment Deadline: June 28, 2019.
 
 Agency Contact: Lance Gregory, Director, Division of
 Onsite Sewage and Water Services, Virginia Department of Health, 109 Governor
 Street, Richmond, VA 23219, telephone (804) 864-7491, or email
 lance.gregory@vdh.virginia.gov.
 
 VA.R. Doc. No. R19-5991; Filed April 30, 2019, 4:36 p.m. 
TITLE 13. HOUSING
Virginia Certification Standards
Notice of Intended Regulatory Action
 
 Notice is hereby given in accordance with § 2.2-4007.01 of
 the Code of Virginia that the Board of Housing and Community Development
 intends to consider amending 13VAC5-21, Virginia Certification Standards.
 The purpose of the proposed action is to update the regulation to coordinate
 with the building (13VAC5-63) and fire (13VAC5-51) regulations, which are being
 updated to reference the newest available nationally recognized model codes and
 standards. As the national codes are comprehensive in scope, the agency will
 accept comments on all provisions of the Virginia Certification Standards to
 ensure compatibility with the latest codes.
 
 In addition, this regulation will undergo a periodic review
 pursuant to Executive Order 14 (as amended, July 16, 2018) and a small business
 impact review pursuant to § 2.2-4007.1 of the Code of Virginia to determine
 whether this regulation should be terminated, amended, or retained in its
 current form. Public comment is sought on the review of any issue relating to
 this regulation, including whether the regulation (i) is necessary for the
 protection of public health, safety, and welfare or for the economical
 performance of important governmental functions; (ii) minimizes the economic
 impact on small businesses in a manner consistent with the stated objectives of
 applicable law; and (iii) is clearly written and easily understandable.
 
 The agency intends to hold a public hearing on the proposed
 action after publication in the Virginia Register. 
 
 Statutory Authority: § 36-137 of the Code of Virginia.
 
 Public Comment Deadline: June 26, 2019.
 
 Agency Contact: Kyle Flanders, Senior Policy Analyst,
 Department of Housing and Community Development, Main Street Centre, 600 East
 Main Street, Suite 300, Richmond, VA 23219, telephone (804) 786-6761, FAX (804)
 371-7090, TTY (804) 371-7089, or email kyle.flanders@dhcd.virginia.gov.
 
 VA.R. Doc. No. R19-5980; Filed April 25, 2019, 8:30 a.m. 
TITLE 13. HOUSING
Virginia Uniform Statewide Building Code
Notice of Intended Regulatory Action 
 
 Notice is hereby given in accordance with § 2.2-4007.01 of the
 Code of Virginia that the Board of Housing and Community Development intends to
 consider amending 13VAC5-63, Virginia Uniform Statewide Building Code.
 The purpose of the proposed action is to lower to 77° Fahrenheit the required
 cooling temperature as provided in the Uniform Statewide Building Code (USBC).
 Currently, the Virginia Maintenance Code (VMC), a part of the USBC, requires
 that when cooling is provided to tenants of certain multifamily buildings, it
 must be provided to a temperature of at least 80° Fahrenheit. The current threshold
 has been identified as a public health concern in multiple localities that
 adopt the VMC. 
 
 The agency intends to hold a public hearing on the proposed
 action after publication in the Virginia Register. 
 
 Statutory Authority: § 36-98 of the Code of Virginia.
 
 Public Comment Deadline: July 10, 2019.
 
 Agency Contact: Kyle Flanders, Senior Policy Analyst,
 Department of Housing and Community Development, Main Street Centre, 600 East
 Main Street, Suite 300, Richmond, VA 23219, telephone (804) 786-6761, FAX (804)
 371-7090, TTY (804) 371-7089, or email kyle.flanders@dhcd.virginia.gov.
 
 VA.R. Doc. No. R19-5869; Filed May 14, 2019, 4:47 p.m. 
TITLE 13. HOUSING
Virginia Manufactured Home Safety Regulations
Notice of Intended Regulatory Action
 
 Notice is hereby given in accordance with § 2.2-4007.01 of the
 Code of Virginia that the Board of Housing and Community Development intends to
 consider amending 13VAC5-95, Virginia Manufactured Home Safety Regulations.
 The purpose of the proposed action is to update the regulations to include the
 most current federal installation standard based on current construction
 standards of the U.S. Department of Housing and Urban Development and to amend
 any administrative or enforcement provision of the regulation as determined
 necessary. 
 
 In addition, pursuant to
 Executive Order 14 (as amended, July 16, 2018) and § 2.2-4007.1 of the Code of
 Virginia, the Board of Housing and Community Development is conducting a
 periodic review and small business impact review of this regulation to
 determine whether this regulation should be terminated, amended, or retained in
 its current form. Public comment is sought on the review of any issue relating
 to this regulation, including whether the regulation (i) is necessary for the
 protection of public health, safety, and welfare; (ii) minimizes the economic
 impact on small businesses consistent with the stated objectives of applicable
 law; and (iii) is clearly written and easily understandable. 
 
 The agency intends to hold a public hearing on the proposed
 action after publication in the Virginia Register. 
 
 Statutory Authority: § 36-85.7 of the Code of
 Virginia.
 
 Public Comment Deadline: June 26, 2019.
 
 Agency Contact: Kyle Flanders, Senior Policy Analyst,
 Department of Housing and Community Development, Main Street Centre, 600 East
 Main Street, Suite 300, Richmond, VA 23219, telephone (804) 786-6761, FAX (804)
 371-7090, TTY (804) 371-7089, or email kyle.flanders@dhcd.virginia.gov.
 
 VA.R. Doc. No. R19-5981; Filed April 25, 2019, 8:31 a.m. 
TITLE 18. PROFESSIONAL AND OCCUPATIONAL LICENSING
Regulations of the Board of Funeral Directors and Embalmers
Notice of Intended Regulatory Action
 
 Notice is hereby given in
 accordance with § 2.2-4007.01 of the Code of Virginia that the Board of Funeral
 Directors and Embalmers intends to consider amending 18VAC65-20, Regulations
 of the Board of Funeral Directors and Embalmers. The purpose of the
 proposed action is to amend the regulations governing the practice of funeral
 services to include clarifying certain provisions, updating the regulations,
 and strengthening the provisions for surface transportation, removal service,
 and courtesy cards.
 
 This Notice of Intended
 Regulatory Action serves as the report of the findings of the regulatory review
 pursuant to § 2.2-4007.1 of the Code of Virginia.
 
 The agency intends to hold a
 public hearing on the proposed action after publication in the Virginia
 Register. 
 
 Statutory Authority: §§ 54.1-2400 and 54.1-2803 of the Code of
 Virginia.
 
 Public Comment Deadline: June 26, 2019.
 
 Agency Contact: Corie Tillman Wolf, Executive Director, Board of
 Funeral Directors and Embalmers, 9960 Mayland Drive, Suite 300, Richmond, VA
 23233, telephone (804) 367-4479, FAX (804) 527-4471, or email
 fanbd@dhp.virginia.gov.
 
 VA.R. Doc. No. R19-5988; Filed April 30, 2019, 1:06 p.m.
TITLE 18. PROFESSIONAL AND OCCUPATIONAL LICENSING
Regulations for Preneed Funeral Planning
Notice of Intended Regulatory Action
 
 Notice of Intended Regulatory Action 
 
 Notice is hereby given in
 accordance with § 2.2-4007.01 of the Code of Virginia that the Board of Funeral
 Directors and Embalmers intends to consider amending 18VAC65-30, Regulations
 for Preneed Funeral Planning. The purpose of the proposed action is to
 ensure greater protections for the public, including disclosures of information
 regarding the content of a contract, retention of documentation, and
 notification when a funeral home closes or changes ownership.
 
 This Notice of Intended
 Regulatory Action serves as the report of the findings of the regulatory review
 pursuant to § 2.2-4007.1 of the Code of Virginia.
 
 The agency intends to hold a
 public hearing on the proposed action after publication in the Virginia
 Register. 
 
 Statutory Authority: §§ 54.1-2400 and 54.1-2803 of the Code of Virginia.
 
 Public Comment Deadline: June 26, 2019.
 
 Agency Contact: Corie Tillman Wolf, Executive Director, Board of
 Funeral Directors and Embalmers, 9960 Mayland Drive, Suite 300, Richmond, VA 23233-1463,
 telephone (804) 367-4546, FAX (804) 527-4637, or email
 corie.wolf@dhp.virginia.gov.
 
 VA.R. Doc. No. R19-5826; Filed April 30, 2019, 1:07 p.m. 
 
                                                        REGULATIONS
Vol. 35 Iss. 20 - May 27, 2019
TITLE 1. ADMINISTRATION
OFFICE OF THE STATE INSPECTOR GENERAL
Final Regulation
 
 Title of Regulation: 1VAC42-30. Fraud and Abuse
 Whistle Blower Reward Fund (adding 1VAC42-30-10 through 1VAC42-30-100). 
 
 Statutory Authority: § 2.2-3014 of the Code of Virginia.
 
 Effective Date: June 27, 2019. 
 
 Agency Contact: Mark Courtney, Regulatory Coordinator,
 Office of the State Inspector General, P.O. Box 1151, Richmond, VA 23218,
 telephone (804) 625-3255, FAX (804) 371-0165, or email
 mark.courtney@osig.virginia.gov.
 
 Summary:
 
 The regulation defines the Fraud and Abuse Whistle Blower
 Reward Fund and its administration by the Office of the State Inspector
 General, including (i) eligibility requirements, (ii) amount and distribution,
 (iii) process for leftover moneys at the end of the fiscal year, and (iv) the
 fund's establishment on the books of the Comptroller.
 
 Summary of Public Comments and Agency's Response: No
 public comments were received by the promulgating agency. 
 
 CHAPTER 30
 FRAUD AND ABUSE WHISTLE BLOWER REWARD FUND
 
 1VAC42-30-10. Definitions.
 
 The following words and terms when used in this chapter
 shall have the following meanings unless the context clearly indicates
 otherwise:
 
 "Abuse" means an employer's or employee's
 conduct or omissions that result in substantial misuse, destruction, waste, or
 loss of funds or resources belonging to or derived from federal, state, or
 local government sources.
 
 "Commonwealth" means the Commonwealth of
 Virginia.
 
 "Disclosure" means a voluntary formal or
 informal communication or transmission of (i) any violation of any law, rule,
 or regulation; (ii) gross mismanagement; (iii) a gross waste of funds; (iv) an
 abuse of authority; or (v) a substantial and specific danger to public health
 or safety.
 
 "Employee" means any individual who is employed
 on either a salaried or wage basis, whose tenure is not restricted as to
 temporary or provisional appointment, in the service of and whose compensation
 is payable no more often than biweekly in whole or in part by a Virginia
 governmental agency.
 
 "Employer" means a person supervising one or
 more employees, including the employee filing a good faith report, a superior
 of that supervisor, or an agent of the governmental agency.
 
 "Executive branch agency" or "agency"
 means any agency, institution, board, bureau, commission, council, public
 institution of higher education, or instrumentality of state government in the
 executive department listed in the appropriation act.
 
 "Fraud" means the intentional deception
 perpetrated by an individual or an organization, either internal or external to
 state government, that could result in a tangible or intangible benefit to
 themselves, others, or the Commonwealth, including local government, or could
 cause detriment to others or the Commonwealth. Fraud includes a false
 representation of the facts, whether by words or by conduct. Fraud also
 includes false or misleading statements, the concealment of essential
 information, or information or actions that deceive or are intended to deceive.
 
 
 "Fraud and Abuse Whistle Blower Protection Act
 Program" or "WBPA Program" means the policy of the Commonwealth
 that Commonwealth citizens and employees of state government are freely able to
 report instances of wrongdoing or abuse committed by their employing agency,
 other state agencies, or independent contractors of state agencies.
 
 "Fraud and Abuse Whistle Blower Reward Fund" or
 "fund" means the fund used solely to provide monetary rewards to
 Commonwealth citizens who have disclosed information of wrongdoing or abuse
 under the WBPA Program that results in a recovery of at least $5,000. 
 
 "Good faith report" means a reported incident of
 possible wrongdoing or abuse made without malice, for which the person
 reporting has reasonable cause to believe wrongdoing or abuse occurred.
 
 "Governmental agency" means (i) any agency,
 institution, board, bureau, commission, council, or instrumentality of state
 government in the executive branch listed in the appropriation act and any
 independent agency; (ii) any county, city, town, or local or regional
 governmental authority; and (iii) any local school division as defined in § 22.1-280.2:2
 of the Code of Virginia.
 
 "Hotline coordinator" means a qualified
 employee, designated by a governmental agency director or chief administrator,
 responsible for conducting State Fraud, Waste and Abuse Hotline investigations
 referred to the agency by OSIG. 
 
 "Internal audit director" means a director of a
 governmental agency internal audit program.
 
 "Misconduct" means conduct or behavior by an
 employee that is inconsistent with state, local, or agency standards for which
 specific corrective or disciplinary action is warranted.
 
 "Nonstate agency" means any public or private
 foundation, authority, institute, museum, corporation, or similar organization
 that is (i) not a unit of state government or a political subdivision of the
 Commonwealth as established by general law or special act and (ii) wholly or
 principally supported by state funds. "Nonstate agency" shall not
 include any such entity that receives state funds (a) as a subgrantee of a
 state agency; (b) through a state grant-in-aid program authorized by law; (c)
 as a result of an award of a competitive grant or a public contract for the
 procurement of goods, services, or construction; or (d) pursuant to a lease of
 real property as described in subdivision 5 of § 2.2-1149 of the Code of
 Virginia.
 
 "Office of the State Inspector General" or
 "OSIG" means the governmental agency that conducts independent
 investigations, performance audits, and other services designed to provide
 objective and useful information to the Commonwealth and those charged with its
 governance and promotes efficiency and effectiveness in state government
 executive branch agencies in accordance with Article 1 (§ 2.2-307 et seq.)
 of Chapter 13.2 of the Code of Virginia.
 
 "Public body" means any legislative body; any
 authority, board, bureau, commission, district, agency, or political
 subdivision of the Commonwealth, including counties, cities, towns, city
 councils, boards of supervisors, school boards, planning commissions, and
 boards of visitors of institutions of higher education; and other
 organizations, corporations, or agencies in the Commonwealth supported wholly
 or principally by public funds. "Public body" includes any committee,
 subcommittee, or other entity however designated of the public body or formed
 to advise the public body, including those with private sector or citizen
 members and corporations organized by the Virginia Retirement System. For the
 purposes of this chapter, the term "public body" does not include the
 courts of the Commonwealth.
 
 "Reward" means a monetary benefit payable from
 the fund by OSIG to an eligible whistle blower. 
 
 "Screening process" means OSIG's internal review
 to ensure reports of information or disclosures of wrongdoing fall within the
 authority of the WBPA Program. 
 
 "State Fraud, Waste and Abuse Hotline" or
 "hotline" means the program (i) that provides Commonwealth citizens
 with a confidential and anonymous method to report suspected occurrences of
 fraud, waste, and abuse in state agencies and institutions and (ii) that
 provides the Commonwealth a way to investigate such occurrences to determine
 their validity and make appropriate recommendations to address deficiencies.
 
 "Whistle blower" means a Commonwealth employee
 or citizen who witnesses or has evidence of wrongdoing or abuse and who makes a
 good faith, open, and public report of the wrongdoing or abuse to one of the
 employee's superiors, an agent of the employer, or an appropriate authority.
 
 "Wrongdoing" means a violation, which is not of
 a merely technical or minimal nature, of a federal or state law or regulation
 or a formally adopted code of conduct or ethics of a professional organization
 designed to protect the interests of the public or an employee.
 "Wrongdoing" includes (i) any violation of any law, rule, or
 regulation; (ii) gross mismanagement; (iii) a gross waste of funds; (iv) an
 abuse of authority; or (v) a substantial and specific danger to public health
 or safety.
 
 1VAC42-30-20. Office of the State Inspector General
 responsibilities.
 
 A. OSIG is responsible for administering the WBPA Program
 and fund and the following tasks: 
 
 1. Notifying annually Commonwealth employees, citizens, and
 governmental bodies, including state agencies, of the WBPA Program and fund
 regulations and procedures for submitting information regarding wrongdoing or
 abuse.
 
 2. Protecting the identity of Commonwealth employees and
 citizens who make allegations of wrongdoing or abuse through the WBPA Program.
 OSIG will keep this information confidential to the extent allowed by law.
 
 3. Conducting appropriate investigations and preparing
 official reports.
 
 4. Receiving and evaluating fund claims.
 
 5. Ensuring payment of approved fund moneys to whistle
 blowers.
 
 6. Submitting an annual report on WBPA Program activities
 to the Governor and General Assembly.
 
 7. Notifying individuals making allegations of the possible
 incentives as a result of moneys recovered and available through the fund.
 
 B. OSIG is responsible for assigning, coordinating, and
 investigating alleged wrongdoing or abuse reported to OSIG under the WBPA
 Program. OSIG may work with executive branch agency internal audit directors,
 executive branch agency hotline coordinators, or representatives of public
 bodies when performing WBPA Program investigations.
 
 1VAC42-30-30. Fraud and Abuse Whistle Blower Protection Act
 Program and Reward Fund notification.
 
 A. Annually, the State Inspector General will communicate
 with all state agency heads. The communication will: 
 
 1. Publicize the WBPA Program and fund.
 
 2. Explain the protections afforded to individuals who
 report instances of wrongdoing or abuse committed within executive branch
 agencies and nonstate agencies.
 
 3. Notify state agency heads of relevant statutory
 amendments or program changes.
 
 4. Contain the requirements for reporting allegations to
 OSIG and the incentives under the WBPA Program.
 
 5. Clarify pertinent differences between the WBPA Program
 and the hotline regarding the rules governing anonymity and confidentiality.
 
 6. Provide available materials to assist agency heads in
 promoting the WBPA Program and fund, as well as available training for Commonwealth
 employees regarding the WBPA Program and fund.
 
 B. Annually, OSIG will publicize the WBPA Program and fund
 on the OSIG website and to Commonwealth citizens through the distribution of a
 news release to Virginia media, as well as to state employees through an
 electronic communication in partnership with the Department of Human Resource
 Management. The communication will:
 
 1. Contain the requirements for reporting allegations to
 OSIG and the incentives under the WBPA Program.
 
 2. Clarify pertinent differences between the WBPA Program
 and the hotline regarding the rules governing anonymity and confidentiality.
 
 
 1VAC42-30-40. Reporting alleged fraud, abuse, or wrongdoing.
 
 A. A Commonwealth employee or citizen with an allegation
 of wrongdoing or abuse under the WBPA Program may contact OSIG by phone, email,
 online complaint form, United States Postal Service, or FAX.
 
 B. OSIG staff is available to advise citizens on what to
 report that meets the definition of wrongdoing or abuse.
 
 C. If an investigation results in recoverable funds, and
 the whistle blower seeks to file a fund claim under the WBPA Program, the
 whistle blower will be required to provide his name and lawful residence.
 
 While not anonymous, OSIG will keep this information
 confidential to the extent allowed by law.
 
 1VAC42-30-50. Office of the State Inspector General receipt
 of an allegation.
 
 A. Allegations of wrongdoing or abuse received by OSIG
 undergo the hotline screening process.
 
 B. Allegations submitted by an individual who is not a
 Commonwealth employee or citizen will be referred to the appropriate
 governmental agency or organization. 
 
 C. If the agency or organization reported is not an
 executive branch or independent state agency or entity or a local governmental
 agency or entity or school division, the information will be forwarded to that
 entity where possible for informational purposes only.
 
 1VAC42-30-60. Allegation investigative process.
 
 A. OSIG will prepare a detailed written summary that
 describes the allegation of wrongdoing or abuse submitted through the WBPA
 Program.
 
 B. The hotline manager or designee will create a
 confidential tracking number for each case and assign it for formal
 investigation. 
 
 C. OSIG will monitor the progress of each investigation
 and provide the State Inspector General with regular status updates of the
 assignment.
 
 D. Upon completion of an investigation, the investigator
 will prepare and submit a case report for management review and approval. When
 appropriate, recommendations for corrective action to address procedural
 deficiencies disclosed during the investigation will be included in the case
 report.
 
 E. Formal case reports will describe all financial
 recovery realized on behalf of the Commonwealth as a result of the information
 received from the whistle blower and the subsequent investigation. 
 
 F. Case reports will be forwarded to the State Inspector
 General for review. Upon authorization by the State Inspector General, the
 investigator will prepare an executive summary that recaps the findings of the
 investigation, the recommendations, the recovery of funds, and the status of
 applicable fund claims. Upon signature approval of the State Inspector General,
 the executive summary will be forwarded to the subject state executive branch
 agency head, respective secretariat, and the Chief of Staff of the Governor.
 
 1VAC42-30-70. Nonreverting fund.
 
 A. OSIG will coordinate with the State Comptroller to
 establish a special nonreverting fund. 
 
 B. The fund will be established on the books of the State
 Comptroller and administered by the State Inspector General.
 
 C. All moneys recovered by an OSIG investigation as a
 result of whistle blower activity shall be deposited in the fund.
 
 D. Except for the moneys described in subsection F of this
 section, moneys remaining in the fund at the end of each fiscal year, including
 interest, shall not revert to the general fund, but shall remain in the fund. 
 
 E. Moneys in the fund shall solely be used to: 
 
 1. Provide monetary rewards to Commonwealth employees and
 citizens who have disclosed information of wrongdoing or abuse under the WBPA
 Program (§ 2.2-3009 et seq. of the Code of Virginia), and the disclosure
 resulted in a recovery of at least $5,000.
 
 2. Support the administration of the fund, defray fund
 advertising costs, or subsidize the operation of the hotline. 
 
 F. Per the State Inspector General's authorization by the
 end of each calendar quarter, 85% of all sums recovered by an OSIG
 investigation will be remitted to the institutions or agencies concerned,
 unless otherwise directed by a court of law. 
 
 1VAC42-30-80. Fund payments to whistle blowers.
 
 A. Within 10 working days, excluding state holidays and
 weekends, of the closing of a WBPA Program investigation that verifies a final
 recovery and deposit in the fund of $5,000 or more, the State Inspector General
 will review and certify the fund claim. Within five working days after the
 State Inspector General's verification, the whistle blower will be notified of
 the award amount he is eligible to receive. Upon approval of the fund claim,
 the State Inspector General will submit a written request to the State
 Comptroller to make a reward payment from the fund to the whistle blower. 
 
 B. The State Treasurer will make reward payments from the
 fund based on a warrant issued by the State Comptroller and a written request
 signed by the State Inspector General.
 
 C. Award amounts. 
 
 1. The amount of the fund reward shall be up to 10% of the
 actual sums recovered by the Commonwealth as a result of the disclosure of the
 wrongdoing or abuse.
 
 2. OSIG will consider many factors in determining the
 amount of an award based on the unique facts and circumstances of each case.
 OSIG may increase the award percentage up to the maximum allowed based on the
 following factors: (i) the significance of the information provided to OSIG to
 the success of any proceeding brought against wrongdoers; (ii) the extent of
 the assistance provided to OSIG in its investigation and any resulting
 findings; (iii) OSIG's law-enforcement interest in deterring violations of the
 applicable laws by making awards to whistle blowers who provide information
 that leads to the successful enforcement of these laws; and (iv) whether and
 the extent to which the whistle blower participated in his agency's internal
 compliance systems, such as, for example, reporting the possible violations
 through internal whistle blower, legal, or compliance procedures, before or at
 the same time the possible violations were reported to OSIG.
 
 3. OSIG may reduce the amount of an award based on the
 following: (i) if the whistle blower was a participant in or culpable for the
 violations reported; (ii) if the whistle blower unreasonably delayed reporting
 the violations to OSIG; and (iii) if the whistle blower interfered with his
 agency's internal compliance and reporting systems, such as, for example,
 making false statements to the compliance department that hindered its efforts
 to investigate possible wrongdoing or abuse.
 
 4. The amount of the reward will not exceed the balance of
 the fund, regardless of the sums recovered. 
 
 5. In the event that multiple whistle blowers have
 simultaneously reported the same fund-eligible occurrence of wrongdoing or
 abuse, the fund moneys may be split up to 10% among the whistle blowers at the
 State Inspector General's discretion. The State Inspector General's decision
 regarding the allocation of fund moneys is final and binding upon all parties
 and cannot be appealed.
 
 6. The request for payment will include the name and
 address of the whistle blower and the payment amount. OSIG will provide
 documentation supporting the amount of the payment to the State Comptroller.
 
 7. Once approved, the State Comptroller shall forward the
 request to Finance and Administration of the Department of Accounts (DOA) with
 a request that Finance and Administration process the payment to the whistle
 blower.
 
 8. DOA will ensure the amount of the fund reward is
 properly included in the whistle blower's federal and state tax records (i.e.,
 W-2 for employees; 1099 for Commonwealth citizens).
 
 9. OSIG will confirm that DOA processes the fund request
 and that the reward payment is made to the whistle blower for the amount
 approved by the State Inspector General.
 
 D. Five percent of all sums recovered on behalf of the
 Commonwealth will be retained in the fund to support the administration of the
 fund, defray advertising costs, and subsidize the operation of the hotline.
 Expenditures for administrative costs for management of the fund will be
 approved by the State Inspector General. 
 
 1VAC42-30-90. Whistle blower protections.
 
 A. Employee protections.
 
 1. No employer may discharge,
 threaten, or otherwise discriminate or retaliate against a whistle blower,
 whether acting individually or under the direction of another individual.
 
 2. No employer may discharge, threaten, or otherwise
 discriminate or retaliate against a whistle blower who is requested or
 subpoenaed by an appropriate authority to participate in an investigation,
 hearing, or inquiry.
 
 3. Nothing in this chapter shall prohibit an employer from
 disciplining or discharging a whistle blower for misconduct or violation of
 criminal law.
 
 4. If an employee has, in
 good faith, exhausted existing internal procedures for reporting and seeking
 recovery of falsely claimed sums through official channels, and if the
 Commonwealth failed to act on the information provided in a reasonable period
 of time, no court shall have jurisdiction over an action brought under § 8.01-216.5 of the Code of Virginia based on information
 discovered by a present or former employee of the Commonwealth during the
 course of his employment.
 
 5. Any whistle blower covered
 by the state grievance procedure may initiate a grievance alleging retaliation
 for reporting wrongdoing or abuse through the WBPA Program and may request
 relief throughout that procedure.
 
 B. Commonwealth citizen protections.
 
 1. No governmental agency may
 threaten or otherwise discriminate or retaliate against a citizen whistle
 blower because the whistle blower is requested or subpoenaed by an appropriate
 authority to participate in an investigation, hearing, or inquiry.
 
 2. Except for the provisions
 of § 2.2-3011 E of the Code of Virginia, the WBPA Program does not limit the
 remedies provided by the Virginia Fraud Against Taxpayers Act (§ 8.01-216.1
 et seq. of the Code of Virginia).
 
 C. Protection against
 discrimination and retaliation - good faith required. 
 
 1. To be protected by the
 provisions of this chapter, an employee or Commonwealth citizen who discloses
 information about suspected wrongdoing or abuse shall do so in good faith and
 upon a reasonable belief information provided is accurate. 
 
 2. Reckless disclosures or
 disclosures the employee or citizen knows or should have known were false,
 confidential by law, or malicious are not deemed good faith reports and are not
 protected.
 
 1VAC42-30-100. Whistle Blower Protection Act Program and
 Reward Fund annual report.
 
 A. OSIG shall submit an annual report to the Governor and
 the General Assembly of Virginia summarizing the activities of the fund. 
 
 B. OSIG will provide a copy of the WBPA Program annual
 report to the Chief of Staff to the Governor, the Secretary of Finance, and the
 State Comptroller.
 
 VA.R. Doc. No. R16-4186; Filed May 7, 2019, 10:34 a.m. 
TITLE 2. AGRICULTURE
BOARD OF AGRICULTURE AND CONSUMER SERVICES
Final Regulation
 
 
 
 REGISTRAR'S NOTICE: The
 Board of Agriculture and Consumer Services is claiming an exemption from the
 Administrative Process Act in accordance with § 2.2-4002 A 13 of the Code
 of Virginia, which excludes the board when promulgating regulations pursuant to
 § 3.2-5206 of the Code of Virginia.
 
  
 
 Title of Regulation: 2VAC5-490. Regulations Governing
 Grade "A" Milk (amending 2VAC5-490-50). 
 
 Statutory Authority: § 3.2-5206 of the Code of Virginia.
 
 Effective Date: May 27, 2019. 
 
 Agency Contact: Ryan Davis, Program Manager, Office of
 Dairy and Foods, Department of Agriculture and Consumer Services, P.O. Box
 1163, Richmond, VA 23218, telephone (804) 786-8899, FAX (804) 371-7792, TTY
 (800) 828-1120, or email ryan.davis@vdacs.virginia.gov.
 
 Summary:
 
 In response to a petition for rulemaking, the amendments
 reduce maximum bacteria count to 50,000 bacteria per milliliter of milk and
 reduce maximum somatic cell count to 500,000 per milliliter of milk as
 standards that must be met for milk to be considered grade A in Virginia.
 Additional amendments since publication of the proposed regulation clarify that
 these reductions only apply to cow's milk. 
 
 Part VI 
 Standards for Milk and Milk Products 
 
 2VAC5-490-50. Quality standards for milk and milk products. 
 
 A. No person may produce, provide, manufacture, sell, offer
 for sale, or store in the Commonwealth, or bring, send, or receive into the
 Commonwealth, any milk, milk product, condensed milk product, or dry milk
 product for use in the commercial preparation of grade A pasteurized,
 ultra-pasteurized, or aseptically processed milk or milk products that do not
 comply with the following: 
 
 1. Grade A raw milk for pasteurization or
 ultra-pasteurization, aseptic processing and packaging, or retort processed
 after packaging and all grade A pasteurized, ultra-pasteurized, aseptically
 processed and packaged, or retort processed after packaged milk or milk
 products shall be produced, processed, manufactured and pasteurized,
 ultra-pasteurized, aseptically processed and packaged, or retort processed
 after packaged to conform with the following chemical, physical,
 bacteriological, somatic cell, and temperature standards, and with the
 requirements of this chapter; 
 
 2. No process or manipulation other than (i) pasteurization;
 (ii) ultra-pasteurization; (iii) aseptic processing and packaging; (iv) retort
 processed after packaging; or (v) processing methods integral with
 pasteurization, ultra-pasteurization, aseptic processing and packaging, or
 retort processed after packaging; and refrigeration may be applied to milk or
 milk products for the purpose of removing or deactivating microorganisms
 provided that filtration, bactofugation, or filtration and bactofugation may be
 performed in the plant in which the milk or milk product is pasteurized,
 ultra-pasteurized, aseptically processed and packaged, or retort processed
 after packaged. Nothing in this chapter is deemed to prohibit any grade A
 permit holder who operates a milk plant from preparing bulk shipments of cream,
 skim milk, reduced fat or lowfat milk labeled as "heat treated"; if
 the raw milk, raw cream, skim milk, reduced fat or lowfat milk is heated, one
 time, to a temperature warmer than 125°F but cooler than 161°F for separation
 purposes. In the case of heat treated cream, the cream may be further heated to
 less than 166°F in a continuing heating process and immediately cooled to 45°F
 or less when necessary for enzyme deactivation (such as lipase reduction) for a
 functional reason; 
 
 3. Grade A raw milk and milk products for pasteurization,
 ultra-pasteurization, aseptic processing and packaging, or retort processed
 after packaging shall comply with the following standards: 
 
 a. The temperature of the raw milk shall be cooled to 40°F or
 cooler, but not frozen, within two hours after milking and the temperature
 after the first or any subsequent milking shall not be warmer than 50°F; 
 
 b. The bacteria count of [ the ] raw [ cow's ]
 milk shall not exceed 100,000 50,000 bacteria per milliliter
 prior to commingling with any other milk; and the bacteria count of [ the ]
 raw [ cow's ] milk that is commingled shall not exceed 300,000
 bacteria per milliliter prior to pasteurization; 
 
 c. [ The bacteria count of raw sheep's milk, raw
 goat's milk, raw water buffalo's milk, or raw milk from any other hooved mammal
 shall not exceed 100,000 bacteria per milliliter prior to commingling with any
 other milk; and the bacteria count of raw sheep's milk, raw goat's milk, raw
 water buffalo's milk, or raw milk from any other hooved mammal that is
 commingled shall not exceed 300,000 bacteria per milliliter prior to
 pasteurization;
 
 d. ] Raw milk shall freeze at or below -0.530°
 Hortvet; 
 
 [ d. e. ] Raw milk shall have no
 positive results of tests for drug residues by detection methods reported to
 the State Regulatory Authority by official laboratories, officially designated
 laboratories, milk plants, receiving stations, or transfer stations; 
 
 [ e. f. ] The somatic cell count of
 raw cow's milk [ , raw water buffalo's milk, or raw sheep's milk ]
 shall not exceed 750,000 500,000 somatic cells per milliliter.
 [ The somatic cell count of raw water buffalo's milk, raw sheep's milk,
 or raw milk from any other hooved mammal shall not exceed 750,000 somatic cells
 per milliliter. ] The somatic cell count of raw goat's milk shall not
 exceed 1,500,000 somatic cells per milliliter; 
 
 [ f. g. ] Raw milk shall not exceed
 the actionable level, tolerance level, or safe level for any chemical residue
 or pesticide residue specified in 40 CFR Part 180 and 21 CFR Parts 70, 71,
 73, 74, 80, 82, 130, 131, 133, 170, 172, 173, 174, 175, 176, 177, 178, 189,
 556, 570, 573, and 589. In the event that no actionable level, tolerance
 level, or safe level for a chemical residue or pesticides residue has been
 established in 40 CFR Part 180 and 21 CFR Parts 70, 71, 73, 74, 80, 82,
 130, 131, 133, 170, 172, 173, 174, 175, 176, 177, 178, 189, 556, 570, 573, and
 589, the tolerance level shall be deemed to be zero; and 
 
 [ g. h. ] Raw milk shall not contain
 aflatoxin residues equal to or greater than 0.50 parts per billion as
 determined by the Charm II aflatoxin test or other equivalent method; 
 
 4. Grade A pasteurized or ultra-pasteurized milk and milk
 products shall comply with the following standards: 
 
 a. The temperature of milk products shall be cooled to 45°F or
 cooler (but not frozen) and maintained at that temperature; 
 
 b. The bacteria count for any milk or milk products (except
 acidified or cultured milk or milk products, eggnog, cottage cheese, and other
 milk or milk products as identified in FDA M-a-98) shall not exceed 20,000
 bacteria per milliliter; 
 
 c. Except for commingled milk shipped in a transport tank the
 coliform count for any milk or milk products shall not exceed 10 coliform
 organisms per milliliter. Commingled milk shipped in a transport tank shall not
 exceed 100 coliform organisms per milliliter; 
 
 d. The phenol value of test samples of pasteurized finished
 product shall be no greater than the maximum specified for the particular
 product as determined and specified by (i) any phosphatase test method
 prescribed in the Official Methods of Analysis, 19th Edition, 2012, published
 by the Association of Official Analytical Chemists; (ii) the Fluorometer test
 method; (iii) the Charm ALP test method; or (iv) other equivalent method as
 determined by the Virginia Department of Agriculture and Consumer Services. A
 phenol value greater than the maximum specified for the particular product
 shall mean that the product was not properly pasteurized. A phenol value less
 than the maximum specified for the particular product shall not be deemed to
 mean that the product was properly pasteurized, unless there is evidence of
 proper pasteurization equipment in conformance with this chapter and records to
 determine an adequate pasteurization process has been completed for each
 separate batch or lot of milk, milk product, condensed milk, condensed milk
 product, dry milk, or dry milk product;
 
 e. Milk or milk products shall have no positive results of
 tests for drug residues by detection methods reported to the State Regulatory
 Authority by official laboratories, officially designated laboratories, milk
 plants, receiving stations, or transfer stations; 
 
 f. Milk or milk products shall not exceed the actionable
 level, tolerance level, or safe level for any chemical residue or pesticide
 residue specified in 40 CFR Part 180 and 21 CFR Parts 70, 71, 73, 74, 80, 82,
 130, 131, 133, 170, 172, 173, 174, 175, 176, 177, 178, 189, 556, 570, 573, and
 589. In the event that no actionable level, tolerance level, or safe level for
 a chemical residue or pesticides residue has been established in 40 CFR Part
 180 and 21 CFR Parts 70, 71, 73, 74, 80, 82, 130, 131, 133, 170, 172, 173, 174,
 175, 176, 177, 178, 189, 556, 570, 573, and 589, the tolerance level
 shall be deemed to be zero; and 
 
 g. Milk or milk products shall not contain aflatoxin residues
 equal to or greater than 0.50 parts per billion as determined by the Charm II
 aflatoxin test or other equivalent method;
 
 5. Grade A pasteurized concentrated (condensed) milk or milk
 product shall comply with the following standards: 
 
 a. The temperature of milk products shall be cooled to 45°F or
 cooler (but not frozen) and maintained thereat unless drying is commenced
 immediately after condensing; 
 
 b. Except for commingled milk shipped in a transport tank, the
 coliform count for any milk or milk product shall not exceed 10 coliform
 organisms per gram. Commingled milk shipped in a transport tank shall not
 exceed 100 coliform organisms per gram; 
 
 6. Grade A aseptically processed and packaged milk and milk
 products shall comply with the following standards: 
 
 a. Aseptically processed and packaged milk and milk products
 shall be commercially sterile; 
 
 b. Aseptically processed and packaged milk and milk products
 shall have no positive results of tests for drug residues by detection methods
 reported to the State Regulatory Authority by official laboratories, officially
 designated laboratories, milk plants, receiving stations, or transfer stations;
 
 
 c. Aseptically processed and packaged milk and milk products
 shall not exceed the actionable level, tolerance level, or safe level for any
 chemical residue or pesticide residue specified in 40 CFR Part 180 and 21 CFR
 Parts 70, 71, 73, 74, 80, 82, 130, 131, 133, 170, 172, 173, 174, 175, 176, 177,
 178, 189, 556, 570, 573, and 589. In the event that no actionable level,
 tolerance level, or safe level for a chemical residue or pesticides residue has
 been established in 40 CFR Part 180 and 21 CFR Parts 70, 71, 73, 74, 80, 82,
 130, 131, 133, 170, 172, 173, 174, 175, 176, 177, 178, 189, 556, 570, 573, and
 589, the tolerance level shall be deemed to be zero; and 
 
 d. Aseptically processed and packaged milk and milk products
 milk shall not contain aflatoxin residues equal to or greater than 0.05 parts
 per billion;
 
 7. Grade A nonfat dry milk and dry milk or milk products shall
 comply with the following standards:
 
 a. The bacteria count shall not exceed 10,000 bacteria per
 gram, and
 
 b. The coliform count shall not exceed 10 coliform organisms
 per gram;
 
 8. Grade A whey for condensing or drying shall be maintained
 at a temperature of 45°F (7°C) or less, or 135°F (57°C) or greater; provided that,
 acid-type whey with a titratable acidity of 0.40% or above or a pH of 4.6 or
 below shall be exempt for the requirements of this subdivision;
 
 9. Grade A pasteurized condensed whey and whey products shall
 be cooled to 50°F (10°C) or less during crystallization and within 72 hours of
 condensing. The coliform count of grade A pasteurized condensed whey and whey
 products shall not exceed 10 coliform organisms per gram; and
 
 10. The coliform count of grade A dry whey, grade A dry whey
 products, grade A dry buttermilk, and grade A dry buttermilk products shall not
 exceed 10 coliform organisms per gram.
 
 B. Sanitation requirements for grade A raw milk. 
 
 1. Each person who holds a grade A permit to produce raw milk
 for pasteurization, ultra-pasteurization, aseptic processing and packaging, or
 retort processed after packaging shall comply with: 
 
 a. The following administrative procedures contained in the
 "Grade "A" Pasteurized Milk Ordinance, 2013 Revision":
 Section 4; Section 7, Items 1r, 2r, 3r, 4r, 5r, 6r, 7r, 8r, 9r, 10r(1), 10r(2),
 11r, 12r, 13r, 14r, 15r, 16r, 17r, 18r(2), 18r(3), and 19r; Section 8;
 Section 10; and Section 13; 
 
 b. The following appendices contained in the "Grade
 "A" Pasteurized Milk Ordinance, 2013 Revision": Appendices A, B,
 C, D, F, G, H, N, Q, and R; 
 
 c. Item 1r. Abnormal milk. Each person who holds a grade A
 permit to produce raw milk for pasteurization, ultra-pasteurization, aseptic
 processing and packaging, or retort processed after packaging shall: 
 
 (1) Milk last or with separate equipment cows, sheep, goats,
 water buffalo, or other mammals that show evidence of the secretion of abnormal
 milk in one or more quarters (based upon bacteriological, chemical, or physical
 examination) and discard the milk obtained from cows, sheep, goats, water
 buffalo, or other mammals that show evidence of the secretion of abnormal milk
 in one or more quarters based upon bacteriological, chemical, or physical
 examination; and 
 
 (2) Milk last or with separate equipment cows, sheep, goats,
 water buffalo, or other mammals treated with, or that have consumed, chemical,
 medicinal, or radioactive agents that are capable of being secreted in the milk
 and that may be deleterious to human health; and dispose of in a manner that
 will not pollute the environment or any human food the milk obtained from cows,
 sheep, goats, water buffalo, or other mammals treated with, or that have
 consumed, chemical, medicinal, or radioactive agents that are capable of being
 secreted in the milk and that may be deleterious to human health; 
 
 d. Item 2r. Milking barn, stable, or parlor; construction.
 Each person who holds a grade A permit to produce raw milk for pasteurization,
 ultra-pasteurization, aseptic processing and packaging, or retort processed
 after packaging shall: 
 
 (1) Provide on the person's dairy farm a milking barn, stable,
 or parlor in which the milking herd shall be housed during milking time; 
 
 (2) Provide on the grade A permit holder's dairy farm a
 milking barn, stable, or parlor, which milking barn, stable, or parlor shall: 
 
 (a) Have floors constructed of concrete or equally impervious
 material; 
 
 (b) Have walls and ceiling that are smooth, painted, or
 finished in an approved manner, and in good repair and have a ceiling which is
 dust tight; 
 
 (c) Have separate stalls or pens for horses, calves, and
 bulls; 
 
 (d) Have natural or artificial light, well distributed for day
 or night milking; 
 
 (e) Have sufficient air space and air circulation to prevent
 condensation and excessive odors; 
 
 (f) Have dust-tight covered boxes or bins, or separate storage
 facilities for ground, chopped, or concentrated feed; and 
 
 (g) Not be overcrowded; and
 
 (3) Provide and use only an "automatic milking
 installation" that complies with the requirements of Appendix Q of the
 "Grade "A" Pasteurized Milk Ordinance, 2013 Revision" if
 the person milks any cows, goats, sheep, water buffalo, or other mammals
 (except humans) using robots or other automated means in the absence of any
 human;
 
 e. Item 3r. Milking barn, stable, or parlor; cleanliness. Each
 person who holds a grade A permit to produce raw milk for pasteurization,
 ultra-pasteurization, aseptic processing and packaging, or retort processed
 after packaging shall: 
 
 (1) Keep the interior of the milking barn, stable, or parlor
 clean; 
 
 (2) Keep the floors, walls, ceilings, windows, pipelines, and
 equipment in the milking barn, stable, or parlor free of filth or litter and
 clean; 
 
 (3) Keep swine and fowl out of the milking barn, stable, and
 parlor; 
 
 (4) Keep surcingles, belly straps, milk stools, and
 antikickers clean and stored above the floor; and
 
 (5) Store feed in a manner that will not increase the dust
 content of the air or interfere with the cleaning of the floor;
 
 f. Item 4r. Cow yard, sheep yard, goat yard, water buffalo
 yard, or other milking mammal yard. Each person who holds a grade A permit to
 produce raw milk for pasteurization, ultra-pasteurization, aseptic processing
 and packaging, or retort processed after packaging shall:
 
 (1) Provide and maintain the cow yard, sheep yard, goat yard,
 water buffalo yard or other milking mammal yard, to be graded and drained, and
 to have no standing pools of water or accumulations of organic wastes; 
 
 (2) In the cow loafing, goat loafing, sheep loafing, water
 buffalo loafing, or other milking mammal loafing, cattle-housing, sheep-housing,
 goat-housing, water buffalo-housing, or other milking mammal-housing areas
 remove cow droppings, sheep droppings, goat droppings, water buffalo droppings,
 and other milking mammal droppings and remove soiled bedding or add clean
 bedding at sufficiently frequent intervals to prevent the soiling of the cow's,
 sheep's, goat's, water buffalo's, or other milking mammal's udder and flanks; 
 
 (3) Assure that waste feed does not accumulate in the goat
 yard, cow yard, sheep yard, water buffalo yard, other milking mammal yard, cow
 loafing, sheep loafing, goat loafing, water buffalo loafing, other milking
 mammal loafing, cattle-housing, sheep-housing, goat-housing, water
 buffalo-housing, or other milking mammal-housing area;
 
 (4) Maintain any manure packs so as to be properly drained and
 so as to provide a reasonably firm footing; and 
 
 (5) Keep swine and fowl out of the cow yard, sheep yard, goat
 yard, water buffalo yard, other milking mammal yard, cow loafing, sheep
 loafing, goat loafing, water buffalo loafing, other milking mammal loafing,
 cattle-housing, sheep-housing, goat-housing, water buffalo-housing, or other
 milking mammal-housing area;
 
 g. Item 5r. Milkhouse or room; construction and facilities.
 Each who holds a grade A permit to produce raw milk for pasteurization,
 ultra-pasteurization, aseptic processing and packaging, or retort processed
 after packaging shall: 
 
 (1) Provide a milkhouse or milkroom of sufficient size in
 which the cooling, handling, and storing of milk and the washing, sanitizing,
 and storing of milk containers and utensils shall be conducted except as
 provided under subdivision 1 n of this subsection;
 
 (2) Provide a milkhouse with a smooth floor, constructed of
 concrete or equally impervious material graded to drain, and maintained in good
 repair; 
 
 (3) Dispose of in a sanitary manner all liquid waste generated
 in the milkhouse; 
 
 (4) Provide one or more floor drains in the milkhouse, which
 floor drains shall be accessible, and if connected to a sanitary sewer system
 trapped; 
 
 (5) Provide in the milkhouse walls and ceilings constructed of
 a smooth material, in good repair, well painted, or finished in an equally
 suitable manner; 
 
 (6) Provide adequate natural or artificial light and
 ventilation in the milkhouse; 
 
 (7) Use the milkhouse for no other purpose than milkhouse
 operations; 
 
 (8) Provide no direct opening from the milkhouse into any
 barn, stable, or into any room used for domestic purposes, other than a direct
 opening between the milkhouse and milking barn, stable, or parlor provided with
 a tight-fitting, self-closing, solid door, which door has been hinged to be
 single or double acting. Screened vents in the wall between the milkhouse and a
 breezeway, which separates the milkhouse from the milking parlor, are
 permitted, provided animals are not housed within the milking facility; 
 
 (9) Provide in the milkhouse water under pressure which has
 been piped into the milkhouse; 
 
 (10) Provide in the milkhouse a two-compartment wash vat and
 adequate hot water heating facilities;
 
 (11) Except as provided for under subdivision 1 g (12) of this
 subsection provide a suitable shelter for the receipt of milk when the grade A
 permit holder uses a transportation tank for the cooling or storage of milk on
 the grade A permit holder's dairy farm, which shelter adjacent to, but not a
 part of, the milkroom; and with the requirements of the milkroom shall comply
 with respect to construction, light, drainage, insect and rodent control, and
 general maintenance. In addition to providing a suitable shelter as required by
 this subsection, the grade A permit holder shall:
 
 (a) Install an accurate, accessible temperature-recording
 device in the milk line used to fill the transportation tank downstream from an
 effective cooling device capable of cooling the milk to 40°F or less before the
 milk enters the transportation tank. Electronic records that comply with the
 applicable provisions as referred to in Sections IV and V of Appendix H of the
 "Grade "A" Pasteurized Milk Ordinance, 2013 Revision," with
 or without hard copy, may be used in place of temperature-recording records;
 
 (b) Install an indicating thermometer as close as possible to
 the temperature-recording device in the milk line used to fill the
 transportation tank to be used for verification of recording temperatures,
 which indicating thermometer shall:
 
 (i) Have a temperature span of not less than 50°F including
 normal storage temperatures plus or minus 5°F, with an extension of the scale
 on either side permitted and graduated in not more than 2°F divisions;
 
 (ii) Have temperature scale divisions spaced not less than
 0.0625 inches apart between 35°F and 55°F;
 
 (iii) Have an accuracy within plus or minus 2°F throughout the
 scale range; and
 
 (iv) Have the stem fitting installed in a pressure-tight seat
 or other sanitary fitting with no threads exposed;
 
 (c) Provide an effective means to agitate the transport tank
 or an approved in-line sampling device in order to collect a representative
 milk sample;
 
 (12) If the State Regulatory Authority determines conditions
 exist whereby the milk transport tank may be adequately protected and sampled
 without contamination, a shelter need not be provided if the grade A permit
 holder:
 
 (a) Provides a means to make all milk hose connections to the
 transport tank accessible from within the milkhouse;
 
 (b) Provides a means to completely protect the milk hose
 connection to the transport tank from the outside environment. With approval of
 the State Regulatory Authority, the direct loading of milk from the milkhouse
 to the milk tank truck may be conducted through a properly designed hose port
 that adequately protects the milkhouse opening or by stubbing the milk transfer
 and associated CIP cleaned lines outside the milkhouse wall in accordance with
 Item 5r, Administrative Procedure #15, of the "Grade "A"
 Pasteurized Milk Ordinance, 2013 Revision";
 
 (c) Ensures only milk transport tanks the manholes of which
 have been sealed after cleaning and sanitizing are utilized;
 
 (d) Ensures only milk transport tanks that have been washed
 and sanitized at permitted dairy plants or a permitted milk tank truck cleaning
 facilities acceptable to the State Regulatory Agency are utilized;
 
 (e) Installs an accurate, accessible temperature-recording
 device in the milk line used to fill the transportation tank downstream from an
 effective cooling device capable of cooling the milk to 40°F or less before the
 milk enters the transportation tank. Electronic records that comply with the
 applicable provisions as referred to in Sections IV and V of Appendix H of the
 "Grade "A" Pasteurized Milk Ordinance, 2013 Revision," with
 or without hard copy, may be used in place of temperature-recording records;
 
 (f) Installs an indicating thermometer as close as possible to
 the temperature-recording device in the milk line used to fill the transportation
 tank to be used for verification of recording temperatures, which indicating
 thermometer shall:
 
 (i) Have a temperature span of not less than 50°F including
 normal storage temperatures plus or minus 5°F, with an extension of the scale
 on either side permitted and graduated in not more than 2°F divisions;
 
 (ii) Have temperature scale divisions spaced not less than
 0.0625 inches apart between 35°F and 55°F;
 
 (iii) Have an accuracy within plus or minus 2°F throughout the
 scale range; and
 
 (iv) Have the stem fitting installed in a pressure-tight seat
 or other sanitary fitting with no threads exposed;
 
 (g) Provides an effective means to agitate the transport tank
 or an approved in-line sampling device in order to collect a representative
 milk sample; and
 
 (h) Provides a self-draining concrete or equally impervious
 surface on which the transport tank can be parked during filling and storage;
 
 h. Item 6r. Milkhouse or milkroom; cleanliness. Each person
 who holds a grade A permit to produce raw milk for pasteurization,
 ultra-pasteurization, aseptic processing and packaging, or retort processed
 after packaging shall: 
 
 (1) Keep clean the floors, walls, ceilings, windows, tables,
 shelves, cabinets, wash vats, nonproduct contact surfaces of milk containers,
 utensils, equipment, and other milkroom equipment in the milkroom; 
 
 (2) Place in the milkroom only those articles directly related
 to milkroom activities; and 
 
 (3) Keep the milkroom free of trash, animals, and fowl;
 
 i. Item 7r. Toilets. Each person who holds a grade A permit to
 produce raw milk for pasteurization, ultra-pasteurization, aseptic processing
 and packaging, or retort processed after packaging shall: 
 
 (1) Provide on the person's grade A dairy farm one or more
 toilets, which shall be conveniently located and properly constructed, and
 operated, and maintained in a sanitary manner; 
 
 (2) Prevent the access of flies to the waste contained in or
 from the toilet; 
 
 (3) Prevent the waste contained in or from the toilet from
 polluting the soil surface or contaminating any water supply; and 
 
 (4) Assure that there is no direct opening from the toilet
 into any milkroom;
 
 j. Item 8r. Water supply. Each person who holds a grade A
 permit to produce raw milk for pasteurization, ultra-pasteurization, aseptic
 processing and packaging, or retort processed after packaging shall: 
 
 (1) Provide water for milkhouse and milking operations from a
 water supply properly located, protected, and operated. The water supply shall
 be easily accessible, adequate, of a safe, sanitary quality, and meet the
 construction standards of Appendix D of the "Grade "A"
 Pasteurized Milk Ordinance, 2013 Revision"; 
 
 (2) Construct the water supply so that no cross connections
 between a safe water supply and any unsafe or questionable water supply or
 other source of pollution exists; and
 
 (3) Construct the water supply so that no submerged inlets
 exist through which a safe water supply may be contaminated;
 
 k. Item 9r. Utensils and equipment-construction. Each person
 who holds a grade A permit to produce raw milk for pasteurization,
 ultra-pasteurization, aseptic processing and packaging, or retort processed
 after packaging shall: 
 
 (1) Provide multiuse containers, equipment, and utensils for
 use in the handling, storage, or transportation of any milk, which multiuse containers,
 equipment, and utensils, shall be made of smooth, nonabsorbent,
 corrosion-resistant, and nontoxic materials; constructed as to be easily
 cleaned; and maintained in good repair; 
 
 (2) Provide milk pails that are constructed to be seamless and
 of the hooded type if the grade A permit holder does hand milking and
 stripping; 
 
 (3) Abstain from using multiple-use woven material for
 straining any milk; 
 
 (4) Use only single-service articles that have been
 manufactured, packaged, transported, stored, and handled in a sanitary manner
 and that comply with the requirements of subdivision C 1 of this section; 
 
 (5) Abstain from reusing any article intended for
 single-service use; and 
 
 (6) Provide farm holding or cooling tanks, welded sanitary
 piping, and transportation tanks that comply with the requirements of
 subdivisions C 1 l and C 1 m of this section on any grade A dairy farm; 
 
 l. Item 10r. Utensils and equipment; cleaning. Each person who
 holds a grade A permit to produce raw milk for pasteurization,
 ultra-pasteurization, aseptic processing and packaging, or retort processed
 after packaging shall: 
 
 (1) Clean after each use, or once every 24 hours in the case
 of continuous operations, the product-contact surfaces of all multiuse
 containers, multiuse equipment, and multiuse utensils used in the handling,
 storage, or transportation of any milk; 
 
 (2) Offer for sale or sell no milk that has passed through any
 equipment if the milk-contact surfaces of the equipment are no longer visible
 or are covered or partially covered by an accumulation of milk solids, milk
 fat, cleaning compounds, or other soils. Any milk that passes through
 equipment, the milk-contact surfaces of which are no longer visible, or are
 covered or partially covered by an accumulation of milk solids, milk fat,
 cleaning compounds, or other soils shall be deemed adulterated; and
 
 (3) Construct a separate wash manifold for all CIP cleaned
 milk pipelines in all new or extensively remodeled facilities;
 
 m. Item 11r. Utensils and equipment; sanitization. Each person
 who holds a grade A permit to produce raw milk for pasteurization,
 ultra-pasteurization, aseptic processing and packaging, or retort processed
 after packaging shall sanitize before each use the product-contact surfaces of
 all multiuse containers, equipment, and utensils used in the handling, storage,
 or transportation of any milk; 
 
 n. Item 12r. Utensils and equipment; storage. Each person who
 holds a grade A permit to produce raw milk for pasteurization,
 ultra-pasteurization, aseptic processing and packaging, or retort processed
 after packaging shall store containers, utensils, and equipment used in the
 handling, storage, or transportation of any milk in a sanitizing solution or
 store the containers, utensils, and equipment used in the handling, storage, or
 transportation of any milk to assure complete drainage, and protected from
 contamination prior to use. Nothing in this requirement shall be deemed to
 prohibit a grade A permit holder from storing in a milking barn or milking
 parlor a milk pipeline, or the following pipeline milking equipment: milker
 claw, inflation, weigh jar, meter, milk hose, milk receiver, tubular cooler,
 plate cooler, or milk pump; if the milk pipeline or pipeline milking equipment
 specified in this subdivision is designed for mechanical cleaning; and
 designed, installed, and operated to protect the milk product and
 solution-contact surfaces from contamination at all times; 
 
 o. Item 13r. Milking; flanks, udders, and teats. Each person
 who holds a grade A permit to produce raw milk for pasteurization,
 ultra-pasteurization, aseptic processing and packaging, or retort processed
 after packaging shall:
 
 (1) Milk all cows, sheep, goats, water buffalo, and other
 mammals in a milking barn, stable, or parlor;
 
 (2) Trim the hair from the udder and tail of all milking cows,
 sheep, goats, water buffalo, and other mammals to facilitate cleaning of the
 udder and tail;
 
 (3) Keep the flanks, udders, bellies, and tails of all milking
 cows, sheep, goats, water buffalo, and other mammals free of visible dirt;
 
 (4) Keep the hair on the udders of all milking cows, sheep,
 goats, water buffalo, and other mammals to a length that the hair on the udder
 of any cow, sheep, goat, water buffalo, or other mammal cannot be incorporated
 with the teat in the inflation during milking;
 
 (5) Abstain from milking any cow, sheep, goat, water buffalo,
 or other mammal whose udder or teats is not clean and dry;
 
 (6) Treat with a sanitizing solution, just prior to milking,
 the teats of each milking cow, sheep, goat, water buffalo, and other mammal and
 dry the teats of each milking cow, sheep, goat, water buffalo, and other mammal
 before milking; and
 
 (7) Milk all cows, sheep, goats, water buffalo, and other
 mammal with dry hands;
 
 p. Item 14r. Protection from contamination. Each person who
 holds a grade A permit to produce raw milk for pasteurization,
 ultra-pasteurization, aseptic processing and packaging, or retort processed
 after packaging shall:
 
 (1) Locate and operate the milking and milk house operations,
 equipment, and facilities to prevent any contamination of the milk, equipment,
 containers, or utensils;
 
 (2) Transfer immediately from the milking barn, stable, or
 parlor to the milkhouse each pail or container of milk;
 
 (3) Strain, pour, transfer, or store any milk unless it is
 protected from contamination; 
 
 (4) Handle all containers, utensils and equipment that have
 been sanitized in such a manner as to prevent contamination of any
 product-contact surfaces;
 
 (5) Transport from the grade A permit holder's dairy farm to a
 milk plant or receiving station all milk in cans, using vehicles that are
 constructed and operated to protect the milk from sun, freezing, and
 contamination;
 
 (6) Keep clean the inside and outside of each vehicle used to
 transport from the grade A permit holder's dairy farm to a milk plant or
 receiving station any milk in cans; and
 
 (7) Transport no substance capable of contaminating the milk
 when transporting milk;
 
 q. Item 15r. Drug and chemical control. Each person who holds
 a grade A permit to produce raw milk for pasteurization, ultra-pasteurization,
 aseptic processing and packaging, or retort processed after packaging shall:
 
 (1) Store all drugs and medicinals in such a manner that
 neither the drugs nor the medicinals can contaminate any milk or the milk
 product-contact surface of any equipment, containers, or utensils;
 
 (2) Abstain from using unapproved or improperly labeled
 medicinals or drugs to treat any dairy animals or store unapproved or
 improperly labeled medicinals or drugs in the milkhouse, milking barn, stable
 or parlor. Except for topical antiseptics, wound dressings (unless intended for
 direct injection into the teat), vaccines and other biologics, and dosage form
 vitamins and mineral products, a drug or medicinal is properly labeled only if
 the drug or medicinal is labeled with the following:
 
 (a) For over-the-counter medicinals or drugs, the name and
 address of the manufacturer or distributor, or for prescription and extra-label
 use medicinals or drugs, the name of the veterinary practitioner dispensing the
 product;
 
 (b) Directions for use of the drug or medicinal and the
 prescribed holding time;
 
 (c) Any cautionary statement for the drug or medicinal, if
 needed; and
 
 (d) The active ingredient or ingredients in the drug or
 medicinal;
 
 (3) Except for topical antiseptics, wound dressings (unless
 intended for direct injection into the teat), vaccines and other biologics, and
 dosage form vitamins and mineral products, segregate all medicinals and drugs
 used for lactating dairy animals from any medicinals and drugs used for
 nonlactating dairy animals to include dairy calves, dairy heifers, and dairy
 bulls;
 
 (4) Except for topical antiseptics, wound dressings (unless
 intended for direct injection into the teat), vaccines and other biologics, and
 dosage form vitamins and mineral products, provide separate shelves in a
 cabinet, refrigerator, or other storage facility for the storage of all
 medicinals and drugs for treatment of nonlactating dairy animals, to include
 dairy calves, dairy heifers, and dairy bulls, separate from those medicinals or
 drugs used for lactating dairy animals; and
 
 (5) Store topical antiseptics, wound dressings (unless
 intended for direct injection into the teat), vaccines and other biologics, and
 dosage-form vitamins and mineral products in a manner that does not contaminate
 any milk or the milk-product surfaces of any containers or utensils;
 
 r. Item 16r. Personnel; hand-washing facilities. Each person
 who holds a grade A permit to produce raw milk for pasteurization,
 ultra-pasteurization, aseptic processing and packaging, or retort processed
 after packaging shall provide hand-washing facilities that are convenient to
 the milkhouse, milking barn, stable, or parlor, and flush toilet and that
 include separate hot and cold running water; soap or detergent; and individual
 sanitary towels or other approved hand-drying devices. When individual sanitary
 towels are used, covered trash containers shall be provided; 
 
 s. Item 17r. Personnel; cleanliness. Each person who holds a
 grade A permit to produce raw milk for pasteurization, ultra-pasteurization,
 aseptic processing and packaging, or retort processed after packaging shall: 
 
 (1) Wash clean and dry with an individual sanitary towel or other
 approved hand drying device the person's hands immediately before milking,
 before performing any milkhouse function, and immediately after the
 interruption of milking or performing any milkhouse function; and 
 
 (2) Wear clean outer garments while milking or handling any
 milk, milk containers, utensils, or equipment. Bulk milk haulers shall wear
 clean outer garments while handling any milk, milk containers, utensils, or
 equipment; 
 
 t. Item 18r. Cooling. Each person who holds a grade A permit
 to produce raw milk for pasteurization, ultra-pasteurization, aseptic
 processing and packaging, or retort processed after packaging shall: 
 
 (1) Cool to 40°F or cooler (but not freeze) all raw milk for
 pasteurization, ultra-pasteurization, aseptic processing and packaging, or
 retort processed after packaging within two hours after the grade A permit
 holder completes milking and assure that the temperature of the grade A permit
 holder's raw milk is not warmer than 50°F after the first milking or any
 subsequent milking. Raw milk for pasteurization that is warmer than a
 temperature of 50°F after the first milking or any subsequent milking shall be
 deemed a public health hazard and shall not be offered for sale or sold; 
 
 (2) Assure that circular recording charts are operated
 continuously and maintained in a properly functioning manner. Circular charts
 shall not overlap; and 
 
 (3) Agitate all raw milk for pasteurization for not less than
 five minutes at least once every hour; assure that the milk in the farm's bulk
 milk cooling or holding tank covers the agitator paddle sufficiently to
 facilitate proper cooling and sampling after the completion of the first
 milking; and abstain from selling or offering for sale milk that does not cover
 the agitator paddle sufficiently to facilitate proper cooling and sampling
 after the completion of the first milking; 
 
 u. Item 19r. Insect and rodent control. Each person who holds
 a grade A permit to produce raw milk for pasteurization, ultra-pasteurization,
 aseptic processing and packaging, or retort processed after packaging shall: 
 
 (1) Take effective measures to prevent the contamination of
 any milk, containers, equipment, and utensils by insects, rodents, and other
 animals, and by chemicals used to control insects, rodents, and other animals; 
 
 (2) Maintain the milkroom free of insects, rodents and other
 animals; 
 
 (3) Keep the areas surrounding the milkhouse; milking barn;
 milking stable; milking parlor; cattle, sheep, water buffalo, other mammal, or
 goat housing; cattle, sheep, water buffalo, other mammal, or goat loafing area;
 water supply; or other facilities on the grade A permit holder's dairy farm
 neat, clean, and free of conditions that might harbor or be conducive to the
 breeding of insects and rodents; and
 
 (4) Store all feed in such a manner that the feed will not
 attract birds, rodents, or insects.
 
 C. Sanitation requirements for grade A pasteurized,
 ultra-pasteurized, aseptically processed and packaged, or retort processed
 after packaged milk or milk products. 
 
 1. Each person who holds a grade A permit to produce grade A
 pasteurized, ultra-pasteurized, aseptically processed and packaged, or retort
 processed after packaged milk or milk products shall comply with: 
 
 a. The following administrative procedures contained in the
 "Grade "A" Pasteurized Milk Ordinance, 2013 Revision":
 Section 7, Items 1p, 2p, 3p, 4p, 5p, 6p, 7p, 8p, 9p, 10p, 11p, 12p, 13p, 14p,
 15p, 16p, 17p, 18p, 19p, 20p, 21p, and 22p (provided in the case of milk plants
 or portions of milk plants that are IMS Listed to produce aseptically processed
 and packaged milk or milk products, the APPS or RPPS, respectively, as defined
 in the "Grade "A" Pasteurized Milk Ordinance, 2013
 Revision," shall be exempt from Items 7p, 10p, 11p, 12p, 13p, 15p, 16p,
 17p, 18p, and 19p of the "Grade "A" Pasteurized Milk Ordinance,
 2013 Revision" and shall comply with the applicable portions of 21 CFR
 Parts 108, 110, and 113); Section 13; and Section 14;
 
 b. The following appendices contained in the "Grade
 "A" Pasteurized Milk Ordinance, 2013 Revision": Appendices D, F,
 G, H, I, J, K, L, N, O, R, and S;
 
 c. Item 1p. Floors; construction. Each person who holds a
 grade A permit to produce grade A pasteurized, ultra-pasteurized, aseptically
 processed and packaged, or retort processed after packaged milk or milk
 products shall: 
 
 (1) Except as specified in subdivision C 1 c (2) of this
 section, provide floors for all rooms in which milk or milk products are
 processed, handled, packaged, or stored, or in which milk containers,
 equipment, or utensils are washed, constructed of concrete or other equally
 impervious and easily cleaned material and that are smooth, properly sloped,
 provided with trapped drains, and kept in good repair; 
 
 (2) The floor in any cold-storage room used for storing milk
 and milk products need not be provided with floor drains if the floors are
 sloped to drain to one or more exits from the cold-storage room. The floor in
 any storage room used for storing dry ingredients or packaging materials need
 not be provided with drains, and the floor in any storage room used for storing
 dry ingredients or packaging materials may be constructed of tightly joined
 wood; 
 
 d. Item 2p. Walls and ceilings; construction. Each person who
 holds a grade A permit to produce grade A pasteurized, ultra-pasteurized, aseptically
 processed and packaged, or retort processed after packaged milk or milk
 products shall provide walls and ceilings of rooms in which milk or milk
 products are handled, processed, packaged, or stored, or in which milk
 containers, utensils, or equipment are washed, that have a smooth, washable,
 light-colored surface, and that are in good repair; 
 
 e. Item 3p. Doors and windows. Each person who holds a grade A
 permit to produce grade A pasteurized, ultra-pasteurized, aseptically processed
 and packaged, or retort processed after packaged milk or milk products shall
 provide: 
 
 (1) Effective means to prevent the access of insects and
 rodents to any part of a milk plant, receiving station, or transfer station;
 and 
 
 (2) Solid doors or glazed windows for all openings to the
 outside of any milk plant, receiving station, or transfer station and keep the
 doors and windows closed during dusty weather; 
 
 f. Item 4p. Lighting and ventilation. Each person who holds a
 grade A permit to produce grade A pasteurized, ultra-pasteurized, aseptically
 processed and packaged, or retort processed after packaged milk or milk
 products shall provide rooms in which any milk or milk products are handled,
 processed, packaged, or stored, or in which any milk containers, equipment, or
 utensils are washed, that are well lighted and well ventilated; 
 
 g. Item 5p. Separate rooms. Each person who holds a grade A
 permit to produce grade A pasteurized, ultra-pasteurized, aseptically processed
 and packaged, or retort processed after packaged milk or milk products shall: 
 
 (1) Provide separate rooms for: (i) pasteurizing, processing,
 cooling, reconstituting, condensing, drying, and packaging of milk, dry milk,
 and milk products; (ii) cleaning milk cans, containers, bottles, cases, and dry
 milk or dry milk product containers; (iii) the fabrication of containers and
 closures for milk and milk products, except for aseptically processed and packaged
 milk and milk products, or retort processed after packaging milk and milk
 products in which the containers and closures are fabricated within the APPS or
 RPPS, respectively; (iv) cleaning and sanitizing facilities for bulk milk
 transport tanks if the grade A permit holder receives any milk or milk product
 in bulk milk transport tanks; and (v) receiving cans of milk and milk products
 separate from clauses (i), (ii) and (iii) of this subdivision, unless all of
 the grade A permit holder's milk or milk products are received in bulk milk
 transport tanks; 
 
 (2) Not use any room with a direct opening into any stable or
 room used for domestic purposes to handle, process, or store any milk or milk
 products or to wash or store any milk containers, utensils, or equipment; 
 
 (3) Use rooms of sufficient size so as not to be crowded to
 handle, process, or store any milk or milk products or to wash or store any
 milk containers, utensils, or equipment; and
 
 (4) Provide designated areas or rooms for the receiving,
 handling, and storage of returned packaged milk and milk products if the permit
 holder receives any returned packaged milk or milk products;
 
 h. Item 6p. Toilet-sewage disposal facilities. Each person who
 holds a grade A permit to produce grade A pasteurized, ultra-pasteurized,
 aseptically processed and packaged, or retort processed after packaged milk or
 milk products shall provide each milk plant with toilet facilities conforming
 with the regulations of the Commonwealth and the following requirements: no
 toilet room may open directly into any room in which milk or milk products are
 processed; the toilet room shall be completely enclosed and shall have
 tight-fitting, self-closing doors; the dressing room, toilet room, and fixtures
 shall be kept in a clean condition, in good repair, and shall be well
 ventilated and well lighted; and sewage and other liquid wastes from the toilet
 room shall be disposed of in a sanitary manner; 
 
 i. Item 7p. Water supply. Each person who holds a grade A
 permit to produce grade A pasteurized, ultra-pasteurized, aseptically processed
 and packaged, or retort processed after packaged milk or milk products shall: 
 
 (1) Provide water for each milk plant from a supply that is
 properly located, protected, and operated; and 
 
 (2) Provide water from a supply that is easily accessible for
 inspection by the State Regulatory Authority, adequate, and of a safe, sanitary
 quality; 
 
 j. Item 8p. Hand-washing facilities. Each person who holds a
 grade A permit to produce grade A pasteurized, ultra-pasteurized, aseptically
 processed and packaged, or retort processed after packaged milk or milk
 products shall: 
 
 (1) Provide hand-washing facilities, including separate hot
 and cold running water, mix valve, soap, and individual sanitary towels or
 other approved hand-drying devices, convenient in any area where milk or milk
 products are handled, processed, or stored, and any area where containers,
 utensils, or equipment, are washed or stored; and 
 
 (2) Keep the hand-washing facilities clean and in good repair;
 
 
 k. Item 9p. Milk plant cleanliness. Each person who holds a
 grade A permit to produce grade A pasteurized, ultra-pasteurized, aseptically
 processed and packaged, or retort processed after packaged milk or milk
 products shall: 
 
 (1) Keep clean, neat, and free of any evidence of animals,
 insects, or rodents all rooms in which milk or milk products are handled,
 processed, or stored or in which containers, utensils, or equipment are washed
 or stored; and
 
 (2) Permit only equipment directly related to processing
 operations or to the handling of containers, utensils, and equipment, in
 pasteurizing, processing, cooling, condensing, drying, packaging, bulk milk, or
 milk product storage rooms; 
 
 l. Item 10p. Sanitary piping. Each person who holds a grade A
 permit to produce grade A pasteurized, ultra-pasteurized, aseptically processed
 and packaged, or retort processed after packaged milk or milk products shall: 
 
 (1) Use only sanitary piping, fittings, and connections
 consisting of smooth, impervious corrosion-resistant, nontoxic, easily
 cleanable materials that are exposed to any milk or milk products, or from
 which liquids may drip, drain, or be drawn into any milk or milk products; 
 
 (2) Keep all piping in good repair; 
 
 (3) Except as specified in subdivision 1 l of this subsection,
 use only sanitary piping to transfer any pasteurized or ultra-pasteurized milk
 or milk products from one piece of equipment to another piece of equipment; and
 
 
 (4) Transport cottage cheese, cheese dressings, or cheese
 ingredients by methods that protect the product from contamination; 
 
 m. Item 11p. Construction and repair of containers and
 equipment. Each person who holds a grade A permit to produce grade A
 pasteurized, ultra-pasteurized, aseptically processed and packaged, or retort
 processed after packaged milk or milk products shall: 
 
 (1) Use only multiuse containers and equipment, that may come
 in contact with any milk or milk products constructed of smooth, impervious,
 corrosion-resistant, and nontoxic materials; constructed for ease of cleaning; and
 kept in good repair; 
 
 (2) Use only single-service containers, closures, gaskets, and
 other articles that may come in contact with any milk or milk products that are
 nontoxic and have been manufactured, packaged, transported, and handled in a
 sanitary manner; 
 
 (3) Abstain from using more than once any articles intended
 for single-service use; and 
 
 (4) Use only single-service containers, closures, caps,
 gaskets, and similar articles manufactured, packed, transported, and handled in
 a manner that complies with the requirements of Appendix J, "Standards for
 the Fabrication of Single-Service Containers and Closures for Milk and Milk
 Products" contained in the "Grade "A" Pasteurized Milk
 Ordinance, 2013 Revision";
 
 n. Item 12p. Cleaning and sanitizing of containers and
 equipment. Each person who holds a grade A permit to produce grade A
 pasteurized, ultra-pasteurized, aseptically processed and packaged, or retort
 processed after packaged milk or milk products shall: 
 
 (1) Effectively clean and sanitize before each use the
 product-contact surfaces of all multiuse containers and equipment, utensils,
 and equipment used in the transportation, processing, handling, and storage of
 any milk or milk products; 
 
 (2) Use only multiuse containers for packaging pasteurized milk
 and milk products that comply with the following: (i) the residual bacteria
 count on multiuse containers may not exceed one per milliliter of capacity when
 the rinse test is used, or the residual bacteria count on multiuse containers
 shall not exceed 50 colonies per eight square inches (one per square
 centimeter) of product-contact surface when the swab test is used; in
 three-out-of-four samples taken at random on a given day; and (ii) all multiuse
 containers shall be free of coliform organisms; and 
 
 (3) Use only single-service containers for packaging
 pasteurized milk and milk products that comply with the following: (i) the
 residual bacteria count of single-service containers shall not exceed 50 per
 container when the rinse test is used, except that in containers less than 100
 milliliters, the count shall not exceed 10, or the residual bacteria count of
 single-service containers shall not exceed 50 colonies per eight square inches
 (one per square centimeter) of product contact surface when the swab test is
 used; in three-out-of-four samples taken at random on a given day; and (ii) all
 single-service containers shall be free of coliform organisms; 
 
 o. Item 13p. Storage of cleaned containers and equipment. Each
 person who holds a grade A permit to produce grade A pasteurized,
 ultra-pasteurized, aseptically processed and packaged, or retort processed
 after packaged milk or milk products, shall after cleaning any multiuse milk or
 milk product containers, utensils, or equipment, transport or store the multiuse
 milk or milk product containers, utensils, or equipment in a manner that
 assures complete drainage and in a manner that protects the multiuse milk or
 milk product containers, utensils, or equipment from contamination before use; 
 
 p. Item 14p. Storage of single-service containers, utensils,
 and materials. Each person who holds a grade A permit to produce grade A
 pasteurized, ultra-pasteurized, aseptically processed and packaged, or retort
 processed after packaged milk or milk products shall: 
 
 (1) Purchase all single-service caps, cap stock, parchment
 paper, containers, gaskets, and other single-service articles for use in
 contact with milk or milk products in sanitary tubes, wrappings, or cartons; 
 
 (2) Store in a clean dry place until used, single-service caps,
 cap stock, parchment paper, containers, gaskets, and other single-service
 articles for use in contact with milk or milk products; 
 
 (3) Store single-service caps, cap stock, parchment paper,
 containers, gaskets, and other single-service articles for use in contact with
 milk or milk products in sanitary tubes, wrappings, or cartons; and 
 
 (4) Handle single-service caps, cap stock, parchment paper,
 containers, gaskets, and other single-service articles for use in contact with
 milk or milk products in a sanitary manner; 
 
 q. Item 15p. Protection from contamination. Each person who
 holds a grade A permit to produce grade A pasteurized, ultra-pasteurized,
 aseptically processed and packaged, or retort processed after packaged milk or
 milk products shall: 
 
 (1) Locate the person's equipment and facilities and conduct
 milk plant operations to prevent any contamination of any milk or milk
 products, ingredients, equipment, containers, or utensils; 
 
 (2) Discard all milk, milk products, or ingredients that have
 been spilled, overflowed, or leaked; 
 
 (3) Perform the processing and handling of products other than
 grade A milk and milk products in the person's milk plant to preclude the
 contamination of any grade A milk or milk products; 
 
 (4) Store, handle, or use any poisonous or toxic material to
 preclude the contamination of any milk, milk product, or ingredient and the
 milk product contact surfaces of all equipment, containers, or utensils; and 
 
 (5) Clean, prior to use, all multiuse cases used to encase
 packaged milk or milk product containers; 
 
 r. Item 16p. Pasteurization and ultra-pasteurization. Each
 person who holds a grade A permit to produce grade A pasteurized,
 ultra-pasteurized, aseptically processed and packaged, or retort processed
 after packaged milk or milk products shall:
 
 (1) Perform pasteurization or ultra-pasteurization as defined
 in 2VAC5-490-10, and Item 16p of the "Grade "A" Pasteurized Milk
 Ordinance, 2013 Revision"; and
 
 (2) Perform aseptic processing and packaging and retort
 processed after packaging in accordance with the applicable requirements of 21
 CFR Parts 108, 110, and 113;
 
 s. Item 17p. Cooling of milk. Each person who holds a grade A
 permit to produce grade A pasteurized, ultra-pasteurized, aseptically processed
 and packaged, or retort processed after packaged milk or milk products shall: 
 
 (1) Maintain all raw milk and milk products at a temperature
 of 45°F or cooler, but not frozen, until processed; 
 
 (2) Maintain all whey and whey products for condensing,
 drying, or condensing and drying at a temperature of 45°F (7°C) or cooler; or
 135°F (57°C) or greater until processed, except that acid-type whey with a
 titratable acidity of 0.40% or above, or a pH of 4.6 or below, is exempted from
 these temperature requirements;
 
 (3) Completely empty and clean the tanks and vessels used to
 blend and hold all milk or milk product flavoring slurries that contain milk
 and milk products after each four hours of operation or less if such tanks are
 not intended to be injected within a HTST pasteurization system as part of a
 liquid ingredient injection system as outlined in Appendix H of the "Grade
 "A" Pasteurized Milk Ordinance, 2013 Revision" or unless the
 slurry is stored at a temperature of 45°F (7°C) or cooler, or at a temperature
 of 150°F (66°C) or greater and maintained thereat;
 
 (4) Immediately cool, except for the following milk or milk
 products, all pasteurized or ultra-pasteurized milk or milk products prior to
 filling or packaging in approved cooling equipment to a temperature of 45°F or
 cooler, but not frozen, unless drying is commenced immediately after
 condensing:
 
 (a) Those milk or milk products to be cultured;
 
 (b) Cultured sour cream at all milkfat levels with a pH of
 4.70 or below;
 
 (c) Acidified sour cream at all milkfat levels with a pH of
 4.60 or below;
 
 (d) All yogurt products at all milkfat levels with an initial
 pH of 4.80 or below at filling;
 
 (e) Cultured buttermilk at all milkfat levels with a pH of
 4.60 or below; 
 
 (f) All condensed whey and whey products shall be cooled
 during the crystallization process to 50°F (10°C) or less within 72 hours of
 condensing, including the filling and emptying time, unless filling occurs
 above 135°F (57°C), in which case, the 72-hour time period begins when cooling
 started; and
 
 (g) All cultured cottage cheese at all milkfat levels with a
 pH of 5.2 or below shall be cooled as per specifications of Item 17p (6a-6e) of
 the "Grade "A" Pasteurized Milk Ordinance, 2013 Revision";
 
 (5) Store, transport, and deliver at a temperature of 45°F or
 cooler, but not frozen, all pasteurized or ultra-pasteurized milk or milk
 products with the following exceptions:
 
 (a) Cultured sour cream at all milkfat levels with a pH of
 4.70 or below shall be cooled to 45°F (7°C) or cooler within 168 hours of
 filling;
 
 (b) Acidified sour cream at all milkfat levels with a pH of
 4.60 or below shall be cooled to 45°F (7°C) or cooler within 168 hours of
 filling;
 
 (c) All yogurt products at all milkfat levels with an initial
 pH of 4.80 or below at filling and with a subsequent pH of 4.60 or below within
 24 hours after filling shall be cooled to 45°F (7°C) or cooler within 96 hours
 after filling; 
 
 (d) Cultured buttermilk at all milkfat levels with a pH of
 4.60 or below shall be cooled to 45°F (7°C) or cooler within 24 hours after
 filling; and
 
 (e) Cultured cottage cheese at all milkfat levels with a pH of
 5.2 or below shall be stored as per specifications of item 17p (5a-5d) of the
 "Grade "A" Pasteurized Milk Ordinance, 2013 Revision";
 
 (6) Store all pasteurized milk and milk products to be
 condensed, dried, or condensed and dried at a temperature of 50°F (10°C) or
 cooler until further processed;
 
 (7) Equip with an accurate indicating thermometer each of the
 rooms or tanks in which any milk, milk products, whey, or whey products are
 stored; 
 
 (8) Maintain the temperature on delivery vehicles of milk and
 milk products at 45°F (7°C) or cooler. Aseptically processed and packaged milk
 and milk products and retort processed after packaged milk and milk products to
 be packaged in hermetically sealed containers shall be exempt from the cooling
 requirements of this item; and
 
 (9) Provide ready access at the plant to cleaning records and
 product storage temperature records stored electronically for review by the
 State Regulatory Authority. Electronic records of cleaning shall comply with
 the applicable provisions of Appendix H, Sections IV and V of the "Grade
 "A" Pasteurized Milk Ordinance, 2013 Revision"; 
 
 t. Item 18p. Bottling and packaging. Each person who holds a
 grade A permit to produce grade A pasteurized, ultra-pasteurized, aseptically
 processed and packaged, or retort processed after packaged milk or milk
 products shall: 
 
 (1) Bottle or package all milk or milk products at the place
 of pasteurization in the grade A permit holder's milk plant and in approved
 mechanical equipment; 
 
 (2) Package and store in a sanitary manner all dry milk
 products in new containers, which protect the contents from contamination; and
 
 (3) Transport and store in a sanitary manner all condensed and
 dry milk products in sealed containers from one milk plant to another milk
 plant for further processing or packaging; 
 
 u. Item 19p. Capping. Each person who holds a grade A permit
 to produce grade A pasteurized, ultra-pasteurized, aseptically processed and
 packaged, or retort processed after packaged milk or milk products shall: 
 
 (1) Cap or close all milk or milk product containers in a
 sanitary manner by use of approved mechanical capping or closing and sealing
 equipment; and 
 
 (2) Use only caps or closures for all milk or milk products
 that protect the pouring lip of a milk or milk product container to at least
 its largest diameter and, use with respect to fluid product containers, only
 caps or closures that the removal of the cap or closure cannot be made without
 detection; 
 
 v. Item 20p. Personnel; cleanliness. No person who holds a
 grade A permit to produce grade A pasteurized, ultra-pasteurized, aseptically
 processed and packaged, or retort processed after packaged milk or milk
 products shall: 
 
 (1) Permit any person in a milk plant to commence any plant
 function before the person has thoroughly washed the person's hands to remove
 soil and contamination or to permit any person in a milk plant to continue any
 plant function if the person's hands are not clean; 
 
 (2) Permit any person in a milk plant to resume work after the
 person has visited the toilet room before the person has thoroughly washed the
 person's hands; 
 
 (3) Permit any person in a milk plant to engage in the
 processing, pasteurization, handling, storage, or transportation of any milk,
 milk products, containers, equipment or utensils, unless the person is wearing
 clean outer garments; 
 
 (4) Permit any person in a milk plant to engage in the
 processing of any milk or milk products unless the person wears adequate hair
 covering; or 
 
 (5) Permit any person in a milk plant to engage in the
 processing of any milk or milk products if the person is using tobacco; 
 
 w. Item 21p. Vehicles. Each person who holds a grade A permit
 to produce grade A pasteurized, ultra-pasteurized, aseptically processed and
 packaged, or retort processed after packaged milk or milk products shall use
 vehicles to transport pasteurized and ultra-pasteurized milk and milk products
 that are constructed and operated so that the milk or milk products are
 maintained at a temperature of 45°F or cooler, but not frozen, and protected
 from sunlight, from freezing, and from contamination; 
 
 x. Item 22p. Surroundings. Each person who holds a grade A
 permit to produce grade A pasteurized, ultra-pasteurized, aseptically processed
 and packaged, or retort processed after packaged milk or milk products shall
 keep neat, clean, and free from conditions that might attract or harbor flies,
 other insects, rodents, or other pests that otherwise constitute a nuisance,
 the area surrounding any milk plant; 
 
 y. Each grade A permit holder's receiving station shall comply
 with subdivisions C 1 a through q of this section, inclusive, and subdivisions
 C 1 s, v, and x of this section, except that the partitioning requirement of
 subdivision C 1 g of this section shall not be deemed to apply; 
 
 z. Each grade A permit holder's transfer station shall comply
 with subdivisions C 1 c, f, h through n, p, q, s, v, and x of this section, and
 as climatic and operating conditions require, the provisions of subdivisions C
 1 d and e of this section; except that each person shall provide overhead
 protection for a transfer station; and
 
 a1. Each grade A permit holder's facilities for the cleaning
 and sanitizing of bulk tanks that transport milk and milk products shall comply
 with subdivisions C 1 a, f, h through n, p, q, v, and x of this section, and as
 climatic and operating conditions require, the provisions of subdivisions C 1 d
 and e of this section except that each grade A permit holder shall provide
 overhead protection for facilities for the cleaning and sanitizing of bulk
 tanks which transport milk and milk products in the grade A permit holder's
 milk plant, receiving station, or transfer station.
 
 D. Minimum facilities requirements for milk processing plant.
 Each person who holds a grade A permit to produce grade A pasteurized,
 ultra-pasteurized, aseptically processed and packaged, or retort processed
 after packaging milk or milk products shall:
 
 1. Provide a separate receiving room meeting the requirements
 of subdivision C 1 y of this section from any other area of the plant for the
 receipt of milk or milk products in bulk if the plant receives any milk or milk
 products in bulk;
 
 2. Provide cleaning and sanitizing facilities for milk tank
 trucks as part of the plant's receiving room facilities if the plant receives
 any milk or milk products in bulk;
 
 3. Provide a separate receiving room from any other area of
 the plant for the receipt of milk or milk product in cans or other containers
 if the plant receives any milk or milk product in cans or other containers;
 
 4. Provide a separate room from any other area of the plant
 for the cleaning of milk cans or containers, bottles, milk cases, and dry milk
 or milk product containers if the plant receives any milk in cans or containers
 or washes any bottles, milk cases, or dry milk or milk product containers;
 
 5. Provide a separate room for the fabrication of containers
 and closures for milk and milk products if the plant fabricates any containers
 or closures;
 
 6. Provide a separate room for the packaging of dry milk or
 milk products if the plant packages any dry milk or milk product; and
 
 7. Provide separate rooms from any other area of the plant for
 each of the following operations performed on any milk, milk product, or
 condensed and dry milk product: (i) pasteurization; (ii) processing; (iii)
 cooling; (iv) reconstitution; (v) condensing; (vi) drying; and (vii) packaging,
 if the operation is performed in the plant.
 
 VA.R. Doc. No. R18-34; Filed May 6, 2019, 4:35 p.m. 
TITLE 3. ALCOHOLIC BEVERAGES
ALCOHOLIC BEVERAGE CONTROL AUTHORITY
Final Regulation
 
 
 
 REGISTRAR'S NOTICE: The
 Alcoholic Beverage Control Authority is claiming an exemption from Article 2 of
 the Administrative Process Act in accordance with § 2.2-4006 A 4 a of the
 Code of Virginia, which excludes regulations that are necessary to conform to
 changes in Virginia statutory law or the appropriation act where no agency
 discretion is involved. The Alcoholic Beverage Control Authority will receive,
 consider, and respond to petitions by any interested person at any time with
 respect to reconsideration or revision.
 
  
 
 Title of Regulation: 3VAC5-50. Retail Operations (amending 3VAC5-50-60). 
 
 Statutory Authority: § 4.1-103 and 4.1-111 Code of
 Virginia.
 
 Effective Date: July 1, 2019. 
 
 Agency Contact: LaTonya D. Hucks-Watkins, Legal Liaison,
 Virginia Alcoholic Beverage Control Authority, 2901 Hermitage Road, Richmond,
 VA 23220, telephone (804) 213-4698, FAX (804) 213-4574, or email
 latonya.hucks-watkins@abc.virginia.gov.
 
 Summary:
 
 Pursuant to Chapter 706 of the 2019 Acts of Assembly, the
 amendments provide that the Board of Directors of the Alcoholic Beverage
 Control Authority may suspend the privilege of a mixed beverage licensee to
 purchase spirits from the board if the licensee fails to submit records or
 other documents necessary to verify the licensee's compliance with applicable
 minimum food sale requirements within 30 days of the date such records or
 documents are due. 
 
 3VAC5-50-60. Procedures for mixed Mixed beverage
 licensees generally; mixed beverage restaurant licensees; sales of
 spirits in closed containers; suspension of purchase privileges. 
 
 A. No mixed beverage restaurant or carrier licensee shall: 
 
 1. Serve as one drink the entire contents of a container of
 spirits in its original container for on-premises consumption except as
 provided by subsections C, D, and E of this section. 
 
 2. Sell any mixed beverage to which alcohol has been added. 
 
 B. No mixed beverage restaurant licensee shall: 
 
 1. Allow to be kept upon the licensed premises any container
 of alcoholic beverages of a type authorized to be purchased under his license
 that does not bear the required mixed beverage stamp imprinted with his license
 number and purchase report number. 
 
 2. Use in the preparation of a mixed beverage any alcoholic
 beverage not purchased from the board or a wholesale wine licensee. 
 
 3. Fail to obliterate the mixed beverage stamp immediately
 when any container of spirits is emptied. 
 
 4. Allow any patron to possess more than two drinks of mixed
 beverages at any one time, except that a mixed beverage licensee may sell to a
 patron who may lawfully purchase mixed beverages a flight of distilled spirits
 products consisting of samples of not more than five different spirits
 products. Each distilled spirits product shall contain no more than one-half
 ounce of distilled spirits. 
 
 C. If a restaurant for which a mixed beverage restaurant
 license has been issued under § 4.1-210 of the Code of Virginia is located
 on the premises of a hotel or motel, whether the hotel or motel be under the
 same or different ownership, sales of mixed beverages, including sales of
 spirits packaged in original closed containers purchased from the board, as
 well as other alcoholic beverages, for consumption in bedrooms and private
 rooms of such hotel or motel, may be made by the licensee subject to the
 following conditions in addition to other applicable laws: 
 
 1. Spirits sold by the drink as mixed beverages or in original
 closed containers must have been purchased under the mixed beverage restaurant
 license upon purchase forms provided by the board; 
 
 2. Delivery of sales of mixed beverages and spirits in
 original closed containers shall be made only in the bedroom of the registered
 guest or to the sponsoring group in the private room of a scheduled function.
 This section shall not be construed to prohibit a licensee catering a scheduled
 private function from delivering mixed beverage drinks to guests in attendance
 at such function; 
 
 3. Receipts from the sale of mixed beverages and spirits sold
 in original closed containers, as well as other alcoholic beverages, shall be
 included in the gross receipts from sales of all such merchandise made by the
 licensee; and 
 
 4. Complete and accurate records of sales of mixed beverages
 and sales of spirits in original closed containers to registered guests in
 bedrooms and to sponsors of scheduled private functions in private rooms shall
 be kept separate and apart from records of all mixed beverage sales. 
 
 D. Carrier licensees may serve miniatures not in excess of
 two fluid ounces or 50 milliliters, in their original containers, for
 on-premises consumption. 
 
 E. A mixed beverage restaurant may serve as one drink the
 entire contents of a container of soju in its original container for
 on-premises consumption under the following conditions: 
 
 1. The container may be no larger than 375 milliliters. 
 
 2. Each container of soju served must be served for
 consumption by at least two patrons legally eligible to consume alcoholic
 beverages. 
 
 F. A mixed beverage restaurant licensee may infuse, store,
 and sell flavored distilled spirits under the following circumstances: 
 
 1. If infused in the original spirits container, the mixed
 beverage stamp must remain affixed to the bottle.
 
 2. If infused in a container other than the original spirits
 container, the substitute container, which shall not exceed 20 liters in
 volume, will be labeled with the following information: 
 
 a. Date of infusion;
 
 b. Brand of spirits; and
 
 c. Amount of spirits used.
 
 3. Accurate records must be kept by the mixed beverage
 licensee as to the spirits used in any spirits infusion process.
 
 4. Licensees infusing distilled spirits shall comply with all
 applicable state and federal food safety regulations.
 
 G. Mixed beverage licensees may premix containers of sangria
 and other mixed beverages and serve such alcoholic beverages in pitchers
 subject to the following limitations:
 
 1. Pitchers of mixed beverages may only be sold in containers
 with a maximum capacity of 32 fluid ounces or one liter if the container is in
 metric size containing a spirits product mixed with nonalcoholic beverages.
 
 2. A pitcher of mixed beverages may only be served to two or
 more patrons. A licensee shall not allow any two patrons to possess more than
 one pitcher at any one time.
 
 3. Containers of premixed sangria and other mixed beverages
 must be labeled as to the type of mixed beverage and the quantities of the
 products used to produce the mixed beverage.
 
 H. The board may suspend the privilege of a mixed beverage
 licensee to purchase spirits from the board upon such licensee's failure to
 submit any records or other documents necessary to verify the licensee's
 compliance with applicable minimum food sale requirements within 30 days of the
 date such records or documents are due.
 
 VA.R. Doc. No. R19-5972; Filed May 1, 2019, 9:43 a.m. 
TITLE 9. ENVIRONMENT
STATE AIR POLLUTION CONTROL BOARD
Final Regulation
 
 Title of Regulation: 9VAC5-140. Regulation for Emissions
 Trading Programs (adding 9VAC5-140-6010 through 9VAC5-140-6440). 
 
 Statutory Authority: §§ 10.1-1308 and 10.1-1322.3
 of the Code of Virginia; §§ 108, 109, 110, and 302 of the Clean Air Act;
 40 CFR Part 51.
 
 Effective Date: June 26, 2019. 
 
 Agency Contact: Karen G. Sabasteanski, Department of
 Environmental Quality, 1111 East Main Street, Suite 1400, P.O. Box 1105,
 Richmond, VA 23218, telephone (804) 698-4426, FAX (804) 698-4510, or email
 karen.sabasteanski@deq.virginia.gov.
 
 Summary:
 
 This action establishes the Virginia CO2 Budget
 Trading Program. The regulation includes provisions to (i) implement a
 declining cap on carbon emissions and establish an allowance that will be issued
 for each ton of carbon emitted by an electricity generating facility, which can
 then decide whether to reduce carbon emissions and sell the resulting
 additional allowances or not reduce carbon emissions and make up the difference
 with purchased allowances; (ii) establish a consignment auction as the
 mechanism for determining the cost of allowances; (iii) provide cost
 containment reserve allowances and emission containment reserve allowances to
 ensure market stability; (iv) implement monitoring, recording, and
 recordkeeping requirements; and (v) allocate conditional allowances to the
 Department of Mines, Minerals and Energy.
 
 Amendments since publication of the revised proposed
 regulation in 35:12 VA.R. 1404-1438 February 4, 2019,
 include (i) modifying several definitions, (ii) adding a section to address
 program implementation, (iii) modifying 9VAC5-140-6040 and 9VAC5-140-6050
 regarding applicability, (iv) removing 2031–2040 budget reductions from
 9VAC5-140-6190, and (v) providing that post-2031 base budgets may be modified
 as a result of program review and regulatory action.
 
 Summary of Public Comments and Agency's Response: A
 summary of comments made by the public and the agency's response may be
 obtained from the promulgating agency or viewed at the office of the Registrar
 of Regulations. 
 
 Part VII
 CO2 Budget Trading Program
 
 Article 1
 CO2 Budget Trading Program General Provisions
 
 9VAC5-140-6010. Purpose.
 
 This part establishes the Virginia component of the CO2
 Budget Trading Program, which is designed to reduce anthropogenic emissions of
 CO2, a greenhouse gas, from CO2 budget sources in an
 economically efficient manner a manner that is protective of human health
 and the environment and is economically efficient.
 
 9VAC5-140-6020. Definitions.
 
 A. As used in this part, all words or terms not defined
 here shall have the meanings given them in 9VAC5-10 (General Definitions),
 unless otherwise required by the context.
 
 B. For the purpose of this part and any related use, the
 words or terms shall have the meanings given them in this section.
 
 C. Terms defined.
 
 "Account number" means the identification number
 given by the department or its agent to each COATS account. 
 
 "Acid rain emission limitation" means, as defined
 in 40 CFR 72.2, a limitation on emissions of sulfur dioxide (SO2)
 or nitrogen oxides (NOX) under the Acid Rain Program under Title IV
 of the CAA.
 
 "Acid Rain Program" means a multistate SO2
 and NOX air pollution control and emission reduction program
 established by the administrator under Title IV of the CAA and 40 CFR Parts 72
 through 78.
 
 "Adjustment for banked allowances" means an
 adjustment applied to the Virginia CO2 Budget Trading Program base
 budget for allocation years 2021 through 2025 to address allowances held in
 general and compliance accounts, including compliance accounts established
 pursuant to the CO2 Budget Trading Program, but not including
 accounts opened by participating states, that are in addition to the aggregate quantity
 of emissions from all CO2 budget sources in all of the participating
 states at the end of the [ initial ] control period in
 2020 and as reflected in the CO2 Allowance Tracking System on March
 [ 17 15 ], 2021.
 
 "Administrator" means the administrator of the
 U.S. Environmental Protection Agency or the administrator's authorized
 representative.
 
 "Allocate" or "allocation" means the
 determination by the department of the number of [ CO2 ]
 conditional allowances [ allocated to a CO2 budget
 unit recorded in the conditional allowance account of a CO2
 budget unit ] or to the Department of Mines, Minerals and Energy
 (DMME) pursuant to 9VAC5-140-6211.
 
 "Allocation year" means a calendar year for which
 the department allocates [ CO2 ] conditional
 allowances pursuant to Article 5 (9VAC5-140-6190 et seq.) of this part. The
 allocation year of each [ CO2 ] conditional
 allowance is reflected in the unique identification number given to the
 allowance pursuant to 9VAC5-140-6250 C.
 
 "Allowance" means an allowance up to one ton
 of CO2 purchased from the consignment auction in accordance with
 Article 9 (9VAC5-140-6410 et seq.) of this part and that may be deposited in
 the compliance account of a CO2 budget source. 
 
 "Allowance auction" or "auction" means
 an auction in which the department or its agent offers [ CO2
 conditional ] allowances for sale.
 
 "Alternate CO2 authorized account
 representative" means, for a CO2 budget source and each CO2
 budget unit at the source, the alternate natural person who is authorized by the
 owners and operators of the source and all CO2 budget units at the
 source, in accordance with Article 2 (9VAC5-140-6080 et seq.) of this part, to
 represent and legally bind each owner and operator in matters pertaining to the
 CO2 Budget Trading Program or, for a general account, the alternate
 natural person who is authorized, under Article 6 (9VAC5-140-6220 et seq.) of
 this part, to transfer or otherwise dispose of CO2 allowances held
 in the general account. If the CO2 budget source is also subject to
 the Acid Rain Program, CSAPR NOX Annual Trading Program, CSAPR NOX
 Ozone Season Trading Program, CSAPR SO2 Group 1 Trading Program, or
 CSAPR SO2 Group 2 Trading Program then, for a CO2 Budget
 Trading Program compliance account, this alternate natural person shall be the
 same person as the alternate designated representative as defined in the
 respective program.
 
 "Attribute" means a characteristic associated
 with electricity generated using a particular renewable fuel, such as its
 generation date, facility geographic location, unit vintage, emissions output,
 fuel, state program eligibility, or other characteristic that can be
 identified, accounted for, and tracked.
 
 "Attribute credit" means a credit that represents
 the attributes related to one megawatt-hour of electricity generation.
 
 "Automated Data Acquisition and Handling System"
 or "DAHS" means that component of the Continuous Emissions Monitoring
 System (CEMS), or other emissions monitoring system approved for use under
 Article 8 (9VAC5-140-6330 et seq.) of this part, designed to interpret and
 convert individual output signals from pollutant concentration monitors, flow
 monitors, diluent gas monitors, and other component parts of the monitoring
 system to produce a continuous record of the measured parameters in the
 measurement units required by Article 8 (9VAC5-140-6330 et seq.) of this part.
 
 "Billing meter" means a measurement device used
 to measure electric or thermal output for commercial billing under a contract.
 The facility selling the electric or thermal output shall have different owners
 from the owners of the party purchasing the electric or thermal output.
 
 "Boiler" means an enclosed fossil or other
 fuel-fired combustion device used to produce heat and to transfer heat to
 recirculating water, steam, or other medium.
 
 "CO2 allowance" means a limited
 authorization by the department or another participating state under the CO2
 Budget Trading Program to emit up to one ton of CO2, subject to all
 applicable limitations contained in this part. CO2 offset allowances
 generated by other participating states will be recognized by the department.
 
 "CO2 allowance deduction" or
 "deduct CO2 allowances" means the permanent withdrawal of
 CO2 allowances by the department or its agent from a COATS
 compliance account to account for the number of tons of CO2 emitted
 from a CO2 budget source for the [ initial control
 period, ] a control period [ , ] or an
 interim control period [ , ] determined in accordance
 with Article 8 (9VAC5-140-6330 et seq.) of this part, or for the forfeit or
 retirement of CO2 allowances as provided by this part.
 
 "CO2 Allowance Tracking System" or
 "COATS" means the system by which the department or its agent records
 allocations, deductions, and transfers of CO2 allowances under the
 CO2 Budget Trading Program. The tracking system may also be used to
 track CO2 allowance prices and emissions from affected sources.
 
 "CO2 Allowance Tracking System
 account" means an account in COATS established by the department or its
 agent for purposes of recording the allocation, holding, transferring, or
 deducting of CO2 allowances.
 
 "CO2 allowance transfer deadline"
 means midnight of March 1 occurring after the end of the [ relevant
 initial control period, the ] control period [ , ]
 and each [ relevant ] interim control period
 [ , ] or [ , ] if that March
 1 is not a business day, midnight of the first business day thereafter and is
 the deadline by which CO2 allowances shall be submitted for recordation
 in a CO2 budget source's compliance account for the source to meet
 the CO2 requirements of 9VAC5-140-6050 C for the [ initial
 control period, a ] control period [ , ] and
 each interim control period immediately preceding such deadline.
 
 "CO2 allowances held" or "hold CO2
 allowances" means the CO2 allowances recorded by the department
 or its agent, or submitted to the department or its agent for recordation, in
 accordance with Article 6 (9VAC5-140-6220 et seq.) and Article 7
 (9VAC5-140-6300 et seq.) of this part, in a COATS account.
 
 "CO2 authorized account
 representative" means, for a CO2 budget source and each CO2
 budget unit at the source, the natural person who is authorized by the owners
 and operators of the source and all CO2 budget units at the source,
 in accordance with Article 2 (9VAC5-140-6080 et seq.) of this part, to
 represent and legally bind each owner and operator in matters pertaining to the
 CO2 Budget Trading Program or, for a general account, the natural
 person who is authorized, under Article 6 (9VAC5-140-6220 et seq.) of this
 part, to transfer or otherwise dispose of CO2 allowances held in the
 general account. If the CO2 budget source is also subject to the
 Acid Rain Program, CSAPR NOX Annual Trading Program, CSAPR NOX
 Ozone Season Trading Program, CSAPR SO2 Group 1 Trading Program, or
 CSAPR SO2 Group 2 Trading Program, then for a CO2 Budget
 Trading Program compliance account, this natural person shall be the same
 person as the designated representative as defined in the respective program.
 
 "CO2 authorized alternate account
 representative" means, for a CO2 budget source and each CO2
 budget unit at the source, the alternate natural person who is authorized by
 the owners and operators of the source and all CO2 budget units at
 the source, in accordance with Article 2 (9VAC5-140-6080 et seq.) of this part,
 to represent and legally bind each owner and operator in matters pertaining to
 the CO2 Budget Trading Program or, for a general account, the
 alternate natural person who is authorized, under Article 6 (9VAC5-140-6220 et
 seq.) of this part, to transfer or otherwise dispose of CO2
 allowances held in the general account. If the CO2 budget source is
 also subject to the Acid Rain Program, CSAPR NOX Annual Trading
 Program, CSAPR NOX Ozone Season Trading Program, CSAPR SO2
 Group 1 Trading Program, or CSAPR SO2 Group 2 Trading Program then,
 for a CO2 Budget Trading Program compliance account, this alternate
 natural person shall be the same person as the alternate designated representative
 as defined in the respective program.
 
 "CO2 budget emissions limitation"
 means, for a CO2 budget source, the tonnage equivalent, in CO2
 emissions in [ the initial control period, ] a control
 period [ , ] or an interim control period [ , ]
 of the CO2 allowances available for compliance deduction for the
 source for a control period or an interim control period.
 
 "CO2 budget permit" means the portion
 of the legally binding permit issued by the department pursuant to 9VAC5-85
 (Permits for Stationary Sources of Pollutants Subject to Regulation) to a CO2
 budget source or CO2 budget unit that specifies the CO2
 Budget Trading Program requirements applicable to the CO2 budget
 source, to each CO2 budget unit at the CO2 budget source,
 and to the owners and operators and the CO2 authorized account
 representative of the CO2 budget source and each CO2
 budget unit.
 
 "CO2 budget source" means a source
 that includes one or more CO2 budget units.
 
 "CO2 Budget Trading Program" means the
 Regional Greenhouse Gas Initiative (RGGI), a multistate CO2 air
 pollution control and emissions reduction program established according to this
 part and corresponding regulations in other states as a means of reducing
 emissions of CO2 from CO2 budget sources.
 
 "CO2 budget unit" means a unit that is
 subject to the CO2 Budget Trading Program requirements under
 9VAC5-140-6040.
 
 "CO2 cost containment reserve
 allowance" or "CO2 CCR allowance" means [ a
 conditional CO2 allowance that is offered for sale an
 allowance that has been sold ] at an auction for the purpose of
 containing the cost of CO2 allowances. CO2 CCR allowances
 offered for sale at an auction are separate from and additional to CO2
 allowances allocated from the Virginia CO2 Budget Trading Program
 base and adjusted budgets. CO2 CCR allowances are subject to all
 applicable limitations contained in this part.
 
 "CO2 cost containment reserve trigger
 price" or "CCR trigger price" means the minimum price at which
 CO2 CCR allowances are offered for sale at an auction. Beginning
 in 2020 and each calendar year thereafter, the CCR trigger price shall be 1.025
 multiplied by the CCR trigger price from the previous calendar year, rounded to
 the nearest whole cent. The CCR trigger price in calendar year 2020 shall
 be $10.77. The CCR trigger price in calendar year 2021 shall be $13. Each
 calendar year thereafter, the CCR trigger price shall be 1.07 multiplied by the
 CCR trigger price from the previous calendar year, rounded to the nearest whole
 cent, as shown in Table 140-1A.
 
 
  
   | Table 140-1A CO2 CCR Trigger Price | 
  
   | 2020 | $10.77 | 
  
   | 2021 | $13.00 | 
  
   | 2022 | $13.91 | 
  
   | 2023 | $14.88 | 
  
   | 2024 | $15.93$15.92
 | 
  
   | 2025 | $17.04$17.03
 | 
  
   | 2026 | $18.23$18.22
 | 
  
   | 2027 | $19.51$19.50
 | 
  
   | 2028 | $20.88$20.87
 | 
  
   | 2029 | $22.34$22.33
 | 
  
   | 2030 | $23.90$23.89
 | 
 
 
 "CO2 [ emission
 emissions ] containment reserve allowance" or "CO2
 ECR allowance" means a [ CO2
 conditional ] allowance that is withheld from sale at an auction by
 the department for the purpose of additional emission reduction in the event of
 lower than anticipated emission reduction costs.
 
 "CO2 [ emission
 emissions ] containment reserve trigger price" or "ECR
 trigger price" means the price below which [ CO2
 conditional ] allowances will be withheld from sale by the
 department or its agent at an auction. The ECR trigger price in calendar year
 2021 shall be $6.00. Each calendar year thereafter, the ECR trigger price shall
 be 1.07 multiplied by the ECR trigger price from the previous calendar year,
 rounded to the nearest whole cent, as shown in Table 140-1B.
 
 
  
   | Table 140-1B CO2 ECR Trigger Price | 
  
   | 2021 | $ 6.00 | 
  
   | 2022 | $ 6.42 | 
  
   | 2023 | $ 6.87 | 
  
   | 2024 | $ 7.35 | 
  
   | 2025 | $ 7.86 | 
  
   | 2026 | $ 8.42$8.41
 | 
  
   | 2027 | $ 9.00 | 
  
   | 2028 | $ 9.63 | 
  
   | 2029 | $10.31$10.30
 | 
  
   | 2030 | $11.03$11.02
 | 
 
 
 "CO2 offset allowance" means a CO2
 allowance that is awarded to the sponsor of a CO2 emissions offset
 project by a participating state and is subject to the relevant compliance
 deduction limitations of the participating state's corresponding offset
 regulations as a means of reducing CO2 from CO2 budget
 sources.
 
 "Combined cycle system" means a system comprised
 of one or more combustion turbines, heat recovery steam generators, and steam
 turbines configured to improve overall efficiency of electricity generation or
 steam production.
 
 "Combustion turbine" means an enclosed fossil or
 other fuel-fired device that is comprised of a compressor (if applicable), a
 combustor, and a turbine, and in which the flue gas resulting from the
 combustion of fuel in the combustor passes through the turbine, rotating the
 turbine.
 
 "Commence commercial operation" means, with
 regard to a unit that serves a generator, to have begun to produce steam, gas,
 or other heated medium used to generate electricity for sale or use, including
 test generation. For a unit that is a CO2 budget unit under
 9VAC5-140-6040 on the date the unit commences commercial operation, such date
 shall remain the unit's date of commencement of commercial operation even if
 the unit is subsequently modified, reconstructed, or repowered. For a unit that
 is not a CO2 budget unit under 9VAC5-140-6040 on the date the unit
 commences commercial operation, the date the unit becomes a CO2
 budget unit under 9VAC5-140-6040 shall be the unit's date of commencement of
 commercial operation.
 
 "Commence operation" means to begin any
 mechanical, chemical, or electronic process, including, with regard to a unit,
 start-up of a unit's combustion chamber. For a unit that is a CO2
 budget unit under 9VAC5-140-6040 on the date of commencement of operation, such
 date shall remain the unit's date of commencement of operation even if the unit
 is subsequently modified, reconstructed, or repowered. For a unit that is not a
 CO2 budget unit under 9VAC5-140-6040 on the date of commencement of
 operation, the date the unit becomes a CO2 budget unit under
 9VAC5-140-6040 shall be the unit's date of commencement of operation. 
 
 "Compliance account" means a COATS account,
 established by the department or its agent for a CO2 budget source
 under Article 6 (9VAC5-140-6220 et seq.) of this part, in which [ are
 held ] CO2 allowances available for use by the
 source for [ the initial control period, ] a control
 period [ , ] and each interim control period
 [ are held ] for the purpose of meeting the CO2
 requirements of 9VAC5-140-6050 C.
 
 "Conditional allowance" means an allowance
 allocated by the department to [ a ] CO2
 budget [ sources and source or ] to DMME.
 Such conditional allowance shall be consigned by the entity to whom it is
 allocated to the consignment auction as specified under Article 9
 (9VAC5-140-6410 et seq.) of this part, after which the conditional allowance
 becomes an allowance to be used for compliance purposes. a CO2
 allowance once it is sold to an auction participant. [ A
 conditional allowance may also be contained in the CCR and may be auctioned. ]
 
  "Conditional [ allowance
 account" means a general COATS account established by the department for
 CO2 budget sources and DMME or its contractor where conditional
 allowances allocated to CO2 budget sources and DMME are held until
 auction.
 
 "Conditional cost containment reserve allowance"
 or "conditional ] CCR allowance" means [ a
 CCR an ] allowance that may be offered for sale when the
 CCR is triggered. If any [ conditional ] CCR allowances
 are unsold, they [ shall be returned to the CCR account and ]
 may be offered for sale in future auctions during the same year. [ Conditional
 CCR allowances offered for sale at an auction are separate from and additional
 to conditional allowances allocated from the Virginia CO2 Budget
 Trading Program base and adjusted budgets. Conditional CCR allowances are
 subject to all applicable limitations contained in this part. ]
 
 "Consignment auction" or "auction"
 means the CO2 auction conducted on a quarterly basis by RGGI,
 Inc. the CO2 Budget Trading Program, in which CO2
 budget sources and DMME are allocated a share of allowances by the department
 that CO2 budget sources and the holder of a public contract with
 DMME consign into the auction, and auction revenue is returned to CO2
 budget sources and the holder of a public contract with DMME in accordance with
 procedures established by the department.
 
 "Continuous Emissions Monitoring System" or
 "CEMS" means the equipment required under Article 8 (9VAC5-140-6330
 et seq.) of this part to sample, analyze, measure, and provide, by means of
 readings recorded at least once every 15 minutes (using an automated DAHS), a
 permanent record of stack gas volumetric flow rate, stack gas moisture content,
 and oxygen or carbon dioxide concentration (as applicable), in a manner
 consistent with 40 CFR Part 75 and Article 8 (9VAC5-140-6330 et seq.) of
 this part. The following systems are types of CEMS required under Article 8
 (9VAC5-140-6330 et seq.) of this part:
 
 a. A flow monitoring system, consisting of a stack flow
 rate monitor and an automated DAHS and providing a permanent, continuous record
 of stack gas volumetric flow rate, in standard cubic feet per hour (scf);
 
 b. A NOX emissions rate (or NOX-diluent)
 monitoring system, consisting of a NOX pollutant concentration
 monitor, a diluent gas (CO2 or O2) monitor, and an
 automated DAHS and providing a permanent, continuous record of NOX
 concentration, in parts per million (ppm), diluent gas concentration, in
 percent CO2 or O2, and NOX emissions rate, in
 pounds per million British thermal units (lb/MMBtu);
 
 c. A moisture monitoring system, as defined in 40 CFR
 75.11(b)(2) and providing a permanent, continuous record of the stack gas
 moisture content, in percent H2O;
 
 d. A CO2 monitoring system, consisting of a CO2
 pollutant concentration monitor (or an O2 monitor plus suitable
 mathematical equations from which the CO2 concentration is derived)
 and an automated DAHS and providing a permanent, continuous record of CO2
 emissions, in percent CO2; and
 
 e. An O2 monitoring system, consisting of an O2
 concentration monitor and an automated DAHS and providing a permanent,
 continuous record of O2, in percent O2.
 
 "Control period" means a three-calendar-year time
 period. The [ first fifth ] control
 period is from January 1, 2021, to December 31, 2023, inclusive [ .
 Each subsequent compliance control period shall be a sequential
 three-calendar-year period. , which is the first control period of
 Virginia's participation in the CO2 Budget Trading Program. ]
 The first two [ compliance calendar ] years
 of each control period are each defined as an interim control period, beginning
 on January 1, [ 2022 2021 ].
 
 "Cross State Air Pollution Rule (CSAPR) NOX
 Annual Trading Program" means a multistate NOX air pollution
 control and emission reduction program established in accordance with Subpart AAAAA
 of 40 CFR Part 97 and 40 CFR 52.38(a), including such a program that is
 revised in a SIP revision approved by the administrator under 40 CFR
 52.38(a)(3) or (4) or that is established in a SIP revision approved by the
 administrator under 40 CFR 52.38(a)(5), as a means of mitigating interstate
 transport of fine particulates and NOX.
 
 "Cross State Air Pollution Rule (CSAPR) NOX
 Ozone Season Trading Program" means a multistate NOX air
 pollution control and emission reduction program established in accordance with
 Subpart BBBBB of 40 CFR Part 97 and 40 CFR 52.38(b), including such a
 program that is revised in a SIP revision approved by the administrator under
 40 CFR 52.38(b)(3) or (4) or that is established in a SIP revision approved by
 the administrator under 40 CFR 52.38(b)(5), as a means of mitigating
 interstate transport of ozone and NOX.
 
 "Cross State Air Pollution Rule (CSAPR) SO2
 Group 1 Trading Program" means a multistate SO2 air pollution
 control and emission reduction program established in accordance with Subpart
 CCCCC of 40 CFR Part 97 and 40 CFR 52.39(a), (b), (d) through (f), (j),
 and (k), including such a program that is revised in a SIP revision approved by
 the administrator under 40 CFR 52.39(d) or (e) or that is established in a SIP
 revision approved by the administrator under 40 CFR 52.39(f), as a means of
 mitigating interstate transport of fine particulates and SO2.
 
 "Cross State Air Pollution Rule (CSAPR) SO2
 Group 2 Trading Program" means a multistate SO2 air pollution
 control and emission reduction program established in accordance with Subpart
 DDDDD of 40 CFR Part 97 and 40 CFR 52.39(a), (c), and (g) through (k),
 including such a program that is revised in a SIP revision approved by the
 administrator under 40 CFR 52.39(g) or (h) or that is established in a SIP
 revision approved by the administrator under 40 CFR 52.39(i), as a means of
 mitigating interstate transport of fine particulates and SO2.
 
 "Department" means the Virginia Department of
 Environmental Quality.
 
 "DMME" means the Virginia Department of Mines,
 Minerals and Energy.
 
 "Excess emissions" means any tonnage of CO2
 emitted by a CO2 budget source during [ the initial
 control period or ] a control period that exceeds the CO2
 budget emissions limitation for the source.
 
 "Excess interim emissions" means any tonnage of
 CO2 emitted by a CO2 budget source during an interim
 control period multiplied by 0.50 that exceeds the CO2 budget
 emissions limitation for the source.
 
 "Fossil fuel" means natural gas, petroleum, coal,
 or any form of solid, liquid, or gaseous fuel derived from such material.
 
 "Fossil fuel-fired" means the combustion of
 fossil fuel, alone or in combination with any other fuel, where the fossil fuel
 combusted comprises, or is projected to comprise, more than 10% 5.0% of
 the annual heat input on a Btu basis during any year.
 
 "General account" means a COATS account
 [ , ] established under Article 6 (9VAC5-140-6220 et
 seq.) of this part that is not a compliance account.
 
 "Gross generation" means the electrical output in
 MWe at the terminals of the generator.
 
 "Initial control period" means the period
 beginning January 1, 2020, and ending December 31, 2020.
 
 "Interim control period" means a
 one-calendar-year time period [ , ] during each
 of the first and second calendar years of each three-year control period. The
 first interim control period starts January 1, 2021, and ends December 31,
 2021, inclusive. The second interim control period starts January 1, 2022, and
 ends December 31, 2022, inclusive. Each successive three-year control period
 will have two interim control periods, comprised of each of the first two
 calendar years of that control period.
 
 "Life-of-the-unit contractual arrangement" means
 a unit participation power sales agreement under which a customer reserves, or
 is entitled to receive, a specified amount or percentage of nameplate capacity
 or associated energy from any specified unit pursuant to a contract:
 
 a. For the life of the unit;
 
 b. For a cumulative term of no less than 30 years,
 including contracts that permit an election for early termination; or
 
 c. For a period equal to or greater than 25 years or 70% of
 the economic useful life of the unit determined as of the time the unit is
 built, with option rights to purchase or release some portion of the nameplate
 capacity and associated energy generated by the unit at the end of the period.
 
 "Maximum design heat input" means the ability
 of a unit to combust a stated maximum amount of fuel per hour on a steady state
 basis, as determined by the physical design and physical characteristics of the
 unit.
 
 "Maximum potential hourly heat input" means an
 hourly heat input used for reporting purposes when a unit lacks certified
 monitors to report heat input. If the unit intends to use Appendix D of 40 CFR
 Part 75 to report heat input, this value shall be calculated, in accordance
 with 40 CFR Part 75, using the maximum fuel flow rate and the maximum
 gross calorific value. If the unit intends to use a flow monitor and a diluent
 gas monitor, this value shall be reported, in accordance with 40 CFR Part 75,
 using the maximum potential flow rate and either the maximum CO2
 concentration in percent CO2 or the minimum O2
 concentration in percent O2.
 
 "Minimum reserve price" means, in calendar year
 2020, $2.00 $2.32. Each calendar year thereafter, the minimum reserve
 price shall be 1.025 multiplied by the minimum reserve price from the previous
 calendar year, rounded to the nearest whole cent.
 
 "Monitoring system" means any monitoring system
 that meets the requirements of Article 8 (9VAC5-140-6330 et seq.) of this part,
 including a CEMS, an excepted monitoring system, or an alternative monitoring
 system.
 
 "Nameplate capacity" means the maximum electrical
 output in MWe that a generator can sustain over a specified period of time when
 not restricted by seasonal or other deratings as measured in accordance with
 the U.S. Department of Energy standards. 
 
 "Net-electric output" means the amount of gross
 generation in MWh the generators produce, including output from steam turbines,
 combustion turbines, and gas expanders, as measured at the generator terminals,
 less the electricity used to operate the plant (i.e., auxiliary loads); such
 uses include fuel handling equipment, pumps, fans, pollution control equipment,
 other electricity needs, and transformer losses as measured at the transmission
 side of the step up transformer (e.g., the point of sale). 
 
 "Non-CO2 budget unit" means a unit
 that does not meet the applicability criteria of 9VAC5-140-6040.
 
 "Operator" means any person who operates,
 controls, or supervises a CO2 budget unit or a CO2 budget
 source and shall include any holding company, utility system, or plant manager
 of such a unit or source.
 
 "Owner" means any of the following persons:
 
 a. Any holder of any portion of the legal or equitable
 title in a CO2 budget unit;
 
 b. Any holder of a leasehold interest in a CO2
 budget unit, other than a passive lessor, or a person who has an equitable
 interest through such lessor, whose rental payments are not based, either
 directly or indirectly, upon the revenues or income from the CO2
 budget unit;
 
 c. Any purchaser of power from a CO2 budget unit
 under a life-of-the-unit contractual arrangement in which the purchaser
 controls the dispatch of the unit; or
 
 d. With respect to any general account, any person who has
 an ownership interest with respect to the CO2 allowances held in the
 general account and who is subject to the binding agreement for the CO2
 authorized account representative to represent that person's ownership interest
 with respect to the CO2 allowances.
 
 "Participating state" means a state that has
 established a corresponding regulation as part of participates in
 the CO2 Budget Trading Program. 
 
 "Receive" or "receipt of" means, with
 regard to CO2 allowances, the movement of CO2 allowances
 by the department or its agent from one COATS account to another, for purposes
 of allocation, transfer, or deduction when referring to the department or
 its agent, to come into possession of a document, information, or
 correspondence (whether sent in writing or by authorized electronic
 transmission) as indicated in an official correspondence log, or by a notation
 made on the document, information, or correspondence by the department or its
 agent in the regular course of business.
 
 "Recordation," "record," or
 "recorded" means, with regard to CO2 allowances, the
 movement of CO2 allowances by the department or its agent from one
 COATS account to another, for purposes of allocation, transfer, or deduction.
 
 "RGGI, Inc." means the 501(c)(3) nonprofit
 corporation created to support development and implementation of the Regional
 Greenhouse Gas Initiative (RGGI). Participating RGGI states use RGGI, Inc., as
 their agent to conduct the consignment auction and to operate and manage COATS. 
 
 "Reserve price" means the minimum acceptable
 price for each [ CO2 conditional ]
 allowance in a specific auction. The reserve price at an auction is either
 the minimum reserve price or the CCR trigger price, as specified in Article 9 (9VAC5-140-6410
 et seq.) of this part.
 
 "Serial number" means, when referring to CO2
 allowances, the unique identification number assigned to each CO2
 allowance by the department or its agent under 9VAC5-140-6250 C.
 
 "Source" means any governmental, institutional,
 commercial, or industrial structure, installation, plant, building, or facility
 that emits or has the potential to emit any air pollutant. A source, including
 a source with multiple units, shall be considered a single facility.
 
 "State" means the Commonwealth of Virginia.
 The term "state" shall have its conventional meaning where such
 meaning is clear from the context.
 
 "Submit" or "serve" means to send or
 transmit a document, information, or correspondence to the person specified in
 accordance with the applicable regulation:
 
 a. In person;
 
 b. By U.S. United States Postal Service; or
 
 c. By other means of dispatch or transmission and delivery.
 
 Compliance with any "submission,"
 "service," or "mailing" deadline shall be determined by the
 date of dispatch, transmission, or mailing and not the date of receipt.
 
 "Ton" or "tonnage" means any short ton,
 or 2,000 pounds. For the purpose of determining compliance with the CO2
 requirements of 9VAC5-140-6050 C, total tons for [ the initial
 control period, an interim control period, or ] a control period
 shall be calculated as the sum of all recorded hourly emissions, or the tonnage
 equivalent of the recorded hourly emissions rates, in accordance with Article 8
 (9VAC5-140-6330 et seq.) of this part, with any remaining fraction of a ton
 equal to or greater than 0.50 ton deemed to equal one ton and any fraction of a
 ton less than 0.50 ton deemed to equal zero tons. A short ton is equal to
 0.9072 metric tons.
 
 "Total useful energy" means the sum of gross
 electrical generation and useful net thermal energy.
 
 "Undistributed [ CO2
 conditional ] allowances" means [ CO2
 conditional ] allowances originally allocated to a set aside
 account as pursuant to 9VAC5-140-6210 that were not distributed. 
 
 "Unit" means a fossil fuel-fired stationary
 boiler, combustion turbine, or combined cycle system.
 
 "Unit operating day" means a calendar day in
 which a unit combusts any fuel.
 
 "Unsold [ CO2
 conditional ] allowances" means [ CO2
 conditional ] allowances that have been made available for sale in
 an auction conducted by the department or its agent, but not sold.
 
 "Useful net thermal energy" means energy:
 
 1. In the form of direct heat, steam, hot water, or other
 thermal form that is used in the production and beneficial measures for
 heating, cooling, humidity control, process use, or other thermal end use
 energy requirements, excluding thermal energy used in the power production
 process (e.g., house loads and parasitic loads); and
 
 2. For which fuel or electricity would otherwise be
 consumed.
 
 "Virginia CO2 Budget Trading Program
 adjusted budget" means an adjusted budget determined in accordance with
 9VAC5-140-6210 and is the annual amount of CO2 tons available in
 Virginia for allocation in a given allocation year, in accordance with the CO2
 Budget Trading Program. [ CO2 Conditional ]
 CCR allowances offered for sale at an auction are separate from and
 additional to [ CO2 conditional ]
 allowances allocated from the Virginia CO2 Budget Trading Program
 adjusted budget.
 
 "Virginia CO2 Budget Trading Program base
 budget" means the budget specified in 9VAC5-140-6190. [ CO2
 Conditional ] CCR allowances offered for sale at an auction are
 separate from and additional to [ CO2
 conditional ] allowances allocated from the Virginia CO2
 Budget Trading Program base budget.
 
  9VAC5-140-6030. Measurements, abbreviations, and
 acronyms.
 
 Measurements, abbreviations, and acronyms used in this part
 are defined as follows: 
 
 Btu - British thermal unit.
 
 CAA - federal Clean Air Act.
 
 CCR - cost containment reserve.
 
 CEMS - Continuous Emissions Monitoring System.
 
 COATS - CO2 Allowance Tracking System.
 
 CO2 - carbon dioxide.
 
 DAHS - Data Acquisition and Handling System.
 
 EEM - efficiency measure. 
 
 H2O - water.
 
 lb - pound.
 
 LME - low mass emissions.
 
 MMBtu - million British thermal units.
 
 MW - megawatt.
 
 MWe - megawatt electrical.
 
 MWh - megawatt hour.
 
 NOX - nitrogen oxides.
 
 O2 - oxygen.
 
 ORIS - Office of Regulatory Information Systems.
 
 QA/QC - quality assurance/quality control.
 
 ppm - parts per million.
 
 scf - standard cubic feet per hour. 
 
 SO2 - sulfur dioxide.
 
 9VAC5-140-6040. Applicability.
 
 A. Any fossil fuel-fired unit that serves an electricity
 generator with a nameplate capacity equal to or greater than 25 MWe shall be a
 CO2 budget unit, and any source that includes one or more such units
 shall be a CO2 budget source, subject to the requirements of this
 part. 
 
 B. Exempt from the requirements of this part is any
 [ fossil fuel ] power generating unit owned by an
 individual facility and located at that individual facility that generates
 electricity and heat from fossil fuel for the primary use of operation of the
 facility CO2 budget source located at or adjacent to and
 physically interconnected with a manufacturing facility that, prior to January
 1, 2019, and in every subsequent calendar year, met either of the following
 requirements:
 
 1. Supplies less than or equal to 10% of its annual net
 electrical generation to the electric grid; or 
 
 2. Supplies less than or equal to 15% of its annual total
 useful energy to any entity other than the manufacturing facility to which the
 CO2 budget source is interconnected.
 
 For the purpose of subdivision 1 of this subsection,
 annual net electrical generation shall be determined as follows:
 
 (ES – EP) / EG x 100
 
 Where:
 
 ES = electricity sales to the grid from the CO2
 budget source
 
 EP = electricity purchases from the grid by the CO2
 budget source and the manufacturing facility to which the CO2 budget
 source is interconnected
 
 EG = electricity generation
 
 Such CO2 budget source shall have an operating
 permit containing the applicable restrictions under this subsection.
 
 [ 9VAC5-140-6045. CO2 Budget Trading Program
 implementation.
 
 In the event the allocation of conditional allowances by
 the department as required by 9VAC5-140-6190 B has not occurred by January 1,
 2020, the program will be considered to be operating and effective as of the
 calendar year following the date on which the department allocates the
 conditional allowances as it corresponds to the schedule of 9VAC5-140-6190 A.
 Permitting and compliance dates, including the due date for a permit as
 required by 9VAC5-140-6150, shall be adjusted to be in force six months after
 the date the department allocates the conditional allowances. Any excess emissions
 tonnage identified by the new program implementation date may be addressed
 through program review and regulatory action as necessary to ensure compliance
 with the final compliance date. The department will notify the board and each
 affected CO2 budget source accordingly. ]
 
 9VAC5-140-6050. Standard requirements.
 
 A. Permit requirements shall be as follows.
 
 1. The CO2 authorized account representative of
 each CO2 budget source required to have an operating permit pursuant
 to 9VAC5-85 (Permits for Stationary Sources of Pollutants Subject to
 Regulation) and each CO2 budget unit required to have an operating
 permit pursuant to 9VAC5-85 shall:
 
 a. Submit to the department a complete CO2
 budget permit application under 9VAC5-140-6160 in accordance with the deadlines
 specified in 9VAC5-140-6150; and
 
 b. Submit in a timely manner any supplemental information
 that the department determines is necessary in order to review the CO2
 budget permit application and issue or deny a CO2 budget permit.
 
 2. The owners and operators of each CO2 budget
 source required to have an operating permit pursuant to 9VAC5-85 (Permits for
 Stationary Sources of Pollutants Subject to Regulation) and each CO2
 budget unit required to have an operating permit pursuant to 9VAC5-85 for the
 source shall have a CO2 budget permit and operate the CO2
 budget source and the CO2 budget unit at the source in compliance
 with such CO2 budget permit.
 
 B. Monitoring requirements shall be as follows.
 
 1. The owners and operators and, to the extent applicable,
 the CO2 authorized account representative of each CO2
 budget source and each CO2 budget unit at the source shall comply
 with the monitoring requirements of Article 8 (9VAC5-140-6330 et seq.) of this
 part.
 
 2. The emissions measurements recorded and reported in
 accordance with Article 8 (9VAC5-140-6330 et seq.) of this part shall be used
 to determine compliance by the unit with the CO2 requirements under
 subsection C of this section.
 
 C. CO2 requirements shall be as follows.
 
 1. The owners and operators of each CO2 budget
 source and each CO2 budget unit at the source shall hold CO2
 allowances available for compliance deductions under 9VAC5-140-6260, as of the
 CO2 allowance transfer deadline, in the source's compliance account
 in an amount not less than the total CO2 emissions [ that
 have been generated as a result of combusting fossil fuel ] for the
 [ initial control period, an interim control period, or ] control
 period from all CO2 budget units at the source, less the CO2
 allowances deducted to meet the requirements of subdivision 2 of this
 subsection, with respect to the previous two interim control periods as
 determined in accordance with Article 6 (9VAC5-140-6220 et seq.) and Article 8
 (9VAC5-140-6330 et seq.) of this part.
 
 2. The owners and operators of each CO2 budget
 source and each CO2 budget unit at the source shall hold CO2
 allowances available for compliance deductions under 9VAC5-140-6260, as of the
 CO2 allowance transfer deadline, in the source's compliance account
 in an amount not less than the total CO2 emissions [ that
 have been generated as a result of combusting fossil fuel ] for the
 [ initial control period, an interim control period, or ] for
 the interim control period from all CO2 budget units at the source
 multiplied by 0.50, as determined in accordance with Article 6 (9VAC5-140-6220
 et seq.) and Article 8 (9VAC5-140-6330 et seq.) of this part.
 
 3. Each ton of CO2 emitted in excess of the CO2
 budget emissions limitation for [ the initial control period or ]
 a control period shall constitute a separate violation of this part and
 applicable state law.
 
 4. Each ton of excess interim emissions shall constitute a
 separate violation of this part and applicable state law.
 
 5. A CO2 budget unit shall be subject to the
 requirements under subdivision 1 of this subsection starting on the later of
 January 1, 2020, or the date on which the unit commences operation.
 
 6. CO2 allowances shall be held in, deducted
 from, or transferred among COATS accounts in accordance with Article 5
 (9VAC5-140-6190 et seq.), Article 6 (9VAC5-140-6220 et seq.), and Article 7
 (9VAC5-140-6300 et seq.) of this part.
 
 7. A CO2 allowance shall not be deducted, to
 comply with the requirements under subdivision 1 or 2 of this subsection, for a
 control period that ends prior to the year for which the CO2
 allowance was allocated.
 
 8. A CO2 allowance under the CO2
 Budget Trading Program is a limited authorization by the department to emit one
 ton of CO2 in accordance with the CO2 Budget Trading
 Program. No provision of the CO2 Budget Trading Program, the CO2
 budget permit application, or the CO2 budget permit or any provision
 of law shall be construed to limit the authority of the department or a
 participating state to terminate or limit such authorization.
 
 9. A CO2 allowance under the CO2
 Budget Trading Program does not constitute a property right.
 
 D. The owners and operators of a CO2 budget
 source that has excess emissions in [ any an initial
 control period or a ] control period shall:
 
 1. Forfeit the CO2 allowances required for
 deduction under 9VAC5-140-6260 D 1; and
 
 2. Pay any fine, penalty, or assessment or comply with any
 other remedy imposed under 9VAC5-140-6260 D 2.
 
 E. Recordkeeping and reporting requirements shall be as
 follows:
 
 1. Unless otherwise provided, the owners and operators of
 the CO2 budget source and each CO2 budget unit at the source
 shall keep on site at the source each of the following documents for a period
 of 10 years from the date the document is created. This period may be extended
 for cause, at any time prior to the end of 10 years, in writing by the
 department.
 
 a. The account certificate of representation for the CO2
 authorized account representative for the source and each CO2 budget
 unit at the source and all documents that demonstrate the truth of the
 statements in the account certificate of representation, in accordance with
 9VAC5-140-6110, provided that the certificate and documents shall be retained
 on site at the source beyond such 10-year period until such documents are
 superseded because of the submission of a new account certificate of
 representation changing the CO2 authorized account representative.
 
 b. All emissions monitoring information, in accordance with
 Article 8 (9VAC5-140-6330 et seq.) of this part and 40 CFR 75.57.
 
 c. Copies of all reports, compliance certifications, and
 other submissions and all records made or required under the CO2
 Budget Trading Program.
 
 d. Copies of all documents used to complete a CO2
 budget permit application and any other submission under the CO2
 Budget Trading Program or to demonstrate compliance with the requirements of
 the CO2 Budget Trading Program.
 
 2. The CO2 authorized account representative of
 a CO2 budget source and each CO2 budget unit at the
 source shall submit the reports and compliance certifications required under
 the CO2 Budget Trading Program, including those under Article 4
 (9VAC5-140-6170 et seq.) of this part.
 
 F. Liability requirements shall be as follows.
 
 1. No permit revision shall excuse any violation of the
 requirements of the CO2 Budget Trading Program that occurs prior to
 the date that the revision takes effect.
 
 2. Any provision of the CO2 Budget Trading
 Program that applies to a CO2 budget source, including a provision
 applicable to the CO2 authorized account representative of a CO2
 budget source, shall also apply to the owners and operators of such source and
 of the CO2 budget units at the source.
 
 3. Any provision of the CO2 Budget Trading
 Program that applies to a CO2 budget unit, including a provision
 applicable to the CO2 authorized account representative of a CO2
 budget unit, shall also apply to the owners and operators of such unit.
 
 G. No provision of the CO2 Budget Trading
 Program, a CO2 budget permit application, or a CO2 budget
 permit shall be construed as exempting or excluding the owners and operators
 and, to the extent applicable, the CO2 authorized account
 representative of the CO2 budget source or CO2 budget
 unit from compliance with any other provisions of applicable state and federal
 law or regulations.
 
 9VAC5-140-6060. Computation of time.
 
 A. Unless otherwise stated, any time period scheduled,
 under the CO2 Budget Trading Program, to begin on the occurrence of
 an act or event shall begin on the day the act or event occurs. 
 
 B. Unless otherwise stated, any time period scheduled,
 under the CO2 Budget Trading Program, to begin before the occurrence
 of an act or event shall be computed so that the period ends the day before the
 act or event occurs. 
 
 C. Unless otherwise stated, if the final day of any time
 period, under the CO2 Budget Trading Program, falls on a weekend or
 a state or federal holiday, the time period shall be extended to the next
 business day.
 
 9VAC5-140-6070. Severability.
 
 If any provision of this part, or its application to any
 particular person or circumstances, is held invalid, the remainder of this
 part, and the application thereof to other persons or circumstances, shall not
 be affected thereby. 
 
 Article 2
 CO2 Authorized Account Representative for CO2 Budget
 Sources
 
 9VAC5-140-6080. Authorization and responsibilities of the CO2
 authorized account representative.
 
 A. Except as provided under 9VAC5-140-6090, each CO2
 budget source, including all CO2 budget units at the source, shall
 have one and only one CO2 authorized account representative, with
 regard to all matters under the CO2 Budget Trading Program
 concerning the source or any CO2 budget unit at the source.
 
 B. The CO2 authorized account representative of
 the CO2 budget source shall be selected by an agreement binding on
 the owners and operators of the source and all CO2 budget units at
 the source and must act in accordance with the [ account ]
 certificate of representation under 9VAC5-140-6110.
 
 C. Upon receipt by the department or its agent of a
 complete account certificate of representation under 9VAC5-140-6110, the CO2
 authorized account representative of the source shall represent and, by his
 representations, actions, inactions, or submissions, legally bind each owner
 and operator of the CO2 budget source represented and each CO2
 budget unit at the source in all matters pertaining to the CO2
 Budget Trading Program, notwithstanding any agreement between the CO2
 authorized account representative and such owners and operators. The owners and
 operators shall be bound by any decision or order issued to the CO2
 authorized account representative by the department or a court regarding the
 source or unit.
 
 D. No CO2 budget permit shall be issued, and no
 COATS account shall be established for a CO2 budget source, until
 the department or its agent has received a complete account certificate of
 representation under 9VAC5-140-6110 for a CO2 authorized account
 representative of the source and the CO2 budget units at the source.
 
 E. Each submission under the CO2 Budget Trading
 Program shall be submitted, signed, and certified by the CO2
 authorized account representative for each CO2 budget source on
 behalf of which the submission is made. Each such submission shall include the
 following certification statement by the CO2 authorized account
 representative: "I am authorized to make this submission on behalf of the
 owners and operators of the CO2 budget sources or CO2
 budget units for which the submission is made. I certify under penalty of law
 that I have personally examined, and am familiar with, the statements and
 information submitted in this document and all its attachments. Based on my
 inquiry of those individuals with primary responsibility for obtaining the
 information, I certify that the statements and information are to the best of
 my knowledge and belief true, accurate, and complete. I am aware that there are
 significant penalties for submitting false statements and information or
 omitting required statements and information, including the possibility of fine
 or imprisonment."
 
 F. The department or its agent will accept or act on a
 submission made on behalf of owners or operators of a CO2 budget
 source or a CO2 budget unit only if the submission has been made,
 signed, and certified in accordance with subsection E of this section.
 
 9VAC5-140-6090. Alternate CO2 authorized
 alternate account representative.
 
 A. An account certificate of representation may designate
 one and only one alternate CO2 authorized alternate account
 representative who may act on behalf of the CO2 authorized account
 representative. The agreement by which the alternate CO2
 authorized alternate account representative is selected shall include a
 procedure for authorizing the alternate CO2 authorized
 alternate account representative to act in lieu of the CO2
 authorized account representative. 
 
 B. Upon receipt by the department or its agent of a
 complete account certificate of representation under 9VAC5-140-6110, any
 representation, action, inaction, or submission by the alternate CO2
 authorized alternate account representative shall be deemed to be a
 representation, action, inaction, or submission by the CO2
 authorized account representative. 
 
 C. Except in this section and 9VAC5-140-6080 A,
 9VAC5-140-6100, 9VAC5-140-6110, and 9VAC5-140-6230, whenever the term "CO2
 authorized account representative" is used in this part, the term shall be
 construed to include the alternate CO2 authorized alternate
 account representative.
 
 9VAC5-140-6100. Changing the CO2 authorized
 account representatives and the alternate CO2 authorized
 alternate account representative; changes in the owners and operators.
 
 A. The CO2 authorized account representative
 may be changed at any time upon receipt by the department or its agent of a
 superseding complete account certificate of representation under
 9VAC5-140-6110. Notwithstanding any such change, all representations, actions,
 inactions, and submissions by the previous CO2 authorized account
 representative or alternate CO2 authorized alternate account
 representative prior to the time and date when the department or its agent
 receives the superseding account certificate of representation shall be binding
 on the new CO2 authorized account representative and the owners and
 operators of the CO2 budget source and the CO2 budget
 units at the source.
 
 B. The alternate CO2 authorized
 alternate account representative may be changed at any time upon receipt by the
 department or its agent of a superseding complete account certificate of
 representation under 9VAC5-140-6110. Notwithstanding any such change, all
 representations, actions, inactions, and submissions by the previous or
 alternate CO2 authorized alternate account representative or alternate
 CO2 authorized alternate account representative prior to the time
 and date when the department or its agent receives the superseding account
 certificate of representation shall be binding on the new alternate CO2
 authorized alternate account representative and the owners and operators of the
 CO2 budget source and the CO2 budget units at the source.
 
 
 C. Changes in the owners and operators shall be addressed
 as follows.
 
 1. In the event a new owner or operator of a CO2
 budget source or a CO2 budget unit is not included in the list of
 owners and operators submitted in the account certificate of representation,
 such new owner or operator shall be deemed to be subject to and bound by the
 account certificate of representation, the representations, actions, inactions,
 and submissions of the CO2 authorized account representative and any
 alternate CO2 authorized alternate account representative of
 the source or unit, and the decisions, orders, actions, and inactions of the
 department, as if the new owner or operator were included in such list. 
 
 2. Within 30 days following any change in the owners and
 operators of a CO2 budget source or a CO2 budget unit,
 including the addition of a new owner or operator, the CO2
 authorized account representative or alternate CO2
 authorized alternate account representative shall submit a revision to the
 account certificate of representation amending the list of owners and operators
 to include the change.
 
 9VAC5-140-6110. Account certificate of representation.
 
 A. A complete account certificate of representation for a
 CO2 authorized account representative or an alternate a
 CO2 authorized alternate account representative shall include the
 following elements in a format prescribed by the department or its agent: 
 
 1. Identification of the CO2 budget source and
 each CO2 budget unit at the source for which the account certificate
 of representation is submitted; 
 
 2. The name, address, email address, telephone number, and
 facsimile transmission number of the CO2 authorized account
 representative and any alternate CO2 authorized alternate
 account representative; 
 
 3. A list of the owners and operators of the CO2
 budget source and of each CO2 budget unit at the source; 
 
 4. The following certification statement by the CO2
 authorized account representative and any alternate CO2
 authorized alternate account representative: "I certify that I was
 selected as the CO2 authorized account representative or alternate
 CO2 authorized alternate account representative, as applicable, by
 an agreement binding on the owners and operators of the CO2 budget
 source and each CO2 budget unit at the source. I certify that I have
 all the necessary authority to carry out my duties and responsibilities under
 the CO2 Budget Trading Program on behalf of the owners and operators
 of the CO2 budget source and of each CO2 budget unit at
 the source and that each such owner and operator shall be fully bound by my
 representations, actions, inactions, or submissions and by any decision or
 order issued to me by the department or a court regarding the source or
 unit."; and 
 
 5. The signature of the CO2 authorized account
 representative and any alternate CO2 authorized alternate
 account representative and the dates signed. 
 
 B. Unless otherwise required by the department or its
 agent, documents of agreement referred to in the account certificate of
 representation shall not be submitted to the department or its agent. Neither
 the department nor its agent shall be under any obligation to review or
 evaluate the sufficiency of such documents, if submitted. 
 
 9VAC5-140-6120. Objections concerning the CO2
 authorized account representative.
 
 A. Once a complete account certificate of representation
 under 9VAC5-140-6110 has been submitted and received, the department and its
 agent will rely on the account certificate of representation unless and until
 the department or its agent receives a superseding complete account certificate
 of representation under 9VAC5-140-6110. 
 
 B. Except as provided in 9VAC5-140-6100 A or B, no
 objection or other communication submitted to the department or its agent
 concerning the authorization, or any representation, action, inaction, or
 submission of the CO2 authorized account representative shall affect
 any representation, action, inaction, or submission of the CO2
 authorized account representative or the finality of any decision or order by
 the department or its agent under the CO2 Budget Trading Program. 
 
 C. Neither the department nor its agent will adjudicate
 any private legal dispute concerning the authorization or any representation,
 action, inaction, or submission of any CO2 authorized account
 representative, including private legal disputes concerning the proceeds of CO2
 allowance transfers.
 
 9VAC5-140-6130. Delegation by CO2 authorized
 account representative and alternate CO2 authorized alternate
 account representative.
 
 A. A CO2 authorized account representative may
 delegate, to one or more natural persons, his authority to make an electronic
 submission to the department or its agent under this part.
 
 B. An alternate A CO2 authorized
 alternate account representative may delegate, to one or more natural persons,
 his authority to make an electronic submission to the department or its agent
 under this part.
 
 C. To delegate authority to make an electronic submission
 to the department or its agent in accordance with subsections A and B of this
 section, the CO2 authorized account representative or alternate
 CO2 authorized alternate account representative, as appropriate,
 shall submit to the department or its agent a notice of delegation, in a format
 prescribed by the department that includes the following elements:
 
 1. The name, address, email address, telephone number, and
 facsimile transmission number of such CO2 authorized account
 representative or alternate CO2 authorized alternate account
 representative;
 
 2. The name, address, email address, telephone number, and
 facsimile transmission number of each such natural person, referred to as the
 "electronic submission agent";
 
 3. For each such natural person, a list of the type of
 electronic submissions under subsection A or B of this section for which
 authority is delegated to him; and 
 
 4. The following certification statement by such CO2
 authorized account representative or alternate CO2 authorized
 alternate account representative: "I agree that any electronic submission
 to the department or its agent that is by a natural person identified in this
 notice of delegation and of a type listed for such electronic submission agent
 in this notice of delegation and that is made when I am a CO2
 authorized account representative or alternate CO2 authorized
 alternate account representative, as appropriate, and before this notice of
 delegation is superseded by another notice of delegation under 9VAC5-140-6130 D
 shall be deemed to be an electronic submission by me. Until this notice of
 delegation is superseded by another notice of delegation under 9VAC5-140-6130
 D, I agree to maintain an email account and to notify the department or its agent
 immediately of any change in my email address unless all delegation authority
 by me under 9VAC5-140-6130 is terminated."
 
 D. A notice of delegation submitted under subsection C of
 this section shall be effective, with regard to the CO2 authorized
 account representative or alternate CO2 authorized alternate
 account representative identified in such notice, upon receipt of such notice
 by the department or its agent and until receipt by the department or its agent
 of a superseding notice of delegation by such CO2 authorized account
 representative or alternate CO2 authorized alternate account
 representative as appropriate. The superseding notice of delegation may replace
 any previously identified electronic submission agent, add a new electronic
 submission agent, or eliminate entirely any delegation of authority.
 
 E. Any electronic submission covered by the certification
 in subdivision C 4 of this section and made in accordance with a notice of
 delegation effective under subsection D of this section shall be deemed to be
 an electronic submission by the CO2 authorized account
 representative or alternate CO2 authorized alternate account
 representative submitting such notice of delegation.
 
 F. A CO2 authorized account representative may
 delegate, to one or more natural persons, his authority to review information
 in the CO2 allowance tracking system under this part.
 
 G. An alternate A CO2 authorized
 alternate account representative may delegate, to one or more natural persons,
 his authority to review information in the CO2 allowance tracking
 system under this part.
 
 H. To delegate authority to review information in the CO2
 allowance tracking system in accordance with subsections F and G of this
 section, the CO2 authorized account representative or alternate
 CO2 authorized alternate account representative, as appropriate, must
 shall submit to the department or its agent a notice of delegation, in a format
 prescribed by the department that includes the following elements:
 
 1. The name, address, email address, telephone number, and
 facsimile transmission number of such CO2 authorized account
 representative or alternate CO2 authorized alternate account
 representative;
 
 2. The name, address, email address, telephone number, and
 facsimile transmission number of each such natural person, referred to as the
 "reviewer";
 
 3. For each such natural person, a list of the type of
 information under subsection F or G of this section for which authority is
 delegated to him; and
 
 4. The following certification statement by such CO2
 authorized account representative or alternate CO2 authorized
 alternate account representative: "I agree that any information that is
 reviewed by a natural person identified in this notice of delegation and of a
 type listed for such information accessible by the reviewer in this notice of
 delegation and that is made when I am a CO2 authorized account
 representative or alternate CO2 authorized alternate account
 representative, as appropriate, and before this notice of delegation is
 superseded by another notice of delegation under subsection I of this section
 shall be deemed to be a reviewer by me. Until this notice of delegation is
 superseded by another notice of delegation under subsection I of this section,
 I agree to maintain an email account and to notify the department or its agent
 immediately of any change in my email address unless all delegation authority
 by me under this section is terminated."
 
 I. A notice of delegation submitted under subsection H of
 this section shall be effective, with regard to the CO2 authorized
 account representative or alternate CO2 authorized alternate
 account representative identified in such notice, upon receipt of such notice
 by the department or its agent and until receipt by the department or its agent
 of a superseding notice of delegation by such CO2 authorized account
 representative or alternate CO2 authorized alternate account
 representative as appropriate. The superseding notice of delegation may replace
 any previously identified reviewer, add a new reviewer, or eliminate entirely
 any delegation of authority.
 
 Article 3
 Permits
 
 9VAC5-140-6140. CO2 budget permit requirements.
 
 A. Each CO2 budget source shall have a permit
 issued by the department pursuant to 9VAC5-85 (Permits for Stationary Sources
 of Pollutants Subject to Regulation). 
 
 B. Each CO2 budget permit shall contain all
 applicable CO2 Budget Trading Program requirements and shall be a
 complete and distinguishable portion of the permit under subsection A of this
 section.
 
 9VAC5-140-6150. Submission of CO2 budget permit
 applications.
 
 For any CO2 budget source, the CO2
 authorized account representative shall submit a complete CO2 budget
 permit application under 9VAC5-140-6160 covering such CO2 budget
 source to the department by the later of January 1, 2020, or 12 months before
 the date on which the CO2 budget source, or a new unit at the
 source, commences operation.
 
 9VAC5-140-6160. Information requirements for CO2
 budget permit applications.
 
 A complete CO2 budget permit application shall
 include the following elements concerning the CO2 budget source for
 which the application is submitted, in a format prescribed by the department:
 
 1. Identification of the CO2 budget source,
 including plant name and the ORIS (Office of Regulatory Information Systems) or
 facility code assigned to the source by the Energy Information Administration
 of the U.S. Department of Energy if applicable; 
 
 2. Identification of each CO2 budget unit at the
 CO2 budget source; and 
 
 3. The standard requirements under 9VAC5-140-6050.
 
 Article 4
 Compliance Certification
 
 9VAC5-140-6170. Compliance certification report.
 
 A. For [ the initial control period and ]
 each control period in which a CO2 budget source is subject to
 the CO2 requirements of 9VAC5-140-6050 C, the CO2
 authorized account representative of the source shall submit to the department
 by March 1 following the relevant control period, a compliance certification
 report. A compliance certification report is not required as part of the
 compliance obligation during an interim control period.
 
 B. The CO2 authorized account representative
 shall include in the compliance certification report under subsection A of this
 section the following elements, in a format prescribed by the department:
 
 1. Identification of the source and each CO2
 budget unit at the source;
 
 2. At the CO2 authorized account representative's
 option, the serial numbers of the CO2 allowances that are to be
 deducted from the source's compliance account under 9VAC5-140-6260 for the
 control period; and
 
 3. The compliance certification under subsection C of this
 section.
 
 C. In the compliance certification report under subsection
 A of this section, the CO2 authorized account representative shall
 certify, based on reasonable inquiry of those persons with primary
 responsibility for operating the source and the CO2 budget units at
 the source in compliance with the CO2 Budget Trading Program,
 whether the source and each CO2 budget unit at the source for which
 the compliance certification is submitted was operated during the calendar
 years covered by the report in compliance with the requirements of the CO2
 Budget Trading Program, including:
 
 1. Whether the source was operated in compliance with the
 CO2 requirements of 9VAC5-140-6050 C;
 
 2. Whether the monitoring plan applicable to each unit at
 the source has been maintained to reflect the actual operation and monitoring
 of the unit, and contains all information necessary to attribute CO2
 emissions to the unit, in accordance with Article 8 (9VAC5-140-6330 et seq.) of
 this part;
 
 3. Whether all the CO2 emissions from the units
 at the source were monitored or accounted for through the missing data
 procedures and reported in the quarterly monitoring reports, including whether
 conditional data were reported in the quarterly reports in accordance with
 Article 8 (9VAC5-140-6330 et seq.) of this part. If conditional data were
 reported, the owner or operator shall indicate whether the status of all
 conditional data has been resolved and all necessary quarterly report
 resubmissions have been made;
 
 4. Whether the facts that form the basis for certification
 under Article 8 (9VAC5-140-6330 et seq.) of this part of each monitor at each
 unit at the source, or for using an excepted monitoring method or alternative
 monitoring method approved under Article 8 (9VAC5-140-6330 et seq.) of this
 part, if any, have changed; and
 
 5. If a change is required to be reported under subdivision
 4 of this subsection, specify the nature of the change, the reason for the
 change, when the change occurred, and how the unit's compliance status was
 determined subsequent to the change, including what method was used to
 determine emissions when a change mandated the need for monitor
 recertification.
 
 9VAC5-140-6180. Action on compliance certifications.
 
 A. The department or its agent may review and conduct
 independent audits concerning any compliance certification or any other
 submission under the CO2 Budget Trading Program and make appropriate
 adjustments of the information in the compliance certifications or other
 submissions. 
 
 B. The department or its agent may deduct CO2
 allowances from or transfer CO2 allowances to a source's compliance
 account based on the information in the compliance certifications or other
 submissions, as adjusted under subsection A of this section.
 
 Article 5 
 CO2 Allowance Allocations
 
 Editor's Note: Two versions of 9VAC5-140-6190 are
 provided for comment. The board seeks comment on whether the base budget should
 be 33 million tons or 34 million tons, with corresponding 3.0% per year
 reductions. The first version (Version 1) represents a 33 million ton base
 budget, and the second version (Version 2) represents a 34 million ton base
 budget. 
 
 9VAC5-140-6190. Base budgets.
 
 Version
 1, 33 million ton base budget: 
 
 A. The Virginia CO2 Budget Trading Program base
 budget shall be as follows:
 
 1. For 2020, the Virginia CO2 Budget Trading Program
 base budget is 33 28 million tons.
 
 2. For 2021, the Virginia CO2 Budget Trading
 Program base budget is 32.01 27.16 million tons.
 
 3. For 2022, the Virginia CO2 Budget Trading
 Program base budget is 31.02 26.32 million tons.
 
 4. For 2023, the Virginia CO2 Budget Trading
 Program base budget is 30.03 25.48 million tons.
 
 5. For 2024, the Virginia CO2 Budget Trading
 Program base budget is 29.04 24.64 million tons.
 
 6. For 2025, the Virginia CO2 Budget Trading
 Program base budget is 28.05 23.80 million tons.
 
 7. For 2026, the Virginia CO2 Budget Trading
 Program base budget is 27.06 22.96 million tons.
 
 8. For 2027, the Virginia CO2 Budget Trading
 Program base budget is 26.07 22.12 million tons.
 
 9. For 2028, the Virginia CO2 Budget Trading
 Program base budget is 25.08 21.28 million tons.
 
 10. For 2029, the Virginia CO2 Budget Trading
 Program base budget is 24.09 20.44 million tons.
 
 11. For 2030, the Virginia CO2 Budget Trading
 Program base budget is 23.10 19.60 million tons.
 
 B. The department will allocate conditional allowances to
 CO2 budget units and to DMME. After a conditional allowance has been
 consigned in an auction by a CO2 budget unit [ and
 or ] the holder of a public contract with DMME as specified under
 Article 9 (9VAC5-140-6410 et seq.) of this part, the conditional allowance
 becomes [ an allowance to be used for compliance purposes
 a CO2 allowance once it is sold to an auction participant ].
 
 C. For 2031 and each succeeding calendar year, the
 Virginia CO2 Budget Trading Program base budget is 23.10 million
 tons [ the department will review the Virginia CO2
 Budget Trading Program base budget and recommend to the board appropriate
 adjustments in the base budget for such succeeding years. The department will
 consider the best available science and all relevant information and policies
 available from any CO2 multistate trading program in which Virginia
 is participating when considering further reductions. Absent any adjustment,
 the Virginia CO2 Budget Trading Program base budget for each year of
 the decade 2031-2040 shall be reduced by 840,000 tons from the preceding year
 the Virginia CO2 Budget Trading Program base budget is 19.60 million
 tons unless modified as a result of a program review and future regulatory
 action ].
 
 Version
 2, 34 million ton base budget:
 
 A. The Virginia CO2 Budget Trading Program
 base budget shall be as follows:
 
 1. For 2020, the Virginia CO2 Budget Trading
 Program base budget is 34 million tons.
 
 2. For 2021, the Virginia CO2 Budget Trading
 Program base budget is 32.98 million tons.
 
 3. For 2022, the Virginia CO2 Budget Trading
 Program base budget is 31.96 million tons.
 
 4. For 2023, the Virginia CO2 Budget Trading
 Program base budget is 30.94 million tons.
 
 5. For 2024, the Virginia CO2 Budget Trading
 Program base budget is 29.92 million tons.
 
 6. For 2025, the Virginia CO2 Budget Trading
 Program base budget is 28.90 million tons.
 
 7. For 2026, the Virginia CO2 Budget Trading
 Program base budget is 27.88 million tons.
 
 8. For 2027, the Virginia CO2 Budget Trading
 Program base budget is 26.86 million tons.
 
 9. For 2028, the Virginia CO2 Budget Trading
 Program base budget is 25.84 million tons.
 
 10. For 2029, the Virginia CO2 Budget Trading
 Program base budget is 24.82 million tons.
 
 11. For 2030, the Virginia CO2 Budget Trading
 Program base budget is 23.80 million tons.
 
 B. The department will allocate conditional allowances
 to CO2 budget units and to DMME. After a conditional allowance has
 been consigned in an auction by a CO2 budget unit and the holder of
 a public contract with DMME as specified under Article 9 (9VAC5-140-6410 et
 seq.) of this part, the conditional allowance becomes an allowance to be used
 for compliance purposes.
 
 C. For 2031 and each succeeding calendar year, the
 Virginia CO2 Budget Trading Program base budget is 23.80 million
 tons. 
 
 9VAC5-140-6200. Undistributed and unsold [ CO2
 conditional ] allowances.
 
 A. The department may will retire undistributed CO2
 conditional allowances at the end of [ the initial control period
 and ] each [ subsequent ] control period. 
 
 B. The department may will retire unsold CO2
 conditional allowances at the end of [ the initial control period
 and ] each [ subsequent ] control period.
 
 Editor's
 Note:
 Two versions of 9VAC5-140-6210 are provided for comment. The board seeks
 comment on whether the base budget should be 33 million tons or 34 million
 tons, with corresponding 3.0% per year reductions. The first version (Version
 1) represents a 33 million ton base budget, and the second version (Version 2)
 represents a 34 million ton base budget.
 
 9VAC5-140-6210. [ CO2
 Conditional ] allowance allocations.
 
 Version
 1, 33 million ton base budget:
 
 A. The department will allocate 95% of the Virginia
 CO2 Budget Trading Program base budget [ conditional ]
 allowances to CO2 budget sources to be consigned to auction to
 the Virginia Consignment Auction Account.
 
 B. The department will allocate 5.0% of the Virginia CO2
 Budget Trading Program base budget to DMME to be consigned to auction by DMME
 to assist the department for the abatement and control of air pollution,
 specifically, CO2.
 
 C. B. For allocation years 2020 through
 2031, the Virginia CO2 Budget Trading Program adjusted budget shall
 be the maximum number of allowances available for allocation in a given
 allocation year, except for [ CO2
 conditional ] CCR allowances.
 
 D. C. [ Conditional allowances
 allocated for a calendar year will be automatically transferred to the Virginia
 Consignment Auction Account to be consigned to auction. Following each auction,
 all conditional allowances sold at the auction will be transferred from the
 Virginia Consignment Auction Account to winning bidders' accounts as CO2
 allowances.
 
 D. ] The cost containment reserve (CCR)
 allocation shall be managed as follows. The department will allocate
 [ CO2 conditional ] CCR
 allowances, separate from and additional to the Virginia CO2 Budget
 Trading Program base budget set forth in 9VAC5-140-6190 [ , ]
 to the Virginia [ Consignment ] Auction Account. The
 CCR allocation is for the purpose of containing the cost of CO2
 allowances. The department will allocate [ CO2
 conditional ] CCR allowances as follows [ .: ]
 
 1. The Beginning in
 calendar year 2020, the department will initially allocate 3.3 million [ CO2, ] on
 a pro rata basis to CO2 budget sources, 2.8 million [ conditional ]
 CO2 CCR allowances for calendar year 2020.
 
 2. On or before January 1,
 2021, and each year thereafter, the department will allocate, on a pro rata
 basis to CO2 budget sources, current vintage year [ conditional ] CCR allowances
 equal to the quantity in Table 140-5A [ , and withdraw the
 number of CO2 CCR allowances that remain in the Virginia Auction
 Account at the end of the prior calendar year ].
 
 
  
   | Table 140-5A[ Conditional ] CCR Allowances from 2021 Forward
 | 
  
   | 2021 | 3.2012.716 million tons
 | 
  
   | 2022 | 3.1022.632 million tons
 | 
  
   | 2023 | 3.0032.548 million tons
 | 
  
   | 2024 | 2.9042.464 million tons
 | 
  
   | 2025 | 2.8052.380 million tons
 | 
  
   | 2026 | 2.7062.296 million tons
 | 
  
   | 2027 | 2.6072.212 million tons
 | 
  
   | 2028 | 2.5082.128 million tons
 | 
  
   | 2029 | 2.4092.044 million tons
 | 
  
   | 2030 and each year thereafter | 2.3101.960 million tons
 | 
 
 
 3. The pro rata calculation to be used for the distribution
 of [ CO2 conditional ] CCR
 allowances is as follows:
 
 SAA/TAA * CCR = SCCR
 
 Where:
 
 SAA = source adjusted allocation
 
 TAA = total adjusted allocation
 
 SCCR = source CCR
 
 [ 4. Conditional CCR allowances allocated for a
 calendar year will be automatically transferred to the Virginia Consignment
 Auction Account to be consigned to auction. Following each auction, all
 conditional CCR allowances sold at auction will be transferred to winning
 bidders' accounts as CO2 CCR allowances.
 
 5. Unsold conditional CCR allowances will remain in the
 Virginia Consignment Auction Account to be re-offered for sale at auction
 within the same calendar year. Conditional CCR allowances remaining unsold at
 the end of the calendar year in which they were originated will be made
 unavailable for sale at future auctions. ]
 
 [ E. ] Annual
 base budgets as described in subsections A and B of this section may be
 decreased in any year as necessary to account for transfers to the Virginia
 Emission Containment Reserve (ECR) account and adjustments for banked
 allowances [ D. ] In the event that the ECR
 is triggered during an auction, the department will authorize its agent to
 withhold conditional allowances as needed. The department will further
 authorize its agent to convert and transfer any CO2
 conditional allowances that have been withheld from any auction in the prior
 year into the Virginia ECR account. The ECR withholding is for the purpose
 of additional emission reduction in the event of lower than anticipated
 emission reduction costs. The department department's agent will
 withhold CO2 ECR allowances as follows:
 
 1. If the condition in 9VAC5-140-6420 D 1 is met at an
 auction, then the maximum number of CO2 ECR allowances that will be
 withheld from that auction will be equal to the quantity shown in Table 140-5B
 minus the total quantity of CO2 ECR allowances that have been
 withheld from any prior auction in that calendar year. Any CO2 ECR
 allowances withheld from an auction will be transferred into the Virginia ECR
 account.
 
 
  
   | Table 140-5BECR Allowances from 2021 Forward
 | 
  
   | 2021 | 3.2012.716 million tons
 | 
  
   | 2022 | 3.1022.632 million tons
 | 
  
   | 2023 | 3.0032.548 million tons
 | 
  
   | 2024 | 2.9042.464 million tons
 | 
  
   | 2025 | 2.8052.380 million tons
 | 
  
   | 2026 | 2.7062.296 million tons
 | 
  
   | 2027 | 2.6072.212 million tons
 | 
  
   | 2028 | 2.5082.128 million tons
 | 
  
   | 2029 | 2.4092.044 million tons
 | 
  
   | 2030 and each year thereafter | 2.3101.960 million tons
 | 
 
 
 2. Allowances that have been transferred into the Virginia
 ECR account shall not be withdrawn.
 
 F. E. The adjustment for banked allowances shall
 will be as follows. On March [ 15 17 ], 2021,
 the department will may determine the third adjustment for banked
 allowances quantity for allocation years 2021 through 2025 through the
 application of the following formula: 
 
 TABA = ((TA – TAE)/5) x RS%
 
 Where: 
 
 TABA is the adjustment for banked allowances quantity in
 tons. 
 
 TA, adjustment, is the total quantity of allowances of
 vintage years prior to 2021 held in general and compliance accounts, including
 compliance accounts established pursuant to the CO2 Budget Trading
 Program but not including accounts opened by participating states, as reflected
 in the CO2 Allowance Tracking System on March 15, 2021. 
 
 TAE, adjustment emissions, is the total quantity of 2018,
 2019, and 2020 emissions from all CO2 budget sources in all
 participating states, reported pursuant to CO2 Budget Trading
 Program as reflected in the CO2 Allowance Tracking System on March
 [ 15 17 ], 2021. 
 
 RS% is Virginia budget divided by the regional budget.
 
 G. F. CO2 Budget Trading Program
 adjusted budgets for 2021 through 2025 shall be determined as follows
 [ . On: on April 15, 2021, the department will determine
 the Virginia CO2 Budget Trading Program adjusted budgets for the
 2021 through 2025 allocation years by the following formula:
 
 AB = BB – TABA
 
 Where:
 
 AB is the Virginia CO2 Budget Trading Program
 adjusted budget. 
 
 BB is the Virginia CO2 Budget Trading Program
 base budget. 
 
 TABA is the adjustment for banked allowances quantity in
 tons.
 
 H. G. The department or its agent will publish the
 CO2 trading program adjusted budgets for the 2021 through 2025
 allocation years. 
 
 I. H. Timing requirements for [ CO2
 conditional ] allowance allocations shall be as follows.:
 
 1. By [  May 1 August 25 ],
 2019, the department will submit to RGGI, Inc., its agent the CO2
 conditional allowance allocations, in a format prescribed by RGGI, Inc., and
 in accordance with 9VAC5-140-6215 A and B, for the initial control period,
 2020.
 
 2. By [ May 1 the month and day
 established by subdivision 1 of this subsection ], 2020, the
 department will submit to its agent 50% of the conditional allowance
 allocations in accordance with 9VAC5-140-6215 A and B, for the 2021 control
 period. By [ April 1 the month and day one month
 before the date established by subdivision 1 of this subsection ],
 2021, the department will submit to its agent the remainder of the conditional
 allowance allocations in accordance with 9VAC5-140-6215 A and B, for 2021.
 
 3. By [ May 1, ] 2020
 [ the month and day established by subdivision 1 of this subsection, ]
 2021, and [ May 1 the month and day established by
 subdivision 1 of this subsection ] of every third
 subsequent year thereafter, the department will submit to RGGI, Inc.,
 its agent the [ CO2 conditional ]
 allowance allocations, in a format prescribed by RGGI, Inc., for the
 applicable control period, and in accordance with 9VAC5-140-6215 A and
 B.
 
 I. J. Implementation of the CCR (subsection
 C of this section), the ECR (subsection D of this section) and the banking
 adjustment (subsection E of this section) shall be determined based on the
 extent of the CO2 trading program.
 
 [ K. Conditional allowances and conditional CCR
 allowances allocated for a calendar year will be automatically transferred to
 the Virginia Consignment Auction Account to be consigned to auction. Following
 each auction, all conditional allowances sold at the auction will be transferred
 from the Virginia Consignment Auction Account to winning bidders' accounts as
 CO2 allowances. Conditional CCR allowances sold at auction will be
 transferred to winning bidders' accounts as CO2 CCR allowances.
 Unsold conditional CCR allowances will remain in the Virginia Consignment
 Auction Account to be re-offered for sale at auction within the same calendar
 year. Conditional CCR allowances remaining unsold at the end of the calendar
 year in which they were originated will be made unavailable for sale at future
 auctions. ]
 
 Version
 2, 34 million ton base budget:
 
 A. The department will allocate 95% of the Virginia CO2
 Budget Trading Program base budget to CO2 budget sources to be
 consigned to auction to the Virginia Consignment Auction Account.
 
 B. The department will allocate 5.0% of the Virginia CO2
 Budget Trading Program base budget to DMME to be consigned to auction by the
 holder of a public contract with DMME to assist the department for the
 abatement and control of air pollution, specifically CO2.
 
 C. For allocation years 2020 through 2031, the Virginia
 CO2 Budget Trading Program adjusted budget shall be the maximum
 number of allowances available for allocation in a given allocation year,
 except for CO2 CCR allowances.
 
 D. The cost containment reserve (CCR) allocation shall
 be managed as follows. The department will allocate CO2 CCR
 allowances, separate from and additional to the Virginia CO2 Budget
 Trading Program base budget set forth in 9VAC5-140-6190, to the Virginia
 Auction Account. The CCR allocation is for the purpose of containing the cost
 of CO2 allowances. The department will allocate CO2 CCR
 allowances as follows.
 
 1. The department will initially allocate 3.4 million CO2
 CCR allowances for calendar year 2020.
 
 2. On or before January 1, 2021, and each year
 thereafter, the department will allocate current vintage year CCR allowances
 equal to the quantity in Table 140-5A, and withdraw the number of CO2
 CCR allowances that remain in the Virginia Auction Account at the end of the
 prior calendar year.
 
 
  
   | Table 140-5ACCR Allowances from 2021 Forward
 | 
  
   | 2021
 | 3.298 million tons
 | 
  
   | 2022
 | 3.196 million tons
 | 
  
   | 2023
 | 3.094 million tons
 | 
  
   | 2024
 | 2.992 million tons
 | 
  
   | 2025
 | 2.890 million tons
 | 
  
   | 2026
 | 2.788 million tons
 | 
  
   | 2027
 | 2.686 million tons
 | 
  
   | 2028
 | 2.584 million tons
 | 
  
   | 2029
 | 2.482 million tons
 | 
  
   | 2030 and each year thereafter
 | 2.390 million tons
 | 
 
 
 E. Annual base budgets as described in subsections A
 and B of this section may be decreased in any year as necessary to account for
 transfers to the Virginia Emission Containment Reserve (ECR) account and
 adjustments for banked allowances. The department will convert and transfer any
 CO2 allowances that have been withheld from any auction in the prior
 year into the Virginia ECR account. The ECR withholding is for the purpose of
 additional emission reduction in the event of lower than anticipated emission
 reduction costs. The department will withhold CO2 ECR allowances as
 follows:
 
 1. If the condition in 9VAC5-140-6420 D 1 is met at an
 auction, then the maximum number of CO2 ECR allowances that will be
 withheld from that auction will be equal to the quantity shown in Table 140-5B
 minus the total quantity of CO2 ECR allowances that have been
 withheld from any prior auction in that calendar year. Any CO2 ECR
 allowances withheld from an auction will be transferred into the Virginia ECR
 account.
 
 
  
   | Table 140-5BECR Allowances from 2021 Forward
 | 
  
   | 2021
 | 3.298 million tons
 | 
  
   | 2022
 | 3.196 million tons
 | 
  
   | 2023
 | 3.094 million tons
 | 
  
   | 2024
 | 2.992 million tons
 | 
  
   | 2025
 | 2.890 million tons
 | 
  
   | 2026
 | 2.788 million tons
 | 
  
   | 2027
 | 2.686 million tons
 | 
  
   | 2028
 | 2.584 million tons
 | 
  
   | 2029
 | 2.482 million tons
 | 
  
   | 2030 and each year thereafter
 | 2.390 million tons
 | 
 
 
 2. Allowances that have been transferred into the
 Virginia ECR account shall not be withdrawn.
 
 F. The adjustment for banked allowances shall be as
 follows. On March 15, 2021, the department will determine the third adjustment
 for banked allowances quantity for allocation years 2021 through 2025 through
 the application of the following formula:
 
 TABA = ((TA – TAE)/5) x RS%
 
 Where: 
 
 TABA is the adjustment for banked allowances quantity in
 tons. 
 
 TA, adjustment, is the total quantity of allowances of
 vintage years prior to 2021 held in general and compliance accounts, including
 compliance accounts established pursuant to the CO2 Budget Trading
 Program but not including accounts opened by participating states, as reflected
 in the CO2 Allowance Tracking System on March 15, 2021.
 
 TAE, adjustment emissions, is the total quantity of
 2018, 2019, and 2020 emissions from all CO2 budget sources in all
 participating states, reported pursuant to CO2 Budget Trading
 Program as reflected in the CO2 Allowance Tracking System on March
 15, 2021.
 
 RS% is Virginia budget divided by the regional budget.
 
 G. CO2 Budget Trading Program adjusted
 budgets for 2021 through 2025 shall be determined as follows. On April 15,
 2021, the department will determine the Virginia CO2 Budget Trading
 Program adjusted budgets for the 2021 through 2025 allocation years by the
 following formula: 
 
 AB = BB – TABA
 
 Where:
 
 AB is the Virginia CO2 Budget Trading Program
 adjusted budget.
 
 BB is the Virginia CO2 Budget Trading Program
 base budget.
 
 TABA is the adjustment for banked allowances quantity in
 tons.
 
 H. The department or its agent will publish the CO2
 trading program adjusted budgets for the 2021 through 2025 allocation years. 
 
 I. Timing requirements for CO2 allowance
 allocations shall be as follows:
 
 1. By May 1, 2019, the department will submit to RGGI,
 Inc., the CO2 conditional allowance allocations, in a format
 prescribed by RGGI, Inc., and in accordance with 9VAC5-140-6215 A and B, for
 the initial control period, 2020.
 
 2. By May 1, 2020, and May 1 of every third year
 thereafter, the department will submit to RGGI, Inc., the CO2
 allowance allocations, in a format prescribed by RGGI, Inc., for the applicable
 control period, and in accordance with 9VAC5-140-6215 A and B. 
 
 9VAC5-140-6211. [ CO2
 Conditional ] allowance allocations, DMME allowances.
 
 Notwithstanding 9VAC5-140-6210, the department will
 allocate 5.0% of the Virginia CO2 Budget Trading Program base or
 adjusted budget allowances, as applicable, to DMME to be consigned to auction
 by the holder of a public contract with DMME to assist the department for the
 abatement and control of air pollution, specifically CO2, by the
 implementation of programs that lower base and peak electricity demand and
 reduce the cost of the program to consumers and budget sources.
 
 9VAC5-140-6215. [ CO2
 Conditional ] allocation methodology.
 
 A. The net-electric output in MWh used with respect to
 [ CO2 conditional ] allowance
 allocations under subsection B of this section for each CO2 budget
 unit shall be:
 
 1. For units operating on or before January 1, 2020, the
 average of the three amounts of the unit's net-electric output during 2016,
 2017, and 2018 to determine allocations for the initial control period.
 
 2. For all units operating in each control period after
 2020, the average of the three amounts of the unit's total net-electric output
 during the three most recent years for which data are available prior to the
 start of the control period.
 
 B. 1. For each control period beginning in 2020 and
 thereafter, the department will allocate to all CO2 budget units
 that have a net-electric output, as determined under subsection A of this
 section, a total amount of [ CO2 ] conditional
 allowances equal to the CO2 base budget.
 
 2. The department will allocate [ CO2 ]
 conditional allowances to each [ CO2
 conditional ] budget unit under subdivision 1 of this subsection in
 an amount determined by multiplying the total amount of CO2
 allowances allocated under subdivision 1 of this subsection by the ratio of the
 baseline electrical output of such CO2 budget unit to the total
 amount of baseline electrical output of all such CO2 budget units
 and rounding to the nearest whole allowance as appropriate.
 
 3. New CO2 budget units will be allocated
 [ CO2 ] conditional allowances once they
 have established electrical output data to be used in the conditional allowance
 allocation process.
 
 C. For the purpose of the allocation process as described
 in subsections A and B of this section, CO2 budget units shall
 report the unit's net-electric output to the department on a yearly basis as
 follows:
 
 1. By [ March 1 August 25 ],
 2019, each CO2 budget unit shall report yearly net-electric output data
 during 2016, 2017, and 2018.
 
 2. By [ March 1, the month and
 day established by subdivision 1 of this subsection, ] 2020, and
 each year thereafter, each CO2 budget unit shall report yearly
 net-electric output data for the previous year.
 
 Article 6
 CO2 Allowance Tracking System
 
 9VAC5-140-6220. CO2 Allowance Tracking System
 accounts.
 
 A. Consistent with 9VAC5-140-6230 A, the department or its
 agent will establish one compliance account for each CO2 budget
 source. Allocations of [ CO2 ] conditional
 allowances pursuant to Article 5 (9VAC5-140-6190 et seq.) of this part and
 deductions or transfers of [ CO2 ] conditional
 allowances pursuant to 9VAC5-140-6180, 9VAC5-140-6260, 9VAC5-140-6280, or
 Article 7 (9VAC5-140-6300 et seq.) of this part will be recorded in the
 compliance accounts in accordance with this section.
 
 B. Consistent with 9VAC5-140-6230 B, the department or its
 agent will establish, upon request, a general account for any person. Transfers
 of CO2 allowances pursuant to Article 7 (9VAC5-140-6300 et seq.) of
 this part will be recorded in the general account in accordance with this
 article.
 
 9VAC5-140-6230. Establishment of accounts.
 
 A. Upon receipt of a complete account certificate of
 representation under 9VAC5-140-6110, the department or its agent will establish
 a conditional allowance account and a compliance account for each CO2
 budget source [ for which an account certificate of representation
 was submitted ] and a conditional [ compliance
 allowance ] account for DMME [ for which the account
 certificate of representation was submitted ].
 
 B. General accounts shall operate as follows.
 
 1. Any person may apply to open a general account for the
 purpose of holding and transferring CO2 allowances. An application
 for a general account may designate one and only one CO2 authorized
 account representative and one and only one alternate CO2
 authorized alternate account representative who may act on behalf of the CO2
 authorized account representative. The agreement by which the alternate
 CO2 authorized alternate account representative is selected shall
 include a procedure for authorizing the alternate CO2
 authorized alternate account representative to act in lieu of the CO2
 authorized account representative. A complete application for a general account
 shall be submitted to the department or its agent and shall include the
 following elements in a format prescribed by the department or its agent:
 
 a. Name, address, email address, telephone number, and
 facsimile transmission number of the CO2 authorized account
 representative and any alternate CO2 authorized
 alternate account representative;
 
 b. At the option of the CO2 authorized account
 representative, organization name and type of organization;
 
 c. A list of all persons subject to a binding agreement for
 the CO2 authorized account representative or any alternate CO2
 authorized alternate account representative to represent their ownership
 interest with respect to the CO2 allowances held in the general
 account;
 
 d. The following certification statement by the CO2
 authorized account representative and any alternate CO2
 authorized alternate account representative: "I certify that I was
 selected as the CO2 authorized account representative or the CO2
 alternate authorized alternate account representative, as applicable, by
 an agreement that is binding on all persons who have an ownership interest with
 respect to CO2 allowances held in the general account. I certify
 that I have all the necessary authority to carry out my duties and
 responsibilities under the CO2 Budget Trading Program on behalf of
 such persons and that each such person shall be fully bound by my
 representations, actions, inactions, or submissions and by any order or
 decision issued to me by the department or its agent or a court regarding the
 general account.";
 
 e. The signature of the CO2 authorized account
 representative and any alternate CO2 authorized alternate
 account representative and the dates signed; and
 
 f. Unless otherwise required by the department or its
 agent, documents of agreement referred to in the application for a general
 account shall not be submitted to the department or its agent. Neither the
 department nor its agent shall be under any obligation to review or evaluate
 the sufficiency of such documents, if submitted.
 
 2. Authorization of the CO2 authorized account
 representative shall be as follows:
 
 a. Upon receipt by the department or its agent of a
 complete application for a general account under subdivision 1 of this
 subsection:
 
 (1) The department or its agent will establish a general
 account for the person for whom the application is submitted.
 
 (2) The CO2 authorized account representative
 and any alternate CO2 authorized alternate account
 representative for the general account shall represent and, by his
 representations, actions, inactions, or submissions, legally bind each person
 who has an ownership interest with respect to CO2 allowances held in
 the general account in all matters pertaining to the CO2 Budget
 Trading Program, notwithstanding any agreement between the CO2
 authorized account representative or any alternate CO2
 authorized alternate account representative and such person. Any such person
 shall be bound by any order or decision issued to the CO2 authorized
 account representative or any alternate CO2 authorized
 alternate account representative by the department or its agent or a court
 regarding the general account.
 
 (3) Any representation, action, inaction, or submission by
 any alternate CO2 authorized alternate account representative
 shall be deemed to be a representation, action, inaction, or submission by the
 CO2 authorized account representative.
 
 b. Each submission concerning the general account shall be
 submitted, signed, and certified by the CO2 authorized account
 representative or any alternate CO2 authorized alternate
 account representative for the persons having an ownership interest with
 respect to CO2 allowances held in the general account. Each such
 submission shall include the following certification statement by the CO2
 authorized account representative or any alternate CO2
 authorized alternate account representative: "I am authorized to make this
 submission on behalf of the persons having an ownership interest with respect
 to the CO2 allowances held in the general account. I certify under
 penalty of law that I have personally examined, and am familiar with, the
 statements and information submitted in this document and all its attachments.
 Based on my inquiry of those individuals with primary responsibility for
 obtaining the information, I certify that the statements and information are to
 the best of my knowledge and belief true, accurate, and complete. I am aware
 that there are significant penalties for submitting false statements and
 information or omitting required statements and information, including the
 possibility of fine or imprisonment."
 
 c. The department or its agent will accept or act on a
 submission concerning the general account only if the submission has been made,
 signed, and certified in accordance with subdivision 2 b of this subsection.
 
 3. Changing CO2 authorized account
 representative and alternate CO2 authorized alternate account
 representative, and changes in persons with ownership interest, shall be
 accomplished as follows:
 
 a. The CO2 authorized account representative for
 a general account may be changed at any time upon receipt by the department or
 its agent of a superseding complete application for a general account under
 subdivision 1 of this subsection. Notwithstanding any such change, all
 representations, actions, inactions, and submissions by the previous CO2
 authorized account representative, or the previous alternate CO2
 authorized alternate account representative, prior to the time and date when
 the department or its agent receives the superseding application for a general
 account shall be binding on the new CO2 authorized account
 representative and the persons with an ownership interest with respect to the
 CO2 allowances in the general account.
 
 b. The alternate CO2 authorized
 alternate account representative for a general account may be changed at
 any time upon receipt by the department or its agent of a superseding complete
 application for a general account under subdivision 1 of this subsection.
 Notwithstanding any such change, all representations, actions, inactions, and
 submissions by the previous CO2 authorized account representative,
 or the previous alternate CO2 authorized alternate account
 representative, prior to the time and date when the department or its agent
 receives the superseding application for a general account shall be binding on
 the new alternate CO2 authorized account representative and the
 persons with an ownership interest with respect to the CO2
 allowances in the general account.
 
 c. In the event a new person having an ownership interest
 with respect to CO2 allowances in the general account is not
 included in the list of such persons in the application for a general account,
 such new person shall be deemed to be subject to and bound by the application
 for a general account, the representations, actions, inactions, and submissions
 of the CO2 authorized account representative and any alternate
 CO2 authorized alternate account representative, and the decisions,
 orders, actions, and inactions of the department or its agent, as if the new
 person were included in such list.
 
 d. Within 30 days following any change in the persons
 having an ownership interest with respect to CO2 allowances in the
 general account, including the addition or deletion of persons, the CO2
 authorized account representative or any alternate CO2
 authorized alternate account representative shall submit a revision to the
 application for a general account amending the list of persons having an
 ownership interest with respect to the CO2 allowances in the general
 account to include the change.
 
 4. Objections concerning CO2 authorized account
 representative shall be governed as follows:
 
 a. Once a complete application for a general account under
 subdivision 1 of this subsection has been submitted and received, the
 department or its agent will rely on the application unless and until a
 superseding complete application for a general account under subdivision 1 of
 this subsection is received by the department or its agent.
 
 b. Except as provided in subdivisions 3 a and 3 b of this
 subsection, no objection or other communication submitted to the department or
 its agent concerning the authorization, or any representation, action,
 inaction, or submission of the CO2 authorized account representative
 or any alternate CO2 authorized alternate account
 representative for a general account shall affect any representation, action,
 inaction, or submission of the CO2 authorized account representative
 or any alternate CO2 authorized alternate account
 representative or the finality of any decision or order by the department or
 its agent under the CO2 Budget Trading Program.
 
 c. Neither the department nor its agent will adjudicate any
 private legal dispute concerning the authorization or any representation,
 action, inaction, or submission of the CO2 authorized account
 representative or any alternate CO2 authorized alternate
 account representative for a general account, including private legal disputes
 concerning the proceeds of CO2 allowance transfers.
 
 5. Delegation by CO2 authorized account
 representative and alternate CO2 authorized alternate account
 representative shall be accomplished as follows:
 
 a. A CO2 authorized account representative may
 delegate, to one or more natural persons, his authority to make an electronic
 submission to the department or its agent provided for under this article and
 Article 7 (9VAC5-140-6300 et seq.) of this part.
 
 b. An alternate A CO2 authorized
 alternate account representative may delegate, to one or more natural persons,
 his authority to make an electronic submission to the department or its agent
 provided for under this article and Article 7 (9VAC5-140-6300 et seq.) of this
 part.
 
 c. To delegate authority to make an electronic submission
 to the department or its agent in accordance with subdivisions 5 a and 5 b of
 this subsection, the CO2 authorized account representative or alternate
 CO2 authorized alternate account representative, as appropriate,
 shall submit to the department or its agent a notice of delegation, in a format
 prescribed by the department that includes the following elements:
 
 (1) The name, address, email address, telephone number, and
 facsimile transmission number of such CO2 authorized account
 representative or alternate CO2 authorized alternate account
 representative;
 
 (2) The name, address, email address, telephone number, and
 facsimile transmission number of each such natural person, referred to as
 "electronic submission agent";
 
 (3) For each such natural person, a list of the type of
 electronic submissions under subdivision 5 c (1) or 5 c (2) of this subsection
 for which authority is delegated to him; and
 
 (4) The following certification statement by such CO2
 authorized account representative or alternate CO2 authorized
 alternate account representative: "I agree that any electronic submission
 to the department or its agent that is by a natural person identified in this
 notice of delegation and of a type listed for such electronic submission agent
 in this notice of delegation and that is made when I am a CO2
 authorized account representative or alternate CO2 authorized
 alternate account representative, as appropriate, and before this notice of
 delegation is superseded by another notice of delegation under 9VAC5-140-6230 B
 5 d shall be deemed to be an electronic submission by me. Until this notice of
 delegation is superseded by another notice of delegation under 9VAC5-140-6230 B
 5 d, I agree to maintain an email account and to notify the department or its
 agent immediately of any change in my email address unless all delegation
 authority by me under 9VAC5-140-6230 B 5 is terminated."
 
 d. A notice of delegation submitted under subdivision 5 c
 of this subsection shall be effective, with regard to the CO2
 authorized account representative or alternate CO2 authorized
 alternate account representative identified in such notice, upon receipt of
 such notice by the department or its agent and until receipt by the department
 or its agent of a superseding notice of delegation by such CO2
 authorized account representative or alternate CO2 authorized
 alternate account representative as appropriate. The superseding notice of
 delegation may replace any previously identified electronic submission agent,
 add a new electronic submission agent, or eliminate entirely any delegation of
 authority.
 
 e. Any electronic submission covered by the certification
 in subdivision 5 c (4) of this subsection and made in accordance with a notice
 of delegation effective under subdivision 5 d of this subsection shall be
 deemed to be an electronic submission by the CO2 authorized account
 representative or alternate CO2 authorized alternate account
 representative submitting such notice of delegation.
 
 C. The department or its agent will assign a unique
 identifying number to each account established under subsection A or B of this
 section.
 
 9VAC5-140-6240. CO2 Allowance Tracking System
 responsibilities of CO2 authorized account representative.
 
 Following the establishment of a COATS account, all
 submissions to the department or its agent pertaining to the account, including
 submissions concerning the deduction or transfer of CO2 allowances
 in the account, shall be made only by the CO2 authorized account
 representative for the account.
 
 9VAC5-140-6250. Recordation of [ CO2
 conditional ] allowance allocations.
 
 A. By January 1 of each calendar year, the department or
 its agent will record in the following accounts:
 
 1. In each CO2 budget source's and DMME's
 conditional allowance account, the [ CO2 ]
 conditional allowances allocated to those sources and DMME by the department
 prior to being consigned to auction; and 
 
 2. In each CO2 budget source's compliance
 account, the CO2 allowances purchased at auction by CO2
 budget units at the source under 9VAC5-140-6210 A. 
 
 B. Each year the department or its agent will record
 [ CO2 conditional ] allowances, as
 allocated to the unit under Article 5 (9VAC5-140-6190 et seq.) of this part, in
 the compliance account for the year after the last year for which [ CO2
 conditional ] allowances were previously allocated to the
 compliance account. Each year, the department or its agent will also record
 [ CO2 conditional ] allowances, as
 allocated under Article 5 (9VAC5-140-6190 et seq.) of this part, in an
 allocation set-aside for the year after the last year for which [ CO2
 conditional ] allowances were previously allocated to an allocation
 set-aside. 
 
 C. Serial numbers for allocated [ CO2
 conditional ] allowances shall be managed as follows. When
 allocating [ CO2 conditional ] allowances
 to and recording them in an account, the department or its agent will assign
 each [ CO2 conditional ] allowance
 a unique identification number that will include digits identifying the year
 for which the [ CO2 conditional ]
 allowance is allocated.
 
 9VAC5-140-6260. Compliance.
 
 A. CO2 allowances that meet the following
 criteria are available to be deducted for a CO2 budget source to
 comply with the CO2 requirements of 9VAC5-140-6050 C for [ the
 initial control period, ] a control period [ , ]
 or an interim control period.
 
 1. The CO2 allowances are of allocation years
 that fall within [ an initial control period, ] a prior
 control period, the same control period, or the same interim control period for
 which the allowances will be deducted.
 
 2. The CO2 allowances are held in the CO2
 budget source's compliance account as of the CO2 allowance transfer
 deadline for that [ initial control period, ] control
 period [ , ] or interim control period or are
 transferred into the compliance account by a CO2 allowance transfer
 correctly submitted for recordation under 9VAC5-140-6300 by the CO2
 allowance transfer deadline for that [ initial control period, ]
 control period [ , ] or interim control period.
 
 3. For CO2 offset allowances generated by other
 participating states, the number of CO2 offset allowances that are
 available to be deducted in order for a CO2 budget source to comply
 with the CO2 requirements of 9VAC5-140-6050 C for a control period
 [ or an ] initial control period [ , or an
 interim control period ] shall not exceed 3.3% of the CO2
 budget source's CO2 emissions for that control period, or may not
 exceed 3.3% of 0.50 times the CO2 budget source's CO2
 emissions for an interim control period, as determined in accordance with this
 article and Article 8 (9VAC5-140-6330 et seq.) of this part.
 
 3. 4. The CO2 allowances are not
 necessary for deductions for excess emissions for a prior [ initial
 control period or a ] control period under subsection D of this
 section.
 
 B. Following the recordation, in accordance with
 9VAC5-140-6310, of CO2 allowance transfers submitted for recordation
 in the CO2 budget source's compliance account by the CO2
 allowance transfer deadline for [ the initial control period, ]
 a control period [ , ] or [ an ]
 interim control period, the department or its agent will deduct CO2
 allowances available under subsection A of this section to cover the source's
 CO2 emissions, as determined in accordance with Article 8
 (9VAC5-140-6330 et seq.) of this part, for the [ initial control
 period, ] control period [ , ] or interim
 control period, as follows:
 
 1. Until the amount of CO2 allowances deducted
 equals the number of tons of total CO2 emissions, or 0.50 times the
 number of tons of total CO2 emissions for an interim control period,
 determined in accordance with Article 8 (9VAC5-140-6330 et seq.) of this part,
 from all CO2 budget units at the CO2 budget source for
 the [ initial control period, ] control period
 [ , ] or interim control period; or
 
 2. If there are insufficient CO2 allowances to
 complete the deductions in subdivision 1 of this subsection, until no more CO2
 allowances available under subsection A of this section remain in the
 compliance account.
 
 C. Identification of available CO2 allowances
 by serial number and default compliance deductions shall be managed as follows:
 
 1. The CO2 authorized account representative for
 a source's compliance account may request that specific CO2
 allowances, identified by serial number, in the compliance account be deducted
 for emissions or excess emissions for [ the initial control period, ]
 a control period [ , ] or interim control period in
 accordance with subsection B or D of this section. Such identification shall be
 made in the compliance certification report submitted in accordance with
 9VAC5-140-6170.
 
 2. The department or its agent will deduct CO2
 allowances for [ the initial control period, an interim control
 period, or ] a control period from the CO2 budget
 source's compliance account, in the absence of an identification or in the case
 of a partial identification of available CO2 allowances by serial
 number under subdivision 1 of this subsection, as follows: Any CO2
 allowances that are available for deduction under subdivision 1 of this
 subsection. CO2 allowances shall be deducted in chronological order
 (i.e., CO2 allowances from earlier allocation years shall be
 deducted before CO2 allowances from later allocation years). In the
 event that some, but not all, CO2 allowances from a particular
 allocation year are to be deducted, CO2 allowances shall be deducted
 by serial number, with lower serial number allowances deducted before higher
 serial number allowances.
 
 D. Deductions for excess emissions shall be managed as
 follows.
 
 1. After making the deductions for compliance under
 subsection B of this section, the department or its agent will deduct from the
 CO2 budget source's compliance account a number of CO2
 allowances equal to three times the number of the source's excess emissions. In
 the event that a source has insufficient CO2 allowances to cover
 three times the number of the source's excess emissions, the source shall be
 required to immediately transfer sufficient allowances into its compliance
 account.
 
 2. Any CO2 allowance deduction required under
 subdivision 1 of this subsection shall not affect the liability of the owners
 and operators of the CO2 budget source or the CO2 budget
 units at the source for any fine, penalty, or assessment, or their obligation
 to comply with any other remedy, for the same violation, as ordered under
 applicable state law. The following guidelines will be followed in assessing
 fines, penalties, or other obligations:
 
 a. For purposes of determining the number of days of
 violation, if a CO2 budget source has excess emissions for a control
 period, each day in the control period constitutes a day in violation unless
 the owners and operators of the unit demonstrate that a lesser number of days
 should be considered.
 
 b. Each ton of excess emissions is a separate violation.
 
 c. For purposes of determining the number of days of
 violation, if a CO2 budget source has excess interim emissions for
 an interim control period, each day in the interim control period constitutes a
 day in violation unless the owners and operators of the unit demonstrate that a
 lesser number of days should be considered.
 
 d. Each ton of excess interim emissions is a separate
 violation.
 
 3. The propriety of the department's determination that a
 CO2 budget source had excess emissions and the concomitant deduction
 of CO2 allowances from that CO2 budget source's account
 may be later challenged in the context of the initial administrative
 enforcement, or any civil or criminal judicial action arising from or
 encompassing that excess emissions violation. The commencement or pendency of
 any administrative enforcement, or civil or criminal judicial action arising
 from or encompassing that excess emissions violation will not act to prevent
 the department or its agent from initially deducting the CO2
 allowances resulting from the department's original determination that the
 relevant CO2 budget source has had excess emissions. Should the
 department's determination of the existence or extent of the CO2
 budget source's excess emissions be revised either by a settlement or final
 conclusion of any administrative or judicial action, the department will act as
 follows:
 
 a. In any instance where the department's determination of
 the extent of excess emissions was too low, the department will take further
 action under subdivisions 1 and 2 of this subsection to address the expanded
 violation.
 
 b. In any instance where the department's determination of
 the extent of excess emissions was too high, the department will distribute to
 the relevant CO2 budget source a number of CO2 allowances
 equaling the number of CO2 allowances deducted which are
 attributable to the difference between the original and final quantity of
 excess emissions. Should such CO2 budget source's compliance account
 no longer exist, the CO2 allowances will be provided to a general
 account selected by the owner or operator of the CO2 budget source
 from which they were originally deducted.
 
 E. The department or its agent will record in the
 appropriate compliance account all deductions from such an account pursuant to
 subsections B and D of this section.
 
 F. Action by the department on submissions shall be as
 follows:
 
 1. The department may review and conduct independent audits
 concerning any submission under the CO2 Budget Trading Program and
 make appropriate adjustments of the information in the submissions.
 
 2. The department may deduct CO2 allowances from
 or transfer CO2 allowances to a source's compliance account based on
 information in the submissions, as adjusted under subdivision 1 of this
 subsection.
 
 9VAC5-140-6270. Banking.
 
 Each CO2 allowance that is held in a compliance
 account or a general account will remain in such account unless and until the
 CO2 allowance is deducted or transferred under 9VAC5-140-6180,
 9VAC5-140-6260, 9VAC5-140-6280, or Article 7 (9VAC5-140-6300 et seq.) of this
 part.
 
 9VAC5-140-6280. Account error.
 
 The department or its agent may, at its sole discretion
 and on its own motion, correct any error in any COATS account. Within 10
 business days of making such correction, the department or its agent will
 notify the CO2 authorized account representative for the account.
 
 9VAC5-140-6290. Closing of general accounts.
 
 A. A CO2 authorized account representative of a
 general account may instruct the department or its agent to close the account
 by submitting a statement requesting deletion of the account from the COATS and
 by correctly submitting for recordation under 9VAC5-140-6300 a CO2
 allowance transfer of all CO2 allowances in the account to one or
 more other COATS accounts.
 
 B. If a general account shows no activity for a period of
 one year or more and does not contain any CO2 allowances, the
 department or its agent may notify the CO2 authorized account
 representative for the account that the account will be closed in the COATS 30
 business days after the notice is sent. The account will be closed after the
 30-day period unless before the end of the 30-day period the department or its
 agent receives a correctly submitted transfer of CO2 allowances into
 the account under 9VAC5-140-6300 or a statement submitted by the CO2
 authorized account representative demonstrating to the satisfaction of the
 department or its agent good cause as to why the account should not be closed.
 The department or its agent will have sole discretion to determine if the owner
 or operator of the unit demonstrated that the account should not be closed.
 
 Article 7
 CO2 Allowance Transfers
 
 9VAC5-140-6300. Submission of CO2 allowance
 transfers.
 
 The CO2 authorized account representatives
 seeking recordation of a CO2 allowance transfer shall submit the
 transfer to the department or its agent. To be considered correctly submitted,
 the CO2 allowance transfer shall include the following elements in a
 format specified by the department or its agent: 
 
 1. The numbers identifying both the transferor and
 transferee accounts; 
 
 2. A specification by serial number of each CO2
 allowance to be transferred; 
 
 3. The printed name and signature of the CO2
 authorized account representative of the transferor account and the date
 signed; 
 
 4. The date of the completion of the last sale or purchase
 transaction for the allowance, if any; and
 
 5. The purchase or sale price of the allowance that is the
 subject of a sale or purchase transaction under subdivision 4 of this section.
 
 9VAC5-140-6310. Recordation.
 
 A. Within five business days of receiving a CO2
 allowance transfer, except as provided in subsection B of this section, the
 department or its agent will record a CO2 allowance transfer by
 moving each CO2 allowance from the transferor account to the
 transferee account as specified by the request, provided that:
 
 1. The transfer is correctly submitted under
 9VAC5-140-6300; and 
 
 2. The transferor account includes each CO2
 allowance identified by serial number in the transfer. 
 
 B. A CO2 allowance transfer into or out of a
 compliance account that is submitted for recordation following the CO2
 allowance transfer deadline and that includes any CO2 allowances
 that are of allocation years that fall within a control period prior to or the
 same as the control period to which the CO2 allowance transfer
 deadline applies will not be recorded until after completion of the process
 pursuant to 9VAC5-140-6260 B. 
 
 C. Where a CO2 allowance transfer submitted for
 recordation fails to meet the requirements of subsection A of this section, the
 department or its agent will not record such transfer.
 
 9VAC5-140-6320. Notification.
 
 A. Within five business days of recordation of a CO2
 allowance transfer under 9VAC5-140-6310, the department or its agent will
 notify each party to the transfer. Notice will be given to the CO2
 authorized account representatives of both the transferor and transferee
 accounts.
 
 B. Within 10 business days of receipt of a CO2
 allowance transfer that fails to meet the requirements of 9VAC5-140-6310 A, the
 department or its agent will notify the CO2 authorized account
 representatives of both accounts subject to the transfer of (i) a decision not
 to record the transfer and (ii) the reasons for such nonrecordation. 
 
 C. Nothing in this section shall preclude the submission
 of a CO2 allowance transfer for recordation following notification
 of nonrecordation.
 
 Article 8
 Monitoring, Reporting, and Recordkeeping
 
 9VAC5-140-6330. General requirements.
 
 A. The owners and operators, and to the extent applicable,
 the CO2 authorized account representative of a CO2 budget
 unit shall comply with the monitoring, recordkeeping, and reporting
 requirements as provided in this section and all applicable sections of 40 CFR
 Part 75. Where referenced in this article, the monitoring requirements of 40 CFR
 Part 75 shall be adhered to in a manner consistent with the purpose of
 monitoring and reporting CO2 mass emissions pursuant to this part.
 For purposes of complying with such requirements, the definitions in
 9VAC5-140-6020 and in 40 CFR 72.2 shall apply, and the terms
 "affected unit," "designated representative," and
 "CEMS" in 40 CFR Part 75 shall be replaced by the terms "CO2
 budget unit," "CO2 authorized account
 representative," and "CEMS," respectively, as defined in
 9VAC5-140-6020. For units not subject to an acid rain emissions limitation, the
 term "administrator" in 40 CFR Part 75 shall be replaced with
 "the department or its agent." Owners or operators of a CO2
 budget unit who monitor a non-CO2 budget unit pursuant to the
 common, multiple, or bypass stack procedures in 40 CFR 75.72(b)(2)(ii), or 40
 CFR 75.16 (b)(2)(ii)(B) pursuant to 40 CFR 75.13, for purposes of complying with
 this part, shall monitor and report CO2 mass emissions from such
 non-CO2 budget unit units according to the procedures for CO2
 budget units established in this article.
 
 B. The owner or operator of each CO2 budget
 unit shall meet the following general requirements for installation,
 certification, and data accounting.
 
 1. Install all monitoring systems necessary to monitor CO2
 mass emissions in accordance with 40 CFR Part 75, except for equation G-1.
 Equation G-1 in Appendix G shall not be used to determine CO2
 emissions under this part. This may require systems to monitor CO2
 concentration, stack gas flow rate, O2 concentration, heat input,
 and fuel flow rate.
 
 2. Successfully complete all certification tests required
 under 9VAC5-140-6340 and meet all other requirements of this section and 40 CFR
 Part 75 applicable to the monitoring systems under subdivision 1 of this
 subsection.
 
 3. Record, report, and quality-assure the data from the
 monitoring systems under subdivision 1 of this subsection.
 
 C. The owner or operator shall meet the monitoring system
 certification and other requirements of subsection B of this section on or
 before the following dates. The owner or operator shall record, report, and
 quality-assure the data from the monitoring systems under subdivision B 1 of
 this section on and after the following dates:
 
 1. The owner or operator of a CO2 budget unit,
 except for a CO2 budget unit under subdivision 2 of this subsection,
 shall comply with the requirements of this section by January 1, 2020.
 
 2. The owner or operator of a CO2 budget unit
 that commences commercial operation July 1, 2020, shall comply with the
 requirements of this section by (i) January 1, 2021, or (ii) the earlier of 90
 unit operating days after the date on which the unit commences commercial
 operation, or 180 calendar days after the date on which the unit
 commences commercial operation.
 
 3. For the owner or operator of a CO2 budget
 unit for which construction of a new stack or flue installation is completed
 after the applicable deadline under subdivision 1 or 2 of this subsection by
 the earlier of (i) 90 unit operating days after the date on which emissions
 first exit to the atmosphere through the new stack or flue or (ii) 180 calendar
 days after the date on which emissions first exit to the atmosphere through the
 new stack or flue.
 
 D. Data shall be reported as follows:
 
 1. Except as provided in subdivision 2 of this subsection,
 the owner or operator of a CO2 budget unit that does not meet the
 applicable compliance date set forth in subsection C of this section for any
 monitoring system under subdivision B 1 of this section shall, for each such
 monitoring system, determine, record, and report maximum potential, or as
 appropriate minimum potential, values for CO2 concentration, CO2
 emissions rate, stack gas moisture content, fuel flow rate, heat input, and any
 other parameter required to determine CO2 mass emissions in
 accordance with 40 CFR 75.31(b)(2) or (c)(3) or Section 2.4 of Appendix D of 40
 CFR Part 75 as applicable.
 
 2. The owner or operator of a CO2 budget unit
 that does not meet the applicable compliance date set forth in subdivision C 3
 of this section for any monitoring system under subdivision B 1 of this section
 shall, for each such monitoring system, determine, record, and report
 substitute data using the applicable missing data procedures in Subpart D, or
 Appendix D of 40 CFR Part 75, in lieu of the maximum potential, or as
 appropriate minimum potential, values for a parameter if the owner or operator
 demonstrates that there is continuity between the data streams for that
 parameter before and after the construction or installation under subdivision C
 3 of this section.
 
 a. CO2 budget units subject to an acid rain
 emissions limitation or CSAPR NOX Ozone Season Trading Program that
 qualify for the optional SO2, NOX, and CO2
 (for acid rain) or NOX (for CSAPR NOX Ozone Season
 Trading Program) emissions calculations for low mass emissions (LME) units
 under 40 CFR 75.19 and report emissions for such programs using the
 calculations under 40 CFR 75.19, shall also use the CO2
 emissions calculations for LME units under 40 CFR 75.19 for purposes of
 compliance with these regulations.
 
 b. CO2 budget units subject to an acid rain
 emissions limitation that do not qualify for the optional SO2, NOX,
 and CO2 (for acid rain) or NOX (for CSAPR NOX
 Ozone Season Trading Program) emissions calculations for LME units under 40 CFR
 75.19 shall not use the CO2 emissions calculations for LME units
 under 40 CFR 75.19 for purposes of compliance with these regulations.
 
 c. CO2 budget units not subject to an acid rain
 emissions limitation shall qualify for the optional CO2 emissions
 calculation for LME units under 40 CFR 75.19, provided that they emit less than
 100 tons of NOX annually and no more than 25 tons of SO2
 annually.
 
 3. The owner or operator of a CO2 budget unit
 shall report net-electric output data to the department as required by Article
 5 (9VAC5-140-6190 et seq.) of this part.
 
 E. Prohibitions shall be as follows.
 
 1. No owner or operator of a CO2 budget unit
 shall use any alternative monitoring system, alternative reference method, or
 any other alternative for the required CEMS without having obtained prior
 written approval in accordance with 9VAC5-140-6380.
 
 2. No owner or operator of a CO2 budget unit
 shall operate the unit so as to discharge, or allow to be discharged, CO2
 emissions to the atmosphere without accounting for all such emissions in
 accordance with the applicable provisions of this article and 40 CFR Part 75.
 
 3. No owner or operator of a CO2 budget unit
 shall disrupt the CEMS, any portion thereof, or any other approved emissions
 monitoring method, and thereby avoid monitoring and recording CO2
 mass emissions discharged into the atmosphere, except for periods of
 recertification or periods when calibration, quality assurance testing, or
 maintenance is performed in accordance with the applicable provisions of this
 article and 40 CFR Part 75.
 
 4. No owner or operator of a CO2 budget unit
 shall retire or permanently discontinue use of the CEMS, any component thereof,
 or any other approved emissions monitoring system under this article, except
 under any one of the following circumstances:
 
 a. The owner or operator is monitoring emissions from the
 unit with another certified monitoring system approved, in accordance with the
 applicable provisions of this article and 40 CFR Part 75, by the department for
 use at that unit that provides emissions data for the same pollutant or
 parameter as the retired or discontinued monitoring system; or
 
 b. The CO2 authorized account representative
 submits notification of the date of certification testing of a replacement
 monitoring system in accordance with 9VAC5-140-6340 D 3 a.
 
 9VAC5-140-6340. Initial certification and recertification
 procedures.
 
 A. The owner or operator of a CO2 budget unit
 shall be exempt from the initial certification requirements of this section for
 a monitoring system under 9VAC5-140-6330 B 1 if the following conditions are
 met:
 
 1. The monitoring system has been previously certified in
 accordance with 40 CFR Part 75; and 
 
 2. The applicable quality-assurance and quality-control
 requirements of 40 CFR 75.21 and Appendix B and Appendix D of 40 CFR Part 75
 are fully met for the certified monitoring system described in subdivision 1 of
 this subsection.
 
 B. The recertification provisions of this section shall
 apply to a monitoring system under 9VAC5-140-6330 B 1 exempt from initial
 certification requirements under subsection A of this section.
 
 C. Notwithstanding subsection A of this section, if the
 administrator has previously approved a petition under 40 CFR
 75.72(b)(2)(ii), or 40 CFR 75.16(b)(2)(ii)(B) as pursuant to 40 CFR 75.13 for
 apportioning the CO2 emissions rate measured in a common stack or a
 petition under 40 CFR 75.66 for an alternative requirement in 40 CFR Part
 75, the CO2 authorized account representative shall submit the
 petition to the department under 9VAC5-140-6380 A to determine whether the
 approval applies under this program.
 
 D. Except as provided in subsection A of this section, the
 owner or operator of a CO2 budget unit shall comply with the
 following initial certification and recertification procedures for a CEMS and
 an excepted monitoring system under Appendix D of 40 CFR Part 75 and under 9VAC5-140-6330
 B 1. The owner or operator of a unit that qualifies to use the low mass
 emissions excepted monitoring methodology in 40 CFR 75.19 or that
 qualifies to use an alternative monitoring system under Subpart E of 40 CFR
 Part 75 shall comply with the procedures in subsection E or F of this section,
 respectively.
 
 1. For initial certification, the owner or operator shall
 ensure that each CEMS required under 9VAC5-140-6330 B 1, which includes the
 automated DAHS, successfully completes all of the initial certification testing
 required under 40 CFR 75.20 by the applicable deadlines specified in
 9VAC5-140-6330 C. In addition, whenever the owner or operator installs a
 monitoring system to meet the requirements of this article in a location where
 no such monitoring system was previously installed, initial certification in
 accordance with 40 CFR 75.20 is required.
 
 2. For recertification, the following requirements shall
 apply.
 
 a. Whenever the owner or operator makes a replacement,
 modification, or change in a certified CEMS under 9VAC5-140-6330 B 1 that the
 administrator or the department determines significantly affects the ability of
 the system to accurately measure or record CO2 mass emissions or to
 meet the quality-assurance and quality-control requirements of 40 CFR 75.21 or
 Appendix B to 40 CFR Part 75, the owner or operator shall recertify the
 monitoring system according to 40 CFR 75.20(b).
 
 b. For systems using stack measurements such as stack flow,
 stack moisture content, CO2 or O2 monitors, whenever the
 owner or operator makes a replacement, modification, or change to the flue gas
 handling system or the unit's operation that the administrator or the
 department determines to significantly change the flow or concentration
 profile, the owner or operator shall recertify the CEMS according to 40 CFR
 75.20(b). Examples of changes that require recertification include replacement
 of the analyzer, change in location or orientation of the sampling probe or
 site, or change of flow rate monitor polynomial coefficients.
 
 3. The approval process for initial certifications and
 recertification shall be as follows: Subdivisions subdivisions 3 a
 through 3 d of this subsection apply to both initial certification and
 recertification of a monitoring system under 9VAC5-140-6330 B 1. For
 recertifications, replace the words "certification" and "initial
 certification" with the word "recertification," replace the word
 "certified" with "recertified," and proceed in the manner
 prescribed in 40 CFR 75.20(b)(5) and (g)(7) in lieu of subdivision 3 e of this
 subsection.
 
 a. The CO2 authorized account representative
 shall submit to the department or its agent, the appropriate EPA Regional
 Office and the administrator a written notice of the dates of certification in
 accordance with 9VAC5-140-6360.
 
 b. The CO2 authorized account representative
 shall submit to the department or its agent a certification application for
 each monitoring system. A complete certification application shall include the
 information specified in 40 CFR 75.63.
 
 c. The provisional certification date for a monitor shall
 be determined in accordance with 40 CFR 75.20(a)(3). A provisionally certified
 monitor may be used under the CO2 Budget Trading Program for a
 period not to exceed 120 days after receipt by the department of the complete
 certification application for the monitoring system or component thereof under
 subdivision 3 b of this subsection. Data measured and recorded by the
 provisionally certified monitoring system or component thereof, in accordance
 with the requirements of 40 CFR Part 75, will be considered valid
 quality-assured data, retroactive to the date and time of provisional
 certification, provided that the department does not invalidate the provisional
 certification by issuing a notice of disapproval within 120 days of receipt of
 the complete certification application by the department.
 
 d. The department will issue a written notice of approval
 or disapproval of the certification application to the owner or operator within
 120 days of receipt of the complete certification application under subdivision
 3 b of this subsection. In the event the department does not issue such a
 notice within such 120-day period, each monitoring system that meets the
 applicable performance requirements of 40 CFR Part 75 and is included in the
 certification application will be deemed certified for use under the CO2
 Budget Trading Program.
 
 (1) If the certification application is complete and shows
 that each monitoring system meets the applicable performance requirements of 40
 CFR Part 75, then the department will issue a written notice of approval of the
 certification application within 120 days of receipt.
 
 (2) If the certification application is incomplete, then
 the department will issue a written notice of incompleteness that sets a
 reasonable date by which the CO2 authorized account representative
 shall submit the additional information required to complete the certification
 application. If the CO2 authorized account representative does not
 comply with the notice of incompleteness by the specified date, then the
 department may issue a notice of disapproval under subdivision 3 d (3) of this
 subsection. The 120-day review period shall not begin before receipt of a
 complete certification application.
 
 (3) If the certification application shows that any
 monitoring system or component thereof does not meet the performance
 requirements of 40 CFR Part 75, or if the certification application is
 incomplete and the requirement for disapproval under subdivision 3 d (2) of
 this subsection is met, then the department will issue a written notice of
 disapproval of the certification application. Upon issuance of such notice of
 disapproval, the provisional certification is invalidated by the department and
 the data measured and recorded by each uncertified monitoring system or
 component thereof shall not be considered valid quality assured data beginning
 with the date and hour of provisional certification. The owner or operator
 shall follow the procedures for loss of certification in subdivision 3 e of
 this subsection for each monitoring system or component thereof, which is
 disapproved for initial certification.
 
 (4) The department may issue a notice of disapproval of the
 certification status of a monitor in accordance with 9VAC5-140-6350 B.
 
 e. If the department issues a notice of disapproval of a
 certification application under subdivision 3 d (3) of this subsection or a
 notice of disapproval of certification status under subdivision 3 d (3) of this
 subsection, then:
 
 (1) The owner or operator shall substitute the following
 values for each disapproved monitoring system, for each hour of unit operation
 during the period of invalid data beginning with the date and hour of
 provisional certification and continuing until the time, date, and hour specified
 under 40 CFR 75.20(a)(5)(i) or 40 CFR 75.20(g)(7): (i) for units using or
 intending to monitor for CO2 mass emissions using heat input or for
 units using the low mass emissions excepted methodology under 40 CFR
 75.19, the maximum potential hourly heat input of the unit; or (ii) for units
 intending to monitor for CO2 mass emissions using a CO2
 pollutant concentration monitor and a flow monitor, the maximum potential
 concentration of CO2 and the maximum potential flow rate of the unit
 under Section 2.1 of Appendix A of 40 CFR Part 75 [ .; ]
 
 
 (2) The CO2 authorized account representative
 shall submit a notification of certification retest dates and a new
 certification application in accordance with subdivisions 3 a and 3 b of this
 subsection; and
 
 (3) The owner or operator shall repeat all certification
 tests or other requirements that were failed by the monitoring system, as
 indicated in the department's notice of disapproval, no later than 30 unit
 operating days after the date of issuance of the notice of disapproval.
 
 E. The owner or operator of a unit qualified to use the
 low mass emissions excepted methodology under 9VAC5-140-6330 D 3 shall meet the
 applicable certification and recertification requirements of 40 CFR
 75.19(a)(2), 40 CFR 75.20(h), and this section. If the owner or operator
 of such a unit elects to certify a fuel flow meter system for heat input
 determinations, the owner or operator shall also meet the certification and
 recertification requirements in 40 CFR 75.20(g).
 
 F. The CO2 authorized account of each unit for
 which the owner or operator intends to use an alternative monitoring system
 approved by the administrator and, if applicable, the department under Subpart
 E of 40 CFR Part 75 shall comply with the applicable notification and
 application procedures of 40 CFR 75.20(f).
 
 9VAC5-140-6350. Out-of-control periods.
 
 A. Whenever any monitoring system fails to meet the
 quality assurance/quality control (QA/QC) requirements or data validation
 requirements of 40 CFR Part 75, data shall be substituted using the applicable
 procedures in Subpart D or Appendix D of 40 CFR Part 75. 
 
 B. Whenever both an audit of a monitoring system and a
 review of the initial certification or recertification application reveal that
 any monitoring system should not have been certified or recertified because it
 did not meet a particular performance specification or other requirement under
 9VAC5-140-6340 or the applicable provisions of 40 CFR Part 75, both at the
 time of the initial certification or recertification application submission and
 at the time of the audit, the department or administrator will issue a notice
 of disapproval of the certification status of such monitoring system. For the
 purposes of this subsection, an audit shall be either a field audit or an audit
 of any information submitted to the department or the administrator. By issuing
 the notice of disapproval, the department or administrator revokes
 prospectively the certification status of the monitoring system. The data
 measured and recorded by the monitoring system shall not be considered valid
 quality-assured data from the date of issuance of the notification of the
 revoked certification status until the date and time that the owner or operator
 completes subsequently approved initial certification or recertification tests
 for the monitoring system. The owner or operator shall follow the initial
 certification or recertification procedures in 9VAC5-140-6340 for each
 disapproved monitoring system.
 
 9VAC5-140-6360. Notifications.
 
 The CO2 authorized account representative for a
 CO2 budget unit shall submit written notice to the department and
 the administrator in accordance with 40 CFR 75.61.
 
 9VAC5-140-6370. Recordkeeping and reporting.
 
 A. The CO2 authorized account representative
 shall comply with all recordkeeping and reporting requirements in this section,
 the applicable recordkeeping and reporting requirements under 40 CFR 75.73, and
 the requirements of 9VAC5-140-6080 E.
 
 B. The owner or operator of a CO2 budget unit
 shall submit a monitoring plan in the manner prescribed in 40 CFR 75.62.
 
 C. The CO2 authorized account representative
 shall submit an application to the department within 45 days after completing
 all CO2 monitoring system initial certification or recertification
 tests required under 9VAC5-140-6340, including the information required under
 40 CFR 75.63 and 40 CFR 75.53(e) and (f).
 
 D. The CO2 authorized account representative
 shall submit quarterly reports, as follows:
 
 1. The CO2 authorized account representative
 shall report the CO2 mass emissions data for the CO2
 budget unit, in an electronic format prescribed by the department unless
 otherwise prescribed by the department for each calendar quarter.
 
 2. The CO2 authorized account representative
 shall submit each quarterly report to the department or its agent within 30
 days following the end of the calendar quarter covered by the report. Quarterly
 reports shall be submitted in the manner specified in Subpart H of 40 CFR Part
 75 and 40 CFR 75.64. Quarterly reports shall be submitted for each CO2
 budget unit, or group of units using a common stack, and shall include all of
 the data and information required in Subpart G of 40 CFR Part 75, except for
 opacity, heat input, NOX, and SO2 provisions.
 
 3. The CO2 authorized account representative
 shall submit to the department or its agent a compliance certification in
 support of each quarterly report based on reasonable inquiry of those persons
 with primary responsibility for ensuring that all of the unit's emissions are
 correctly and fully monitored. The certification shall state that:
 
 a. The monitoring data submitted were recorded in
 accordance with the applicable requirements of this article and 40 CFR
 Part 75, including the quality assurance procedures and specifications;
 
 b. For a unit with add-on CO2 emissions controls
 and for all hours where data are substituted in accordance with 40 CFR
 75.34(a)(1), the add-on emissions controls were operating within the range of
 parameters listed in the QA/QC program under Appendix B of 40 CFR Part 75 and
 the substitute values do not systematically underestimate CO2
 emissions; and
 
 c. The CO2 concentration values substituted for
 missing data under Subpart D of 40 CFR Part 75 do not systematically underestimate
 CO2 emissions.
 
 9VAC5-140-6380. Petitions.
 
 A. Except as provided in subsection C of this section, the
 CO2 authorized account representative of a CO2 budget
 unit that is subject to an acid rain emissions limitation may submit a petition
 to the administrator under 40 CFR 75.66 and to the department requesting
 approval to apply an alternative to any requirement of 40 CFR Part 75.
 Application of an alternative to any requirement of 40 CFR Part 75 is in
 accordance with this article only to the extent that the petition is approved
 in writing by the administrator, and subsequently approved in writing by the
 department.
 
 B. Petitions for a CO2 budget unit that is not
 subject to an acid rain emissions limitation shall meet the following
 requirements.
 
 1. The CO2 authorized account representative of
 a CO2 budget unit that is not subject to an acid rain emissions
 limitation may submit a petition to the administrator under 40 CFR 75.66
 and to the department requesting approval to apply an alternative to any
 requirement of 40 CFR Part 75. Application of an alternative to any requirement
 of 40 CFR Part 75 is in accordance with this article only to the extent
 that the petition is approved in writing by the administrator and subsequently
 approved in writing by the department.
 
 2. In the event that the administrator declines to review a
 petition under subdivision 1 of this subsection, the CO2 authorized
 account representative of a CO2 budget unit that is not subject to
 an acid rain emissions limitation may submit a petition to the department
 requesting approval to apply an alternative to any requirement of this article.
 That petition shall contain all of the relevant information specified in 40 CFR
 75.66. Application of an alternative to any requirement of this article is in
 accordance with this article only to the extent that the petition is approved
 in writing by the department.
 
 C. The CO2 authorized account representative of
 a CO2 budget unit that is subject to an acid rain emissions
 limitation may submit a petition to the administrator under 40 CFR 75.66
 and to the department requesting approval to apply an alternative to a
 requirement concerning any additional CEMS required under the common stack
 provisions of 40 CFR 75.72 or a CO2 concentration CEMS used under 40 CFR
 75.71(a)(2). Application of an alternative to any such requirement is in
 accordance with this article only to the extent the petition is approved in
 writing by the administrator and subsequently approved in writing by the
 department.
 
 9VAC5-140-6390. (Reserved.)
 
 9VAC5-140-6400. (Reserved.)
 
 Article 9
 Auction of CO2 CCR and ECR Allowances
 
 9VAC5-140-6410. Purpose.
 
 The following requirements shall apply to each allowance
 auction. The department or its agent may specify additional information in the
 auction notice for each auction. Such additional information may include the
 time and location of the auction, auction rules, registration deadlines, and
 any additional information deemed necessary or useful.
 
 9VAC5-140-6420. General requirements.
 
 A. The department's agent will include the following
 information in the auction notice for each auction:
 
 1. The number of [ CO2
 conditional ] allowances offered for sale at the auction, not including
 any [ CO2 conditional ] CCR
 allowances;
 
 2. The number of [ CO2
 conditional ] CCR allowances that will be offered for sale at the
 auction if the condition of subdivision [ B ] 1 of this
 [ subsection section ] is met;
 
 3. The minimum reserve price for the auction; 
 
 4. The CCR trigger price for the auction;
 
 5. The maximum number of [ CO2
 conditional ] allowances that may be withheld from sale at the
 auction if the condition of subdivision D 1 of this section is met; and
 
 6. The ECR trigger price for the auction.
 
 B. The department's agent will follow these rules for the
 sale of [ CO2 conditional ] CCR
 allowances.
 
 1. [ CO2 Conditional ]
 CCR allowances shall only be sold at an auction in which total demand for
 allowances, above the CCR trigger price, exceeds the number of [ CO2
 conditional ] allowances available for purchase at the auction, not
 including any [ CO2 conditional ]
 CCR allowances.
 
 2. If the condition of subdivision 1 of this subsection is
 met at an auction, then the number of [ CO2
 conditional ] CCR allowances offered for sale by the department or
 its agent at the auction shall be equal to the number of [ CO2
 conditional ] CCR allowances in the Virginia [ auction
 account Consignment Auction Account ] at the time of the
 auction. 
 
 3. After all of the [ CO2
 conditional ] CCR allowances in the Virginia [ auction
 Consignment Auction Account ] account have been sold in a given
 calendar year, no additional [ CO2
 conditional ] CCR allowances will be sold at any auction for the
 remainder of that calendar year, even if the condition of subdivision 1 of this
 subsection is met at an auction.
 
 4. At an auction in which [ CO2
 conditional ] CCR allowances are sold, the reserve price for the
 auction shall be the CCR trigger price.
 
 5. If the condition of subdivision 1 of this subsection is
 not satisfied, no [ CO2 conditional ]
 CCR allowances shall be offered for sale at the auction, and the reserve
 price for the auction shall be equal to the minimum reserve [ prices
 price ].
 
 C. The department's agent shall implement the reserve
 price as follows: (i) no allowances shall be sold at any auction for a price
 below the reserve price for that auction and (ii) if the total demand for
 allowances at an auction is less than or equal to the total number of
 allowances made available for sale in that auction, then the auction clearing
 price for the auction shall be the reserve price.
 
 D. The department's agent will meet the following rules
 for the withholding of CO2 ECR allowances from an auction.
 
 1. CO2 ECR allowances shall only be withheld
 from an auction if the demand for allowances would result in an auction
 clearing price that is less than the ECR trigger price prior to the withholding
 from the auction of any ECR allowances.
 
 2. If the condition in subdivision 1 of this subsection is
 met at an auction, then the maximum number of CO2 ECR allowances
 that may be withheld from that auction will be equal to the quantity shown in
 Table 140-5B of 9VAC5-140-6210 E minus the total quantity of CO2 ECR
 allowances that have been withheld from any prior auction in that calendar
 year. Any CO2 ECR allowances withheld from an auction will be
 transferred into the Virginia ECR Account.
 
 9VAC5-140-6430. Consignment auction.
 
 In accordance with Article 5 (9VAC5-140-6190 et seq.) of
 this part, one quarter of the annual conditional allowances
 allowance allocation shall be consigned by the CO2 budget source to
 whom they are allocated or the holder of a public contract with DMME to each
 auction on a quarterly pro rata basis in accordance with procedures
 specified by the department. At the completion of the consignment auction, a
 conditional allowance sold at auction shall become an allowance to be used
 for compliance purposes a CO2 allowance.
 
 9VAC5-140-6435. Other auction.
 
 Notwithstanding the requirements of 9VAC5-140-6430, the
 department may participate in a direct auction of allowances without
 consignment in accordance with requirements established by the Virginia General
 Assembly. A "direct auction" means a CO2 auction conducted
 by a CO2 Budget Trading Program in which Virginia is a participating
 state. 
 
 Article 10
 Program Monitoring and Review
 
 9VAC5-140-6440. Program monitoring and review.
 
 In conjunction with the CO2 Budget Trading
 Program program monitoring and review process, the department will evaluate
 impacts of the program specific to Virginia, including economic, energy, and
 environmental impacts and impacts on vulnerable and environmental justice and
 underserved communities. The department will, in evaluating the impacts on
 environmental justice communities, including low income, minority, and tribal
 communities, develop and implement a plan to ensure increased participation of
 environmental justice communities in the review. 
 
 VA.R. Doc. No. R17-5140; Filed May 1, 2019, 3:08 p.m. 
TITLE 12. HEALTH
DEPARTMENT OF HEALTH
Forms
 
 
 
 REGISTRAR'S NOTICE:
 Forms used in administering the regulation have been filed by the agency. The
 forms are not being published; however, online users of this issue of the
 Virginia Register of Regulations may click on the name of a form with a
 hyperlink to access it. The forms are also available from the agency contact or
 may be viewed at the Office of the Registrar of Regulations, 900 East Main
 Street, 11th Floor, Richmond, Virginia 23219. 
 
  
 
 Title of Regulation: 12VAC5-115. Virginia
 Immunization Information System.
 
 Contact Information: Kristin Collins, Policy Analyst,
 Office of Epidemiology, Virginia Department of Health, 109 Governor Street,
 Office 642, Richmond, VA 23219-3623, telephone (804) 864-7298, or email kristin.collins@vdh.virginia.gov.
 
 FORMS (12VAC5-115)
 
 Administrator Information, VIISADM (eff. 10/2012)
 
 Electronic Data Exchange with VIIS (eff. 10/2012)
 
 Information Systems Security Access Agreement
 (eff. 10/2012)
 
 Organization Information, VIISORG (eff. 10/2012)
 
 VIIS Security Policy and User Confidentiality Agreement
 
 Memorandum of Agreement between Virginia
 Department of Health/Division of Immunization (VDH/DOI) and VIIS Organization
 Interested in Data Exchange (8/2011)
 
 Virginia Immunization Information System (VIIS)
 Opt-In of VIIS (reviewed 6/2015)
 
 Virginia Immunization Information System (VIIS)
 Opt-Out of VIIS (reviewed 6/2015) 
 
 VIIS
 Security Policy and User Confidentiality Agreement (rev. 5/2019)
 
 VIIS User Acknowledgement Page
 
 VIIS User Signature Page
 
 VA.R. Doc. No. R19-5998; Filed May 10, 2019, 4:01 p.m. 
TITLE 12. HEALTH
DEPARTMENT OF MEDICAL ASSISTANCE SERVICES
Final Regulation
 
 Title of Regulation: 12VAC30-141. Family Access to
 Medical Insurance Security Plan (amending 12VAC30-141-10 through 12VAC30-141-70,
 12VAC30-141-100, 12VAC30-141-110, 12VAC30-141-150, 12VAC30-141-160,
 12VAC30-141-175, 12VAC30-141-500, 12VAC30-141-660 through 12VAC30-141-760,
 12VAC30-141-790, 12VAC30-141-800, 12VAC30-141-880; repealing 12VAC30-141-120). 
 
 Statutory Authority: § 32.1-351 of the Code of
 Virginia; 42 USC § 1396 et seq.
 
 Effective Date: June 26, 2019. 
 
 Agency Contact: Emily McClellan, Regulatory Supervisor,
 Policy Division, Department of Medical Assistance Services, 600 East Broad
 Street, Suite 1300, Richmond, VA 23219, telephone (804) 371-4300, FAX (804)
 786-1680, or email emily.mcclellan@dmas.virginia.gov.
 
 Summary:
 
 Effective January 1, 2014, the Affordable Care Act required
 eligibility for health coverage under all health insurance affordability
 programs to be based on a new modified adjusted gross income (MAGI)
 methodology. Calculating MAGI eligibility entails defining household
 composition and executing income counting procedures based on Internal Revenue
 Service rules. Federal law requires these changes to be made in the State Child
 Health Plan under Title XXI of the Social Security Act. 
 
 The amendments incorporate the required changes in
 eligibility determination standards and update operational processes supporting
 eligibility and renewal actions, including (i) adding new definitions and
 modifying existing definitions pertinent to MAGI and operational processes; (ii)
 updating operational processes to reflect current practice; (iii) updating the
 reference to the Children's Health Insurance Program Advisory Committee; (iv)
 specifying financial and nonfinancial eligibility standards consistent with
 MAGI requirements and updating operational processes pertinent to the Virginia
 Department of Social Services (VDSS) and Cover Virginia, the central processing
 unit (CPU); (v) clarifying that inpatient status in an institution for mental
 disease is a factor for ineligibility at initial enrollment or renewal; (vi)
 updating terminology regarding VDSS and CPU consistent with implementation of
 MAGI standards; (vii) streamlining application, case documentation, and
 maintenance processes in implementation of MAGI standards; and (viii)
 specifying that a choice of managed care organization may be made at the time
 of application.
 
 Technical, nonsubstantive amendments to conform to style
 guidelines were made for publication of the final regulation. 
 
 Summary of Public Comments and Agency's Response: No
 public comments were received by the promulgating agency. 
 
 Part I 
 General Provisions 
 
 12VAC30-141-10. Definitions. 
 
 The following words and terms when used in this chapter shall
 have the following meanings unless the context clearly indicates otherwise: 
 
 "Act" means the Social Security Act. 
 
 "Adult caretaker relative" or "caretaker
 relative" means an individual who is age 18 or older, who is not the
 parent of, but who is related to, the child by blood or marriage, and who lives
 with and assumes responsibility for day-to-day care of the child in a place of
 residence maintained as his or their own home. 
 
 "Adverse action," consistent with 42 CFR
 457.1130, means the denial of eligibility; failure to make a timely
 determination of eligibility; suspension or termination of enrollment,
 including disenrollment for failure to pay cost sharing; or delay, denial,
 reduction, suspension, or termination of health services, in whole or in part,
 including a determination about the type or level of services; and failure to
 approve, furnish, or provide payment for health services in a timely manner;
 provided, however, that determination of eligibility to participate in and
 termination of participation in the FAMIS Select program shall not constitute
 an adverse action. 
 
 "Adverse benefit determination," consistent with
 42 CFR 438.400, means the denial or limited authorization of a requested
 service; the failure to take action or timely take action on a request for
 service; the reduction, suspension, or termination of a previously authorized
 service; denial in whole or in part of a payment for a service; failure to
 provide services within the timeframes required by the state; for a resident of
 a rural exception area with only one MCO, the denial of a enrollee's request to
 exercise the enrollee's right under 42 CFR 438.52(b)(2)(ii) to obtain services
 outside of the network; the denial of a enrollee's request to dispute a
 financial liability as provided in 42 CFR [ 438(b)(7)
 438.400(b)(7) ]; or the failure of an MCO to act within the
 timeframes provided in 42 CFR 438.408(b).
 
 "Agency" means a local department of social
 services, the central processing unit, or other entity designated by DMAS to
 make eligibility determinations for FAMIS. 
 
 "Agency error" means a person or persons
 received benefits to which they were not entitled as a result of an error on
 the part of an eligibility worker at a local department of social services or
 the central processing unit. 
 
 "Agent" means an individual designated in writing
 to act on behalf of a FAMIS Plan applicant or enrollee during the
 administrative review process. 
 
 "Appeal" means an enrollee's request for review
 of an adverse benefit determination by an MCO or an adverse action by the LDSS,
 CPU, or DMAS.
 
 "Applicant" means a child who has filed an
 application (or who has an application filed on his behalf) for child health
 insurance and is awaiting a determination of eligibility. A child is an
 applicant until his eligibility has been determined. 
 
 "Application for health insurance" means the form
 or forms developed and approved by the Department of Medical Assistance
 Services that are used for determining eligibility for Family Access to Medical
 Insurance Security Plan (FAMIS), FAMIS Plus (Children's Medicaid), for Medicaid
 for pregnant women, and for FAMIS MOMS. single streamlined application
 for determining eligibility in public health insurance programs operated by the
 Commonwealth.
 
 "Authorized representative" means a person, 18
 years of age or older, who is authorized to conduct the personal or
 financial affairs for an individual who is 18 years of age or older. 
 
 "Board" or "BMAS" means that policy
 board created by § 32.1-324 of the Code of Virginia to administer the
 plans established by the Social Security Act. 
 
 "CMSIP" means that original child health
 insurance program that preceded FAMIS. 
 
 "Central processing unit" or "CPU" means Cover
 Virginia, which is the private contractor that will determine
 eligibility for and administer part of the Family Access to Medical Insurance
 Security Plan or FAMIS centralized entity supported by DMAS to accept
 and act on applications for health insurance.
 
 "Child" means an individual under the age of
 younger than 19 years of age. 
 
 "Competent individual" means a person who has
 not been judged by a court to be legally incapacitated. 
 
 "Comprehensive health insurance coverage" means
 health benefits coverage, which includes the following categories of services
 at a minimum: inpatient and outpatient hospital services; physician's surgical
 and medical services; and laboratory and radiological services. 
 
 "Conservator" means a person appointed by a court
 of competent jurisdiction to manage the estate and financial affairs of an
 incapacitated individual. 
 
 "Continuation of enrollment coverage"
 means ensuring an enrollee's benefits are continued until completion of the
 review process, with the condition that should the enrollee not prevail in the
 review process, the enrollee shall be liable for the repayment of all benefits
 received during the review process. 
 
 "Director" means the individual, or his designee,
 specified in § 32.1-324 of the Code of Virginia with all of the attendant
 duties and responsibilities to administer the State Plan for Medical Assistance
 and the State Plan for FAMIS. 
 
 "DMAS" or "department" means the
 Department of Medical Assistance Services. 
 
 [ "Eligibility worker" means an
 individual who, under supervision, applies regulations, policies, and
 procedures to determine eligibility for public assistance programs, including
 FAMIS and FAMIS MOMS."Enrollee" means a child who has been determined
 eligible to participate in FAMIS and is enrolled in the FAMIS program. ]
 
 
 "Ex parte review" means the review of
 administratively available information pertinent to the application or renewal
 process, conducted by eligibility staff, in order to expediently process the
 applicant's renewal without seeking that information from the applicant.
 
 "External quality review organization" means the
 independent contractor assigned by DMAS to handle quality reviews and to
 conduct final review of MCHIP adverse actions for FAMIS. 
 
 "Family" means parents, including adoptive and
 stepparents, and their children under the age of 19, who are living in the same
 household. Family shall not mean grandparents, other relatives, or legal
 guardians. 
 
 "Family," when used in the context of the FAMIS
 Select component, means a unit or group that has access to an a
 private or employer's group health plan. Thus, it includes the policyholder
 or employee and any dependents who can be covered under the employer's
 plan. 
 
 "Family income" means the total income of all
 family members in a household. Income includes, but is not necessarily limited
 to, before-tax earnings from a job, including cash, wages, salary, commissions,
 tips, self-employment net profits, Social Security, Retirement Survivor
 Disability Insurance (RSDI), veterans benefits, Railroad Retirement, disability
 workers' compensation, unemployment benefits, child support, alimony, spousal
 support, pensions, retirement benefits, settlement benefits, rental income, and
 lottery/bingo winnings. Income excludes public assistance program benefits such
 as SSI and TANF payments, foster care payments, general relief, loans, grants,
 or scholarships for educational expenses or earned income of a child who is a
 student. 
 
 "FAMIS" means the Family Access to Medical
 Insurance Security Plan. 
 
 "FAMIS Select" means an optional program available
 to children determined eligible for FAMIS, whereby DMAS provides premium
 assistance to the family to cover the child through a private or
 employer-sponsored health plan instead of directly through the FAMIS program. 
 
 "Federal poverty level" or "FPL" means
 that income standard as published annually by the U.S. Department of Health and
 Human Services in the Federal Register. 
 
 "Fee-for-service" means the traditional Medicaid
 health care delivery and payment system in which physicians and other providers
 receive a payment for each unit of service they provide. 
 
 "Fixed premium assistance amount" means a
 predetermined amount of premium assistance that DMAS will pay per child to a
 family who chooses to enroll its FAMIS eligible child in a private or
 employer-sponsored health plan. The fixed premium assistance amount will be
 determined annually by DMAS to ensure that the FAMIS Select program is
 cost-effective as compared to the cost of covering a child directly through the
 FAMIS program. 
 
 "Fraud" means an intentional deception or
 misrepresentation made by a person with the knowledge that the deception could
 result in some unauthorized benefit to himself or some other person. It
 includes any act that constitutes fraud under applicable federal or state laws.
 
 
 "Group health plan" or "health insurance
 coverage" means that health care coverage as defined in § 2791 of the
 Public Health Services Act (42 USC § 300gg-91(a) and (b)(1)). 
 
 "Guardian" means a person appointed by a court of
 competent jurisdiction to be responsible for the affairs of an incapacitated
 individual, including responsibility for making decisions regarding the
 person's support, care, health, safety, habilitation, education, and
 therapeutic treatment, and if not inconsistent with an order of commitment,
 residence. 
 
 "Household" means the household composition and
 follows the federal tax rules through the use of modified adjusted gross income
 (MAGI) methodology. An individual's household is based upon the tax filing
 relationships of applicant, persons living with the individual, and those
 claimed as dependents and as outlined in 42 USC § 435.603(3)(f)(1) through
 (f)(4) [ ,. ] 
 
 "Household income" means the sum of MAGI-based
 income as outlined in 42 USC § 435.603(3)(d) through (3)(e) to include every
 individual in the household.
 
 "Incapacitated individual" means a person who,
 pursuant to an order of a court of competent jurisdiction, has been found to be
 incapable of receiving and evaluating information effectively or responding to
 people, events, or environments to such an extent that the individual lacks the
 capacity to (i) meet the essential requirements of his health, care, safety, or
 therapeutic needs without the assistance or protection of a guardian, or (ii)
 manage property or financial affairs or provide for his support or for the
 support of his legal dependents without the assistance or protection of a
 conservator. 
 
 "Internal appeal" means a request to the MCO by
 an enrollee, an enrollee's authorized representative, or a provider, acting on
 behalf of the enrollee and with the enrollee's written consent, for review of
 an MCO's adverse benefit determination. The internal appeal is the only level
 of appeal with the MCO and must be exhausted by an enrollee or deemed exhausted
 according to 42 CFR 438.408(c)(3) before the enrollee may initiate a state fair
 hearing.
 
 "Lawfully residing" means the individual is
 lawfully present in the United States.
 
 "Legally emancipated" means that the parents and
 child have gone through the court and a judge has declared that the parents
 have surrendered the right to care, custody, and earnings of the child and have
 renounced parental duties. A married minor is not emancipated unless a court
 has declared the married minor emancipated from his parents. 
 
 "LDSS" or "local department" means the
 local department of social services. 
 
 "Managed care health insurance plan" or
 "MCHIP" as defined in § 32.1-137.1 of the Code of Virginia means an
 arrangement for the delivery of health care in which a health carrier means
 under contract with DMAS for Title XXI delivery systems, undertakes to provide,
 arrange and pay for, or reimburse any of the costs of health care services for
 a covered person on a prepaid or insured basis, which contains one or more
 incentive arrangements, including any credential requirements intended to
 influence the cost of the health care services between the health carrier and
 one or more providers and requires or creates benefit payment differential
 incentives for covered persons to use providers that are directly or indirectly
 managed, owned, under contract with or employed by the health carrier. 
 
 "Maternal and child health insurance
 application" means the form or forms developed and approved by the
 Department of Medical Assistance Services that are used by local departments of
 social services and the FAMIS CPU for determining eligibility for Medicaid for
 poverty-level children and for the Family Access to Medical Insurance Security
 Plan (FAMIS). 
 
 "Member of a family," for purposes of
 determining whether the child is eligible for coverage under a state employee
 health insurance plan, means a parent or parents, including stepparents with
 whom the child is living if the stepparent claims the child as a dependent on
 the employee's federal tax return. 
 
  
 
 "Managed care organization" or "MCO"
 means an organization that offers managed care health insurance plans (MCHIPs)
 as [ "MCHIP" is ] defined in [ this
 section § 32.1-137.1 of the Code of Virginia ].
 
 
 [ "Notice of reasonable opportunity"
 means the written notice that is sent to the applicant to inform the applicant
 that the applicant must provide verification of citizenship and identity within
 90 calendar days. ] 
 
 "Premium assistance" means the portion of the
 family's cost of participating in a private or employer's health plan
 that DMAS will pay to cover the FAMIS-eligible children under the private or
 employer-sponsored plan if DMAS determines it is cost effective to do so. 
 
 "Private or employer-sponsored health insurance
 coverage plan" means a health insurance policy that is either
 purchased by an individual directly or through an employer. This component of
 FAMIS refers to the ability of DMAS to provide coverage to FAMIS-eligible
 children by providing premium assistance to families who enroll the
 FAMIS-eligible children in a private or employer-sponsored health plan. 
 
 "Provider" means the individual, facility or other
 entity registered, licensed, or certified, as appropriate, and enrolled by an
 MCHIP or in fee-for-service to render services to FAMIS enrollees eligible for
 services. 
 
 "Supplemental coverage" means coverage provided
 to FAMIS-eligible children covered under the FAMIS Select component so that
 they can receive all childhood immunizations included in the FAMIS benefits. 
 
 "Reasonable opportunity period" means a
 90-calendar-day period given to applicants to supply verification of
 citizenship and identity.
 
 "State fair hearing" means, consistent with 42
 CFR 438.400, the process set forth in 42 CFR 431 Subpart E.
 
 "Targeted low-income child" means an uninsured
 child younger than age 19 years whose household income is within the FAMIS
 eligibility standards established by the Commonwealth.
 
 [ "Targeted low-income pregnant woman"
 means an uninsured pregnant woman whose household income is within the Medicaid
 or FAMIS MOMS eligibility standards established by the Commonwealth. ]
 
 
 "Title XXI" means the federal State Children's
 Health Insurance Program as established by Subtitle J of the Balanced Budget
 Act of 1997.  
 
 "Virginia State Employee Health Insurance Plan"
 means a health insurance plan offered by the Commonwealth of Virginia to its
 employees. 
 
 12VAC30-141-20. Administration and general background. 
 
 A. The state shall use funds provided under Title XXI for
 obtaining coverage that meets the requirements for a State Child Health
 Insurance Plan (also known as Title XXI). 
 
 B. The DMAS director will have the authority to contract with
 entities for the purpose of establishing a centralized processing site,
 determining eligibility, enrolling eligible children into health plans,
 performing outreach, data collection, reporting, and other services necessary
 for the administration of the Family Access to Medical Insurance Security Plan and
 for employing state staff to perform Medicaid eligibility determinations on
 children referred by FAMIS staff. 
 
 C. Health care services under FAMIS shall be provided through
 MCHIPs and through fee-for-service or through any other health care delivery
 system deemed appropriate by the Department of Medical Assistance Services. 
 
 12VAC30-141-30. Outreach and public participation. 
 
 A. DMAS will work cooperatively with other state agencies and
 contractors to ensure that federal law and any applicable federal regulations
 are met. 
 
 B. Pursuant to § 32.1-351.2 of the Code of Virginia, DMAS
 shall establish an Outreach Oversight Committee (committee) to discuss
 strategies to improve outreach activities. The committee members shall be
 selected by DMAS and shall be composed of representatives from community-based
 organizations engaged in outreach activities, social services eligibility
 workers, the provider community, health plans, and consumers. The committee
 shall meet on a quarterly basis. As may be appropriate, the committee shall
 make recommendations regarding state-level outreach activities, the
 coordination of regional and local outreach activities, and procedures for
 streamlining and simplifying the application process, brochures, other printed
 materials, forms, and applicant correspondence.
 
 C. The board, in consultation with the committee, shall
 develop a comprehensive, statewide community-based outreach plan to enroll
 children in the FAMIS program and, if so eligible, in Medicaid. The outreach
 plan shall include specific strategies for: (i) improving outreach and
 enrollment in those localities where enrollment is less than the statewide
 average and (ii) enrolling uninsured children of former Temporary Assistance to
 Needy Families (TANF) recipients.
 
 D. B. DMAS shall develop a comprehensive
 marketing and outreach effort. The marketing and outreach efforts will be aimed
 at promoting the FAMIS and Medicaid programs and increasing enrollment,
 and may include contracting with a public relations firm, nonprofit
 agencies, and foundations; coordination with other state agencies,;
 coordination with the business community,; and coordination with
 health care associations and providers. 
 
 C. DMAS shall ensure consultation by Native American
 tribes on the development and implementation of enrollment processes and
 procedures to exempt cost-sharing for American Indian and Alaskan Native
 children in compliance with 42 CFR 457.120 and 42 CFR 457.125.
 
 Part II 
 Review Appeal of Adverse Actions 
 
 12VAC30-141-40. Review Appeal of adverse actions or
 adverse benefit determinations. 
 
 A. Upon written request, all FAMIS Plan applicants and
 enrollees shall have the right to a review state fair hearing of
 an adverse action made by the MCHIP, local department of social
 services, CPU, or DMAS and to an internal appeal of an adverse
 benefit determination made by an MCO. 
 
 B. During review the appeal of a suspension or
 termination of enrollment or a reduction, suspension, or termination of
 services, the enrollee shall have the right to continuation of coverage if the
 enrollee requests review an internal appeal with the MCO or an appeal
 to DMAS prior to the effective date of the suspension or termination of
 enrollment or suspension, reduction, or termination of services. 
 
 C. Review An appeal of an adverse action made
 by the local department of social services, CPU, or DMAS shall be heard
 and decided by an agent of DMAS who has not been directly involved in the
 adverse action under review appeal. 
 
 D. Review An internal appeal of an adverse action
 benefit determination made by the MCHIP MCO must be
 conducted by a person or agent of the MCHIP MCO who has not been
 directly involved in the adverse action benefit determination
 under review appeal. 
 
 E. After final review by the MCHIP, Pursuant to 42 CFR
 438.402(c)(1)(B), after exhausting the MCO's internal appeals process,
 there shall also be opportunity for final independent the
 enrollee to request an external medical review by the an
 independent external quality review organization. [ "External
 quality review organization" means the independent contractor assigned by
 DMAS to handle quality reviews and to conduct final review of MCHIP adverse
 actions for FAMIS. ] The review is optional and shall not be
 required before proceeding to a state fair hearing. The review shall not extend
 any of the timeframes for issuing a decision and shall not disrupt any
 continuation of coverage granted to the enrollee.
 
 F. There will be no opportunity for review appeal
 of an adverse action to the extent that such adverse action is based on a
 determination by the director that funding for FAMIS has been terminated or
 exhausted. There will be no opportunity for review based on which type of
 delivery system (i.e., fee-for-service, MCHIP) is assigned. There will be
 no opportunity for review appeal if the sole basis for the adverse
 action is a state or federal law or regulation requiring an automatic change
 that affects all applicants or enrollees or a group of applicants or enrollees
 without regard to their individual circumstances. decision is a
 provision in the State Plan or in a state or federal law requiring an automatic
 change in eligibility or enrollment or is a change in coverage under the health
 benefits package that affects all applicants or enrollees or a group of applicants
 or enrollees without regard to their individual circumstances.
 
 G. The burden of proof shall be upon the applicant or
 enrollee to show that an adverse action or adverse benefit determination
 is incorrect. 
 
 H. At no time shall the MCHIP's, local department's
 department of social services, the CPU's, or DMAS' MCO, CPU,
 or DMAS failure to meet the time frames timeframes set in
 this chapter or set in the MCHIP's MCO or DMAS' DMAS
 written review appeal procedures constitute a basis for granting
 the applicant or enrollee the relief sought. 
 
 I. Adverse actions related to health benefits covered through
 the FAMIS Select program shall be resolved between the insurance company or
 employer's plan and the FAMIS Select enrollee, and are not subject to
 further review appeal by DMAS or its contractors. Adverse
 actions made by an MCHIP, the local department of social services, the CPU, or
 DMAS shall be subject to the review process set forth in Part II
 (12VAC30-141-40 et seq.) of this chapter. 
 
 12VAC30-141-50. Notice of adverse action or adverse benefit
 determination. 
 
 A. The local department of social services, the CPU,
 or DMAS shall send written notification to enrollees at least 10 calendar days
 prior to suspension or termination of enrollment. 
 
 B. DMAS or the MCHIP MCO shall send written
 notification to enrollees at least 10 calendar days prior to reduction,
 suspension, or termination of a previously authorized health service. 
 
 C. The local department of social services, the CPU,
 DMAS, or the MCHIP MCO shall send written notification to
 applicants and enrollees of all other adverse actions within 10 calendar days
 of the adverse action. 
 
 D. Notice shall include the reasons for determination, an
 explanation of applicable rights to a review of that determination, the standard
 and expedited time frames for review, the manner in which a review can be
 requested, and the circumstances under which enrollment or services may
 continue pending review.:
 
 1. The determination the LDSS, CPU, DMAS, or MCO has made
 or intends to make;
 
 2. The reasons for the determination, including the right
 of the enrollee to be provided, upon request and free of charge, reasonable
 access to and copies of all documents, records, and other information relevant
 to the determination;
 
 3. An explanation of applicable rights to request an appeal
 of that determination. For adverse benefit determinations by an MCO, this shall
 include information on the MCO's internal appeal process and, after the
 internal appeal process is exhausted, a state fair hearing pursuant to 42 CFR
 402(b) and 42 CFR 402(c);
 
 4. The procedure for exercising these appeal rights;
 
 5. The circumstances under which an appeal process can be
 expedited and how to request it; and
 
 6. The circumstances under which enrollment or services may
 continue pending appeal, how to request benefits be continued, and the
 circumstances, consistent with state policy, under which the enrollee may be
 required to pay the costs of these services.
 
 12VAC30-141-60. Request for review appeal.
 
 A. Requests for review internal appeal of MCHIP
 MCO adverse actions benefit determinations shall be
 submitted orally or in writing to the MCHIP MCO. Unless
 the enrollee requests an expedited appeal, an oral appeal request must be
 followed by a written appeal request. The enrollee must exhaust the MCO's
 internal appeals process before appealing to DMAS.
 
 B. If the MCO fails to adhere to the notice or timing
 requirements set forth in this part, the enrollee is deemed to have exhausted
 the MCO's internal appeals process and may initiate a state fair hearing.
 
 C. Requests for review appeal of adverse
 actions made by the local department of social services, the CPU, or
 DMAS or of internal appeal decisions by the MCO shall be submitted in
 writing to DMAS.
 
 C. D. Any written communication clearly
 expressing a desire to have an adverse action benefit determination
 by an MCO reviewed shall be treated as a request for review an
 internal appeal. Any communication expressing a desire to have an
 adverse action by the LDSS, CPU, or DMAS reviewed shall be treated as a request
 for a state fair hearing. Any communication expressing a desire to have an
 MCO's internal appeal decision reviewed shall be treated as a request for a
 state fair hearing.
 
 D. E. To be timely, requests for review internal
 appeal of a MCHIP an MCO's adverse benefit determination
 shall be received by the MCHIP MCO no later than 30 60
 calendar days from the date of the MCHIP's MCO's notice of
 adverse action benefit determination.
 
 E. F. To be timely, a request for an appeal of an
 adverse benefit determination upheld in whole or in part by the MCO's internal
 appeal decision shall be received by DMAS within 120 calendar days from the
 date of the internal appeal decision. 
 
 G. To be timely, requests for review appeal
 of a local department of social services, DMAS, or CPU determination adverse
 action shall be filed with DMAS no later than 30 calendar days from the
 date of the CPU's, LDSS' or DMAS' notice of adverse action. Requests for
 review appeal of a local department of social services, DMAS,
 or CPU an agency determination shall be considered filed with DMAS
 on the date the request is postmarked, if mailed, or on the date the
 request is received, if delivered other than by mail, by DMAS. 
 
 12VAC30-141-70. Review Appeal procedures. 
 
 A. At a minimum, the MCHIP review MCO internal
 appeal shall be conducted pursuant to written procedures as defined in §
 32.1-137.6 of the Code of Virginia and as may be further defined by DMAS
 42 CFR 438.400 et seq. Such procedures shall be subject to review and
 approval by DMAS. 
 
 B. Any adverse benefit determination upheld in whole or in
 part by the internal appeal decision issued by the MCO may be appealed by the
 enrollee to DMAS in accordance with the DMAS client appeals regulations at
 12VAC30-110-10 through 12VAC30-110-370. DMAS shall conduct an evidentiary
 hearing in accordance with the 12VAC30-110-10 through 12VAC30-110-370 and shall
 not base any appealed decision on the record established by any internal appeal
 decision of the MCO. The MCO shall comply with the DMAS appeal decision. The
 DMAS decision in these matters shall be final and shall not be subject to
 appeal by the MCO.
 
 The DMAS review C. Appeals of adverse actions by
 the LDSS, CPU, or DMAS shall be conducted pursuant to written procedures
 developed by DMAS 12VAC30-110. 
 
 C. The procedures in effect on the date a particular
 request for review is received by the MCHIP or DMAS shall apply throughout the
 review. 
 
 D. Copies of the procedures shall be promptly mailed provided
 by the MCHIP MCO or DMAS to applicants and enrollees upon receipt
 of timely requests for review internal appeals or state fair hearings.
 Such written procedures shall include but not be limited to the
 following: 
 
 1. The right to representation by an attorney or other agent
 of the applicant's or enrollee's choice, but at no time shall the MCHIP MCO,
 local department of social services, DSS, or DMAS be required to obtain or
 compensate attorneys or other agents acting on behalf of applicants or
 enrollees; 
 
 2. The right to timely review of their files and other
 applicable information relevant to the review of the internal appeal
 or state fair hearing decision; 
 
 3. The right to fully participate in the review internal
 appeal or state fair hearing process, whether the review internal
 appeal or state fair hearing is conducted in person or in writing,
 including the presentation of supplemental information during the review
 internal appeal or state fair hearing process; 
 
 4. The right to have personal and medical information and
 records maintained as confidential; and 
 
 5. The right to a written final decision within 90 calendar
 days of receipt of the request for review, unless the applicant or enrollee
 requests or causes a delay.:
 
 a. For internal appeals to the MCO, within 30 calendar days
 of receipt of the request for an internal appeal; or
 
 b. For state fair hearings, within the time limitations for
 appeals imposed by federal regulations and as permitted in 12VAC30-110-30;
 
 6. For eligibility and enrollment matters, if the applicant's
 or enrollee's physician or health plan determines that the 90-calendar-day
 timeframe could seriously jeopardize the applicant's or enrollee's life or
 health or ability to attain, maintain, or regain maximum function, an applicant
 or enrollee will have the opportunity to request an expedited review
 appeal. Under these conditions, a request for review an
 expedited appeal shall result in a written final decision within three
 business days 72 hours after DMAS receives, the expedited
 appeal request from the physician or health plan, with the
 case record and information indicating that taking the time for a standard
 resolution of the review appeal request could seriously
 jeopardize the applicant's or enrollee's life or health or ability to attain,
 maintain, or regain maximum function, unless the applicant or enrollee or
 his authorized representative causes a delay. requests an extension;
 
 
 7. For health services matters for FAMIS enrollees receiving
 services through MCHIPs, if an MCO: 
 
 a. If the enrollee's physician or health plan
 determines that the 90-calendar-day 30-calendar-day timeframe for
 a standard internal appeal could seriously jeopardize the enrollee's life
 or health or ability to attain, maintain, or regain maximum function, an
 enrollee will have the opportunity to request an expedited review
 internal appeal. Under these conditions, a request for review an
 internal appeal shall result in a written decision by the external
 quality review organization MCO within 72 hours from the time an
 enrollee requests the expedited review internal appeal is
 requested, unless the applicant, enrollee, or authorized representative
 requests or causes a delay. If a delay is requested or caused by
 the applicant, enrollee, or authorized representative, then the
 expedited review internal appeal may be extended up to 14
 calendar days. 
 
 b. If the adverse benefit determination is upheld in whole
 or in part by the expedited internal appeal decision issued by the MCO, and if
 the enrollee's physician or health plan determines that the timeframe for a
 standard appeal to DMAS could seriously jeopardize the enrollee's life or
 health or ability to attain, maintain, or regain maximum function, and enrollee
 will have the opportunity to request an expedited appeal to DMAS. Under these
 conditions, a request for a state fair hearing shall result in a written
 decision within 72 hours from the time an enrollee requests the expedited
 appeal, unless the applicant, enrollee, or authorized representative requests a
 delay. If a delay is requested by the applicant, enrollee, or authorized
 representative, then the expedited appeal may be extended up to 14 calendar
 days; and
 
 8. For health services matters for FAMIS enrollees receiving
 services through fee-for-service, if the enrollee's physician or health plan
 determines that the 90-calendar-day timeframe for a standard appeal
 could seriously jeopardize the enrollee's life, health, or ability to
 attain, maintain, or regain maximum function, an enrollee will have the
 opportunity to request an expedited review. Under these conditions, a
 request for review an expedited appeal shall result in a written
 decision within 72 hours from the time an enrollee requests the
 expedited review appeal is requested, unless the applicant,
 enrollee, or authorized representative requests or causes a delay. If a
 delay is requested or caused by the applicant, enrollee, or authorized
 representative, then expedited review appeal may be extended up
 to 14 calendar days. 
 
 Part III 
 Eligibility Determination and Application Requirements 
 
 12VAC30-141-100. Eligibility requirements General
 conditions of eligibility.
 
 A. This section shall be used to determine eligibility of
 children for FAMIS. An LDSS, DMAS, or the CPU determines eligibility for
 Title XXI services.
 
 B. FAMIS shall be in effect statewide. 
 
 C. Eligible children must: FAMIS serves targeted
 low-income children consistent with requirements at 42 CFR 457.310, 42 CFR
 457.315, and 42 CFR 457.320.
 
 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 United States citizens, United States
 nationals or qualified noncitizens; 
 
 5. Be uninsured, that is, not have comprehensive health
 insurance coverage; and 
 
 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 and 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. United States 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 United States 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 
 
 D. Each individual covered under the plan shall be:
 
 1. Financially eligible to receive services as established
 using the methods and standards described in subsection F of this section; and 
 
 2. Meet the applicable nonfinancial eligibility conditions.
 
 E. Nonfinancial eligibility conditions.
 
 1. Eligible individuals shall be younger than 19 years of
 age.
 
 2. Eligible individuals shall be residents of the
 Commonwealth. A child is considered to be a resident of the Commonwealth under
 the following conditions: 
 
 a. A noninstitutionalized child if capable of indicating
 intent and who is emancipated or married if the child is living in the state
 and intends to reside in the state, including without a fixed address;
 
 b. A noninstitutionalized child not described in
 subdivision E 2 a of this section and who is not in the custody of the state:
 
 (1) Residing in the state, with or without a fixed address;
 or
 
 (2) The state of residency of the parent or caretaker, in
 accordance with 42 CFR.435.403(h)(1), with whom the individual resides;
 
 c. An institutionalized child who is not a ward of the
 state if the state is the state of residence of the child's custodial parent or
 caretaker at the time of placement;
 
 d. A child who is in the custody of the state regardless of
 where the child lives; or
 
 e. A child physically located in the state when there is a
 dispute with one or more states as to the child's actual state of residence.
 
 3. FAMIS eligibility is open to: 
 
 a. United States citizens;
 
 b. United States nationals;
 
 c. Qualified noncitizens as defined in § 431 of the
 Personal Responsibility and Work Opportunity Reconciliation Act (PRWORA) (8 USC
 § 1641) or whose eligibility is required by § 402(b) of PRWORA (8 USC
 § 1612(b)) and is not prohibited by § 403 of PRWORA (8 USC § 1613);
 
 d. Individuals who have declared themselves to be citizens
 or nationals of the United States or an individual having satisfactory
 immigration status, during a reasonable opportunity period pending verification
 of their citizenship, nationality, or satisfactory immigration status
 consistent with requirements of §§ 1903(x), 1137(d), and 1902(ee) of the
 Social Security Act and 42 CFR 435.407, 42 CFR 407, [ 42
 CFR 956 42 CFR 435.956 ], and 42 CFR 457.380.
 
 (1) The reasonable opportunity period begins on and extends
 90 calendar days from the date the notice of reasonable opportunity is received
 by the individual. [ "Notice of reasonable opportunity"
 means the written notice that is sent to the applicant to inform the applicant
 that the applicant must provide verification of citizenship and identity within
 90 calendar days. ] 
 
 (2) An extension of the reasonable opportunity period is
 allowed if the individual is making a good faith effort to resolve any
 inconsistencies or obtain any necessary documentation, or the agency
 determining eligibility needs more time to complete the verification process. 
 
 (3) The agency will provide benefits to otherwise eligible
 individuals during the reasonable opportunity period;
 
 e. Lawfully residing in the United States, as provided in § 2107(e)(1)(J)
 of the Social Security Act (§ 214 of CHIPRA 2009, P.L. 111-3). An
 individual is considered to be lawfully residing in the United States if the
 person is:
 
 (1) A qualified noncitizen as defined in 8 USC § 1641(b)
 and (c);
 
 (2) A noncitizen in a valid nonimmigrant status as defined
 in 8 USC § 1101(a)(15) or otherwise under the immigration laws (as defined in 8
 USC § 1101 (a)(17));
 
 (3) A noncitizen who has been paroled into the United
 States in accordance with 8 USC § 1182(d)(5) for less than one year,
 except for an individual paroled for prosecution, for deferred inspection, or
 pending removal proceedings;
 
 (4) A noncitizen who belongs to one of the following
 classes:
 
 (a) Granted temporary resident status in accordance with 8
 USC § 1160 or 1255a, respectively;
 
 (b) Granted temporary protected status (TPS) in accordance
 with 8 USC § 1254a and individuals with pending applications for TPS who have
 been granted employment authorization;
 
 (c) Granted employment authorization under 8 CFR § 274a.12(c);
 
 (d) Family unity beneficiaries in accordance with § 301
 of P.L. 101-649, as amended;
 
 (e) Under deferred enforced departure in accordance with a
 decision made by the President;
 
 (f) Granted deferred action status;
 
 (g) Granted an administrative stay of removal under 8 CFR
 241; or
 
 (h) Beneficiary of approved visa petition who has a pending
 application for adjustment of status;
 
 (5) Is an individual with a pending application for asylum
 under 8 USC § 1158, for withholding of removal under 8 USC § 1231, or
 under the Convention Against Torture who:
 
 (a) Has been granted employment authorization; or
 
 (b) Is younger than 14 years of age and has had an
 application pending for at least 180 calendar days; 
 
 (6) Has been granted withholding of removal under the
 Convention Against Torture;
 
 (7) Is a child who has a pending application for Special
 Immigrant Juvenile Status as described in 8 USC § 1101(a)(27)(J);
 
 (8) Is lawfully present in American Samoa under the
 immigration laws of American Samoa; or
 
 (9) Is a victim of severe trafficking in persons, in
 accordance with the Victims of Trafficking and Violence Protection Act of 2000,
 P.L. 106-386, as amended (22 USC § 7105(b)).
 
 f. An individual with deferred action under the Department
 of Homeland Security's deferred action for the childhood arrivals process, as
 described in the Secretary of Homeland Security's June 15, 2012, memorandum,
 shall not be considered to be lawfully present with respect to any of the
 categories in subdivision E 3 e of this section. 
 
 4. Eligible individuals shall be uninsured, that is, not
 have creditable health insurance coverage. [ "Creditable
 health insurance coverage" means coverage that meets the definition of 42
 CFR 457.10. ] 
 
 a. Individuals eligible for FAMIS shall not be found
 eligible or potentially eligible for Medicaid under policies of the State Plan
 determined through the screening process described at 42 CFR 457.350.
 
 b. 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.
 
 (1) FAMIS shall not be a substitution for private
 insurance.
 
 (2) 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.
 
 (3) Health insurance does not include Medicare, Medicaid,
 FAMIS, or insurance for which DMAS paid premiums under Title XIX through the
 Health Insurance Premium Payment Program or under Title XXI through the state
 children's health insurance program premium assistance program known as FAMIS
 Select. 
 
 5. Residents of an institution. Eligible individuals may
 not be an inpatient in an institution for mental diseases or an inmate in a
 public institution that is not a medical facility at the time of the initial
 eligibility determination or redetermination. 
 
 6. Social Security Number. 
 
 a. All eligible individuals shall furnish their Social
 Security Numbers (SSNs), with the following exceptions: (i) individuals
 refusing to obtain a SSN because of well-established religious objections
 [ ;, ] (ii) individuals who are not eligible
 for a SSN [ ;, ] or (iii) individuals who
 are issued a SSN only for a valid nonwork purpose.
 
 b. DMAS or its designee shall:
 
 (1) Assist individuals who are required to provide their
 SSN to apply for or obtain an SSN from the Social Security Administration if
 the individuals do not have or forgot their SSNs;
 
 (2) Inform individuals required to provide their SSNs (i)
 by what statutory authority the number is required to be provided; and (ii) how
 the Commonwealth will use the SSN;
 
 (3) Verify each SSN furnished by applicants or beneficiaries
 with the Social Security Administration; and
 
 (4) Not deny or delay services to an otherwise eligible
 applicant pending issuance or verification of the individual's SSN by the
 Social Security Administration.
 
 c. The utilization of the SSN is consistent with §§ 205
 and 1137 of the Social Security Act and the Privacy Act of 1974.
 
 d. DMAS requests nonapplicant household members to
 voluntarily provide their SSNs. When requesting an SSN for nonapplicant
 household members, DMAS (i) informs the nonapplicant that this information is
 voluntary and provides information regarding how the SSN will be used and (ii)
 uses the SSN for determination of eligibility for Children's Health Insurance
 Program (CHIP) or other insurance affordability programs or for a purpose
 directly connected with the administration of the state plan.
 
 F. Financial eligibility.
 
 1. Screening. All applications shall have a Medicaid income
 eligibility screen completed. Children determined to be ineligible for Medicaid
 due to excess income will have their eligibility for FAMIS determined. 
 
 2. Standards. 
 
 a. The Commonwealth shall apply modified adjusted gross
 income (MAGI) methodologies for all separate CHIP covered groups, consistent
 with 42 CFR 457.315 and 435.603(b) through (i). FAMIS shall be available for
 targeted low-income children. Income standards shall be applied statewide.
 Children from birth to age 19 years who have income above the Medicaid-eligible
 limit at or below 200% of the federal poverty level, with a 5% income disregard,
 shall be income eligible to participate in FAMIS. 
 
 b. In determining family size for the eligibility
 determination of other individuals in the household that includes a pregnant
 woman, the pregnant woman is counted just as herself. 
 
 c. Financial eligibility is determined consistent with the
 following provisions:
 
 (1) For new applicants, financial eligibility is based on
 the monthly income and family size.
 
 (2) When determining eligibility for current beneficiaries,
 financial eligibility is based on current monthly household income and family
 size.
 
 (3) In determining current household income, the agency
 will use reasonable methods to account for current income and reasonable
 prediction of changes in future income or family size.
 
 d. Unless an exception exists, as provided at 42 CFR
 457.315 and 42 CFR 435.603(d)(2) through (d)(4), household income is the sum of
 the MAGI-based income for every person counted in the individual's MAGI
 household.
 
 3. Spenddown. The Commonwealth shall not apply a spenddown
 process for FAMIS where household income exceeds the income eligibility limit
 for FAMIS.
 
 I. G. Eligibility of newborns. 
 
 1. 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.
 
 2. A child born to a targeted low-income pregnant woman is
 deemed to have applied for and be eligible for FAMIS or Medicaid until the
 child turns age one year in accordance with § 2112 of the Social Security Act.
 [ "Targeted low-income pregnant woman" means an uninsured
 pregnant woman whose household income is within the Medicaid or FAMIS MOMS
 eligibility standards established by the Commonwealth. ] 
 
 a. The child is deemed to have applied for and been found
 eligible for FAMIS or Medicaid, as appropriate, as of the date of the child's
 birth and remains eligible without regard to changes in circumstances until the
 child's first birthday.
 
 b. DMAS shall cover as a deemed newborn a child born to a
 mother who is covered under Medicaid or CHIP through the authority of the
 state's § 1115 demonstration on the date of the newborn's birth.
 
 12VAC30-141-110. Duration of eligibility and renewal.
 
 A. The effective date of FAMIS eligibility shall be the date
 of birth for a newborn deemed eligible under 12VAC30-141-100 I G.
 Otherwise For all other children, the effective date of FAMIS
 eligibility shall be the first day of the month in which a signed completed
 application was received by either the FAMIS central processing unit or a
 local department of social services LDSS or CPU if the applicant met
 all eligibility requirements in that month. In no case shall a child's
 eligibility be effective earlier than the date of the child's birth. 
 
 B. Eligibility for FAMIS will continue for 12 months so long
 as the child remains a resident of Virginia and the child's countable income
 does not exceed 200% of the federal poverty level. A child born to a mother who
 was enrolled in FAMIS, under either the Title XXI Plan or a related
 waiver (such as FAMIS MOMS), on the date of the child's birth shall remain
 eligible for one year regardless of income unless otherwise found to be
 eligible for Medicaid. A change in eligibility will be effective the first of
 the month following expiration of a 10-day 10-calendar-day
 advance notice. Eligibility based on all eligibility criteria listed in
 12VAC30-141-100 C D will be redetermined no less often than
 annually. 
 
 C. Renewal of coverage.
 
 1. Renewal of coverage for individuals whose financial
 eligibility is based on the applicable modified adjusted gross income (MAGI)
 standard are performed as follows, consistent with 42 CFR 457.343:
 
 a. Renewal of coverage is completed once every 12 months,
 and
 
 b. Without requiring information from the individual if
 able to do so based on an ex parte review of reliable information contained in
 the individual's account or other more current information available to the
 agency.
 
 2. If the agency cannot determine eligibility solely on the
 basis of the ex parte review or otherwise needs additional information to
 complete the redetermination, the individual is provided with a renewal form
 that is prepopulated with information contained in the individual's case. The
 individual shall be allowed 30 calendar days to return the renewal form and the
 necessary verifications.
 
 If the individual's coverage is canceled because the
 renewal was not completed (either electronically, by phone, or on paper) or
 because verifications needed to complete the renewal were not returned, the
 individual has 90 calendar days after the coverage is canceled to provide the
 information necessary to complete the renewal without having to file a new
 application. This 90-calendar-day period is called the reconsideration period.
 If all necessary information is provided during the reconsideration period and
 the individual found eligible, enrollment will be restored without any lapse in
 coverage.
 
 12VAC30-141-120. Children ineligible for FAMIS. (Repealed.)
 
 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. An inmate of a public institution as defined in 42 CFR §435.1009,
 he shall be ineligible for FAMIS; or 
 
 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. 
 
 12VAC30-141-150. Application requirements. 
 
 A. Availability of program information. DMAS or its designee
 shall furnish the following information in written form and orally as
 appropriate to all applicants and to other individuals who request it: 
 
 1. The eligibility requirements; 
 
 2. Summary of covered benefits; 
 
 3. Copayment amounts required; and 
 
 4. The rights and responsibilities of applicants and
 enrollees. 
 
 B. Opportunity to apply. DMAS or its designee must afford an
 individual, wishing to do so, the opportunity to apply for child health
 insurance. Applications for health insurance will be accepted at a
 central site designated by DMAS and at local departments of social services
 throughout the Commonwealth. Applicants may file an application for
 child health insurance by mail, by fax, by phone, via the internet,
 or in person at local departments of social services. Applications filed at
 the FAMIS CPU can be submitted by mail, by fax, via the Internet, or by phone.
 Face-to-face interviews for the program are not required. Eligibility
 determinations for FAMIS shall occur at either local departments of social
 services or at the, DMAS designated central site, or
 the CPU. 
 
 C. Application. DMAS or its designee shall require an
 application from the applicant if the applicant is at least 18 years of age or
 older, or from a parent, adult relative caretaker, guardian, legal custodian,
 or authorized representative if the applicant is younger than 18 years of age
 or the applicant is incapacitated. [ "Incapacitated” means a
 person who, pursuant to an order of a court of competent jurisdiction, has been
 found to be incapable of receiving and evaluating information effectively or
 responding to people, events, or environments to such an extent that the
 individual lacks the capacity to (i) meet the essential requirements of his
 health, care, safety, or therapeutic needs without the assistance or protection
 of a guardian, or (ii) manage property or financial affairs or provide for his
 support or for the support of his legal dependents without the assistance or
 protection of a conservator. ]
 
 1. DMAS employs a single, streamlined application developed
 by the state and approved by the Secretary of the Department of Health and
 Human Services in accordance with § 1413(b)(I)(B) of the Affordable Care Act.
 
 2. DMAS may employ an alternative application used to apply
 for multiple human service programs approved by the Secretary of the Department
 of Health and Human Services, provided that the agency makes readily available
 the single or alternative application used only for insurance affordability programs
 to individuals seeking assistance only through such programs.
 
 C. D. Right to apply. An individual who is 18
 years of age shall not be refused the right to complete an application for health
 insurance for himself and shall not be discouraged from asking for
 assistance for himself under any circumstances. 
 
 D. E. Applicant's signature. The applicant must
 sign state-approved application forms submitted, even if another person fills
 out the form, unless the application is filed and signed by the applicant's
 parent, adult relative caretaker, legal guardian or conservator,
 attorney-in-fact or authorized representative. 
 
 E. F. The authorized representative for an
 individual 18 years of age or older shall be those individuals as set forth in
 12VAC30-110-1380. 
 
 F. G. The authorized representative for
 children younger than 18 years of age shall be those individuals as set forth
 in 12VAC30-110-1390. 
 
 G. H. Persons prohibited from signing an
 application. An employee of, or an entity hired by, a medical service provider
 who stands to obtain FAMIS payments shall not sign an application for health
 insurance on behalf of an individual who cannot designate an authorized
 representative. 
 
 H. Written application. DMAS or its designee shall require
 a written application from the applicant if he is at least 18 years of age or
 older, or from a parent, adult relative caretaker, guardian, legal custodian,
 or authorized representative if the applicant is less than 18 years of age or
 the applicant is incapacitated. The application must be on a form prescribed by
 DMAS, and must be signed under a penalty of perjury. The application form shall
 contain information sufficient to determine Medicaid and FAMIS eligibility. 
 
 I. Assistance with application. DMAS or its designee shall
 allow an individual or individuals of the applicant's choice to assist
 and represent the applicant in the application process, or a redetermination
 renewal process for eligibility, or both. 
 
 J. Timely determination of eligibility. The time processing
 standards for determining eligibility for child health insurance begin
 with the date a signed an application is submitted online, by
 telephone, by fax, or received in hard copy either at a local
 department of social services LDSS or the FAMIS CPU. An
 application for health insurance received at local departments of social
 services must shall have a full Medicaid eligibility
 determination and, when a child is determined to be ineligible for Medicaid due
 to excess income, a FAMIS eligibility determination an eligibility determination
 performed, within the same Medicaid established federal
 case processing time standards. 
 
 Except in cases of unusual circumstances as described
 below, an application for health insurance received at the FAMIS CPU and
 screened as ineligible for Medicaid, shall have a FAMIS eligibility
 determination completed within 10 business days of the date the complete
 application was received at the CPU. Applications that are screened as Medicaid
 likely will be processed within Medicaid case processing time standards. 
 
 1. Unusual circumstances include: administrative or other
 emergency beyond the agency's control. In such case, DMAS, or its designee, or
 the LDSS must document, in the applicant's case record, the reasons for delay.
 DMAS or its designee or the local department of social services must not use
 the time standards as a waiting period before determining eligibility or as a
 reason for denying eligibility because it has not determined eligibility within
 the time standards. 
 
 2. Incomplete applications shall be held open for a period
 of 30 calendar days to enable applicants to provide outstanding information
 needed for an eligibility determination. Any applicant who fails to provide,
 within 30 calendar days of the receipt of the initial application, information
 or verifications necessary to determine eligibility, shall have his application
 for FAMIS eligibility denied. 
 
 K. Notice of DMAS', its designee's or the local
 department of social services' decision concerning eligibility. DMAS,
 its designee or the local department of social services must The
 determining agency shall send each applicant a written notice of the agency's/designee's
 agency's or designee's decision on his the applicant's
 application, and, if approved, his the applicant's
 obligations under the program. If eligibility for both FAMIS and
 Medicaid is denied, notice must be given concerning the reasons for the
 action and an explanation of the applicant's right to request a review of the
 adverse actions, as described in 12VAC30-141-50. 
 
 L. Case documentation. DMAS, its designee, or the local
 department of social services must The determining agency shall
 include in each applicant's record all necessary facts to support the decision
 on his the applicant's application, and must dispose of
 each application by a finding of eligibility or ineligibility, unless (i) there
 is an entry in the case record that the applicant voluntarily withdrew the
 application and that the agency or its designee sent a notice confirming his
 the applicant's decision; or (ii) there is a supporting entry in the
 case record that the applicant cannot be located. 
 
 M. Case maintenance. All cases approved for FAMIS shall be
 maintained at the FAMIS CPU local departments of social services or
 another entity designated by DMAS. Children determined by local
 departments of social services to be eligible for FAMIS shall have their cases
 transferred to the FAMIS CPU for ongoing case maintenance. The FAMIS CPU The
 determining agency will be responsible for providing newly enrolled
 recipients with program information, benefits available, how to secure services
 under the program, a FAMIS handbook, and for processing changes in eligibility
 and annual renewals within established time frames timeframes. DMAS
 outreach resources may also provide information or assistance to the enrollee.
 
 N. Redetermination Renewal of eligibility. DMAS,
 LDSS, or the FAMIS CPU must shall redetermine the
 eligibility of enrollees with respect to circumstances that may change at least
 every 12 months. During the 12-month period of coverage, enrollees must make
 timely and accurate reports if an enrollee no longer resides in the
 Commonwealth of Virginia or when changes in income exceed 200% of the federal
 poverty level plus a 5.0% income disregard. DMAS or the FAMIS CPU must
 The agency responsible for managing the case shall promptly redetermine
 eligibility when it receives information about changes in a FAMIS enrollee's
 circumstances that may affect eligibility. DMAS or its designee may assist
 with documenting changes reported by the enrollee. 
 
 O. Notice of decision concerning eligibility. DMAS or the
 FAMIS CPU must The agency responsible for managing the case shall
 give enrollees timely notice of proposed action to terminate their eligibility
 under FAMIS. The notice must meet the requirements of 42 CFR 457.1180. 
 
 Part IV 
 Cost Sharing 
 
 12VAC30-141-160. Copayments for families not participating in
 FAMIS Select. 
 
 A. Copayments shall apply to all enrollees in an MCHIP. 
 
 B. These cost-sharing provisions shall be implemented with
 the following restrictions: 
 
 1. Total cost sharing for each 12-month eligibility period
 shall be limited to (i) for families with incomes equal to or less than 150% of
 FPL federal poverty level (FPL), the lesser of (a) $180 and (b)
 2.5% of the family's income for the year (or 12-month eligibility period); and
 (ii) for families with incomes greater than 150% of FPL, the lesser of $350 and
 5.0% of the family's income for the year (or 12-month eligibility period). 
 
 2. DMAS or its designee shall ensure that the annual aggregate
 cost sharing for all FAMIS enrollees in a family does not exceed the
 aforementioned caps. 
 
 3. Families will be required to submit documentation to DMAS
 or its designee showing that their maximum copayment amounts are met for the
 year. 
 
 4. Once the cap is met, DMAS or its designee will issue a new
 eligibility card excluding such families from paying additional copays for
 the 12-month enrollment period. 
 
 C. Exceptions to the above cost-sharing provisions: 
 
 1. Copayments shall not be required for [ well-child
 well child ], well baby, and pregnancy-related services. This shall
 include: 
 
 a. All healthy newborn inpatient physician visits, including
 routine screening (inpatient or outpatient); 
 
 b. Routine physical examinations, laboratory tests,
 immunizations, and related office visits; 
 
 c. Routine preventive and diagnostic dental services (i.e.,
 oral examinations, prophylaxis and topical fluoride applications, sealants, and
 x-rays); 
 
 d. Services to pregnant females related to the pregnancy; and 
 
 e. Other preventive services as defined by the department. 
 
 2. Enrollees are not held liable for any additional costs,
 beyond the standard copayment amount, for emergency services furnished outside
 of the individual's managed care network. Only one copayment charge will be
 imposed for a single office visit. 
 
 3. No cost sharing will be charged to American Indians and
 Alaska Natives. 
 
 12VAC30-141-175. FAMIS Select. 
 
 A. Enrollees in FAMIS may, but shall not be required to,
 enroll in a private or employer-sponsored health plan if DMAS or its designee
 determines that such enrollment is cost effective, as defined in this section. 
 
 B. Eligibility determination. FAMIS children may elect to
 receive coverage under a health plan purchased privately or through an employer
 and DMAS may elect to provide coverage by paying all or a portion of the
 premium if all of the following conditions are met: 
 
 1. The children are determined to be eligible for FAMIS; 
 
 2. The cost of coverage for the child [ or children ]
 under FAMIS Select is equal to or less than the Commonwealth's cost of
 obtaining coverage under FAMIS only for the eligible targeted low-income
 children involved. The cost-effectiveness determination methodology is
 described in subsection E of this section; 
 
 3. The policyholder agrees to assign rights to benefits under
 the private or [ employer's employer-sponsored health ]
 plan to DMAS to assist the Commonwealth in pursuing these third-party payments
 for childhood immunizations. When a child is provided coverage under a private
 or [ employer's employer-sponsored health ] plan, that
 plan becomes the payer for all other services covered under that plan; and 
 
 4. The policyholder is not under a court order to provide
 medical support for the applicant child. 
 
 C. DMAS will continually verify the child's or [ or
 children's ] coverage under the private or [ employer's employer-sponsored
 health ] plan and will redetermine the eligibility of the child
 [ or children ] for the FAMIS Select component when it
 receives information concerning an applicant's or enrollee's circumstances that
 may affect eligibility. 
 
 D. Application requirements. 
 
 1. DMAS shall furnish the following information in written form
 and orally, as appropriate, to the families of FAMIS children who have
 indicated an interest in FAMIS Select: 
 
 a. The eligibility requirements for FAMIS Select; 
 
 b. A description of how the program operates, the amount of
 premium assistance available, and how children can move from FAMIS Select into
 FAMIS if requested; 
 
 c. A summary of the covered benefits and cost-sharing
 requirements available through FAMIS; 
 
 d. A guide to help families make an informed choice by
 comparing the FAMIS plan to their private or employer-sponsored health plan.
 Such guide shall include a notice to the effect that children covered by FAMIS
 Select will not receive FAMIS-covered services, but only those health services
 covered by their private or employer-sponsored health plan, and that the FAMIS
 Select enrollee shall be responsible for any and all costs associated with
 their chosen health plan; 
 
 e. Information on coverage for childhood immunizations through
 FAMIS; and 
 
 f. The rights and responsibilities of applicants and enrollees.
 
 
 2. DMAS will provide interested families with applications for
 FAMIS Select. 
 
 3. A An electronic or written application for
 the FAMIS Select component shall be required from interested families. 
 
 4. DMAS shall determine eligibility for the FAMIS Select
 component promptly, within 45 calendar days from the date of receiving an
 application that contains all information and verifications necessary to
 determine eligibility, except in unusual circumstances beyond the agency's
 control. Actual enrollment into the FAMIS Select component may not occur for
 extended periods of time, depending on the ability of the family to enroll in
 the employer's plan. 
 
 5. Incomplete FAMIS Select applications shall be held for a
 period of 30 calendar days to enable applicants to provide outstanding
 information needed for a FAMIS Select eligibility determination. Any applicant
 who, within 30 calendar days of the receipt of the initial application, fails
 to provide information or verifications necessary to determine FAMIS Select
 eligibility shall have his application denied. 
 
 6. DMAS must send each applicant a written notice of the
 agency's decision on his application for FAMIS Select and, if approved, his
 obligations under the program. If eligibility is denied, notice will be given
 concerning the reasons for the denial. 
 
 E. Cost effectiveness. DMAS may elect to provide coverage to
 FAMIS children by paying all or a portion of the family's private or
 employer-sponsored health insurance premium if the cost of such premium
 assistance under FAMIS Select is equal to or less than the Commonwealth's cost
 of obtaining coverage under FAMIS only for the eligible, targeted, low-income
 child [ or children ] involved. Providing premium assistance
 for the FAMIS-eligible children may result in the coverage of an adult or other
 relative/dependent relative or dependent; however, this coverage
 shall be solely incidental to covering the FAMIS child. 
 
 1. To ensure that the FAMIS Select program remains cost
 effective, DMAS will establish a fixed premium assistance amount per child that
 will be paid to a family choosing to enroll their FAMIS-eligible child in FAMIS
 Select. The fixed premium assistance amount will be determined annually by: 
 
 a. Determining the cost of covering a child under FAMIS. The
 cost will be determined by using the capitated payment rate paid to MCHIPs, or
 an average cost amount developed by DMAS; 
 
 b. Determining the administrative costs associated with the
 FAMIS Select program; and 
 
 c. Establishing a fixed premium assistance amount that
 includes administrative costs and is less than or equal to the cost of covering
 the FAMIS child [ or children ] under FAMIS. 
 
 DMAS will ensure that the total of the fixed premium
 assistance amounts for all the FAMIS-eligible children per family do not exceed
 the total cost of the family's health insurance premium payment for the private
 or employer-sponsored [ coverage health plan ]. If the
 total fixed premium assistance amounts do exceed the family's premium payment,
 then the family premium assistance will be reduced by an amount necessary to
 ensure the premium assistance payment is less than or equal to the family's
 premium payment. 
 
 F. Enrollment and disenrollment. 
 
 1. FAMIS children applying for FAMIS Select will receive
 coverage under FAMIS until their eligibility for coverage under the FAMIS
 Select component is established and until they are able to enroll in the
 private or employer-sponsored health plan. 
 
 2. The timing and procedures employed to transfer FAMIS
 children's coverage to the FAMIS Select component will be coordinated between
 DMAS and the CPU agency managing the case to ensure continuation
 of health plan coverage. 
 
 3. Participation by families in the FAMIS Select component
 shall be voluntary. Families may disenroll their child [ or children ]
 from the FAMIS Select component as long as the proper timing and procedures
 established by DMAS are followed to ensure continued health coverage. 
 
 G. Premium assistance. When a child is determined eligible
 for coverage under the FAMIS Select component, premium assistance payments
 shall become effective the month in which the FAMIS child [ or children
 are is ] enrolled in the employer's plan. Payment of premium
 assistance shall end: 
 
 1. On the last day of the month in which FAMIS eligibility
 ends; 
 
 2. The last day of the month in which the child [ or
 children lose loses ] eligibility for coverage under the
 private or [ employer's employer-sponsored health ]
 plan; 
 
 3. The last day of the month in which the family notifies DMAS
 that it wishes to disenroll its child [ or children ] from the
 FAMIS Select component; or 
 
 4. On the next business day following a request by the family
 to immediately transfer the child from FAMIS Select into the FAMIS program. The
 request must include notification that the child's private or
 employer-sponsored [ coverage health plan ] has been
 terminated as of the date of transfer and an agreement by the family to return
 to DMAS the premium assistance payment prorated for that portion of the month
 in which the child was not enrolled in the private or employer-sponsored
 [ health ] plan. 
 
 H. Supplemental health benefits coverage will be provided to
 ensure that FAMIS children enrolled in the FAMIS Select component receive all
 childhood immunizations available under the FAMIS benefits. FAMIS children can
 obtain these supplemental benefits through Medicaid providers. 
 
 I. Cost sharing. FAMIS Select families will be responsible
 for all copayments, deductibles, coinsurance, fees, or other cost-sharing
 requirements of the private or employer-sponsored health plan in which they
 enroll their children. There is no Title XXI family cost-sharing cap applied to
 families with children enrolled in FAMIS Select. 
 
 There is no copayment required for the supplemental
 immunization benefits provided through FAMIS. 
 
 12VAC30-141-500. Benefits reimbursement. 
 
 A. Reimbursement for the services covered under FAMIS
 fee-for-service and MCHIPs shall be as specified in this section. 
 
 B. Reimbursement for physician services, surgical services,
 clinic services, prescription drugs, laboratory and radiological services,
 outpatient mental health services, early intervention services, emergency
 services, home health services, immunizations, mammograms, medical transportation,
 organ transplants, skilled nursing services, well baby and well child care,
 vision services, durable medical equipment, disposable medical supplies, dental
 services, case management services, physical therapy/occupational
 therapy/speech-language therapy, occupational therapy, or
 speech-language therapy services, hospice services, school-based health
 services, behavioral therapy services including but not limited to
 applied behavior analysis, and certain community-based mental health services
 shall be based on the Title XIX rates. 
 
 C. Reimbursement to MCHIPs shall be determined on the basis
 of the estimated cost of providing the MCHIP benefit package and services to an
 actuarially equivalent population. MCHIP rates will be determined annually and
 published 30 days prior to the effective date. 
 
 D. Exceptions. 
 
 1. Prior authorization is required after five visits in a
 fiscal year for physical therapy, occupational therapy, and speech
 speech-language therapy provided by home health providers and outpatient
 rehabilitation facilities and for home health skilled nursing visits. Prior
 authorization is required after 26 visits for outpatient mental health
 visits in the first year of service and prior authorization is required for
 the following nonemergency outpatient procedures: Magnetic Resonance Imaging,
 including Magnetic Resonance Angiography (MRA), Computerized Axial Tomography
 (CAT) scans, including Computed Tomography Angiography (CTA), or Positron Emission
 Tomography (PET) scans performed for the purpose of diagnosing a disease
 process or physical injury. Prior authorization for dental services will be
 based on the Title XIX prior authorization requirements for dental services. 
 
 2. Reimbursement for inpatient hospital services will be based
 on the Title XIX rates in effect for each hospital. Reimbursement shall not
 include payments for disproportionate share or graduate medical education
 payments made to hospitals. Payments made shall be final and there shall be no
 retrospective cost settlements. 
 
 3. Reimbursement for outpatient hospital services shall be
 based on the Title XIX rates in effect for each hospital. Payments made will be
 final and there will be no retrospective cost settlements. 
 
 4. Reimbursement for inpatient mental health services other
 than by free standing psychiatric hospitals will be based on the Title XIX
 rates in effect for each hospital. Reimbursement will not include payments for
 disproportionate share or graduate medical education payments made to
 hospitals. Payments made will be final and there will be no retrospective cost
 settlements. 
 
 5. Reimbursement for outpatient rehabilitation services will
 be based on the Title XIX rates in effect for each rehabilitation agency.
 Payments made will be final and there will be no retrospective cost
 settlements. 
 
 6. Reimbursement for outpatient substance abuse treatment
 services will be based on rates determined by DMAS for children ages six
 through 18 years. Payments made will be final and there will be no
 retrospective cost settlements. 
 
 7. Reimbursement for prescription drugs will be based on the
 Title XIX rates in effect. Reimbursements for Title XXI do not receive drug
 rebates as under Title XIX. 
 
 8. Reimbursement for covered prescription drugs for
 noninstitutionalized FAMIS recipients receiving the fee-for-service benefits
 will be subject to review and prior authorization when their current number of
 prescriptions exceeds nine unique prescriptions within 180 calendar
 days, and as may be further defined by the agency's guidance documents for
 pharmacy utilization review and the prior authorization program. The prior
 authorization process shall be applied consistent with the process set forth in
 12VAC30-50-210 A 7. 
 
 12VAC30-141-660. Assignment to managed care.
 
 A. Except for children enrolled in the Virginia Birth-Related
 Neurological Injury Compensation Program established pursuant to Chapter 50
 (§ 38.2-5000 et seq.) of Title 38.2 of the Code of Virginia, all eligible
 enrollees shall be assigned in managed care through the department or the
 central processing unit (CPU) under contract to DMAS CPU. FAMIS
 individuals, during the preassignment period to an MCHIP, shall receive Title
 XXI benefits via fee-for-service utilizing a FAMIS card issued by DMAS. After
 assignment to an MCHIP, benefits and the delivery of benefits shall be
 administered specific to the managed care program in which the individual is
 enrolled. DMAS shall contract with MCHIPs to deliver health care services for
 infants born to mothers enrolled in FAMIS for the month of birth plus two
 additional months regardless of the status of the newborn's application for
 FAMIS. If federal funds are not available for those months of coverage, DMAS
 shall use state funding only.
 
 1. MCHIPs shall be offered to enrollees in all areas.
 
 2. All enrollees shall be assigned to the contracted MCHIPs.
 
 3. Enrollees Applicants for FAMIS may choose an
 MCHIP at the time of application. If a choice is not made at application,
 enrollees shall be assigned through a random system algorithm; provided
 however, all children within the same family shall be assigned to the same
 MCHIP.
 
 4. All children enrolled in the Virginia Birth-Related
 Neurological Injury Compensation Program shall be assigned to the
 fee-for-service component.
 
 5. Enrolled individuals will receive a letter indicating that
 they may select one of the contracted MCHIPs that serve such area. Enrollees
 who do not select an MCHIP as described above, shall be assigned to an MCHIP as
 described in subdivision 3 of this subsection.
 
 6. Individuals assigned to an MCHIP who lose and then regain
 eligibility for FAMIS within 60 days will be reassigned to their previous
 MCHIP.
 
 B. Following their initial assignment to an MCHIP, those
 enrollees shall be restricted to that MCHIP until their next annual eligibility
 redetermination, unless appropriately disenrolled by the department.
 
 1. During the first 90 calendar days of managed care
 assignment, an enrollee may request reassignment for any reason. Such
 reassignment shall be effective no later than the first day of the second month
 after the month in which the enrollee requests reassignment.
 
 2. Enrollees may only request reassignment to another MCHIP
 serving that geographic area. 
 
 3. After the first 90 calendar days of the assignment period,
 the enrollee may only be reassigned from one MCHIP to another MCHIP upon
 determination by DMAS that good cause exists pursuant to subsection C of this
 section or for any reason at annual renewal.
 
 C. Disenrollment for good cause, defined in
 12VAC30-120-370, may be requested at any time.
 
 1. After the first 90 calendar days of assignment in
 managed care, enrollees may request disenrollment from DMAS based on good
 cause. The request must be made in writing to DMAS and cite the reasons
 why the enrollee wishes to be reassigned. The department shall establish
 procedures for good cause reassignment through written policy directives. 
 
 2. DMAS shall determine whether good cause exists for
 reassignment.
 
 Part VII 
 FAMIS MOMS 
 
 12VAC30-141-670. Definitions. 
 
 The following words and terms when used in this chapter shall
 have the following meanings unless the context clearly indicates otherwise: 
 
 "Act" means the Social Security Act. 
 
 "Adult caretaker relative" or "caretaker
 relative" means an individual who is 18 years of age or older, who is not
 the parent of but who is related to the child applicant by blood or marriage,
 and who lives with and assumes responsibility for day-to-day care of the child
 applicant in a place of residence maintained as his or their own home. 
 
 "Adverse action," consistent with 42 CFR
 457.1130, means the denial of eligibility; failure to make a timely
 determination of eligibility; suspension or termination of enrollment,
 including disenrollment for failure to pay cost sharing; or delay, denial,
 reduction, suspension, or termination of health services, in whole or in part,
 including a determination about the type or level of services; and failure to
 approve, furnish, or provide payment for health services in a timely manner;
 provided, however, that determination of eligibility to participate in and
 termination of participation in the FAMIS Select program shall not constitute
 an adverse action. 
 
 "Adverse benefit determination," consistent with
 42 CFR 438.400, means the denial or limited authorization of a requested
 service; the failure to take action or timely take action on a request for
 service; the reduction, suspension, or termination of a previously authorized
 service; denial in whole or in part of a payment for a service; failure to
 provide services within the timeframes required by the state; for a resident of
 a rural exception area with only one MCO, the denial of a enrollee's request to
 exercise the enrollee's right under 42 CFR 438.52(b)(2)(ii) to obtain services
 outside of the network; the denial of a enrollee's request to dispute a
 financial liability as provided in 42 CFR [ 438(b)(7)
 438.400(b)(7) ]; or the failure of an MCO to act within the
 timeframes provided in 42 CFR 438.408(b).
 
 "Agency" means a local department of social
 services, the central processing unit, or other entity designated by DMAS to
 make eligibility determinations for FAMIS MOMS. the same as defined in
 12VAC30-141-10.
 
 "Agency error" means a person or persons
 received benefits to which they were not entitled as a result of an error on
 the part of an eligibility worker at a local department of social services or
 the central processing unit. 
 
 "Agent" means an individual designated in writing
 to act on behalf of a FAMIS MOMS Plan applicant or enrollee during the
 administrative review process. 
 
 "Appeal" means an enrollee's request for review
 of an adverse benefit determination by an MCO or an adverse action by the LDSS,
 CPU, or DMAS.
 
 "Applicant" means a pregnant woman who has filed an
 application (or who has an application filed on her behalf) for health
 insurance and is awaiting a determination of eligibility. A pregnant woman is
 an applicant until her eligibility has been determined. 
 
 "Application for health insurance" means the form
 or forms developed and approved by the Department of Medical Assistance
 Services that are used for determining eligibility for Medicaid for poverty
 level children, for the Family Access to Medical Insurance Security Plan
 (FAMIS) for children, for Medicaid for pregnant women, and for FAMIS MOMS
 coverage for pregnant women single streamlined application for
 determining eligibility in public health insurance programs operated by the
 Commonwealth.
 
 "Authorized representative" means a person who is
 authorized to conduct the personal or financial affairs for an individual who
 is 18 years of age or older. 
 
 "Board" or "BMAS" means that policy
 board created by § 32.1-324 of the Code of Virginia to administer the
 plans established by the Social Security Act. 
 
 "Central processing unit" or "CPU" means Cover
 Virginia, which is the private contractor that will determine
 eligibility for and administer part of the FAMIS MOMS Plan same as
 defined in 12VAC30-141-10.
 
 "Child" means an individual under the age of
 younger than 19 years of age. 
 
 "Competent individual" means a person who has
 not been judged by a court to be legally incapacitated. 
 
 "Comprehensive health insurance coverage" means
 health benefits coverage, which includes the following categories of services
 at a minimum: inpatient and outpatient hospital services, physician's surgical
 and medical services, and laboratory and radiological services. 
 
 "Conservator" means a person appointed by a court
 of competent jurisdiction to manage the estate and financial affairs of an
 incapacitated individual. 
 
 "Continuation of enrollment coverage"
 means ensuring an enrollee's benefits are continued until completion of the
 review process, with the condition that should the enrollee not prevail in the
 review process, the enrollee shall be liable for the repayment of all benefits
 received during the review process. 
 
 "Director" means the individual, or his designee,
 specified in § 32.1-324 of the Code of Virginia with all of the attendant
 duties and responsibilities to administer the State Plan for Medical Assistance
 and the State Plan for Title XXI. 
 
 "DMAS" or "department" means the
 Department of Medical Assistance Services. 
 
 "Enrollee" means a pregnant woman who has been
 determined eligible to participate in FAMIS MOMS and is enrolled in the FAMIS
 MOMS program. 
 
 "External quality review organization" means the
 independent contractor assigned by DMAS to handle quality reviews and to
 conduct final review of MCHIP adverse actions for FAMIS MOMS. 
 
 "Family" for a pregnant woman under the age of
 21, means parents, including adoptive parents, if they are all residing
 together and the spouse of the pregnant woman if the woman is married and
 living with her spouse, as well as any children under the age of 21 the woman
 may have. 
 
 For a pregnant woman over the age of 21,
 "family" means her spouse, if married and living together, as well as
 any children under the age of 21 the pregnant woman may have. 
 
 "Family income" means the total income of all
 family members in a household. Income includes, but is not necessarily limited
 to, before-tax earnings from a job, including cash, wages, salary, commissions,
 tips, self-employment net profits, Social Security, Retirement Survivor
 Disability Insurance (RSDI), veterans benefits, Railroad Retirement, disability
 workers' compensation, unemployment benefits, child support, alimony, spousal
 support, pensions, retirement benefits, settlement benefits, rental income, and
 lottery/bingo winnings. Income excludes public assistance program benefits such
 as SSI and TANF payments, foster care payments, general relief, loans, grants,
 or scholarships for educational expenses or earned income of a child who is a
 student. 
 
 "FAMIS" means the Family Access to Medical
 Insurance Security Plan. 
 
 "FAMIS MOMS" means the Title XXI program available
 to eligible pregnant women. 
 
 "Federal poverty level" or "FPL" means
 that income standard as published annually by the U.S. Department of Health and
 Human Services in the Federal Register. 
 
 "Fee-for-service" means the traditional Medicaid
 health care delivery and payment system in which physicians and other providers
 receive a payment for each unit of service they provide. 
 
 "Fraud" means an intentional deception or
 misrepresentation made by a person with the knowledge that the deception could
 result in some unauthorized benefit to herself or some other person. It
 includes any act that constitutes fraud under applicable federal or state laws.
 
 
 "Group health plan" or "health insurance
 coverage" means that health care coverage as defined in § 2791 of the
 Public Health Services Act (42 USC § 300gg-91(a) and (b)(1)). 
 
 "Guardian" means a person appointed by a court of
 competent jurisdiction to be responsible for the affairs of an incapacitated
 individual, including responsibility for making decisions regarding the
 person's support, care, health, safety, habilitation, education, and
 therapeutic treatment, and, if not inconsistent with an order of commitment,
 residence. 
 
 "Incapacitated individual" means a person
 who, pursuant to an order of a court of competent jurisdiction, has been found
 to be incapable of receiving and evaluating information effectively or
 responding to people, events, or environments to such an extent that the
 individual lacks the capacity to (i) meet the essential requirements of her
 health, care, safety, or therapeutic needs without the assistance or protection
 of a guardian, or (ii) manage property or financial affairs or provide for her
 support or for the support of her legal dependents without the assistance or
 protection of a conservator. 
 
 "Legally emancipated" means that the parents and
 child have gone through the court and a judge has declared that the parents
 have surrendered the right to care, custody, and earnings of the child and have
 renounced parental duties. A married minor is not emancipated unless a court
 has declared the married minor emancipated from her parents. 
 
 [ "Lawfully residing" means the
 individual is lawfully present in the United States and meets state residency
 requirements. ] 
 
 "LDSS" or "local department" means the
 local department of social services. 
 
 "Managed care health insurance plan" or
 "MCHIP," as defined in § 32.1-137.1 of the Code of Virginia,
 means an arrangement for the delivery of health care in which a health carrier
 under contract with DMAS for Title XXI delivery systems undertakes to provide,
 arrange and pay for, or reimburse any of the costs of health care services for
 a covered person on a prepaid or insured basis, which contains one or more
 incentive arrangements, including any credential requirements intended to
 influence the cost of the health care services between the health carrier and
 one or more providers and requires or creates benefit payment differential
 incentives for covered persons to use providers that are directly or indirectly
 managed, owned, under contract with, or employed by the health carrier. 
 
 "Member of a family," for purposes of
 determining whether the applicant is eligible for coverage under a state
 employee health insurance plan, means a spouse, parent or parents, including
 stepparents with whom the child is living if the stepparent claims the child as
 a dependent on the employee's federal tax return. 
 
 "Managed care organization" or "MCO"
 means an organization that offers managed care health insurance plans (MCHIPs)
 as defined in [ this section § 32.1-137.1 of the Code
 of Virginia ].
 
 "Pregnant woman" means a woman of any age who is
 medically determined to be pregnant. The pregnant woman definition is met from
 the first day of the earliest month that the medical practitioner certifies as
 being a month in which the woman was pregnant, through the last day of the
 month in which the 60th day occurs, following the last day of the month in
 which her pregnancy ended, regardless of the reason the pregnancy ended. 
 
 "Provider" means the individual, facility, or other
 entity registered, licensed, or certified, as appropriate, and enrolled by an
 MCHIP or in fee-for-service to render services to FAMIS MOMS enrollees eligible
 for services. 
 
 "State fair hearing" means, consistent with 42
 CFR 438.400, the process set forth in 42 CFR 431 Subpart E.
 
 "Title XXI" means the federal State Children's
 Health Insurance Program as established by Subtitle J of the Balanced Budget
 Act of 1997. 
 
 "Virginia State Employee Health Insurance Plan"
 means a health insurance plan offered by the Commonwealth of Virginia to its
 employees. 
 
 12VAC30-141-680. Administration and general background. 
 
 A. The state shall use funds provided under Title XXI for
 obtaining coverage that meets the requirements of Title XXI of the Social
 Security Act and any waiver of federal regulations approved by the Centers for
 Medicare and Medicaid Services. 
 
 B. The DMAS director will have the authority to contract with
 entities for the purpose purposes of establishing a centralized
 processing site, determining eligibility, enrolling eligible pregnant women into
 health plans, performing outreach, data collection, reporting, and other
 services necessary for the administration of the FAMIS MOMS program; and for
 employing state staff to perform Medicaid eligibility determinations on
 pregnant women referred by the contractor's staff.
 
 C. Health care services under FAMIS MOMS shall be provided
 through MCHIPs and fee-for-service or through any other health care delivery
 system deemed appropriate by the Department of Medical Assistance Services. 
 
 12VAC30-141-690. Outreach and public participation. 
 
 A. DMAS will work cooperatively with other state agencies and
 contractors to ensure that state and federal law and any applicable state and
 federal regulations are met. 
 
 B. DMAS shall develop a comprehensive marketing and outreach
 effort. The marketing and outreach efforts will be aimed at promoting FAMIS
 MOMS and Medicaid for pregnant women and increasing enrollment, and may
 include contracting with a public relations firm, nonprofit agencies, and
 foundations, and coordination with other state agencies, coordination with
 the business community, and coordination with health care associations and
 providers. 
 
 12VAC30-141-700. Review Appeal of adverse actions
 or adverse benefit determinations. 
 
 A. Upon written request, all FAMIS MOMS program
 applicants and enrollees shall have the right to a review state fair
 hearing of an adverse action made by the MCHIP, local department of
 social services, CPU, or DMAS, or an internal appeal of an adverse
 benefit determination made by the MCO. 
 
 B. During review the appeal of a suspension or
 termination of enrollment or a reduction, suspension, or termination of
 services, the enrollee shall have the right to continuation of coverage if the
 enrollee requests review an internal appeal with the MCO or an appeal
 to DMAS prior to the effective date of the suspension or termination of
 enrollment or suspension, reduction, or termination of services. 
 
 C. Review An appeal of an adverse action made
 by the local department of social services, CPU, or DMAS shall be heard
 and decided by an agent of DMAS who has not been directly involved in the
 adverse action under review appeal. 
 
 D. Review An internal appeal of an adverse action
 benefit determination made by the MCHIP MCO must be
 conducted by a person or agent of the MCHIP MCO who has not been
 directly involved in the adverse action benefit determination
 under review appeal. 
 
 E. After final review by Pursuant to 42 CFR
 438.402(c)(1)(B), after exhausting the MCHIP MCO's internal
 appeals process, there shall also be opportunity for final
 independent the enrollee to request an external medical
 review by the an independent external quality review
 organization. [ "External quality review organization" means
 the independent contractor assigned by DMAS to handle quality reviews and to
 conduct final review of MCHIP adverse actions for FAMIS MOMS. ] The
 review is optional and shall not be required before proceeding to a state fair
 hearing. The review shall not extend any of the timeframes for issuing a
 decision and shall not disrupt any continuation of coverage granted to the
 enrollee.
 
 F. There will be no opportunity for review appeal
 of an adverse action to the extent that such adverse action is based on a
 determination by the director that funding for FAMIS MOMS has been terminated
 or exhausted. There will be no opportunity for review based on which type of
 delivery system (i.e., fee-for-service, MCHIP) is assigned. There will be
 no opportunity for review appeal if the sole basis for the adverse
 action decision is a provision in the State Plan or in a
 state or federal law or regulation requiring an automatic change in
 eligibility or enrollment or a change in coverage under the health benefits
 package that affects all applicants or enrollees or a group of applicants
 or enrollees without regard to their individual circumstances. 
 
 G. The burden of proof shall be upon the applicant or
 enrollee to show that an adverse action or adverse benefit determination
 is incorrect. 
 
 H. At no time shall the MCHIP's, local department's of social
 services, the CPU's MCO, LDSS, CPU, or DMAS' DMAS
 failure to meet the time frames timeframes set in this chapter or
 set in the MCHIP's MCO or DMAS' DMAS written review
 procedures appeal procedure constitute a basis for granting the
 applicant or enrollee the relief sought. 
 
 12VAC30-141-710. Notice of adverse action or adverse benefit
 determination. 
 
 A. The CPU or LDSS, CPU, DMAS, or DMAS
 contractor shall send written notification to enrollees at least 10
 calendar days prior to suspension or termination of enrollment. 
 
 B. DMAS or the MCHIP MCO shall send written
 notification to enrollees at least 10 calendar days prior to reduction,
 suspension, or termination of a previously authorized health service. 
 
 C. The local department of social services, the CPU,
 DMAS, or the MCHIP MCO shall send written notification to
 applicants and enrollees of all other adverse actions within 10 calendar days
 of the adverse action. 
 
 D. Notice shall include the reasons for determination, an
 explanation of applicable rights to a review of that determination, the
 standard and expedited time frames for review, the manner in which a review can
 be requested, and the circumstances under which enrollment or services may
 continue pending review.:
 
 1. The determination the LDSS, CPU, DMAS, or MCO has made
 or intends to make;
 
 2. The reasons for the determination, including the right
 of the enrollee to be provided upon request and free of charge reasonable
 access to and copies of all documents, records, and other information relevant
 to the determination;
 
 3. An explanation of applicable rights to request an appeal
 of that determination. For adverse benefit determinations by an MCO, this shall
 include information on the MCO's internal appeals process and, after the
 internal appeals process is exhausted, a state fair hearing pursuant to 42 CFR
 402(b) and 42 CFR 402(c);
 
 4. The procedures for exercising these appeal rights;
 
 5. The circumstances under which an appeal process can be
 expedited and how to request it; and
 
 6. The circumstances under which enrollment or services may
 continue pending appeal, how to request benefits be continued, and the
 circumstances, consistent with state policy, under which the enrollee may be
 required to pay the costs of these services.
 
 12VAC30-141-720. Request for review appeal.
 
 A. Requests for review internal appeal of MCHIP
 MCO adverse actions benefit determinations shall be
 submitted orally or in writing to the MCHIP MCO. Unless
 the enrollee requests an expedited appeal, an oral appeal request must be
 followed by a written appeal request. The enrollee must exhaust the MCO's
 internal appeals process before appealing to DMAS.
 
 B. If the MCO fails to adhere to the notice or timing
 requirements set forth in this part, the enrollee is deemed to have exhausted
 the MCO's internal appeals process and may initiate a state fair hearing.
 
 [ B. ] C. Requests for review appeal
 of adverse actions made by the local department of social services, LDSS,
 the CPU, or DMAS, or of internal appeal decisions by the MCO
 shall be submitted in writing to DMAS.
 
 C. D. Any written communication clearly
 expressing a desire to have an adverse action benefit determination
 by an MCO reviewed shall be treated as a request for review an
 internal appeal. Any communication expressing a desire to have an
 adverse action by the LDSS, CPU, or DMAS reviewed shall be treated as a request
 for a state fair hearing. Any communication expressing a desire to have an MCO
 internal appeal decision reviewed shall be treated as a request for a state
 fair hearing.
 
 D. E. To be timely, requests for review an
 internal appeal of a MCHIP an MCO's adverse benefit
 determination shall be received by the MCHIP MCO no later than 30
 60 calendar days from the date of the MCHIP's MCO's notice
 of adverse action benefit determination.
 
 E. F. To be timely, requests for an appeal of an
 adverse benefit determination upheld in whole or in part by the MCO's internal
 appeal decision shall be received by DMAS within 120 calendar days from the
 date of the internal appeal decision.
 
 G. To be timely, requests for review appeal
 of a local department of social services, DMAS, or CPU determination adverse
 action shall be filed with DMAS no later than 30 calendar days from the
 date of the CPU's, LDSS' or DMAS' notice of adverse action. Requests for
 review appeal of a local department of social services, DMAS,
 or CPU an agency determination shall be considered filed with DMAS
 on the date the request is postmarked, if mailed, or on the date the
 request is received, if delivered other than by mail, by DMAS.
 
 12VAC30-141-730. Review Appeal procedures. 
 
 A. At a minimum, the MCHIP review MCO internal
 appeal shall be conducted pursuant to written procedures as defined in §
 32.1-137.6 of the Code of Virginia and as may be further defined by DMAS
 42 CFR 438.400 et seq. Such procedures shall be subject to review and
 approval by DMAS. 
 
 B. Any adverse benefit determination upheld in whole or in
 part by the internal appeal decision issued by the MCO may be appealed by the
 enrollee to DMAS in accordance with the DMAS client appeals regulations at
 12VAC30-110-10 through 12VAC30-110-370. DMAS shall conduct an evidentiary
 hearing in accordance with 12VAC30-110-10 through 12VAC30-110-370 and shall not
 base any appealed decision on the record established by any internal appeal
 decision of the MCO. The MCO shall comply with the DMAS appeal decision. The
 DMAS decision in these matters shall be final and shall not be subject to
 appeal by the MCO. 
 
 The DMAS review C. Appeals of adverse actions by
 the LDSS, CPU, or DMAS shall be conducted pursuant to written procedures
 developed by DMAS 12VAC30-110.
 
 C. The procedures in effect on the date a particular
 request for review is received by the MCHIP or DMAS shall apply throughout the
 review. 
 
 D. Copies of the procedures shall be promptly mailed provided
 by the MCHIP MCO or DMAS to applicants and enrollees upon receipt
 of timely requests for review internal appeals or state fair hearings.
 Such written procedures shall include but not be limited to the
 following: 
 
 1. The right to representation by an attorney or other agent
 of the applicant's or enrollee's choice, but at no time shall the MCHIP,
 local department of social services, MCO, LDSS, DSS, or DMAS be
 required to obtain or compensate attorneys or other agents acting on behalf of
 applicants or enrollees; 
 
 2. The right to timely review of their files and other
 applicable information relevant to the review internal appeal or
 state fair hearing of the decision; 
 
 3. The right to fully participate in the review internal
 appeal or state fair hearing process, whether the review internal
 appeal or state fair hearing is conducted in person or in writing,
 including the presentation of supplemental information during the review
 internal appeal or state fair hearing process; 
 
 4. The right to have personal and medical information and
 records maintained as confidential; and 
 
 5. The right to a written final decision within 90 calendar
 days of receipt of the request for review, unless the applicant or enrollee
 requests or causes a delay.:
 
 a. For internal appeals to the MCO, within 30 calendar days
 of receipt of the request for an internal appeal; or
 
 b. For state fair hearings, within the time limitations for
 appeals imposed by federal regulations and as permitted in 12VAC30-110-30; 
 
 E. 6. For eligibility and enrollment matters, if
 the applicant's or enrollee's physician or health plan determines that the
 90-calendar-day timeframe could seriously jeopardize the applicant's or
 enrollee's life or health or ability to attain, maintain, or regain maximum
 function, an applicant or enrollee will have the opportunity to request an
 expedited review appeal. Under these conditions, a request for review
 an expedited appeal shall result in a written final decision within three
 business days 72 hours after DMAS receives, the expedited
 appeal request from the physician or health plan, with the
 case record and information indicating that taking the time for a standard
 resolution of the review appeal request could seriously
 jeopardize the applicant's or enrollee's life or health or ability to attain,
 maintain, or regain maximum function, unless the applicant or enrollee or
 her authorized representative causes a delay. requests an extension;
 
 F. 7. For health services matters for FAMIS MOMS
 enrollees receiving services through MCHIPs, if an MCO: 
 
 a. If the enrollee's physician or health plan
 determines that the 90-calendar-day 30-calendar-day timeframe for
 a standard internal appeal could seriously jeopardize the enrollee's life or,
 health, or ability to attain, maintain, or regain maximum function, an
 enrollee will have the opportunity to request an expedited review
 internal appeal. Under these conditions, a request for review an
 internal appeal shall result in a written decision by the external
 quality review organization MCO within 72 hours from the time
 an enrollee requests the expedited review internal
 appeal is requested, unless the applicant, enrollee, or authorized
 representative requests or causes a delay. If a delay is requested or
 caused by the applicant, enrollee, or authorized representative, then
 expedited review internal appeal may be extended up to 14
 calendar days. 
 
 b. If the adverse benefit determination is upheld in whole
 or in part by the expedited internal appeal decision issued by the MCO, and if
 the enrollee's physician or health plan determines that the timeframe for a
 standard appeal to DMAS could seriously jeopardize the enrollee's life or
 health or ability to attain, maintain, or regain maximum function, an enrollee
 will have the opportunity to request an expedited appeal to DMAS. Under these
 conditions, a request for a state fair hearing shall result in a written
 decision within 72 hours from the time an enrollee requests the expedited
 appeal, unless the applicant, enrollee, or authorized representative requests
 or causes a delay. If a delay is requested by the applicant, enrollee, or
 authorized representative, then the expedited appeal may be extended up to 14
 calendar days; and
 
 G. 8. For health services matters for FAMIS MOMS
 enrollees receiving services through fee-for-service, if the enrollee's
 physician or health plan determines that the 90-calendar-day timeframe for a
 standard appeal could seriously jeopardize the enrollee's life, health,
 or ability to attain, maintain, or regain maximum function, an enrollee will
 have the opportunity to request an expedited review. Under these
 conditions, a request for review an expedited appeal shall result
 in a written decision within 72 hours from the time an enrollee requests
 the expedited review appeal is requested, unless the
 applicant, enrollee, or authorized representative requests or causes a delay.
 If a delay is requested or caused by the applicant, enrollee, or authorized
 representative, then expedited review appeal may be extended up
 to 14 calendar days. 
 
 12VAC30-141-740. Eligibility requirements General
 conditions of eligibility.
 
 A. This section shall be used to determine eligibility of
 pregnant women for FAMIS MOMS.
 
 B. FAMIS MOMS shall be in effect statewide.
 
 C. Eligible pregnant women must:
 
 1. Be determined ineligible for Medicaid due to excess income
 by a local department of social services or LDSS, by DMAS eligibility
 staff co-located at the FAMIS, or by the CPU;
 
 2. Be a pregnant woman at the time of application; 
 
 3. Be a resident of the Commonwealth as described in
 12VAC30-141-100 E;
 
 4. Be either a U.S. United States citizen, U.S.
 United States national, lawfully residing, or a qualified
 noncitizen as described in 12VAC30-141-100 E;
 
 5. Be uninsured, that is, not have comprehensive creditable
 health insurance coverage; and
 
 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.  
 
 [ "Lawfully residing" means the individual
 is lawfully present in the United States and meets state residency
 requirements. "Creditable health insurance coverage" means coverage
 that meets the definition at 42 CFR 457.10. ] 
 
 D. Income Financial eligibility.
 
 1. Screening. All applications for FAMIS MOMS coverage received
 at the FAMIS central processing unit must be screened to identify
 applicants who are potentially eligible for Medicaid shall have a
 Medicaid income eligibility screen completed. Pregnant women screened
 and found potentially eligible for Medicaid cannot be enrolled in FAMIS MOMS
 until there has been a finding of ineligibility for Medicaid. Pregnant women
 who do not appear to be eligible for Medicaid due to excess income determined
 to be ineligible for Medicaid due to excess income shall have their
 eligibility for FAMIS MOMS determined and, if eligible, will be enrolled in
 the FAMIS MOMS program. Applications for FAMIS MOMS received at a local
 department of social services shall have a full Medicaid eligibility
 determination completed. Pregnant women determined to be ineligible for Medicaid
 due to excess income will have their eligibility for FAMIS MOMS determined and,
 if eligible, the local department of social services will enroll the pregnant
 woman in the FAMIS MOMS program.
 
 2. Standards. Income standards for FAMIS MOMS are based on
 a comparison of countable income to 200% of the federal poverty level for the
 family size. Countable income and family size are based on the methodology
 utilized by the Medicaid program as defined in 12VAC30-40-100 B 1 b. Pregnant
 women 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 MOMS the same as those described at 12VAC30-141-100
 F 2, applied to pregnant women. For purposes of income determination, the
 family size of the pregnant woman will count the unborn child.
 
 3. Spenddown. Deduction of incurred medical expenses from
 countable income (spenddown) shall not apply in FAMIS MOMS. If the family
 income exceeds the income limits described in this section, the individual
 shall be ineligible for FAMIS MOMS regardless of the amount of any incurred
 medical expenses DMAS does not apply a spenddown process for FAMIS MOMS
 where household income exceeds the income eligibility limit for FAMIS MOMS.
 
 E. Residency. The requirements for residency, as set forth
 in 42 CFR 435.403, will be used when determining whether a pregnant woman is a
 resident of Virginia for purposes of eligibility for FAMIS MOMS. A child who is
 not emancipated and is temporarily living away from home is considered living
 with her 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. citizenship 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 pregnant woman is a qualified noncitizen for
 purposes of FAMIS MOMS eligibility.
 
 H. E. Coverage under other health plans.
 
 1. Any pregnant woman 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
 MOMS.
 
 2. No FAMIS MOMS
 shall not be a substitution for private insurance.
 
 a. Only uninsured pregnant
 women shall be eligible for FAMIS MOMS. A pregnant woman is not considered to
 be insured if the health insurance plan covering the pregnant woman does not
 have a network of providers in the area where the pregnant woman resides. Each
 application for FAMIS MOMS coverage shall include an inquiry about health
 insurance the pregnant woman has at the time of application.
 
 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.
 
 12VAC30-141-750. Duration of eligibility. 
 
 A. The effective date of FAMIS MOMS eligibility shall be the
 first day of the month in which a signed an application was
 received by either the FAMIS central processing unit or a local department
 of social services LDSS, DMAS, or the CPU if the applicant met all
 eligibility requirements in that month. 
 
 B. Eligibility for FAMIS MOMS will continue through the last
 day of the month in which the 60th day occurs, following the last day the woman
 was pregnant, regardless of the reason the pregnancy ended. Eligibility will
 continue until the end of the coverage period, regardless of changes in
 circumstances such as income or family size. 
 
 12VAC30-141-760. Pregnant women ineligible for FAMIS MOMS. 
 
 A. If a pregnant woman is: 
 
 1. Eligible for Medicaid, or would be eligible if she
 applied for Medicaid, she shall be ineligible for coverage under FAMIS MOMS.
 A pregnant woman 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 MOMS; 
 
 2. An inmate of a public institution as defined provided
 in 42 CFR 435.1009 435.1009(a)(1), she shall be ineligible for
 FAMIS MOMS at the initial determination of eligibility; or 
 
 3. An inpatient in an institution for mental disease (IMD)
 as [ defined provided ] in [ 42 CFR 435.1010 42 CFR
 435.1010(a)(2) ], she shall be ineligible for FAMIS MOMS at the
 initial determination of eligibility. 
 
 B. If a pregnant woman age 18 years or older or, if younger
 than age 18 years, a 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 pregnant woman shall be
 ineligible for FAMIS MOMS. 
 
 C. If a pregnant woman age 18 years or older, or if younger
 than age 18 years, a parent, adult relative caretaker, guardian, or legal
 custodian obtained benefits for a pregnant woman who would otherwise be
 ineligible by willfully misrepresenting material facts on the application or
 failing to report changes, the pregnant woman for whom the application is made
 shall be ineligible for FAMIS MOMS. The pregnant woman age 18 years or older,
 or if younger than age 18 years, 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.
 
 
 12VAC30-141-790. Application requirements. 
 
 A. Availability of program information. DMAS or its designee
 shall furnish the following information in written form and orally as
 appropriate to all applicants and to other individuals who request it: 
 
 1. The eligibility requirements; 
 
 2. Summary of covered benefits; 
 
 3. Copayment amounts required; and 
 
 4. The rights and responsibilities of applicants and
 enrollees. 
 
 B. Opportunity to apply. DMAS or its designee must afford a
 pregnant woman, wishing to do so, the opportunity to apply for the FAMIS MOMS
 program. Applications from pregnant women will be accepted at a central site
 designated by DMAS and at local departments of social services throughout the
 Commonwealth. Applicants may file an application for health insurance
 by mail, by fax, by phone, via the internet, or in person at local
 departments of social services. Applications filed at the FAMIS CPU can be
 submitted by mail, by fax, by the Internet, or by phone. Face-to-face
 interviews for the program are not required. Eligibility determinations for
 FAMIS MOMS shall occur at either local departments of social services or at
 the DMAS-designated central site LDSS, DMAS, or the CPU.
 
 C. Application. DMAS or its designee shall require an
 application from the applicant if the applicant is at least 18 years of age or
 older, or from a parent, adult relative caretaker, guardian, legal custodian,
 or authorized representative if the applicant is younger than 18 years of age
 or the applicant is incapacitated.
 
 1. DMAS employs a single, streamlined application developed
 by the state and approved by the Secretary of the Department of Health and
 Human Services in accordance with § 1413(b)(1)(B) of the Affordable Care
 Act. 
 
 2. DMAS may employ an alternative application used to apply
 for multiple human service programs approved by the Secretary of the Department
 of Health and Human Services, provided that the agency makes readily available
 the single or alternative application used only for insurance affordability
 programs to individuals seeking assistance only through such programs.
 
 D. Right to apply. An individual who is 18 years of
 age or older shall not be refused the right to complete an application for
 health insurance for herself and shall not be discouraged from asking for
 assistance for herself under any circumstances. 
 
 D. E. Applicant's signature. The applicant must
 sign state-approved application forms submitted, even if another person fills
 out the form, unless the application is filed and signed by the applicant's
 parent, spouse, adult relative caretaker, legal guardian or conservator,
 attorney-in-fact or authorized representative.  
 
 E. F. The authorized representative for an
 individual 18 years of age or older shall be those individuals as set forth in
 12VAC30-110-1380. 
 
 F. G. The authorized representative for
 children younger than 18 years of age shall be those individuals as set forth
 in 12VAC30-110-1390. 
 
 G. H. Persons prohibited from signing an
 application. An employee of, or an entity hired by, a medical service provider
 who stands to obtain FAMIS MOMS payments shall not sign an application for
 health insurance on behalf of an individual who cannot designate an authorized
 representative. 
 
 H. Written application. DMAS or its designee shall require
 a written application from the applicant if she is at least 18 years of age or
 older, or from a parent, adult relative caretaker, guardian, legal custodian,
 or authorized representative if the applicant is less than 18 years of age or
 the applicant is incapacitated. The application must be on a form prescribed by
 DMAS and must be signed under a penalty of perjury. The application form shall
 contain information sufficient to determine Medicaid and FAMIS MOMS
 eligibility. 
 
 I. Assistance with application. DMAS or its designee shall
 allow an individual or individuals of the applicant's choice to assist
 and represent the applicant in the application process, or a redetermination
 renewal process for eligibility. 
 
 J. Timely determination of eligibility. The time processing
 standards for determining eligibility for FAMIS MOMS coverage begin with the
 date a signed an application is submitted online, by
 telephone, by fax, or received either in hard copy at a local
 department of social services or the FAMIS CPU. All Applications
 received at local departments of social services must applications
 shall have a full Medicaid an eligibility determination and,
 when a pregnant woman is determined to be ineligible for Medicaid due to
 excess income, a for pregnant women and FAMIS MOMS eligibility
 determination performed, within the same Medicaid case
 processing time standards (10 business days) if all information necessary to
 make the determination has been received. 
 
 Except in cases of unusual circumstances as described
 below, health insurance applications for pregnant women received at the local
 department of social services shall have a Medicaid eligibility determination
 completed and, if denied Medicaid for excess income, a FAMIS MOMS eligibility
 determination completed within 10 business days of the date the signed
 application was received at the local department. An application from a
 pregnant woman received at the FAMIS CPU and screened as ineligible for
 Medicaid, shall have a FAMIS MOMS eligibility determination completed within 10
 business days of the date the complete application was received at the CPU.
 Complete applications that are screened as Medicaid likely will be processed
 within the 10 business day time standard. If the application cannot be
 processed within this standard, a notice will be sent to the applicant
 explaining why a decision has not yet been made. 
 
 1. Unusual circumstances include administrative or other
 emergency beyond the agency's control. In such case, DMAS or its designee or
 the LDSS must document, in the applicant's case record, the reasons for delay.
 DMAS or its designee or the local department of social services must not use
 the time standards as a waiting period before determining eligibility or as a
 reason for denying eligibility because it has not determined eligibility within
 the time standards. 
 
 2. Applications filed at the CPU that are incomplete shall
 be held open for a period of 30 calendar days to enable applicants to provide
 outstanding information needed for an eligibility determination. Incomplete
 applications determined complete by the receipt of additional information
 required to determine FAMIS MOMS eligibility will be processed in an expedited
 manner upon receipt of the additional information. Any applicant who fails to
 provide, within 30 calendar days of the receipt of the initial application,
 information or verifications necessary to determine eligibility, shall have her
 application for FAMIS MOMS eligibility denied. 
 
 K. Notice of DMAS', its designee's or the local
 department of social services' decision concerning eligibility. DMAS, its
 designee or the local department of social services must an LDSS, or the
 CPU shall send each applicant a written notice of the agency's/designee's
 agency's or designee's decision on her the applicant's
 application, and, if approved, her the applicant's
 obligations under the program. If eligibility for FAMIS MOMS is denied, notice must
 shall be given concerning the reasons for the action and an explanation
 of the applicant's right to request a review of the adverse actions, as
 described in 12VAC30-141-50. 
 
 L. Case documentation. DMAS, its designee, or the
 local department of social services must, or the CPU shall include
 in each applicant's record all necessary facts to support the decision on her
 the applicant's application, and must shall dispose
 of each application by a finding of eligibility or ineligibility, unless (i)
 there is an entry in the case record that the applicant voluntarily withdrew
 the application and that the agency or its designee sent a notice confirming her
 the applicant's decision; or (ii) there is a supporting entry in
 the case record that the applicant cannot be located. 
 
 M. Case maintenance. All cases approved for FAMIS MOMS shall
 be maintained at the FAMIS CPU departments of social services or the
 CPU. Pregnant women determined by local departments of social services
 to be eligible for FAMIS MOMS shall have their cases transferred to the FAMIS
 CPU for ongoing case maintenance. The FAMIS CPU The LDSS or the
 agency determining eligibility will be responsible for providing newly
 enrolled recipients with program information, benefits available, how to secure
 services under the program, a FAMIS MOMS handbook, and for processing changes
 in eligibility within established time frames timeframes. DMAS
 outreach resources may also provide information or assistance to the enrollee.
 
 N. Notice of decision concerning eligibility. DMAS or the
 FAMIS CPU LDSS, DMAS, or the CPU must give enrollees timely notice
 of proposed action to terminate their eligibility under FAMIS MOMS. The notice
 must meet the requirements of 42 CFR 457.1180. 
 
 12VAC30-141-800. Copayments. 
 
 A. Pregnant women enrolled in FAMIS MOMS will be subject to
 copayments for medical services in the same manner and amount as pregnant women
 covered by the Medicaid program as defined in 12VAC30-10-570 B and C. 
 
 B. These cost-sharing provisions shall be implemented with
 the following restrictions: 
 
 1. Total cost sharing for a pregnant woman shall be limited to
 the lesser of (i) $180 and (ii) 2.5% of the family's income (i) for
 families with incomes equal to or less than 150% of federal poverty level
 (FPL), the lesser of (a) $180 and (b) 2.5% of the family's income for the year;
 and (ii) for families with incomes greater than 150% of FPL, the lesser of $350
 and 5.0% of the family's income for the year for the duration of her
 the pregnant woman's enrollment in FAMIS MOMS. 
 
 2. If a family includes a pregnant woman enrolled in FAMIS
 MOMS and a child or children enrolled in FAMIS, DMAS or its designee
 shall ensure that the annual aggregate cost sharing for all Title XXI enrollees
 in a family does not exceed the cost sharing caps as defined in 12VAC30-141-160
 B. 
 
 3. Families will be required to submit documentation to DMAS
 or its designee showing that their maximum copayment amounts are met for the
 year. 
 
 4. Once the cap is met, DMAS or its designee will issue a new
 eligibility card or written documentation excluding such families from paying
 additional copays. 
 
 C. Exceptions to the above cost-sharing provisions. No cost
 sharing will be charged to American Indians and Alaska Natives. 
 
 12VAC30-141-880. Assignment to managed care. 
 
 A. All eligible enrollees shall be assigned in managed care
 through the department or the central processing unit (CPU) under contract to
 DMAS. FAMIS MOMS individuals, during the preassignment period to an MCHIP,
 shall receive Medicaid-like benefits via fee-for-service utilizing a FAMIS MOMS
 card issued by DMAS. After assignment to an MCHIP, benefits and the delivery of
 benefits shall be administered specific to the managed care program in which
 the individual is enrolled. 
 
 1. MCHIPs shall be offered to enrollees in all areas. 
 
 2. All enrollees shall be assigned to that contracted MCHIP. 
 
 3. Enrollees shall be assigned through a random system
 algorithm. 
 
 4. Enrolled individuals will receive a letter indicating that
 they may select one of the contracted MCHIPs that serve such area. Enrollees
 who do not select an MCHIP as described above, shall be assigned to an MCHIP as
 described in subdivision 3 of this subsection. 
 
 5. Individuals assigned to an MCHIP who lose and then regain
 eligibility for FAMIS MOMS within 60 calendar days will be reassigned to
 their previous MCHIP. 
 
 B. Following their initial assignment to an MCHIP, those
 enrollees shall be restricted to that MCHIP until their next annual eligibility
 redetermination, unless appropriately disenrolled by the department. 
 
 1. During the first 90 calendar days of managed care
 assignment, an enrollee may request reassignment for any reason from that MCHIP
 to another MCHIP serving that geographic area. Such reassignment shall be
 effective no later than the first day of the second month after the month in
 which the enrollee requests reassignment. 
 
 2. After the first 90 calendar days of the assignment period,
 the enrollee may only be reassigned from one MCHIP to another MCHIP upon
 determination by DMAS that good cause exists pursuant to subsection C of this
 section. 
 
 C. Disenrollment for good cause may be requested at any time.
 
 
 1. After the first 90 calendar days of assignment in
 managed care, enrollees may request disenrollment from DMAS based on good
 cause. The request must be made in writing to DMAS and cite the reasons
 why the enrollee wishes to be reassigned. The department shall establish
 procedures for good cause reassignment through written policy directives. 
 
 2. DMAS shall determine whether good cause exists for
 reassignment. 
 
 D. Exclusion for assignment to a MCHIP. The following
 individuals shall be excluded from assignment to a MCHIP. Newly eligible individuals
 who are in the third trimester of pregnancy and who request exclusion within a
 department-specified time frame timeframe of the effective date
 of their MCHIP enrollment. Exclusion may be granted only if the member's
 obstetrical provider (physician or hospital) does not participate with the
 enrollee's assigned MCHIP. Exclusion requests made during the third trimester
 may be made by the enrollee, MCHIP, or provider. DMAS shall determine if the
 request meets the criteria for exclusion.
 
 VA.R. Doc. No. R17-4662; Filed April 30, 2019, 4:22 p.m. 
TITLE 13. HOUSING
BOARD OF HOUSING AND COMMUNITY DEVELOPMENT
Emergency Regulation
 
 Title of Regulation: 13VAC5-63. Virginia Uniform
 Statewide Building Code (amending 13VAC5-63-540).
 
 Statutory Authority: § 36-98 of the Code of Virginia.
 
 Effective Dates: May 14, 2019, through November 12,
 2020.
 
 Agency Contact: Kyle Flanders, Senior Policy Analyst,
 Department of Housing and Community Development, Main Street Centre, 600 East
 Main Street, Suite 300, Richmond, VA 23219, telephone (804) 786-6761, FAX (804)
 371-7090, TTY (804) 371-7089, or email kyle.flanders@dhcd.virginia.gov.
 
 Preamble:
 
 Section 2.2-4011 A of the Code of Virginia states that
 regulations that an agency finds are necessitated by an emergency situation may
 be adopted upon consultation with the Attorney General, which approval shall be
 granted only after the agency has submitted a request stating in writing the
 nature of the emergency, and the necessity for such action shall be at the sole
 discretion of the Governor. 
 
 Currently, the Virginia Maintenance Code (VMC), a part of
 the Uniform Statewide Building Code (USBC), requires that when cooling is
 provided to tenants of certain multifamily buildings, it must be provided to a
 temperature of at least 80° Fahrenheit. The current threshold has been
 identified as a public health concern in multiple localities that adopt the
 VMC. The amendment lowers the required cooling temperature as provided in the
 USBC to to 77° Fahrenheit.
 
 13VAC5-63-540. Chapter 6 Mechanical and electrical
 requirements. 
 
 A. Delete the following sections from Chapter 6 of the IPMC:
 
 1. Section 601.2 Responsibility.
 
 2. Section 603.6 Energy conservation devices.
 
 3. Section 604.2 Service.
 
 4. Section 604.3.2 Abatement of electrical hazards associated
 with fire exposure.
 
 B. Change the following sections in Chapter 6 of the IPMC to
 read:
 
 1. Section 601.1 General. The provisions of this chapter shall
 govern the maintenance of mechanical and electrical facilities and equipment.
 
 2. Section 602 Heating and cooling facilities.
 
 3. Section 602.2 Heat supply. Every owner and operator of a
 Group R-2 apartment building or other residential building who rents, leases,
 or lets one or more dwelling unit, rooming unit, dormitory, or guestroom on
 terms, either expressed or implied, to furnish heat to the occupants thereof
 shall supply heat during the period from October 15 to May 1 to maintain a
 temperature of not less than 68°F (20°C) in all habitable rooms, bathrooms, and
 toilet rooms. The code official may also consider modifications as provided in
 Section 104.5.2 when requested for unusual circumstances or may issue notice
 approving building owners to convert shared heating and cooling piping HVAC
 systems 14 calendar days before or after the established dates when extended
 periods of unusual temperatures merit modifying these dates.
 
 Exception: When the outdoor temperature is below the winter
 outdoor design temperature for the locality, maintenance of the minimum room
 temperature shall not be required provided that the heating system is operating
 at its full design capacity. The winter outdoor design temperature for the
 locality shall be as indicated in Appendix D of the IPC.
 
 4. Section 602.3 Occupiable work spaces. Indoor occupiable
 work spaces shall be supplied with heat during the period from October 1 to May
 15 to maintain a minimum temperature of 65°F (18°C) during the period the
 spaces are occupied.
 
 Exceptions:
 
 1. Processing, storage, and operation areas that require
 cooling or special temperature conditions.
 
 2. Areas in which persons are primarily engaged in vigorous
 physical activities.
 
 5. Section 602.4 Cooling supply. Every owner and operator of a
 Group R-2 apartment building who rents, leases, or lets one or more dwelling
 units, rooming units, or guestrooms on terms, either expressed or implied, to
 furnish cooling to the occupants thereof shall supply cooling during the period
 from May 15 to October 1 to maintain a temperature of not more than 80°F
 (27°C) 77°F (25°C) in all habitable rooms. The code official may
 also consider modifications as provided in Section 104.5.2 when requested for
 unusual circumstances or may issue notice approving building owners to convert
 shared heating and cooling piping HVAC systems 14 calendar days before or after
 the established dates when extended periods of unusual temperatures merit
 modifying these dates.
 
 Exception: When the outdoor temperature is higher than the
 summer design temperature for the locality, maintenance of the room temperature
 shall not be required provided that the cooling system is operating at its full
 design capacity. The summer outdoor design temperature for the locality shall
 be as indicated in the IECC.
 
 6. Section 603.1 Mechanical equipment and appliances. Required
 or provided mechanical equipment, appliances, fireplaces, solid fuel-burning
 appliances, cooking appliances, chimneys, vents, and water heating appliances
 shall be maintained in compliance with the code under which the appliances,
 system, or equipment was installed, kept in safe working condition, and capable
 of performing the intended function.
 
 7. Section 603.2 Removal of combustion products. Where
 required by the code under which installed, fuel-burning equipment and
 appliances shall be connected to an approved chimney or vent.
 
 8. Section 603.5 Combustion air. Where required by the code
 under which installed, a supply of air for complete combustion of the fuel
 shall be provided for the fuel-burning equipment.
 
 9. Section 604.1 Electrical system. Required or provided
 electrical systems and facilities shall be maintained in accordance with the
 applicable building code.
 
 10. Section 604.3 Electrical system hazards. Where it is found
 that the electrical system in a structure constitutes a hazard to the occupants
 or the structure by reason of deterioration or damage or for similar reasons,
 the code official shall require the defects to be corrected to eliminate the
 hazard.
 
 11. Section 604.3.1.1 Electrical equipment. Electrical
 distribution equipment, motor circuits, power equipment, transformers, wire,
 cable, flexible cords, wiring devices, ground fault circuit interrupters, surge
 protectors, molded case circuit breakers, low-voltage fuses, luminaires,
 ballasts, motors, and electronic control, signaling, and communication
 equipment that have been exposed to water shall be replaced in accordance with
 the provisions of the VCC.
 
 Exception: The following equipment shall be allowed to be
 repaired or reused where an inspection report from the equipment manufacturer,
 an approved representative of the equipment manufacturer, a third party
 licensed or certified electrician, or an electrical engineer indicates that the
 exposed equipment has not sustained damage that requires replacement: 
 
 1. Enclosed switches, rated 600 volts or less; 
 
 2. Busway, rated 600 volts or less; 
 
 3. Panelboards, rated 600 volts or less; 
 
 4. Switchboards, rated 600 volts or less; 
 
 5. Fire pump controllers, rated 600 volts or less; 
 
 6. Manual and magnetic motor controllers; 
 
 7. Motor control centers; 
 
 8. Alternating current high-voltage circuit breakers; 
 
 9. Low-voltage power circuit breakers; 
 
 10. Protective relays, meters, and current transformers; 
 
 11. Low-voltage and medium-voltage switchgear; 
 
 12. Liquid-filled transformers; 
 
 13. Cast-resin transformers; 
 
 14. Wire or cable that is suitable for wet locations and whose
 ends have not been exposed to water; 
 
 15. Wire or cable, not containing fillers, that is suitable
 for wet locations and whose ends have not been exposed to water; 
 
 16. Luminaires that are listed as submersible; 
 
 17. Motors; or
 
 18. Electronic control, signaling, and communication
 equipment.
 
 12. 604.3.2.1 Electrical equipment. Electrical switches,
 receptacles and fixtures, including furnace, water heating, security system and
 power distribution circuits, that have been exposed to fire shall be replaced
 in accordance with the provisions of the Virginia Construction Code.
 
 Exception: Electrical switches, receptacles and fixtures that
 shall be allowed to be repaired or reused where an inspection report from the
 equipment manufacturer or an approved representative of the equipment
 manufacturer, a third party licensed or certified electrician, or an electrical
 engineer indicates that the equipment has not sustained damage that requires
 replacement.
 
 13. Section 605.1 Electrical components. Electrical equipment,
 wiring, and appliances shall be maintained in accordance with the applicable
 building code.
 
 14. Section 605.2 Power distribution and receptacles. Required
 or provided power circuits and receptacles shall be maintained in accordance
 with the applicable building code, and ground fault and arc-fault circuit
 interrupter protection shall be provided where required by the applicable
 building code. All receptacle outlets shall have the appropriate faceplate
 cover for the location when required by the applicable building code.
 
 15. Section 605.3 Lighting distribution and luminaires. Required
 or provided lighting circuits and luminaires shall be maintained in accordance
 with the applicable building code.
 
 16. Section 605.4 Flexible cords. Flexible cords shall not be
 run through doors, windows, or cabinets or concealed within walls, floors, or
 ceilings.
 
 17. Section 606.1 General. Elevators, dumbwaiters, and
 escalators shall be maintained in compliance with ASME A17.1. The most current
 certificate of inspection shall be on display at all times within the elevator
 or attached to the escalator or dumbwaiter, be available for public inspection
 in the office of the building operator, or be posted in a publicly conspicuous
 location approved by the code official. Where not displayed in the elevator or
 attached on the escalator or dumbwaiter, there shall be a notice of where the
 certificate of inspection is available for inspection. An annual periodic
 inspection and test is required of elevators and escalators. A locality shall
 be permitted to require a six-month periodic inspection and test. All periodic
 inspections shall be performed in accordance with Section 8.11 of ASME A17.1.
 The code official may also provide for such inspection by an approved agency or
 through agreement with other local certified elevator inspectors. An approved
 agency includes any individual, partnership, or corporation who has met the
 certification requirements established by the VCS.
 
 C. Add the following sections to Chapter 6 of the IPMC:
 
 1. Section 602.2.1 Prohibited use. In dwelling units subject
 to Section 602.2, one or more unvented room heaters shall not be used as the
 sole source of comfort heat in a dwelling unit.
 
 2. Section 607.2 Clothes dryer exhaust duct. Required or
 provided clothes dryer exhaust systems shall be maintained in accordance with
 the applicable building code.
 
 VA.R. Doc. No. R19-5869; Filed May 14, 2019, 4:47 p.m. 
TITLE 13. HOUSING
VIRGINIA MANUFACTURED HOUSING BOARD
Final Regulation
 
 Title of Regulation: 13VAC6-20. Manufactured Housing
 Licensing and Transaction Recovery Fund Regulations (amending 13VAC6-20-10, 13VAC6-20-30,
 13VAC6-20-50, 13VAC6-20-60, 13VAC6-20-80, 13VAC6-20-90, 13VAC6-20-100,
 13VAC6-20-170, 13VAC6-20-320). 
 
 Statutory Authority: § 36-85.18 of the Code of Virginia.
 
 Effective Date: July 1, 2019. 
 
 Agency Contact: Kyle Flanders, Senior Policy Analyst,
 Department of Housing and Community Development, 600 East Main Street, Suite
 300, Richmond, VA 23219, telephone (804) 786-6761, FAX (804) 371-7090, TTY
 (804) 371-7089, or email kyle.flanders@dhcd.virginia.gov.
 
 Summary:
 
 The amendments include (i) clarifying the parameters for
 warranties on manufactured homes, (ii) eliminating unnecessary individual
 biographical information of license applicants, (iii) expanding the list of
 specific items that must be included on a sales contract, and (iv) providing
 when and what disclosures must be given to buyers.
 
 Summary of Public Comments and Agency's Response: No
 public comments were received by the promulgating agency. 
 
 Part I 
 General 
 
 13VAC6-20-10. Definitions.
 
 The following words and terms when used in this chapter shall
 have the following meanings unless the context clearly indicates otherwise. 
 
 "Board" means the Virginia Manufactured Housing
 Board. 
 
 "Buyer" means the person who purchases at retail
 from a dealer or manufacturer a manufactured home for personal use as a
 residence or other related use. 
 
 "Claimant" means any person who has filed a
 verified claim under Chapter 4.2 (§ 36-85.16 et seq.) of Title 36 of the
 Code of Virginia. 
 
 "Code" means the appropriate standards of the
 Virginia Uniform Statewide Building Code (13VAC5-63) and the
 Manufactured Home Safety Regulations (13VAC5-95) adopted by the Board of
 Housing and Community Development and administered by the Department of Housing
 and Community Development pursuant to the National Manufactured Housing
 Construction and Safety Standards Act of 1974 (42 USC § 5401 et seq.)
 for manufactured homes. 
 
 "Controlling financial interest" means the direct
 or indirect ownership or control of a firm.
 
 "Date of delivery" means the date on which all
 terms or conditions of the sales contract agreed to or required of the regulant
 have been completed.
 
 "Dealer/manufacturer sales agreement" means a
 written contract or agreement between a manufactured housing manufacturer and a
 manufactured housing dealer whereby the dealer is granted the right to engage
 in the business of offering, selling, and servicing new manufactured homes of a
 particular line or make of the stated manufacturer of such line or make. The
 term shall include any severable part [ or parts ] of such
 sales agreement which separately provides for selling or servicing different
 lines or makes of the manufacturer. 
 
 "Defect" means any deficiency in or damage to materials
 or workmanship occurring in a manufactured home which has been reasonably
 maintained and cared for in normal use. The term also means any failure of any
 structural element, utility system or the inclusion of a component part of the
 manufactured home which fails to comply with the Code. 
 
 "Department" means the Department of Housing and
 Community Development. 
 
 "Director" means the Director of the Department of
 Housing and Community Development, or his the director's
 designee. 
 
 "Fund" or "recovery fund" means the
 Virginia Manufactured Housing Transaction Recovery Fund. 
 
 "HUD" means the United States U.S.
 Department of Housing and Urban Development. 
 
 "Imminent safety hazard" means a hazard that
 presents an imminent and unreasonable risk of death or severe personal injury
 that may or may not be related to failure to comply with an applicable federal
 manufactured home construction or safety standard.
 
 "Licensed" means the regulant has met all
 applicable requirements of this chapter, paid all required fees, and been
 authorized by the board to manufacture or offer for sale or sell manufactured
 homes in accordance with this chapter. 
 
 "Manufactured home" means a structure constructed
 to federal standards, transportable in one or more sections, which, in the
 traveling mode is eight feet or more in width and is 40 feet or more in length,
 or when erected on site, is 320 or more square feet, and which is built on a
 permanent chassis and designed to be used as a dwelling with or without a
 permanent foundation when connected to the required utilities, and includes the
 plumbing, heating, air conditioning, and electrical systems contained therein. 
 
 "Manufactured home broker" or "broker"
 means any person, partnership, association or corporation, resident or
 nonresident, who, for compensation or valuable consideration, sells or offers
 for sale, buys or offers to buy, negotiates the purchase or sale or exchange,
 or leases or offers to lease used manufactured homes that are owned by a party
 other than the broker. 
 
 "Manufactured home dealer" or "dealer"
 means any person engaged in the business of buying, selling, or dealing
 in manufactured homes or offering or displaying manufactured homes for sale in
 Virginia. Any person who buys, sells, or deals in three or more manufactured
 homes in any 12-month period shall be presumed to be a manufactured home
 dealer. The terms "selling" and "sale" include lease-purchase
 transactions. The term "manufactured home dealer" does not include
 banks and finance companies that acquire manufactured homes as an incident to
 their regular business. 
 
 "Manufactured home manufacturer" or
 "manufacturer" means any persons, resident or nonresident, who manufacture
 or assemble manufactured homes for sale in Virginia. 
 
 "Manufactured home salesperson" or
 "salesperson" means any person who for compensation or valuable
 consideration is employed either directly or indirectly by, or affiliated as an
 independent contractor with, a manufactured home dealer to sell or offer to
 sell; or to buy or offer to buy; or to negotiate the purchase, sale or
 exchange; or to lease or offer to lease new or used manufactured homes. 
 
 "New manufactured home" means any manufactured home
 that (i) has not been previously sold except in good faith for the purpose of
 resale, (ii) has not been previously occupied as a place of habitation, (iii)
 has not been previously used for commercial purposes such as offices or
 storage, and (iv) has not been titled by the Virginia Department of Motor
 Vehicles and is still in the possession of the original dealer. If the home is
 later sold to another dealer and then sold to a consumer within two years of
 the date of manufacture, the home is still considered new and must continue to
 meet all state warranty requirements. However, if a home is sold from the
 original dealer to another dealer and it is more than two years after the date
 of manufacture, and it is then sold to a consumer, the home must be sold as
 "used" for warranty purposes. Notice of the "used" status
 of the manufactured home and how this status affects state warranty
 requirements must be provided, in writing, to the consumer prior to the closing
 of the sale. 
 
 "Person" means any individual, natural person,
 firm, partnership, association, corporation, legal representative, or other
 recognized legal entity. 
 
 "Regulant" means any person, firm, corporation,
 association, partnership, joint venture, or any other legal entity required by
 Chapter 4.2 (§ 36-85.16 et seq.) of Title 36 of the Code of Virginia to be
 licensed by the board. 
 
 "Regulations" or "these regulations"
 means this chapter, the Virginia Manufactured Housing Licensing and
 Transaction Recovery Fund Regulations. 
 
 "Reinstatement" means having a license restored to
 effectiveness after the expiration date has passed or license has been revoked
 or not renewed by the board.
 
 "Relevant market area" means the geographical area
 established in the dealer/manufacturer sales agreement and agreed to by both
 the dealer and the manufacturer in the agreement. 
 
 "Renewal" means continuing the effectiveness of a
 license for another period of time.
 
 "Responsible management" means the following
 individuals:
 
 1. The sole proprietor of a sole proprietorship;
 
 2. The partners of a general partnership;
 
 3. The managing partners of a limited partnership;
 
 4. The officers of a corporation;
 
 5. The managers of a limited liability company;
 
 6. The officers or directors of an association or both; and
 
 7. Individuals in other business entities recognized under the
 laws of the Commonwealth as having a fiduciary responsibility to the firm.
 
 "Responsible party" means a manufacturer, dealer,
 or supplier of manufactured homes. 
 
 "Set-up" means the operations performed at the
 occupancy site which render a manufactured home fit for habitation. Such
 operations include, but are not limited to, transportation, positioning,
 blocking, leveling, supporting, anchoring, connecting utility systems, making
 minor adjustments, or assembling multiple or expandable units. Such operations
 do not include lawful transportation services performed by public utilities
 operating under certificates or permits issued by the State Corporation
 Commission. 
 
 "Standards" means the Federal Manufactured Home
 Construction and Safety Standards adopted by the U.S. Department of Housing and
 Urban Development. 
 
 "Statement of Compliance" means the statement found
 on the initial license application and on the renewal application, that
 the regulant licensed by the board will comply with the Manufactured Housing
 Licensing and Transaction Recovery Fund Law, this chapter, and the
 orders of the board. 
 
 "Substantial identity of interest" means (i) a
 controlling financial interest by the individual or corporate principals of the
 manufactured home broker, dealer, or manufacturer whose license has been
 revoked or not renewed for cause by the board or (ii) substantially identical
 principals or officers as the manufactured home broker, dealer, or manufacturer
 whose license has been revoked or not renewed for cause by the board.
 
 "Supplier" means the original producers of
 completed components, including refrigerators, stoves, water heaters,
 dishwashers, cabinets, air conditioners, heating units, and similar components,
 and materials such as floor coverings, paneling, siding, trusses, and similar
 materials, which are furnished to a manufacturer or a dealer for installation
 in the manufactured home prior to sale to a buyer. 
 
 "Used manufactured home" means any manufactured
 home other than a new home as defined in this section. 
 
 "Warranty" means any written assurance of the
 manufacturer, dealer, or supplier or any promise made by a regulant in
 connection with the sale of a manufactured home that becomes part of the basis
 of the sale. The term "warranty" pertains to the obligations of the
 regulant in relation to materials, workmanship, and fitness of a manufactured
 home for ordinary and reasonable use of the home for the term of the promise or
 assurance. 
 
 13VAC6-20-30. Application for licensing; renewal. 
 
 A. Application for license or renewal shall be on forms
 supplied by the department and may be submitted as designated in hard copy or
 by electronic means. All information required on the form shall be furnished by
 the applicant for the board's review. 
 
 B. Each application for original licensure shall be
 accompanied by the following: 
 
 1. Deposit in the Transaction Recovery Fund required by
 13VAC6-20-420 A 1. 
 
 2. Licensing fee required by 13VAC6-20-200 A 1. 
 
 3. Copy of the manufacturer's homeowner and installation manual
 or manuals. 
 
 4. Statement of Compliance compliance. 
 
 5. List of salespeople licensed in Virginia with the
 following biographical information for each:. 
 
 Date of birth 
 
 Sex 
 
 Weight 
 
 Height 
 
 Eye/hair color 
 
 C. The Department of Housing and Community Development will
 mail a notice of renewal to the licensee at the last known address of record. 
 Licensees may submit renewals by mail or electronically.  Failure to
 receive this notice shall not relieve the licensee of the obligation to
 renew.  If the licensee does not receive the notice of renewal, a copy of
 the license may be substituted with the required fee. Each application for
 renewal shall be accompanied by the following: 
 
 1. Licensing fee required by 13VAC6-20-200 A 2. 
 
 2. If revised, a copy of the revised homeowner and
 installation manual or manuals. 
 
 3. Statement of Compliance compliance. 
 
 4. Updated list of salespeople employed. 
 
 Article 2 
 Dealers 
 
 13VAC6-20-50. License required; annual renewal. 
 
 A. Any person located in or outside of the Commonwealth
 buying or selling or offering or displaying manufactured homes for sale in
 Virginia and meeting the definition of a dealer in 13VAC6-20-10 shall apply to
 the board for a license. The license shall be displayed in a conspicuous place
 accessible to the public in the office of the business location. The license
 shall be issued for a term of one year from the date of issuance. 
 
 B. Each licensed dealer shall apply for license renewal
 annually, by application and accompanied by the required fee. Applicants
 for license renewal shall meet all the criteria for original licensing. Upon
 failure to renew, the license shall automatically expire. 
 
 C. Should the department fail to receive a licensed dealer's
 renewal form and appropriate fee within 30 days of the license expiration date,
 the dealer shall be required to reinstate the license according to the terms
 and conditions of Article 8 (13VAC6-20-201 et seq.) of this part.
 
 D. For licensing purposes, a dealer operating more than one
 retail location shall have each location treated as a separate entity and shall
 adhere to all requirements for dealer licensing including posting a license at
 each location. 
 
 E. Each dealer licensed under this chapter shall also obtain
 a certificate of dealer registration from the Virginia Department of
 Motor Vehicles Vehicle Dealer Board (MVDB). The certificate of
 registration shall be renewed annually and shall be maintained in effect with
 the Department of Motor Vehicles MVDB as long as the dealer is
 licensed under this chapter. 
 
 13VAC6-20-60. Application for licensing; renewal. 
 
 A. Application for license or renewal shall be on forms
 supplied by the department and may be submitted as designated in hard copy or
 by electronic means. All information required on the form shall be furnished by
 the applicant for the board's review. 
 
 B. Each application for original licensure shall be
 accompanied by the following: 
 
 1. Deposit in the Transaction Recovery Fund required by
 13VAC6-20-420 A 2. 
 
 2. Licensing fee required by 13VAC6-20-200 A 3. 
 
 3. Statement of Compliance compliance. 
 
 4. Verification of a business office with all utilities,
 including a business telephone, and where the required business records are
 maintained. 
 
 5. Verification of a permanent business sign, in view of
 public traffic, bearing the name of the firm. 
 
 6. List of salespeople employed with the following
 biographical information for each:. 
 
 Date of Birth 
 
 Sex 
 
 Weight 
 
 Height 
 
 Eye/hair color 
 
 7. Name of the owner, principal, manager, agent, or
 other person designated as the holder of the dealer's license for the specific
 location and the names of other partners or principals in the dealership. 
 
 Photographs of the front of the business office and required
 sign may be considered as verification required by this subsection. 
 
 C. The Department of Housing and Community Development will
 mail a notice of renewal to the licensee at the last known address of record.
 Licensees may submit renewals by mail or electronically. Failure to receive
 this notice shall not relieve the licensee of the obligation to renew. If the
 licensee does not receive the notice of renewal, a copy of the license may be
 substituted with the required fee. Each application for renewal shall be
 accompanied by the following: 
 
 1. Licensing fee required by 13VAC6-20-200 A 4. 
 
 2. Statement of Compliance compliance. 
 
 3. Notification of any significant changes to the office or
 the business sign. 
 
 4. Updated list of salespeople employed. 
 
 5. Any changes of officers or directors of the company or
 corporation. 
 
 6. A copy of the dealer's current certificate of registration
 from the Department of Motor Vehicles Virginia Motor Vehicle Dealer
 Board.
 
 D. Any change in the form of ownership of the dealer or any
 changes (deletions or additions) in the partners or principals of the dealer
 shall be submitted to the board with an application and fee for a new license.
 If the new owner or owners assume the liabilities of the previous owner or
 owners, then a new recovery fund assessment is not required. New recovery
 fund assessments shall be required when the new owner or owners do does
 not assume the liabilities of the previous owner or owners. The board
 shall be notified immediately by the dealer of any change in the operating name
 of the dealer. The director shall endorse the change on the license without
 requiring an additional fee. The board shall be notified immediately by the
 dealer of any change in the location of the dealer. The dealer shall pay a fee
 of $50 for the change of location on the license, but shall not be
 required to pay an additional assessment to the recovery fund for the change of
 location only. 
 
 13VAC6-20-80. Dealer responsibility for inspections; other
 items.
 
 A. The dealer shall inspect every new manufactured home unit
 upon delivery from a manufacturer. If a dealer becomes aware of a noncompliance
 or an imminent safety hazard in a manufactured home, the dealer shall contact
 the manufacturer, provide full information concerning the problem, and request
 appropriate action by the manufacturer. No dealer shall sell a new manufactured
 home if he becomes aware that it contains a noncompliance defect
 or an imminent safety hazard. 
 
 B. The dealer shall inspect every new manufactured home unit
 prior to selling to determine that all items of furniture, appliances,
 fixtures, and devices are not damaged and are in place and operable. 
 
 C. A dealer shall not alter or cause to be altered any
 manufactured home to which a HUD label has been affixed if such alteration or
 conversion causes the manufactured home to be in violation of the standards. 
 
 D. If the dealer provides for the installation of any
 manufactured home he the dealer sells, the dealer shall be
 responsible for making sure the installation of the home meets the
 manufacturer's installation requirements and the Code. 
 
 E. On each home sold by the dealer, the dealer shall collect
 the applicable title fees and title tax for the manufactured home, to include
 an additional $30 inspection/administrative fee, and forward such fees and
 taxes to the Virginia Department of Motor Vehicles. 
 
 The above fees shall be submitted to the Virginia Department
 of Motor Vehicles within 30 days from the completion date of the sale.
 
 F. On each home sold by the dealer, the dealer shall provide
 the owner with information to file a claim supplied by the department.
 
 Article 3 
 Brokers 
 
 13VAC6-20-90. License required; annual renewal.
 
 A. Any person located in or outside of the Commonwealth (i)
 buying or selling, negotiating the purchase or sale or exchange of, or leasing
 used manufactured homes and (ii) meeting the definition of broker in
 13VAC6-20-10 shall apply to the board for a license. The license shall be
 displayed in a conspicuous place accessible to the public in the office of the
 business location. The license shall be issued for a term of one year from the
 date of issuance. 
 
 B. Each licensed broker shall apply for license renewal
 annually, by application and accompanied by the required fee. Applicants
 for license renewal shall meet all the criteria for original licensing. Upon
 failure to renew, the license shall automatically expire. 
 
 C. Should the department fail to receive a licensed broker's
 renewal form and appropriate fee within 30 days of the license expiration date,
 the broker shall be required to reinstate the license according to the terms
 and conditions of Article 8 (13VAC6-20-201 et seq.) of this part.
 
 D. For licensing purposes, a broker operating more than one
 business location shall have each location treated as a separate entity and
 shall adhere to all requirements for broker licensing, including posting a
 license, at each location. 
 
 E. Each broker licensed under this chapter shall also obtain
 a certificate of dealer registration from the Virginia Department of
 Motor Vehicles Vehicle Dealer Board (MVDB). The certificate of
 registration shall be renewed annually and shall be maintained in effect with
 the Department of Motor Vehicles MVDB as long as the broker is
 licensed under this chapter. 
 
 13VAC6-20-100. Application for licensing; renewal. 
 
 A. Application for license or renewal shall be on forms
 supplied by the department and may be submitted as designated in hard copy or
 by electronic means. All information required on the form shall be furnished by
 the applicant for the board's review. 
 
 B. Each application for original licensure shall be
 accompanied by the following: 
 
 1. Deposit in the Transaction Recovery Fund required by
 13VAC6-20-420 A 3. 
 
 2. Licensing fee required by 13VAC6-20-200 A 5. 
 
 3. Statement of Compliance compliance. 
 
 4. Verification of a business office with all utilities,
 including a business telephone, and where the required business records are
 maintained. 
 
 5. Verification of a permanent business sign, in view of
 public traffic, bearing the name of the firm. 
 
 6. Name of the owner, principal, manager, agent or other person
 designated as the holder of the broker's license for the specific location and
 the names of the partners or principals in the broker's firm. 
 
 7. List of salespeople employed with the following
 biographical information for each:. 
 
 Date of birth 
 
 Sex 
 
 Weight 
 
 Height 
 
 Eye/hair color 
 
 Photographs of the front of the business office and required
 sign may be considered as verification required by this subsection. 
 
 C. The Department of Housing and Community Development will
 mail a notice of renewal to the licensee at the last known address of
 record.  Licensees may submit renewals by mail or electronically. 
 Failure to receive this notice shall not relieve the licensee of the obligation
 to renew.  If the licensee does not receive the notice of renewal, a copy
 of the license may be substituted with the required fee. Each application for
 renewal shall be accompanied by the following: 
 
 1. Licensing fee required by 13VAC6-20-200 A 6. 
 
 2. Statement of Compliance compliance. 
 
 3. Notification of any significant changes to the office or
 the business sign. 
 
 4. Any changes of officers or directors of the company or
 corporation. 
 
 5. A copy of the broker's current certificate of registration
 from the Department of Motor Vehicles Virginia Motor Vehicle Dealer
 Board. 
 
 6. Updated list of salespeople employed. 
 
 D. Any change in the form of ownership of the broker or any
 changes (deletions or additions) in the partners or principals of the broker
 shall be submitted to the board with an application and fee for a new license.
 If the new owner(s) owner assume the liabilities of the previous owner(s)
 owner, then a new recovery fund assessment is not required. New recovery
 fund assessments shall be required when the new owner(s) do owner
 does not assume the liabilities of the previous owner(s) owner.
 
 
 The board shall be notified immediately by the broker of any
 change in the operating name of the broker. The director shall endorse the
 change on the license without requiring an additional fee. The board shall be
 notified immediately by the broker of any change in location of the broker. The
 broker shall pay a fee of $50 for the change of location on the license,
 but shall not be required to pay an additional assessment to the recovery fund
 for the change of location only. 
 
 Article 6 
 Violations and Hearings 
 
 13VAC6-20-170. Prohibited conduct; grounds for denying,
 suspending or revoking license. 
 
 A. The following acts by regulants are prohibited and may be
 considered by the board as grounds for action against the regulant: 
 
 1. Engaging in business as a manufactured home manufacturer,
 dealer, or broker without first obtaining a license from the board. 
 
 2. Engaging in business as a manufactured home salesperson
 without first applying to the board for a license. 
 
 3. Making a material misstatement in an application for
 license. 
 
 4. Failing to pay a required assessment to the Transaction
 Recovery Fund. 
 
 5. Failing to comply with the warranty service obligations and
 claims procedures required by this chapter. 
 
 6. Failing to comply with the set-up and tie-down requirements
 of the Code. 
 
 7. Knowingly failing or refusing to account for or pay over
 money or other valuables belonging to others which have come into the
 regulant's possession due to the sale of a manufactured home. 
 
 8. Using unfair methods of competition or unfair or deceptive
 commercial acts or practices. 
 
 9. Failing to comply with the advertising provisions in Part
 IV of this chapter (13VAC6-20-270 et seq.) of this chapter. 
 
 10. Defrauding any buyer to the buyer's damage, and any other
 person in the conduct of the regulant's business. 
 
 11. Employing an unlicensed salesperson. 
 
 12. Knowingly offering for sale a manufactured home produced
 by a manufacturer which that is not licensed as a manufacturer
 under this chapter. 
 
 13. Knowingly selling a manufactured home to a dealer who is
 not licensed as a dealer under this chapter. 
 
 14. Failing to appear before the board upon due notice. 
 
 15. Failing to comply with orders issued by the board pursuant
 to this chapter. 
 
 16. Failing to renew a license and continuing to engage in
 business as a manufacturer, dealer, broker, or salesperson after the
 expiration of any license. 
 
 17. A salesperson selling, exchanging, or offering to
 sell or exchange a manufactured home for any dealer or broker other than the
 licensed dealer or broker employing the salesperson. 
 
 18. A salesperson offering, transferring, or assigning
 any negotiated sale or exchange of a manufactured home to another dealer,
 broker, manufacturer, or salesperson. 
 
 19. Failing to comply with the Statement statement
 of Compliance compliance. 
 
 20. Failing to notify the board of a change of location or
 address of the business office. 
 
 21. Failing to comply with any provisions of this chapter.
 
 a. The board may revoke or deny renewal of an existing license
 or refuse to issue a license to any manufactured home broker, dealer,
 manufacturer, or salesperson who is shown to have a substantial identity of
 interest with a manufactured home broker, dealer, or manufacturer whose license
 has been revoked or not renewed by the board.
 
 b. Any person whose license is revoked or not renewed for
 cause by the board shall not be eligible for a license under any circumstances
 or under any name, except as provided by regulations of the board pursuant to § 36-85.18
 of the Code of Virginia.
 
 22. Failing to comply with the regulations of state or federal
 agencies regarding the financing, titling, taxation, or transporting of
 manufactured homes. 
 
 23. Failing to perform a written contract between the
 regulant and seller or buyer that contains the following minimum requirements:
 
 a. A statement of the total cost of the contract and the
 amounts, including specific statement on the cost of the home, any additional
 costs for work to be performed, and the amount of the down payment, taxes, and
 titling fees.
 
 b. A listing of specified materials and work to be
 performed and who is to supply the materials and perform that work.
 
 c. Contract to identify the business name as shown on the
 license issued per this chapter and to include the address and the phone number
 of the business.
 
 d. Specify the make and model of the home.
 
 e. Specify if the home is new or used.
 
 f. Specify the length and width of the home as defined by
 the HUD Standards.
 
 g. Specify the date of manufacture and the serial number,
 except when the home is specially ordered from the manufacturer for the buyer
 and this information is not known.
 
 24. Failing to provide a statement notifying consumers of
 the limitations on damages retained by dealer disclosure to the buyer.
 
 25. Failing to provide a statement notifying consumers of
 the dispute resolution program available to resolve disputes concerning defects
 in manufactured homes.
 
 B. The board may deny, suspend, revoke, or refuse to
 renew or reinstate the license of a regulant because of, but not limited to,
 one or more of the following grounds: 
 
 1. Having had a license previously denied, revoked, or
 suspended under this chapter. 
 
 2. Having a license denied, suspended, or revoked by a
 similar licensing entity in another state. 
 
 3. Engaging in conduct in another state which that
 would have been a violation of this chapter if the actions were committed in
 Virginia. 
 
 4. Failing to obtain a required certification of registration
 from the Department of Motor Vehicles Vehicle Dealer Board
 (MVDB), failing to renew the annual certificate of registration from the
 MVDB, or having the certificate of registration suspended or revoked by the
 Department of Motor Vehicles MVDB. 
 
 5. Having been convicted or found guilty in any jurisdiction
 of a felony. 
 
 13VAC6-20-320. Duration of warranties. 
 
 All warranties provided by regulants as required by
 13VAC6-20-310 shall be for a period of not less than 12 months, measured
 from the date of delivery of the home to the buyer. The date of delivery
 shall be the date on which all terms or conditions of the sales contract agreed
 to or required of the regulant have been completed. 
 
 
 
 NOTICE: The forms used in administering the regulation were
 filed by the agency. The forms are not being published; however, online users
 of this issue of the Virginia Register of Regulations may click on the
 accompanying web address to access the online forms. Contact the State Building
 Codes office, (804) 371-7060 or sbco@dhcd.virginia.gov, with questions regarding the online application.
 
  
 
 FORMS (13VAC6-20)
 
 Complete license registration
 application forms for broker, dealer, manufacturer, salesperson, and special licensing online at
 https://dmz1.dhcd.virginia.gov/BFR/Main/LogOn.aspx.
 
 
 VA.R. Doc. No. R17-5104; Filed May 1, 2019, 3:25 p.m. 
TITLE 18. PROFESSIONAL AND OCCUPATIONAL LICENSING
VIRGINIA BOARD FOR ASBESTOS, LEAD, AND HOME INSPECTORS
Final Regulation
 
 Title of Regulation: 18VAC15-20. Virginia Asbestos
 Licensing Regulations (amending 18VAC15-20-10, 18VAC15-20-20,
 18VAC15-20-33, 18VAC15-20-52, 18VAC15-20-53, 18VAC15-20-454, 18VAC15-20-456,
 18VAC15-20-459.4; adding 18VAC15-20-33.1, 18VAC15-20-33.2, 18VAC15-20-456.1). 
 
 Statutory Authority: §§ 54.1-201 and 54.1-501 of
 the Code of Virginia.
 
 Effective Date: September 1, 2019. 
 
 Agency Contact: Trisha Henshaw, Executive Director,
 Virginia Board for Asbestos, Lead, and Home Inspectors, 9960 Mayland Drive,
 Suite 400, Richmond, VA 23233, telephone (804) 367-8595, FAX (866) 350-5354, or
 email alhi@dpor.virginia.gov.
 
 Summary:
 
 The amendments (i) clarify requirements for entities
 required to obtain a license for asbestos-related work by amending the
 definition of "person," the licensure requirements for asbestos
 analytical laboratories with multiple locations, the asbestos firm entry
 requirements for consistency with other similar regulations applicable to
 firms, and the information applicants need to be licensed; (ii) specify that
 firm licenses may not be transferred and are valid only so long as the business
 entity holding the license is in existence and when asbestos analytical
 laboratories must notify the board of changes to responsible personnel and
 types of analysis performed at laboratory locations; (iii) expand the responsibilities
 of asbestos project monitors to include changes to air sample reporting
 requirements; and (iv) add language (a) detailing specific entry requirements
 for asbestos contractors and asbestos analytical laboratories, respectively and
 (b) pertaining to conduct during onsite analysis. 
 
 Amendments since publication of the proposed regulation
 clarify that to qualify for onsite phase contrast microscopy analysis a
 laboratory must maintain a training and quality control document demonstrating
 the competency of each onsite analyst who performs onsite analysis. 
 
 Summary of Public Comments and Agency's Response: No
 public comments were received by the promulgating agency. 
 
 Part I 
 Scope 
 
 18VAC15-20-10. Scope. 
 
 The purpose of this section is to identify individuals and
 firms persons, as defined in 18VAC15-20-20, who need to be licensed.
 
 
 Asbestos Contractor's License: Required for firms that
 contract with another person, for compensation, to carry out an asbestos
 abatement project that exceeds 10 linear or 10 square feet. 
 
 Asbestos Worker's License: Required for individuals who remove
 or otherwise engage in an asbestos project.* 
 
 Asbestos Supervisor's License: Required for individuals who
 supervise an asbestos abatement project. The Commonwealth of Virginia National
 Emission Standards for Hazardous Air Pollutants (NESHAP) Program recognizes the
 "competent person" as an individual licensed under this
 classification.* 
 
 Asbestos Inspector's License: Required for individuals who
 inspect buildings to identify asbestos-containing material.* 
 
 Asbestos Management Planner's License: Required for
 individuals who prepare or update an asbestos management plan.* 
 
 Asbestos Project Monitor's License: Required for individuals
 who act as a project monitor on asbestos abatement sites. Project monitors
 who analyze Phase Contrast Microscopy (PCM) asbestos air samples on an asbestos
 abatement project shall be employed by a firm that holds a valid Virginia
 Asbestos Analytical Laboratory license, and shall have National Institute of
 Occupational Safety and Health (NIOSH) 582 training, or equivalent. 
 
 Asbestos Analytical Laboratory License: Required for firms
 serving as laboratories that analyze air or bulk samples for the presence
 of asbestos by Polarized Light Microscopy polarized light microscopy
 (PLM), phase contrast microscopy (PCM), or Transmission
 Electron Microscopy transmission electron microscopy (TEM). A
 laboratory that has multiple locations shall obtain an asbestos analytical
 laboratory license for the main office, and submit the remaining offices as
 branch offices in accordance with this chapter. 
 
 Asbestos Project Designer's License: Required for individuals
 who prepare or update an asbestos abatement project design, specifications for
 asbestos abatement projects, and addenda to the specifications.* 
 
 Accredited Asbestos Training Program: Required Approval
 from the board is required for those who offer asbestos training programs
 to individuals seeking licensure as an asbestos worker, supervisor, inspector,
 management planner, project monitor or project designer. 
 
 *Employees who conduct asbestos response actions, inspections,
 prepare management plans or project designs for their employer, on property
 owned or leased by the employer, are exempt from Virginia asbestos licensure;
 however, they are required to meet all OSHA and EPA training requirements. 
 
 Part II 
 Definitions and General 
 
 18VAC15-20-20. Definitions. 
 
 The following words and terms when used in this chapter shall
 have the following meanings unless the context clearly indicates otherwise: 
 
 "AAR" means the Asbestos Analyst Analysts
 Registry program offered by the AIHA Registry Programs. 
 
 "AAT" means Asbestos Analyst Testing. 
 
 [ "ACM" means asbestos-containing material. ]
 
 
 "Accredited asbestos training program" means a training
 program that has been approved by the board to provide training for individuals
 to engage in asbestos abatement, conduct asbestos inspections, prepare
 management plans, prepare project designs or act as a project monitor. 
 
 "Accredited asbestos training provider" means a
 firm or individual who has been approved by the board to offer an accredited
 asbestos training program. 
 
 "AHERA" means Asbestos Hazard Emergency Response
 Act, 40 CFR Part 763, Subpart E. 
 
 "AIHA" means American Industrial Hygiene Association.
 
 
 "Approval letter" means a written notice confirming
 the firm or individual applicant's licensure or accreditation by the board. 
 
 "Asbestos" means the asbestiform varieties of
 actinolite, amosite, anthophyllite, chrysotile, crocidolite, and tremolite. 
 
 "Asbestos Analytical Laboratory License" means an
 authorization issued by the board to perform phase contrast, polarized light,
 or transmission electron microscopy on material known or suspected to contain
 asbestos. 
 
 "Asbestos-containing material" or "ACM"
 means any material or product which contains more than 1.0% asbestos or such
 percentage as established by EPA final rule. 
 
 "Asbestos contractor" means any person who has met
 the board's requirements and has been issued an asbestos contractor's license
 by the board to enter into contracts to perform asbestos projects. 
 
 "Asbestos Contractor's License" means an
 authorization issued by the board permitting a person to enter into contracts
 to perform an asbestos abatement project. 
 
 "Asbestos inspector" means any person who performs
 an inspection as defined in this chapter. 
 
 "Asbestos Inspector's License" means an
 authorization issued by the board permitting a person to perform on-site
 onsite investigations to identify, classify, record, sample, test and
 prioritize by exposure potential asbestos-containing materials. 
 
 "Asbestos Management Plan" means a program designed
 to control or abate any potential risk to human health from asbestos. 
 
 "Asbestos management planner" means any person
 preparing or updating a management plan. 
 
 "Asbestos Management Planner's License" means an
 authorization issued by the board permitting a person to prepare or update an
 asbestos management plan. 
 
 "Asbestos project" or "asbestos abatement
 project" means an activity involving job set-up for containment, removal,
 encapsulation, enclosure, encasement, renovation, repair, construction or
 alteration of asbestos-containing materials. An asbestos project or asbestos
 abatement project shall not include nonfriable asbestos-containing roofing,
 flooring and siding material which when installed, encapsulated or removed does
 not become friable. 
 
 "Asbestos project design" means any descriptive
 form written as instructions or drafted as a plan describing the construction
 of an asbestos abatement area or site, response action or work practices to be
 utilized on the asbestos abatement project. 
 
 "Asbestos project designer" means any person
 providing an asbestos project design or specifications for an asbestos abatement
 project. 
 
 "Asbestos Project Designer's License" means an
 authorization issued by the board permitting a person to design an asbestos
 abatement project. 
 
 "Asbestos project monitor" means any person hired
 by a building owner, lessee or his agent to monitor, inspect, provide visual
 clearance or clearance monitoring of an asbestos abatement project. 
 
 "Asbestos Project Monitor's License" means an
 authorization issued by the board permitting a person to monitor an asbestos
 project, subject to board regulations. 
 
 "Asbestos supervisor" means any person so
 designated by an asbestos contractor who provides on-site onsite
 supervision and direction to the workers engaged in asbestos projects. 
 
 "Asbestos Supervisor's License" means an
 authorization issued by the board permitting an individual to supervise and
 work on an asbestos project. 
 
 "Asbestos worker" means any person who engages in
 an asbestos abatement project. 
 
 "Asbestos Worker's License" means an authorization
 issued by the board permitting an individual to work on an asbestos project. 
 
 "ASHARA" means Asbestos School Hazard Abatement
 Reauthorization Act, 40 CFR Part 763, Subpart E. 
 
 "BAPAT" means the Bulk Asbestos Proficiency
 Analytical Testing Program of the AIHA Proficiency Analytical Testing Programs.
 
 "Board" means the Virginia Board for Asbestos,
 Lead, and Home Inspectors. 
 
 "Department" means the Department of Professional
 and Occupational Regulation. 
 
 "Direct supervision" means a licensed or accredited
 inspector, management planner, project monitor or project designer, who
 undertakes to supervise the activities of an unlicensed inspector, management
 planner, project monitor or project designer, shall be physically present on
 the premises at all times while any unlicensed inspector, management planner,
 project monitor or project designer under his supervision is engaged in the
 activities of an inspector, management planner, project monitor or project
 designer. 
 
 "Director" means the Director of the Department of
 Professional and Occupational Regulation. 
 
 "Employee" means all persons in the service of
 another under any contract of hire, express or implied, oral or written. 
 
 "Encapsulation" means the treatment of
 asbestos-containing material (ACM) with a material that surrounds or embeds
 asbestos fibers in an adhesive matrix to prevent the release of fibers, as the
 encapsulant creates a membrane over the surface (bridging encapsulant) or
 penetrates the material and binds its components together (penetrating
 encapsulant). 
 
 "Encasement" means any process by which an asbestos-containing
 material (ACM) is sprayed with an insulating sealer which is then mechanically
 fastened to the asbestos covered substrate. The insulating sealer is then
 covered with a sealer to give structural strength and durability. 
 
 "Enclosure" means the construction or installation
 over or around the asbestos-containing material (ACM) of any leak tight solid
 or flexible coverings, which will not deteriorate or decompose for an extended
 period of time, so as to conceal the ACM, contain ACM fibers, and render the
 ACM inaccessible. 
 
 "Environmental remediation activity" means any
 activity planned or carried out for the purpose of reducing or eliminating any
 environmental hazard, including activities necessary to train individuals in
 the proper or lawful conduct of such activities, which are regulated by federal
 or state law or regulation. 
 
 "EPA" means United States U.S.
 Environmental Protection Agency. 
 
 "Financial interest" means financial benefit
 accruing to an individual or to a member of his immediate family. Such interest
 shall exist by reason of (i) ownership in a business if the ownership exceeds
 3.0% of the total equity of the business; (ii) annual gross income that
 exceeds, or may be reasonably anticipated to exceed $1,000 from ownership in
 real or personal property or a business; (iii) salary, other compensation,
 fringe benefits, or benefits from the use of property, or any combination of
 it, paid or provided by a business that exceeds or may be reasonably expected
 to exceed $1,000 annually; (iv) ownership of real or personal property if the
 interest exceeds $1,000 in value and excluding ownership in business, income,
 salary, other compensation, fringe benefits or benefits from the use of
 property. 
 
 "Firm" means any company, partnership, corporation,
 sole proprietorship, association, or other business entity. 
 
 "Friable" means that the material when dry, may be
 crumbled, pulverized or reduced to powder by hand pressure and includes
 previously nonfriable material after such previously nonfriable material
 becomes damaged to the extent that when dry it may be crumbled, pulverized, or
 reduced to powder by hand pressure. 
 
 "Guest instructor" means an instructor who is
 invited to instruct a specific topic or topics in an accredited asbestos
 training program and whose instruction is limited to two hours per day. 
 
 "Hands-on experience" means the physical
 participation of students in an asbestos training program. The physical
 participation includes mock sampling and inspection techniques, report
 preparation, writing project specifications, glovebag demonstrations and
 containment construction. 
 
 "IHLAP" means the Industrial Hygiene Laboratory
 Accreditation Program of the AIHA Laboratory Accreditation Programs, LLC.
 
 "IHPAT" means the Industrial Hygiene Proficiency
 Analytical Testing Program of the AIHA Proficiency Analytical Testing Programs
 [ , LLC ].
 
 "Immediate family" means (i) a spouse, (ii) a
 sibling or step sibling, (iii) a parent or step parent, (iv) children or step
 children, or (v) any other person residing in the same household as the
 individual. 
 
 "Inspection" means an activity undertaken to
 determine the presence or location, or to access the condition of, friable or
 nonfriable asbestos-containing material (ACM) or suspected ACM, whether by
 visual or physical examination, or by collecting samples of such material. This
 term includes reinspections of friable and nonfriable known or assumed ACM that
 has been previously identified. The term does not include the following: 
 
 1. Periodic surveillance of the type described in 40 CFR
 763.92(b) solely for the purpose of recording or reporting a change in the
 condition of known or assumed ACM; 
 
 2. Inspections performed by employees or agents of federal,
 state, or local governments solely for the purpose of determining compliance
 with applicable statutes or regulations; or 
 
 3. Visual inspections solely for the purpose of determining
 completion of response actions. 
 
 "Instructor" means a person who instructs one or
 more accredited asbestos training programs, to include the principal
 instructor, but excluding guest instructors. 
 
 "Licensee" means any person, as [ "person"
 is ] defined by § 54.1-500 of the Code of Virginia, who has been
 issued and holds a currently valid license as an asbestos worker, asbestos
 supervisor, asbestos inspector, asbestos management planner, asbestos project
 designer, asbestos project monitor or asbestos contractor under this chapter. 
 
 "NIOSH" means National Institute of Occupational
 Safety and Health. 
 
 "NIST" means National Institute of Standards and
 Technology. 
 
 "NVLAP" means the Asbestos Fiber Analysis
 Program of the National Institute of Standards and Technology National
 Voluntary Laboratory Accreditation Program. 
 
 "Occupied" means any area of any building designed
 or intended for human occupancy for any purpose. 
 
 "OSHA" means the U.S. Department of Labor
 Occupational Safety and Health Administration. 
 
 "OSHA Class III Work" means repair and maintenance
 operations where asbestos-containing material (ACM), including thermal system
 insulation and surfacing material, is likely to be disturbed. 
 
 "PAT" means Proficiency Analytical Testing proficiency
 analytical testing. 
 
 "PCM" means phase contrast microscopy. 
 
 "Person" means a corporation, partnership, sole
 proprietorship, firm, enterprise, franchise, association or any other firm,
 individual, or any other entity. 
 
 "PLM" means polarized light microscopy. 
 
 "Preliminary review" means a review conducted by
 the department following the submission of training materials to ascertain if
 the proposed asbestos training program meets the standards established by this
 chapter. 
 
 "Principal instructor" means an instructor whose
 main responsibility is to instruct accredited asbestos training programs,
 supervise other instructors, and manage the overall asbestos training
 program curriculum. 
 
 "Removal" means the physical removal of
 asbestos-containing material (ACM) in accordance with all applicable
 regulations. 
 
 "Renovation" means altering in any way, one or more
 facility components. 
 
 "Repair" means returning damaged
 asbestos-containing material (ACM) to an undamaged condition or to an intact
 state so as to prevent fiber release. 
 
 "Residential buildings" means site-built homes,
 modular homes, condominium units, mobile homes, manufactured housing, and
 duplexes, or other multi-unit dwellings consisting of four units or fewer that
 are currently in use or intended for use only for residential purposes. 
 
 "Response action" means any method, including
 removal, encapsulation, enclosure, encasement, or operation and maintenance,
 that protects human health and the environment from friable asbestos-containing
 material.
 
 "Responsible individual" means the employee,
 officer, manager, owner, or principal of the firm who shall be designated by
 each firm to ensure compliance with Chapter 5 (§ 54.1-500 et seq.) of
 Title 54.1 of the Code of Virginia and all regulations of the board and to
 receive communications and notices from the board that may affect the
 firm.  In the case of a sole proprietorship, the sole proprietor shall be
 the responsible individual. 
 
 "Substantial change" means a change in overall
 asbestos training program, materials, principal instructors, training managers,
 directors, ownership, facilities, equipment, examinations, and certificates of
 completion. The addition of updated regulations, exam questions or news
 articles shall not be considered a substantial change. 
 
 "TEM" means transmission electron microscopy. 
 
 "Training manager" means the individual responsible
 for administering a training program and monitoring the performance of the
 instructors. 
 
 "Visual inspection" means a process of looking for
 conditions [ , which that ] if not corrected during the
 asbestos abatement project, will lead to residual asbestos-containing dust or
 debris. Visual inspection includes examination of an asbestos abatement project
 area prior to clearance air monitoring for evidence that the project has been successfully
 completed as indicated by the absence of residue, dust and debris. 
 
 18VAC15-20-33. Qualifications General qualifications
 for licensure—business entities licensure: firms. 
 
 A. General. Every business entity shall secure a license
 before transacting business. Each firm applying for a license shall meet
 the requirements of this section.
 
 B. Name. The business name shall be disclosed on the
 application. The name under which the entity conducts business and holds itself
 out to the public (i.e., the trade or fictitious name) shall also be disclosed
 on the application. Business entities The applicant shall
 disclose the name under which the business entity conducts business and holds
 itself out to the public. The firm shall register their trade or
 fictitious names, when applicable, with the State Corporation Commission
 or the clerk of the circuit court in the county or jurisdiction locality
 where the business is to be conducted in accordance with §§ 59.1-69 through
 59.1-76 Chapter 5 (§ 59.1-69 et seq.) of Title 59.1 of the Code
 of Virginia before submitting their an application to the board. 
 
 C. Address. The applicant shall disclose the firm's
 mailing address, and the firm's physical address. A post office box is
 only acceptable as a mailing address when a physical address is also provided. 
 
 D. Form of organization. Applicants shall meet the
 additional requirements listed below in this subsection for their
 business type the firm's form of organization: 
 
 1. Corporations. All applicants Applicants shall
 have been incorporated in the Commonwealth of Virginia or, if a foreign
 corporation, shall have obtained a certificate of authority to conduct business
 in Virginia from the State Corporation Commission in accordance with §
 13.1-544.2 requirements governing corporations pursuant to Title 13.1
 of the Code of Virginia. The corporation Corporations shall be in
 good standing with the State Corporation Commission at the time of application
 to the board and at all times when the license is in effect. 
 
 2. Limited liability companies. All applicants Applicants
 shall have obtained a certificate of organization in the Commonwealth of
 Virginia or, if a foreign limited liability company, shall have obtained a
 certificate of registration to do business in Virginia from the State
 Corporation Commission in accordance with § 13.1-1105 requirements
 governing limited liability companies pursuant to Title 13.1 of the Code of
 Virginia. The company Companies shall be in good standing with
 the State Corporation Commission at the time of application to the board and at
 all times when the license is in effect. 
 
 3. Partnerships. All applicants Applicants shall
 have a written partnership agreement. The partnership agreement shall state
 that all professional asbestos abatement services of the
 partnership shall be under the direction and control of a licensed or
 certified professional the appropriate asbestos abatement licensee. 
 
 4. Sole proprietorships. Sole proprietorships desiring to
 use an assumed or fictitious name, that is, a name other than the individual's
 full name, shall have their assumed or fictitious name recorded by the clerk of
 the court of the county or jurisdiction wherein the business is to be
 conducted. 
 
 E. Qualifications. 
 
 1. Asbestos contractor. Each applicant shall hold a valid
 Virginia contractor license issued by the Virginia Board for Contractors with
 an asbestos specialty and shall be in compliance with all other requirements
 found in Chapter 11 (§ 54.1-1100 et seq.) of Title 54.1 of the Code of Virginia
 governing the regulation of contractors. 
 
 2. Asbestos analytical laboratory. Each applicant shall
 submit evidence of meeting the standards to perform one or more of the
 following analysis: 
 
 a. For PLM analysis, a current NVLAP accreditation for bulk
 asbestos fiber analysis or a current AIHA accreditation and proficiency in the
 AIHA bulk asbestos program. A copy of the NVLAP Certificate of Accreditation,
 Scope of Accreditation and documentation of NVLAP proficiency or a copy of an
 AIHA accreditation certificate and proof of proficiency in the AIHA bulk
 program shall be submitted with the application. 
 
 b. For PCM analysis: 
 
 (1) At fixed laboratory sites, a current accreditation by
 AIHA or evidence that each facility has been rated "proficient" in
 the PAT Program's most recent round of asbestos evaluations, or evidence that
 each analyst is listed or has applied for listing in the Asbestos Analyst
 Registry (AAR) and has a performance rating of "acceptable" for the
 most recent Asbestos Analyst Testing (AAT) round. Each analyst shall have
 completed the NIOSH 582 training program or equivalent. 
 
 (2) For on-site analysis, each on-site analyst shall be
 listed or shall have applied for listing in the AAR and have a performance
 rating of "acceptable" for the most recent AAT round, or is
 accredited by AIHA or has been rated "proficient" in the PAT
 Program's most recent round of asbestos evaluations. Each analyst shall have
 completed the NIOSH 582 training program or equivalent. 
 
 c. For TEM analysis, a current accreditation by NVLAP to
 analyze asbestos airborne fibers using TEM. A copy of the NVLAP Certificate of
 Accreditation, Scope of Accreditation and documentation of NVLAP proficiency
 shall be submitted with the application. 
 
 F. Conviction or guilt. Neither E. In accordance
 with § 54.1-204 of the Code of Virginia, the applicant shall disclose the
 following information about the firm nor the and its owners,
 officers or, managers, members, and directors shall have been
 convicted or found guilty, regardless of adjudication, in any jurisdiction of
 any felony or of any misdemeanor involving lying, cheating or stealing or of
 any violation while engaged in environmental remediation activity that resulted
 in the significant harm or the imminent and substantial threat of significant
 harm to human health or the environment, there being no appeal pending
 therefrom or the time of appeal having lapsed. Any plea of nolo contendre shall
 be considered a conviction for the purposes of this section. A certified copy
 of the final order, decree or case decision by a court or regulatory agency
 with lawful authority to issue such order, decree or case decision shall be
 admissible as prima facie evidence of such conviction or discipline. The board,
 at its discretion, may deny licensure to any applicant in accordance with §
 54.1-204 of the Code of Virginia, as applicable: 
 
 1. All felony convictions;
 
 2. All misdemeanor convictions involving lying, cheating,
 or stealing; and
 
 3. Any conviction resulting from engaging in environmental
 remediation activity that resulted in the significant harm or the imminent and
 substantial threat of significant harm to human health or the environment.
 
 Any plea of nolo contendre or finding of guilt, regardless
 of adjudication or deferred adjudication, shall be considered a conviction for
 the purposes of this section. The board, at its discretion, may deny licensure
 to any applicant in accordance with § 54.1-204 of the Code of Virginia.
 The applicant has the right to request further review of any such action by the
 board under the Administrative Process Act (§ 2.2-4000 et seq. of the Code
 of Virginia).
 
 G. Standards of practice and conduct. Applicants shall be
 in compliance with the standards of practice and conduct set forth
 18VAC15-20-400 through 18VAC15-20-454 and 18VAC15-20-459.2 through
 18VAC15-20-459.5 at the time of application to the board, while the application
 is under review by the board, and at all times when the license is in effect. 
 
 H. Standing. Both the firm and the owners, officers and
 directors shall be in good standing in every jurisdiction where licensed and
 the applicant shall not have had a license that was suspended, revoked or
 surrendered in connection with any disciplinary action in any jurisdiction
 prior to applying for licensure in Virginia. F. The applicant shall
 report (i) the suspension, revocation, or surrender of a license,
 certification, or registration in connection with a disciplinary action by any
 jurisdiction and (ii) whether the firm, owners, officers, managers, members, or
 directors have been the subject of discipline in any jurisdiction prior to
 applying for licensure and while the application is under review by the board.
 The board, at its discretion, may deny licensure to any an
 applicant based on disciplinary action by any jurisdiction.
 
 I. Denial of license. The board may refuse to issue a
 license to any asbestos contractor or asbestos analytical laboratory applicant
 if the applicant or its owners, officers or directors have a financial interest
 in an asbestos contractor whose asbestos license has been revoked, suspended,
 or denied renewal in any jurisdiction. 
 
 G. The board may deny the application of an applicant who
 is shown to have a substantial identity of interest with a person whose license
 or certificate has been revoked or not renewed by the board. A substantial
 identity of interest includes (i) a controlling financial interest by the
 individual or corporate principals of the person whose license or certificate
 has been revoked or has not been renewed or (ii) substantially identical
 owners, officers, managers, members, or directors, as applicable.
 
 H. An applicant shall not knowingly make a materially
 false statement, submit falsified documents, or fail to disclose a material
 fact requested in connection with an application submitted to the board. 
 
 18VAC15-20-33.1. Qualifications for asbestos contractor
 license.
 
 In addition to the requirements of 18VAC15-20-33, each
 applicant for an asbestos contractor license shall hold a valid Virginia
 contractor license issued by the Virginia Board for Contractors with an
 asbestos contracting specialty and shall be in compliance with all other
 requirements found in Chapter 11 (§ 54.1-1100 et seq.) of Title 54.1 of the
 Code of Virginia governing the regulation of contractors.
 
 18VAC15-20-33.2. Qualifications for asbestos analytical
 laboratory license.
 
 A. In addition to the requirements of 18VAC15-20-33, each
 applicant for an asbestos analytical laboratory license shall submit evidence
 of meeting the standards to perform one or more of PLM, PCM, or TEM analysis.
 
 1. For PLM analysis, one of the following:
 
 a. Current NVLAP accreditation demonstrated by submittal of
 a copy of the Certificate of Accreditation, Scope of Accreditation, and
 documentation of proficiency with the application;
 
 b. The asbestos analytical laboratory is rated
 "proficient" in the BAPAT Program and maintains the training and
 quality control document such as is necessary to demonstrate competency in
 performing analysis; or 
 
 c. The asbestos analytical laboratory is accredited under
 the IHLAP and maintains the training and quality control documentation such as
 is necessary to demonstrate competency.
 
 2. For PCM analysis, each analyst shall have completed the
 NIOSH 582 or NIOSH 582 Equivalency course. In addition, at least one of the following
 must be satisfied:
 
 a. At fixed laboratory sites, one of the following
 qualifications must be met:
 
 (1) The asbestos analytical laboratory is accredited under
 the IHLAP and maintains the training and quality control documentation such as
 is necessary to demonstrate competency;
 
 (2) The asbestos analytical laboratory is rated
 "proficient" in the IHPAT Program and maintains the training and
 quality control document such as is necessary to demonstrate competency in
 performing analysis; or
 
 (3) Each analyst is listed in the AAR and has a performance
 rating of "acceptable" for the most recent AAT round.
 
 b. For onsite analysis, one of the following qualifications
 must be met:
 
 (1) The asbestos analytical laboratory is rated
 "proficient" in the IHPAT Program and maintains the training and
 quality control document such as is necessary to demonstrate competency in
 performing onsite analysis [ for each onsite analyst ];
 
 (2) The asbestos analytical laboratory is accredited under
 the IHLAP and maintains compliance with the requirements of its accreditation,
 as well as the training and quality control document such as is necessary to
 demonstrate competency in performing [ onsite ] analysis
 [ for each onsite analyst ]; or
 
 (3) Each analyst is listed in the AAR and has a performance
 rating of "acceptable" for the most recent AAT round.
 
 3. For TEM analysis, a current accreditation by NVLAP to
 analyze asbestos airborne fibers using TEM. A copy of the NVLAP Certificate of
 Accreditation, Scope of Accreditation, and documentation of NVLAP proficiency
 shall be submitted with the application.
 
 B. The applicant shall name a responsible individual for
 the asbestos analytical laboratory.
 
 C. Any branch office of an asbestos analytical laboratory
 shall complete a branch office application from the board. Each branch office
 shall name a resident responsible individual at each branch office.
 
 D. The branch office application shall provide the
 information contained in subsection A of this section for the applicable branch
 office.
 
 E. Any of the training and quality control documentation
 required to be maintained pursuant to this section shall be provided to the
 board upon request.
 
 18VAC15-20-52. Application fees. 
 
 Application fees are set out in this section. 
 
 
  
   | Fee Type | Fee Amount | When Due | 
  
   | Application for worker,
   supervisor, inspector, management planner, project designer or project
   monitor license | $80 | With application | 
  
   | Application for asbestos
   analytical laboratory license | $120 | With application | 
  
   | Application for asbestos analytical laboratory branch office | $100 | With application | 
  
   | Application for an asbestos
   contractor license | $110 | With application | 
  
   | Application for accredited
   asbestos training program approval | $500 per day of training | With application | 
 
 
 18VAC15-20-53. Renewal and late renewal fees. 
 
 A. Renewal and late renewal fees are set out in this section.
 
 
 
  
   | Fee Type | Fee Amount | When Due | 
  
   | Renewal for worker,
   supervisor, inspector, management planner, project designer or project
   monitor license | $45 | With renewal application | 
  
   | Renewal for asbestos
   analytical laboratory license | $75 | With renewal application | 
  
   | Renewal for asbestos
   analytical laboratory branch office | $55 | With renewal application | 
  
   | Renewal for asbestos
   contractor's license | $70 | With renewal application | 
  
   | Renewal for accredited
   asbestos training program approval | $125 | With renewal application | 
  
   | Late renewal for worker,
   supervisor, inspector, management planner, project designer or project
   monitor license (includes a $35 late renewal fee in addition to the regular
   $45 renewal fee) | $80 | With renewal application | 
  
   | Late
   renewal for asbestos analytical laboratory license (includes a $35 late
   renewal fee in addition to the regular $75 renewal fee) | $110 | With
   renewal application | 
  
   | Late renewal for asbestos
   analytical laboratory branch office (includes $35 late renewal fee in
   addition to the regular $55 renewal fee) | $90 | With renewal application | 
  
   | Late renewal for asbestos
   contractor's license (includes a $35 late renewal fee in addition to the
   regular $70 renewal fee) | $105 | With renewal application | 
  
   | Late renewal for accredited
   asbestos training program approval (includes a $35 late renewal fee in
   addition to the regular $125 renewal fee) | $160 | With renewal application | 
 
 
 B. For licenses expiring after February 1, 2018, and before
 February 1, 2020, the renewal fees shall be as follows:
 
 
  
   | Renewal for worker, supervisor, inspector, management
   planner, project designer, or project monitor license | $25 | 
  
   | Renewal for asbestos analytical laboratory license | $40 | 
  
   | Renewal for asbestos contractor's license | $30 | 
  
   | Renewal for accredited asbestos training program approval | $40 | 
 
 
 For late renewals received after March 1, 2018, and on or
 before February 28, 2020, the late renewal fees shall be as follows:
 
 
  
   | Late renewal for worker, supervisor, inspector, management
   planner, project designer, or project monitor license | $60 | 
  
   | Late renewal for asbestos analytical laboratory license | $75 | 
  
   | Late renewal for asbestos contractor's license | $65 | 
  
   | Late renewal for accredited asbestos training program
   approval | $75 | 
 
 
 18VAC15-20-454. Transfer of asbestos contractor license. 
 
 The transfer of an asbestos contractor license is
 prohibited. 
 
 Asbestos contractor licenses are issued to firms as
 defined in this chapter and are not transferable. Whenever the legal firm
 holding the license is dissolved or altered to form a new firm, the original
 license becomes void and shall be returned to the board within 30 days of the
 change. Additionally, the new firm shall apply for a new license, on a form
 provided by the board, within 30 days of the change in the firm. Such changes
 include:
 
 1. Death of a sole proprietor;
 
 2. Death or withdrawal of a general partner in a general
 partnership or the managing partner in a limited partnership; 
 
 3. Termination or cancellation of a corporation or limited
 liability company; and
 
 4. Conversion, formation, or dissolution of a corporation,
 a limited liability company, or an association or any other firm recognized
 under the laws of the Commonwealth of Virginia. 
 
 18VAC15-20-456. Responsibilities. 
 
 A. Asbestos project monitors shall conduct inspections of the
 contractor's work practices and inspections of the containment. 
 
 B. Asbestos project monitors shall be present on the job site
 each day response actions are being conducted or in accordance with the
 owner-approved contractual agreement with the project monitor, shall perform
 the duties and functions established in 18VAC15-20-455, and shall maintain a
 daily log of all work performed. The daily log shall include, but not be
 limited to, inspection reports, air sampling data, type of work performed
 by the contractor, problems encountered and corrective action taken. 
 
 C. Asbestos project monitors shall take final air samples on
 all abatement projects, except for abatement projects in residential buildings.
 
 
 D. Project monitors who analyze PCM air samples on site
 shall be employed by a licensed analytical laboratory and shall be listed or
 have applied for listing in the AAR and rated "acceptable" or is
 accredited by AIHA or has been rated "proficient" in the PAT
 Program's most recent round of asbestos evaluations. The asbestos
 project monitor shall include, prior to reoccupancy, the air sample report on
 the employing asbestos analytical laboratory's letterhead in the final
 clearance report. Such report shall include the licensed asbestos project
 monitor's signature. 
 
 18VAC15-20-456.1. Onsite analysis by project monitors.
 
 Project monitors who analyze PCM air samples on site shall
 (i) be employed by a licensed asbestos analytical laboratory, (ii) have
 completed the NIOSH 582 or NIOSH 582 Equivalency Course, and (iii) satisfy one
 of the following:
 
 1. The project monitor is listed in the AAR and rated
 "acceptable" for the most recent AAT round;
 
 2. The licensed asbestos analytical laboratory employing
 the project monitor is rated as "proficient" in the IHPAT Program and
 maintains training and quality control documentation necessary to demonstrate
 competency in performing onsite analysis; or
 
 3. The licensed asbestos analytical laboratory employing the
 project monitor is accredited under the IHLAP, remains in compliance with
 accreditation requirements, and maintains training and quality control
 documentation necessary to demonstrate competency in performing onsite
 analysis.
 
 18VAC15-20-459.4. Change of status. 
 
 A. The licensee shall notify the department immediately
 within 10 days of any addition or deletion regarding employment of
 trained and experienced supervisors, and any changes regarding the signing
 officer's relationship with the company changes to the resident
 responsible individual for each laboratory location. 
 
 B. The licensee shall notify the board within 10 business
 days upon the loss of accreditation or proficiency rating by NVLAP or AIHA,
 IHLAP, or IHPAT by any laboratory location. The asbestos analytical
 laboratory shall notify the board if an employed analyst or project monitor
 performing asbestos laboratory analysis is removed from the AAR. 
 
 C. The licensee shall notify the board, in writing, if the type
 of analysis to be performed it will undertake is different
 from the type of analysis in for which the initial license was
 issued. The licensee shall submit a new application or branch office
 application, as applicable, reflecting the changes and submit evidence
 of meeting the qualifications required by this chapter to perform the
 analysis. The above information shall be submitted to the board prior to
 performing the analysis. The licensee must receive approval from the
 board prior to performing the analysis. No additional fees are required to upgrade
 amend the type of analysis performed by the analytical laboratory
 license licensee.
 
 D. The licensee shall notify the department within 10 days
 of any changes in the laboratory location.
 
 E. Asbestos analytical laboratory licenses are issued to
 firms as defined in this chapter and are not transferable. Whenever the legal
 firm holding the license is dissolved or altered to form a new firm, the
 original license becomes void and shall be returned to the board within 30 days
 of the change. Additionally, the new firm shall apply for a new license, on a
 form provided by the board, within 30 days of the change in the firm. Such
 changes include:
 
 1. Death of a sole proprietor;
 
 2. Death or withdrawal of a general partner in a general
 partnership or the managing partner in a limited partnership; 
 
 3. Termination or cancellation of a corporation or limited
 liability company; and
 
 4. Conversion, formation, or dissolution of a corporation,
 a limited liability company, or an association or any other firm recognized
 under the laws of the Commonwealth of Virginia. 
 
 
 
 NOTICE: Forms used in
 administering the regulation have been filed by the agency. The forms are not
 being published; however, online users of this issue of the Virginia Register
 of Regulations may click on the name of a form with a hyperlink to access it.
 The forms are also available from the agency contact or may be viewed at the
 Office of the Registrar of Regulations, 900 East Main Street, 11th Floor,
 Richmond, Virginia 23219. 
 
  
 
 [ FORMS (18VAC15-20) 
 
 Asbestos Worker License Application,
 A506-3301LIC-v4 (rev. 8/2015)
 
 Asbestos Supervisor License Application,
 A506-3302LIC-v4 (rev. 8/2015)
 
 Asbestos Inspector License Application,
 A506-3303LIC-v5 (rev. 8/2015)
 
 Asbestos Management Planner License Application,
 A506-3304LIC-v4 (rev. 8/2015)
 
 Asbestos Project Designer License Application,
 A506-3305LIC-v4 (rev. 8/2015)
 
 Asbestos Project Monitor License Application,
 A506-3309LIC-v5 (rev. 8/2015)
 
 Individual - Asbestos License Renewal Form,
 A506-33AREN-v4 (rev. 2/2018)
 
 Asbestos Analytical Laboratory License Renewal Form,
 A506-3333REN-v4 (rev. 2/2018)
 
 Contractor - Asbestos & Lead License Renewal Form,
 A506-33CONREN-v4 (rev. 2/2018)
 
 Asbestos
 Analytical Laboratory License Renewal/Branch Office Renewal Form,
 A506-3333REN-v4 (rev. 9/2019)
 
 Contractor
 - Asbestos & Lead License Renewal Form, A506-33CONREN-v5 (rev. 9/2019)
 
 Asbestos - Experience Verification Application,
 A506-33AEXP-v4 (rev. 8/2015)
 
 Asbestos - Education Verification Application,
 A506-33AED-v3 (rev. 8/2015)
 
 Virginia Asbestos Licensing Consumer Information Sheet,
 A506-33ACIS-v2 (rev. 8/2013)
 
 Inspector/Project Designer/Contractor Disclosure
 Form, A506-33DIS-v2 (rev. 8/2013)
 
 Asbestos Contractor License Application, A506-3306LIC-v4
 (rev. 8/2015)
 
 Asbestos Analytical Laboratory License Application,
 A506-3333LIC-v6 (rev. 8/2015)
 
 Asbestos
 Contractor License Application, A506-3306LIC-v5 (rev. 9/2019)
 
 Asbestos
 Analytical Laboratory License Application, A506-3333LIC-v7 (rev. 9/2019)
 
 Asbestos
 Analytical Laboratory - Branch Office Application, A506-3333BR-v1 (rev. 9/2019)
 
 Change
 of Laboratory Analysis Type Form, A506-3333COA-v1 (rev. 9/2019)
 
 Asbestos Training Program Review and Audit
 Application, A506-3331ACRS-v4 (rev. 8/2015)
 
 Asbestos Project Monitor - Work Experience Log,
 A506-3309EXP-v3 (rev. 8/2015) ] 
 
 VA.R. Doc. No. R17-4855; Filed May 6, 2019, 3:55 p.m. 
TITLE 18. PROFESSIONAL AND OCCUPATIONAL LICENSING
BOARD OF NURSING
Fast-Track Regulation
 
 Title of Regulation: 18VAC90-25. Regulations
 Governing Certified Nurse Aides (amending 18VAC90-25-10, 18VAC90-25-15,
 18VAC90-25-70, 18VAC90-25-71, 18VAC90-25-80 through 18VAC90-25-120; adding
 18VAC90-25-16; repealing 18VAC90-25-130, 18VAC90-25-140). 
 
 Statutory Authority: §§ 54.1-2400 and 54.1-3005 of the
 Code of Virginia.
 
 Public Hearing Information: No public hearings are
 scheduled. 
 
 Public Comment Deadline: June 26, 2019.
 
 Effective Date: July 15, 2019. 
 
 Agency Contact: Jay P. Douglas, R.N., Executive
 Director, Board of Nursing, 9960 Mayland Drive, Suite 300, Richmond, VA
 23233-1463, telephone (804) 367-4520, FAX (804) 527-4455, or email
 jay.douglas@dhp.virginia.gov.
 
 Basis: Regulations are promulgated under the general
 authority of § 54.1-2400 of the Code of Virginia. The specific statutory
 authority for registration of medication aides and approval of training
 programs is found in § 54.1-3005 of the Code of Virginia.
 
 Purpose: It is necessary to retain the current chapter
 because its provisions protect the health and safety of a vulnerable population
 of patients or clients who receive services from a nurse aide. The regulatory
 changes are consistent with the principle that regulations should be clearly
 written and easily understandable.
 
 Rationale for Using Fast-Track Rulemaking Process: As
 required by Executive Order 14 (2018), the Board of Nursing conducted a
 periodic review of this chapter. The amendments are either less restrictive and
 clarifying or intended for consistency with similar regulations for medication
 aides or nursing. There are no substantive changes, so the amendments are not
 expected to be controversial.
 
 Substance: Pursuant to its periodic review of 18VAC90-25,
 the Board of Nursing has amended regulations to clarify certain provisions,
 make some rules less burdensome, and add requirements that are necessary for
 protection of the public or clients of nurse aides. Additional requirements
 include (i) a requirement for an applicant who does not take the state
 examination within two years of approval or who fails it three times to take
 another training program; (ii) a new subsection on reinstatement after
 revocation or suspension; and (iii) repeal of 18VAC90-25-130 and 18VAC90-25-140
 and move of the requirements for an approved nurse aide advanced certification
 education program to 18VAC90-26.
 
 Issues: There are no substantive changes to the
 regulation, so there are no real advantages or disadvantages to the public. The
 consolidation of fees into one section and the nametag changes are advantageous
 to a certified nursing aide (CNA) or a person seeking registration as a CNA.
 Most of the amendments are technical and clarifying.
 
 There are no advantages or disadvantages to the agency or the
 Commonwealth, except clearer regulations may result in fewer inquiries to
 staff.
 
 Small Business Impact Review Report of Findings: This
 fast-track regulatory action serves as the report of the findings of the
 regulatory review pursuant to § 2.2-4007.1 of the Code of Virginia.
 
 Department of Planning and Budget's Economic Impact
 Analysis:
 
 Summary of the Proposed Amendments to Regulation. Pursuant to a
 periodic review,1 the Board of Nursing (Board) proposes to 1)
 require certified nurse aides (aides), who do not take the certification exam
 within two years of completing training or who fail it three times, repeat the
 training program before reapplying for certification, 2) incorporate in the
 regulations the option to send license renewal notices electronically, 3) allow
 facilities to establish their own policy for the name identification (nametags)
 of aides subject to certain requirements, and 4) clarify existing processes and
 requirements and change the location of some of the requirements.
 
 Result of Analysis. The benefits likely exceed the costs for
 all proposed changes.
 
 Estimated Economic Impact. The Board proposes to require that
 an aide who does not take the certification exam within two years of completing
 training or who fails the exam three times to repeat the training program
 before applying for certification. According to Department of Health
 Professions (DHP), it is highly unlikely that an applicant who has not taken
 the examination within two years of completion or who has failed three times
 would be able to pass the skills and written portions of the exam. Nurse aide
 training programs are usually offered by the community colleges. The training
 consists of seven credit hours and can be completed over a semester or an
 eight-week period. The costs include tuition ($1,085 -$1,140), trainee's time
 (approximately 180 hours of class time), and other costs such as background
 check, drug screen, immunizations, textbooks, uniform, stethoscope, etc. ($200
 -$300). DHP does not have an estimate on the number of individuals who may have
 to repeat training. However, the proposed change would encourage the applicants
 to achieve certification and help ensure that they are competent to perform
 their tasks.
 
 The Board also proposes to
 incorporate in the regulations the option of sending license renewal notices
 electronically as has been the current practice. Currently, licensees are
 providing an email address for the purpose of receiving notices and
 communications from the Board. As with other boards under DHP, the Board's
 renewal notices are currently being sent to the email address on record. If a
 licensee fails to renew before the renewal deadline, a paper renewal notice is
 also sent as a courtesy to the licensee.
 
 According to DHP, each paper
 renewal notice costs $0.45 ($0.38 for postage and $0.07 for tri-fold generic
 stock). Currently, there are 53,055 certified nurse aides who would likely
 renew their licenses every two years with a cost of about $11,937 per year
 which has been avoided by the electronic notifications. However, the cost
 savings from electronic notices would likely be less than this amount because
 the Board may not have an email address for some of the licensees, and a paper
 copy would still be sent if renewal does not occur 30 days prior to the
 expiration of the license. In addition to the savings, electronic notices are
 likely beneficial because they expedite the renewal process with an almost
 instantaneous delivery process and also mitigate potential issues that could
 result from the delivery of paper notices. Since the Board already sends
 electronic notices, the main impact of this change is providing consistency
 between the current practice and the regulatory text.
 
 Another amendment would replace
 the current requirement that the nametag include the aide's first and last name
 with a requirement that the facility employing the aide set the policy for
 identifying the aide on nametags. The requirement that the nametag must include
 the title under which the person is practicing would be retained. It should be
 noted that a similar change was made in the nursing regulations in response to
 a petition for rulemaking.2
 
 In a survey of 320 nurses in the
 Commonwealth conducted by the Virginia Nurses Association, 81% preferred that
 that the nametag not include their full name.3 Those supporting the
 change cited concerns for safety and stalking as reasons to establish a more
 confidential method of identification. The proposal to allow flexibility to
 employers concerning name identification on the badge would potentially be
 beneficial due to the chance that some or many employers may elect to not list
 the full name, which may reduce the occurrences of stalking and harassment of
 aides.
 
 The proposed regulations maintain
 the requirement that the nametag have the person's appropriate title, but does
 not establish a minimum criteria for name identification. An employer could
 potentially choose to not have the name on the badge at all. It seems likely
 though, that most employers would prefer to have a form of name (first name and
 last initial for example) on the badge so that patients or family members could
 correctly identify an aide.
 
 The remaining amendments would
 provide clarification to existing board processes and regulatory requirements
 and change the location of existing requirements. These amendments would not
 reflect a change in current practice and would not create any significant
 economic impact beyond adding clarity to existing processes and expectations.
 
 Businesses and Entities Affected.
 There are 53,055 certified nurse aides in the Commonwealth.
 
 Localities Particularly Affected.
 The proposed amendments would not disproportionately affect particular
 localities. 
 
 Projected Impact on Employment.
 The proposed retraining requirement would likely add to the demand for nurse
 aide educators by a small amount. Switching from paper to electronic renewal
 notices may have reduced the demand for U.S. Postal Service workers by a
 negligible amount. However, the proposed amendments are unlikely to
 significantly affect total employment.
 
 Effects on the Use and Value of
 Private Property. The proposed amendments would not significantly affect the
 use and value of private property.
 
 Real Estate Development Costs.
 The proposed amendments would 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. Most
 training programs are offered by community colleges and large health care
 entities. Thus, proposed amendments would not significantly affect small
 businesses.
 
 Alternative Method that Minimizes
 Adverse Impact. The proposed amendments would not impose adverse impact on
 small businesses.
 
 Adverse Impacts:
 
 Businesses. The proposed
 amendments would not impose adverse impact on businesses.
 
 Localities. The proposed amendments
 would not adversely affect localities.
 
 Other Entities. Switching from
 paper to electronic renewal notices may have reduced the demand for U.S. Postal
 Service workers by a negligible amount. In addition, the demand for training
 offered by community colleges and large health care institutions may increase
 by a small amount.
 
 _____________________________
 
 1http://townhall.virginia.gov/l/ViewPReview.cfm?PRid=1635
 
 2http://townhall.virginia.gov/L/ViewStage.cfm?stageid=8139
 
 3http://townhall.virginia.gov/L/viewcomments.cfm?commentid=55675
 
 Agency's Response to Economic Impact Analysis: The Board
 of Nursing concurs with the analysis of the Department of Planning and Budget.
 
 Summary:
 
 Pursuant to a periodic review of 18VAC90-25, the amendments
 (i) require certified nurse aides who do not take the certification exam within
 two years of completing training or who fail it three times to repeat the
 training program before reapplying for certification, (ii) incorporate into the
 regulations an option to send license renewal notices electronically, (iii)
 allow a facility to establish its own policy for the name identification of
 aides subject to certain requirements, (iv) add a new subsection on
 reinstatement after revocation or suspension, and (v) remove the requirements
 for an approved nurse aide advanced certification education program from this
 chapter because they are being added to 18VAC90-26.
 
 Part I 
 General Provisions
 
 18VAC90-25-10. Definitions. 
 
 The following words and terms when used in this chapter shall
 have the following meanings unless the context clearly indicates otherwise: 
 
 "Board" means the Virginia Board of Nursing. 
 
 "Client" means a person receiving the services of a
 certified nurse aide, to include a patient in a health care facility or at home
 or a resident of a long-term care facility. 
 
 "Nurse aide education program" means a program
 designed to prepare nurse aides for certification that is approved by the
 board. 
 
 18VAC90-25-15. Identification; accuracy of records.
 
 A. Any person regulated by this chapter who provides direct
 patient care shall, while on duty, wear identification that is clearly visible
 and indicates the person's first and last name and the appropriate title
 issued to such person by the board under which he is practicing in that
 setting. Any person practicing in hospital emergency departments,
 psychiatric and mental health units and programs, or in health care facilities
 units offering treatment for patients in custody of state or local
 law-enforcement agencies may use identification badges of first name and first
 letter only of last name and appropriate title. Name identification on a
 badge shall follow the policy of the facility in which the nurse aide is
 employed.
 
 B. A certificate holder who has changed his name shall submit
 as legal proof to the board a copy of the marriage certificate, a certificate
 of naturalization, or court order evidencing the change. A duplicate
 certificate shall be issued by the board upon receipt of such evidence.
 
 C. Each certificate holder shall maintain an address of
 record with the board. Any change in the address of record or in the public
 address, if different from the address of record, shall be submitted in writing
 or electronically to the board within 30 days of such change. All notices
 required by law and by this chapter to be mailed sent by the
 board to any certificate holder shall be validly given when mailed sent
 to the latest address of record on file with the board.
 
 18VAC90-25-16. Fees.
 
 A. The following fees shall apply:
 
 
  
   | 1. Annual renewal for certified nurse aide | $30 | 
  
   | 2. Returned check | $35 | 
  
   | 3. Application for certification as an advanced certified
   nurse aide 4. Renewal of advanced certified nurse aide certification 5. Reinstatement of advanced certified nurse aide
   certification | $25 $20 $30 | 
 
 
 B. Fees shall not be refunded once submitted.
 
 Part II 
 Certification of Nurse Aides 
 
 18VAC90-25-70. Initial certification for the nurse aide
 registry. 
 
 A. The executive director of the board shall issue a
 certificate as a certified nurse aide to each applicant who qualifies for such
 a certificate under §§ 54.1-3024, 54.1-3025, 54.1-3026, and 54.1-3028 of
 the Code of Virginia and provisions of this chapter.
 
 B. Nurse aide competency evaluation.
 
 1. The board may contract with a test service for the
 development and administration of a competency evaluation, which shall be a
 state examination.
 
 2. All individuals completing a nurse aide education program
 in Virginia shall successfully complete the competency evaluation state
 examination required by the board prior to being certified and to using the
 title Certified Nurse Aide.
 
 3. The board shall determine the minimum passing standard on
 the competency evaluation state examination.
 
 C. Initial certification shall be for two years.
 
 18VAC90-25-71. Certification by examination.
 
 A. To be placed on the registry and certified by
 examination, the nurse aide must:
 
 1. Have satisfactorily completed:
 
 a. A nurse aide education program approved by the board; 
 
 b. At least one clinical nursing course that includes at least
 40 hours of clinical experience involving direct client care within the past 12
 months while enrolled in a nursing education program preparing for registered
 nurse or practical nurse licensure; or 
 
 c. A nursing education program preparing for registered nurse
 licensure or practical nurse licensure;
 
 2. Pass the competency evaluation state examination
 required by the board; and
 
 3. Submit the required application and testing fee as
 prescribed by the board.
 
 B. An applicant who fails to take the board-approved
 skills and written portions of the state examination within two years of
 completion of the training or who has failed the examination in three attempts
 shall reenroll and successfully complete another approved nurse aide training
 program before reapplying.
 
 18VAC90-25-80. Renewal or reinstatement of certification. 
 
 A. Renewal of certification.
 
 1. No less than 30 days prior to the expiration date of the
 current certification, a notice for renewal shall be mailed sent
 by the board to the address of record of each currently registered
 certified nurse aide.
 
 2. The certified nurse aide shall annually submit a completed
 renewal application with the required fee of $30 and verification
 attestation of performance of nursing-related activities for
 compensation within the two years immediately preceding the expiration date.
 
 3. Failure to receive the application for renewal shall not
 relieve the certificate holder of the responsibility for renewing the certification
 by the expiration date.
 
 4. A certified nurse aide who has not performed
 nursing-related activities for compensation during the two years preceding the
 expiration date of the certification shall repeat and pass the nurse aide competency
 evaluation state examination prior to applying for recertification
 renewal of certification.
 
 5. The board shall also charge a fee of $35 for a returned
 check.
 
 B. Reinstatement of certification.
 
 1. An individual whose certification has lapsed for more than
 90 days shall submit the required application and renewal fee and provide:
 
 a. Verification of performance of nursing-related activities
 for compensation in the two years prior to the expiration date of the
 certificate and within the preceding two years; or
 
 b. Evidence of having repeated and passed the nurse aide competency
 evaluation state examination.
 
 2. An individual who has previously had a finding of abuse,
 neglect, or misappropriation of property is not eligible for
 reinstatement of his certification, except as provided in 18VAC90-25-81,
 which provides a process for removal of the finding of neglect based on a
 single occurance.
 
 C. A certified nurse aide whose certification has been
 suspended or revoked by the board and who is eligible for reinstatement may
 apply for reinstatement by filing a reinstatement application and fulfilling
 requirements of subsection B of this section. 
 
 18VAC90-25-81. Removal of a finding of neglect.
 
 A. If a finding of neglect was made against a certificate
 holder based on a single occurrence, an individual may petition for removal of
 the finding of neglect provided:
 
 1. A period of at least one year has passed since the finding
 was made; and
 
 2. The individual seeking reinstatement demonstrates
 sufficient evidence that employment and personal history do not reflect a
 pattern of abusive behavior or neglect.
 
 B. A certificate holder can petition the board only once for
 removal of a finding of neglect. 
 
 18VAC90-25-100. Disciplinary provisions for nurse aides. 
 
 The board has the authority to deny, revoke, or
 suspend a certificate issued, or to otherwise discipline a certificate holder
 upon proof that he the certificate holder has violated any of the
 provisions of § 54.1-3007 of the Code of Virginia. For the purpose of
 establishing allegations to be included in the notice of hearing, the board has
 adopted the following definitions:
 
 1. Fraud or deceit in order to procure or maintain a
 certificate shall mean, but shall not be limited to:
 
 a. Filing false credentials;
 
 b. Falsely representing facts on an application for initial
 certification, reinstatement or renewal of a certificate; or
 
 c. Giving or receiving assistance in taking the competency
 evaluation state examination.
 
 2. Unprofessional conduct shall mean, but shall not be
 limited to:
 
 a. Performing acts beyond those authorized for practice as a
 nurse aide or an advanced certified nurse aide as defined in Chapter 30 (§
 54.1-3000 et seq.) of Title 54.1 of the Code of Virginia, and beyond those
 authorized by the Drug Control Act (§ 54.1-3400 et seq. of the Code of
 Virginia) or by provisions for delegation of nursing tasks in Part X
 (18VAC90-20-420 VI (18VAC90-19-240 et seq.) of 18VAC90-20 18VAC90-19.
 
 b. Assuming duties and responsibilities within the practice of
 a nurse aide or an advanced certified nurse aide without adequate training or
 when competency has not been maintained;
 
 c. Obtaining supplies, equipment or drugs for personal or
 other unauthorized use;
 
 d. Falsifying or otherwise altering client or employer
 records, including falsely representing facts on a job application or other
 employment-related documents;
 
 e. Abusing, neglecting, or abandoning clients;
 
 f. Having been denied a license or certificate or having had a
 license or certificate issued by the board revoked or suspended;
 
 g. Giving to or accepting from a client property or money for
 any reason other than fee for service or a nominal token of appreciation;
 
 h. Obtaining money or property of a client by fraud,
 misrepresentation, or duress;
 
 i. Entering into a relationship with a client or the
 client's family that constitutes a professional boundary violation in which
 the nurse aide uses his professional position to take advantage of the
 vulnerability of a client or his family, to include but not limited to
 actions that result in personal gain at the expense of the client, an
 inappropriate personal involvement or sexual conduct with a client;
 
 j. Violating state laws relating to the privacy of client
 information, including but not limited to § 32.1-127.1:03 of the
 Code of Virginia; or
 
 k. Providing false information to staff or board members
 during the course of an investigation or proceeding.
 
 3. For the purposes of interpreting provisions of subdivision
 7 of § 54.1-3007 (7) of the Code of Virginia, a restriction on nurse
 aide certification shall be interpreted as having a finding of abuse, neglect,
 or misappropriation of patient property made in another state or being placed
 on the abuse registry in another state.
 
 Part III 
 Advanced Certification 
 
 18VAC90-25-110. Requirements for initial certification as an
 advanced certified nurse aide. 
 
 A. In order to be certified as and use the title of
 "Advanced Certified Nurse Aide," an applicant shall meet the
 following qualifications:
 
 1. Hold current certification as a certified nurse aide in
 Virginia;
 
 2. Have been certified for at least three years as a certified
 nurse aide;
 
 3. Have never had a finding of abuse, neglect, or
 misappropriation of patient property entered on a nurse aide registry in any
 jurisdiction and have not had any disciplinary actions taken by the board
 within the five years preceding application for advanced certification;
 
 4. Have a recommendation for advanced certification from a
 licensed nurse who has supervised the applicant in providing direct patient
 care for at least six months within the past year; and
 
 5. Have successfully completed a minimum of 120 hours of
 advanced training in an approved program that includes a competency evaluation
 acceptable to the board.
 
 B. An application for certification shall be accompanied by
 an application fee of $25 as specified in 18VAC90-25-16.
 
 18VAC90-25-120. Renewal and reinstatement of certification as
 an advanced certified nurse aide. 
 
 A. Current certification as a nurse aide in Virginia must be
 maintained in order to hold certification as an advanced certified nurse aide.
 
 B. Renewal. If an individual is not eligible to renew as a
 certified nurse aide, certification as an advanced certified nurse aide may not
 be renewed. An advanced certification shall be renewed concurrently with the
 renewal of the basic certification as a nurse aide in Virginia by:
 
 1. Submitting a completed renewal form and renewal fee of
 $20 as specified in 18VAC90-25-16; and
 
 2. Attesting to completion of at least three contact hours per
 year of continuing education and training in any of the competency areas
 identified in the advanced certification training program. The board may grant
 an extension or waiver of the continuing education requirement based on good
 cause shown by the certified nurse aide.
 
 C. Late renewal. An advanced certified nurse aide may renew
 certification for 90 days following the expiration date by meeting the
 requirements of subsection A of this section.
 
 D. Reinstatement. If an advanced certification has not been
 renewed for 90 days following the expiration date, it shall only be reinstated
 if the applicant for reinstatement:
 
 1. Holds current certification as a nurse aide in Virginia;
 
 2. Submits a completed reinstatement application on a form
 provided by the board;
 
 3. Pays the reinstatement fee of $30 as specified in
 18VAC90-25-16; and
 
 4. Provides evidence that he the applicant has
 completed all required hours of continuing education and training.
 
 18VAC90-25-130. Requirements for an approved advanced
 certification education program. (Repealed.)
 
 A. The advanced certification education program shall be
 approved by the Virginia Board of Nursing. An approved advanced certification
 education program shall also be an approved nurse aide education program as set
 forth in 18VAC90-25-20.
 
 B. An advanced certification education program shall
 consist of a minimum of 120 hours including a minimum of 40 hours of clinical
 skills instruction in direct client care with on-site supervision by
 instructional personnel. When nurse aides are engaged in direct client care in
 the course of advanced certification training, the ratio shall not exceed 10
 students to one instructor.
 
 C. The instructional personnel in an approved advanced
 certification education program shall meet the requirements as set forth in
 18VAC90-25-30.
 
 D. The curricula of an approved advanced certification
 education program shall, at a minimum, meet the requirements of 18VAC90-25-140.
 
 E. Each advanced certification program shall develop an
 individual record of major skills taught and the date of performance by the
 student. At the completion of the program, the program shall provide each nurse
 aide with a copy of this record and a certificate of completion.
 
 F. An advanced certification education program shall
 develop and submit to the board a competency evaluation based on the curriculum
 content required in 18VAC90-25-140. Such an evaluation shall include both a
 written test on the curriculum and an assessment of manual skills. A record of
 the reports of graduates' performance on the approved competency evaluation
 program shall be maintained for a minimum of three years.
 
 G. Program review shall be in accordance with requirements
 of 18VAC90-25-60 and shall be conducted concurrently with the on-site review of
 the basic nurse aide education program. Loss of board approval for the basic
 nurse aide education program shall automatically result in the loss of approval
 for the advanced certification education program.
 
 H. When an advanced certification education program
 closes, the provider shall notify the board of the date of closing and submit a
 list of all graduates with their date of graduation.
 
 18VAC90-25-140. Required curriculum content for an advanced
 certification education program. (Repealed.)
 
 A. An advanced certification education program shall
 include classroom and clinical instruction in the following curriculum: 
 
 1. Leadership and mentoring skills. 
 
 a. Principles of adult learning; 
 
 b. Learning styles; 
 
 c. Evaluation methods to assess learner knowledge; 
 
 d. Communication techniques and communication barriers;
 emphasizing cultural diversity of coworkers and clients; 
 
 e. Conflict management; 
 
 f. Precepting and mentoring new certified nurse aides; 
 
 g. Teamwork; 
 
 h. Contributing to care plan development and
 implementation; 
 
 i. Organizational responsibilities; and 
 
 j. Principles of documentation. 
 
 2. Care of the cognitively impaired client. 
 
 a. Signs and symptoms of dementia; 
 
 b. Concepts and techniques for addressing the unique needs
 and behaviors of individuals with dementia, including but not limited to
 agitation, combativeness, sundown syndrome, wandering, forgetfulness; 
 
 c. Basic concepts of communication with cognitively
 impaired clients, including techniques to reduce the effects of cognitive
 impairment; 
 
 d. Basic concepts of behavior management with cognitively
 impaired clients; and 
 
 e. Recognizing changes in the client's condition and
 reporting and documenting such changes. 
 
 3. Restorative care. 
 
 a. Anatomy and physiology with emphasis on the effects of
 aging; 
 
 b. Pathophysiology of common disorders of the elderly; 
 
 c. Measures to assist clients with common medical problems;
 
 
 d. Recognizing changes in the client's condition and
 reporting and documenting such changes; 
 
 e. Concepts to maintain or improve client mobility and
 ability to perform activities of daily living; and 
 
 f. Rehabilitation procedures. 
 
 4. Wound care. 
 
 a. Prevention, identification and treatment of Stage I and
 Stage II pressure ulcers; 
 
 b. Positioning; 
 
 c. Sterile and clean technique; 
 
 d. Dressing changes; 
 
 e. Concepts of hydration; 
 
 f. Nutrition and weight loss; and 
 
 g. Recognizing changes in the client's condition and
 reporting and documenting such changes. 
 
 B. Written objectives for each unit of instruction shall
 be stated in behavioral terms that are measurable and shall be reviewed with
 the students at the beginning of each unit. 
 
 VA.R. Doc. No. R19-5681; Filed April 30, 2019, 1:09 p.m. 
TITLE 18. PROFESSIONAL AND OCCUPATIONAL LICENSING
BOARD OF NURSING
Fast-Track Regulation
 
 Title of Regulation: 18VAC90-60. Regulations
 Governing the Registration of Medication Aides (amending 18VAC90-60-20, 18VAC90-60-30,
 18VAC90-60-40, 18VAC90-60-60, 18VAC90-60-70, 18VAC90-60-90, 18VAC90-60-91,
 18VAC90-60-92, 18VAC90-60-100, 18VAC90-60-120; adding 18VAC90-60-75). 
 
 Statutory Authority: §§ 54.1-2400 and 54.1-3005 of the
 Code of Virginia.
 
 Public Hearing Information: No public hearings are
 scheduled. 
 
 Public Comment Deadline: June 26, 2019.
 
 Effective Date: July 15, 2019. 
 
 Agency Contact: Jay P. Douglas, R.N., Executive
 Director, Board of Nursing, 9960 Mayland Drive, Suite 300, Richmond, VA
 23233-1463, telephone (804) 367-4520, FAX (804) 527-4455, or email
 jay.douglas@dhp.virginia.gov.
 
 Basis: Regulations are promulgated under the general authority
 of § 54.1-2400 of the Code of Virginia. The specific statutory authority for
 registration of medication aides and approval of training programs is found in
 § 54.1-3005 of the Code of Virginia.
 
 Purpose: It is necessary to retain the current chapter
 because its provisions protect the health and safety of a vulnerable population
 of residents in assisted living to whom medications are administered. The
 regulatory changes are consistent with the principle that regulations should be
 clearly written and easily understandable.
 
 Rationale for Using Fast-Track Rulemaking Process: As
 required by Executive Order 14 (2018), the Board of Nursing conducted a
 periodic review of this chapter. The amendments are either less restrictive and
 clarifying or intended for consistency with similar regulations for nurse aide
 or nursing education programs. There are no substantive changes, so the
 amendments are not expected to be controversial.
 
 Substance: Pursuant to its periodic review of
 18VAC90-60, the Board of Nursing has amended regulations to clarify certain
 provisions, make some rules less burdensome, and add requirements that are
 necessary for protection of the public or the medication aide. Additional
 requirements include (i) more information on the certificate of completion;
 (ii) a process for conditional approval or withdrawal of approval of a
 medication aide training program; (iii) a new section on reinstatement after
 revocation or suspension; and (iv) language clarifying that the board may take
 disciplinary action for any violation of the chapter, including the standards
 of practice.
 
 Issues: There are no substantive changes to the
 regulation, so there are no real advantages or disadvantages to the public. The
 additional information on a certificate of completion and the additional year
 in which the applicant has to take the examination are advantageous to a person
 seeking registration as a medication aide. Most of the amendments are technical
 and clarifying.
 
 There are no advantages or disadvantages to the agency or the
 Commonwealth, except that clearer regulations may result in fewer inquiries to
 staff.
 
 Small Business Impact Review Report of Findings: This
 fast-track regulatory action serves as the report of the findings of the
 regulatory review pursuant to § 2.2-4007.1 of the Code of Virginia.
 
 Department of Planning and Budget's Economic Impact
 Analysis:
 
 Summary of the Proposed Amendments to Regulation. Pursuant to a
 periodic review,1 the Board of Nursing (Board) proposes to 1) allow
 an additional year for medication aides (aides) to take the certification exam,
 2) add a fourth option for aides to meet the clinical training requirement, 3)
 allow assisted living facilities to establish their own policy for the name
 identification (nametags) of aides subject to certain requirements, and 4)
 clarify several existing processes and requirements.
 
 Result of Analysis. The benefits likely exceed the costs for
 all proposed changes.
 
 Estimated Economic Impact. Currently, an aide has one year to
 pass the board-approved exam for registration after completing a training
 program. Those who cannot pass the exam in one year are required to repeat
 their training. The Board proposes to allow an additional year to pass the
 exam. The additional time afforded to the applicants would likely help them
 pass the exam (in terms of providing more time to study and/or flexibility to
 find the time to prepare) and avoid the costs of repeating training for some of
 them.
 
 The Board also proposes to provide an additional option for an
 aide to document training requirements in client/patient care that would
 include a clinical nursing course with at least 40 hours of clinical experience
 in direct client care within the past 12 months. There are currently three
 pathways to provide documentation of training in client/patient care in the
 regulation; this fourth option would allow an applicant who has completed such
 a course to meet the criteria for documentation of training without incurring
 additional costs or repeating additional training in client care.
 
 Another amendment would replace the current requirement that
 the nametag include the aide's first and last name with a requirement that the
 assisted living facility employing the aide set the policy for identifying the
 aide on nametags. The requirement that the nametag must include the title under
 which the person is practicing would be retained. It should be noted that a
 similar change was made in the nursing regulations in response to a petition
 for rulemaking.2
 
 In a survey of 320 nurses in the Commonwealth conducted by the
 Virginia Nurses Association, 81% preferred that that the nametag not include
 their full name.3 Those supporting the change cited concerns for
 safety and stalking as reasons to establish a more confidential method of
 identification. The proposal to allow flexibility to employers concerning name
 identification on the badge would potentially be beneficial due to the chance
 that some or many employers may elect to not list the full name, which may
 reduce the occurrences of stalking and harassment of aides.
 
 The proposed regulation maintains the requirement that the
 nametag have the person's appropriate title, but does not establish a minimum
 criteria for name identification. An employer could potentially choose to not
 have the name on the badge at all. It seems likely though, that most employers
 would prefer to have a form of name (first name and last initial for example)
 on the badge so that patients or family members could correctly identify an
 aide.
 
 The remaining amendments would provide clarification to
 existing board processes and regulatory requirements. The Board proposes to add
 language to describe the existing process for conditional approval and
 withdrawal of approval of an aide training program. Language would also be
 added to include the instructions for reinstatement of an aide after revocation
 or suspension of a registration. The proposal would add language to specify
 that the certificate of completion issued by training providers include the
 name of the program, the board approval number, and the signature of the
 instructor. An additional amendment would clarify that disciplinary action
 would result if an aide violated any provision of this chapter, rather than
 only including the standards of practice. Although all of these processes and
 requirements are currently reflected in practice, the Board is proposing to
 clarify them in regulation due to inquiries received from training programs or
 applicants. These amendments would not reflect a change in current practice and
 would not create any significant economic impact beyond adding clarity to
 existing processes and expectations.
 
 Businesses and Entities Affected. There are 284 medication aide
 training programs and 6,595 registered medication aides in the Commonwealth.
 
 Localities Particularly Affected. The proposed amendments would
 not disproportionately affect particular localities. 
 
 Projected Impact on Employment. The proposed amendments are
 unlikely to significantly affect total employment.
 
 Effects on the Use and Value of Private Property. The proposed
 amendments would not affect the use and value of private property.
 
 Real Estate Development Costs. The proposed amendments would
 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. While some training programs are
 offered by large health care entities that include assisted living facilities,
 most are operated by small businesses. The proposed amendments would not affect
 costs for them.
 
 Alternative Method that Minimizes Adverse Impact. The proposed
 amendments would not impose adverse impact on small businesses.
 
 Adverse Impacts:
 
 Businesses. The proposed amendments would not impose adverse
 impact on businesses.
 
 Localities. The proposed amendments would not adversely affect
 localities.
 
 Other Entities. The proposed amendments would not adversely
 affect other entities.
 
 ________________________________
 
 1http://townhall.virginia.gov/l/ViewPReview.cfm?PRid=1637
 
 2http://townhall.virginia.gov/L/ViewStage.cfm?stageid=8139
 
 3http://townhall.virginia.gov/L/viewcomments.cfm?commentid=55675
 
 Agency's Response to Economic Impact Analysis: The Board
 of Nursing concurs with the analysis of the Department of Planning and Budget.
 
 Summary:
 
 Pursuant to a periodic review of 18VAC90-60, amendments
 include (i) allowing an additional year for medication aides to take the
 certification exam; (ii) adding a fourth option for aides to meet the clinical
 training requirement; (iii) allowing assisted living facilities to establish
 their own policy for the name identification of aides, subject to certain
 requirements; (iv) requiring more information on the certificate of completion
 and a process for withdrawal of approval of a medication aide training program;
 (v) adding a new section on reinstatement after revocation or suspension; and
 (vi) clarifying that the board may take disciplinary action for any violation
 of the chapter, including the standards of practice.
 
 18VAC90-60-20. Identification; accuracy of records.
 
 A. Any person regulated by this chapter shall, while on duty,
 wear identification that is clearly visible to the client and that indicates
 the person's first and last name and the appropriate title issued to
 such person by the board under which he the person is practicing
 in that setting. Name identification on a badge shall follow the policy of
 the assisted living facility in which the medication aide is employed.
 
 B. A medication aide who has changed his name shall submit as
 legal proof to the board a copy of the marriage certificate, a certificate of
 naturalization, or a court order evidencing the change. A duplicate certificate
 shall be issued by the board upon receipt of such evidence.
 
 C. A medication aide shall maintain an address of record with
 the board. Any change in the address of record or in the public address, if
 different from the address of record, shall be submitted electronically or in
 writing to the board within 30 days of such change. All notices required by law
 and by this chapter to be mailed sent by the board to any
 registrant shall be validly given when mailed sent to the latest
 address of record on file with the board.
 
 18VAC90-60-30. Fees.
 
 A. The following fees shall
 apply:
 
 
  
   | 1. Application for program approval | $500 | 
  
   | 2. Application for registration as a medication aide | $50 | 
  
   | 3. Annual renewal for medication aide | $30 | 
  
   | 4. Late renewal | $15 | 
  
   | 5. Reinstatement of registration | $90 | 
  
   | 6. Returned check | $35 | 
  
   | 7. Duplicate registration | $15 | 
  
   | 8. Reinstatement following suspension, mandatory suspension,
   or revocation | $120 | 
 
 
 B. Fees shall not be refunded once submitted.
 
 C. The fee for the competency evaluation state
 examination shall be paid directly to the examination service contracted by
 the board for its administration.
 
 D. For renewal of registration from July 1, 2017, through
 June 30, 2018, the following fee shall be in effect:
 
 
  
   | Annual renewal for medication aide
 | $22
 | 
 
 
 Part II 
 Medication Aide Training Programs 
 
 18VAC90-60-40. Establishing and maintaining a medication aide
 training program.
 
 A. Establishing a medication aide training program.
 
 1. A program provider wishing to establish a medication aide
 training program shall submit a completed application and pay the prescribed
 fee to the board at least 90 days in advance of the first expected offering of
 the program.
 
 2. Initial approval may be granted when all documentation of
 the program's compliance with requirements as set forth in this part has been
 submitted and deemed satisfactory to the board.
 
 3. If approval is denied, the applicant may request, within 30
 days of the mailing of the decision, an informal conference committee to be
 convened in accordance with § 2.2-4019 of the Code of Virginia.
 
 4. If the committee's recommendation is to deny approval, no
 further action will be required of the board unless the program requests a
 hearing before the board or a panel thereof in accordance with § 2.2-4020
 and subdivision 11 of § 54.1-2400 of the Code of Virginia. 
 
 B. Maintaining an approved medication aide training program.
 To maintain approval, the program shall:
 
 1. Continue to comply with requirements as set forth in this
 part.
 
 2. Document that the cumulative passing rate for the program's
 first-time test takers taking the competency evaluation required for
 registration over the past two years is not less than 80%.
 
 3. Report all substantive changes within 10 days of the change
 to the board to include, but not be limited to, a change in the program
 instructors, curriculum or program location.
 
 4. Cooperate with any unannounced visits to the program
 conducted by board representatives for the purpose of ensuring compliance with
 requirements for approval or in response to complaints about the program.
 
 5. Provide documentation that each student enrolled in such
 program has been given a copy of applicable Virginia law and regulation for the
 registration and practice of medication aides.
 
 6. Provide each student with a certificate of completion,
 which shall include the name of the program, the approval number provided by
 the board, and the signature of the instructor.
 
 18VAC90-60-60. Requirements for the program curriculum.
 
 A. Prerequisite for the program. A student seeking enrollment
 in a medication aide training program shall have successfully completed the
 direct care staff training required by the Department of Social Services for
 employment in an assisted living facility or an approved nurse aide education
 program.
 
 B. Hours of instruction. An approved program shall consist of
 a minimum of 68 hours of student instruction and training to include:
 
 1. At least 40 hours of classroom or didactic instruction over
 and above any facility orientation program or training in direct client care
 provided by the facility;
 
 2. At least 20 hours of supervised skills practice in
 medication administration to residents of an assisted living facility, after
 which the training program shall evaluate the student's minimal competency in
 the clinical skills of administering medications on a form provided by the
 board. Up to 20% of the supervised skills practice may be completed by a
 simulation experience in a simulation laboratory. The clinical evaluation shall
 be conducted one-on-one with a qualified instructor with experience in
 medications in long-term care; and
 
 3. An eight-hour module in facilitating client
 self-administration or assisting with the administration of insulin to include
 instruction and skills practice in the administration of insulin as specified
 in the board-approved curriculum.
 
 C. Content of the curriculum. An approved program shall use
 the curriculum developed and provided by the board, which shall, at a minimum,
 include the following topics:
 
 1. Preparing for safe administration of medications to clients
 in assisted living facilities;
 
 2. Maintaining aseptic conditions;
 
 3. Understanding of basic pharmacology;
 
 4. Facilitating client self-administration or assisting with
 medication administration;
 
 5. Following proper procedure for preparing, administering,
 and maintaining medications; and
 
 6. Following appropriate procedures for documentation and
 reporting to the licensed health care professional on duty at the facility or
 to the client's prescriber.
 
 D. In addition to the training curriculum, the program shall
 may provide one or more four-hour modules that can be used by facilities
 as refresher courses or by medication aides to satisfy requirements for
 continuing education.
 
 18VAC90-60-70. Other program requirements.
 
 A. Ratio. An approved training program shall maintain a ratio
 of no more than 10 students for one instructor for the 20 hours of supervised
 skills practice as required by 18VAC90-60-60 B.
 
 B. Records.
 
 1. Each medication aide training education program shall
 develop and maintain an individual record of major skills taught and the date
 of performance by the student. At the completion of the program, the medication
 aide must receive a copy of this record and a certificate of completion from
 the program, as specified in 18VAC90-60-40.
 
 2. A record of the reports of graduates' performance on the
 approved competency evaluation program shall be maintained.
 
 3. A record that documents the disposition of complaints
 against the program shall be maintained.
 
 4. All records required by this section shall be maintained
 for at least five years.
 
 C. Student identification. The medication aide students shall
 wear identification that clearly distinguishes them as a "medication aide
 student" while engaged in practical skills training under direct
 supervision by an instructor. Name identification shall follow the policy of
 the assisted living facility in which the medication aide is engaged in practical
 training.
 
 18VAC90-60-75. Conditional or withdrawal of approval of a
 medication aide training program.
 
 A. If the board determines that a medication aide training
 program is not maintaining the requirements of Part II (18VAC90-60-40 et seq.)
 of this chapter, the board may:
 
 1. Place the program on conditional approval with terms and
 conditions to be met within the timeframe specified by the board; or 
 
 2. Withdraw program approval.
 
 B. If the board either places a program on conditional
 approval with terms and conditions to be met within a timeframe specified by
 the board or withdraws approval, the following shall apply:
 
 1. No further action will be required of the board unless
 the program requests an informal conference pursuant to §§ 2.2-4019 and
 54.1-109 of the Code of Virginia.
 
 2. If withdrawal or continued program approval with terms
 and conditions is recommended following the informal conference, the
 recommendation shall be presented to the board or a panel of the board for
 review and action.
 
 3. If the recommendation of the informal conference
 committee is accepted by the board or a panel of the board, the decision shall
 be reflected in a board order, and no further action by the board is required
 unless the program requests a formal hearing within 30 days from entry of the
 order in accordance with § 2.2-4020 of the Code of Virginia.
 
 4. If the decision of the board or a panel of the board
 following a formal hearing is to withdraw approval or continue on conditional
 approval with terms or conditions, the program shall be advised of the right to
 appeal the decision to the appropriate circuit court in accordance with
 § 2.2-4026 of the Code of Virginia and Part 2A of the Rules of the Supreme
 Court of Virginia.
 
 Part III 
 Registration of Medication Aides 
 
 18VAC90-60-90. Requirements for initial registration.
 
 A. To be registered as a medication aide, an applicant shall:
 
 1. Provide documentation of successful completion of a:
 
 
 a. A staff training program in direct client care
 approved by the Department of Social Services, a; 
 
 b. A nursing education program, or; 
 
 c. An approved nurse aide education program, an;
 or 
 
 d. A clinical nursing course that includes at least 40
 hours of clinical experience involving direct client care within the past 12
 months; 
 
 2. Provide documentation of successful completion of one of
 the following:
 
 a. A medication aide training program approved by the board in
 accordance with this chapter; or
 
 b. A nursing education program preparing for registered nurse
 licensure or practical nurse licensure; 
 
 3. Submit the required application and fee as prescribed by
 the board;
 
 4. Disclose whether there are grounds for denial of
 registration as specified in § 54.1-3007 of the Code of Virginia; and
 
 5. Provide documentation of successful completion of competency
 evaluations consisting of:
 
 a. A clinical evaluation of minimal competency in the skills
 of administering medications as specified in 18VAC90-60-60 B 2; and
 
 b. A written examination as specified by the board with a
 passing score determined by the board.
 
 B. An applicant who fails to take the board-approved
 examination within one year two years of completion of the
 training or who has failed the examination in three attempts shall reenroll and
 successfully complete another approved medication aide training program before
 reapplying for registration.
 
 18VAC90-60-91. Requirements for provisional practice.
 
 A. An applicant for registration who wants to practice as a
 medication aide on a provisional basis shall:
 
 1. Submit the required application for registration and fee as
 prescribed by the board; and
 
 2. Provide evidence to the board of successful completion of
 the medication aide training course or a nursing education program.
 
 B. An applicant shall practice for no more than 120 days from
 the date of a letter from the board acknowledging receipt of the documentation
 required in subsection A of this section and granting provisional
 authorization.  
 
 C. An applicant acting as a medication aide under provisional
 authorization shall be identified as a "provisional medication aide"
 on a nametag worn in the facility.
 
 D. An applicant with provisional authorization shall
 immediately cease acting as a medication aide at the conclusion of the 120-day
 period or upon notification of failure after three attempts to pass the written
 examination required for registration, whichever comes first.
 
 18VAC90-60-92. Requirements for registration by endorsement.
 
 An applicant applying for registration by endorsement who has
 met the requirements for registration or certification as a medication aide in
 another state or the District of Columbia may be deemed eligible to sit for the
 competency evaluation state examination if there are no grounds
 for denial of registration as specified in § 54.1-3007 of the Code of Virginia
 and upon submission of:
 
 1. A completed application and fee; and
 
 2. Verification of registration or certification as a
 medication aide in another state or the District of Columbia that is current or
 eligible for reinstatement. 
 
 18VAC90-60-100. Renewal or reinstatement of registration.
 
 A. Renewal of registration.
 
 1. Registered medication aides shall renew by the last day of
 their birth month each year.
 
 2. The medication aide shall complete the application renewal
 notice and submit it with the required fee and an attestation that he has
 completed continuing education as required by subsection B of this section.
 
 3. Failure to receive the application notice for
 renewal shall not relieve the medication aide of the responsibility for
 renewing his registration by the expiration date.
 
 4. The registration shall automatically lapse if the
 medication aide fails to renew by the expiration date.
 
 5. Any person administering medications in an assisted living
 facility during the time a registration has lapsed shall be considered an
 illegal practitioner and shall be subject to prosecution under the provisions
 of § 54.1-3008 of the Code of Virginia.
 
 B. Continuing education required for renewal.
 
 1. In addition to hours of continuing education in direct
 client care required for employment in an assisted living facility, a
 medication aide shall have the following: 
 
 a. Four hours each year of population-specific training in
 medication administration in the assisted living facility in which the aide is
 employed; or 
 
 b. A refresher course in medication administration offered by
 an approved program.
 
 2. A medication aide shall maintain documentation of
 continuing education for a period of four years following the renewal period
 for which the records apply.
 
 3. The board shall periodically conduct a random audit of its
 registrants to determine compliance. A medication aide selected for audit shall
 provide documentation as evidence of compliance within 30 days of receiving
 notification of the audit.
 
 4. The board may grant an extension for compliance with continuing
 education requirements for up to one year, for good cause shown, upon a written
 request from the registrant prior to the renewal deadline.
 
 C. Reinstatement of registration.
 
 1. An individual whose registration has lapsed for less than
 one renewal cycle may renew by payment of the renewal fee and late fee and
 attestation that he the individual has completed all required
 continuing education for the period since his last renewal.
 
 2. An individual whose registration has lapsed for more than
 one year shall:
 
 a. Apply for reinstatement of registration by submission of a
 completed application and fee;
 
 b. Provide evidence of completion of all required continuing
 education for the period since his last renewal, not to exceed eight hours of
 training in medication administration;
 
 c. Retake the written and practical competency evaluation as
 required by the board; and
 
 d. Attest that there are no grounds for denial of registration
 as specified in § 54.1-3007 of the Code of Virginia.
 
 D. A medication aide whose registration has been suspended
 or revoked by the board may apply for reinstatement by filing a reinstatement
 application, fulfilling requirements of subsection C of this section, and
 paying the fee for reinstatement after suspension or revocation. A medication
 aide whose registration has been revoked may not apply for reinstatement sooner
 than three years from entry of the order of revocation.
 
 18VAC90-60-120. Disciplinary provisions for medication aides.
 
 The board has the authority to deny, revoke, or
 suspend a registration issued, or to otherwise discipline a registrant upon
 proof that he the registrant has violated any of the provisions
 of § 54.1-3007 of the Code of Virginia. For the purpose of establishing
 allegations to be included in the notice of hearing, the board has adopted the
 following definitions:
 
 1. Fraud or deceit in order to procure or maintain a
 registration shall mean, but shall not be limited to: 
 
 a. Filing false credentials;
 
 b. Falsely representing facts on an application for initial
 registration, reinstatement or renewal of a registration; or
 
 c. Giving or receiving assistance in taking the competency
 evaluation.
 
 2. Unprofessional conduct shall mean, but shall not be limited
 to:
 
 a. Performing acts beyond those authorized by the Code of
 Virginia and this chapter for practice as a medication aide;
 
 b. Assuming duties and responsibilities within the practice of
 a medication aide without adequate training or when competency has not been
 maintained;
 
 c. Obtaining supplies, equipment or drugs for personal or
 other unauthorized use;
 
 d. Falsifying or otherwise altering client or drug records
 relating to administration of medication;
 
 e. Falsifying or otherwise altering employer records,
 including falsely representing facts on a job application or other
 employment-related documents;
 
 f. Abusing, neglecting or abandoning clients;
 
 g. Having been denied a license, certificate, or registration
 or having had a license, certificate, or registration issued by the board
 revoked or suspended;
 
 h. Giving to or accepting from a client property or money for
 any reason other than fee for service or a nominal token of appreciation;
 
 i. Obtaining money or property of a client by fraud,
 misrepresentation or duress;
 
 j. Entering into a relationship with a client that constitutes
 a professional boundary violation in which the medication aide uses his
 professional position to take advantage of a client's vulnerability, to include
 but not limited to actions that result in personal gain at the expense
 of the client, an inappropriate personal involvement or sexual conduct with a
 client;
 
 k. Violating state laws relating to the privacy of client
 information, including but not limited to § 32.1-127.1:03 of the
 Code of Virginia;
 
 l. Failing to follow provisions of the Medication Management
 Plan for the assisted living facility in which the aide is employed; or
 
 m. Violating any provision of this chapter, including the
 standards of practice as set forth in 18VAC90-60-110.
 
 3. For the purposes of interpreting provisions of subdivision 5
 of § 54.1-3007 of the Code of Virginia, a pattern of medication errors may
 constitute practice that presents a danger to the health and welfare of clients
 or to the public.
 
 VA.R. Doc. No. R19-5680; Filed April 30, 2019, 1:10 p.m. 
TITLE 18. PROFESSIONAL AND OCCUPATIONAL LICENSING
BOARD OF PHARMACY
Final Regulation
 
 Title of Regulation: 18VAC110-20. Regulations
 Governing the Practice of Pharmacy (amending 18VAC110-20-80, 18VAC110-20-105;
 adding 18VAC110-20-22). 
 
 Statutory Authority: § 54.1-2400 of the Code of
 Virginia.
 
 Effective Date: June 26, 2019. 
 
 Agency Contact: Caroline Juran, RPh, Executive Director,
 Board of Pharmacy, 9960 Mayland Drive, Suite 300, Richmond, VA 23233-1463,
 telephone (804) 367-4456, FAX (804) 527-4472, or email
 caroline.juran@dhp.virginia.gov.
 
 Summary:
 
 The amendments require a pharmacist, pharmacy intern, or
 pharmacy technician applicant to provide an e-profile identification number
 from the National Association of Boards of Pharmacy in an application for a
 license, registration, or renewal or reinstatement of license or registration.
 
 Summary of Public Comments and Agency's Response: No
 public comments were received by the promulgating agency. 
 
 18VAC110-20-22. Application to include e-profile number.
 
 An application for licensure as a pharmacist by
 examination or endorsement or for registration as a pharmacy intern or pharmacy
 technician shall include an e-profile number issued by NABP.
 
 18VAC110-20-80. Renewal and reinstatement of license. 
 
 A. Pharmacist licenses expire on December 31 and shall be
 renewed annually prior to that date by the submission of a renewal fee, renewal
 form, an e-profile number issued by NABP, and statement of compliance
 with continuing education requirements. 
 
 B. A pharmacist newly licensed on or after October 1 shall
 not be required to renew that license until December 31 of the following year. 
 
 C. A pharmacist who fails to renew his license by the
 expiration date may renew his license at any time within one year of its expiration
 by submission of the renewal fee and late fee, renewal form, and statement of
 compliance with continuing education requirements. 
 
 D. A pharmacist who fails to renew his license for more than
 one year following expiration and who wishes to reinstate such license shall
 submit an application for reinstatement, pay the current renewal fee and a
 reinstatement fee, and submit documentation showing compliance with continuing
 education requirements. Reinstatement is at the discretion of the board and may
 be granted by the executive director of the board provided no grounds exist to
 deny said reinstatement. 
 
 E. A pharmacist who has been registered as inactive for more
 than one year must apply for reinstatement, submit documentation showing
 compliance with continuing education requirements, and pay the current year
 active renewal fee in order to resume active licensure. 
 
 F. In order to reactivate or reinstate a license to active
 status, a pharmacist who holds an inactive license, who has allowed his license
 to lapse, or who has had his license suspended or revoked must submit evidence
 of completion of CEU's or hours equal to the requirements for the number of
 years in which his license has not been active, not to exceed a total of 60
 hours of CE. 
 
 G. A pharmacist whose license has been lapsed, in inactive
 status, or suspended or revoked for more than five years shall, as a condition
 of reinstatement in addition to 60 hours CE, take and receive a passing score
 on the board-approved law examination and furnish acceptable documentation of
 one of the following: 
 
 1. Active pharmacy practice within the past five years as a
 properly licensed pharmacist in another state; or 
 
 2. Practical experience as a pharmacy intern registered with
 the board of at least 160 hours within six months immediately prior to being
 reinstated. 
 
 H. The practice of pharmacy without a current, active
 pharmacist license is unlawful and shall constitute grounds for disciplinary
 action by the board. 
 
 I. It shall be the duty and responsibility of each licensee
 to inform the board of his current address. A licensee shall notify the board
 within 14 days in writing or electronically of any change of an address of
 record. Properly updating address of record directly through the board's
 web-based application or other approved means shall constitute lawful
 notification. All notices required by law or by these rules and regulations are
 deemed to be legally given when mailed to the address of record and shall not
 relieve the licensee of the obligation to comply. 
 
 18VAC110-20-105. Renewal and reinstatement of registration. 
 
 A. Pharmacy technician registrations expire on December 31
 and shall be renewed annually prior to that date by the submission of a renewal
 fee, and renewal form, and an e-profile number issued by NABP. A
 pharmacy technician newly registered on or after July 1 shall not be required
 to renew that registration until December 31 of the following year. Failure to
 receive the application for renewal shall not relieve the pharmacy technician
 of the responsibility for renewing the registration by the expiration date. 
 
 B. A pharmacy technician who fails to renew his registration
 by the expiration date may renew his registration at any time within one year
 of its expiration by submission of the renewal fee and late fee, renewal form,
 and attestation of having obtained required continuing education. 
 
 C. A pharmacy technician who fails to renew his registration
 for more than one year following expiration and who wishes to reinstate such
 registration shall submit an application for reinstatement, pay the current
 renewal fee and a reinstatement fee, and submit documentation showing
 compliance with continuing education requirements. Reinstatement is at the
 discretion of the board and may be granted by the executive director of the
 board provided no grounds exist to deny said reinstatement. Conducting tasks
 associated with a pharmacy technician with a lapsed registration shall be
 illegal and may subject the registrant to disciplinary action by the board. 
 
 D. A person who fails to reinstate a pharmacy technician
 registration within five years of expiration, shall not be eligible for
 reinstatement and shall repeat an approved training program and repeat and pass
 the examination, or hold current PTCB certification, before applying to be
 reregistered. 
 
 VA.R. Doc. No. R18-5278; Filed April 30, 2019, 12:18 p.m. 
TITLE 18. PROFESSIONAL AND OCCUPATIONAL LICENSING
BOARD OF PHARMACY
Final Regulation
 
 
 
 REGISTRAR'S NOTICE: The
 Board of Pharmacy is claiming an exemption from Article 2 of the Administrative
 Process Act in accordance with § 2.2-4006 A 13 of the Code of Virginia,
 which exempts amendments to regulations of the board to schedule a substance in
 Schedule I or II pursuant to subsection D of § 54.1-3443 of the Code of
 Virginia. The board will receive, consider, and respond to petitions by any
 interested person at any time with respect to reconsideration or revision.
 
  
 
 Title of Regulation: 18VAC110-20. Regulations Governing
 the Practice of Pharmacy (amending 18VAC110-20-322). 
 
 Statutory Authority: §§ 54.1-2400 and 54.1-3443 of the
 Code of Virginia.
 
 Effective Date: June 26, 2019. 
 
 Agency Contact: Caroline Juran, RPh, Executive Director,
 Board of Pharmacy, 9960 Mayland Drive, Suite 300, Richmond, VA 23233-1463,
 telephone (804) 367-4456, FAX (804) 527-4472, or email
 caroline.juran@dhp.virginia.gov.
 
 Summary:
 
 The amendments add three compounds into Schedule I of the
 Drug Control Act as recommended by the Virginia Department of Forensic Science
 pursuant to § 54.1-3443 of the Code of Virginia. The compounds
 added by this regulatory action will remain in effect for 18 months or until
 the compounds are placed in Schedule I by legislative action of the General
 Assembly. 
 
 18VAC110-20-322. Placement of chemicals in Schedule I.
 
 A. Pursuant to subsection D of § 54.1-3443 of the Code of
 Virginia, the Board of Pharmacy places the following in Schedule I of the Drug
 Control Act:
 
 1. 2-(methylamino)-2-phenyl-cyclohexanone (other name:
 Deschloroketamine), its optical, position, and geometric isomers, salts, and
 salts of isomers whenever the existence of such salts, isomers, and salts of
 isomers is possible within the specific chemical designation.
 
 2. 2-methyl-1-(4-(methylthio)phenyl)-2-morpholinopropiophenone
 (other name: MMMP), its optical, position, and geometric isomers, salts, and
 salts of isomers whenever the existence of such salts, isomers, and salts of
 isomers is possible within the specific chemical designation.
 
 3. Alpha-ethylaminohexanophenone (other name:
 N-ethylhexedrone), its optical, position, and geometric isomers, salts, and
 salts of isomers whenever the existence of such salts, isomers, and salts of
 isomers is possible within the specific chemical designation.
 
 4. N-ethyl-1-(3-methoxyphenyl)cyclohexylamine (other name:
 3-methoxy-PCE), its optical, position, and geometric isomers, salts, and salts
 of isomers whenever the existence of such salts, isomers, and salts of isomers
 is possible within the specific chemical designation.
 
 5. 4-fluoro-alpha-pyrrolidinohexiophenone (other name:
 4-fluoro-alpha-PHP), its optical, position, and geometric isomers, salts, and
 salts of isomers whenever the existence of such salts, isomers, and salts of
 isomers is possible within the specific chemical designation.
 
 6. N-ethyl-1,2-diphenylethylamine (other name: Ephenidine),
 its optical, position, and geometric isomers, salts, and salts of isomers
 whenever the existence of such salts, isomers, and salts of isomers is possible
 within the specific chemical designation.
 
 7. Synthetic opioids:
 
 a.
 N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl]-1,3-benzodioxole-5-carboxamide
 (other name: Benzodioxole fentanyl), its isomers, esters, ethers, salts, and
 salts of isomers, esters, and ethers, unless specifically excepted, whenever
 the existence of these isomers, esters, ethers, and salts is possible within
 the specific chemical designation.
 
 b. 3,4-dichloro-N-[2-(diethylamino)cyclohexyl]-N-methylbenzamide
 (other name: U-49900), its isomers, esters, ethers, salts, and salts of
 isomers, esters, and ethers, unless specifically excepted, whenever the
 existence of these isomers, esters, ethers, and salts is possible within the
 specific chemical designation.
 
 c. 2-(2,4-dichlorophenyl)-N-[2-(dimethylamino)
 cyclohexyl]-N-methylacetamide (other name: U-48800), its isomers, esters,
 ethers, salts, and salts of isomers, esters, and ethers, unless specifically
 excepted, whenever the existence of these isomers, esters, ethers, and salts is
 possible within the specific chemical designation.
 
 8. Central nervous system stimulants:
 
 a. Methyl 2-(4-fluorophenyl)-2-(2-piperidinyl)acetate (other
 name: 4-fluoromethylphenidate), including its salts, isomers, and salts of
 isomers.
 
 b. Isopropyl-2-phenyl-2-(2-piperidinyl)acetate (other name:
 Isopropylphenidate), including its salts, isomers, and salts of isomers. 
 
 The placement of drugs listed in this subsection shall remain
 in effect until August 21, 2019, unless enacted into law in the Drug Control
 Act.
 
 B. Pursuant to subsection D of § 54.1-3443 of the Code of
 Virginia, the Board of Pharmacy places the following in Schedule I of the Drug
 Control Act: 
 
 1. Research chemicals: 
 
 a. 2-(ethylamino)-2-phenyl-cyclohexanone (other name:
 deschloro-N-ethyl-ketamine), its optical, position, and geometric isomers,
 salts, and salts of isomers, whenever the existence of such salts, isomers, and
 salts of isomers is possible within the specific chemical designation. 
 
 b. 3,4-methylenedioxy-N-tert-butylcathinone, its optical,
 position, and geometric isomers, salts, and salts of isomers, whenever the
 existence of such salts, isomers, and salts of isomers is possible within the
 specific chemical designation. 
 
 c. 4-fluoro-N-ethylamphetamine, its optical, position, and
 geometric isomers, salts, and salts of isomers, whenever the existence of such
 salts, isomers, and salts of isomers is possible within the specific chemical
 designation. 
 
 d. Beta-keto-4-bromo-2,5-dimethoxyphenethylamine (other name:
 bk-2C-B), its optical, position, and geometric isomers, salts, and salts of
 isomers, whenever the existence of such salts, isomers, and salts of isomers is
 possible within the specific chemical designation. 
 
 2. Synthetic opioids: 
 
 a. N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl]-2butenamide
 (other name: Crotonyl fentanyl), its isomers, esters, ethers, salts, and salts
 of isomers, esters, and ethers, unless specifically excepted, whenever the
 existence of these isomers, esters, ethers, and salts is possible within the
 specific chemical designation. 
 
 b. 2-(3,4-dichlorophenyl)-N-[2-(dimethylamino)
 cyclohexyl]-N-methylacetamide (other name: U-51754), its isomers, esters,
 ethers, salts, and salts of isomers, esters, and ethers, unless specifically
 excepted, whenever the existence of these isomers, esters, ethers, and salts is
 possible within the specific chemical designation. 
 
 c.
 N-phenyl-N-[4-phenyl-1-(2-phenylethyl)-4piperidinyl]-propanamide (other name:
 4phenylfentanyl), its isomers, esters, ethers, salts, and salts of isomers,
 esters, and ethers, unless specifically excepted, whenever the existence of
 these isomers, esters, ethers, and salts is possible within the specific
 chemical designation. 
 
 The placement of drugs listed in this subsection shall remain
 in effect until December 12, 2019, unless enacted into law in the Drug Control
 Act.
 
 C. Pursuant to subsection D of § 54.1-3443 of the Code of
 Virginia, the Board of Pharmacy places the following in Schedule I of the Drug
 Control Act:
 
 1. 2,5-dimethoxy-4-chloroamphetamine (other name: DOC), its
 optical, position, and geometric isomers, salts, and salts of isomers whenever
 the existence of such salts, isomers, and salts of isomers is possible within
 the specific chemical designation.
 
 2. Synthetic opioids:
 
 a.
 N-(2-fluorophenyl)-2-methoxy-N-[1-(2-phenylethyl)-4-piperidinyl]-acetamide
 (other name: Ocfentanil), its isomers, esters, ethers, salts, and salts of
 isomers, esters, and ethers, unless specifically excepted, whenever the
 existence of these isomers, esters, ethers, and salts is possible within the
 specific chemical designation.
 
 b.
 N-(4-methoxyphenyl)-N-[1-(2-phenylethyl)-4-piperidinyl]-butanamide (other name:
 4-methoxybutyrylfentanyl), its isomers, esters, ethers, salts, and salts of
 isomers, esters, and ethers, unless specifically excepted, whenever the
 existence of these isomers, esters, ethers, and salts is possible within the
 specific chemical designation.
 
 c.
 N-phenyl-2-methyl-N-[1-(2-phenylethyl)-4-piperidinyl]-propanamide (other name:
 Isobutyryl fentanyl), its isomers, esters, ethers, salts, and salts of isomers,
 esters, and ethers, unless specifically excepted, whenever the existence of
 these isomers, esters, ethers, and salts is possible within the specific
 chemical designation.
 
 d. N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl]-cyclopentanecarboxamide
 (other name: Cyclopentyl fentanyl), its isomers, esters, ethers, salts, and
 salts of isomers, esters, and ethers, unless specifically excepted, whenever
 the existence of these isomers, esters, ethers, and salts is possible within
 the specific chemical designation.
 
 e. N-phenyl-N-(1-methyl-4-piperidinyl)-propanamide (other
 name: N-methyl norfentanyl), its isomers, esters, ethers, salts, and salts of
 isomers, esters, and ethers, unless specifically excepted, whenever the
 existence of these isomers, esters, ethers, and salts is possible within the
 specific chemical designation.
 
 3. Cannabimimetic agent:
 1-(4-cyanobutyl)-N-(1-methyl-1-phenylethyl)-1H-indazole-3-carboxamide (other
 name: 4-cyano CUMYL-BUTINACA), its salts, isomers, and salts of isomers
 whenever the existence of such salts, isomers, and salts of isomers is possible
 within the specific chemical designation.
 
 4. Benzodiazepine: Flualprazolam, its salts, isomers, and
 salts of isomers whenever the existence of such salts, isomers, and salts of
 isomers is possible within the specific chemical designation.
 
 The placement of drugs listed in this subsection shall remain
 in effect until March 4, 2020, unless enacted into law in the Drug Control Act.
 
 D. Pursuant to subsection D of § 54.1-3443 of the Code of
 Virginia, the Board of Pharmacy places the following in Schedule I of the Drug
 Control Act:
 
 1. Synthetic opioid:
 N-[2-(dimethylamino)cyclohexyl]-N-methyl-1,3-benzodioxole-5-carboxamide (other
 names: 3,4-methylenedioxy U-47700 or 3,4-MDO-U-47700), its isomers, esters,
 ethers, salts, and salts of isomers, esters, and ethers, unless specifically
 excepted, whenever the existence of these isomers, esters, ethers, and salts is
 possible within the specific chemical designation.
 
 2. Cannabimimetic agent: N-(adamantanyl)-1-(5-chloropentyl)
 indazole-3-carboxamide (other name: 5-chloro-AKB48), its salts, isomers, and
 salts of isomers whenever the existence of such salts, isomers, and salts of
 isomers is possible within the specific chemical designation.
 
 The placement of drugs listed in this subsection shall remain
 in effect until May 27, 2020, unless enacted into law in the Drug Control Act.
 
 E. Pursuant to subsection D of § 54.1-3443 of the Code of
 Virginia, the Board of Pharmacy places the following in Schedule I of the Drug
 Control Act:
 
 1. Synthetic opioid:
 N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl]-benzamide (other names: Phenyl
 fentanyl, Benzoyl fentanyl), its isomers, esters, ethers, salts, and salts of
 isomers, esters, and ethers, unless specifically excepted, whenever the
 existence of these isomers, esters, ethers, and salts is possible within the
 specific chemical designation.
 
 2. Research chemicals:
 
 a. 4-acetyloxy-N,N-diallyltryptamine (other name: 4-AcO-DALT),
 its optical, position, and geometric isomers, salts, and salts of isomers
 whenever the existence of such salts, isomers, and salts of isomers is possible
 within the specific chemical designation.
 
 b. 4-chloro-N,N-dimethylcathinone, its optical, position, and geometric
 isomers, salts, and salts of isomers whenever the existence of such salts,
 isomers, and salts of isomers is possible within the specific chemical
 designation.
 
 c. 4-hydroxy-N,N-methylisopropyltryptamine (other name:
 4-hydroxy-MiPT), its optical, position, and geometric isomers, salts, and salts
 of isomers whenever the existence of such salts, isomers, and salts of isomers
 is possible within the specific chemical designation.
 
 d. 3,4-Methylenedioxy-alpha-pyrrolidinohexanophenone (other
 name: MDPHP), its optical, position, and geometric isomers, salts, and salts of
 isomers whenever the existence of such salts, isomers, and salts of isomers is
 possible within the specific chemical designation.
 
 3. Cannabimimetic agent: Methyl 2-[1-(5-fluoropentyl)-1H-indole-3-carboxamido]-3,3-dimethylbutanoate
 (other name: 5-Fluoro-MDMB-PICA), its salts, isomers, and salts of isomers
 whenever the existence of such salts, isomers, and salts of isomers is possible
 within the specific chemical designation.
 
 The placement of drugs listed in this subsection shall remain
 in effect until October 2, 2020, unless enacted into law in the Drug Control
 Act.
 
 F. Pursuant to subsection D of § 54.1-3443 of the Code of
 Virginia, the Board of Pharmacy places the following in Schedule I of the Drug
 Control Act:
 
 1.
 3,4-dichloro-N-[2-(dimethylamino)cyclohexyl]-N-isopropyl-benzamide (other name:
 Isopropyl U-47700), its isomers, esters, ethers, salts, and salts of isomers,
 esters, and ethers, unless specifically excepted, whenever the existence of
 these isomers, esters, ethers, and salts is possible within the specific
 chemical designation. 
 
 2. Alpha-pyrrolidinoisohexiophenone (other name:
 alpha-PiHP), its optical, position, and geometric isomers, salts, and salts of
 isomers whenever the existence of such salts, isomers, and salts of isomers is
 possible within the specific chemical designation.
 
 3. 1-[1-(3-hydroxyphenyl)cyclohexyl]piperidine (other name:
 3-hydroxy PCP), its optical, position, and geometric isomers, salts, and salts
 of isomers whenever the existence of such salts, isomers, and salts of isomers
 is possible within the specific chemical designation.
 
 The placement of drugs listed in this subsection shall
 remain in effect until December 25, 2020, unless enacted into law in the Drug
 Control Act.
 
 VA.R. Doc. No. R19-5898; Filed May 2, 2019, 8:20 a.m. 
TITLE 18. PROFESSIONAL AND OCCUPATIONAL LICENSING
BOARD OF PHARMACY
Proposed Regulation
 
 Titles of Regulations: 18VAC110-20. Regulations
 Governing the Practice of Pharmacy (amending 18VAC110-20-20, 18VAC110-20-121).
 
 18VAC110-30. Regulations for Practitioners of the Healing
 Arts to Sell Controlled Substances (amending 18VAC110-30-15).
 
 18VAC110-50. Regulations Governing Wholesale Distributors,
 Manufacturers, and Warehousers (amending 18VAC110-50-20). 
 
 Statutory Authority: §§ 54.1-2400 and 54.1-3307 of the
 Code of Virginia.
 
 Public Hearing Information:
 
 June 5, 2019 - 9:05 a.m. - Department of Health
 Professions, Perimeter Center, 9960 Mayland Drive, Suite 201, Board Room 2,
 Richmond, VA 23233
 
 Public Comment Deadline: July 26, 2019.
 
 Agency Contact: Caroline Juran, RPh, Executive Director,
 Board of Pharmacy, 9960 Mayland Drive, Suite 300, Richmond, VA 23233-1463,
 telephone (804) 367-4456, FAX (804) 527-4472, or email
 caroline.juran@dhp.virginia.gov.
 
 Basis: Regulations of the Board of Pharmacy are promulgated
 under the general authority of § 54.1-2400 of the Code of Virginia. The
 proposed regulation is mandated by § 54.1-113 of the Code of Virginia.
 
 Purpose: Fees charged to applicants and licensees of the
 Board of Pharmacy have not been increased since 2002. During that time period,
 there have been three reductions in renewal fees, in 2005, 2006 and 2009. The
 number of regulated entities has substantially increased in recent years from
 12,861 in 2002 to 37,608 in 2018, so the need for additional staff, six in 2002
 to 12 in 2018, has increased costs to the board. Additionally, the cost of
 inspections has increased, as have expenditures for investigation and
 adjudication of disciplinary cases. Enforcement inspection and investigative
 hours have increased from 7,179.30 in fiscal year (FY) 2002 to 13,220.30 in
 FY17. The number of cases adjudicated have increased from 269 in 2002 to 651 in
 2017. Additionally, the board's share of allocated expenditures has grown as
 costs to the department have increased. For example, in FY02, information
 technology costs were approximately $300,000; in FY17, they were $1.84 million.
 
 Expenditures are now projected to exceed revenues in the
 2018-2020 biennium. While the board has maintained a positive cash balance due
 to carry-over revenue, expenditures in FY18 of $3,745,630 are projected to
 exceed revenue of $3,131,895 by June 30, 2018. The imbalance will continue to
 grow in the next biennium and beyond. Therefore, the board will have a
 projected shortfall in its budget by 2021 of $648,614, which is projected to
 grow to $2,657,527 by June 30, 2022. The Board of Pharmacy must amend
 regulations as soon as possible to avoid the additional fee assessments that
 other boards had to adopt or being forced to curtail vital functions of inspection
 and investigation.
 
 Without adequate revenue to support inspections of pharmacy
 facilities, licensing, and discipline functions, applicants for licensure or
 pharmacy permits cannot be approved in a timely manner, thus depriving the
 citizens of the Commonwealth with the pharmacy services needed. Additionally,
 if there is a substantial backlog of disciplinary cases, public health and
 safety may be at risk by allowing practitioners guilty of drug diversion or
 unprofessional conduct to continue in practice for several months while
 awaiting a review and adjudication of an investigative report.
 
 Substance: The board has proposed a 30% increase in all
 fees with the exception of those functions that require an inspection,
 including an initial pharmacy permit and changes in location or remodeling.
 Those fees are set at an amount to offset the actual charge to the board by the
 enforcement division of the department.
 
 Issues: The primary advantage to the public is avoidance
 of a reduction in investigations or inspections. There are no disadvantages to
 the public. The advantage to the agency is adequate revenue to offset
 expenditures so that a growing shortfall can be avoided, which would
 necessitate a one-time assessment for all regulated entities or an additional
 fee increase. 
 
 Department of Planning and Budget's Economic Impact
 Analysis:
 
 Summary of the Proposed Amendments to Regulation. The Board of
 Pharmacy (Board) proposes to raise fees.
 
 Result of Analysis. The benefits likely1 outweigh
 the costs for the proposed amendments.
 
 Estimated Economic Impact.
 
 Background:
 
 Fees charged to applicants and licensees of the Board of
 Pharmacy have not increased since December 2002.2 During that
 period, there have been three reductions in renewal fees (2005, 2006 and 2009),
 while the rate of price inflation has been 33 percent.3 The number
 of regulated entities has substantially increased in recent years (12,861 in
 2002 to 37,608 in 2018); so the need for additional staff (six in 2002 to 12 in
 2018) has increased costs to the Board. Additionally, the cost of inspections
 has increased, as have expenditures for investigation and adjudication of
 disciplinary cases. Enforcement inspection and investigative hours have
 increased from 7,179.30 in Fiscal Year (FY) 2002 to 13,220.30 in FY 2017. The
 number of cases adjudicated have increased from 269 in 2002 to 651 in 2017.
 Additionally, the Board's share of allocated expenditures has grown as costs to
 the Department of Health Professions (DHP) have increased. For example, in FY
 2002, information technology (IT) costs were approximately $300,000; in FY
 2017, IT costs were $1.84 million.4
 
 Code of Virginia § 54.1-113.A (commonly called the
 Callahan Act)5 states that: 
 
 Following the close of any biennium, when the account for any
 regulatory board within the Department of Professional and Occupational
 Regulation or the Department of Health Professions maintained under
 § 54.1-308 or 54.1-2505 shows expenses allocated to it for
 the past biennium to be more than 10 percent greater or less than moneys
 collected on behalf of the board, it shall revise the fees levied by it for
 certification, licensure, registration, or permit and renewal thereof so that
 the fees are sufficient but not excessive to cover expenses.
 
 In FY2017, the Board's expenditures were $3,272,687, while its
 revenues were $3,293,583. DHP projects that expenditures for FY2018 will be
 $3,745,630 and revenues will be $3,131,895. Thus, total expenditures for the
 biennium are projected to be $7,018,317, with revenues projected at $6,425,478.
 The projected expenditures are 9.2 percent higher than the projected revenues.
 This being less than 10 percent, the mandate to raise fees via the Callahan Act
 is not yet triggered. Nevertheless, DHP does anticipate that expenditures will
 continue to rise faster than revenues, necessitating higher fees to cover
 costs.
 
 Proposal:
 
 The Board proposes to increase 110 different fees in this
 regulatory action, primarily those paid by pharmacists, pharmacies, pharmacist
 interns, and pharmacy technicians. In addition, the Board is also proposing fee
 increases for practitioners of the healing arts and wholesale manufacturers,
 distributors, and warehousers. The minimum dollar value of the proposed fee
 increases is $5,6 while the maximum dollar value of the proposed fee
 increases is $230.7
 
 The majority of the fees would increase by approximately thirty
 percent.8 For the fees that result from an inspection, the Board
 plans to increase the current fees to an amount to offset the actual costs of
 enforcement. There are 91 separate fees that would be subject to the roughly
 thirty percent fee increase.9 For pharmacists, these cover such
 areas as initial application fees, annual renewal fees, late fees,
 reinstatement fees, facility change and inspection fees, and the innovative
 program approval fee. For practitioners of the healing arts, these cover
 initial application fees, annual renewal fees, late fees, and reinstatement
 fees. For manufacturers and distributors, these cover application fees, renewal
 fees, late fees, and reinstatement fees. 
 
 The Board also proposes to increase the fee for facility
 permits where practitioners of the healing arts sell controlled substances,
 from $40 to $50. In addition, the Board proposes to repeal several fees related
 to humane society permits; these fees are no longer assessed since these
 facilities now pay a controlled substance registration fee. With the proposed
 fee increases, the DHP projects that the Board will have sufficient revenue to
 offset expenditures by June 30, 2021.
 
 Analysis:
 
 DHP points out that without adequate revenue to support
 inspections of pharmacy facilities, licensing and discipline functions,
 applicants for licensure or pharmacy permits cannot be approved in a timely
 manner. This may slow the growth of pharmacy services for the citizens of the
 Commonwealth. In addition, sufficient funding is needed to carry out the
 investigative and disciplinary activities of the board without creating significant
 delays in both activities.  If there is a substantial backlog of
 disciplinary cases, public health and safety may be at risk by allowing
 practitioners guilty of drug diversion, unprofessional conduct, or careless
 security to continue in practice for several months awaiting a review and
 adjudication of an investigative report. Thus, there are both clear benefits
 and clear costs introduced by the fee increases.
 
 It is not 100 percent certain whether or not the benefits
 exceed the costs. Since regulation of professions is not a market good, there
 is not an obvious market price at which speedier license processing and
 disciplinary investigations are valued. Nevertheless, since the proposed fee
 increases bring fees to approximately the same level as 15 years ago once
 inflation is taken into consideration, the benefits likely outweigh the costs.
 
 Businesses and Entities Affected. The proposed amendments
 affect all entities that and individuals who are regulated by the Board,
 including: 1,857 pharmacies, 14,714 pharmacists, 1,848 pharmacy interns, 14,552
 pharmacy technicians, 140 pharmacy technician-training programs, 727 physicians
 selling controlled substances, 175 physician selling drugs locations, 10 pilot
 programs, 2 repackaging training programs, 66 restricted manufacturers, 47
 warehousers, 116 wholesale distributors, 1,196 business controlled substance
 registrants, 9 continuing education course providers, 19 limited use pharmacy
 technicians, 258 medical equipment suppliers, 335 nonresident medical equipment
 suppliers, 26 nonresident outsourcing facilities, 732 nonresident pharmacies,
 749 nonresident wholesale distributors, 29 non-restricted manufacturers, and 1
 permitted physician.10
 
 Localities Particularly Affected. The proposed amendments do
 not disproportionately affect particular localities. 
 
 Projected Impact on Employment. The proposed fee increases are
 not likely to significantly affect employment but may at the margin discourage
 the creation of a limited number of positions at affected firms.
 
 Effects on the Use and Value of Private Property. The proposed
 fee increases moderately increase costs for affected businesses and would have
 a commensurate moderate effect on their value.
 
 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 fee increases raise costs
 for small pharmacies and other small businesses.
 
 Alternative Method that Minimizes Adverse Impact. If decision makers
 were to decide that not all current functions of the Board were necessary, or
 necessary to perform at the frequency or speed supported by the revenue that
 would be raised by the proposed fee increases, then smaller fee increases could
 potentially be set.
 
 Adverse Impacts:
 
 Businesses. The proposed fee increases raise costs for
 pharmacies, pharmacy technician-training programs, repackaging training
 programs, manufacturers, warehousers, wholesale distributors, continuing
 education course providers, medical equipment suppliers, outsourcing
 facilities, and physician practices that sell drugs.
 
 Localities. The proposed fee increases would not likely
 significantly adversely affect localities.
 
 Other Entities. The proposed fee increases would not likely
 significantly adversely affect other entities.
 
 __________________________
 
 1This is not 100 percent certain. See Analysis
 subsection for discussion.
 
 2This applies to fees that existed in 2002. There have
 been new fees introduced since then. Verification fees for the pharmacy
 professions were added in 2015 (http://townhall.virginia.gov/L/ViewAction.cfm
 ?actionid=3444), and permit fees for
 practitioners selling controlled substances were added in 2017 (http://townhall.virginia.gov/L/ViewAction.cfm?actionid=4451).
 
 3This rate of inflation is calculated using the Gross
 Domestic Product: Implicit Price Deflator. See https://fred.stlouisfed.org/series/GDPDEF
 
 4All data (other than inflation rate) provided by
 Department of Health Professions.
 
 5See https://law.lis.virginia.gov/vacode/title54.1/chapter1/section54.1-113/
 
 6Several fees are proposed to increase from $15 to $20
 (the pharmacy intern registration fee, the late fee for an inactive pharmacist
 license, and the late fee for approval of a pharmacy technician training
 program), or from $10 to $15 (the late fee for approval of a repackaging
 training program, and the duplicate license or registration fee).
 
 7Some fees would increase from $270 to $500; these
 include the pharmacy permit application fee and the permit for a physician who
 is licensed to dispense drugs. This latter fee was just introduced in 2017. See
 http://townhall.virginia.gov/l/ViewAction.cfm?actionid=4451.
 
 8The actual percentages range from 28.57 percent to
 33.33 percent for those fees that are increasing by approximately 30 percent.
 
 9For a more complete list of the proposed fee increases,
 see http://townhall.virginia.gov/L/ViewXML.cfm?textid=12504.
 
 10Data source: Department of Health Professions
 
 Agency's Response to Economic Impact Analysis: The Board
 of Pharmacy concurs with the Analysis of the Department of Planning and Budget.
 
 Summary: 
 
 The proposed amendments increase Board of Pharmacy fees to
 cover expenses for essential functions of reviewing applications, licensing,
 inspecting, investigating complaints against licensees, and adjudicating and
 monitoring disciplinary cases. The board proposes a 30% increase in all fees,
 with the exception of those functions that require an inspection, including an
 initial pharmacy permit and changes in location or remodeling, which are set at
 the actual charge to the board by the enforcement division of the Department of
 Health Professions. 
 
 18VAC110-20-20. Fees.
 
 A. Unless otherwise provided, fees listed in this section
 shall not be refundable.
 
 B. Unless otherwise provided, any fees for taking required
 examinations shall be paid directly to the examination service as specified by
 the board.
 
 C. Initial application fees. 
 
 
  
   | 1. Pharmacist license | $180$235
 | 
  
   | 2. Pharmacy intern registration | $15$20
 | 
  
   | 3. Pharmacy technician registration | $25$35
 | 
  
   | 4. Pharmacy permit | $270$500
 | 
  
   | 5. Permitted physician licensed to dispense drugs | $270$500
 | 
  
   | 6. Medical equipment supplier permit | $180$235
 | 
  
   | 7. Humane society permit
 | $20
 | 
  
   | 8.7. Outsourcing facility permit
 | $270$350
 | 
  
   | 9.8. Nonresident pharmacy registration
 | $270$350
 | 
  
   | 10.9. Nonresident outsourcing facility
   registration
 | $270$350
 | 
  
   | 11.10. Controlled substances registrations
 | $90$120
 | 
  
   | 12.11. Innovative program approval.
 If the board determines that a technical consultant is
   required in order to make a decision on approval, any consultant fee, not to
   exceed the actual cost, shall also be paid by the applicant in addition to
   the application fee. | $250$325
 | 
  
   | 13.12. Approval of a pharmacy technician
   training program
 | $150$200
 | 
  
   | 14.13. Approval of a continuing education
   program
 | $100$130
 | 
  
   | 15.14. Approval of a repackaging training
   program
 | $50$65
 | 
 
 
 D. Annual renewal fees. 
 
 
  
   | 1. Pharmacist active license – due no later than December 31 | $90$120
 | 
  
   | 2. Pharmacist inactive license – due no later than December 31 | $45$60
 | 
  
   | 3. Pharmacy technician registration – due no later than
   December 31 | $25$35
 | 
  
   | 4. Pharmacy permit – due no later than April 30 | $270$350
 | 
  
   | 5. Physician permit to practice pharmacy – due no later than
   February 28 | $270$350
 | 
  
   | 6. Medical equipment supplier permit – due no later than
   February 28 | $180$235
 | 
  
   | 7. Humane society permit – due no later than February 28
 | $20
 | 
  
   | 8.7. Outsourcing facility permit – due no later
   than April 30
 | $270$350
 | 
  
   | 9.8. Nonresident pharmacy registration – due no
   later than the date of initial registration
 | $270$350
 | 
  
   | 10.9. Nonresident outsourcing facility
   registration – due no later than the date of initial registration
 | $270$350
 | 
  
   | 11.10. Controlled substances registrations –
   due no later than February 28
 | $90$120
 | 
  
   | 12.11. Innovative program continued approval
   based on board order not to exceed$200$260 per approval
   period.
 |   | 
  
   | 13.12. Approval of a pharmacy technician
   training program
 | $75$100 every two years
 | 
  
   | 14.13. Approval of a repackaging training
   program
 | $30$40 every two years
 | 
 
 
 E. Late fees. The following late fees shall be paid in
 addition to the current renewal fee to renew an expired license within one year
 of the expiration date or within two years in the case of a pharmacy technician
 training program. In addition, engaging in activities requiring a license,
 permit, or registration after the expiration date of such license, permit, or
 registration shall be grounds for disciplinary action by the board. 
 
 
  
   | 1. Pharmacist license | $30$40
 | 
  
   | 2. Pharmacist inactive license | $15$20
 | 
  
   | 3. Pharmacy technician registration | $10$15
 | 
  
   | 4. Pharmacy permit | $90$120
 | 
  
   | 5. Physician permit to practice pharmacy | $90$120
 | 
  
   | 6. Medical equipment supplier permit | $60$80
 | 
  
   | 7. Humane society permit
 | $5
 | 
  
   | 8.7. Outsourcing facility permit
 | $90$120
 | 
  
   | 9.8. Nonresident pharmacy registration
 | $90$120
 | 
  
   | 10.9. Nonresident outsourcing facility
   registration
 | $90$120
 | 
  
   | 11.10. Controlled substances registrations
 | $30$40
 | 
  
   | 12.11. Approval of a pharmacy technician
   training program
 | $15$20
 | 
  
   | 13.12. Approval of a repackaging training
   program
 | $10$15
 | 
 
 
 F. Reinstatement fees. Any person or entity attempting to
 renew a license, permit, or registration more than one year after the
 expiration date, or more than two years after the expiration date in the case
 of a pharmacy technician training program, shall submit an application for
 reinstatement with any required fees. Reinstatement is at the discretion of the
 board and, except for reinstatement following license revocation or suspension,
 may be granted by the executive director of the board upon completion of an
 application and payment of any required fees. 
 
 
  
   | 1. Pharmacist license | $210$275
 | 
  
   | 2. Pharmacist license after revocation or suspension | $500$650
 | 
  
   | 3. Pharmacy technician registration | $35$45
 | 
  
   | 4. Pharmacy technician registration after revocation or
   suspension | $125$165
 | 
  
   | 5. Facilities or entities that cease operation and wish to
   resume shall not be eligible for reinstatement but shall apply for a new
   permit or registration. Facilities or entities that failed to renew and
   continued to operate for more than one renewal cycle shall pay the current
   and all back renewal fees for the years in which they were operating plus the
   following reinstatement fees: |   | 
  
   | a. Pharmacy permit | $240$315
 | 
  
   | b. Physician permit to practice pharmacy | $240$315
 | 
  
   | c. Medical equipment supplier permit | $210$275
 | 
  
   | d. Humane society permit
 | $30
 | 
  
   | e.d. Outsourcing facility permit
 | $240$315
 | 
  
   | f.e. Nonresident pharmacy registration
 | $115$150
 | 
  
   | g.f. Nonresident outsourcing facility
   registration
 | $240$315
 | 
  
   | h.g. Controlled substances registration
 | $180$235
 | 
  
   | i.h. Approval of a pharmacy technician
   training program
 | $75$100
 | 
  
   | j.i. Approval of a repackaging training
   program
 | $50$65
 | 
 
 
 G. Application for change or inspection fees for facilities
 or other entities. 
 
 
  
   | 1. Change of pharmacist-in-charge | $50$65
 | 
  
   | 2. Change of ownership for any facility | $50$65
 | 
  
   | 3. Inspection for remodeling or
   change of location for any facility | $150$300
 | 
  
   | 4. Reinspection of any facility | $150$300
 | 
  
   | 5. Board-required inspection
   for a robotic pharmacy system | $150$300
 | 
  
   | 6. Board-required inspection of an innovative program location | $150$300
 | 
  
   | 7. Change of pharmacist responsible for an approved innovative
   program | $25$35
 | 
 
 
 H. Miscellaneous fees. 
 
 
  
   | 1. Duplicate wall certificate | $25$50
 | 
  
   | 2. Returned check | $35 | 
  
   | 3. Duplicate license or registration | $10$15
 | 
  
   | 4. Verification of licensure or registration | $25$35
 | 
 
 
 18VAC110-20-121. Innovative program approval. 
 
 A. An informal conference committee of the board may approve
 an innovative or pilot program in accordance with § 54.1-3307.2 of the Code of
 Virginia upon receipt of an application and fee specified in 18VAC110-20-20. 
 
 B. If the informal conference committee determines that an
 inspection is necessary to adequately consider an application, it may require
 that the applicant pay a fee specified in 18VAC110-20-20 to cover the cost of
 the inspection. 
 
 C. If the informal conference committee determines that a
 technical consultant is necessary in order for the board to make an informed
 decision on approval of a program, the applicant shall pay a consultant fee,
 not to exceed the actual cost of the consultation. 
 
 D. In the initial order granting approval of a program, the
 informal conference committee shall set the approval period with a schedule for
 submission of required reports and outcome data. The frequency of required
 reports shall not exceed four times a year. 
 
 E. The informal conference committee shall determine the
 appropriate fee for continued approval of the program based on the requirements
 for review and monitoring. Such renewal fee shall not exceed $200 $260
 per approval period. 
 
 18VAC110-30-15. Fees. 
 
 A. Unless otherwise provided, fees listed in this section
 shall not be refundable. 
 
 B. Initial application fees.
 
 1. License for practitioner of the healing arts to sell
 controlled substances: $180 $235.
 
 2. Permit for facility in which practitioners of the healing
 arts sell controlled substances: $240 $315.
 
 C. Annual renewal fees.
 
 1. License for practitioner of the healing arts to sell
 controlled substances: $90 $120.
 
 2. Permit for facility in which practitioners of the healing
 arts sell controlled substances: $240 $315.
 
 D. Late fees. The following late fees shall be paid in
 addition to the current renewal fee to renew an expired license within one year
 of the expiration date.
 
 1. License for practitioner of the healing arts to sell
 controlled substances: $30 $40.
 
 2. Permit for facility in which practitioners of the healing
 arts sell controlled substances: $40 $50.
 
 E. Reinstatement fees. Any person or entity attempting to
 renew a license or permit more than one year after the expiration date shall
 submit an application for reinstatement with any required fees.
 
 1. License for practitioner of the healing arts to sell
 controlled substances: $150 $195.
 
 2. Permit for facility in which practitioners of the healing
 arts sell controlled substances: $240 $315.
 
 3. Application fee for reinstatement of a license or permit
 that has been revoked or suspended indefinitely: $500 $650.
 
 F. Facilities in which only one practitioner of the healing
 arts is licensed by the board to sell controlled substances shall be exempt
 from fees associated with obtaining and renewing a facility permit. Facilities
 that change from only one practitioner to more than one shall notify the board
 within 30 days of such change. 
 
 G. The fee for reinspection of any facility shall be $150
 300. 
 
 H. The fee for a returned check shall be $35. 
 
 18VAC110-50-20. Fees. 
 
 A. Unless otherwise provided, fees listed in this section
 shall not be refundable. 
 
 B. Initial application fees. 
 
 
  
   | 1. Nonrestricted manufacturer
   permit | $270$350
 | 
  
   | 2. Restricted manufacturer
   permit | $180$235
 | 
  
   | 3. Wholesale distributor license | $270$350
 | 
  
   | 4. Warehouser permit | $270$350
 | 
  
   | 5. Nonresident wholesale
   distributor registration | $270$350
 | 
  
   | 6. Controlled substances
   registration | $90$120
 | 
  
   | 7. Third-party logistics
   provider permit | $270$350
 | 
  
   | 8. Nonresident manufacturer
   registration | $270$350
 | 
  
   | 9. Nonresident warehouser
   registration | $270$350
 | 
  
   | 10. Nonresident third-party
   logistics provider registration | $270$350
 | 
 
 
 C. Annual renewal fees shall be due on February 28 of each
 year. 
 
 
  
   | 1. Nonrestricted manufacturer permit | $270$350
 | 
  
   | 2. Restricted manufacturer permit | $180$235
 | 
  
   | 3. Wholesale distributor license | $270$350
 | 
  
   | 4. Warehouser permit | $270$350
 | 
  
   | 5. Nonresident wholesale distributor registration | $270$350
 | 
  
   | 6. Controlled substances registration | $90$120
 | 
  
   | 7. Third-party logistics provider permit | $270$350
 | 
  
   | 8. Nonresident manufacturer registration | $270$350
 | 
  
   | 9. Nonresident warehouser registration | $270$350
 | 
  
   | 10. Nonresident third-party logistics provider registration | $270$350
 | 
 
 
 D. Late fees. The following late fees shall be paid in
 addition to the current renewal fee to renew an expired license within one year
 of the expiration date. In addition, engaging in activities requiring a
 license, permit, or registration after the expiration date of such license,
 permit, or registration shall be grounds for disciplinary action by the board. 
 
 
  
   | 1. Nonrestricted manufacturer permit | $90$120
 | 
  
   | 2. Restricted manufacturer permit | $60$80
 | 
  
   | 3. Wholesale distributor license | $90$120
 | 
  
   | 4. Warehouser permit | $90$120
 | 
  
   | 5. Nonresident wholesale distributor registration | $90$120
 | 
  
   | 6. Controlled substances registration | $30$40
 | 
  
   | 7. Third-party logistics provider permit | $90$120
 | 
  
   | 8. Nonresident manufacturer registration | $90$120
 | 
  
   | 9. Nonresident warehouser registration | $90$120
 | 
  
   | 10. Nonresident third-party logistics provider registration | $90$120
 | 
 
 
 E. Reinstatement fees. 
 
 1. Any entity attempting to renew a license, permit, or
 registration more than one year after the expiration date shall submit an
 application for reinstatement with any required fees. Reinstatement is at the
 discretion of the board and, except for reinstatement following license
 revocation or suspension, may be granted by the executive director of the board
 upon completion of an application and payment of any required fees. 
 
 2. Engaging in activities requiring a license, permit, or
 registration after the expiration date of such license, permit, or registration
 shall be grounds for disciplinary action by the board. Facilities or entities
 that cease operation and wish to resume shall not be eligible for reinstatement,
 but shall apply for a new permit or registration. 
 
 3. Facilities or entities that failed to renew and continued
 to operate for more than one renewal cycle shall pay the current and all back
 renewal fees for the years in which they were operating plus the following
 reinstatement fees: 
 
 
  
   | a. Nonrestricted manufacturer permit | $240$315
 | 
  
   | b. Restricted manufacturer permit | $210$275
 | 
  
   | c. Wholesale distributor license | $240$315
 | 
  
   | d. Warehouser permit | $240$315
 | 
  
   | e. Nonresident wholesale distributor registration | $240$315
 | 
  
   | f. Controlled substances registration | $180$235
 | 
  
   | g. Third-party logistics provider permit | $240$315
 | 
  
   | h. Nonresident manufacturer registration | $240$315
 | 
  
   | i. Nonresident warehouser registration | $240$315
 | 
  
   | j. Nonresident third-party logistics provider registration | $240$315
 | 
 
 
 F. Application for change or inspection fees. 
 
 
  
   | 1. Reinspection fee | $150$300
 | 
  
   | 2. Inspection fee for change of location, structural changes,
   or security system changes | $150$300
 | 
  
   | 3. Change of ownership fee | $50$65
 | 
  
   | 4. Change of responsible party | $50$65
 | 
 
 
 G. The fee for a returned check shall be $35. 
 
 H. The fee for verification of license, permit, or
 registration shall be $25 $35.
 
 VA.R. Doc. No. R18-5322; Filed May 8, 2019, 2:58 p.m. 
TITLE 18. PROFESSIONAL AND OCCUPATIONAL LICENSING
BOARD OF PHARMACY
Proposed Regulation
 
 Titles of Regulations: 18VAC110-20. Regulations
 Governing the Practice of Pharmacy (amending 18VAC110-20-20, 18VAC110-20-121).
 
 18VAC110-30. Regulations for Practitioners of the Healing
 Arts to Sell Controlled Substances (amending 18VAC110-30-15).
 
 18VAC110-50. Regulations Governing Wholesale Distributors,
 Manufacturers, and Warehousers (amending 18VAC110-50-20). 
 
 Statutory Authority: §§ 54.1-2400 and 54.1-3307 of the
 Code of Virginia.
 
 Public Hearing Information:
 
 June 5, 2019 - 9:05 a.m. - Department of Health
 Professions, Perimeter Center, 9960 Mayland Drive, Suite 201, Board Room 2,
 Richmond, VA 23233
 
 Public Comment Deadline: July 26, 2019.
 
 Agency Contact: Caroline Juran, RPh, Executive Director,
 Board of Pharmacy, 9960 Mayland Drive, Suite 300, Richmond, VA 23233-1463,
 telephone (804) 367-4456, FAX (804) 527-4472, or email
 caroline.juran@dhp.virginia.gov.
 
 Basis: Regulations of the Board of Pharmacy are promulgated
 under the general authority of § 54.1-2400 of the Code of Virginia. The
 proposed regulation is mandated by § 54.1-113 of the Code of Virginia.
 
 Purpose: Fees charged to applicants and licensees of the
 Board of Pharmacy have not been increased since 2002. During that time period,
 there have been three reductions in renewal fees, in 2005, 2006 and 2009. The
 number of regulated entities has substantially increased in recent years from
 12,861 in 2002 to 37,608 in 2018, so the need for additional staff, six in 2002
 to 12 in 2018, has increased costs to the board. Additionally, the cost of
 inspections has increased, as have expenditures for investigation and
 adjudication of disciplinary cases. Enforcement inspection and investigative
 hours have increased from 7,179.30 in fiscal year (FY) 2002 to 13,220.30 in
 FY17. The number of cases adjudicated have increased from 269 in 2002 to 651 in
 2017. Additionally, the board's share of allocated expenditures has grown as
 costs to the department have increased. For example, in FY02, information
 technology costs were approximately $300,000; in FY17, they were $1.84 million.
 
 Expenditures are now projected to exceed revenues in the
 2018-2020 biennium. While the board has maintained a positive cash balance due
 to carry-over revenue, expenditures in FY18 of $3,745,630 are projected to
 exceed revenue of $3,131,895 by June 30, 2018. The imbalance will continue to
 grow in the next biennium and beyond. Therefore, the board will have a
 projected shortfall in its budget by 2021 of $648,614, which is projected to
 grow to $2,657,527 by June 30, 2022. The Board of Pharmacy must amend
 regulations as soon as possible to avoid the additional fee assessments that
 other boards had to adopt or being forced to curtail vital functions of inspection
 and investigation.
 
 Without adequate revenue to support inspections of pharmacy
 facilities, licensing, and discipline functions, applicants for licensure or
 pharmacy permits cannot be approved in a timely manner, thus depriving the
 citizens of the Commonwealth with the pharmacy services needed. Additionally,
 if there is a substantial backlog of disciplinary cases, public health and
 safety may be at risk by allowing practitioners guilty of drug diversion or
 unprofessional conduct to continue in practice for several months while
 awaiting a review and adjudication of an investigative report.
 
 Substance: The board has proposed a 30% increase in all
 fees with the exception of those functions that require an inspection,
 including an initial pharmacy permit and changes in location or remodeling.
 Those fees are set at an amount to offset the actual charge to the board by the
 enforcement division of the department.
 
 Issues: The primary advantage to the public is avoidance
 of a reduction in investigations or inspections. There are no disadvantages to
 the public. The advantage to the agency is adequate revenue to offset
 expenditures so that a growing shortfall can be avoided, which would
 necessitate a one-time assessment for all regulated entities or an additional
 fee increase. 
 
 Department of Planning and Budget's Economic Impact
 Analysis:
 
 Summary of the Proposed Amendments to Regulation. The Board of
 Pharmacy (Board) proposes to raise fees.
 
 Result of Analysis. The benefits likely1 outweigh
 the costs for the proposed amendments.
 
 Estimated Economic Impact.
 
 Background:
 
 Fees charged to applicants and licensees of the Board of
 Pharmacy have not increased since December 2002.2 During that
 period, there have been three reductions in renewal fees (2005, 2006 and 2009),
 while the rate of price inflation has been 33 percent.3 The number
 of regulated entities has substantially increased in recent years (12,861 in
 2002 to 37,608 in 2018); so the need for additional staff (six in 2002 to 12 in
 2018) has increased costs to the Board. Additionally, the cost of inspections
 has increased, as have expenditures for investigation and adjudication of
 disciplinary cases. Enforcement inspection and investigative hours have
 increased from 7,179.30 in Fiscal Year (FY) 2002 to 13,220.30 in FY 2017. The
 number of cases adjudicated have increased from 269 in 2002 to 651 in 2017.
 Additionally, the Board's share of allocated expenditures has grown as costs to
 the Department of Health Professions (DHP) have increased. For example, in FY
 2002, information technology (IT) costs were approximately $300,000; in FY
 2017, IT costs were $1.84 million.4
 
 Code of Virginia § 54.1-113.A (commonly called the
 Callahan Act)5 states that: 
 
 Following the close of any biennium, when the account for any
 regulatory board within the Department of Professional and Occupational
 Regulation or the Department of Health Professions maintained under
 § 54.1-308 or 54.1-2505 shows expenses allocated to it for
 the past biennium to be more than 10 percent greater or less than moneys
 collected on behalf of the board, it shall revise the fees levied by it for
 certification, licensure, registration, or permit and renewal thereof so that
 the fees are sufficient but not excessive to cover expenses.
 
 In FY2017, the Board's expenditures were $3,272,687, while its
 revenues were $3,293,583. DHP projects that expenditures for FY2018 will be
 $3,745,630 and revenues will be $3,131,895. Thus, total expenditures for the
 biennium are projected to be $7,018,317, with revenues projected at $6,425,478.
 The projected expenditures are 9.2 percent higher than the projected revenues.
 This being less than 10 percent, the mandate to raise fees via the Callahan Act
 is not yet triggered. Nevertheless, DHP does anticipate that expenditures will
 continue to rise faster than revenues, necessitating higher fees to cover
 costs.
 
 Proposal:
 
 The Board proposes to increase 110 different fees in this
 regulatory action, primarily those paid by pharmacists, pharmacies, pharmacist
 interns, and pharmacy technicians. In addition, the Board is also proposing fee
 increases for practitioners of the healing arts and wholesale manufacturers,
 distributors, and warehousers. The minimum dollar value of the proposed fee
 increases is $5,6 while the maximum dollar value of the proposed fee
 increases is $230.7
 
 The majority of the fees would increase by approximately thirty
 percent.8 For the fees that result from an inspection, the Board
 plans to increase the current fees to an amount to offset the actual costs of
 enforcement. There are 91 separate fees that would be subject to the roughly
 thirty percent fee increase.9 For pharmacists, these cover such
 areas as initial application fees, annual renewal fees, late fees,
 reinstatement fees, facility change and inspection fees, and the innovative
 program approval fee. For practitioners of the healing arts, these cover
 initial application fees, annual renewal fees, late fees, and reinstatement
 fees. For manufacturers and distributors, these cover application fees, renewal
 fees, late fees, and reinstatement fees. 
 
 The Board also proposes to increase the fee for facility
 permits where practitioners of the healing arts sell controlled substances,
 from $40 to $50. In addition, the Board proposes to repeal several fees related
 to humane society permits; these fees are no longer assessed since these
 facilities now pay a controlled substance registration fee. With the proposed
 fee increases, the DHP projects that the Board will have sufficient revenue to
 offset expenditures by June 30, 2021.
 
 Analysis:
 
 DHP points out that without adequate revenue to support
 inspections of pharmacy facilities, licensing and discipline functions,
 applicants for licensure or pharmacy permits cannot be approved in a timely
 manner. This may slow the growth of pharmacy services for the citizens of the
 Commonwealth. In addition, sufficient funding is needed to carry out the
 investigative and disciplinary activities of the board without creating significant
 delays in both activities.  If there is a substantial backlog of
 disciplinary cases, public health and safety may be at risk by allowing
 practitioners guilty of drug diversion, unprofessional conduct, or careless
 security to continue in practice for several months awaiting a review and
 adjudication of an investigative report. Thus, there are both clear benefits
 and clear costs introduced by the fee increases.
 
 It is not 100 percent certain whether or not the benefits
 exceed the costs. Since regulation of professions is not a market good, there
 is not an obvious market price at which speedier license processing and
 disciplinary investigations are valued. Nevertheless, since the proposed fee
 increases bring fees to approximately the same level as 15 years ago once
 inflation is taken into consideration, the benefits likely outweigh the costs.
 
 Businesses and Entities Affected. The proposed amendments
 affect all entities that and individuals who are regulated by the Board,
 including: 1,857 pharmacies, 14,714 pharmacists, 1,848 pharmacy interns, 14,552
 pharmacy technicians, 140 pharmacy technician-training programs, 727 physicians
 selling controlled substances, 175 physician selling drugs locations, 10 pilot
 programs, 2 repackaging training programs, 66 restricted manufacturers, 47
 warehousers, 116 wholesale distributors, 1,196 business controlled substance
 registrants, 9 continuing education course providers, 19 limited use pharmacy
 technicians, 258 medical equipment suppliers, 335 nonresident medical equipment
 suppliers, 26 nonresident outsourcing facilities, 732 nonresident pharmacies,
 749 nonresident wholesale distributors, 29 non-restricted manufacturers, and 1
 permitted physician.10
 
 Localities Particularly Affected. The proposed amendments do
 not disproportionately affect particular localities. 
 
 Projected Impact on Employment. The proposed fee increases are
 not likely to significantly affect employment but may at the margin discourage
 the creation of a limited number of positions at affected firms.
 
 Effects on the Use and Value of Private Property. The proposed
 fee increases moderately increase costs for affected businesses and would have
 a commensurate moderate effect on their value.
 
 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 fee increases raise costs
 for small pharmacies and other small businesses.
 
 Alternative Method that Minimizes Adverse Impact. If decision makers
 were to decide that not all current functions of the Board were necessary, or
 necessary to perform at the frequency or speed supported by the revenue that
 would be raised by the proposed fee increases, then smaller fee increases could
 potentially be set.
 
 Adverse Impacts:
 
 Businesses. The proposed fee increases raise costs for
 pharmacies, pharmacy technician-training programs, repackaging training
 programs, manufacturers, warehousers, wholesale distributors, continuing
 education course providers, medical equipment suppliers, outsourcing
 facilities, and physician practices that sell drugs.
 
 Localities. The proposed fee increases would not likely
 significantly adversely affect localities.
 
 Other Entities. The proposed fee increases would not likely
 significantly adversely affect other entities.
 
 __________________________
 
 1This is not 100 percent certain. See Analysis
 subsection for discussion.
 
 2This applies to fees that existed in 2002. There have
 been new fees introduced since then. Verification fees for the pharmacy
 professions were added in 2015 (http://townhall.virginia.gov/L/ViewAction.cfm
 ?actionid=3444), and permit fees for
 practitioners selling controlled substances were added in 2017 (http://townhall.virginia.gov/L/ViewAction.cfm?actionid=4451).
 
 3This rate of inflation is calculated using the Gross
 Domestic Product: Implicit Price Deflator. See https://fred.stlouisfed.org/series/GDPDEF
 
 4All data (other than inflation rate) provided by
 Department of Health Professions.
 
 5See https://law.lis.virginia.gov/vacode/title54.1/chapter1/section54.1-113/
 
 6Several fees are proposed to increase from $15 to $20
 (the pharmacy intern registration fee, the late fee for an inactive pharmacist
 license, and the late fee for approval of a pharmacy technician training
 program), or from $10 to $15 (the late fee for approval of a repackaging
 training program, and the duplicate license or registration fee).
 
 7Some fees would increase from $270 to $500; these
 include the pharmacy permit application fee and the permit for a physician who
 is licensed to dispense drugs. This latter fee was just introduced in 2017. See
 http://townhall.virginia.gov/l/ViewAction.cfm?actionid=4451.
 
 8The actual percentages range from 28.57 percent to
 33.33 percent for those fees that are increasing by approximately 30 percent.
 
 9For a more complete list of the proposed fee increases,
 see http://townhall.virginia.gov/L/ViewXML.cfm?textid=12504.
 
 10Data source: Department of Health Professions
 
 Agency's Response to Economic Impact Analysis: The Board
 of Pharmacy concurs with the Analysis of the Department of Planning and Budget.
 
 Summary: 
 
 The proposed amendments increase Board of Pharmacy fees to
 cover expenses for essential functions of reviewing applications, licensing,
 inspecting, investigating complaints against licensees, and adjudicating and
 monitoring disciplinary cases. The board proposes a 30% increase in all fees,
 with the exception of those functions that require an inspection, including an
 initial pharmacy permit and changes in location or remodeling, which are set at
 the actual charge to the board by the enforcement division of the Department of
 Health Professions. 
 
 18VAC110-20-20. Fees.
 
 A. Unless otherwise provided, fees listed in this section
 shall not be refundable.
 
 B. Unless otherwise provided, any fees for taking required
 examinations shall be paid directly to the examination service as specified by
 the board.
 
 C. Initial application fees. 
 
 
  
   | 1. Pharmacist license | $180$235
 | 
  
   | 2. Pharmacy intern registration | $15$20
 | 
  
   | 3. Pharmacy technician registration | $25$35
 | 
  
   | 4. Pharmacy permit | $270$500
 | 
  
   | 5. Permitted physician licensed to dispense drugs | $270$500
 | 
  
   | 6. Medical equipment supplier permit | $180$235
 | 
  
   | 7. Humane society permit
 | $20
 | 
  
   | 8.7. Outsourcing facility permit
 | $270$350
 | 
  
   | 9.8. Nonresident pharmacy registration
 | $270$350
 | 
  
   | 10.9. Nonresident outsourcing facility
   registration
 | $270$350
 | 
  
   | 11.10. Controlled substances registrations
 | $90$120
 | 
  
   | 12.11. Innovative program approval.
 If the board determines that a technical consultant is
   required in order to make a decision on approval, any consultant fee, not to
   exceed the actual cost, shall also be paid by the applicant in addition to
   the application fee. | $250$325
 | 
  
   | 13.12. Approval of a pharmacy technician
   training program
 | $150$200
 | 
  
   | 14.13. Approval of a continuing education
   program
 | $100$130
 | 
  
   | 15.14. Approval of a repackaging training
   program
 | $50$65
 | 
 
 
 D. Annual renewal fees. 
 
 
  
   | 1. Pharmacist active license – due no later than December 31 | $90$120
 | 
  
   | 2. Pharmacist inactive license – due no later than December 31 | $45$60
 | 
  
   | 3. Pharmacy technician registration – due no later than
   December 31 | $25$35
 | 
  
   | 4. Pharmacy permit – due no later than April 30 | $270$350
 | 
  
   | 5. Physician permit to practice pharmacy – due no later than
   February 28 | $270$350
 | 
  
   | 6. Medical equipment supplier permit – due no later than
   February 28 | $180$235
 | 
  
   | 7. Humane society permit – due no later than February 28
 | $20
 | 
  
   | 8.7. Outsourcing facility permit – due no later
   than April 30
 | $270$350
 | 
  
   | 9.8. Nonresident pharmacy registration – due no
   later than the date of initial registration
 | $270$350
 | 
  
   | 10.9. Nonresident outsourcing facility
   registration – due no later than the date of initial registration
 | $270$350
 | 
  
   | 11.10. Controlled substances registrations –
   due no later than February 28
 | $90$120
 | 
  
   | 12.11. Innovative program continued approval
   based on board order not to exceed$200$260 per approval
   period.
 |   | 
  
   | 13.12. Approval of a pharmacy technician
   training program
 | $75$100 every two years
 | 
  
   | 14.13. Approval of a repackaging training
   program
 | $30$40 every two years
 | 
 
 
 E. Late fees. The following late fees shall be paid in
 addition to the current renewal fee to renew an expired license within one year
 of the expiration date or within two years in the case of a pharmacy technician
 training program. In addition, engaging in activities requiring a license,
 permit, or registration after the expiration date of such license, permit, or
 registration shall be grounds for disciplinary action by the board. 
 
 
  
   | 1. Pharmacist license | $30$40
 | 
  
   | 2. Pharmacist inactive license | $15$20
 | 
  
   | 3. Pharmacy technician registration | $10$15
 | 
  
   | 4. Pharmacy permit | $90$120
 | 
  
   | 5. Physician permit to practice pharmacy | $90$120
 | 
  
   | 6. Medical equipment supplier permit | $60$80
 | 
  
   | 7. Humane society permit
 | $5
 | 
  
   | 8.7. Outsourcing facility permit
 | $90$120
 | 
  
   | 9.8. Nonresident pharmacy registration
 | $90$120
 | 
  
   | 10.9. Nonresident outsourcing facility
   registration
 | $90$120
 | 
  
   | 11.10. Controlled substances registrations
 | $30$40
 | 
  
   | 12.11. Approval of a pharmacy technician
   training program
 | $15$20
 | 
  
   | 13.12. Approval of a repackaging training
   program
 | $10$15
 | 
 
 
 F. Reinstatement fees. Any person or entity attempting to
 renew a license, permit, or registration more than one year after the
 expiration date, or more than two years after the expiration date in the case
 of a pharmacy technician training program, shall submit an application for
 reinstatement with any required fees. Reinstatement is at the discretion of the
 board and, except for reinstatement following license revocation or suspension,
 may be granted by the executive director of the board upon completion of an
 application and payment of any required fees. 
 
 
  
   | 1. Pharmacist license | $210$275
 | 
  
   | 2. Pharmacist license after revocation or suspension | $500$650
 | 
  
   | 3. Pharmacy technician registration | $35$45
 | 
  
   | 4. Pharmacy technician registration after revocation or
   suspension | $125$165
 | 
  
   | 5. Facilities or entities that cease operation and wish to
   resume shall not be eligible for reinstatement but shall apply for a new
   permit or registration. Facilities or entities that failed to renew and
   continued to operate for more than one renewal cycle shall pay the current
   and all back renewal fees for the years in which they were operating plus the
   following reinstatement fees: |   | 
  
   | a. Pharmacy permit | $240$315
 | 
  
   | b. Physician permit to practice pharmacy | $240$315
 | 
  
   | c. Medical equipment supplier permit | $210$275
 | 
  
   | d. Humane society permit
 | $30
 | 
  
   | e.d. Outsourcing facility permit
 | $240$315
 | 
  
   | f.e. Nonresident pharmacy registration
 | $115$150
 | 
  
   | g.f. Nonresident outsourcing facility
   registration
 | $240$315
 | 
  
   | h.g. Controlled substances registration
 | $180$235
 | 
  
   | i.h. Approval of a pharmacy technician
   training program
 | $75$100
 | 
  
   | j.i. Approval of a repackaging training
   program
 | $50$65
 | 
 
 
 G. Application for change or inspection fees for facilities
 or other entities. 
 
 
  
   | 1. Change of pharmacist-in-charge | $50$65
 | 
  
   | 2. Change of ownership for any facility | $50$65
 | 
  
   | 3. Inspection for remodeling or
   change of location for any facility | $150$300
 | 
  
   | 4. Reinspection of any facility | $150$300
 | 
  
   | 5. Board-required inspection
   for a robotic pharmacy system | $150$300
 | 
  
   | 6. Board-required inspection of an innovative program location | $150$300
 | 
  
   | 7. Change of pharmacist responsible for an approved innovative
   program | $25$35
 | 
 
 
 H. Miscellaneous fees. 
 
 
  
   | 1. Duplicate wall certificate | $25$50
 | 
  
   | 2. Returned check | $35 | 
  
   | 3. Duplicate license or registration | $10$15
 | 
  
   | 4. Verification of licensure or registration | $25$35
 | 
 
 
 18VAC110-20-121. Innovative program approval. 
 
 A. An informal conference committee of the board may approve
 an innovative or pilot program in accordance with § 54.1-3307.2 of the Code of
 Virginia upon receipt of an application and fee specified in 18VAC110-20-20. 
 
 B. If the informal conference committee determines that an
 inspection is necessary to adequately consider an application, it may require
 that the applicant pay a fee specified in 18VAC110-20-20 to cover the cost of
 the inspection. 
 
 C. If the informal conference committee determines that a
 technical consultant is necessary in order for the board to make an informed
 decision on approval of a program, the applicant shall pay a consultant fee,
 not to exceed the actual cost of the consultation. 
 
 D. In the initial order granting approval of a program, the
 informal conference committee shall set the approval period with a schedule for
 submission of required reports and outcome data. The frequency of required
 reports shall not exceed four times a year. 
 
 E. The informal conference committee shall determine the
 appropriate fee for continued approval of the program based on the requirements
 for review and monitoring. Such renewal fee shall not exceed $200 $260
 per approval period. 
 
 18VAC110-30-15. Fees. 
 
 A. Unless otherwise provided, fees listed in this section
 shall not be refundable. 
 
 B. Initial application fees.
 
 1. License for practitioner of the healing arts to sell
 controlled substances: $180 $235.
 
 2. Permit for facility in which practitioners of the healing
 arts sell controlled substances: $240 $315.
 
 C. Annual renewal fees.
 
 1. License for practitioner of the healing arts to sell
 controlled substances: $90 $120.
 
 2. Permit for facility in which practitioners of the healing
 arts sell controlled substances: $240 $315.
 
 D. Late fees. The following late fees shall be paid in
 addition to the current renewal fee to renew an expired license within one year
 of the expiration date.
 
 1. License for practitioner of the healing arts to sell
 controlled substances: $30 $40.
 
 2. Permit for facility in which practitioners of the healing
 arts sell controlled substances: $40 $50.
 
 E. Reinstatement fees. Any person or entity attempting to
 renew a license or permit more than one year after the expiration date shall
 submit an application for reinstatement with any required fees.
 
 1. License for practitioner of the healing arts to sell
 controlled substances: $150 $195.
 
 2. Permit for facility in which practitioners of the healing
 arts sell controlled substances: $240 $315.
 
 3. Application fee for reinstatement of a license or permit
 that has been revoked or suspended indefinitely: $500 $650.
 
 F. Facilities in which only one practitioner of the healing
 arts is licensed by the board to sell controlled substances shall be exempt
 from fees associated with obtaining and renewing a facility permit. Facilities
 that change from only one practitioner to more than one shall notify the board
 within 30 days of such change. 
 
 G. The fee for reinspection of any facility shall be $150
 300. 
 
 H. The fee for a returned check shall be $35. 
 
 18VAC110-50-20. Fees. 
 
 A. Unless otherwise provided, fees listed in this section
 shall not be refundable. 
 
 B. Initial application fees. 
 
 
  
   | 1. Nonrestricted manufacturer
   permit | $270$350
 | 
  
   | 2. Restricted manufacturer
   permit | $180$235
 | 
  
   | 3. Wholesale distributor license | $270$350
 | 
  
   | 4. Warehouser permit | $270$350
 | 
  
   | 5. Nonresident wholesale
   distributor registration | $270$350
 | 
  
   | 6. Controlled substances
   registration | $90$120
 | 
  
   | 7. Third-party logistics
   provider permit | $270$350
 | 
  
   | 8. Nonresident manufacturer
   registration | $270$350
 | 
  
   | 9. Nonresident warehouser
   registration | $270$350
 | 
  
   | 10. Nonresident third-party
   logistics provider registration | $270$350
 | 
 
 
 C. Annual renewal fees shall be due on February 28 of each
 year. 
 
 
  
   | 1. Nonrestricted manufacturer permit | $270$350
 | 
  
   | 2. Restricted manufacturer permit | $180$235
 | 
  
   | 3. Wholesale distributor license | $270$350
 | 
  
   | 4. Warehouser permit | $270$350
 | 
  
   | 5. Nonresident wholesale distributor registration | $270$350
 | 
  
   | 6. Controlled substances registration | $90$120
 | 
  
   | 7. Third-party logistics provider permit | $270$350
 | 
  
   | 8. Nonresident manufacturer registration | $270$350
 | 
  
   | 9. Nonresident warehouser registration | $270$350
 | 
  
   | 10. Nonresident third-party logistics provider registration | $270$350
 | 
 
 
 D. Late fees. The following late fees shall be paid in
 addition to the current renewal fee to renew an expired license within one year
 of the expiration date. In addition, engaging in activities requiring a
 license, permit, or registration after the expiration date of such license,
 permit, or registration shall be grounds for disciplinary action by the board. 
 
 
  
   | 1. Nonrestricted manufacturer permit | $90$120
 | 
  
   | 2. Restricted manufacturer permit | $60$80
 | 
  
   | 3. Wholesale distributor license | $90$120
 | 
  
   | 4. Warehouser permit | $90$120
 | 
  
   | 5. Nonresident wholesale distributor registration | $90$120
 | 
  
   | 6. Controlled substances registration | $30$40
 | 
  
   | 7. Third-party logistics provider permit | $90$120
 | 
  
   | 8. Nonresident manufacturer registration | $90$120
 | 
  
   | 9. Nonresident warehouser registration | $90$120
 | 
  
   | 10. Nonresident third-party logistics provider registration | $90$120
 | 
 
 
 E. Reinstatement fees. 
 
 1. Any entity attempting to renew a license, permit, or
 registration more than one year after the expiration date shall submit an
 application for reinstatement with any required fees. Reinstatement is at the
 discretion of the board and, except for reinstatement following license
 revocation or suspension, may be granted by the executive director of the board
 upon completion of an application and payment of any required fees. 
 
 2. Engaging in activities requiring a license, permit, or
 registration after the expiration date of such license, permit, or registration
 shall be grounds for disciplinary action by the board. Facilities or entities
 that cease operation and wish to resume shall not be eligible for reinstatement,
 but shall apply for a new permit or registration. 
 
 3. Facilities or entities that failed to renew and continued
 to operate for more than one renewal cycle shall pay the current and all back
 renewal fees for the years in which they were operating plus the following
 reinstatement fees: 
 
 
  
   | a. Nonrestricted manufacturer permit | $240$315
 | 
  
   | b. Restricted manufacturer permit | $210$275
 | 
  
   | c. Wholesale distributor license | $240$315
 | 
  
   | d. Warehouser permit | $240$315
 | 
  
   | e. Nonresident wholesale distributor registration | $240$315
 | 
  
   | f. Controlled substances registration | $180$235
 | 
  
   | g. Third-party logistics provider permit | $240$315
 | 
  
   | h. Nonresident manufacturer registration | $240$315
 | 
  
   | i. Nonresident warehouser registration | $240$315
 | 
  
   | j. Nonresident third-party logistics provider registration | $240$315
 | 
 
 
 F. Application for change or inspection fees. 
 
 
  
   | 1. Reinspection fee | $150$300
 | 
  
   | 2. Inspection fee for change of location, structural changes,
   or security system changes | $150$300
 | 
  
   | 3. Change of ownership fee | $50$65
 | 
  
   | 4. Change of responsible party | $50$65
 | 
 
 
 G. The fee for a returned check shall be $35. 
 
 H. The fee for verification of license, permit, or
 registration shall be $25 $35.
 
 VA.R. Doc. No. R18-5322; Filed May 8, 2019, 2:58 p.m. 
TITLE 18. PROFESSIONAL AND OCCUPATIONAL LICENSING
BOARD OF PHARMACY
Proposed Regulation
 
 Titles of Regulations: 18VAC110-20. Regulations
 Governing the Practice of Pharmacy (amending 18VAC110-20-20, 18VAC110-20-121).
 
 18VAC110-30. Regulations for Practitioners of the Healing
 Arts to Sell Controlled Substances (amending 18VAC110-30-15).
 
 18VAC110-50. Regulations Governing Wholesale Distributors,
 Manufacturers, and Warehousers (amending 18VAC110-50-20). 
 
 Statutory Authority: §§ 54.1-2400 and 54.1-3307 of the
 Code of Virginia.
 
 Public Hearing Information:
 
 June 5, 2019 - 9:05 a.m. - Department of Health
 Professions, Perimeter Center, 9960 Mayland Drive, Suite 201, Board Room 2,
 Richmond, VA 23233
 
 Public Comment Deadline: July 26, 2019.
 
 Agency Contact: Caroline Juran, RPh, Executive Director,
 Board of Pharmacy, 9960 Mayland Drive, Suite 300, Richmond, VA 23233-1463,
 telephone (804) 367-4456, FAX (804) 527-4472, or email
 caroline.juran@dhp.virginia.gov.
 
 Basis: Regulations of the Board of Pharmacy are promulgated
 under the general authority of § 54.1-2400 of the Code of Virginia. The
 proposed regulation is mandated by § 54.1-113 of the Code of Virginia.
 
 Purpose: Fees charged to applicants and licensees of the
 Board of Pharmacy have not been increased since 2002. During that time period,
 there have been three reductions in renewal fees, in 2005, 2006 and 2009. The
 number of regulated entities has substantially increased in recent years from
 12,861 in 2002 to 37,608 in 2018, so the need for additional staff, six in 2002
 to 12 in 2018, has increased costs to the board. Additionally, the cost of
 inspections has increased, as have expenditures for investigation and
 adjudication of disciplinary cases. Enforcement inspection and investigative
 hours have increased from 7,179.30 in fiscal year (FY) 2002 to 13,220.30 in
 FY17. The number of cases adjudicated have increased from 269 in 2002 to 651 in
 2017. Additionally, the board's share of allocated expenditures has grown as
 costs to the department have increased. For example, in FY02, information
 technology costs were approximately $300,000; in FY17, they were $1.84 million.
 
 Expenditures are now projected to exceed revenues in the
 2018-2020 biennium. While the board has maintained a positive cash balance due
 to carry-over revenue, expenditures in FY18 of $3,745,630 are projected to
 exceed revenue of $3,131,895 by June 30, 2018. The imbalance will continue to
 grow in the next biennium and beyond. Therefore, the board will have a
 projected shortfall in its budget by 2021 of $648,614, which is projected to
 grow to $2,657,527 by June 30, 2022. The Board of Pharmacy must amend
 regulations as soon as possible to avoid the additional fee assessments that
 other boards had to adopt or being forced to curtail vital functions of inspection
 and investigation.
 
 Without adequate revenue to support inspections of pharmacy
 facilities, licensing, and discipline functions, applicants for licensure or
 pharmacy permits cannot be approved in a timely manner, thus depriving the
 citizens of the Commonwealth with the pharmacy services needed. Additionally,
 if there is a substantial backlog of disciplinary cases, public health and
 safety may be at risk by allowing practitioners guilty of drug diversion or
 unprofessional conduct to continue in practice for several months while
 awaiting a review and adjudication of an investigative report.
 
 Substance: The board has proposed a 30% increase in all
 fees with the exception of those functions that require an inspection,
 including an initial pharmacy permit and changes in location or remodeling.
 Those fees are set at an amount to offset the actual charge to the board by the
 enforcement division of the department.
 
 Issues: The primary advantage to the public is avoidance
 of a reduction in investigations or inspections. There are no disadvantages to
 the public. The advantage to the agency is adequate revenue to offset
 expenditures so that a growing shortfall can be avoided, which would
 necessitate a one-time assessment for all regulated entities or an additional
 fee increase. 
 
 Department of Planning and Budget's Economic Impact
 Analysis:
 
 Summary of the Proposed Amendments to Regulation. The Board of
 Pharmacy (Board) proposes to raise fees.
 
 Result of Analysis. The benefits likely1 outweigh
 the costs for the proposed amendments.
 
 Estimated Economic Impact.
 
 Background:
 
 Fees charged to applicants and licensees of the Board of
 Pharmacy have not increased since December 2002.2 During that
 period, there have been three reductions in renewal fees (2005, 2006 and 2009),
 while the rate of price inflation has been 33 percent.3 The number
 of regulated entities has substantially increased in recent years (12,861 in
 2002 to 37,608 in 2018); so the need for additional staff (six in 2002 to 12 in
 2018) has increased costs to the Board. Additionally, the cost of inspections
 has increased, as have expenditures for investigation and adjudication of
 disciplinary cases. Enforcement inspection and investigative hours have
 increased from 7,179.30 in Fiscal Year (FY) 2002 to 13,220.30 in FY 2017. The
 number of cases adjudicated have increased from 269 in 2002 to 651 in 2017.
 Additionally, the Board's share of allocated expenditures has grown as costs to
 the Department of Health Professions (DHP) have increased. For example, in FY
 2002, information technology (IT) costs were approximately $300,000; in FY
 2017, IT costs were $1.84 million.4
 
 Code of Virginia § 54.1-113.A (commonly called the
 Callahan Act)5 states that: 
 
 Following the close of any biennium, when the account for any
 regulatory board within the Department of Professional and Occupational
 Regulation or the Department of Health Professions maintained under
 § 54.1-308 or 54.1-2505 shows expenses allocated to it for
 the past biennium to be more than 10 percent greater or less than moneys
 collected on behalf of the board, it shall revise the fees levied by it for
 certification, licensure, registration, or permit and renewal thereof so that
 the fees are sufficient but not excessive to cover expenses.
 
 In FY2017, the Board's expenditures were $3,272,687, while its
 revenues were $3,293,583. DHP projects that expenditures for FY2018 will be
 $3,745,630 and revenues will be $3,131,895. Thus, total expenditures for the
 biennium are projected to be $7,018,317, with revenues projected at $6,425,478.
 The projected expenditures are 9.2 percent higher than the projected revenues.
 This being less than 10 percent, the mandate to raise fees via the Callahan Act
 is not yet triggered. Nevertheless, DHP does anticipate that expenditures will
 continue to rise faster than revenues, necessitating higher fees to cover
 costs.
 
 Proposal:
 
 The Board proposes to increase 110 different fees in this
 regulatory action, primarily those paid by pharmacists, pharmacies, pharmacist
 interns, and pharmacy technicians. In addition, the Board is also proposing fee
 increases for practitioners of the healing arts and wholesale manufacturers,
 distributors, and warehousers. The minimum dollar value of the proposed fee
 increases is $5,6 while the maximum dollar value of the proposed fee
 increases is $230.7
 
 The majority of the fees would increase by approximately thirty
 percent.8 For the fees that result from an inspection, the Board
 plans to increase the current fees to an amount to offset the actual costs of
 enforcement. There are 91 separate fees that would be subject to the roughly
 thirty percent fee increase.9 For pharmacists, these cover such
 areas as initial application fees, annual renewal fees, late fees,
 reinstatement fees, facility change and inspection fees, and the innovative
 program approval fee. For practitioners of the healing arts, these cover
 initial application fees, annual renewal fees, late fees, and reinstatement
 fees. For manufacturers and distributors, these cover application fees, renewal
 fees, late fees, and reinstatement fees. 
 
 The Board also proposes to increase the fee for facility
 permits where practitioners of the healing arts sell controlled substances,
 from $40 to $50. In addition, the Board proposes to repeal several fees related
 to humane society permits; these fees are no longer assessed since these
 facilities now pay a controlled substance registration fee. With the proposed
 fee increases, the DHP projects that the Board will have sufficient revenue to
 offset expenditures by June 30, 2021.
 
 Analysis:
 
 DHP points out that without adequate revenue to support
 inspections of pharmacy facilities, licensing and discipline functions,
 applicants for licensure or pharmacy permits cannot be approved in a timely
 manner. This may slow the growth of pharmacy services for the citizens of the
 Commonwealth. In addition, sufficient funding is needed to carry out the
 investigative and disciplinary activities of the board without creating significant
 delays in both activities.  If there is a substantial backlog of
 disciplinary cases, public health and safety may be at risk by allowing
 practitioners guilty of drug diversion, unprofessional conduct, or careless
 security to continue in practice for several months awaiting a review and
 adjudication of an investigative report. Thus, there are both clear benefits
 and clear costs introduced by the fee increases.
 
 It is not 100 percent certain whether or not the benefits
 exceed the costs. Since regulation of professions is not a market good, there
 is not an obvious market price at which speedier license processing and
 disciplinary investigations are valued. Nevertheless, since the proposed fee
 increases bring fees to approximately the same level as 15 years ago once
 inflation is taken into consideration, the benefits likely outweigh the costs.
 
 Businesses and Entities Affected. The proposed amendments
 affect all entities that and individuals who are regulated by the Board,
 including: 1,857 pharmacies, 14,714 pharmacists, 1,848 pharmacy interns, 14,552
 pharmacy technicians, 140 pharmacy technician-training programs, 727 physicians
 selling controlled substances, 175 physician selling drugs locations, 10 pilot
 programs, 2 repackaging training programs, 66 restricted manufacturers, 47
 warehousers, 116 wholesale distributors, 1,196 business controlled substance
 registrants, 9 continuing education course providers, 19 limited use pharmacy
 technicians, 258 medical equipment suppliers, 335 nonresident medical equipment
 suppliers, 26 nonresident outsourcing facilities, 732 nonresident pharmacies,
 749 nonresident wholesale distributors, 29 non-restricted manufacturers, and 1
 permitted physician.10
 
 Localities Particularly Affected. The proposed amendments do
 not disproportionately affect particular localities. 
 
 Projected Impact on Employment. The proposed fee increases are
 not likely to significantly affect employment but may at the margin discourage
 the creation of a limited number of positions at affected firms.
 
 Effects on the Use and Value of Private Property. The proposed
 fee increases moderately increase costs for affected businesses and would have
 a commensurate moderate effect on their value.
 
 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 fee increases raise costs
 for small pharmacies and other small businesses.
 
 Alternative Method that Minimizes Adverse Impact. If decision makers
 were to decide that not all current functions of the Board were necessary, or
 necessary to perform at the frequency or speed supported by the revenue that
 would be raised by the proposed fee increases, then smaller fee increases could
 potentially be set.
 
 Adverse Impacts:
 
 Businesses. The proposed fee increases raise costs for
 pharmacies, pharmacy technician-training programs, repackaging training
 programs, manufacturers, warehousers, wholesale distributors, continuing
 education course providers, medical equipment suppliers, outsourcing
 facilities, and physician practices that sell drugs.
 
 Localities. The proposed fee increases would not likely
 significantly adversely affect localities.
 
 Other Entities. The proposed fee increases would not likely
 significantly adversely affect other entities.
 
 __________________________
 
 1This is not 100 percent certain. See Analysis
 subsection for discussion.
 
 2This applies to fees that existed in 2002. There have
 been new fees introduced since then. Verification fees for the pharmacy
 professions were added in 2015 (http://townhall.virginia.gov/L/ViewAction.cfm
 ?actionid=3444), and permit fees for
 practitioners selling controlled substances were added in 2017 (http://townhall.virginia.gov/L/ViewAction.cfm?actionid=4451).
 
 3This rate of inflation is calculated using the Gross
 Domestic Product: Implicit Price Deflator. See https://fred.stlouisfed.org/series/GDPDEF
 
 4All data (other than inflation rate) provided by
 Department of Health Professions.
 
 5See https://law.lis.virginia.gov/vacode/title54.1/chapter1/section54.1-113/
 
 6Several fees are proposed to increase from $15 to $20
 (the pharmacy intern registration fee, the late fee for an inactive pharmacist
 license, and the late fee for approval of a pharmacy technician training
 program), or from $10 to $15 (the late fee for approval of a repackaging
 training program, and the duplicate license or registration fee).
 
 7Some fees would increase from $270 to $500; these
 include the pharmacy permit application fee and the permit for a physician who
 is licensed to dispense drugs. This latter fee was just introduced in 2017. See
 http://townhall.virginia.gov/l/ViewAction.cfm?actionid=4451.
 
 8The actual percentages range from 28.57 percent to
 33.33 percent for those fees that are increasing by approximately 30 percent.
 
 9For a more complete list of the proposed fee increases,
 see http://townhall.virginia.gov/L/ViewXML.cfm?textid=12504.
 
 10Data source: Department of Health Professions
 
 Agency's Response to Economic Impact Analysis: The Board
 of Pharmacy concurs with the Analysis of the Department of Planning and Budget.
 
 Summary: 
 
 The proposed amendments increase Board of Pharmacy fees to
 cover expenses for essential functions of reviewing applications, licensing,
 inspecting, investigating complaints against licensees, and adjudicating and
 monitoring disciplinary cases. The board proposes a 30% increase in all fees,
 with the exception of those functions that require an inspection, including an
 initial pharmacy permit and changes in location or remodeling, which are set at
 the actual charge to the board by the enforcement division of the Department of
 Health Professions. 
 
 18VAC110-20-20. Fees.
 
 A. Unless otherwise provided, fees listed in this section
 shall not be refundable.
 
 B. Unless otherwise provided, any fees for taking required
 examinations shall be paid directly to the examination service as specified by
 the board.
 
 C. Initial application fees. 
 
 
  
   | 1. Pharmacist license | $180$235
 | 
  
   | 2. Pharmacy intern registration | $15$20
 | 
  
   | 3. Pharmacy technician registration | $25$35
 | 
  
   | 4. Pharmacy permit | $270$500
 | 
  
   | 5. Permitted physician licensed to dispense drugs | $270$500
 | 
  
   | 6. Medical equipment supplier permit | $180$235
 | 
  
   | 7. Humane society permit
 | $20
 | 
  
   | 8.7. Outsourcing facility permit
 | $270$350
 | 
  
   | 9.8. Nonresident pharmacy registration
 | $270$350
 | 
  
   | 10.9. Nonresident outsourcing facility
   registration
 | $270$350
 | 
  
   | 11.10. Controlled substances registrations
 | $90$120
 | 
  
   | 12.11. Innovative program approval.
 If the board determines that a technical consultant is
   required in order to make a decision on approval, any consultant fee, not to
   exceed the actual cost, shall also be paid by the applicant in addition to
   the application fee. | $250$325
 | 
  
   | 13.12. Approval of a pharmacy technician
   training program
 | $150$200
 | 
  
   | 14.13. Approval of a continuing education
   program
 | $100$130
 | 
  
   | 15.14. Approval of a repackaging training
   program
 | $50$65
 | 
 
 
 D. Annual renewal fees. 
 
 
  
   | 1. Pharmacist active license – due no later than December 31 | $90$120
 | 
  
   | 2. Pharmacist inactive license – due no later than December 31 | $45$60
 | 
  
   | 3. Pharmacy technician registration – due no later than
   December 31 | $25$35
 | 
  
   | 4. Pharmacy permit – due no later than April 30 | $270$350
 | 
  
   | 5. Physician permit to practice pharmacy – due no later than
   February 28 | $270$350
 | 
  
   | 6. Medical equipment supplier permit – due no later than
   February 28 | $180$235
 | 
  
   | 7. Humane society permit – due no later than February 28
 | $20
 | 
  
   | 8.7. Outsourcing facility permit – due no later
   than April 30
 | $270$350
 | 
  
   | 9.8. Nonresident pharmacy registration – due no
   later than the date of initial registration
 | $270$350
 | 
  
   | 10.9. Nonresident outsourcing facility
   registration – due no later than the date of initial registration
 | $270$350
 | 
  
   | 11.10. Controlled substances registrations –
   due no later than February 28
 | $90$120
 | 
  
   | 12.11. Innovative program continued approval
   based on board order not to exceed$200$260 per approval
   period.
 |   | 
  
   | 13.12. Approval of a pharmacy technician
   training program
 | $75$100 every two years
 | 
  
   | 14.13. Approval of a repackaging training
   program
 | $30$40 every two years
 | 
 
 
 E. Late fees. The following late fees shall be paid in
 addition to the current renewal fee to renew an expired license within one year
 of the expiration date or within two years in the case of a pharmacy technician
 training program. In addition, engaging in activities requiring a license,
 permit, or registration after the expiration date of such license, permit, or
 registration shall be grounds for disciplinary action by the board. 
 
 
  
   | 1. Pharmacist license | $30$40
 | 
  
   | 2. Pharmacist inactive license | $15$20
 | 
  
   | 3. Pharmacy technician registration | $10$15
 | 
  
   | 4. Pharmacy permit | $90$120
 | 
  
   | 5. Physician permit to practice pharmacy | $90$120
 | 
  
   | 6. Medical equipment supplier permit | $60$80
 | 
  
   | 7. Humane society permit
 | $5
 | 
  
   | 8.7. Outsourcing facility permit
 | $90$120
 | 
  
   | 9.8. Nonresident pharmacy registration
 | $90$120
 | 
  
   | 10.9. Nonresident outsourcing facility
   registration
 | $90$120
 | 
  
   | 11.10. Controlled substances registrations
 | $30$40
 | 
  
   | 12.11. Approval of a pharmacy technician
   training program
 | $15$20
 | 
  
   | 13.12. Approval of a repackaging training
   program
 | $10$15
 | 
 
 
 F. Reinstatement fees. Any person or entity attempting to
 renew a license, permit, or registration more than one year after the
 expiration date, or more than two years after the expiration date in the case
 of a pharmacy technician training program, shall submit an application for
 reinstatement with any required fees. Reinstatement is at the discretion of the
 board and, except for reinstatement following license revocation or suspension,
 may be granted by the executive director of the board upon completion of an
 application and payment of any required fees. 
 
 
  
   | 1. Pharmacist license | $210$275
 | 
  
   | 2. Pharmacist license after revocation or suspension | $500$650
 | 
  
   | 3. Pharmacy technician registration | $35$45
 | 
  
   | 4. Pharmacy technician registration after revocation or
   suspension | $125$165
 | 
  
   | 5. Facilities or entities that cease operation and wish to
   resume shall not be eligible for reinstatement but shall apply for a new
   permit or registration. Facilities or entities that failed to renew and
   continued to operate for more than one renewal cycle shall pay the current
   and all back renewal fees for the years in which they were operating plus the
   following reinstatement fees: |   | 
  
   | a. Pharmacy permit | $240$315
 | 
  
   | b. Physician permit to practice pharmacy | $240$315
 | 
  
   | c. Medical equipment supplier permit | $210$275
 | 
  
   | d. Humane society permit
 | $30
 | 
  
   | e.d. Outsourcing facility permit
 | $240$315
 | 
  
   | f.e. Nonresident pharmacy registration
 | $115$150
 | 
  
   | g.f. Nonresident outsourcing facility
   registration
 | $240$315
 | 
  
   | h.g. Controlled substances registration
 | $180$235
 | 
  
   | i.h. Approval of a pharmacy technician
   training program
 | $75$100
 | 
  
   | j.i. Approval of a repackaging training
   program
 | $50$65
 | 
 
 
 G. Application for change or inspection fees for facilities
 or other entities. 
 
 
  
   | 1. Change of pharmacist-in-charge | $50$65
 | 
  
   | 2. Change of ownership for any facility | $50$65
 | 
  
   | 3. Inspection for remodeling or
   change of location for any facility | $150$300
 | 
  
   | 4. Reinspection of any facility | $150$300
 | 
  
   | 5. Board-required inspection
   for a robotic pharmacy system | $150$300
 | 
  
   | 6. Board-required inspection of an innovative program location | $150$300
 | 
  
   | 7. Change of pharmacist responsible for an approved innovative
   program | $25$35
 | 
 
 
 H. Miscellaneous fees. 
 
 
  
   | 1. Duplicate wall certificate | $25$50
 | 
  
   | 2. Returned check | $35 | 
  
   | 3. Duplicate license or registration | $10$15
 | 
  
   | 4. Verification of licensure or registration | $25$35
 | 
 
 
 18VAC110-20-121. Innovative program approval. 
 
 A. An informal conference committee of the board may approve
 an innovative or pilot program in accordance with § 54.1-3307.2 of the Code of
 Virginia upon receipt of an application and fee specified in 18VAC110-20-20. 
 
 B. If the informal conference committee determines that an
 inspection is necessary to adequately consider an application, it may require
 that the applicant pay a fee specified in 18VAC110-20-20 to cover the cost of
 the inspection. 
 
 C. If the informal conference committee determines that a
 technical consultant is necessary in order for the board to make an informed
 decision on approval of a program, the applicant shall pay a consultant fee,
 not to exceed the actual cost of the consultation. 
 
 D. In the initial order granting approval of a program, the
 informal conference committee shall set the approval period with a schedule for
 submission of required reports and outcome data. The frequency of required
 reports shall not exceed four times a year. 
 
 E. The informal conference committee shall determine the
 appropriate fee for continued approval of the program based on the requirements
 for review and monitoring. Such renewal fee shall not exceed $200 $260
 per approval period. 
 
 18VAC110-30-15. Fees. 
 
 A. Unless otherwise provided, fees listed in this section
 shall not be refundable. 
 
 B. Initial application fees.
 
 1. License for practitioner of the healing arts to sell
 controlled substances: $180 $235.
 
 2. Permit for facility in which practitioners of the healing
 arts sell controlled substances: $240 $315.
 
 C. Annual renewal fees.
 
 1. License for practitioner of the healing arts to sell
 controlled substances: $90 $120.
 
 2. Permit for facility in which practitioners of the healing
 arts sell controlled substances: $240 $315.
 
 D. Late fees. The following late fees shall be paid in
 addition to the current renewal fee to renew an expired license within one year
 of the expiration date.
 
 1. License for practitioner of the healing arts to sell
 controlled substances: $30 $40.
 
 2. Permit for facility in which practitioners of the healing
 arts sell controlled substances: $40 $50.
 
 E. Reinstatement fees. Any person or entity attempting to
 renew a license or permit more than one year after the expiration date shall
 submit an application for reinstatement with any required fees.
 
 1. License for practitioner of the healing arts to sell
 controlled substances: $150 $195.
 
 2. Permit for facility in which practitioners of the healing
 arts sell controlled substances: $240 $315.
 
 3. Application fee for reinstatement of a license or permit
 that has been revoked or suspended indefinitely: $500 $650.
 
 F. Facilities in which only one practitioner of the healing
 arts is licensed by the board to sell controlled substances shall be exempt
 from fees associated with obtaining and renewing a facility permit. Facilities
 that change from only one practitioner to more than one shall notify the board
 within 30 days of such change. 
 
 G. The fee for reinspection of any facility shall be $150
 300. 
 
 H. The fee for a returned check shall be $35. 
 
 18VAC110-50-20. Fees. 
 
 A. Unless otherwise provided, fees listed in this section
 shall not be refundable. 
 
 B. Initial application fees. 
 
 
  
   | 1. Nonrestricted manufacturer
   permit | $270$350
 | 
  
   | 2. Restricted manufacturer
   permit | $180$235
 | 
  
   | 3. Wholesale distributor license | $270$350
 | 
  
   | 4. Warehouser permit | $270$350
 | 
  
   | 5. Nonresident wholesale
   distributor registration | $270$350
 | 
  
   | 6. Controlled substances
   registration | $90$120
 | 
  
   | 7. Third-party logistics
   provider permit | $270$350
 | 
  
   | 8. Nonresident manufacturer
   registration | $270$350
 | 
  
   | 9. Nonresident warehouser
   registration | $270$350
 | 
  
   | 10. Nonresident third-party
   logistics provider registration | $270$350
 | 
 
 
 C. Annual renewal fees shall be due on February 28 of each
 year. 
 
 
  
   | 1. Nonrestricted manufacturer permit | $270$350
 | 
  
   | 2. Restricted manufacturer permit | $180$235
 | 
  
   | 3. Wholesale distributor license | $270$350
 | 
  
   | 4. Warehouser permit | $270$350
 | 
  
   | 5. Nonresident wholesale distributor registration | $270$350
 | 
  
   | 6. Controlled substances registration | $90$120
 | 
  
   | 7. Third-party logistics provider permit | $270$350
 | 
  
   | 8. Nonresident manufacturer registration | $270$350
 | 
  
   | 9. Nonresident warehouser registration | $270$350
 | 
  
   | 10. Nonresident third-party logistics provider registration | $270$350
 | 
 
 
 D. Late fees. The following late fees shall be paid in
 addition to the current renewal fee to renew an expired license within one year
 of the expiration date. In addition, engaging in activities requiring a
 license, permit, or registration after the expiration date of such license,
 permit, or registration shall be grounds for disciplinary action by the board. 
 
 
  
   | 1. Nonrestricted manufacturer permit | $90$120
 | 
  
   | 2. Restricted manufacturer permit | $60$80
 | 
  
   | 3. Wholesale distributor license | $90$120
 | 
  
   | 4. Warehouser permit | $90$120
 | 
  
   | 5. Nonresident wholesale distributor registration | $90$120
 | 
  
   | 6. Controlled substances registration | $30$40
 | 
  
   | 7. Third-party logistics provider permit | $90$120
 | 
  
   | 8. Nonresident manufacturer registration | $90$120
 | 
  
   | 9. Nonresident warehouser registration | $90$120
 | 
  
   | 10. Nonresident third-party logistics provider registration | $90$120
 | 
 
 
 E. Reinstatement fees. 
 
 1. Any entity attempting to renew a license, permit, or
 registration more than one year after the expiration date shall submit an
 application for reinstatement with any required fees. Reinstatement is at the
 discretion of the board and, except for reinstatement following license
 revocation or suspension, may be granted by the executive director of the board
 upon completion of an application and payment of any required fees. 
 
 2. Engaging in activities requiring a license, permit, or
 registration after the expiration date of such license, permit, or registration
 shall be grounds for disciplinary action by the board. Facilities or entities
 that cease operation and wish to resume shall not be eligible for reinstatement,
 but shall apply for a new permit or registration. 
 
 3. Facilities or entities that failed to renew and continued
 to operate for more than one renewal cycle shall pay the current and all back
 renewal fees for the years in which they were operating plus the following
 reinstatement fees: 
 
 
  
   | a. Nonrestricted manufacturer permit | $240$315
 | 
  
   | b. Restricted manufacturer permit | $210$275
 | 
  
   | c. Wholesale distributor license | $240$315
 | 
  
   | d. Warehouser permit | $240$315
 | 
  
   | e. Nonresident wholesale distributor registration | $240$315
 | 
  
   | f. Controlled substances registration | $180$235
 | 
  
   | g. Third-party logistics provider permit | $240$315
 | 
  
   | h. Nonresident manufacturer registration | $240$315
 | 
  
   | i. Nonresident warehouser registration | $240$315
 | 
  
   | j. Nonresident third-party logistics provider registration | $240$315
 | 
 
 
 F. Application for change or inspection fees. 
 
 
  
   | 1. Reinspection fee | $150$300
 | 
  
   | 2. Inspection fee for change of location, structural changes,
   or security system changes | $150$300
 | 
  
   | 3. Change of ownership fee | $50$65
 | 
  
   | 4. Change of responsible party | $50$65
 | 
 
 
 G. The fee for a returned check shall be $35. 
 
 H. The fee for verification of license, permit, or
 registration shall be $25 $35.
 
 VA.R. Doc. No. R18-5322; Filed May 8, 2019, 2:58 p.m. 
TITLE 18. PROFESSIONAL AND OCCUPATIONAL LICENSING
BOARD OF PHYSICAL THERAPY
Reproposed Regulation
 
 Title of Regulation: 18VAC112-20. Regulations
 Governing the Practice of Physical Therapy (adding 18VAC112-20-121). 
 
 Statutory Authority: § 54.1-2400 of the Code of
 Virginia.
 
 Public Hearing Information:
 
 June 27, 2019 - 9 a.m. - Department of Health
 Professions, Perimeter Center, 9960 Mayland Drive, 2nd Floor Conference Center,
 Hearing Room 3 Henrico, VA 23233
 
 Public Comment Deadline: July 6, 2019.
 
 Agency Contact: Corie Tillman Wolf, Executive Director,
 Board of Physical Therapy, 9960 Mayland Drive, Suite 300, Richmond, VA 23233,
 telephone (804) 367-4674, FAX (804) 527-4413, or email
 ptboard@dhp.virginia.gov.
 
 Basis: Regulations Governing the Practice of Physical
 Therapy (18VAC112-20) are promulgated under the general authority of § 54.1-2400
 of the Code of Virginia, which provides the Board of Physical Therapy the
 authority to promulgate regulations to administer the regulatory system.
 
 Purpose: The purpose of the action is to specify the
 qualifications for and limitations of the practice of dry needling as performed
 by physical therapists. For physical therapists, dry needling is not an entry
 level skill for which competency has been assured through an accredited
 educational program and national examination. It is an advanced procedure that
 requires additional training, referral and direction, and informed consent.
 Without a regulatory standard, the board cannot hold a physical therapist
 accountable for requirements specific to dry needling. Therefore, the board has
 determined that regulations are necessary to protect the health and safety of
 patients who may receive dry needling in the course of a physical therapy
 treatment.
 
 Substance: Upon recommendation of a regulatory advisory
 panel, which was convened to consider comment on proposed regulations and to
 identify any additional safeguards that should be included in regulation, the following
 clarifications and changes have been proposed:
 
 18VAC112-20-121 B states that dry needling is not an entry
 level skill but an advanced procedure that requires additional training. The
 term "post-graduate" is added to clarify that the additional training
 must occur subsequent to a physical therapist's graduate education in physical
 therapy.
 
 18VAC112-20-121 B 2 specifies that the training must consist of
 didactic and hands-on laboratory education and must include passage of a
 theoretical and practical examination. The hands-on laboratory education shall
 be face-to-face.
 
 18VAC112-20-121 B 3 specifies that the training must be in a
 course certified by the Federation of State Boards of Physical Therapy or
 approved or provided by a sponsor listed in regulations on continuing
 education.
 
 18VAC112-20-121 B 4 specifies that the practitioner shall not
 practice beyond the scope of the highest level of the practitioner's training.
 
 18VAC112-20-121 C is amended to delete a requirement that the
 informed consent must clearly state that the patient is not receiving an
 acupuncture treatment.
 
 18VAC112-20-121 D is added to provide that dry needling can
 only be performed by a physical therapist trained pursuant to 18VAC112-20-121 B
 and cannot be delegated to a physical therapist assistant or other support
 personnel.
 
 Issues: The board believes the proposed regulation
 offers the advantage of protection for patients who receive a dry needling
 procedure during the course of physical therapy treatment. Regulatory
 requirements for referral, training, and informed consent provide greater
 assurance of competency and accountability than the guidance document that
 currently exists. The board does not believe there are disadvantages to the
 public as the procedure is limited in scope and relatively safe to perform.
 
 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
 Physical Therapy (the board) proposes to add to its main regulation provisions
 regarding the practice of dry needling including referral, training, informed
 consent, and disclosure requirements.
 
 Result of Analysis. The benefits likely exceed the costs for
 all proposed changes.
 
 Estimated Economic Impact. Dry
 needling is a technique used in the practice of physical therapy to treat
 muscle tension and pain by inserting a special type of needle into areas of the
 muscle known as trigger points. According to the board, dry needling has been
 performed by physical therapists in Virginia for more than a decade. Currently,
 physical therapists performing the procedure are subject to the board's
 guidance document 112-9, which sets out referral, training, informed consent,
 and disclosure requirements for practice of dry needling.1 The board
 proposes to add to this regulation provisions that are substantially similar to
 those in the guidance document. Adding these provisions to the regulation
 should not create any significant economic effects as there will be no change
 in practice. One notable exception is that 54 hours of post-professional
 training is required under the guidance while the proposed regulation does not
 state a specific number of training hours. This provision is not being added
 because the scope and content of each training may be different. However, a
 practitioner is not permitted to perform dry needling beyond the scope of the
 highest level of his training.
 
 According to the board, if a physical therapist who has not
 received education and training in dry needling chooses to add it as a modality
 for his/her patients, there are a variety of courses offered. Most involve
 multi-day seminars with hands-on training and cost approximately $1,000. Thus,
 under the regulations, some physical therapists may be able to obtain
 sufficient training at less than the current cost while some others may have to
 incur a larger cost. In any event, practice of dry needling is voluntary, and
 by choosing to offer it as a modality, a therapist reveals that expected
 benefits to him or her are greater than the expected costs.
 
 The board also notes that without a regulatory standard, a
 physical therapist cannot be held accountable for requirements specific to dry
 needling. Thus, having the requirements in regulations could improve
 enforcement, should there be a violation.2
 
 Businesses and Entities Affected. Currently, there are 7,786
 physical therapists licensed in Virginia. Not all of the physical therapists
 perform dry needling.
 
 Localities Particularly Affected. The proposed changes apply
 statewide.
 
 Projected Impact on Employment. No impact on employment is
 expected.
 
 Effects on the Use and Value of Private Property. No impact on
 the use and value of private property is expected.
 
 Real Estate Development Costs. No impact on real estate
 development costs is expected.
 
 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. Most if not all of the physical
 therapists work in offices that are small business. 
 
 Alternative Method that Minimizes Adverse Impact
 
 No adverse impact on small businesses is expected.
 
 Adverse Impacts:
 
 Businesses. The proposed amendments do not have an adverse
 impact on businesses.
 
 Localities. The proposed amendments will not adversely affect
 localities.
 
 Other Entities. The proposed amendments will not adversely
 affect other entities.
 
 ________________________
 
 1This guidance document posted on the Regulatory Town
 Hall on August 2010 can be found at: http://townhall.virginia.gov/L/GetFile.cfm?File=C:\TownHall\docroot\GuidanceDocs\223\GDoc_DHP_3650_v2.pdf
 
 2DHP is unaware of any complaints regarding the practice
 of dry needling by physical therapists at least since 2010 when the guidance
 was adopted.
 
 Agency's Response to Economic Impact Analysis: The Board
 of Physical Therapy concurs with the analysis of the Department of Planning and
 Budget.
 
 Summary:
 
 This action establishes the qualifications for and
 limitations of the performance of dry needling by physical therapists,
 including referral and direction from a medical practitioner, training,
 requirements for additional post-graduate training, the content of the
 post-graduate training, and informed consent.
 
 18VAC112-20-121. Practice of dry needling.
 
 A. Dry needling is an invasive procedure that requires
 referral and direction in accordance with § 54.1-3482 of the Code of
 Virginia. Referral should be in writing; if the initial referral is received
 orally, it shall be followed up with a written referral.
 
 B. Dry needling is not an entry level skill but an
 advanced procedure that requires additional [ post-graduate ]
 training. 
 
 [ 1. ] The training shall be specific to
 dry needling and shall include emergency preparedness and response,
 contraindications and precautions, secondary effects or complications,
 palpation and needle techniques, and physiological responses.
 
 [ 2. The training shall consist of didactic and
 hands-on laboratory education and shall include passage of a theoretical and
 practical examination. The hands-on laboratory education shall be face-to-face.
 
 3. The training shall be in a course certified by FSBPT or
 approved or provided by a sponsor listed in subsection B of 18VAC112-20-131.
 
 4. The practitioner shall not perform dry needling beyond
 the scope of the highest level of the practitioner's training. ] 
 
 C. Prior to the performance of dry needling, the physical
 therapist shall obtain informed consent from the patient or his representative.
 The informed consent shall include the risks and benefits of the technique
 [ and shall clearly state that the patient is not receiving an
 acupuncture treatment ]. The informed consent form shall be
 maintained in the patient record.
 
 [ D. Dry needling shall only be performed by a
 physical therapist trained pursuant to subsection B of this section and shall
 not be delegated to a physical therapist assistant or other support personnel. ]
 
 
 VA.R. Doc. No. R16-4433; Filed April 30, 2019, 2:49 p.m.