VOL. 30 ISS. 10 PUBLISHED EVERY OTHER WEEK BY THE VIRGINIA CODE COMMISSION JANUARY 13, 2014

THE VIRGINIA REGISTER OF REGULATIONS (USPS 001-831) is published biweekly by Matthew Bender & Company, Inc., 1275 Broadway, Albany, NY 12204-2694 for $209.00 per year. Periodical postage is paid in Albany, NY and at additional mailing offices. POSTMASTER: Send address changes to The Virginia Register of Regulations, 136 Carlin Road, Conklin, NY 13748-1531.

18VAC110-20. Regulations Governing the Practice of Pharmacy (Final) 1385

18VAC112-20. Regulations Governing the Practice of Physical Therapy (Fast-Track) 1387

18VAC125-15. Regulations Governing Delegation to an Agency Subordinate (Fast-Track) 1394

18VAC125-20. Regulations Governing the Practice of Psychology (Final) 1395

18VAC125-30. Regulations Governing the Certification of Sex Offender Treatment Providers (Final) 1395

18VAC160-20. Board for Waterworks and Wastewater Works Operators and Onsite Sewage System

Professionals Regulations (Proposed) 1396

Governor 1400

General Notices/Errata 1403

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. 29:5 VA.R. 1075-1192 November 5, 2012, refers to Volume 29, Issue 5, pages 1075 through 1192 of the Virginia Register issued on November 5, 2012.

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, Chairman; Gregory D. Habeeb; James M. LeMunyon; Ryan T. McDougle; Robert L. Calhoun; E.M. Miller, Jr.; Thomas M. Moncure, Jr.; Wesley G. Russell, Jr.; Charles S. Sharp; Robert L. Tavenner; Christopher R. Nolen; J. Jasen Eige.

Staff of the Virginia Register: Jane D. Chaffin, Registrar of Regulations; Karen Perrine, Assistant Registrar; Anne Bloomsburg, Regulations Analyst; Rhonda Dyer, Publications Assistant; Terri Edwards, Operations Staff Assistant.

This schedule is available on the Register's Internet home page (http://register.dls.virginia.gov).

January 2014 through March 2015

Volume: Issue	Material Submitted By Noon*	Will Be Published On
30:10	December 20, 2013 (Friday)	January 13, 2014
30:11	January 8, 2014	January 27, 2014
30:12	January 22, 2014	February 10, 2014
30:13	February 5, 2014	February 24, 2014
30:14	February 19, 2014	March 10, 2014
30:15	March 5, 2014	March 24, 2014
30:16	March 19, 2014	April 7, 2014
30:17	April 2, 2014	April 21, 2014
30:18	April 16, 2014	May 5, 2014
30:19	April 30, 2014	May 19, 2014
30:20	May 14, 2014	June 2, 2014
30:21	May 28, 2014	June 16, 2014
30:22	June 11, 2014	June 30, 2014
30:23	June 25, 2014	July 14, 2014
30:24	July 9, 2014	July 28, 2014
30:25	July 23, 2014	August 11, 2014
30:26	August 6, 2014	August 25, 2014
31:1	August 20, 2014	September 8, 2014
31:2	September 3, 2014	September 22, 2014
31:3	September 17, 2014	October 6, 2014
31:4	October 1, 2014	October 20, 2014
31:5	October 15, 2014	November 3, 2014
31:6	October 29, 2014	November 17, 2014
31:7	November 12, 2014	December 1, 2014
31:8	November 25, 2014 (Tuesday)	December 15, 2014
31:9	December 10, 2014	December 29, 2014
31:10	December 23, 2014 (Tuesday)	January 12, 2015
31:11	January 7, 2015	January 26, 2015
31:12	January 21, 2015	February 9, 2015
31:13	February 4, 2015	February 23, 2015
31:14	February 18, 2015	March 9, 2015

*Filing deadlines are Wednesdays unless otherwise specified.

TITLE 18. PROFESSIONAL AND OCCUPATIONAL LICENSING ‌

BOARD OF PHARMACY

Initial Agency Notice

Title of Regulation: 18VAC110-20. Regulations Governing the Practice of Pharmacy.

Statutory Authority: § 54.1-2400 of the Code of Virginia. Name of Petitioner: Daniel Colpo.

Nature of Petitioner's Request: Prohibit acceptance of coupons for dispensing as it has potential for medication safety concerns through incomplete DUR/Profile data and transcription errors.

Agency Plan for Disposition of Request: The petition has been filed with the Virginia Register of Regulations and will be published on January 13, 2014. Comment on the petition may be sent by email, regular mail, or posted on the Virginia Regulatory Townhall at www.townhall.virginia.gov; comment will be requested until February 12, 2014. Following receipt of all comments on the petition to amend regulations, the board will decide whether to make any changes to the regulatory language in Regulations Governing the Practice of Pharmacy. This matter will be on the board's agenda for its meeting scheduled for March 26, 2014.

Public Comment Deadline: February 12, 2014.

Agency Contact: Elaine Yeatts, Agency Regulatory Coordinator, Department of Health Professions, 9960 Mayland Drive, Henrico, VA 23233, telephone (804) 367- 4688, or email elaine.yeatts@dhp.virginia.gov.

VA.R. Doc. No. R14-04; Filed December 12, 2013, 3:22 p.m.

TITLE 4. CONSERVATION AND NATURAL RESOURCES ‌

DEPARTMENT OF MINES, MINERALS AND ENERGY

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 Mines, Minerals and Energy intends to consider amending 4VAC25-150, Virginia Gas and Oil Regulation. The purpose of the proposed action is to ensure the gas and oil regulation reflects current industry best practices and to expand disclosure of ingredients used in gas and oil well stimulation and completion on permitted gas and oil operations in the Commonwealth. The existing regulation will also be reviewed to determine if current requirements are sufficient to properly regulate drilling in different geographical areas of the Commonwealth.

The agency intends to hold a public hearing on the proposed action after publication in the Virginia Register.

Statutory Authority: §§ 45.1-161.3 and 45.1-361.27 of the Code of Virginia.

Public Comment Deadline: February 12, 2014.

Agency Contact: Michael Skiffington, Regulatory Coordinator, Department of Mines, Minerals and Energy, 1100 Bank Street, 8th Floor, Richmond, VA 23219-3402, telephone (804) 692-3212, FAX (804) 692-3237, TTY (800)

828-1120, or email mike.skiffington@dmme.virginia.gov.

VA.R. Doc. No. R14-3940; Filed December 20, 2013, 11:43 a.m.

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TITLE 12. HEALTH

DEPARTMENT OF MEDICAL ASSISTANCE SERVICES

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 Medical Assistance Services intends to consider amending 12VAC30-130, Amount, Duration and Scope of Selected Services. The purpose of the proposed action is to comply with Item 307 UU of Chapter 3 of the 2012 Acts of Assembly, Special Session I, by making programmatic changes to the Client Medical Management program to ensure appropriate utilization, prevent abuse of covered services, and promote improved and cost efficient medical management of essential Medicaid client health care. The proposed action will also assist and educate beneficiaries in appropriately utilizing medical and pharmacy services.

The agency does not intend to hold a public hearing on the proposed action after publication in the Virginia Register.

Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.

Public Comment Deadline: February 12, 2014.

Agency Contact: Brian McCormick, Regulatory Supervisor, Department of Medical Assistance Services, 600 East Broad Street, Suite 1300, Richmond, VA 23219, telephone (804)

371-8856, FAX (804) 786-1680, or email

brian.mccormick@dmas.virginia.gov.

VA.R. Doc. No. R14-2290; Filed December 16, 2013, 12:28 p.m.

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TITLE 18. PROFESSIONAL AND OCCUPATIONAL LICENSING

BOARD OF NURSING

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 Nursing intends to consider amending 18VAC90-20, Regulations of the Board of Nursing. The purpose of the proposed action is to amend provisions on inactive licensure and reinstatement of licensure to ensure that the requirements for evidence of continuing competency are consistent with those for renewal of an active license as a nurse. This action is in response to a petition for rulemaking.

The agency intends to hold a public hearing on the proposed action after publication in the Virginia Register.

Statutory Authority: § 54.1-2400 of the Code of Virginia. Public Comment Deadline: February 12, 2014.

Agency Contact: Jay P. Douglas, R.N., Executive Director, Board of Nursing, 9960 Mayland Drive, Suite 300, Richmond, VA 23233-1463, telephone (804) 367-4515, FAX

(804) 527-4455, or email jay.douglas@dhp.virginia.gov.

VA.R. Doc. No. R14-01; Filed December 18, 2013, 8:32 a.m.

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TITLE 22. SOCIAL SERVICES

STATE BOARD OF SOCIAL SERVICES

Withdrawal of 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 Social Services has WITHDRAWN the Notice of Intended Regulatory Action (NOIRA) for repealing 22VAC40-120, Minimum Standards for Licensed Family Day-Care Systems and promulgating 22VAC40-121, Standards for Licensed Family Day Systems, which was published in 27:12 VA.R. 1269 February 14, 2011. Due to the time this action has been pending, the

agency has decided to withdraw the NOIRA and determine its next course of action.

Statutory Authority: §§ 63.2-217 and 63.2-1734 of the Code of Virginia.

Public Comment Deadline: March 16, 2011.

Agency Contact: Karen Cullen, Division of Licensing Programs, Department of Social Services, 801 East Main Street, Richmond, VA 23219, telephone (804) 726-7152,

FAX (804) 726-7132, TTY (800) 828-1120, or email

karen.cullen@dss.virginia.gov.

VA.R. Doc. No. R11-2732; Filed December 16, 2013, 10:30 a.m.

Withdrawal of 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 Social Services has WITHDRAWN the Notice of Intended Regulatory Action (NOIRA) for repealing 22VAC40-180, Voluntary Registration of Family Day Homes - Requirements for Providers, and promulgating 22VAC40-181, Voluntary Registration of Family Day Homes - Requirements for Providers, which was published in 26:24 VA.R. 2784 August 2, 2010. Due to the time this action has been pending, the agency has decided to withdraw the NOIRA and determine its next course of action.

Statutory Authority: §§ 63.2-217 and 63.2-1704 of the Code of Virginia.

Agency Contact: Debra O'Neill, Children's Program Licensing Consultant, Department of Social Services, Division of Licensing Programs, 801 East Main Street, 9th Floor, Richmond, VA 23219, telephone (804) 726-7648,

FAX (804) 726-7132, TTY (800) 828-1120, or email

debra.oneill@dss.virginia.gov.

VA.R. Doc. No. R10-2243; Filed December 16, 2013, 10:31 a.m.

For information concerning the different types of regulations, see the Information Page.

Symbol Key

Roman type indicates existing text of regulations. Underscored language indicates proposed new text.

Language that has been stricken indicates proposed text for deletion. Brackets are used in final regulations to indicate changes from the proposed regulation.

TITLE 4. CONSERVATION AND NATURAL RESOURCES

DEPARTMENT OF FORESTRY

Proposed Regulation

Title of Regulation: 4VAC10-30. Virginia State Forests Regulations (amending 4VAC10-30-40, 4VAC10-30-120, 4VAC10-30-200, 4VAC10-30-210).

Statutory Authority: §§ 10.1-1101 and 10.1-1152 of the Code of Virginia.

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: March 14, 2014.

Agency Contact: Ronald S. Jenkins, Administrative Officer, Department of Forestry, 900 Natural Resources Drive, Suite 800, Charlottesville, VA 22903, telephone (434) 977-6555,

FAX (434) 293-2768, or email ron.jenkins@dof.virginia.gov.

Basis: Section 10.1-1101 of the Code of Virginia authorizes the Department of Forestry to promulgate regulations necessary or incidental to the performance of duties or execution of powers conferred under Chapter 11 (§ 10.1-1100 et seq.) of Title 10.1 of the Code of Virginia. Section 10.1- 1152 of the Code of Virginia, as amended by Chapter 484 of the 2012 Acts of Assembly, provides that a special use permit for certain activities on state forest lands shall be issued for a fee established by regulations promulgated by the department.

Purpose: The purpose of the proposed amendments is to better protect and serve the health, safety, and welfare of the public who use Virginia State Forests for their recreational activities or while working in the state forests for official business reasons. The authority to charge a fee is being transferred to regulations. The proposed amendments establish an annual fee of $15 for special use permits to hunt, trap, fish, ride bikes, and ride horses on state forest lands. The department adopted an emergency regulation effective September 18, 2012, and this action will ensure the authority granted under the emergency regulation continues as permanent authority.

Substance: The proposed amendments require that any person who hunts, fishes, traps, rides a bike, or rides a horse in a state forest is required to purchase an annual special use permit for a fee of $15.

Issues: The advantage to the agency is that the amendments will enable the agency to continue charging an annual $15 special permit fee for hunting, fishing, trapping, riding horses, and riding bikes on state forest lands. This fee was previously

established by statute, therefore, the proposed amendment is not expected to have any additional impact on the public. This regulatory action poses no disadvantages to the public or the Commonwealth.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The State Forester proposes to: 1) specify that the permit fee to hunt, trap, fish, ride bikes, or ride horses in a state forest is

$15, and 2) add clarifying language to the regulations.

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

Estimated Economic Impact. Prior to 2012, the Code of Virginia (§ 10.1-1152) stated that the State Forester is authorized, with the approval of the Board, to require any person who hunts, fishes, traps, rides mountain bikes, or rides horses on any of the lands described in § 10.1-1151 to obtain a special use permit. A special use permit to engage in these activities on any such lands would be issued for a fee, not to exceed $15 annually, as fixed by the State Forester. Permits to trap on such lands could be issued in combination with the hunting permits, or separately, at a fee not to exceed $15 annually for each such permit, to be fixed by the State Forester.

Chapter 484 of the 2012 Acts of Assembly removed the explicit $15 fee from statute, and instead specifies that the fee is to be established by regulations promulgated by the Department of Forestry. Therefore the State Forester proposes to set the fee as $15 in these regulations. As in practice the fee is not changing, this proposed amendment will have no impact beyond adding clarity. Increased clarity from this amendment and the other clarifying changes is potentially beneficial for interested parties in that they will need to spend less time in determining applicable requirements.

Businesses and Entities Affected. The proposed amendments affect the estimated 6,000 to 7,000 individuals who use state forests for hunting, trapping, fishing, biking or horseback riding.1

Localities Particularly Affected. The regulations potentially affect anyone interested in hunting, trapping, fishing, biking or horseback riding, but may particularly affect those who live near the state forests. The 22 state forests are located in the following counties: Appomattox, Bedford, Buckingham, Carroll, Craig, Cumberland, Essex, Fauquier, Grayson, King and Queen, King William, Lancaster, Nelson, New Kent, Prince Edward, Prince William, Rockbridge, Rockingham, Russell, Shenandoah, Sussex, and Washington.

Volume 30, Issue 10 Virginia Register of Regulations January 13, 2014

Projected Impact on Employment. The proposed amendments are unlikely to significantly affect employment.

Effects on the Use and Value of Private Property. The proposed amendments are unlikely to significantly affect the use and value of private property.

Small Businesses: Costs and Other Effects. The proposed amendments are unlikely to significantly affect small businesses.

Small Businesses: Alternative Method that Minimizes Adverse Impact. The proposed amendments are unlikely to significantly affect small businesses.

Real Estate Development Costs. The proposed amendments are unlikely to significantly affect real estate development costs.

Legal Mandate. The Department of Planning and Budget (DPB) has analyzed the economic impact of this proposed regulation in accordance with § 2.2-4007.04 of the Administrative Process Act and Executive Order Number 14 (10). Section 2.2-4007.04 requires that such economic impact analyses include, but need not be limited to, a determination of the public benefit, the projected number of businesses or other entities to whom the regulation would apply, the identity of any localities and types of businesses or other entities particularly affected, the projected number of persons and employment positions to be affected, the projected costs to affected businesses or entities to implement or comply with the regulation, and the impact on the use and value of private property. Further, if the proposed regulation has an adverse effect on small businesses, § 2.2-4007.04 requires that such economic impact analyses include (i) an identification and estimate of the number of small businesses subject to the regulation; (ii) the projected reporting, recordkeeping, and other administrative costs required for small businesses to comply with the regulation, including the type of professional skills necessary for preparing required reports and other documents; (iii) a statement of the probable effect of the regulation on affected small businesses; and (iv) a description of any less intrusive or less costly alternative methods of achieving the purpose of the regulation. The analysis presented above represents DPB's best estimate of these economic impacts.

1 Data source: Department of Forestry

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

Summary:

In accordance with Chapter 484 of the 2012 Acts of Assembly, the proposed amendments require any person 16 years of age or older who hunts, fishes, traps, rides a bike, or rides a horse in a state forest to purchase an annual special use permit for a fee of $15.

4VAC10-30-40. Permits.

A permit to do any act shall authorize the same only insofar as it may be performed in strict accordance with the terms and conditions thereof. Any violation by its holder or his agents or employees of any term or condition thereof shall constitute grounds for its revocation by the department, or by its authorized representative. In case of revocation of any permit, all moneys paid for or on account thereof shall, at the option of the department, be forfeited to and be retained by it; and the holder of such permit, together with his agents and employees who violated such terms and conditions, shall be jointly and severally liable to the department for all damages and loss suffered by it in excess of money so forfeited and retained; but neither such forfeiture and retention by the department of the whole or any part of such moneys nor the recovery or collection thereby of such damages, or both, shall in any manner relieve such person or persons from liability to punishment for any violation of any provision of any Virginia State Forests Regulation. A state forest ~~hunting~~ special use permit will be required to hunt or, trap, fish, ride bikes, or ride horses on any state forest or portion thereof on which hunting ~~and~~, trapping, fishing, riding bikes, or riding horses is permitted.

4VAC10-30-120. Charges.

No person 16 years of age or older shall make, use, or gain admittance to, or attempt to use or gain admittance to the facilities in any forest for the use of which a ~~charge~~ special use permit is ~~made~~ required by the department unless he shall ~~pay the charge or price fixed by the department~~ obtain a special use permit and pay an annual fee of $15. Any person under 16 years of age may hunt, trap, fish, ride bikes, or ride horses on any state forest and is not required to obtain a special use permit or pay an annual fee.

4VAC10-30-200. Hunting and fishing.

No person within the confines of any forest, shall hunt, trap, shoot, injure, kill or molest in any way any bird or animal, nor shall any person have in his possession any bird or animal, dead or alive, within the forest except any bird or animal designated as a game bird or animal by the Virginia Board of Game and Inland Fisheries, and the trapping of, hunting of, shooting at, or possession of any such bird or animal is prohibited except during the lawful hunting season set for the forest or portion thereof by the Virginia Board of Game and Inland Fisheries and only in those forests or portion thereof designated by the Forest Superintendent as lawful hunting areas. A state forest ~~hunting~~ special use permit will be required. All provisions of the Virginia Code concerning hunting must be complied with.

4VAC10-30-210. Fishing.

Fishing is permitted in designated areas in each forest, the only stipulation being that persons fishing must have a state fishing license, have a special use permit, and comply with the Virginia Game and Inland Fisheries rules and regulations.

VA.R. Doc. No. R13-3185; Filed December 16, 2013, 5:16 p.m.

MARINE RESOURCES COMMISSION

REGISTRAR'S NOTICE: The Marine Resources Commission is claiming an exemption from Article 2 of the Administrative Process Act in accordance with § 2.2-4006 A

11 of the Code of Virginia; however, the commission is required to publish the full text of final regulations.

Final Regulation

Title of Regulation: 4VAC20-252. Pertaining to the Taking of Striped Bass (amending 4VAC20-252-55, 4VAC20-252- 150).

Statutory Authority: § 28.2-201 of the Code of Virginia. Effective Date: January 1, 2014.

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

Summary:

The amendments (i) establish the 2014 Virginia recreational and commercial striped bass quotas as 1,402,325 pounds for each fishery, (ii) establish a 12- pound minimum weight for the coastal striped bass area fishery, and (iii) use the established 12-pound minimum weight to allocate striped bass tags in cases where harvesters reported an average striped bass weight lower than 12 pounds in the previous fishing year.

4VAC20-252-55. Recreational harvest quota.

The total allowable level of all recreational harvest of striped bass for all open seasons and for all legal gear shall be ~~1,230,110~~ 1,402,325 pounds of whole fish. At such time as the total recreational harvest of striped bass is projected to reach ~~1,230,110~~ 1,402,325 pounds, and announced as such, it shall be unlawful for any person to land or possess striped bass caught for recreational purposes.

4VAC20-252-150. Individual commercial harvest quota.

A. The commercial harvest quota for the Chesapeake area shall be determined annually by the Marine Resources Commission. The total allowable level of all commercial harvest of striped bass from the Chesapeake Bay and its tributaries and the Potomac River tributaries of Virginia for all open seasons and for all legal gear shall be ~~1,230,110~~ 1,402,325 pounds of whole fish. At such time as the total commercial harvest of striped bass from the Chesapeake area is projected to reach ~~1,230,110~~ 1,402,325 pounds, and announced as such, it shall be unlawful for any person to land or possess striped bass caught for commercial purposes from the Chesapeake area.

B. The commercial harvest quota for the coastal area of Virginia shall be determined annually by the Marine Resources Commission. The total allowable level of all commercial harvest of striped bass from the coastal area for all open seasons and for all legal gear shall be 184,853

pounds of whole fish. At such time as the total commercial harvest of striped bass from the coastal area is projected to reach 184,853 pounds, and announced as such, it shall be unlawful for any person to land or possess striped bass caught for commercial purposes from the coastal area.

C. For the purposes of assigning an individual's tags for commercial harvests in the Chesapeake area as described in 4VAC20-252-160, the individual commercial harvest quota of striped bass in pounds shall be converted to an estimate in numbers of fish per individual harvest quota based on the average weight of striped bass harvested by the permitted individual during the previous fishing year. The number of striped bass tags issued to each individual will equal the estimated number of fish to be landed by that individual harvest quota, plus a number of striped bass tags equal to 10% of the total allotment determined for each individual.

D. For the purposes of assigning an individual's tags for commercial harvests in the coastal area of Virginia as described in 4VAC20-252-160, the individual commercial harvest quota of striped bass in pounds shall be converted to a quota in numbers of fish per individual commercial harvest quota, based on the ~~estimate of the~~ reported average coastal area harvest weight of striped bass harvested by the permitted individual during the previous fishing year, except as described in subsection E of this section. The number of striped bass tags issued to each individual will equal the estimated number of fish to be landed by that individual harvest quota, plus a number of striped bass tags equal to 10% of the total allotment determined for each individual.

E. For any individual whose reported average coastal area harvest weight of striped bass in the previous fishing year was less than 12 pounds, a 12-pound minimum weight shall be used to convert that individual's harvest quota of striped bass, in pounds of fish, to harvest quota in number of fish.

VA.R. Doc. No. R14-3936; Filed December 18, 2013, 4:40 p.m.

Final Regulation

REGISTRAR'S NOTICE: The Marine Resources Commission is claiming an exemption from Article 2 of the Administrative Process Act in accordance with § 2.2-4006 A

11 of the Code of Virginia; however, the commission is required to publish the full text of final regulations.

Title of Regulation: 4VAC20-490. Pertaining to Sharks (amending 4VAC20-490-41).

Statutory Authority: § 28.2-201 of the Code of Virginia. Effective Date: January 1, 2014.

Volume 30, Issue 10 Virginia Register of Regulations January 13, 2014

Summary:

The amendments establish a maximum smooth dogfish fin-to-carcass weight ratio of 12% and extend the time period commercial fishermen may process smooth dogfish at sea to year round.

4VAC20-490-41. Commercial catch limitations.

A. It shall be unlawful for any person to possess on board a vessel or to land in Virginia more than 33 commercially permitted nonsandbar large coastal sharks in one 24-hour period. The person who owns or operates the vessel is responsible for compliance with the provisions of this subsection.

B. It shall be unlawful for any person to fillet a shark until that shark is offloaded at the dock or on shore, except smooth dogfish as provided in subsection C of this section. A licensed commercial fisherman may eviscerate and remove the head of any shark, but the tail and all fins of any shark, except smooth dogfish as provided in subsection C of this section, shall remain naturally attached to the carcass through landing. The fins of any shark, except smooth dogfish, may be partially cut but some portion of the fin shall remain attached, until the shark is landed.

C. ~~From July 1 through the end of February, commercial~~ ~~fishermen may process smooth dogfish at sea, except the first~~ ~~dorsal fin shall remain attached naturally to the carcass until~~ ~~landed. From March 1 through June 30, commercial~~ Virginia licensed commercial fishermen may completely process smooth dogfish at sea prior to landing., except that it shall be unlawful for anyone to land or possess on board any vessel any amount of processed smooth dogfish whereby the total weight of fins exceeds 12% of the total dressed weight of any smooth dogfish.

D. It shall be unlawful to possess, on board a vessel, or to land in Virginia any species of shark, after NOAA Fisheries has closed the fishery for that species in federal waters.

E. There are no commercial trip limits or possession limits for smooth dogfish or sharks on the lists of commercially permitted pelagic species or commercially permitted small coastal species.

F. Except as described in this section, it shall be unlawful for any person to take, harvest, land, or possess in Virginia any blacktip, bull, great hammerhead, lemon, nurse, scalloped hammerhead, silky, smooth hammerhead, spinner, or tiger shark from May 15 through July 15. These sharks may be transported by vessel, in Virginia waters, during the closed season provided the sharks were caught in a legal manner consistent with federal regulations outside Virginia waters and:

1. The vessel does not engage in fishing, in Virginia waters, while possessing the above species; and

2. All fishing gear aboard the vessel is stowed and not available for immediate use.

G. It shall be unlawful for any person to retain, possess, or purchase any commercially prohibited shark or any research only shark, except as provided in subsection I of this section.

H. All sharks harvested from state waters or federal waters, for commercial purposes, shall only be sold to a federally permitted shark dealer.

I. The commissioner may grant exemptions from the seasonal closure, quota, possession limit, size limit, gear restrictions, and prohibited species restrictions. Exemptions shall be granted only for display or research purposes. Any person granted an exemption for the harvest of any shark for research or display shall report the species, weight, location caught, and gear used for each shark collected within 30 days. Any person granted a permit to possess any shark for research or display shall provide the commissioner, on an annual basis, information on the location and status of the shark throughout the life of the shark.

VA.R. Doc. No. R14-3939; Filed December 18, 2013, 3:34 p.m.

Emergency Regulation

Title of Regulation: 4VAC20-490. Pertaining to Sharks (amending 4VAC20-490-10, 4VAC20-490-42).

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

Effective Dates: January 1, 2014, through January 30, 2014.

Preamble:

This emergency action changes the amount in pounds, from 3,300 to 4,000, of spiny dogfish that can be taken, possessed aboard any vessel, or landed for commercial purposes in Virginia.

4VAC20-490-10. Purpose.

The purpose of this emergency chapter is to ensure the conservation of shark resources by preventing overfishing by commercial and recreational fisheries and to control the practice of finning.

4VAC20-490-42. Spiny dogfish commercial quota and catch limitations.

A. For the 12-month period of May 1, 2013, through April 30, 2014, the spiny dogfish commercial landings quota shall be limited to 4,408,894 pounds.

B. It shall be unlawful for any person to take, possess aboard any vessel or land in Virginia any spiny dogfish harvested from federal waters for commercial purposes after it has been announced that the federal quota for spiny dogfish has been taken.

C. It shall be unlawful for any person to take, possess aboard any vessel or land in Virginia more than ~~3,300~~ 4,000 pounds of spiny dogfish per day for commercial purposes.

D. It shall be unlawful for any person to harvest or to land in Virginia any spiny dogfish for commercial purposes after the quota specified in subsection A of this section has been landed and announced as such.

E. Any spiny dogfish harvested from state waters or federal waters, for commercial purposes, shall only be sold to a federally permitted dealer.

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

VA.R. Doc. No. R14-3941; Filed December 18, 2013, 4:03 p.m.

REGISTRAR'S NOTICE: The Marine Resources Commission is claiming an exemption from Article 2 of the Administrative Process Act in accordance with § 2.2-4006 A

11 of the Code of Virginia; however, the commission is required to publish the full text of final regulations.

Final Regulation

Title of Regulation: 4VAC20-500. Pertaining to the Catching of Eels (amending 4VAC20-500-20, 4VAC20- 500-40, 4VAC20-500-50, 4VAC20-500-55, 4VAC20-500-

60; adding 4VAC20-500-35, 4VAC20-500-45).

Statutory Authority: § 28.2-201 of the Code of Virginia. Effective Date: January 1, 2014.

Summary:

The amendments establish (i) a gear-specific harvest season closure for all commercial gears, except pots and traps, from September 1 through December 31; (ii) a recreational possession limit of 25 eels per individual per day; (iii) a 9-inch minimum recreational and commercial size limit; and (iv) a charter and head boat possession limit of 50 eels per captain and crew per day.

4VAC20-500-20. Definition.

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

"Eel" or "eels," as described in this chapter, means the eel species Anguilla rostrata.

"Elver" means any eel of less than six inches in total length.

"Land" or "landing" means to enter port with eels on board any boat or vessel, to begin offloading eels, or to offload eels.

4VAC20-500-35. Minimum size limit.

It shall be unlawful for any individual to take, catch, possess, or land any eels less than nine inches in length.

4VAC20-500-40. Elvers.

It shall be unlawful for any ~~person~~ individual to possess elvers; provided, however, that elvers may be taken (i) for research only by duly appointed representatives of any institution of higher education in Virginia and by other parties when specifically authorized in writing by the Commissioner of Marine Resources or (ii) by those ~~persons~~ individuals who are approved for a permit for eel aquaculture by the commission.

4VAC20-500-45. Commercial season.

It shall be unlawful for any individual to harvest, take, catch, possess, or land any eels from September 1 through December 31 from any commercial gear, except from pots and traps.

4VAC20-500-50. Minimum mesh size.

A. It shall be unlawful for any ~~person~~ individual to place, set, or fish any eel pot in Virginia tidal waters which has a mesh less than 1/2-inch by 1/2-inch.

B. It shall be unlawful for any ~~person~~ individual to place, set, or fish any 1/2-inch by 1/2-inch mesh rectangular or square eel pot unless such pot contains at least one unrestricted 4-inch by 4-inch escape panel consisting of 1/2- inch by 1-inch mesh. In addition, it shall be unlawful for any ~~person~~ individual to place, set, or fish any 1/2-inch by 1/2- inch mesh cylindrical eel pot unless such pot contains at least one unrestricted 4-inch square escape panel of 1/2-inch by 1- inch mesh.

4VAC20-500-55. Possession limit.

A. It shall be unlawful for any ~~person~~ individual fishing with recreational hook and line, rod and reel, spear, gig, or other recreational gear to possess more than 50 25 eels per day, except as described in subsection B of this section for charter boats and head boats. When fishing is from a boat or vessel where the entire catch is held in a common hold or container, the possession limit shall be for the boat or vessel and shall be equal to the number of ~~persons~~ individuals on board legally eligible to fish multiplied by 50 25, except as described in subsection B of this section for charter boats and head boats. The captain or operator of the boat or vessel shall be responsible for any boat or vessel possession limit. Any eel taken after the possession limit has been reached shall be returned to the water immediately.

B. It shall be unlawful for any captain or mate of any legally licensed charter boat or head boat to possess more than 50 eels per day. When fishing is from a charter boat or head boat, where the entire catch is held in a common hold or container, the possession limit shall be for the charter boat or head boat and shall be equal to the number of captains and mates on board legally eligible to fish multiplied by 50. Passengers on any charter boat or head boat shall possess no

Volume 30, Issue 10 Virginia Register of Regulations January 13, 2014

more than 25 eels per passenger per day. The captain or operator of the charter boat or head boat shall be responsible for any possession limit. Any eel taken after the possession limit has been reached shall be returned to the water immediately.

C. Possession of any quantity of eel ~~which~~ that exceeds the possession limit described in subsection A or B of this section shall be presumed to be for commercial purposes.

4VAC20-500-60. Penalty.

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

VA.R. Doc. No. R14-3937; Filed December 18, 2013, 3:04 p.m.

REGISTRAR'S NOTICE: The Marine Resources Commission is claiming an exemption from Article 2 of the Administrative Process Act in accordance with § 2.2-4006 A

11 of the Code of Virginia; however, the commission is required to publish the full text of final regulations.

Final Regulation

Title of Regulation: 4VAC20-900. Pertaining to Horseshoe Crab (amending 4VAC20-900-21, 4VAC20-900-25, 4VAC20-900-35, 4VAC20-900-39, 4VAC20-900-45,

4VAC20-900-50; adding 4VAC20-900-26; repealing 4VAC20-900-36).

Statutory Authority: § 28.2-201 of the Code of Virginia. Effective Date: January 1, 2014.

Summary:

The amendments (i) establish the 2014 Virginia horseshoe crab commercial quota as no greater than 172,828 horseshoe crabs; (ii) establish a quota category- specific licensing system; (iii) establish quota category- specific daily vessel trip limits; (iv) establish a dredge gear prohibition in the Virginia Blue Crab Sanctuary Area; and (v) establish permit eligibility requirements for individuals who have received a horseshoe crab license or permit transfer from May 1, 2011, through December 10, 2013.

4VAC20-900-21. License Permit requirements and exemption.

A. The taking by hand of as many as five horseshoe crabs in any one day only for ~~personal use only~~ noncommercial use shall be exempt from the licensing requirements.

B. ~~Except as provided for in 4VAC20-900-25 G 3, it~~ It shall be unlawful for any ~~boat or vessel~~ individual to land horseshoe crabs in Virginia for commercial purposes without first obtaining ~~either type of horseshoe crab endorsement~~ ~~license~~ a horseshoe crab permit as described in this section. ~~The~~ A valid horseshoe crab ~~endorsement license~~ permit shall be required of each ~~boat or vessel used~~ individual to land horseshoe crabs for commercial purposes. Possession of any quantity of horseshoe crabs that exceeds the limit described in subsection A of this section shall be presumed for commercial purposes. ~~There shall be no fee for the license.~~

C. To be eligible for an unrestricted horseshoe crab endorsement license, the boat or vessel shall have landed and sold at least 500 horseshoe crabs in Virginia in at least one year during the period 1998 through 2000.

1. The owner shall complete an application for each boat or vessel by providing to the Marine Resources Commission a notarized and signed statement of applicant's name, address, and telephone number, and boat or vessel name and its registration or documentation number.

2. The owner shall complete a notarized authorization to allow the Marine Resources Commission to obtain copies of landings data from the National Marine Fisheries Service.

C. It shall be unlawful for any individual to take, catch, possess, or land any horseshoe crab by trawl gear without first having obtained a Horseshoe Crab Trawl Permit. The Horseshoe Crab Trawl Permit shall only be issued to a Virginia registered commercial fisherman who was issued an unrestricted horseshoe crab endorsement license or horseshoe crab bycatch permit prior to the license moratorium of May 1, 2011, and meets either of the criteria in subdivision 1 or 2 of this subsection:

1. Shall have documentation of a minimum harvest amount of one horseshoe crab at any time from January 1, 1993, through December 31, 2010, by trawl gear in the commission's mandatory harvest reporting system; or

2. Shall have documentation of a minimum harvest amount of one horseshoe crab at any time from January 1, 2004, through December 31, 2010, by trawl gear in the federal dealer reports to the Standard Atlantic Fisheries Information System.

D. To be eligible for a restricted horseshoe crab endorsement license that is limited to using a crab dredge to harvest horseshoe crabs, a Virginia registered commercial fisherman's boat or vessel shall have landed at least 10,000 pounds of whelk in any one year from 2002 through 2005.

1. The Virginia registered commercial fisherman shall complete an application for each boat or vessel by providing to the Marine Resources Commission a notarized and signed statement of applicant's name, address, and telephone number, and boat or vessel name and its registration or documentation number.

2. The Virginia registered commercial fisherman shall complete a notarized authorization to allow the Marine Resources Commission to obtain copies of whelk landings data from the National Marine Fisheries Service.

D. It shall be unlawful for any individual to take, catch, possess, or land any horseshoe crab by dredge gear without first having obtained either and only one of the following two available horseshoe crab dredge permits: a Horseshoe Crab Class A Dredge Permit or a Horseshoe Crab Class B Dredge Permit. The Horseshoe Crab Class A Dredge Permit shall only be issued to a Virginia registered commercial fisherman who was issued an unrestricted horseshoe crab endorsement license prior to the license moratorium of May 1, 2011, and meets either of the criteria in subdivision 1 or 2 of this subsection. The Horseshoe Crab Class B Dredge Permit shall only be issued to a Virginia registered commercial fisherman who was issued a restricted horseshoe crab endorsement license or a horseshoe crab bycatch permit prior to the license moratorium of May 1, 2011, and meets either of the criteria in subdivision 1 or 2 of this subsection.

1. Shall have documentation of a minimum harvest amount of one horseshoe crab at any time from January 1, 1993, through December 31, 2010, by dredge gear in the commission's mandatory harvest reporting system; or

2. Shall have documentation of a minimum harvest amount of one horseshoe crab at any time from January 1, 2004, through December 31, 2010, by dredge gear in the federal dealer reports to the Standard Atlantic Fisheries Information System.

E. ~~To be eligible for a horseshoe crab hand harvester permit,~~ ~~the individual shall have been issued~~ It shall be unlawful for any individual to take, catch, possess, or land any horseshoe crab by hand harvest without first having obtained a Horseshoe Crab Hand Harvest Permit. The Horseshoe Crab Hand Harvest Permit shall only be issued to a Virginia registered commercial fisherman who was issued a horseshoe crab hand harvester permit, prior to the license moratorium of May 1, 2011, ~~and shall have documented on Virginia~~ ~~mandatory harvest reporting forms a minimum harvest of one~~ ~~horseshoe crab by hand harvest methods, at any time from~~ ~~1993 through 2010.~~ and shall have documentation of a minimum harvest amount of one horseshoe crab at any time from January 1, 1993, through December 31, 2010, by hand harvest in the commission's mandatory harvest reporting system.

F. It shall be unlawful for any registered commercial fisherman or seafood landing licensee who does not possess any type of a valid horseshoe crab endorsement license or horseshoe crab hand harvester permit to possess horseshoe crabs, without first obtaining a valid horseshoe crab bycatch permit from the Marine Resources Commission.

F. It shall be unlawful for any individual to take, catch, possess, or land any horseshoe crab by pound net without first having obtained a Horseshoe Crab Pound Net Permit. The

Horseshoe Crab Pound Net Permit shall only be issued to a Virginia registered commercial fisherman who was issued an unrestricted horseshoe crab endorsement license or horseshoe crab bycatch permit prior to the license moratorium of May 1, 2011, and meets either of the criteria in subdivision 1 or 2 of this subsection:

1. Shall have documentation of a minimum harvest amount of one horseshoe crab at any time from January 1, 1993, through December 31, 2010, by pound net in the commission's mandatory harvest reporting system; or

2. Shall have documentation of a minimum harvest amount of one horseshoe crab at any time from January 1, 2004, through December 31, 2010, by pound net in the federal dealer reports to the Standard Atlantic Fisheries Information System.

G. It shall be unlawful for any individual to take, catch, possess, or land any horseshoe crab by any method other than trawl, dredge, pound net, or hand harvest without first having obtained a Horseshoe Crab General Category Permit. The Horseshoe Crab General Category Permit shall only be issued to a Virginia registered commercial fisherman who was issued an unrestricted horseshoe crab endorsement license or horseshoe crab bycatch permit prior to the license moratorium of May 1, 2011.

4VAC20-900-25. Commercial fisheries management measures.

A. It shall be unlawful for any ~~person~~ individual to harvest horseshoe crabs from any shore or tidal waters of Virginia within 1,000 feet in any direction of the mean low water line from May 1 through June 7. The harvests of horseshoe crabs for biomedical use shall not be subject to this limitation.

B. From January 1 through June 7 of each year, it shall be unlawful for any ~~person~~ individual to land, in Virginia, any horseshoe crab harvested from federal waters.

C. Harvests for biomedical purposes shall require a special permit issued by the Commissioner of Marine Resources, and all crabs taken pursuant to such permit shall be returned to the same waters from which they were collected.

D. The commercial quota of horseshoe crab for ~~2013~~ 2014 shall be 172,828 horseshoe crabs. Additional quantities of horseshoe crab may be transferred to Virginia by other jurisdictions, in accordance with the provisions of Addendum I to the Atlantic States Marine Fisheries Commission Fishery Management Plan for Horseshoe Crab, April 2000, provided that the combined total of the commercial quota and transfer from other jurisdictions shall not exceed 355,000 horseshoe crabs. It shall be unlawful for any ~~person~~ individual to harvest from Virginia waters, or to land in Virginia, any horseshoe crab for commercial purposes after any calendar-year commercial quota of horseshoe crab has been attained and announced as such.

1. The horseshoe crab commercial trawl gear quota is equal to 12.488% of the commercial quota of horseshoe crabs described in this subsection or 21,583 horseshoe crabs.

2. The horseshoe crab commercial dredge gear quota is equal to 40.348% of the commercial quota of horseshoe crabs described in this subsection or 69,733 horseshoe crabs.

3. The horseshoe crab commercial hand harvest quota is equal to 22.095% of the commercial quota of horseshoe crabs described in this subsection or 38,186 horseshoe crabs.

4. The horseshoe crab commercial pound net quota is equal to 18.142% of the commercial quota of horseshoe crabs described in this subsection or 31,354 horseshoe crabs.

5. The horseshoe crab commercial general category quota is equal to 6.927% of the commercial quota of horseshoe crabs described in this subsection or 11,972 horseshoe crabs.

E. It shall be unlawful for any ~~person~~ individual to harvest or land horseshoe crabs during any calendar year from waters east of the COLREGS ~~line~~ Line by any gear after 81,331 male horseshoe crabs have been landed and announced as such, and the following provisions shall also apply:

1. It shall be unlawful for any ~~person~~ individual to harvest or land any female horseshoe crabs from waters east of the COLREGS ~~line~~ Line.

2. It shall be unlawful for any ~~person~~ individual to harvest or land any amount of horseshoe crabs from waters east of the COLREGS ~~line~~ Line by any gear, except for trawl or dredge gear.

3. It shall be unlawful for any valid Horseshoe Crab Trawl Permittee or Horseshoe Crab Class A Dredge Permittee to take, catch, possess, or land more than 1,250 male horseshoe crabs from waters east of the COLREGS Line when it is projected and announced that 65,065 male horseshoe crabs have been landed from waters east of the COLREGS Line.

4. It shall be unlawful for any valid Horseshoe Crab Class B Dredge Permittee to take, catch, possess, or land more than 500 male horseshoe crabs from waters east of the COLREGS Line when it is projected and announced that 65,065 male horseshoe crabs have been landed from waters east of the COLREGS Line.

F. For the purposes of this regulation, no horseshoe crab shall be considered a male horseshoe crab unless it possesses at least one modified, hook-like appendage as its first pair of walking legs.

G. Limitations on the daily harvest and possession of horseshoe crabs for any vessel described below are as follows:

1. It shall be unlawful for any ~~person who holds a~~ valid ~~unrestricted horseshoe crab endorsement license~~ Horseshoe

Crab Trawl Permittee, as described in 4VAC20-900-21 C, to possess aboard any vessel or to land any number of horseshoe crabs in excess of 2,500~~, except that when~~ per day. When it is projected and announced that 80% of the horseshoe crab commercial trawl gear quota is has been taken, it shall be unlawful for any ~~person who meets the~~ ~~requirements of 4VAC20-900-21 C and holds a valid~~ ~~horseshoe crab endorsement license~~ valid Horseshoe Crab Trawl Permittee to possess aboard any vessel ~~in Virginia~~ or to land any number of horseshoe crabs in excess of 1,250 per day. When it is projected and announced that 100% of the horseshoe crab commercial trawl quota is taken, it shall be unlawful for any valid Horseshoe Crab Trawl Permittee to possess or land any horseshoe crab taken by trawl gear.

2. It shall be unlawful for any valid Horseshoe Crab Class A Dredge Permittee, as described in 4VAC20-900-21 D, to possess aboard any vessel or to land any number of horseshoe crabs in excess of 2,500 per day. When it is projected and announced that 80% of the horseshoe crab commercial dredge gear quota has been taken, it shall be unlawful for any valid Horseshoe Crab Class A Dredge Permittee to possess aboard any vessel or to land any number of horseshoe crabs in excess of 1,250 per day. When it is projected and announced that 100% of the horseshoe crab commercial dredge gear quota has been taken, it shall be unlawful for any valid Horseshoe Crab Class A Dredge Permittee to possess or land any horseshoe crab taken by dredge gear.

2. 3. It shall be unlawful for any ~~person who holds a~~ valid ~~restricted horseshoe crab endorsement license~~ Horseshoe Crab Class B Dredge Permittee, as described in 4VAC20- 900-21 D, to possess aboard any vessel or to land any number of horseshoe crabs in excess of 1,000~~, except that~~ ~~when~~ per day. When it is projected and announced that 80% of the horseshoe crab commercial dredge gear quota is has been taken, it shall be unlawful for any ~~person who~~ ~~meets the requirements of 4VAC20-900-21 D, and holds a~~ valid ~~horseshoe crab endorsement license~~ Horseshoe Crab Class B Dredge Permittee to possess aboard any vessel in ~~Virginia~~ or to land any number of horseshoe crabs in excess of 500 per day. ~~The harvest of horseshoe crabs,~~ ~~described in this subdivision, shall be restricted to using~~ ~~only crab dredge.~~ When it is projected and announced that 100% of the horseshoe crab commercial dredge gear quota has been taken, it shall be unlawful for any valid Horseshoe Crab Class B Dredge Permittee to possess or land any horseshoe crab taken by dredge gear.

3. It shall be unlawful for a horseshoe crab bycatch permittee to possess aboard any vessel more than 500 horseshoe crabs or for any vessel to land any number of horseshoe crabs in excess of 500 per day except as described in subdivision 4 of this subsection. When it is projected and announced that 80% of the commercial quota is taken, it shall be unlawful for any person with a horseshoe crab bycatch permit to possess aboard any vessel

more than 250 horseshoe crabs or for any vessel to land any number of horseshoe crabs in excess of 250 per day except as described in subdivision 4 of this subsection.

4. It shall be unlawful for any valid Horseshoe Crab Hand Harvest Permittee, as described in 4VAC20-900-21 E, to possess aboard any vessel or to land any number of horseshoe crabs in excess of 500 per day. When it is projected and announced that 80% of the horseshoe crab commercial hand harvest quota has been taken, it shall be unlawful for any valid Horseshoe Crab Hand Harvest Permittee to possess aboard any vessel or to land any number of horseshoe crabs in excess of 250 per day. When it is projected and announced that 100% of the horseshoe crab commercial hand harvest quota has been taken, it shall be unlawful for any valid Horseshoe Crab Hand Harvest Permittee to possess or land any horseshoe crab taken by hand.

5. It shall be unlawful for any valid Horseshoe Crab Pound Net Permittee, as described in 4VAC20-900-21 F, to possess aboard any vessel or to land any number of horseshoe crabs in excess of 500 per day. When it is projected and announced that 80% of the horseshoe crab commercial pound net quota has been taken, it shall be unlawful for any valid Horseshoe Crab Pound Net Permittee to possess aboard any vessel or to land any number of horseshoe crabs in excess of 250 per day. When it is projected and announced that 100% of the horseshoe crab commercial pound net quota has been taken, it shall be unlawful for any valid Horseshoe Crab Pound Net Permittee to possess or land any horseshoe crab taken by pound net.

6. It shall be unlawful for any valid Horseshoe Crab General Category Permittee, as described in 4VAC20-900- 21 G, to possess aboard any vessel or to land any number of horseshoe crabs in excess of 250 per day. When it is projected and announced that 80% of the horseshoe crab commercial general category quota has been taken, it shall be unlawful for any valid Horseshoe Crab General Category Permittee to possess aboard any vessel or to land any number of horseshoe crabs in excess of 125 per day. When it is projected and announced that 100% of the horseshoe crab commercial general category quota has been taken, it shall be unlawful for any valid Horseshoe Crab General Category Permittee to possess or land any horseshoe crab taken by gear other than trawl, dredge, pound net, or by hand.

4. 7. It shall be unlawful for any two ~~horseshoe crab~~ ~~bycatch permittees~~ valid Horseshoe Crab Hand Harvest Permittees when fishing from the same boat or vessel to possess or land more than 1,000 horseshoe crabs per day. When it is projected and announced that 80% of the horseshoe crab commercial hand harvest quota is has been taken, it shall be unlawful for any two ~~horseshoe crab~~ ~~bycatch permittees~~ valid Horseshoe Crab Hand Harvest

Permittees fishing from the same boat or vessel to possess or land more than 500 horseshoe crabs per day.

5. It shall be unlawful for any registered commercial fisherman or seafood landing licensee who does not possess a horseshoe crab endorsement license or a horseshoe crab bycatch permit to possess any horseshoe crabs.

6. 8. It shall be unlawful for any ~~person who possesses a~~ ~~horseshoe crab endorsement license or a horseshoe crab~~ ~~bycatch permit~~ valid Horseshoe Crab General Category Permittee to harvest horseshoe crabs by gill net, except as described in this subdivision.

a. Horseshoe crabs shall only be harvested from a gill net, daily, after sunrise and before sunset.

b. It shall be unlawful for any person to land horseshoe crabs caught by a gill net in excess of 250 horseshoe crabs per day.

c. b. It shall be unlawful for any ~~person~~ individual to harvest or possess horseshoe crabs taken by any gill net that has a stretched mesh measure equal to or greater than six inches, unless the twine size of that gill net is equal to or greater than 0.81 millimeters in diameter (0.031 inches), and that ~~person~~ individual possesses his own valid commercial striped bass permit or his own black drum harvesting and selling permit, as well as either a horseshoe crab endorsement license or horseshoe crab bycatch permit.

H. From April 1 through June 30, in the Toms Cove Area, it shall be unlawful for any ~~person~~ individual to place, set, or fish any gill net, except as described in this subsection.

1. From April 1 through May 31, any gill net licensed as over 600 feet and up to 1,200 feet in length shall have at least one anchored end 800 feet from the mean low water line.

2. From June 1 through June 30, it shall be unlawful to place, set, or fish any gill net after sunset or before sunrise.

I. It shall be unlawful for any ~~fisherman issued a horseshoe~~ ~~crab endorsement license~~ valid Horseshoe Crab Trawl Permittee, Horseshoe Crab Class A Dredge Permittee, or Horseshoe Crab Class B Dredge Permittee to offload any horseshoe crabs between the hours of 10 p.m. and 7 a.m.

J. When it is projected and announced that 65,065 of the commercial quota, as described in subsection E of this section, has been taken from waters east of the COLREGS Line, the limitations on the possession and landing of male horseshoe crabs are as follows:

1. It shall be unlawful for any person who possesses a valid unrestricted horseshoe crab endorsement license to possess aboard any vessel in waters east of the COLREGS Line or to land more than 1,250 male horseshoe crabs per day.

2. It shall be unlawful for any person who possesses a valid restricted horseshoe crab endorsement license to possess

aboard any vessel in waters east of the COLREGS Line or to land more than 500 male horseshoe crabs per day.

3. It shall be unlawful for any person who possesses a valid horseshoe crab bycatch permit to possess aboard any vessel east of the COLREGS Line or to land more than 250 male horseshoe crabs per day.

4. It shall be unlawful for any two horseshoe crab bycatch permittees fishing from the same boat or vessel, east of the COLREGS Line, to possess or land more than 500 male horseshoe crabs per day.

4VAC20-900-26. Commercial gear restricted area.

It shall be unlawful for any person to harvest any horseshoe crabs by dredge gear within Virginia Blue Crab Sanctuary Area 2 as described in 4VAC20-752-20. The Virginia Blue Crab Sanctuary Area 2 consists of all tidal waters of the Chesapeake Bay that are bounded by a line beginning at the mean low water line of Willoughby Spit at its intersection with the center line of the Hampton Roads Bridge Tunnel facility, Latitude 36° 58.0456514' N, Longitude 76° 17.8459721' W; thence in a northwesterly direction to a point 200 feet offshore of mean low water, Latitude 36° 58.0637717' N, Longitude 76° 17.8812821' W; thence and following a line in a general easterly direction, said line being 200 feet offshore of the mean low water line, to a point on Ocean View Fishing Pier (formerly Harrison's Fishing Pier), Latitude 36° 57.6985477' N, Longitude 76° 15.5855211' W; thence northeasterly to Thimble Shoal Light, Latitude 37° 00.8708333' N, Longitude 76° 14.3970000' W; thence northeasterly to Cape Charles Lighthouse, Latitude 37° 07.3743333' N, Longitude 75° 54.3898333' W; thence southwesterly along the COLREGS Line to its intersection with the mean low water line of Cape Henry, Latitude 36° 55.6885268' N, Longitude 76° 00.3772955' W; thence, in a general westerly direction, following the mean low water line of the Chesapeake Bay, crossing the mouth of the Lynnhaven River along the north side of the Lesner Bridge and the mouth of Little Creek at the offshore ends of the stone breakwaters and continuing along said mean low water line to a point at its intersection with the center line of the Hampton Roads Bridge Tunnel facility, said point being the point of beginning.

4VAC20-900-35. Monitoring requirements.

A. Any ~~person~~ individual harvesting or landing horseshoe crabs in Virginia shall report monthly on forms provided by the Marine Resources Commission all harvests of horseshoe crabs including, but not limited to, bait fisheries, bycatch, biomedical industry, and scientific and educational research harvests. Reporting requirements shall consist of numbers and pounds landed by sex, harvest method and harvest location.

B. It shall be unlawful for ~~a restricted or unrestricted~~ ~~horseshoe crab endorsement license holder~~ any valid Horseshoe Crab Trawl Permittee, Horseshoe Crab Class A Dredge Permittee, or Horseshoe Crab Class B Dredge Permittee to fail to contact the Marine Resources Operations Station prior to ~~the vessel issued a horseshoe crab~~

~~endorsement license~~ offloading horseshoe crabs. The horseshoe crab ~~endorsement license holder~~ permittee shall provide the Marine Resources Commission the name of the vessel and its captain and the anticipated or approximate offloading time and site. Following offloading, the horseshoe crab ~~endorsement license holder~~ permittee shall contact the Marine Resources Operation Station and provide the total number of horseshoe crabs landed, gear type, and location of harvest.

C. It shall be unlawful for any ~~horseshoe crab bycatch~~ ~~permittee or horseshoe crab hand harvester permittee~~ valid Horseshoe Crab Pound Net Permittee, Horseshoe Crab Hand Harvest Permittee, or Horseshoe Crab General Category Permittee to fail to contact the Virginia Marine Resources Commission Interactive-Voice-Response (IVR) System within 24 hours of landing and provide his Commercial Fisherman Registration License number, and the time, date, number of horseshoe crabs landed, gear type, and location of harvest.

D. It shall be unlawful for any ~~person~~ individual, firm, or corporation to buy any horseshoe crabs from any lawful harvester on or after July 1, 2007, without first having obtained a Horseshoe Crab Buying Permit from the Marine Resources Commission. The permit application shall be completed in full by the licensed seafood buyer, and a copy of the permit shall be kept in possession of the licensed buyer while buying or possessing horseshoe crabs.

E. Any licensed seafood buyer permitted to purchase horseshoe crabs shall provide written reports to the Marine Resources Commission of daily purchases and harvest information on forms provided by the Marine Resources Commission. Such information shall include the date of the purchase, the buyer's horseshoe crab permit number and harvester's Commercial Fisherman Registration License number, gear type used, water area fished, city or county of landing, and number of female horseshoe crabs and male horseshoe crabs purchased. These reports of any current weekly purchases shall be completed in full and submitted to the Marine Resources Commission no later than Thursday of the following week. In addition, once it has been projected and announced that ~~85% of the commercial quota of~~ ~~horseshoe crab has been landed or 69,131 of the commercial~~ ~~quota of horseshoe crab established for the horseshoe crab~~ ~~harvest~~ 65,065 male horseshoe crabs have been landed from waters east of the COLREGS Line ~~has been landed~~, each permitted buyer shall call the Marine Resources Commission's IVR on a daily basis to report his name and permit number, date, number of female horseshoe crabs and number of male horseshoe crabs purchased, gear used, and water area fished by the harvester.

F. ~~Persons~~ Individuals harvesting horseshoe crabs for biomedical use and owners of facilities using horseshoe crabs for biomedical purposes shall monitor and report monthly to the Marine Resources Commission all harvests or purchases

of horseshoe crabs and the percentage of mortality up to the point of release including that mortality ~~which~~ that occurs during harvest, shipping, handling, and bleeding.

G. Owners of biomedical facilities using horseshoe crabs shall participate in the tagging program of the Marine Resources Commission to evaluate the post-release mortality of horseshoe crabs.

H. Monthly reports shall be due to the Marine Resources Commission no later than the fifth day of the following month.

4VAC20-900-36. Quota allocation. (Repealed.)

A. When it has been projected and announced that 40.348% of the commercial quota, as described in 4VAC20-900-25 D, has been landed by dredge gears, it shall be unlawful for any person to harvest or land horseshoe crabs caught by dredge gears.

B. When it has been projected and announced that 12.488% of the commercial quota, as described in 4VAC20-900-25 D, has been landed by trawl gears, it shall be unlawful for any person to harvest or land horseshoe crabs caught by trawl gears.

C. When it has been projected and announced that 22.095% of the commercial quota, as described in 4VAC20-900-25 D, has been landed by horseshoe crab hand harvester permittees, it shall be unlawful for any person to harvest or land horseshoe crabs caught by hand harvesting.

D. When it has been projected and announced that 18.142% of the commercial quota, as described in 4VAC20-900-25 D, has been landed by pound nets, it shall be unlawful for any person to harvest or land horseshoe crabs caught by pound net.

E. When it has been projected and announced that 6.927% of the commercial quota, as described in 4VAC20-900-25 D, has been landed by gears not described in subsections A through D of this section, it shall be unlawful for any person to harvest or land horseshoe crabs by gears not described in subsections A through D of this section.

4VAC20-900-39. Permit transfers.

A. The commissioner or his designee may approve transfers of a horseshoe crab ~~license or~~ permit, as described in 4VAC20-900-21, to any individual who meets any of the following criteria:

1. Demonstrates a significant hardship on the basis of health and provides the commissioner documentation by an attending physician of the medical condition.

2. Demonstrates a significant hardship on the basis of a call to active military duty and provides the commissioner an explanation in writing and copy of the military orders for active duty.

3. Documents the death of an immediate family member eligible for a horseshoe crab license or permit and

possessing a legal Commercial Fisherman Registration License.

B. The documented harvest history of a former horseshoe crab licensee or permittee, in the commission's mandatory harvest reporting system, whose horseshoe crab license or permit has been transferred in accordance with subsection A of this section from May 1, 2011, through December 10, 2013, shall be considered when determining permit requirements of any individual receiving the transferred license or permit.

4VAC20-900-45. Requirements of authorized agents.

A. It shall be unlawful for any ~~person~~ individual to serve as an agent for a horseshoe crab hand harvest permittee.

B. Any ~~person~~ individual serving as an agent to harvest horseshoe crabs for any lawful licensed or permitted horseshoe crab fisherman, except as described in subsection A of this section, shall be limited to the use of only one registered commercial fisherman's horseshoe crab license or permit.

4VAC20-900-50. Penalty.

VA.R. Doc. No. R14-3938; Filed December 19, 2013, 12:07 p.m.

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TITLE 6. CRIMINAL JUSTICE AND CORRECTIONS

CRIMINAL JUSTICE SERVICES BOARD

Fast-Track Regulation

Title of Regulation: 6VAC20-110. Rules Relating to Compulsory Minimum Training Standards for Private Security Services Business Personnel (repealing 6VAC20- 110-10 through 6VAC20-110-90).

Statutory Authority: §§ 9.1-102 and 9.1-141 of the Code of Virginia.

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: February 12, 2014.

Effective Date: February 27, 2014.

Agency Contact: Lisa McGee, Regulatory Manager, Department of Criminal Justice Services, 1100 Bank Street, Richmond, VA 23219, telephone (804) 371-2419, FAX (804) 786-6344, or email lisa.mcgee@dcjs.virginia.gov.

Basis: The Governor's 2012 Regulatory Reform Initiative instructed all agencies to conduct a comprehensive review of

regulations currently in place and repeal regulations that are unnecessary or no longer in use. These regulations have been replaced by current regulations promulgated pursuant to § 9.1-141 of the Code of Virginia and in accordance with the § 2.2-4012.1 of the Code of Virginia.

Purpose: The regulatory chapter no longer serves its intended purpose and was replaced by newly promulgated regulations in July 1994. Repealing these regulations is not expected to have any impact on public health, safety, or welfare.

Rationale for Using Fast-Track Process: The department is seeking to repeal the entire chapter 6VAC20-110. These regulations have not been enforced since they were replaced with a new chapter, 6VAC20-170, in 1994, which has since been repealed and replaced with the current chapter 6VAC20- 171.

Substance: This action repeals existing regulations because they have been superseded and are therefore obsolete.

Issues: These regulations have not been enforced since they were replaced in 1994. 6VAC20-171 is in effect and governs the private security services industry, and these regulations are obsolete. The advantage to the public and the agency of repealing these regulations is that such action would eliminate unnecessary regulations. There are no known disadvantages to the public or the agency.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The Criminal Justice Services Board (Board) proposes to repeal this regulation.

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

Estimated Economic Impact. According to the Department of Criminal Justice Services, the Rules Relating to Compulsory Minimum Training Standards for Private Securities Business Personnel (6VAC20-110) became obsolete in 1994 when they were replaced by the Regulations Relating to Private Security Services (6VAC20-170), which included the training standards for private security services business personnel. Thus these regulations have not been in use since 1994 and repealing them will have no impact beyond helping eliminate potential confusion by readers of the administrative code.1

Businesses and Entities Affected. The proposed repeal of these regulations will not directly affect any businesses or entities.

Localities Particularly Affected. The proposed repeal does not disproportionately affect particular localities.

Projected Impact on Employment. The proposed repeal will not affect employment.

Effects on the Use and Value of Private Property. The proposed repeal will not significantly affect the use and value of private property.

Small Businesses: Costs and Other Effects. The proposed repeal will not affect costs for small businesses.

Small Businesses: Alternative Method that Minimizes Adverse Impact. The proposed repeal does not adversely affect small businesses.

Real Estate Development Costs. The proposed repeal does not affect real estate development costs.

(i) an identification and estimate of the number of small businesses subject to the regulation; (ii) the projected reporting, recordkeeping, and other administrative costs required for small businesses to comply with the regulation, including the type of professional skills necessary for preparing required reports and other documents; (iii) a statement of the probable effect of the regulation on affected small businesses; and (iv) a description of any less intrusive or less costly alternative methods of achieving the purpose of the regulation. The analysis presented above represents DPB's best estimate of these economic impacts.

1 The Regulations Relating to Private Security Services (6VAC20-170) was subsequently repealed in 2000 and replaced with Regulations Relating to Private Security Services (6VAC20-171), which are currently in effect.

Agency's Response to the Department of Planning and Budget's economic impact analysis: The Department of Criminal Justice Services concurs generally with the economic impact analysis of the Department of Planning and Budget.

Summary:

Pursuant to the Governor's 2012 Regulatory Reform Initiative, the amendments repeal regulations that are unnecessary because they are no longer in use.

VA.R. Doc. No. R14-3824; Filed December 18, 2013, 1:52 p.m.

FORENSIC SCIENCE BOARD

Fast-Track Regulation

Title of Regulation: 6VAC40-50. Regulations for the Approval of Marijuana Field Tests for Detection of Marijuana Plant Material (amending 6VAC40-50-10 through 6VAC40-50-60, 6VAC40-50-80).

Statutory Authority: §§ 9.1-1110 and 19.2-188.1 of the Code of Virginia.

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: February 13, 2014.

Effective Date: February 27, 2014.

Agency Contact: Stephanie Merritt, Department Counsel, Department of Forensic Science, 700 North Fifth Street, Richmond, VA 23219, telephone (804) 786-2281, or email stephanie.merritt@dfs.virginia.gov.

Basis: Section 19.2-188.1 of the Code of Virginia requires the department to evaluate and, where applicable, approve field tests for the detection of marijuana, pursuant to regulations adopted in accordance with the Administrative Process Act, for use by law-enforcement officials. Law-enforcement officers may then testify to the results of department- approved field tests at certain misdemeanor trials. The proposed amendments to the Regulations for the Approval of Marijuana Field Tests for Detection of Marijuana Plant Material were adopted by the Forensic Science Board pursuant to §§ 9.1-1101 and 9.1-1110 of the Code of Virginia.

Purpose: The Regulations for the Approval of Marijuana Field Tests for Detection of Marijuana Plant Material (6VAC40-50) assist law enforcement and the criminal justice system by providing information critical to criminal charging decisions and subsequent trials for the misdemeanor possession of marijuana. This process positively impacts judicial economy and, in turn, due process. Ultimately, the ability of law enforcement and the courts to rely on the results of marijuana field tests protects the health, safety, and welfare of the citizens of the Commonwealth.

Unlike the recent proposed amendments to the Regulations for the Approval of Field Tests for the Detection of Drugs (6VAC40-30), the department determined the marijuana field test kit manufacturers need not be required to pay the cost of the street drug preparation for this evaluation process because of the availability of the material, low material costs, relative stability in the field test market, and low rate of disapproval.

Rationale for Using Fast-Track Process: The proposed amendments to 6VAC40-50 are minor and do not alter existing, substantive procedures. In September 2012, the department conducted a periodic review of this regulation and received no public comment. Likewise, the Forensic Science Board discussed and voted to adopt these proposed amendments at its January 2013 public meeting, and no

member of the public offered a comment. Therefore, the department does not anticipate these proposed amendments will be controversial.

Substance: In addition to nonsubstantive verbiage changes regarding the "evaluation" process, the proposed amendments clarify the resubmission process by noting that resubmitted requests for approval shall be accompanied by a detailed explanation of all modifications or changes to the test, the test instructions, or the manufacturer's claims since the most recent evaluation. This procedure merely formalizes the current practice in which the department and field test manufacturers discuss issues surrounding the resubmission of a previously disapproved field test.

Issues: The proposed clarification of the existing language and resubmission procedure will inform and, therefore, benefit the public, stakeholders, and kit manufacturers. The public generally benefits from the efficient and neutral field test evaluation process to the extent the proper use of department-approved marijuana field tests assist law- enforcement officials with criminal charging decisions and facilitate the judicial process. To the extent the amendments require additional information from a kit manufacturer seeking to resubmit following a disapproval, which is rare for marijuana field tests, the proposed amendments could minimally impact four out-of-state kit manufacturers. The proposed amendments emphasize the neutrality of the evaluation process and clarify resubmission procedures after disapproval. The department is unaware of any disadvantages to the agency or the Commonwealth. The department is unaware of any disadvantage to the public or the Commonwealth and expects the proposed amendments will generally benefit the Commonwealth and its citizens.

Small Business Impact Report of Findings: This regulatory action serves as the report of 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. The Forensic Science Board (Board) proposes to amend language in these regulations in order to improve clarity.

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

Estimated Economic Impact. The Regulations for the Approval of Marijuana Field Tests for Detection of Marijuana Plant Material concern the evaluation/approval of marijuana field test kits submitted by manufacturers. The evaluation/approval of the marijuana field test kits assists law enforcement and the criminal justice system by providing information critical to criminal charging decisions and subsequent trials for the misdemeanor possession of marijuana. This process positively impacts judicial economy and, in turn, due process. Ultimately, the ability of law enforcement and the courts to rely on the results of marijuana

field tests protects the health, safety and welfare of the citizens of the Commonwealth.

The Board's proposed language amendments do not change any requirements in practice. Thus, the proposed amendments will have no impact beyond providing a small benefit through a potential reduction in confusion concerning the requirements by readers of the regulations.

Businesses and Entities Affected. The regulations affect the four manufacturers of marijuana field test kits who have or have indicated an interest in submitting field test kits for evaluation/approval. All four firms are located outside of the Commonwealth.

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

Projected Impact on Employment. The proposed amendments are unlikely to significantly affect employment.

Effects on the Use and Value of Private Property. The proposed amendments are unlikely to significantly affect the use and value of private property.

Small Businesses: Costs and Other Effects. The proposed amendments are unlikely to significantly affect small businesses within the Commonwealth.

Small Businesses: Alternative Method that Minimizes Adverse Impact. The proposed amendments are unlikely to significantly affect small businesses in the Commonwealth.

Real Estate Development Costs. The proposed amendments are unlikely to significantly affect real estate development costs.

presented above represents DPB's best estimate of these economic impacts.

Agency's Response to Economic Impact Analysis: The Department of Forensic Science concurs with the economic impact analysis prepared by the Department of Planning and Budget.

Summary:

The proposed amendments change verbiage relating to the Department of Forensic Science's assessment of marijuana field test kits pursuant to § 19.2-188.1 of the Code of Virginia from an "approval" process to an "evaluation" process and clarify the procedure for resubmitting requests for evaluation after disapproval.

Part I Definitions

6VAC40-50-10. Definitions.

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

"Agency" means any federal, state or local government law- enforcement organization in the Commonwealth.

"Approval authority" means the Director of the Department of Forensic Science or his designee.

"Department" means the Department of Forensic Science.

"List of approved marijuana field tests" means a list of Duquenois-Levine field tests approved by the department for use by law-enforcement agencies in the Commonwealth and periodically published by the department in the Virginia Register of Regulations in accordance with § 19.2-188.1 B of the Code of Virginia.

"Manufacturer" means any entity that makes or assembles marijuana field tests or marijuana field test kits to be used by any law-enforcement officer or agency in the Commonwealth for the purpose of detecting marijuana plant material.

"Manufacturer's instructions and claims" means those testing procedures, requirements, instructions, precautions and proposed conclusions that are published by the manufacturer and supplied with the marijuana field tests or marijuana field test kits.

"Marijuana" means marijuana as defined in § 18.2-247 of the Code of Virginia.

"Marijuana field test" means any Duquenois-Levine test unit used outside of a chemical laboratory environment to detect the presence of marijuana plant material.

"Marijuana field test kit" means a combination of individual marijuana field test units.

Part II

Process for Approval of Field Tests

6VAC40-50-20. Authority for approval.

Section 19.2-188.1 B of the Code of Virginia provides that the Department of Forensic Science shall approve marijuana

field tests for use by law-enforcement officers to enable them to testify to the results obtained in any trial for a violation of

§ 18.2-250.1 of the Code of Virginia regarding whether or not any plant material, the identity of which is at issue, is marijuana.

6VAC40-50-30. Request for approval evaluation.

A. Any manufacturer who wishes to ~~have~~ submit marijuana field tests or marijuana field test kits ~~approved~~ for evaluation pursuant to this chapter shall submit a written request for ~~approval~~ evaluation to the department director at the following address:

Director

Department of Forensic Science 700 North Fifth Street Richmond, VA 23219

B. Materials sufficient for at least 10 marijuana field tests shall be supplied by each manufacturer. The materials shall include all instructions, precautions, color charts, flow charts and the like which are provided with the marijuana field test or marijuana field test kit and that describe the use and interpretation of the tests.

C. The manufacturer shall also include exact specifications as to the chemical composition of all chemicals or reagents used in the marijuana field tests. These shall include the volume or weight of the chemicals and the nature of their packaging. Material safety data sheets for each chemical or reagent shall be sufficient for this purpose.

D. ~~This approval~~ The department's evaluation process may require up to 90 days from the receipt of the written request and all needed materials from the manufacturer.

E. The department will use marijuana plant material to assess those marijuana field tests submitted for ~~approval~~ evaluation. In order to be approved, the marijuana field test must correctly and consistently react in a clearly observable fashion to the naked eye, and perform in accordance with manufacturer's instructions and claims.

6VAC40-50-40. Notice of approval decision.

The department will notify each manufacturer in writing of the approval or disapproval of each test for which ~~approval~~ evaluation was requested. Should any test not be approved, the manufacturer may resubmit their request for ~~approval~~ evaluation of that marijuana field test according to the previously outlined procedures ~~at any time~~ along with a detailed explanation of all alterations or changes to the test or related instructions or claims since the department's disapproval of the previously submitted test.

6VAC40-50-50. Maintenance of approved status.

The department may require that this ~~approval~~ evaluation be done as often as annually for routine purposes. If any modifications are made to an approved marijuana field test by the manufacturer, the department shall be notified in writing of the changes. If unreported modifications are discovered by

the department, the department may require that ~~all testing~~ ~~and approval~~ evaluations be repeated for the particular manufacturers' approved marijuana field tests. The department shall notify the manufacturer in writing of this requirement. Any modified marijuana field test must be approved before it can be used in accordance with § 19.2-

188.1 B of the Code of Virginia. These changes shall include, but are not limited to, any chemical, procedural or instructional modifications made to the marijuana field test.

6VAC40-50-60. Publication.

Upon completion of such ~~testing~~ evaluations and in concurrence with the approval authority, the department will periodically publish a list of approved marijuana field tests in the General Notices section of the Virginia Register of Regulations. The department will also periodically publish the list on its website. The department may, in addition, provide copies of its approved list to any law-enforcement agency. The department may share any information or data developed from this testing with these agencies.

Part III Fees

6VAC40-50-80. Fees.

Manufacturers will be charged a fee of $50 for each marijuana field test for which individual ~~approval~~ evaluation is requested. The department will ~~evaluate~~ review the ~~manufacturers~~' manufacturer's request and notify ~~them~~ the manufacturer in writing of the amount due before ~~testing~~ evaluation begins. Manufacturers who wish to withdraw a request for ~~approval~~ evaluation shall immediately notify the department in writing ~~of the amount due before testing~~ ~~begins. Manufacturers who wish to withdraw a request for~~ ~~approval shall immediately notify the department in writing~~. The department's assessment of the amount of payment required will be based upon a detailed ~~evaluation~~ review of the manufacturer's request and that amount will be final. ~~Approval will not be granted~~ The evaluation process will not be initiated before full payment is made to the Treasurer of Virginia.

VA.R. Doc. No. R14-3821; Filed December 19, 2013, 1:42 p.m.

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TITLE 8. EDUCATION

STATE BOARD OF EDUCATION

Fast-Track Regulation

Title of Regulation: 8VAC20-640. Regulations Governing Substitute Teachers (repealing 8VAC20-640-10).

Statutory Authority: §§ 22.1-16 and 22.1-30 of the Code of Virginia.

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: February 12, 2014.

Effective Date: February 27, 2014.

Agency Contact: Anne Wescott, Assistant Superintendent for Policy and Communications, Department of Education, 101 North 14th Street, 25th Floor, Richmond, VA 23219, telephone (804) 225-2403, or email anne.wescott@doe.virginia.gov.

Chapter 644 of the 2013 Acts of Assembly removes the requirement that the Board of Education promulgate regulations concerning temporarily employed teachers.

Purpose: The Governor's 2012 Regulatory Reform Initiative was established to repeal regulations that are unnecessary or no longer in use; reduce unnecessary regulatory burdens on individuals, businesses, and other regulated groups; and identify statutes that require unnecessary or overly burdensome regulations. Repealing this regulation is necessary to comport with the Governor's 2012 Regulatory Reform Initiative. Repealing this regulation will have no impact on the public health, safety, or welfare.

Rationale for Using Fast-Track Process: Repeal of the regulation is not expected to be controversial because Chapter 644 of the 2013 Acts of Assembly passed the General Assembly unanimously, and there was no opposition from any of the education organizations or other entities during the General Assembly discussion of the bill. The regulations simply duplicate the provisions already in the Code of Virginia.

Substance: The amendments repeal regulations that duplicate provisions of the Code of Virginia.

Issues: The advantage of repealing these regulations is that such action would eliminate unnecessary regulations. There are no disadvantages.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The Board of Education (Board) proposes to repeal these regulations.

Result of Analysis. Repealing these regulations will have no economic impact.

Estimated Economic Impact. The regulations in their entirety state that substitute teachers must: 1) be a minimum of 18 years of age (21 years of age preferred), 2) possess good moral character, 3) have earned a high school diploma or GED, and 4) attend orientation to school policies and procedures conducted by the local school division. The minimum age and high school diploma/GED requirements are explicitly stated in Virginia Code § 22.1-302, while the

moral character and orientation requirements are not. Thus by eliminating the regulations, the Board is eliminating requirements that substitute teachers "possess good moral character" and "attend orientation to school policies and procedures conducted by the local school division." The Department of Education does not expect this to have any practical impact, as most school divisions have historically had more stringent standards than what was contained within the regulation.

Businesses and Entities Affected. These regulations concern the 132 public school divisions in the Commonwealth.

Localities Particularly Affected. Repealing these regulations does not disproportionately affect particular localities.

Projected Impact on Employment. Repealing these regulations will not affect employment.

Effects on the Use and Value of Private Property. Repealing these regulations will not affect the use and value of private property.

Small Businesses: Costs and Other Effects. Repealing these regulations will not affect small businesses.

Small Businesses: Alternative Method that Minimizes Adverse Impact. Repealing these regulations will not affect small businesses.

Real Estate Development Costs. Repealing these regulations will not affect real estate development costs.

Agency's Response to Economic Impact Analysis: The State Board of Education concurs with the economic impact

Volume 30, Issue 10 Virginia Register of Regulations January 13, 2014

analysis completed by the Department of Planning and Budget.

Summary:

Chapter 644 of the 2013 Acts of Assembly removed the mandate that the Board of Education promulgate regulations concerning temporarily employed teachers. This action repeals the associated regulations as unnecessary.

VA.R. Doc. No. R14-3778; Filed December 19, 2013, 11:07 a.m.

Fast-Track Regulation

Title of Regulation: 8VAC20-700. Regulations for Conducting Division-Level Academic Reviews (repealing 8VAC20-700-10 through 8VAC20-700-50).

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

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: February 12, 2014.

Effective Date: February 27, 2014.

Purpose: The Governor's 2012 Regulatory Reform Initiative was established to repeal regulations that are unnecessary or no longer in use; reduce unnecessary regulatory burdens on individuals, businesses, and other regulated groups; and identify statutes that require unnecessary or overly burdensome regulations. Repealing this regulation is necessary to comport with the Governor's Regulatory Reform Initiative. Repealing these regulations will have no impact on public health, safety, or welfare.

Rationale for Using Fast-Track Process: Repeal of the regulation is not expected to be controversial. The Department of Education has determined that the regulations duplicate provisions in guidance documents and are not needed.

Substance: The amendments repeal regulations pertaining to conducting division-level academic reviews.

Issues: The advantage of repealing these regulations is that such action would eliminate unnecessary regulations. There are no disadvantages.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The Board of Education (Board) proposes to repeal these regulations.

Result of Analysis. Repealing these regulations will have no economic impact.

Estimated Economic Impact. House Bill 1294 of the 2004 Virginia General Assembly amended Code of Virginia

§ 22.1-253.13:3 to allow the Board to conduct division-level academic reviews when the failure of schools within a division to achieve full accreditation status is related to division-level failure to implement the Standards of Quality. The bill also instructed the Board to promulgate regulations to implement the provisions of the act.

Senate Bill 1201 of the 2013 Virginia General Assembly eliminated the statutory requirement for the Board to promulgate these regulations. The Board now proposes to repeal the regulations. According to the Department of Education, all of the provisions in the regulations are also in guidance documents. Thus repealing the regulations will not change the provisions in practice.

Businesses and Entities Affected. These regulations concern the Board of Education, the Department of Education, and the 132 public school divisions in the Commonwealth.

Localities Particularly Affected. These regulations particularly affect localities with poorly performing schools.

Projected Impact on Employment. Repealing these regulations is unlikely to affect employment.

Effects on the Use and Value of Private Property. Repealing these regulations is unlikely to affect the use and value of private property.

Small Businesses: Costs and Other Effects. Repealing these regulations is unlikely to affect small businesses.

Small Businesses: Alternative Method that Minimizes Adverse Impact. Repealing these regulations is unlikely to affect small businesses.

Real Estate Development Costs. Repealing these regulations is unlikely to affect real estate development costs.

regulation has adverse effect on small businesses, § 2.2- 4007.04 requires that such economic impact analyses include

Agency's Response to Economic Impact Analysis: The agency concurs with the economic impact analysis completed by the Department of Planning and Budget.

Summary:

This action repeals the Regulations for Conducting Division-Level Academic Reviews.

VA.R. Doc. No. R14-3791; Filed December 19, 2013, 11:08 a.m.

Fast-Track Regulation

Title of Regulation: 8VAC20-710. Regulations Governing the Process for Submitting Proposals to Consolidate School Divisions (repealing 8VAC20-710-10, 8VAC20- 710-20, 8VAC20-710-30).

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

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: February 12, 2014.

Effective Date: February 27, 2014.

Basis: Section 22.1-16 of the Code of Virginia provides the general authority for the Board of Education to promulgate such regulations as may be necessary to carry out its powers and duties and the provisions of Title 22.1 of the Code of Virginia. Chapter 644 of the 2013 Acts of Assembly removes the requirement that the Board of Education promulgate regulations concerning the process for submitting proposals for the consolidation of school divisions.

Purpose: The Governor's 2012 Regulatory Reform Initiative was established to repeal regulations that are unnecessary or no longer in use; reduce unnecessary regulatory burdens on individuals, businesses, and other regulated groups; and identify statutes that require unnecessary or overly burdensome regulations. Repealing this regulation is necessary to comport with the Governor's Regulatory Reform Initiative. Repealing these regulations will have no impact on public health, safety, or welfare.

Rationale for Using Fast-Track Process: Repeal of the regulation is not expected to be controversial. The regulations simply duplicate the provisions already in the Code of Virginia and are, therefore, unnecessary.

Substance: The amendments repeal regulations that duplicate provisions of the Code of Virginia.

Issues: The advantage of repealing these regulations is that such action would eliminate unnecessary regulations. There are no disadvantages.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The Board of Education proposes to repeal these regulations.

Result of Analysis. Repealing these regulations will have no economic impact.

Estimated Economic Impact. These regulations duplicate language in the Code of Virginia. Thus repealing these regulations will have no economic impact.

Businesses and Entities Affected. Repealing these regulations will not affect the 132 public school divisions in the Commonwealth.

Localities Particularly Affected. Repealing these regulations will not affect localities.

Projected Impact on Employment. Repealing these regulations will not affect employment.

Effects on the Use and Value of Private Property. Repealing these regulations will not affect the use and value of private property.

Small Businesses: Costs and Other Effects. Repealing these regulations will not affect small businesses.

Small Businesses: Alternative Method that Minimizes Adverse Impact. Repealing these regulations will not affect small businesses.

Real Estate Development Costs. Repealing these regulations will not affect real estate development costs.

(i) an identification and estimate of the number of small businesses subject to the regulation; (ii) the projected

Volume 30, Issue 10 Virginia Register of Regulations January 13, 2014

reporting, recordkeeping, and other administrative costs required for small businesses to comply with the regulation, including the type of professional skills necessary for preparing required reports and other documents; (iii) a statement of the probable effect of the regulation on affected small businesses; and (iv) a description of any less intrusive or less costly alternative methods of achieving the purpose of the regulation. The analysis presented above represents DPB's best estimate of these economic impacts.

Agency's Response to Economic Impact Analysis: The agency concurs with the economic impact analysis completed by the Department of Planning and Budget.

Summary:

Chapter 644 of the 2013 Acts of Assembly removed the mandate that the Board of Education promulgate regulations to provide a process whereby school divisions may submit proposals for the consolidation of school divisions to the Board of Education. This action repeals the associated regulations as unnecessary.

VA.R. Doc. No. R14-3792; Filed December 19, 2013, 11:09 a.m.

 –––––––––––––––––– 

TITLE 9. ENVIRONMENT

STATE AIR POLLUTION CONTROL BOARD

Final Regulation

Summary:

The amendments update state regulations that incorporate by reference certain federal regulations to reflect the Code of Federal Regulations as published on July 1, 2013. The new standards in the federal regulations that are being incorporated into the regulations by reference are as follows:

1. Three new source performance standards (NSPSs) are being modified: Subpart KKK, Equipment Leaks of VOC from Onshore Natural Gas Processing Plants for which Construction, Reconstruction, or Modification Commenced after January 20, 1984, and on or before August 23, 2011 (40 CFR 60.630-636); Subpart LLL, SO2 Emissions from Onshore Natural Gas Processing for which Construction, Reconstruction, or Modification Commenced after January 20, 1984, and on or before August 23, 2011 (40 CFR 60.640-648); and Subpart F, Portland Cement Plants (40 CFR 60.60-60.66). Three NSPSs are being added: Subpart Ga, Nitric Acid Plants for which Construction, Reconstruction, or Modification Commenced after October 14, 2011 (40 CFR 60.70a-77a); Subpart OOOO, Crude Oil and Natural Gas Production, Transmission and Distribution (40 CFR 60.5360-5430); and Subpart Ja, Petroleum Refineries for which Construction, Reconstruction, or Modification Commenced after May 14, 2007 (40 CFR 60.100a-109a).

REGISTRAR'S NOTICE: The following regulatory action is exempt from Article 2 of the Administrative Process Act in accordance with § 2.2-4006 A 4 c of the Code of Virginia, which excludes regulations that are necessary to meet the requirements of federal law or regulations provided such regulations do not differ materially from those required by federal law or regulation. The State Air Pollution Control Board will receive, consider, and respond to petitions by any interested person at any time with respect to reconsideration or revision.

2. One maximum achievable control technology (MACT) is being incorporated: Subpart DDDDD, Industrial, Commercial, and Institutional Boilers and Process Heaters--major sources (40 CFR 63.7480 through 40 CFR 63.7575).

Titles of Regulations: 9VAC5-50. New and Modified Stationary Sources (Rev. I13) (amending 9VAC5-50-400, 9VAC5-50-410).

9VAC5-60. Hazardous Air Pollutant Sources (Rev. I13) (amending 9VAC5-60-60, 9VAC5-60-90, 9VAC5-60-100).

Statutory Authority: § 10.1-1308 of the Code of Virginia;

§ 112 of the Clean Air Act; 40 CFR Parts 61 and 63.

Effective Date: July 1, 2014.

Agency Contact: Karen G. Sabasteanski, Department of Environmental Quality, 629 East Main Street, P.O. Box 1105, Richmond, VA 23218, telephone (804) 698-4426, FAX (804)

698-4510, TTY (804) 698-4021, or email

karen.sabasteanski@deq.virginia.gov.

Article 5

Environmental Protection Agency Standards of Performance for New Stationary Sources (Rule 5-5)

9VAC5-50-400. General.

The U.S. Environmental Protection Agency Regulations on Standards of Performance for New Stationary Sources (NSPSs), as promulgated in 40 CFR Part 60 and designated in 9VAC5-50-410 are, unless indicated otherwise, incorporated by reference into the regulations of the board as amended by the word or phrase substitutions given in 9VAC5-50-420. The complete text of the subparts in 9VAC5-50-410 incorporated herein by reference is contained in 40 CFR Part 60. The 40 CFR section numbers appearing under each subpart in 9VAC5-50-410 identify the specific provisions of the subpart incorporated by reference. The specific version of the provision adopted by reference shall be that contained in the CFR ~~(2012)~~ (2013) in effect July 1, ~~2012~~ 2013. In making reference to the Code of Federal Regulations, 40 CFR Part 60 means Part 60 of Title 40 of the Code of Federal Regulations; 40 CFR 60.1 means 60.1 in Part 60 of Title 40 of the Code of Federal Regulations.

9VAC5-50-410. Designated standards of performance.

Subpart A - General Provisions.

40 CFR 60.1 through 40 CFR 60.3, 40 CFR 60.7, 40 CFR

60.8, 40 CFR 60.11 through 40 CFR 60.15, 40 CFR 60.18

through 40 CFR 60.19

(applicability, definitions, units and abbreviations, notification and recordkeeping, performance tests, compliance, circumvention, monitoring requirements, modification, reconstruction, general control device requirements, and general notification and reporting requirements)

Subpart B - Not applicable. Subpart C - Not applicable. Subpart Ca - Reserved.

Subpart Cb - Not applicable. Subpart Cc - Not applicable. Subpart Cd - Not applicable. Subpart Ce - Not applicable.

Subpart D - Fossil Fuel-Fired Steam Generators.

40 CFR 60.40 through 40 CFR 60.46

(fossil fuel-fired steam generating units of more than 250 million Btu per hour heat input rate, and fossil fuel-fired and wood residue-fired steam generating units capable of firing fossil fuel at a heat input rate of more than 250 million Btu per hour)

Subpart Da - Electric Utility Steam Generating Units.

40 CFR 60.40Da through 40 CFR 60.52Da

(electric utility steam generating units capable of combusting more than 250 million Btu per hour heat input of fossil fuel (either alone or in combination with any other fuel), and for which construction, reconstruction, or modification is commenced after September 18, 1978)

Subpart Db - Industrial-Commercial-Institutional Steam Generating Units.

40 CFR 60.40b through 40 CFR 60.49b

(industrial-commercial-institutional steam generating units which have a heat input capacity from combusted fuels of more than 100 million Btu per hour)

Subpart Dc - Small Industrial-Commercial-Institutional Steam Generating Units.

40 CFR 60.40c through 40 CFR 60.48c

(industrial-commercial-institutional steam generating units which have a heat input capacity of 100 million Btu per hour or less, but greater than or equal to 10 million Btu per hour)

Subpart E - Incinerators.

40 CFR 60.50 through 40 CFR 60.54

(incinerator units of more than 50 tons per day charging rate)

Subpart Ea - Municipal Waste Combustors for which Construction is Commenced after December 20, 1989, and on or before September 20, 1994

40 CFR 60.50a through 40 CFR 60.59a

(municipal waste combustor units with a capacity greater than 250 tons per day of municipal-type solid waste or refuse-derived fuel)

Subpart Eb - Large Municipal Combustors for which Construction is Commenced after September 20, 1994, or for which Modification or Reconstruction is Commenced after June 19, 1996

40 CFR 60.50b through 40 CFR 60.59b

(municipal waste combustor units with a capacity greater than 250 tons per day of municipal-type solid waste or refuse-derived fuel)

Subpart Ec - Hospital/Medical/Infectious Waste Incinerators for which Construction is Commenced after June 20, 1996

40 CFR 60.50c through 40 CFR 60.58c

(hospital/medical/infectious waste incinerators that combust any amount of hospital waste and medical/infectious waste or both)

Subpart F - Portland Cement Plants.

40 CFR 60.60 through ~~40 CFR 60.64~~ 40 CFR 60.66

(kilns, clinker coolers, raw mill systems, finish mill systems, raw mill dryers, raw material storage, clinker storage, finished product storage, conveyor transfer points, bagging and bulk loading and unloading systems)

Subpart G - Nitric Acid Plants.

40 CFR 60.70 through 40 CFR 60.74

(nitric acid production units)

Subpart Ga - Nitric Acid Plants for which Construction, Reconstruction, or Modification Commenced after October 14, 2011.

40 CFR 60.70a through 40 CFR 60.77a

(nitric acid production units producing weak nitric acid by either the pressure or atmospheric pressure process)

Subpart H - Sulfuric Acid Plants.

40 CFR 60.80 through 40 CFR 60.85

(sulfuric acid production units) Subpart I - Hot Mix Asphalt Facilities.

40 CFR 60.90 through 40 CFR 60.93

(dryers; systems for screening, handling, storing and weighing hot aggregate; systems for loading, transferring and storing mineral filler; systems for mixing asphalt; and the loading, transfer and storage systems associated with emission control systems)

Subpart J - Petroleum Refineries.

40 CFR 60.100 through 40 CFR 60.106

Volume 30, Issue 10 Virginia Register of Regulations January 13, 2014

(fluid catalytic cracking unit catalyst regenerators, fluid catalytic cracking unit incinerator-waste heat boilers and fuel gas combustion devices)

Subpart Ja - Petroleum Refineries for which Construction, Reconstruction, or Modification Commenced after May 14, 2007.

40 CFR 60.100a through 40 CFR 60.109a

(fluid catalytic cracking units, fluid coking units, delayed coking units, fuel gas combustion devices, including flares and process heaters, and sulfur recovery plants)

Subpart K - Storage Vessels for Petroleum Liquids for which Construction, Reconstruction, or Modification Commenced after June 11, 1973, and prior to May 19, 1978.

40 CFR 60.110 through 40 CFR 60.113

(storage vessels with a capacity greater than 40,000 gallons)

Subpart Ka - Storage Vessels for Petroleum Liquids for which Construction, Reconstruction, or Modification Commenced after May 18, 1978, and prior to July 23, 1984.

40 CFR 60.110a through 40 CFR 60.115a

(storage vessels with a capacity greater than 40,000 gallons)

Subpart Kb - Volatile Organic Liquid Storage Vessels (Including Petroleum Liquid Storage Vessels) for which Construction, Reconstruction, or Modification Commenced after July 23, 1984.

40 CFR 60.110b through 40 CFR 60.117b

(storage vessels with capacity greater than or equal to 10,566 gallons)

Subpart L - Secondary Lead Smelters.

40 CFR 60.120 through 40 CFR 60.123

(pot furnaces of more than 550 pound charging capacity, blast (cupola) furnaces and reverberatory furnaces)

Subpart M - Secondary Brass and Bronze Production Plants.

40 CFR 60.130 through 40 CFR 60.133

(reverberatory and electric furnaces of 2205 pound or greater production capacity and blast (cupola) furnaces of 550 pounds per hour or greater production capacity)

Subpart N - Primary Emissions from Basic Oxygen Process Furnaces for which Construction is Commenced after June 11, 1973.

40 CFR 60.140 through 40 CFR 60.144

(basic oxygen process furnaces)

Subpart Na - Secondary Emissions from Basic Oxygen Process Steelmaking Facilities for which Construction is Commenced after January 20, 1983.

40 CFR 60.140a through 40 CFR 60.145a

(facilities in an iron and steel plant: top-blown BOPFs and hot metal transfer stations and skimming stations used with bottom-blown or top-blown BOPFs)

Subpart O - Sewage Treatment Plants.

40 CFR 60.150 through 40 CFR 60.154

(incinerators that combust wastes containing more than 10% sewage sludge (dry basis) produced by municipal sewage treatment plants or incinerators that charge more than 2205 pounds per day municipal sewage sludge (dry basis))

Subpart P - Primary Copper Smelters.

40 CFR 60.160 through 40 CFR 60.166

(dryers, roasters, smelting furnaces, and copper converters) Subpart Q - Primary Zinc Smelters.

40 CFR 60.170 through 40 CFR 60.176

(roasters and sintering machines) Subpart R - Primary Lead Smelters

40 CFR 60.180 through 40 CFR 60.186

(sintering machines, sintering machine discharge ends, blast furnaces, dross reverberatory furnaces, electric smelting furnaces and converters)

Subpart S - Primary Aluminum Reduction Plants.

40 CFR 60.190 through 40 CFR 60.195

(potroom groups and anode bake plants)

Subpart T - Phosphate Fertilizer Industry: Wet-Process Phosphoric Acid Plants.

40 CFR 60.200 through 40 CFR 60.204

(reactors, filters, evaporators, and hot wells)

Subpart U - Phosphate Fertilizer Industry: Superphosphoric Acid Plants.

40 CFR 60.210 through 40 CFR 60.214

(evaporators, hot wells, acid sumps, and cooling tanks)

Subpart V - Phosphate Fertilizer Industry: Diammonium Phosphate Plants.

40 CFR 60.220 through 40 CFR 60.224

(reactors, granulators, dryers, coolers, screens, and mills)

Subpart W - Phosphate Fertilizer Industry: Triple Superphosphate Plants.

40 CFR 60.230 through 40 CFR 60.234

(mixers, curing belts (dens), reactors, granulators, dryers, cookers, screens, mills, and facilities which store run-of- pile triple superphosphate)

Subpart X - Phosphate Fertilizer Industry: Granular Triple Superphosphate Storage Facilities.

40 CFR 60.240 through 40 CFR 60.244

(storage or curing piles, conveyors, elevators, screens and mills)

Subpart Y - Coal Preparation and Processing Plants.

40 CFR 60.250 through 40 CFR 60.258

(plants which process more than 200 tons per day: thermal dryers, pneumatic coal-cleaning equipment (air tables), coal processing and conveying equipment (including breakers and crushers), coal storage systems, and coal transfer and loading systems)

Subpart Z - Ferroalloy Production Facilities. 40 CFR 60.260 through 40 CFR 60.266

(electric submerged arc furnaces which produce silicon metal, ferrosilicon, calcium silicon, silicomanganese zirconium, ferrochrome silicon, silvery iron, high-carbon ferrochrome, charge chrome, standard ferromanganese, silicomanganese, ferromanganese silicon or calcium carbide; and dust-handling equipment)

Subpart AA - Steel Plants: Electric Arc Furnaces Constructed after October 21, 1974, and on or before August 17, 1983.

40 CFR 60.270 through 40 CFR 60.276

(electric arc furnaces and dust-handling systems that produce carbon, alloy or specialty steels)

Subpart AAa - Steel Plants: Electric Arc Furnaces and Argon- Oxygen Decarburization Vessels Constructed after August 17, 1983.

40 CFR 60.270a through 40 CFR 60.276a

(electric arc furnaces, argon-oxygen decarburization vessels, and dust-handling systems that produce carbon, alloy, or specialty steels)

Subpart BB - Kraft Pulp Mills.

40 CFR 60.280 through 40 CFR 60.285

(digester systems, brown stock washer systems, multiple effect evaporator systems, black liquor oxidation systems, recovery furnaces, smelt dissolving tanks, lime kilns, condensate strippers and kraft pulping operations)

Subpart CC - Glass Manufacturing Plants. 40 CFR 60.290 through 40 CFR 60.296

(glass melting furnaces) Subpart DD - Grain Elevators.

40 CFR 60.300 through 40 CFR 60.304

(grain terminal elevators/grain storage elevators: truck unloading stations, truck loading stations, barge and ship unloading stations, barge and ship loading stations, railcar unloading stations, railcar loading stations, grain dryers, and all grain handling operations)

Subpart EE - Surface Coating of Metal Furniture.

40 CFR 60.310 through 40 CFR 60.316

(metal furniture surface coating operations in which organic coatings are applied)

Subpart FF - (Reserved)

Subpart GG - Stationary Gas Turbines.

40 CFR 60.330 through 40 CFR 60.335

(stationary gas turbines with a heat input at peak load equal to or greater than 10 million Btu per hour, based on the lower heating value of the fuel fired)

Subpart HH - Lime Manufacturing Plants. 40 CFR 60.340 through 40 CFR 60.344

(each rotary lime kiln)

Subparts II through JJ - (Reserved)

Subpart KK - Lead-Acid Battery Manufacturing Plants.

40 CFR 60.370 through 40 CFR 60.374

(lead-acid battery manufacturing plants that produce or have the design capacity to produce in one day (24 hours) batteries containing an amount of lead equal to or greater than 6.5 tons: grid casting facilities, paste mixing facilities, three-process operation facilities, lead oxide manufacturing facilities, lead reclamation facilities, and other lead- emitting operations)

Subpart LL - Metallic Mineral Processing Plants.

40 CFR 60.380 through 40 CFR 60.386

(each crusher and screen in open-pit mines; each crusher, screen, bucket elevator, conveyor belt transfer point, thermal dryer, product packaging station, storage bin, enclosed storage area, truck loading station, truck unloading station, railcar loading station, and railcar unloading station at the mill or concentrator with the following exceptions. All facilities located in underground mines are exempted from the provisions of this subpart. At uranium ore processing plants, all facilities subsequent to and including the benefication of uranium ore are exempted from the provisions of this subpart)

Subpart MM - Automobile and Light Duty Truck Surface Coating Operations.

40 CFR 60.390 through 40 CFR 60.397

(prime coat operations, guide coat operations, and top-coat operations)

Subpart NN - Phosphate Rock Plants.

40 CFR 60.400 through 40 CFR 60.404

(phosphate rock plants which have a maximum plant production capacity greater than 4 tons per hour: dryers, calciners, grinders, and ground rock handling and storage facilities, except those facilities producing or preparing phosphate rock solely for consumption in elemental phosphorous production)

Subpart OO - ~~(Reserved)~~ Reserved.

Subpart PP - Ammonium Sulfate Manufacture.

40 CFR 60.420 through 40 CFR 60.424

(ammonium sulfate dryer within an ammonium sulfate manufacturing plant in the caprolactum by-product, synthetic, and coke oven by-product sectors of the ammonium sulfate industry)

Subpart QQ - Graphic Arts Industry: Publication Rotogravure Printing.

40 CFR 60.430 through 40 CFR 60.435

(publication rotogravure printing presses, except proof presses)

Subpart RR - Pressure Sensitive Tape and Label Surface Coating Operations.

40 CFR 60.440 through 40 CFR 60.447

(pressure sensitive tape and label material coating lines) Subpart SS - Industrial Surface Coating: Large Appliances.

40 CFR 60.450 through 40 CFR 60.456

(surface coating operations in large appliance coating lines)

Subpart TT - Metal Coil Surface Coating. 40 CFR 60.460 through 40 CFR 60.466

(metal coil surface coating operations: each prime coat operation, each finish coat operation, and each prime and finish coat operation combined when the finish coat is applied wet on wet over the prime coat and both coatings are cured simultaneously)

Subpart UU - Asphalt Processing and Asphalt Roofing Manufacture.

40 CFR 60.470 through 40 CFR 60.474

(each saturator and each mineral handling and storage facility at asphalt roofing plants; and each asphalt storage tank and each blowing still at asphalt processing plants, petroleum refineries, and asphalt roofing plants)

Subpart VV - Equipment Leaks of Volatile Organic Compounds in the Synthetic Organic Chemicals Manufacturing Industry for which Construction, Reconstruction, or Modification Commenced After January 5, 1981, and On or Before November 7, 2006.

40 CFR 60.480 through 40 CFR 60.489

(all equipment within a process unit in a synthetic organic chemicals manufacturing plant)

Subpart VVa - Equipment Leaks of VOC in the Synthetic Organic Chemicals Manufacturing Industry for Which Construction, Reconstruction, or Modification Commenced After November 7, 2006.

40 CFR 60.480a through 40 CFR 60.489a

(all equipment within a process unit in a synthetic organic chemicals manufacturing plant)

Subpart WW - Beverage Can Surface Coating Industry.

40 CFR 60.490 through 40 CFR 60.496

(beverage can surface coating lines: each exterior base coat operation, each overvarnish coating operation, and each inside spray coating operation)

Subpart XX - Bulk Gasoline Terminals.

40 CFR 60.500 through 40 CFR 60.506

(total of all loading racks at a bulk gasoline terminal which deliver liquid product into gasoline tank trucks)

Subparts YY through ZZ - (Reserved)

Subpart AAA - New Residential Wood Heaters.

40 CFR 60.530 through 40 CFR 60.539b

(wood heaters)

Subpart BBB - Rubber Tire Manufacturing Industry.

40 CFR 60.540 through 40 CFR 60.548

(each undertread cementing operation, each sidewall cementing operation, each tread end cementing operation, each bead cementing operation, each green tire spraying operation, each Michelin-A operation, each Michelin-B operation, and each Michelin-C automatic operation)

Subpart CCC - (Reserved)

Subpart DDD - Volatile Organic Compound (VOC) Emissions from the Polymer Manufacturing Industry.

40 CFR 60.560 through 40 CFR 60.566

(for polypropylene and polyethylene manufacturing using a continuous process that emits continuously or intermittently: all equipment used in the manufacture of these polymers. For polystyrene manufacturing using a continuous process that emits continuously: each material recovery section. For poly(ethylene terephthalate) manufacturing using a continuous process that emits continuously: each polymerization reaction section; if dimethyl terephthalate is used in the process, each material recovery section is also an affected facility; if terephthalic acid is used in the process, each raw materials preparation section is also an affected facility. For VOC emissions from equipment leaks: each group of fugitive emissions equipment within any process unit, excluding poly(ethylene terephthalate) manufacture.)

Subpart EEE - (Reserved)

Subpart FFF - Flexible Vinyl and Urethane Coating and Printing.

40 CFR 60.580 through 40 CFR 60.585

(each rotogravure printing line used to print or coat flexible vinyl or urethane products)

Subpart GGG - Equipment Leaks of VOC in Petroleum Refineries for which Construction, Reconstruction, or Modification Commenced After January 4, 1983, and On or Before November 7, 2006.

40 CFR 60.590 through 40 CFR 60.593

(each compressor, valve, pump pressure relief device, sampling connection system, open-ended valve or line, and flange or other connector in VOC service)

Subpart GGGa - Equipment Leaks of VOC in Petroleum Refineries for which Construction, Reconstruction, or Modification Commenced After November 7, 2006.

40 CFR 60.590a through 40 CFR 60.593a

(each compressor, valve, pump pressure relief device, sampling connection system, open-ended valve or line, and flange or other connector in VOC service)

Subpart HHH - Synthetic Fiber Production Facilities.

40 CFR 60.600 through 40 CFR 60.604

(each solvent-spun synthetic fiber process that produces more than 500 megagrams of fiber per year)

Subpart III - Volatile Organic Compound (VOC) Emissions from the Synthetic Organic Chemical Manufacturing Industry (SOCMI) Air Oxidation Unit Processes.

40 CFR 60.610 through 40 CFR 60.618

(each air oxidation reactor not discharging its vent stream into a recovery system and each combination of an air oxidation reactor or two or more air oxidation reactors and the recovery system into which the vent streams are discharged)

Subpart JJJ - Petroleum Dry Cleaners.

40 CFR 60.620 through 40 CFR 60.625

(facilities located at a petroleum dry cleaning plant with a total manufacturers' rated dryer capacity equal to or greater than 84 pounds: petroleum solvent dry cleaning dryers, washers, filters, stills, and settling tanks)

Subpart KKK - Equipment Leaks of VOC from Onshore Natural Gas Processing Plants for which Construction, Reconstruction, or Modification Commenced after January 20, 1984, and on or before August 23, 2011.

40 CFR 60.630 through 40 CFR 60.636

(each compressor in VOC service or in wet gas service; each pump, pressure relief device, open-ended valve or line, valve, and flange or other connector that is in VOC service or in wet gas service, and any device or system required by this subpart)

Subpart LLL - ~~Onshore Natural Gas Processing: Sulfur~~ ~~Dioxide Emissions~~ Sulfur Dioxide Emissions from Onshore Natural Gas Processing for which Construction, Reconstruction, or Modification Commenced after January 20, 1984, and on or before August 23, 2011.

40 CFR 60.640 through 40 CFR 60.648

(facilities that process natural gas: each sweetening unit, and each sweetening unit followed by a sulfur recovery unit)

Subpart MMM - ~~(Reserved)~~ Reserved.

Subpart NNN - Volatile Organic Compound (VOC) Emissions from Synthetic Organic Chemical Manufacturing Industry (SOCMI) Distillation Operations.

40 CFR 60.660 through 40 CFR 60.668

(each distillation unit not discharging its vent stream into a recovery system, each combination of a distillation unit or of two or more units and the recovery system into which their vent streams are discharged)

Subpart OOO - Nonmetallic Mineral Processing Plants.

40 CFR 60.670 through 40 CFR 60.676

(facilities in fixed or portable nonmetallic mineral processing plants: each crusher, grinding mill, screening operation, bucket elevator, belt conveyor, bagging operation, storage bin, enclosed truck or railcar loading station)

Subpart PPP - Wool Fiberglass Insulation Manufacturing Plants.

40 CFR 60.680 through 40 CFR 60.685

(each rotary spin wool fiberglass insulation manufacturing line)

Subpart QQQ - VOC Emissions from Petroleum Refinery Wastewater Systems.

40 CFR 60.690 through 40 CFR 60.699

(individual drain systems, oil-water separators, and aggregate facilities in petroleum refineries)

Subpart RRR - Volatile Organic Compound Emissions from Synthetic Organic Chemical Manufacturing Industry (SOCMI) Reactor Processes.

40 CFR 60.700 through 40 CFR 60.708

(each reactor process not discharging its vent stream into a recovery system, each combination of a reactor process and the recovery system into which its vent stream is discharged, and each combination of two or more reactor processes and the common recovery system into which their vent streams are discharged)

Subpart SSS - Magnetic Tape Coating Facilities.

40 CFR 60.710 through 40 CFR 60.718

(each coating operation and each piece of coating mix preparation equipment)

Subpart TTT - Industrial Surface Coating: Surface Coating of Plastic Parts for Business Machines.

40 CFR 60.720 through 40 CFR 60.726

(each spray booth in which plastic parts for use in the manufacture of business machines receive prime coats, color coats, texture coats, or touch-up coats)

Subpart UUU - Calciners and Dryers in Mineral Industries.

40 CFR 60.730 through 40 CFR 60.737

(each calciner and dryer at a mineral processing plant)

Subpart VVV - Polymeric Coating of Supporting Substrates Facilities.

40 CFR 60.740 through 40 CFR 60.748

(each coating operation and any onsite coating mix preparation equipment used to prepare coatings for the polymeric coating of supporting substrates)

Subpart WWW - Municipal Solid Waste Landfills.

40 CFR 60.750 through 40 CFR 60.759

(municipal solid waste landfills for the containment of household and RCRA Subtitle D wastes)

Subpart AAAA - Small Municipal Waste Combustors for which Construction is Commenced after August 30, 1999, or for which Modification or Reconstruction is Commenced after June 6, 2001.

40 CFR 60.1000 through 40 CFR 60.1465

(municipal waste combustor units with a capacity less than

250 tons per day and greater than 35 tons per day of municipal solid waste or refuse-derived fuel)

Subpart BBBB - Not applicable.

Subpart CCCC - Commercial/Industrial Solid Waste Incinerators for which Construction is Commenced after November 30, 1999, or for which Modification or Construction is Commenced on or after June 1, 2001.

40 CFR 60.2000 through 40 CFR 60.2265

(an enclosed device using controlled flame combustion without energy recovery that is a distinct operating unit of any commercial or industrial facility, or an air curtain incinerator without energy recovery that is a distinct operating unit of any commercial or industrial facility)

Subpart DDDD - Not applicable.

Subpart EEEE - Other Solid Waste Incineration Units for ~~Which~~ which Construction is Commenced ~~After~~ after December 9, 2004, or for ~~Which~~ which Modification or Reconstruction Is Commenced on or ~~After~~ after June 16, 2006.

40 CFR 60.2880 through 40 CFR 60.2977

(very small municipal waste combustion units with the capacity to combust less than 35 tons per day of municipal solid waste or refuse-derived fuel, and institutional waste incineration units owned or operated by an organization having a governmental, educational, civic, or religious purpose)

Subpart FFFF - Reserved. Subpart GGGG - Reserved. Subpart HHHH - Reserved.

Subpart IIII - Stationary Compression Ignition Internal Combustion Engines.

40 CFR 60.4200 through 40 CFR 60.4219

(NOTE: Authority to enforce the above standard is being retained by EPA and it is not incorporated by reference into these regulations. for any source that is not (i) a major source as defined in 9VAC5-80-60 and subject to Article 1 (9VAC5-80-50 et seq., Federal Operating Permits for Stationary Sources) of Part II of 9VAC5-80 (Permits for Stationary Sources) or (ii) an affected source as defined in 9VAC5-80-370 and subject to Article 3 (9VAC5-80-360 et seq., Federal Operating Permits for Acid Rain Sources) of Part II of 9VAC5-80)

Subpart JJJJ - Stationary Spark Ignition Internal Combustion Engines.

40 CFR 60.4230 through 40 CFR 60.4248

Subpart KKKK - Stationary Combustion Turbines.

40 CFR 60.4300 through 40 CFR 60.4420

(stationary combustion turbine with a heat input at peak load equal to or greater than 10.7 gigajoules (10 MMBtu) per hour)

Subpart LLLL - Sewage Sludge Incineration Units.

40 CFR 60.4760 through 40 CFR 60.4925

(an incineration unit combusting sewage sludge for the purpose of reducing the volume of the sewage sludge by removing combustible matter, including the sewage sludge feed system, auxiliary fuel feed system, grate system, flue gas system, waste heat recovery equipment, and bottom ash system; and all ash handling systems connected with the bottom ash handling system)

Subpart MMMM - Reserved. Subpart NNNN - Reserved.

Subpart OOOO - Crude Oil and Natural Gas Production, Transmission and Distribution

40 CFR 60.5360 through 40 CFR 60.5430

(facilities that operate gas wells, centrifugal compressors, reciprocating compressors, pneumatic controllers, and storage vessels)

Appendix A - Test methods.

Appendix B - Performance specifications.

Appendix C - Determination of Emission Rate Change. Appendix D - Required Emission Inventory Information. Appendix E - ~~(Reserved)~~ Reserved.

Appendix F - Quality Assurance Procedures. Appendix G - (Not applicable)

Appendix H - ~~(Reserved)~~ Reserved.

Appendix I - Removable label and owner's manual.

Part II Emission Standards

Article 1

Environmental Protection Agency National Emission Standards for Hazardous Air Pollutants (Rule 6-1)

9VAC5-60-60. General.

The Environmental Protection Agency (EPA) Regulations on National Emission Standards for Hazardous Air Pollutants (NESHAP), as promulgated in 40 CFR Part 61 and designated in 9VAC5-60-70 are, unless indicated otherwise, incorporated by reference into the regulations of the board as amended by the word or phrase substitutions given in 9VAC5-60-80. The complete text of the subparts in 9VAC5- 60-70 incorporated herein by reference is contained in 40 CFR Part 61. The 40 CFR section numbers appearing under each subpart in 9VAC5-60-70 identify the specific provisions of the subpart incorporated by reference. The specific version of the provision adopted by reference shall be that contained in the CFR ~~(2012)~~ (2013) in effect July 1, ~~2012~~ 2013. In making reference to the Code of Federal Regulations, 40 CFR Part 61 means Part 61 of Title 40 of the Code of Federal Regulations; 40 CFR 61.01 means 61.01 in Part 61 of Title 40 of the Code of Federal Regulations.

Article 2

Environmental Protection Agency National Emission Standards for Hazardous Air Pollutants for Source Categories (Rule 6-2)

9VAC5-60-90. General.

The Environmental Protection Agency (EPA) National Emission Standards for Hazardous Air Pollutants for Source Categories (Maximum Achievable Control Technologies, or MACTs) as promulgated in 40 CFR Part 63 and designated in 9VAC5-60-100 are, unless indicated otherwise, incorporated by reference into the regulations of the board as amended by the word or phrase substitutions given in 9VAC5-60-110. The complete text of the subparts in 9VAC5-60-100 incorporated herein by reference is contained in 40 CFR Part 63. The 40 CFR section numbers appearing under each subpart in 9VAC5-60-100 identify the specific provisions of the subpart incorporated by reference. The specific version of the provision adopted by reference shall be that contained in the CFR ~~(2012)~~ (2013) in effect July 1, ~~2012~~ 2013. In making reference to the Code of Federal Regulations, 40 CFR Part 63 means Part 63 of Title 40 of the Code of Federal Regulations; 40 CFR 63.1 means 63.1 in Part 63 of Title 40 of the Code of Federal Regulations.

9VAC5-60-100. Designated emission standards.

Subpart A - General Provisions.

40 CFR 63.1 through 40 CFR 63.11; 40 CFR 63.16

(applicability, definitions, units and abbreviations, prohibited activities and circumvention, construction and reconstruction, compliance with standards and maintenance requirements, performance testing

requirements, monitoring requirements, notification requirements, recordkeeping and reporting requirements, control device requirements, performance track provisions)

Subpart B - Not applicable.

Subpart C - List of Hazardous Air Pollutants, Petitions Process, Lesser Quantity Designations, Source Category List.

40 CFR 63.60, 40 CFR 63.61, 40 CFR 63.62 and 40 CFR

63.63

(deletion of caprolactam from the list of hazardous air pollutants, deletion of methyl ethyl ketone from the list of hazardous air pollutants, redefinition of glycol ethers listed as hazardous air pollutants, deletion of ethylene glycol monobutyl ether)

Subpart D - Not applicable. Subpart E - Not applicable.

Subpart F - Organic Hazardous Air Pollutants from the Synthetic Organic Chemical Manufacturing Industry.

40 CFR 63.100 through 40 CFR 63.106

(chemical manufacturing process units that manufacture as a primary product one or more of a listed chemical; use as a reactant or manufacture as a product, by-product, or co- product, one or more of a listed organic hazardous air pollutant; and are located at a plant site that is a major source as defined in § 112 of the federal Clean Air Act)

Subpart G - Organic Hazardous Air Pollutants From the Synthetic Organic Chemical Manufacturing Industry for Process Vents, Storage Vessels, Transfer Operations, and Wastewater.

40 CFR 63.110 through 40 CFR 63.152

(all process vents, storage vessels, transfer operations, and wastewater streams within a source subject to Subpart F, 40 CFR 63.100 through 40 CFR 63.106)

Subpart H - Organic Hazardous Air Pollutants for Equipment Leaks.

40 CFR 63.160 through 40 CFR 63.182

(pumps, compressors, agitators, pressure relief devices, sampling connection systems, open-ended valves or lines, valves, connectors, surge control vessels, bottoms receivers, instrumentation systems, and control devices or systems that are intended to operate in organic hazardous air pollutant service 300 hours or more during the calendar year within a source subject to the provisions of a specific subpart in 40 CFR Part 63)

Subpart I - Organic Hazardous Air Pollutants for Certain Processes Subject to the Negotiated Regulation for Equipment Leaks.

40 CFR 63.190 through 40 CFR 63.192

(emissions of designated organic hazardous air pollutants from processes specified in this subpart that are located at a plant site that is a major source as defined in § 112 of the federal Clean Air Act)

Subpart J - Polyvinyl Chloride and Copolymers Production.

40 CFR 63.210 through 40 CFR 63.217

(NOTE: Authority to enforce the above standard is being retained by EPA and it is not incorporated by reference into these regulations.)

Subpart K - Reserved.

Subpart L - Coke Oven Batteries.

40 CFR 63.300 through 40 CFR 63.313

(existing by-product coke oven batteries at a coke plant, and existing nonrecovery coke oven batteries located at a coke plant)

Subpart M - Perchlorethylene Dry Cleaning Facilities.

40 CFR 63.320 through 40 CFR 63.325

(each dry cleaning facility that uses perchlorethylene)

Subpart N - Chromium Emissions from Hard and Decorative Chromium Electroplating and Chromium Anodizing Tanks.

40 CFR 63.340 through 40 CFR 63.347

(each chromium electroplating or chromium anodizing tank at facilities performing hard chromium electroplating, decorative chromium electroplating, or chromium anodizing)

Subpart O - Ethylene Oxide Commercial Sterilization and Fumigation Operations.

40 CFR 63.360 through 40 CFR 63.367

(sterilization sources using ethylene oxide in sterilization or fumigation operations)

Subpart P - Reserved.

Subpart Q - Industrial Process Cooling Towers.

40 CFR 63.400 through 40 CFR 63.406

(industrial process cooling towers that are operated with chromium-based water treatment chemicals)

Subpart R - Gasoline Distribution Facilities. 40 CFR 63.420 through 40 CFR 63.429

(bulk gasoline terminals and pipeline breakout stations) Subpart S - Pulp and Paper Industry.

40 CFR 63.440 through 40 CFR 63.458

(processes that produce pulp, paper, or paperboard, and use the following processes and materials: kraft, soda, sulfite, or semi-chemical pulping processes using wood; or mechanical pulping processes using wood; or any process using secondary or nonwood fibers)

Subpart T - Halogenated Solvent Cleaning. 40 CFR 63.460 through 40 CFR 63.469

(each individual batch vapor, in-line vapor, in-line cold, and batch cold solvent cleaning machine that uses any solvent containing methylene chloride, perchlorethylene, trichloroethylene, 1,1,1-trichloroethane, carbon tetrachloride, or chloroform)

Subpart U - Group I Polymers and Resins. 40 CFR 63.480 through 40 CFR 63.506

(elastomer product process units that produce butyl rubber, halobutyl rubber, epichlorohydrin elastomers, ethylene propylene rubber, Hypalon™, neoprene, nitrile butadiene rubber, nitrile butadiene latex, polysulfide rubber, polybutadiene rubber/styrene butadiene rubber by solution, styrene butadiene latex, and styrene butadiene rubber by emulsion)

Subpart V - Reserved.

Subpart W - Epoxy Resins Production and Non-Nylon Polyamides Production.

40 CFR 63.520 through 40 CFR 63.527

(manufacturers of basic liquid epoxy resins and wet strength resins)

Subpart X - Secondary Lead Smelting.

40 CFR 63.541 through 40 CFR 60.552

(at all secondary lead smelters: blast, reverbatory, rotary, and electric smelting furnaces; refining kettles; agglomerating furnaces; dryers; process fugitive sources; and fugitive dust sources)

Subpart Y - Marine Tank Vessel Tank Loading Operations.

40 CFR 63.560 through 40 CFR 63.567

(marine tank vessel unloading operations at petroleum refineries)

Subpart Z - Reserved.

Subpart AA - Phosphoric Acid Manufacturing Plants.

40 CFR 63.600 through 40 CFR 63.610

(wet-process phosphoric acid process lines, evaporative cooling towers, rock dryers, rock calciners, superphosphoric acid process lines, purified acid process lines)

Subpart BB - Phosphate Fertilizers Production Plants.

40 CFR 63.620 through 40 CFR 63.631

(diammonium and monoammonium phosphate process lines, granular triple superphosphate process lines, and granular triple superphosphate storage buildings)

Subpart CC - Petroleum Refineries.

40 CFR 63.640 through 40 CFR 63.654

(storage tanks, equipment leaks, process vents, and wastewater collection and treatment systems at petroleum refineries)

Subpart DD - Off-Site Waste and Recovery Operations.

40 CFR 63.680 through 40 CFR 63.697

(operations that treat, store, recycle, and dispose of waste received from other operations that produce waste or recoverable materials as part of their manufacturing processes)

Subpart EE - Magnetic Tape Manufacturing Operations.

40 CFR 63.701 through 40 CFR 63.708

(manufacturers of magnetic tape) Subpart FF - Reserved.

Subpart GG - Aerospace Manufacturing and Rework Facilities.

40 CFR 63.741 through 40 CFR 63.752

(facilities engaged in the manufacture or rework of commercial, civil, or military aerospace vehicles or components)

Subpart HH - Oil and Natural Gas Production Facilities.

40 CFR 63.760 through 40 CFR 63.779

(facilities that process, upgrade, or store hydrocarbon liquids or natural gas; ancillary equipment and compressors intended to operate in volatile hazardous air pollutant service)

Subpart II - Shipbuilding and Ship Repair (Surface Coating).

40 CFR 63.780 through 40 CFR 63.788

(shipbuilding and ship repair operations)

Subpart JJ - Wood Furniture Manufacturing Operations.

40 CFR 63.800 through 40 CFR 63.819

(finishing materials, adhesives, and strippable spray booth coatings; storage, transfer, and application of coatings and solvents)

Subpart KK - Printing and Publishing Industry.

40 CFR 63.820 through 40 CFR 63.831

(publication rotogravure, product and packaging rotogravure, and wide-web printing processes)

Subpart LL - Primary Aluminum Reduction Plants.

40 CFR 63.840 through 40 CFR 63.859

(each pitch storage tank, potline, paste production plant, or anode bulk furnace associated with primary aluminum production)

Subpart MM - Chemical Recovery Combustion Sources at Kraft, Soda, Sulfite and Stand-Alone Semichemical Pulp Mills.

40 CFR 63.860 through 40 CFR 63.868

(chemical recovery systems, direct and nondirect contact evaporator recovery furnace systems, lime kilns, sulfite combustion units, semichemical combustion units)

Subpart NN - Reserved. Subpart OO - Tanks--Level 1.

40 CFR 63.900 through 40 CFR 63.907

(for off-site waste and recovery operations, fixed-roof tanks)

Subpart PP - Containers.

40 CFR 63.920 through 40 CFR 63.928

(for off-site waste and recovery operations, containers) Subpart QQ - Surface Impoundments.

40 CFR 63.940 through 40 CFR 63.948

(for off-site waste and recovery operations, surface impoundment covers and vents)

Subpart RR - Individual Drain Systems. 40 CFR 63.960 through 40 CFR 63.966

(for off-site waste and recovery operations, inspection and maintenance of individual drain systems)

Subpart SS - Closed Vent Systems, Control Devices, Recovery Devices and Routing to a Fuel Gas System or a Process.

40 CFR 63.980 through 40 CFR 63.999

(closed vent systems, control devices, recovery devices, and routing to a fuel gas system or a process, when associated with facilities subject to a referencing subpart)

Subpart TT - Equipment Leaks - Control Level 1.

40 CFR 63.1000 through 40 CFR 63.1018

(control of air emissions from equipment leaks when associated with facilities subject to a referencing subpart)

Subpart UU - Equipment Leaks - Control Level 2.

40 CFR 63.1019 through 40 CFR 63.1039

(control of air emissions from equipment leaks when associated with facilities subject to a referencing subpart: pumps, compressors, agitators, pressure relief devices, sampling connection systems, open-ended valves or lines, valves, connectors, instrumentation systems, closed vent systems and control devices)

Subpart VV - Oil-Water Separators and Organic-Water Separators.

40 CFR 63.1040 through 40 CFR 63.1049

(for off-site waste and recovery operations, oil-water separators and organic-water separator roofs and vents)

Subpart WW - Storage Vessels (Tanks) - Control Level 2.

40 CFR 63.1060 through 40 CFR 63.1066

(storage vessels associated with facilities subject to a referencing subpart)

Subpart XX - Ethylene Manufacturing Process Units: Heat Exchange Systems and Waste.

40 CFR 63.1080 through 40 CFR 63.1098

(any cooling tower system or once-through cooling water system)

Subpart YY - Generic Maximum Achievable Control Technology Standards.

40 CFR 63.1100 through 40 CFR 63.1113

(acetal resins production, acrylic and modacrylic fibers production, hydrogen fluoride production, polycarbonate production)

Subpart ZZ - Reserved. Subpart AAA - Reserved. Subpart BBB - Reserved.

Subpart CCC - Steel Pickling - Hydrogen Chloride Process Facilities and Hydrochloric Acid Regeneration Plants.

40 CFR 63.1155 through 40 CFR 63.1174

(steel pickling facilities that pickle carbon steel using hydrochloric acid solution, hydrochloric acid regeneration plants)

Subpart DDD - Mineral Wool Production.

40 CFR 63.1175 through 40 CFR 63.1199

(cupolas and curing ovens at mineral wool manufacturing facilities)

Subpart EEE - Hazardous Waste Combustors. 40 CFR 63.1200 through 40 CFR 63.1221

(hazardous waste combustors) Subpart FFF - Reserved.

Subpart GGG - Pharmaceutical Production. 40 CFR 63.1250 through 40 CFR 63.1261

(pharmaceutical manufacturing operations)

Subpart HHH - Natural Gas Transmission and Storage Facilities.

40 CFR 63.1270 through 40 CFR 63.1289

(natural gas transmission and storage facilities that transport or store natural gas prior to entering the pipeline to a local distribution company or to a final end user)

Subpart III - Flexible Polyurethane Foam Production.

40 CFR 63.1290 through 40 CFR 63.1309

(flexible polyurethane foam or rebond processes) Subpart JJJ - Group IV Polymers and Resins.

40 CFR 63.1310 through 40 CFR 63.1335

(facilities which manufacture acrylonitrile butadiene styrene resin, styrene acrylonitrile resin, methyl methacrylate butadiene styrene resin, polystyrene resin, poly(ethylene terephthalate) resin, or nitrile resin)

Subpart KKK - Reserved.

Subpart LLL - Portland Cement Manufacturing.

40 CFR 63.1340 through 40 CFR 63.1359

(kilns; in-line kilns/raw mills; clinker coolers; raw mills; finish mills; raw material dryers; raw material, clinker, or finished product storage bins; conveying system transfer points; bagging systems; bulk loading or unloading systems)

Subpart MMM - Pesticide Active Ingredient Production.

40 CFR 63.1360 through 40 CFR 63.1369

(pesticide active ingredient manufacturing process units, waste management units, heat exchange systems, and cooling towers)

Subpart NNN - Wool Fiberglass Manufacturing.

40 CFR 63.1380 through 40 CFR 63.1399

(glass melting furnaces, rotary spin wool fiberglass manufacturing lines producing bonded wool fiberglass building insulation or bonded heavy-density product)

Subpart OOO - Amino/Phenolic Resins Production.

40 CFR 63.1400 through 40 CFR 63.1419

(unit operations, process vents, storage vessels, equipment subject to leak provisions)

Subpart PPP - Polyether Polyols Production. 40 CFR 63.1420 through 40 CFR 63.1439

(polyether polyol manufacturing process units) Subpart QQQ - Primary Copper Smelting.

40 CFR 63.1440 through 40 CFR 63.1-1459

(batch copper converters, including copper concentrate dryers, smelting furnaces, slag cleaning vessels, copper converter departments, and the entire group of fugitive emission sources)

Subpart RRR - Secondary Aluminum Production.

40 CFR 63.1500 through 40 CFR 63.1520

(scrap shredders; thermal chip dryers; scrap dryers/delacquering kilns/decoating kilns; group 2, sweat, dross-only furnaces; rotary dross coolers; processing units)

Subpart SSS - Reserved.

Subpart TTT - Primary Lead Smelting.

40 CFR 63.1541 through 40 CFR 63.1550

(sinter machines, blast furnaces, dross furnaces, process fugitive sources, fugitive dust sources)

Subpart UUU - Petroleum Refineries: Catalytic Cracking Units, Catalytic Reforming Units, and Sulfur Recovery Units.

40 CFR 63.1560 through 40 CFR 63.1579

(petroleum refineries that produce transportation and heating fuels or lubricants, separate petroleum, or separate, crack, react, or reform an intermediate petroleum stream, or recover byproducts from an intermediate petroleum stream)

Subpart VVV - Publicly Owned Treatment Works.

40 CFR 63.1580 through 40 CFR 63.1595

(intercepting sewers, outfall sewers, sewage collection systems, pumping, power, and other equipment)

Subpart WWW - Reserved.

Subpart XXX - Ferroalloys Production: Ferromanganese and Silicomanganese.

40 CFR 63.1620 through 40 CFR 63.1679

(submerged arc furnaces, metal oxygen refining processes, crushing and screening operations, fugitive dust sources)

Subpart YYY - Reserved. Subpart ZZZ - Reserved.

Subpart AAAA - Municipal Solid Waste Landfills.

40 CFR 63.1930 through 40 CFR 63.1990

(municipal solid waste landfills that have accepted waste since November 8, 1987, or have additional capacity for waste deposition)

Subpart BBBB - Reserved.

Subpart CCCC - Manufacturing of Nutritional Yeast.

40 CFR 63.2130 through 40 CFR 63.2192

(fermentation vessels)

Subpart DDDD - Plywood and Composite Wood Products.

40 CFR 63.2230 through 40 CFR 63.2292

(manufacture of plywood and composite wood products by bonding wood material or agricultural fiber with resin under heat and pressure to form a structural panel or engineered wood product)

Subpart EEEE - Organic Liquids Distribution (Nongasoline).

40 CFR 63.2330 through 40 CFR 63.2406

(transfer of noncrude oil liquids or liquid mixtures that contain organic hazardous air pollutants, or crude oils downstream of the first point of custody, via storage tanks, transfer racks, equipment leak components associated with pipelines, and transport vehicles)

Subpart FFFF - Miscellaneous Organic Chemical Manufacturing.

40 CFR 63.2430 through 40 CFR 63.2550

(reaction, recovery, separation, purification, or other activity, operation, manufacture, or treatment that are used to produce a product or isolated intermediate)

Subpart GGGG - Solvent Extraction for Vegetable Oil Production.

40 CFR 63.2830 through 40 CFR 63.2872

(vegetable oil production processes)

Subpart HHHH--Wet-formed Fiberglass Mat Production.

40 CFR 63.2980 through 63.3079

(wet-formed fiberglass mat drying and curing ovens)

Subpart IIII - Surface Coating of Automobiles and Light- Duty Trucks.

40 CFR 63.3080 through 40 CFR 63.3176.

(application of topcoat to new automobile or new light- duty truck bodies or body parts)

Subpart JJJJ - Paper and Other Web Coating. 40 CFR 63.3280 through 40 CFR 63.3420

(web coating lines engaged in the coating of metal webs used in flexible packaging and in the coating of fabric

substrates for use in pressure-sensitive tape and abrasive materials)

Subpart KKKK - Surface Coating of Metal Cans.

40 CFR 63.3480 through 40 CFR 63.3561

(application of coatings to a substrate using spray guns or dip tanks, including one- and two-piece draw and iron can body coating; sheetcoating; three-piece can body assembly coating; and end coating)

Subpart LLLL - Reserved.

Subpart MMMM - Surface Coating of Miscellaneous Metal Parts and Products.

40 CFR 63.3880 through 40 CFR 63.3981

(application of coatings to industrial, household, and consumer products)

Subpart NNNN - Surface Coating of Large Appliances.

40 CFR 63.4080 through 40 CFR 63.4181

(surface coating of a large appliance part or product, including cooking equipment; refrigerators, freezers, and refrigerated cabinets and cases; laundry equipment; dishwashers, trash compactors, and water heaters; and HVAC units, air-conditioning, air-conditioning and heating combination units, comfort furnaces, and electric heat pumps)

Subpart OOOO - Printing, Coating, and Dyeing of Fabrics and Other Textiles.

40 CFR 63.4280 through 40 CFR 63.4371

(printing, coating, slashing, dyeing, or finishing of fabric and other textiles)

Subpart PPPP - Surface Coating of Plastic Parts and Products.

40 CFR 63.4480 through 40 CFR 63.4581

(application of coating to a substrate using spray guns or dip tanks, including motor vehicle parts and accessories for automobiles, trucks, recreational vehicles; sporting and recreational goods; toys; business machines; laboratory and medical equipment; and household and other consumer products)

Subpart QQQQ - Surface Coating of Wood Building Products.

40 CFR 63.4680 through 40 CFR 63.4781

(finishing or laminating of wood building products used in the construction of a residential, commercial, or institutional building)

Subpart RRRR - Surface Coating of Metal Furniture.

40 CFR 63.4880 through 40 CFR 63.4981

(application of coatings to substrate using spray guns and dip tanks)

Subpart SSSS - Surface Coating of Metal Coil. 40 CFR 63.5080 through 40 CFR 63.5209

(organic coating to surface of metal coil, including web unwind or feed sections, work stations, curing ovens, wet sections, and quench stations)

Subpart TTTT - Leather Finishing Operations. 40 CFR 63.5280 through 40 CFR 63.5460

(multistage application of finishing materials to adjust and improve the physical and aesthetic characteristics of leather surfaces)

Subpart UUUU - Cellulose Products Manufacturing.

40 CFR 63.5480 through 40 CFR 63.5610

(cellulose food casing, rayon, cellulosic sponge, cellophane manufacturing, methyl cellulose, hydroxypropyl methyl cellulose, hydroxypropyl cellulose, hydroxyethyl cellulose, and carboxymethyl cellulose manufacturing industries)

Subpart VVVV - Boat Manufacturing.

40 CFR 63.5680 through 40 CFR 63.5779

(resin and gel coat operations, carpet and fabric adhesive operations, aluminum recreational boat surface coating operations)

Subpart WWWW - Reinforced Plastic Composites Production.

40 CFR 63.5780 through 40 CFR 63.5935

(reinforced or nonreinforced plastic composites or plastic molding compounds using thermostat resins and gel coats that contain styrene)

Subpart XXXX - Rubber Tire Manufacturing. 40 CFR 63.5980 through 40 CFR 63.6015

(production of rubber tires and components including rubber compounds, sidewalls, tread, tire beads, tire cord and liners)

Subpart YYYY - Stationary Combustion Turbines.

40 CFR 63.6080 through 40 CFR 63.6175

(simple cycle, regenerative/recuperative cycle, cogeneration cycle, and combined cycle stationary combustion turbines)

Subpart ZZZZ - Stationary Reciprocating Internal Combustion Engines.

40 CFR 63.6580 through 40 CFR 63.6675.

(any stationary internal combustion engine that uses reciprocating motion to convert heat energy into mechanical work)

(NOTE: Authority to enforce provisions related to affected facilities located at a major source as defined in 40 CFR 63.6675 is being retained by the Commonwealth. Authority to enforce the area source provisions of the above standard is being retained by EPA~~. The provisions of~~ ~~this subpart as they apply to area sources~~ and are not incorporated by reference into these ~~regulations)~~ regulations for any source that is not (i) a major source as defined in 9VAC5-80-60 and subject to Article 1 (9VAC5-

80-50 et seq., Federal Operating Permits for Stationary Sources) of Part II of 9VAC5-80 (Permits for Stationary Sources) or (ii) an affected source as defined in 9VAC5- 80-370 and subject to Article 3 (9VAC5-80-360 et seq., Federal Operating Permits for Acid Rain Sources) of Part II of 9VAC5-80)

Subpart AAAAA - Lime Manufacturing Plants. 40 CFR 63.7080 through 40 CFR 63.7143.

(manufacture of lime product, including calcium oxide, calcium oxide with magnesium oxide, or dead burned dolomite, by calcination of limestone, dolomite, shells or other calcareous substances)

Subpart BBBBB - Semiconductor Manufacturing.

40 CFR 63.7180 through 40 CFR 63.7195

(semiconductor manufacturing process units used to manufacture p-type and n-type semiconductors and active solid-state devices from a wafer substrate)

Subpart CCCCC - Coke Ovens: Pushing, Quenching, and Battery Stacks.

40 CFR 63.7280 through 40 CFR 63.7352

(pushing, soaking, quenching, and battery stacks at coke oven batteries)

Subpart DDDDD - Industrial, Commercial, and Institutional Boilers and Process Heaters.

40 CFR 63.7480 through 40 CFR 63.7575

~~(NOTE: Authority to enforce the above standard is being~~ ~~retained by EPA and it is not incorporated by reference~~ ~~into these regulations.)~~ (industrial, commercial, and institutional boilers and process heaters)

Subpart EEEEE - Iron and Steel Foundries. 40 CFR 63.7680 through 40 CFR 63.7765

(metal melting furnaces, scrap preheaters, pouring areas, pouring stations, automated conveyor and pallet cooling lines, automated shakeout lines, and mold and core making lines)

Subpart FFFFF - Integrated Iron and Steel Manufacturing.

40 CFR 63.7780 through 40 CFR 63.7852

(each sinter plant, blast furnace, and basic oxygen process furnace at an integrated iron and steel manufacturing facility)

Subpart GGGGG - Site Remediation.

40 CFR 63.7880 through 40 CFR 63.7957

(activities or processes used to remove, destroy, degrade, transform, immobilize, or otherwise manage remediation material)

Subpart HHHHH - Miscellaneous Coating Manufacturing.

40 CFR 63.7980 through 40 CFR 63.8105

(process vessels; storage tanks for feedstocks and products; pumps, compressors, agitators, pressure relief devices,

sampling connection systems, open-ended valves or lines, valves, connectors, and instrumentation systems; wastewater tanks and transfer racks)

Subpart IIIII - Mercury Cell Chlor-Alkali Plants.

40 CFR 63.8180 through 40 CFR 63.8266

(byproduct hydrogen streams, end box ventilation system vents, and fugitive emission sources associated with cell rooms, hydrogen systems, caustic systems, and storage areas for mercury-containing wastes)

Subpart JJJJJ - Brick and Structural Clay Products Manufacturing.

40 CFR 63.8380 through 40 CFR 63.8515

(NOTE: Authority to enforce the above standard is being retained by EPA and it is not incorporated by reference into these regulations.)

Subpart KKKKK - Ceramics Manufacturing. 40 CFR 63.8530 through 40 CFR 63.8665

(NOTE: Authority to enforce the above standard is being retained by EPA and it is not incorporated by reference into these regulations.)

Subpart LLLLL - Asphalt Processing and Asphalt Roof Manufacturing.

40 CFR 63.8680 through 40 CFR 63.8698

(preparation of asphalt flux at stand-alone asphalt processing facilities, petroleum refineries, and asphalt roofing facilities)

Subpart MMMMM - Flexible Polyurethane Foam Fabrication Operations.

40 CFR 63.8780 through 40 CFR 63.8830

(flexible polyurethane foam fabrication plants using flame lamination or loop slitter adhesives)

Subpart NNNNN - Hydrochloric Acid Production.

40 CFR 63.8980 through 40 CFR 63.9075

(HCl production facilities that produce a liquid HCl product)

Subpart OOOOO - Reserved.

Subpart PPPPP - Engine Test Cells and Stands.

40 CFR Subpart 63.9280 through 40 CFR 63.9375

(any apparatus used for testing uninstalled stationary or uninstalled mobile (motive) engines)

Subpart QQQQQ - Friction Materials Manufacturing Facilities.

40 CFR 63.9480 through 40 CFR 63.9579

(friction materials manufacturing facilities that use a solvent-based process)

Subpart RRRRR - Taconite Iron Ore Processing.

40 CFR 63.9580 through 40 CFR 63.9652

(ore crushing and handling, ore dryer stacks, indurating furnace stacks, finished pellet handling, and fugitive dust)

Subpart SSSSS - Refractory Products Manufacturing.

40 CFR 63.9780 through 40 CFR 63.9824

(manufacture of refractory products, including refractory bricks and shapes, monolithics, kiln furniture, crucibles, and other materials for liming furnaces and other high temperature process units)

Subpart TTTTT - Primary Magnesium Refining.

40 CFR 63.9880 through 40 CFR 63.9942

(spray dryer, magnesium chloride storage bin scrubber, melt/reactor system, and launder off-gas system stacks)

Subpart UUUUU - Coal-fired and Oil-fired Electric Utility Steam Generating Units.

40 CFR 63.9980 through 40 CFR 63.10042

(any furnace, boiler, or other device used for combusting fuel for the purpose of producing steam, including fossil fuel-fired steam generators associated with integrated gasification combined cycle gas turbines and excluding nuclear steam generators, for the purpose of powering a generator to produce electricity or electricity and other thermal energy)

Subpart VVVVV - Reserved.

Subpart WWWWW - Hospital Ethylene Oxide Sterilizer Area Sources.

40 CFR 63.10382 through 40 CFR 63.10448

(any enclosed vessel that is filled with ethylene oxide gas or an ethylene oxide/inert gas mixture for the purpose of sterilization)

Subpart XXXXX - Reserved.

Subpart YYYYY - Electric Arc Furnace Steelmaking Facility Area Sources.

40 CFR 63.10680 through 40 CFR 63.10692

(a steel plant that produces carbon, alloy, or specialty steels using an electric arc furnace)

Subpart ZZZZZ - Iron and Steel Foundries Area Sources.

40 CFR 63.10880 through 40 CFR 63.10906

(a facility that melts scrap, ingot, and/or other forms of iron and/or steel and pours the resulting molten metal into molds to produce final or near final shape products for introduction into commerce)

Subpart AAAAAA - Reserved.

Subpart BBBBBB - Gasoline Distribution Bulk Terminals, Bulk Plants, and Pipeline Facilities, Area Sources.

40 CFR 63.11080 through 40 CFR 63.11100

(gasoline storage tanks, gasoline loading racks, vapor collection-equipped gasoline cargo tanks, and equipment components in vapor or liquid gasoline service)

Subpart CCCCCC - Gasoline Dispensing Facilities, Area Sources.

40 CFR 63.11110 through 40 CFR 63.11132

Subpart DDDDDD - Polyvinyl Chloride and Copolymers Production Area Sources.

40 CFR 63.11140 through 40 CFR 63.11145

(plants that produce polyvinyl chloride or copolymers) Subpart EEEEEE - Primary Copper Smelting Area Sources.

40 CFR 63.11146 through 40 CFR 63.11152

(any installation or any intermediate process engaged in the production of copper from copper sulfide ore concentrates through the use of pyrometallurgical techniques)

Subpart FFFFFF - Secondary Copper Smelting Area Sources.

40 CFR 63.11153 through 40 CFR 63.11159

(a facility that processes copper scrap in a blast furnace and converter or that uses another pyrometallurgical purification process to produce anode copper from copper scrap, including low-grade copper scrap)

Subpart GGGGGG - Primary Nonferrous Metals Area Sources--Zinc, Cadmium, and Beryllium.

40 CFR 63.11160 through 40 CFR 63.11168

(cadmium melting furnaces used to melt cadmium or produce cadmium oxide from the cadmium recovered in the zinc production; primary beryllium production facilities engaged in the chemical processing of beryllium ore to produce beryllium metal, alloy, or oxide, or performing any of the intermediate steps in these processes; and primary zinc production facilities engaged in the production, or any intermediate process in the production, of zinc or zinc oxide from zinc sulfide ore concentrates through the use of pyrometallurgical techniques)

Subpart HHHHHH - Paint Stripping and Miscellaneous Surface Coating Operations Area Sources.

40 CFR 63.11169 through 40 CFR 63.11180

9VAC5-80-370 and subject to Article 3 (9VAC5-80-360 et seq., Federal Operating Permits for Acid Rain Sources) of Part II of 9VAC5-80)

Subpart IIIIII - Reserved.

Subpart JJJJJJ - Industrial, Commercial, and Institutional Boiler Area Sources.

40 CFR 63.11193 through 40 CFR 63.11226

(NOTE: Authority to enforce the above standard is being retained by EPA and is not incorporated by reference into these regulations. for any source that is not (i) a major source as defined in 9VAC5-80-60 and subject to Article 1 (9VAC5-80-50 et seq., Federal Operating Permits for Stationary Sources) of Part II of 9VAC5-80 (Permits for Stationary Sources) or (ii) an affected source as defined in 9VAC5-80-370 and subject to Article 3 (9VAC5-80-360 et seq., Federal Operating Permits for Acid Rain Sources) of Part II of 9VAC5-80)

Subpart KKKKKK - Reserved.

Subpart LLLLLL - Acrylic and Modacrylic Fibers Production Area Sources.

40 CFR 63.11393 through 40 CFR 63.11399

(production of either of the following synthetic fibers composed of acrylonitrile units: acrylic fiber or modacrylic fiber)

Subpart MMMMMM - Carbon Black Production Area Sources.

40 CFR 63.11400 through 40 CFR 63.11406

(carbon black production process units including all waste management units, maintenance wastewater, and equipment components that contain or contact HAP that are associated with the carbon black production process unit)

Subpart NNNNNN - Chemical Manufacturing Area Sources: Chromium Compounds.

40 CFR 63.11407 through 40 CFR 63.11413

(any process that uses chromite ore as the basic feedstock to manufacture chromium compounds, primarily sodium dichromate, chromic acid, and chromic oxide)

Subpart OOOOOO - Flexible Polyurethane Foam Production and Fabrication Area Sources.

40 CFR 63.11414 through 40 CFR 63.11420

(a facility where pieces of flexible polyurethane foam are cut, bonded, and/or laminated together or to other substrates)

Subpart PPPPPP - Lead Acid Battery Manufacturing Area Sources.

40 CFR 63.11421 through 40 CFR 63.11427

(grid casting facilities, paste mixing facilities, three- process operation facilities, lead oxide manufacturing facilities, lead reclamation facilities, and any other lead-

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emitting operation that is associated with the lead acid battery manufacturing plant)

Subpart QQQQQQ - Wood Preserving Area Sources.

40 CFR 63.11428 through 40 CFR 63.11434

(pressure or thermal impregnation of chemicals into wood to provide effective long-term resistance to attack by fungi, bacteria, insects, and marine borers)

Subpart RRRRRR - Clay Ceramics Manufacturing Area Sources.

40 CFR 63.11435 through 40 CFR 63.11447

(manufacture of pressed tile, sanitaryware, dinnerware, or pottery with an atomized glaze spray booth or kiln that fires glazed ceramic ware)

Subpart SSSSSS - Glass Manufacturing Area Sources.

40 CFR 63.11448 through 40 CFR 63.11461

(manufacture of flat glass, glass containers, or pressed and blown glass by melting a mixture of raw materials to produce molten glass and form the molten glass into sheets, containers, or other shapes)

Subpart TTTTTT - Secondary Nonferrous Metals Processing Area Sources.

40 CFR 63.11462 through 40 CFR 63.11474

(all crushing and screening operations at a secondary zinc processing facility and all furnace melting operations located at any secondary nonferrous metals processing facility)

Subpart UUUUUU - Reserved.

Subpart VVVVVV - Chemical Manufacturing Area Sources.

40 CFR 63.11494 through 40 CFR 11503

(each chemical manufacturing process unit that uses as feedstocks, generates as byproducts, or produces as products any of the following: 1,3-butadiene; 1,3- dichloropropene; acetaldehyde; chloroform; ethylene dichloride; methylene chloride; hexachlorobenzene; hydrazine; quinoline; or compounds of arsenic, cadmium, chromium, lead, manganese, or nickel)

Subpart WWWWWW - Plating and Polishing Operations, Area Sources.

40 CFR 63.11504 through 40 CFR 63.11513

(new and existing tanks, thermal spraying equipment, and mechanical polishing equipment used in non-chromium electroplating, electroless or non-electrolytic plating, non- electrolytic metal coating, dry mechanical polishing, electroforming, and electropolishing)

Subpart XXXXXX - Nine Metal Fabrication and Finishing Source Categories, Area Sources.

40 CFR 63.11514 through 40 CFR 63.11523

(NOTE: Authority to enforce the above standard is being retained by EPA and it is not incorporated by reference into these regulations. for any source that is not (i) a major

source as defined in 9VAC5-80-60 and subject to Article 1 (9VAC5-80-50 et seq., Federal Operating Permits for Stationary Sources) of Part II of 9VAC5-80 (Permits for Stationary Sources) or (ii) an affected source as defined in 9VAC5-80-370 and subject to Article 3 (9VAC5-80-360 et seq., Federal Operating Permits for Acid Rain Sources) of Part II of 9VAC5-80)

Subpart YYYYYY - Ferroalloys Production Facilities, Area Sources.

40 CFR 63.11524 through 40 CFR 63.11543

(manufacture of silicon metal, ferrosilicon, ferrotitanium using the aluminum reduction process, ferrovanadium, ferromolybdenum, calcium silicon, silicomanganese zirconium, ferrochrome silicon, silvery iron, high-carbon ferrochrome, charge chrome, standard ferromanganese, silicomanganese, ferromanganese silicon, calcium carbide or other ferroalloy products using electrometallurgical operations including electric arc furnaces or other reaction vessels)

Subpart ZZZZZZ - Aluminum, Copper, and Other Nonferrous Foundries, Area Sources.

40 CFR 63.11544 through 40 CFR 63.11558

(melting operations at aluminum, copper, and other nonferrous foundries, including the collection of induction, reverberatory, crucible, tower, or dry hearth furnaces used to melt metal ingot, alloyed ingot and/or metal scrap to produce molten metal that is poured into molds to make castings)

Subpart AAAAAAA - Asphalt Processing and Asphalt Roofing Manufacturing Area Sources.

40 CFR 63.11559 through 40 CFR 63.11567

(asphalt processing operations that prepare asphalt flux at standalone asphalt processing facilities, petroleum refineries, and asphalt roofing facilities that include one or more asphalt flux blowing stills; and asphalt roofing manufacturing operations that manufacture asphalt roofing products through a series of sequential process steps depending upon whether the type of substrate used is organic or inorganic)

Subpart BBBBBBB - Chemical Preparations Industry Area Sources.

40 CFR 63.11579 through 40 CFR 63.11588

(any facility-wide collection of chemical preparation operations, including the collection of mixing, blending, milling, and extruding equipment used to manufacture chemical preparations that contain metal compounds for chromium, lead, manganese, and nickel)

Subpart CCCCCCC - Paints and Allied Products Manufacturing Area Sources.

40 CFR 63.11599 through 40 CFR 63.11638

(paints and allied products manufacturing processes, including, weighing, blending, mixing, grinding, tinting,

dilution or other formulation, as well as cleaning operations, material storage and transfer, and piping)

Subpart DDDDDDD - Prepared Feeds Manufacturing Area Sources.

40 CFR 63.11619 through 40 CFR 63.11638

(production of animal feed from the point in the process where a material containing chromium or manganese is added, to the point where the finished product leaves the facility, including areas where materials containing chromium and manganese are stored, areas where materials containing chromium and manganese are temporarily stored prior to addition to the feed at the mixer, mixing and grinding processes, pelleting and pellet cooling processes, packing and bagging processes, crumblers and screens, bulk loading operations, and all conveyors and other equipment that transfer feed materials)

Subpart EEEEEEE - Gold Mine Ore Processing and Production Area Sources

40 CFR 63.11640 through 40 CFR 63.11653

(any industrial facility engaged in the processing of gold mine ore that uses any of the following processes: roasting operations, autoclaves, carbon kilns, preg tanks, electrowinning, mercury retorts, or melt furnaces)

Subpart FFFFFFF - Reserved. Subpart GGGGGGG - Reserved.

Subpart HHHHHHH - Polyvinyl Chloride and Copolymers Production.

40 CFR 63.11860 through 40 CFR 63.12000

(facility-wide collection of PVCPU, storage vessels, heat exchange systems, surge control vessels, wastewater and process wastewater treatment systems that are associated with producing polyvinyl chloride and copolymers)

Appendix A - Test Methods.

Appendix B - Sources Defined for Early Reduction Provisions.

Appendix C - Determination of the Fraction Biodegraded (Fbio) in a Biological Treatment Unit.

Appendix D - Alternative Validation Procedure for EPA Waste and Wastewater Methods.

VA.R. Doc. No. R14-3856; Filed December 11, 2013, 2:24 p.m.

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TITLE 10. FINANCE AND FINANCIAL INSTITUTIONS

STATE CORPORATION COMMISSION

Final Regulation

Administrative Process Act in accordance with § 2.2-4002 A 2 of the Code of Virginia, which exempts courts, any agency of the Supreme Court, and any agency that by the Constitution is expressly granted any of the powers of a court of record.

Title of Regulation: 10VAC5-40. Credit Unions (adding 10VAC5-40-80, 10VAC5-40-90).

Statutory Authority: §§ 6.2-1303 and 12.1-13 of the Code of Virginia.

Effective Date: January 1, 2014.

Agency Contact: Werner Paul, Deputy Commissioner, Bureau of Financial Institutions, State Corporation Commission, P.O. Box 640, Richmond, VA 23218, telephone (804) 371-9698, FAX (804) 371-9416, or email

werner.paul@scc.virginia.gov. Summary:

The State Corporation Commission is adopting regulations to give state-chartered credit unions the authority to (i) purchase loan participation interests to the same extent, and subject to the same terms and conditions, as is authorized for federal credit unions under 12 CFR 701.22 and (ii) offer employee benefit plans and defined benefit plans on terms and conditions comparable to federal credit unions under 12 CFR 701.19. The regulations also provide state-chartered credit unions the authority to purchase an investment to fund an obligation under an employee benefit plan or defined benefit plan provided that the investment is directly related to the credit union's obligation or potential obligation and the credit union holds the investment only for as long as it has an actual or potential obligation under such plan.

AT RICHMOND, DECEMBER 17, 2013 COMMONWEALTH OF VIRGINIA, ex rel.

STATE CORPORATION COMMISSION

CASE NO. BFI-2013-00097

Ex Parte: In re: parity regulations for state-chartered credit unions

ORDER ADOPTING REGULATIONS

REGISTRAR'S NOTICE: The State Corporation Commission is claiming an exemption from the

On September 27, 2013, the State Corporation Commission ("Commission") entered an Order to Take Notice ("September 27 Order") of a proposal by the Bureau of Financial Institutions to amend Chapter 40 of Title 10 of the Virginia Administrative Code, which governs state-chartered credit unions. The proposed regulations would give state- chartered credit unions the authority to (i) purchase loan participation interests on terms and conditions comparable to federal credit unions under 12 C.F.R. § 701.22; and (ii) offer employee benefit plans as well as defined benefit plans and purchase investments to fund such plans on terms and conditions comparable to federal credit unions under 12 C.F.R. § 701.19. The September 27 Order and proposed regulations were published in the Virginia Register of

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Regulations on October 21, 2013, posted on the Commission's website, and sent to all state-chartered credit unions and other interested parties. Credit unions and other interested parties were afforded the opportunity to file written comments or request a hearing on or before November 8, 2013. The Commission received comment letters from the Virginia Credit Union League and Northern Star Credit Union, Incorporated. Both comment letters supported the proposed regulations. The Commission did not receive any requests for a hearing.

NOW THE COMMISSION, having considered the proposed regulations, the comments filed, the record herein, and applicable law, concludes that the proposed regulations should be adopted with an effective date of January 1, 2014.

Accordingly, IT IS ORDERED THAT:

(1) The proposed regulations, as attached hereto, are adopted effective January 1, 2014.

(2) This Order and the attached regulations shall be posted on the Commission's website: http://www.scc.virginia.gov/case.

(3) The Commission's Division of Information Resources shall provide a copy of this Order, including a copy of the attached regulations, to the Virginia Registrar of Regulations for publication in the Virginia Register of Regulations.

(4) This case is dismissed from the Commission's docket of active cases.

AN ATTESTED COPY hereof, together with a copy of the attached regulations, shall be sent by the Clerk of the Commission to the Commission's Office of General Counsel and the Commissioner of Financial Institutions, who shall forthwith send a copy of this Order, together with a copy of the attached regulations, to all state-chartered credit unions and such other interested parties as he may designate.

10VAC5-40-80. Loan participations.

Notwithstanding any provision of Chapter 13 (§ 6.2-1300 et seq.) of Title 6.2 of the Code of Virginia relating to loan participations or cooperative loans, a state-chartered credit union may purchase a participation interest in a loan to the same extent, and subject to the same terms and conditions, as is authorized for federal credit unions under 12 CFR 701.22.

10VAC5-40-90. Benefits for employees of state-chartered credit unions.

A. A state-chartered credit union may provide employee benefits, including retirement benefits, to its employees and officers. The kind and amount of these benefits shall be reasonable given the credit union's size, financial condition, and the duties of the employees.

B. When a state-chartered credit union is the benefit plan trustee or custodian, the plan shall be authorized and maintained to the same extent, and subject to the same terms and conditions, as is authorized for federal credit unions

under 12 CFR Part 724. When the benefit plan trustee or custodian is a party other than a state-chartered credit union, the benefit plan shall be maintained in accordance with applicable laws, including any applicable regulations adopted by the U.S. Department of Labor, the U.S. Department of the Treasury, or any other federal or state authority exercising jurisdiction over the plan.

C. Notwithstanding the investment limitations set forth in

§ 6.2-1376 of the Code of Virginia, a state-chartered credit union investing to fund an obligation under an employee benefit plan, as defined in 29 USC § 1002(3), may purchase an investment if (i) the investment is directly related to the credit union's obligation or potential obligation under the employee benefit plan and (ii) the credit union holds the investment only for as long as it has an actual or potential obligation under the employee benefit plan.

D. A state-chartered credit union may invest to fund a defined benefit plan, as defined in 29 USC § 1002(35), provided that the investment complies with subsection C of this section. If a credit union invests to fund a defined benefit plan that is not subject to the fiduciary responsibility provisions of Part 4 of the Employee Retirement Income Security Act of 1974 (ERISA), 29 USC § 1001 et seq., it shall diversify its investment portfolio to minimize the risk of large losses unless it is clearly prudent not to do so under the circumstances.

E. A state-chartered credit union shall not occupy the position of a fiduciary, as defined in ERISA and the regulations adopted by the U.S. Department of Labor.

VA.R. Doc. No. R14-3872; Filed December 17, 2013, 12:13 p.m.

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TITLE 12. HEALTH

STATE BOARD OF HEALTH

Proposed Regulation

Title of Regulation: 12VAC5-20. Regulations for the Conduct of Human Research (amending 12VAC5-20-10, 12VAC5-20-30 through 12VAC5-20-130).

Statutory Authority: §§ 32.1-12 and 32.1-12.1 of the Code of Virginia.

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: March 14, 2014.

Agency Contact: Dev Nair, PhD, Director, Division of Policy and Evaluation, Office of Family Health Services, Department of Health, 109 Governor Street, Richmond, VA 23219, telephone (804) 864-7662, or email dev.nair@vdh.virginia.gov.

Basis: Section 32.1-12.1 of the Code of Virginia states that the State Board of Health shall promulgate regulations

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pursuant to the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia) to effectuate the provisions of Chapter 5.1 (§ 32.1-162.16 et seq.) of Title 32.1 of the Code of Virginia for human research, as defined in § 32.1-162.16 of the Code of Virginia, to be conducted or authorized by the department or any facilities or other entities operated, funded, or licensed by the department.

Purpose: To fulfill the statutory mandate to review regulations and to protect the citizens of the Commonwealth, the Virginia Department of Health conducted a periodic review of 12VAC5-20, Regulations for the Conduct of Human Research, pursuant to Executive Order 14 (2010) and

§ 2.2-4007.1 of the Code of Virginia. As a result of this review, and in order to help protect the health, safety, and welfare of citizens, the Virginia Department of Health is providing proposed amendments to the regulations. It is necessary to amend these regulations to make corrections to outdated citations, provide consistency in language, and enhance the clarity of the regulations in order to achieve improvements that will be reasonable, prudent, and will not impose an unnecessary burden on users of the Virginia Department of Health's Institutional Review Board, human subject researchers, or the public.

Substance: The proposed amendments to the regulations include:

12VAC5-20-10:

1. Updating the definition of "human research."

2. Adding a definition of "subject" or "human subject."

3. Replacing the term "participants" with "subjects" in various sections.

4. Eliminating the detailed elements of informed consent. This information is duplicated in 12VAC5-20-100.

5. Amending the definition of "legally authorized representative" to be consistent with § 32.1-162.16 of the Code of Virginia.

6. Adding a definition of "protected health information."

12VAC5-20-30 - Replacing the term "human participants" with "human subjects" to be consistent with language used in § 32.1-162.16.

12VAC5-20-40 - Clarifying that no official or employee of the institution or agency conducting or authorizing the research is qualified to act as a legally authorized representative.

12VAC5-20-50 - Changing the committee reporting requirement from January 31 to March 31 of each year.

12VAC5-20-50 and 12VAC5-20-60 - Amending the term "chairman" to "chair."

12VAC5-20-70 - Requiring that the committee have at least five members instead of at least seven members.

12VAC5-20-80:

1. Clarifying that no human research shall be conducted unless a research committee has reviewed and approved the project. The section is also amended to provide details as to the elements of the project that are to be considered in the review.

2. Deleting the requirement that the committee approve a written procedure for when a subject has a complaint regarding the research. The requirement that the committee develop a procedure is retained.

3. Requiring that the committee chair provide a written report to the head of the institution regarding any violation that led to either a suspension or termination of the research.

4. Requiring that the committee ensure compliance with the Health Insurance Portability and Accountability Act (HIPAA) and federal and state regulations regarding disclosure of personal health information.

5. Providing that cooperating institutions conducting research may enter into a joint review, rely on another qualified committee, or come to an agreement that avoids duplication of review effort.

12VAC5-20-90 - Providing additional clarification on when and how an expedited review can be completed and clarifying the authority to suspend or terminate approval for a project.

12VAC5-20-100 - Clarifying the informed consent requirements and when the committee may waive the informed consent requirement.

12VAC5-20-110 - Eliminating the reference to the Alzheimer's Disease and Related Disorders Registry and the reference to § 32.1-116.1:2 of the Code of Virginia.

12VAC5-20-130 - Changing the reporting date from January 31 to March 31 annually.

Issues: There are no disadvantages to the public. There are no disadvantages to the agency or the Commonwealth. An advantage to the agency and the Commonwealth is that the amended regulations will provide greater clarification on the requirements for human research and clarification on the protection of research subjects.

Small Business Impact Review Report of Findings: This 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. The State Board of Health (Board) proposes to reduce the number of required members on human research committees from seven to five, and make several other clarifying changes to these regulations. These regulations only apply to research either wholly or in part conducted by the Virginia Department

Volume 30, Issue 10 Virginia Register of Regulations January 13, 2014

of Health (Department), local health departments in the Commonwealth and to any facility operated, funded or licensed by the Department which conducts or which proposes to conduct or authorize research which uses human participants.

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

Estimated Economic Impact. The regulations state that human research activity shall be reviewed and approved by a committee composed of representatives of varied backgrounds who shall assure the competent, complete, and professional review of human research activities. The current regulations require that the committee shall have at least seven members. The Board proposes to reduce the number of required members to five. Having five committee members is less burdensome and is consistent with federal regulation.1

and employment positions to be affected, the projected costs to affected businesses or entities to implement or comply with the regulation, and the impact on the use and value of private property. Further, if the proposed regulation has an adverse effect on small businesses, § 2.2-4007.04 requires that such economic impact analyses include (i) an identification and estimate of the number of small businesses subject to the regulation; (ii) the projected reporting, recordkeeping, and other administrative costs required for small businesses to comply with the regulation, including the type of professional skills necessary for preparing required reports and other documents; (iii) a statement of the probable effect of the regulation on affected small businesses; and (iv) a description of any less intrusive or less costly alternative methods of achieving the purpose of the regulation. The analysis presented above represents DPB's best estimate of these economic impacts.

The Board proposes several other changes to the language in

these regulations. None of the other proposed amendments

introduce any new requirements or changes to current requirements that are not either already in federal regulation or Virginia statute. Thus these other proposed changes will have no impact beyond improving clarity.

Businesses and Entities Affected. The proposed amendments affect the Virginia Department of Health, local health departments in the Commonwealth and any facility operated, funded or licensed by the Department which conducts or which proposes to conduct or authorize research which uses human participants.

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

Projected Impact on Employment. The proposed amendments will not likely affect employment.

Effects on the Use and Value of Private Property. The proposed amendments are unlikely to significantly affect the use and value of private property.

Small Businesses: Costs and Other Effects. The proposed amendments are unlikely to significantly affect costs for small businesses.

Small Businesses: Alternative Method that Minimizes Adverse Impact. The proposed amendments are unlikely to significantly affect costs for small businesses.

Real Estate Development Costs. The proposed amendments do not affect real estate development costs.

1 Relevant federal regulation: 45 CFR 46.107

Agency's Response to Economic Impact Analysis: The Virginia Department of Health concurs with the findings of the economic impact analysis.

Summary:

The proposed amendments (i) revise the definitions of human research, informed consent, and legally authorized representative to be consistent with § 32.1-162.16 of the Code of Virginia and 45 CFR Part 46; (ii) provide additional clarity on committee review procedures; (iii) require that the research review committee ensure compliance with the Health Insurance Portability and Accountability Act and federal and state regulations regarding disclosure of personal health information and change committee membership from seven to five; (iv) clarify the informed consent requirements; and (v) revise the required reporting dates for the research review committee to report yearly activities and the commissioner to report the listing of institutions that are subject to federal regulations regarding human subject research and are exempt from 12VAC5-20.

12VAC5-20-10. Definitions.

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

"Affiliated with the institution" means employed by or contracting with the institution or directly or indirectly involved in the management thereof.

"Commissioner" means the Commissioner of the Department of Health.

"Committee" means human research committee assembled pursuant to 12VAC5-20-70 of this chapter by any institution defined herein.

"Department" means the Department of Health.

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"Human research" means any systematic investigation ~~utilizing human participants who may be exposed to physical~~ ~~or psychological injury as a consequence of participation and~~ ~~which departs from the application of established and~~ ~~accepted therapeutic methods appropriate to meet the~~ ~~participants' needs~~, including research development, testing, and evaluation, utilizing human subjects that is designed to develop or contribute to generalized knowledge. Human research shall not be deemed to include research exempt from federal research regulation pursuant to 45 CFR 46.101(b).

"Informed consent" means the knowing and voluntary agreement, without undue inducement or any element of force, fraud, deceit, duress, or other form of constraint or coercion, of a person who is capable of exercising free power of choice. ~~For the purposes of human research, the basic~~ ~~elements of information necessary to such consent shall~~ ~~include:~~

2. A disclosure of any appropriate alternative procedures or therapies that might be advantageous for the individual;

3. An instruction that the person may withdraw his consent and discontinue participation in the human research at any time without prejudice to him;

4. An explanation of any costs or compensation which may accrue to the person and, if applicable, the availability of third party reimbursement for the proposed procedures or protocols; and

5. An offer to answer any inquiries by any individual concerning the procedures and protocols.

In addition to the required elements, the information provided to the individual should also include the following:

1. A statement that the study involves research, and an explanation that includes identification of any procedures which are experimental; the expected duration of the individual's participation; and a statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained; and if any data from this study are published, the individual will not be identified without his written permission;

2. A statement that there may be other risks not yet identified;

3. A disclosure of any appropriate alternative procedures or therapies that might be advantageous for the individual;

4. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the individual is otherwise entitled, and the individual may discontinue participation at any time without penalty or loss of benefits to which he is otherwise entitled;

5. An explanation of whom to contact for answers to pertinent questions about the research and research participants' rights, and whom to contact in the event of a research-related injury; and

6. For research involving more than minimal risk, an explanation as to whether any compensation or medical care is available if injury occurs and, if so, what is included or where further information may be obtained.

Information should be provided in a manner that is understandable to the individual with regard to his educational level and language of greatest fluency.

"Institution" or "agency" means any facility, program, or organization owned or operated by the Commonwealth, by any political subdivision, or by any person, firm, corporation, association, or other legal entity.

"Legally authorized representative" means, in the following specified order of priority, (i) the parent or parents having custody of a prospective ~~participant~~ subject of human research who is a minor; (ii) the agent appointed under an advance directive as defined in § 54.1-2982 of the Code of Virginia, executed by the person who is the prospective subject of human research, provided the advance directive authorizes the agent to make decisions regarding the person's participation in human research; (iii) the legal guardian of a prospective ~~participant~~ subject of human research; (iv) the spouse of a prospective subject of human research, except where a suit for divorce has been filed and the divorce decree is not yet final; (v) an adult child of a prospective subject of human research; (vi) a parent of a prospective subject of human research when the individual is an adult; (vii) an adult brother or sister of a prospective subject of human research; or (viii) any person or judicial or other body authorized by law or regulation to consent on behalf of a prospective ~~participant~~ subject of human research to such person's participation in the particular human research. For the purposes of this chapter, any person authorized by law or regulation to consent on behalf of a prospective ~~participant~~ subject to ~~his~~ such subject's participation in the particular human research shall include an attorney-in-fact appointed under a durable power of attorney, to the extent the power grants the authority to make such a decision. The attorney-in- fact shall not be employed by the person, institution or agency conducting the human research. No official or employee of the institution or agency conducting or authorizing the research shall be qualified to act as a legally authorized representative.

"Minimal risk" means that the risks of harm or discomfort anticipated in the proposed research are not greater, considering probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations, or tests, or treatments.

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"Nontherapeutic research" means human research in which there is no reasonable expectation of direct benefit to the physical or mental condition of the ~~participant~~ subject.

"Protected health information" or "PHI" means individually identifiable health information that is created or received by or on behalf of the institution or agency that is maintained or transmitted in any medium, including electronic media. PHI excludes individually identifiable health information in:

1. Education records covered by the Family Educational Rights and Privacy Act, as amended, 20 USC § 1232g;

2. Records described at 20 USC § 1232g(a)(4)(B)(iv) (educational records not otherwise covered under the Family Educational Rights and Privacy Act in subdivision 1 of this definition); or

3. Employment records held by a covered entity in its role as an employer.

"Subject" or "human subject" means a living person about whom an investigator (whether professional or student) conducting research obtains (i) data through intervention or interaction with the person or (ii) identifiable private information.

12VAC5-20-30. Applicability.

This chapter shall apply to the department, including any local health department and to any facility operated, funded or licensed by the department ~~which~~ that conducts or ~~which~~ proposes to conduct or authorize research ~~which uses~~ using human ~~participants~~ subjects.

12VAC5-20-40. Policy.

A. No human research ~~may~~ shall be conducted without informing the ~~participant~~ subject or his legally authorized representative of the procedures, risks, and discomforts of the research. The consent of the ~~participant~~ subject or his legally authorized representative to participate in the research shall be subscribed to in writing by the ~~participant~~ subject or his legally authorized representative and supported by the signature of a witness not involved in the conduct of the research, except as provided for in 12VAC5-20-100 ~~F and H~~ ~~of this chapter~~. Special arrangements shall be made for those who need assistance in understanding the consequences of participating in the research.

B. Each human research activity shall be reviewed and approved by a committee as set forth in 12VAC5-20-70 of ~~this chapter~~ composed of representatives of varied backgrounds who shall assure the competent, complete, and professional review of human research activities.

C. Every person engaged in the conduct of human research or proposing to conduct human research shall associate himself with an institution or agency having a research review committee, and the human research which he conducts or proposes to conduct shall be subject to review and approval by such committee in the manner set forth in ~~these regulations~~ this chapter.

D. Nontherapeutic research using patients or residents within an institution as defined herein is forbidden unless it is determined by the research review committee that such nontherapeutic research ~~will~~ shall not present greater than minimal risk.

E. The ~~individual~~ person, institution, or agency conducting the human research shall ~~be required to~~ notify all ~~participants~~ subjects of human research of the risks caused by the research ~~which~~ that are discovered after the research has concluded. If consent has been obtained by the signature of the legally authorized representative, the legally authorized representative shall also be notified.

F. No official or employee of the institution or agency conducting or authorizing the human research shall be qualified to act as a legally authorized representative for a subject of the particular human research.

12VAC5-20-50. Review process for department.

A. Prior to the initiation of a human research project by any component of the department, a description of the proposed human research project shall be submitted to a research review committee established by the department for review and approval. The description shall include a statement of the purpose of the proposed project and justification thereof, the criteria for inclusion ~~of a participant~~ as a subject in the research project, a description of what will be done to the ~~participants~~ subjects, and a copy of the informed consent statement.

B. The committee shall report by ~~January~~ March 31 of each year to the commissioner on activities of the committee during the previous calendar year. Such reports shall include:

1. A description of each human research project reviewed and whether it was approved or disapproved;

2. Any significant deviations from proposals as approved;

3. A list of committee members, their qualifications for service on the committee, and their institutional affiliation; and

4. A copy of the minutes of any committee meetings conducted.

C. The ~~chairman~~ chair of the committee shall report as soon as possible to the commissioner any violation of the research protocol ~~which~~ that led the committee to either suspend or terminate the research.

D. The commissioner may inspect the records of the committee.

E. The commissioner shall report at least annually to the Governor and General Assembly on the human research projects conducted by any component of the department as annually reported to the commissioner by the committee.

12VAC5-20-60. Review process for institutions or agencies funded or licensed by the department.

A. Prior to the initiation of a human research project by any institution or agency funded or licensed by the department, a

description of the proposed human research project shall be submitted to a research review committee for review and approval. The description shall include a statement of the purpose of the proposed project and justification thereof, the criteria for inclusion of a ~~participant~~ subject in the research project, a description of what will be done to the ~~participants~~ subjects, and a copy of the informed consent statement.

B. When more than one such institution or agency is involved in a research project, the cooperating entities may enter into joint review.

C. Such institutions or agencies having a committee shall report by ~~January~~ March 31 of each year to the commissioner on activities of the committee during the previous calendar year. Such reports shall include:

1. A description of each human research project reviewed and whether it was approved or disapproved;

2. Any significant deviations from proposals as approved;

3. A list of committee members, their qualifications for service on the committee, and their institutional affiliation; and

4. A copy of the minutes of any committee meetings conducted.

D. The ~~chairman~~ chair of the committee shall report as soon as possible to the head of such institution or agency and to the commissioner any violation of the research protocol which led the committee to ~~either~~ suspend or terminate the research.

E. The commissioner may inspect the records of the committee.

F. The commissioner shall report at least annually to the Governor and General Assembly on the human research projects conducted by such institutions or agencies as annually reported to the commissioner by the relevant research review committees.

12VAC5-20-70. Composition of research review committee.

A. Each committee shall have at least ~~seven~~ five members, appointed by the head of the institution, with varying backgrounds to provide complete and adequate review of activities commonly conducted by the institution. The committee shall be sufficiently qualified through the maturity, experience, and diversity of its members, including consideration of race, gender and cultural background, to promote respect for its advice and counsel in safeguarding the rights and welfare of ~~participants~~ subjects in human research. In addition to possessing the professional competence necessary to review specific activities, the committee shall be able to ascertain the acceptability of applications and proposals in terms of institutional commitments and regulations, applicable law, standards of professional conduct and practice, and community attitudes. If a committee regularly reviews research that has an impact on patients or residents within an institution as defined herein or other vulnerable category of ~~participants~~ subjects, the committee

shall have in its membership one or more individuals who are primarily concerned with the welfare of these ~~participants~~ subjects and who have appropriate experience to serve in that capacity.

B. No committee shall consist entirely of members of one profession, and at least one member ~~must~~ shall be an individual whose primary concerns are in nonscientific areas (e.g., lawyers, ethicists, members of the clergy).

C. Each committee shall include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution.

D. No member of a committee shall participate in the committee's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the committee. The committee has responsibility for determining whether a member has a conflicting interest. The committee size shall be maintained at no fewer than ~~seven~~ five persons by appointment of a substitute representative for each member with a conflicting interest.

E. A committee may, at its discretion, invite individuals with competence in special areas to assist in the review of complex issues which require expertise beyond or in addition to that available on the committee. These individuals ~~may~~ shall not vote with the committee.

F. A quorum of the committee shall consist of a majority of its members including at least one member whose primary concerns are in nonscientific areas.

G. The committee and the institution shall establish procedures and rules of operation necessary to fulfill the requirements of this chapter.

12VAC5-20-80. Elements of committee review process.

A. No human research shall be conducted or authorized by a person, institution, or agency unless a research review committee has reviewed and approved the proposed human research project giving consideration to:

1. The adequacy of the description of the potential benefits and risks involved and the adequacy of the methodology of the human research;

2. The degree of the risk and, if the human research is nontherapeutic, whether it presents greater than minimal risk;

3. Whether the rights and welfare of the human subjects involved are adequately protected;

4. Whether the risks to the human subjects are outweighed by the potential benefits to them;

5. Whether the risks to subjects are minimized (i) by using procedures that are consistent with sound human research design and that do not unnecessarily expose subjects to risk and (ii) whenever appropriate, by using currently accepted procedures for diagnostic or treatment purposes;

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6. Whether additional safeguards have been included in the study to protect the rights and welfare of the subjects when some or all of the subjects are likely to be incapable of providing informed consent or are otherwise vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons;

7. Whether the informed consent is to be obtained by methods that are adequate and appropriate and whether the written consent form is adequate and appropriate in both content and language for the particular human research and for the particular subjects of the human research;

8. Whether the persons proposing to supervise or conduct the particular human research are appropriately competent and qualified;

9. Whether criteria for selection of subjects are equitable; and

10. Whether the human research conforms with other requirements of the department, where applicable.

A. B. The committee shall consider a research ~~proposals~~ proposal within 45 days after its submission to the committee. In order for the research proposal to be approved, it shall receive the approval of a majority of ~~those~~ the committee members present at a meeting in for which a quorum exists. A committee shall notify investigators and the institution in writing of its decision to approve or disapprove the ~~proposed~~ research ~~activity,~~ proposal or of modifications required to secure committee approval.

B. C. During the committee review of research ~~projects~~ proposals, no personal identifiers of present or potential subjects shall be stated.

C. D. The committee shall ~~approve or~~ develop a written description of the procedure to be followed when a subject has a complaint about a research project in which he is participating or has participated.

D. E. Any subject who has a complaint about a research project in which he is participating or has participated shall be referred to the committee to determine if there has been a violation of the protocol.

F. The committee shall have the authority to suspend or terminate approval of research that is not being conducted in accordance with the committee requirements or that has been associated with unexpected serious harm to the subjects. Any suspension or termination of approval shall include a statement of the reasons for the committee's action and shall be reported promptly to the investigator, appropriate institutional officials, the department or agency head, and the commissioner.

G. The chair of the committee shall provide a written report to the head of the institution of any violation of the human research protocol that led the committee to suspend or terminate the human research.

E. H. The committee shall require reports from approved research projects at least annually to ensure conformity with the approved proposal. The frequency of such reports shall be consistent with the nature and degree of risk of each research project. The committee shall also require a report ~~from the~~ ~~research project~~ at the conclusion of the research project.

I. The committee shall ensure compliance with the Health Insurance Portability and Accountability Act of 1996 (42 USC § 1320d et seq.), if applicable, and federal and state regulations regarding the use and disclosure of PHI created for human research. In particular, authorization shall be obtained for the use and disclosure of PHI created for the purpose of human research, except as otherwise permitted by 45 CFR 164.512(i).

J. When cooperating institutions conduct some or all of the human research involving some or all of the subjects of the human research, each cooperating institution shall be responsible for safeguarding the rights and welfare of the subjects and for complying with this chapter, provided however, in complying with this chapter, institutions may enter into joint review, rely upon the review of another qualified committee, or come to similar agreements aimed at avoiding duplication of effort. Any such agreement shall be in writing and designate a lead institution, which shall be the institution responsible for reporting and handling any possible misconduct in the human research. Such agreements shall be entered into by the committee chair with the approval of a majority of the committee members. If an institution or agency does not have a research review committee, such agreements shall be approved and entered into by the chief executive officer of the institution or his designee.

12VAC5-20-90. Expedited review of human research projects.

A. The committee is authorized to conduct an expedited review of a human research project ~~which~~ that involves no more than minimal risk to the subjects ~~if:~~ and involves only research procedures listed in one or more categories established by the Secretary of Health and Human Services and published in the Federal Register pursuant to 45 CFR 46.110.

B. The committee also is authorized to conduct an expedited review of a human research project that involves no more than minimal risk to the subjects if:

1. Another institution's or agency's human research review committee has reviewed and approved the project; or

2. The review involves only minor changes in previously approved research and the changes occur during the approved project period.

C. An expedited review may be carried out by the chair of the committee or by one or more experienced reviewers designated by the chair from among the committee members. In reviewing the research project, the reviewers may exercise all of the authorities of the committee except that the

reviewers may not disapprove the research project. A research project may be disapproved only after review by the full committee in accordance to the procedures set forth in 12VAC5-20-80.

B. D. Each committee ~~which~~ that uses an expedited review procedure shall adopt a method for keeping all members advised of research ~~proposals which~~ projects that have been approved under the procedure.

12VAC5-20-100. Informed consent.

A. "Informed consent" means the knowing and voluntary agreement, without undue inducement or any element of force, fraud, deceit, duress, or other form of constraint or coercion, of a person who is capable of exercising free power of choice. For the purposes of human research, the basic elements of information necessary to determine the existence of such consent shall include the following:

1. A reasonable and comprehensible explanation to the person of the proposed procedures or protocols to be followed, their purposes, including descriptions of any attendant discomforts, and risks and benefits reasonably to be expected, how the results of the human research are disseminated, and how the identity of the person is protected;

2. A disclosure of any appropriate alternative procedures or therapies that might be advantageous for the ~~individual~~ person, together with their side effects, risks, and benefits;

3. A description of any adverse consequences and risks to be expected and an indication of whether there may be other significant risks not yet identified;

3. 4. An instruction that the person may withdraw his consent and discontinue participation in the human research at any time without prejudice to him or fear of reprisal;

4. 5. An explanation of any costs or compensation that may accrue to the person and, if applicable, the availability of third party reimbursement for the proposed procedures or protocols or any medical care that may be available if an injury occurs;

5. 6. An offer to answer any inquiries by ~~any individual~~ the person or, if applicable, his legally authorized representative concerning the procedures and protocols and a description of the ways in which concerns may be raised or questions asked;

6. 7. A statement that the study involves research, and an explanation that includes identification of any procedures that are experimental; the expected duration of the ~~individual's~~ person's participation; a statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained; and if any data from this study are published, the ~~individual~~ person will not be identified without his written permission;

7. 8. A statement that there may be other risks not yet identified;

8. 9. A disclosure of any appropriate alternative procedures or therapies that might be advantageous for the ~~individual~~ person;

9. 10. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the ~~individual~~ person is otherwise entitled, and the ~~individual~~ person may discontinue participation at any time without penalty or loss of benefits to which he is otherwise entitled;

~~10.~~ 11. An explanation of whom to contact for answers to pertinent questions about the research and research participants' rights, and whom to contact in the event of a research-related injury; and

~~11.~~ 12. For research involving more than minimal risk, an explanation as to whether any compensation or medical care is available if injury occurs and, if so, what is included or where further information may be obtained.

Information shall be provided in a manner that is understandable to the ~~individual~~ person with regard to his educational level and language of greatest fluency.

B. No human research shall be conducted in the absence of informed consent subscribed to in writing by the person or by the person's authorized representative except as provided for in subsection E of this section. If the person is capable of providing informed consent, written consent shall be provided by the person and witnessed. If the person is incapable of making an informed decision as defined in § 54.1-2982 of the Code of Virginia, at the time consent is required, written consent shall be provided by the person's legally authorized representative and witnessed. If the person is a minor otherwise capable of rendering informed consent, the consent shall be provided by both the minor and his legally authorized representative. An investigator shall seek such consent only under circumstances that provide the person who is the prospective subject or the representative sufficient opportunity to consider whether to participate and that minimize the possibility of coercion or undue influence. The information that is given to the person or, if applicable, the person's legally authorized representative shall be in language understandable to the person or representative.

C. No person shall participate in human research unless the informed consent requirement in this section is met. No informed consent shall include any language through which the person waives or appears to waive any of his legal rights, including any release of any person, institution, or agency or any agents therof from liability for negligence. No person shall be forced to participate in any human research if the investigator conducting the human research knows that participation in the human research is protested by the person.

D. No legally authorized representative shall consent to nontherapeutic human research unless it is determined by the research review committee that such nontherapeutic research will present no more than a minor increase over minimal risk to the subject. A legally authorized representative may not

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consent to participation in human research on behalf of a subject if the legally authorized representative knows, or upon reasonable inquiry ought to know, that any aspect of the human research protocol is contrary to the religious beliefs or basic values of the subject, whether expressed orally or in writing.

E. The research review committee may approve a consent procedure that does not include or that alters some or all of the elements of informed consent set forth in this section, or that waives the requirements to obtain informed consent provided the committee finds and documents that:

1. The human research involves no more than minimal risk to the subjects;

2. The omission, waiver, or alteration will not adversely affect the rights and welfare of the subjects;

3. The human research could not practicably be performed without the omission, waiver, or alterations; and

4. After participation, the subjects shall be provided with additional pertinent information, whenever appropriate.

B. F. Consent may take the form of either of the following:

1. A written consent document that embodies the elements of informed consent required by this section. This form may be read to the subject or the subject's legally authorized representative, but, in any event, the investigator shall give either the subject or the representative adequate opportunity to read it before it is signed and witnessed; or

2. A short form written consent document stating that the elements of informed consent required by this section have been presented orally to the subject or the subject's legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Also, the committee shall approve a written summary of what is to be said to the subject or the representative. Only the short form ~~itself~~ written consent is ~~to be~~ signed by the subject or the representative. However, the witness shall sign both the short form written consent and a copy of the summary, and the person actually obtaining consent shall sign a copy of the summary. A copy of the summary and a copy of the short form written consent shall be given to the subject or the representative.

G. The research review committee may waive the requirement in subsection B of this section for the investigator to obtain a written informed consent form for some or all subjects if it finds that the only record linking the subject and the human research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject shall be asked whether the subject wants documentation linking the subject with the human research, and the subject's wishes shall govern. In cases where the documentation requirement is waived, the committee may require the investigator to

provide subjects with a written statement explaining the human research.

12VAC5-20-110. Categories of human research exempt from regulation.

Research activities in which the only involvement of human ~~participants will be~~ subjects is in one or more of the following categories are exempt from this chapter:

1. The surveillance and investigation by the department into all preventable diseases and epidemics in the Commonwealth and into the means for the prevention of such diseases and epidemics conducted pursuant to § 32.1- 39 of the Code of Virginia.

2. Research designed to study on a large scale anonymous vital records and registry data collected pursuant to the Code of Virginia, Chapter 7 (§ 32.1-249 et seq.) of Title

32.1 (Vital Records), § 32.1-64.1 (Virginia Hearing Impairment Identification and Monitoring System), § 32.1-

69.1 ~~(Viginia~~ (Virginia Congenital Anomalies Reporting and Education System), § 32.1-70 (Statewide Cancer Registry), ~~§ 32.1-71.l (Statewide Alzheimer's Disease and~~ ~~Related Disorders Registry),~~ § 32.1-46.01 (Virginia Immunization Information System), and §§ § 32.116.1 ~~and~~ ~~32.116.1:2~~ (Emergency Medical Services Patient Care Information System).

3. Research or student learning outcomes assessment conducted in educational settings such as research involving:

a. Regular or special education instructional strategies; or

b. The effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods; or

c. The use of educational tests, whether cognitive, diagnostic, aptitude, or achievement, if the data from such tests are recorded in a manner so that ~~participants~~ subjects cannot be identified, directly or through identifiers linked to the ~~participants~~ subjects.

4. Research involving survey or interview procedures unless responses are recorded in such a manner that the ~~participants~~ subjects can be identified, directly or through identifiers linked to the ~~participants~~ subjects, and either:

a. The ~~participant's~~ subject's responses, if they became known outside the research, could reasonably place the participant at risk of criminal or civil liability or be damaging to his financial standing, employability, or reputation; or

b. The research deals with sensitive aspects of the ~~participant's~~ subject's own behavior such as sexual behavior, drug or alcohol use, or illegal conduct.

5. Research involving survey or interview procedures, when the respondents are elected or appointed public officials or candidates for public office.

6. Research involving solely the observation of public behavior, including observation by participants, unless observations are recorded in such a manner that the ~~participants~~ subjects can be identified, directly or through identifiers linked to the ~~participants~~ subjects, and either:

a. The observations recorded about the ~~individual~~ subject, if they became known outside the research, could reasonably place the ~~participant~~ subject at risk of criminal or civil liability or be damaging to his financial standing, employability, or reputation; or

b. The research deals with sensitive aspects of the ~~participant's~~ subject's own behavior, such as sexual behavior, drug or alcohol use, or illegal conduct.

7. Research involving the collection or study of existing data, documents, records, or pathological specimens, if these sources are publicly available or if the information is recorded by the investigator in a manner so that ~~participants~~ subjects cannot be identified, directly or through identifiers linked to the ~~participants~~ subjects.

12VAC5-20-120. Committee records.

A. Documentation of committee activities shall be prepared and maintained by each such committee and shall include the following:

1. Copies of all research proposals reviewed, scientific evaluations that may accompany the proposals, approved sample consent documents, progress reports submitted by investigators, and reports of injuries to ~~participants~~ subjects;

2. Minutes of committee meetings ~~which shall be~~ in sufficient detail to show attendance at the meetings; actions taken by the committee; the vote on ~~these actions~~ each action, including the number of members voting for, against, and abstaining; the basis for requiring changes in or disapproving research; and a written summary of the discussion of controversial issues and their resolution;

3. Records of continuing review activities;

4. Copies of all correspondence between the committee and the investigators;

5. A list of committee members;

6. Written procedures for the committee; and

7. Statements of significant new findings provided to ~~participants~~ subjects.

B. The records required by this chapter shall be retained for at least three years, and records relating to research ~~which~~ that is conducted shall be retained for at least three years after completion of the research. All records shall be accessible for inspection and copying by authorized employees or agents of the department at reasonable times and in a reasonable manner.

C. An Each research review committee of a state institution or agency shall ensure that an overview of approved human research projects and the results of such projects ~~will be~~ are

made public on ~~the department's~~ such institution's or agency's website unless otherwise exempt from disclosure under the Virginia Freedom of Information Act (§ 2.2-3700 et seq. of the Code of Virginia).

12VAC5-20-130. Applicability of federal policies.

Human research ~~at institutions which are~~ that is subject to policies and regulations for the protection of human ~~participants~~ subjects promulgated by any agency of the federal government shall be exempt from this chapter. ~~Such~~ ~~institutions~~ Institutions where research is performed that is subject to federal policies and regulation shall notify the commissioner annually, by ~~January~~ March 31, of their compliance with the policies and regulations of federal agencies. The commissioner shall identify institutions exempt from this chapter as reported in accordance with this section in the annual report to the Governor and the General Assembly provided in accordance with 12VAC5-20-60 F.

VA.R. Doc. No. R13-3401; Filed December 17, 2013, 5:24 p.m.

Fast-Track Regulation

Title of Regulation: 12VAC5-31. Virginia Emergency Medical Services Regulations (amending 12VAC5-31- 1401; repealing 12VAC5-31-1465).

Statutory Authority: §§ 32.1-12, 32.1-111.4, and 32.1-111.5 of the Code of Virginia.

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: February 12, 2014.

Effective Date: March 1, 2014.

Agency Contact: Michael Berg, Regulatory and Compliance Manager, Department of Health, 1041 Technology Park Drive, Glen Allen, VA 23059-4500, telephone (804) 888- 9131, or email michael.berg@vdh.virginia.gov.

Basis: Section 32.1-12 of the Code of Virginia authorizes the State Board of Health to promulgate regulations to carry out the provisions of Title 32.1 of the Code of Virginia. Section 32.1-111.4 of the Code of Virginia directs the board to establish requirements regarding emergency medical services (EMS). Section 32.1-111.5 of the Code of Virginia requires the board to establish the qualifications required for certification of emergency medical services providers, including those qualifications necessary for authorization to follow Do Not Resuscitate Orders pursuant to § 54.1-2987.1 of the Code of Virginia, and the procedures and the qualifications required for the recertification of EMS providers.

Purpose: This regulatory action will help to strengthen the EMS system, and thereby protect the health, safety, and welfare of citizens, by improving the efficiency of the EMS provider recertification process through the removal of certain unnecessary and burdensome regulatory requirements. There is unanimous consensus by the EMS system that the current method and process used to recertify EMS providers needs to

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be changed. The EMS system is in agreement that the recertification of EMS credentials should be based solely on completion of continuing education hours and should not require a written examination or examination waiver by the provider's EMS agency operational medical director (OMD) to complete the process. Current review of available data reveals greater than 90% of all recertification testing is being waived.

These changes will not adversely affect the health, safety, and welfare of the citizens of the Commonwealth because the ability to provide patient care as an EMS provider is governed by regulations that require authorization by the agency OMD and affiliation with an EMS agency.

Rationale for Using Fast-Track Process: Changes to the regulations are not expected to be controversial as the various stakeholders groups and the EMS community requested this change to simplify the existing recertification process. These changes will mirror the recertification processes of other allied health professions.

Substance: The changes to the regulation allow a certified EMS provider to gain recertification through continuing education only, removes any retesting requirement (written or practical) at the state level, and removes the requirement for the OMD to sign any paperwork to "waive" any test administered by the state. This does not preclude the ability of the individual OMD to implement any local requirements he believes necessary to evaluate the ability of the EMS providers that provide patient care under his authority.

Issues: The primary advantage of this regulatory action is that it removes burdensome and unnecessary regulatory requirements as well as aligns with other allied health care recertification practices in the Commonwealth. This regulatory action poses no disadvantages to either the public or the Commonwealth.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. Pursuant to Chapters 72 and 331 of the 2013 Acts of Assembly, the proposed regulations no longer require Emergency Services (EMS) providers to take a written examination for recertification.

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

Estimated Economic Impact. Pursuant to Chapters 72 and 331 of the 2013 Acts of Assembly, the proposed regulations no longer require EMS providers to take a written examination for recertification. Under the current regulations, EMS providers are required to take a written examination for recertification. However, the written examination requirement may be waived by the relevant operational medical director. According to the Virginia Department of Health (VDH), more than 90% of all recertification testing is currently being waived. With the proposed changes, recertification of EMS

credentials will be based solely on completion of continuing education hours currently required.

The proposed changes will primarily affect EMS providers. EMS providers who are currently obtaining waivers will not have to seek waivers and the ones currently taking the exam will not have to take it under the proposed regulations. VDH estimates that during the five-month period from August to December 2013, approximately 2,137 providers will be required to take the test. Of these, approximately 1,991 will obtain waivers and about 145 will actually take the test. The proposed regulations will benefit the affected providers as they will no longer incur time and travel costs to take the exam or obtain a waiver. The test is administered by VDH free of charge. Thus, VDH is also expected to realize cost savings from reduced administrative workload, reduced postage costs, and reduced printing costs.

Businesses and Entities Affected. There are approximately 37,000 EMS providers in the Commonwealth. These providers work for approximately 684 agencies that are volunteer, commercial, and municipal entities.

Localities Particularly Affected. The proposed regulations apply throughout the Commonwealth.

Projected Impact on Employment. Proposed elimination of the recertification exam is expected to provide time savings to the providers as well as to VDH due to their reduced work load. Thus, a potential increase in supply of EMS providers and a potential decrease in demand for VDH administrative staff time may be expected.

Effects on the Use and Value of Private Property. The proposed regulations are not expected to have a significant effect on the value of private property.

Small Businesses: Costs and Other Effects. Some of the commercial agencies employing EMS providers may be small businesses. However, the proposed regulations do not have a direct impact on these agencies.

Small Businesses: Alternative Method that Minimizes Adverse Impact. The proposed regulations are not anticipated to have a direct impact on commercial agencies that may be small businesses.

Real Estate Development Costs. No effect on real estate development costs is expected.

the regulation, and the impact on the use and value of private property. Further, if the proposed regulation has an adverse effect on small businesses, § 2.2-4007.04 requires that such economic impact analyses include (i) an identification and estimate of the number of small businesses subject to the regulation; (ii) the projected reporting, recordkeeping, and other administrative costs required for small businesses to comply with the regulation, including the type of professional skills necessary for preparing required reports and other documents; (iii) a statement of the probable effect of the regulation on affected small businesses; and (iv) a description of any less intrusive or less costly alternative methods of achieving the purpose of the regulation. The analysis presented above represents DPB's best estimate of these economic impacts.

Agency's Response to Economic Impact Analysis: The Virginia Department of Health has reviewed the economic impact analysis and concurs with the results.

Summary:

In accordance with Chapters 72 and 331 of the 2013 Acts of Assembly, the amendments remove the requirement for emergency medical services (EMS) providers to take a written examination or obtain a waiver from testing from the relevant operational medical director to recertify their EMS certifications.

12VAC5-31-1401. General recertification requirements.

A. An EMS provider ~~must complete the requirements for~~ ~~recertification and the~~ requesting recertification must complete the continuing education hour requirements, as identified in 12VAC5-31-1403, for the level at which the EMS provider is requesting to be recertified. The Office of EMS must receive ~~the required~~ documentation of the EMS provider's completion of continuing education within the issued certification period for the provider to maintain a current certification.

B. An EMS provider requesting recertification must complete the continuing education (CE) hour requirements for the level to be recertified.

C. An EMS provider requesting recertification must pass the written state certification examination.

1. An EMS provider affiliated with an EMS agency may be granted an exam waiver from the state written certification examination by the OMD of the EMS agency, provided:

a. The EMS provider meets the recertification requirements including those established by the OMD; and

b. The EMS provider must submit a completed Virginia EMS Certification Application with the exam waiver approval signed by the EMS agency OMD, which must be received by the Office of EMS within 30 days following the expiration of his certification.

(1) If the Virginia EMS Certification Application form is received by the Office of EMS after the EMS provider's

certification expiration date, the EMS provider may not practice at the expired certification level until a valid certification is received from the Office of EMS.

(2) If the Virginia EMS Certification Application form is received by the Office of EMS more than 30 days after the EMS provider's certification expiration date, his certification will be in reentry and he will be required to test pursuant to 12VAC5-31-1407.

2. B. An EMS provider under legal recognition pursuant to 12VAC5-31-1393 must ~~pass~~ recertify by passing a Virginia written and practical EMS certification examination ~~and is~~ ~~not eligible for examination waiver~~.

12VAC5-31-1465. Recertification examination requirement. (Repealed.)

A. Individuals who are eligible to recertify and hold current certifications are required to successfully complete the state written examination process based upon the following:

1. All individuals who are not affiliated with a licensed EMS agency must take the state written examination to recertify.

2. Individuals affiliated with a licensed EMS agency may be granted an exam waiver from the state written recertification examination by the operational medical director (OMD) of the EMS agency, provided:

a. A completed Virginia EMS Certification Application signed by the OMD and the individual is submitted to the Office of EMS documenting the exam waiver or a format approved by the Office of EMS.

b. A Virginia EMS Certification Application form submitted as an exam waiver must be received by the Office of EMS no later than 30 days following the expiration of the individual's certification at the level being waived.

(1) Virginia EMS Certification Application forms received by the Office of EMS during the 30 days after the individual's certification expiration date will be considered valid for recertification purposes. However, during this period following expiration, the individual may not practice at the expired certification level.

(2) Virginia EMS Certification Application forms received by the Office of EMS more than 30 days after the individual's certification expiration date will be considered as invalid and the individual will be deemed in reentry status and required to test to regain current certification.

B. Candidates in current provider status required or choosing to take the state recertification examination must demonstrate eligibility as evidenced by presentation of a valid recertification eligibility notice letter from the Office of EMS.

VA.R. Doc. No. R14-3703; Filed December 17, 2013, 11:39 a.m.

DEPARTMENT OF MEDICAL ASSISTANCE SERVICES

Emergency Regulation

Title of Regulation: 12VAC30-130. Amount, Duration and Scope of Selected Services (amending 12VAC30-130-800, 12VAC30-130-810, 12VAC30-130-820).

Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.

Effective Dates: December 16, 2013, through June 15, 2015.

Agency Contact: Brian McCormick, Regulatory Supervisor, Department of Medical Assistance Services, 600 East Broad Street, Suite 1300, Richmond, VA 23219, telephone (804)

371-8856, FAX (804) 786-1680, or email

brian.mccormick@dmas.virginia.gov. Preamble:

Section 2.2-4011 of the Administrative Process Act states that an agency may adopt emergency regulations in situations in which Virginia statutory law, the Virginia appropriation act, or federal law or federal regulation requires that a regulation be effective in 280 days or less from its enactment and the regulation is not exempt under the provisions of § 2.2-4006 A 4 of the Code of Virginia. Item 307 UU of Chapter 3 of the 2012 Acts of Assembly, Special Session I, directed the department to make programmatic changes to ensure appropriate utilization, prevent abuse, and promote improved and cost-efficient medical management of essential Medicaid client health care (as described in Item 307 UU) within 280 days or less from its enactment date.

The purpose of this regulatory action is to comply with the legislative mandate by making programmatic changes to the Client Medical Management (CMM) program to ensure appropriate utilization, prevent abuse, and promote improved and cost-efficient medical management of essential health care and to assist and educate beneficiaries in appropriately utilizing medical and pharmacy services.

The amendments to the Medicaid Client Medical Management program are not essential to protect the health, safety, or welfare of citizens. However, the amendments could be essential to protect the health, safety, and welfare of Medicaid clients who abuse prescription drugs. The current regulations promote case management of Medicaid individuals who have been identified as abusers of specific medical services provided by physicians and pharmacists. The current regulations lack an education component, therefore leaving enrollees with only the option of being restricted for a certain period of time to a specific physician or pharmacy. The revisions provide for a two-tiered system, allowing for an educational component as well as restrictions. The revised regulations provide for the notification of potential abusers that they have been identified and will be monitored closely for a

certain period of time. It is anticipated that the revised regulations will assist recipients, physicians, and pharmacists as they and CMM work together to identify the recipients' utilization patterns and educate them on appropriate use of services.

Currently, the regulations provide for administration of the Client Medical Management program. CMM guidelines lock-in recipients to one physician/pharmacy for a minimum of 36 months. At the end of the lock-in period, if the recipient is deemed to be still inappropriately utilizing services, he is re-enrolled for another 36 months. Despite this approach, the recidivism rate has steadily risen, and recipients are remaining in lock-in for years. Furthermore, providers have also become disinterested in being designated as a recipient's assigned physician or pharmacist while the abuse is ongoing.

Individuals who are determined to be utilizing physician or pharmacy services beyond the specified limits will be evaluated to determine if their utilization warrants being locked in to specific providers. Individuals exceeding 200% of the maximum therapeutic dosage of the same drug or multiple drugs in the same therapeutic class for a period of time exceeding four weeks would be locked in to one pharmacy provider. Individuals having two occurrences of having prescriptions for the same drug filled two or more times on the same or subsequent day would also be restricted. Individuals who utilize services from three or more physicians/pharmacies in a three- month time period would be restricted. Individuals who receive more than 24 prescriptions in a three-month period would be restricted. Finally individuals receiving more than 12 psychotropic prescriptions, more than 12 analgesic prescriptions, or more than 12 controlled drug prescriptions in a three-month period would be restricted.

These changes update references to the computer subsystem that will generate individuals' utilization reports for the purpose of data analysis. A new exception is provided for individuals to not be restricted when evidence indicates that the prescription or medical services utilization, or both, are appropriate for their diagnoses and medical conditions. This action provides for a two- tiered system, allowing for both restriction and education/monitoring. The new restriction period will last for 24 months. DMAS anticipates that reducing the lock-in period to 24 months will counter recidivism, assure providers that recipients are being educated about their utilization patterns in a timely manner, and prevent recipients from stagnating in the CMM program. A 24- month period will also allow for the review of utilization within the first 12 months of the CMM lock-in to determine if a recipient's behavior has been modified.

This action provides for individuals to visit physicians or specialists other than their designated restriction physician upon written referral from the restriction physician.

Volume 30, Issue 10 Virginia Register of Regulations January 13, 2014

Provision is also retained for individuals who have legitimate medical necessity for high numbers of prescription drugs and visits to numerous physicians to appeal a lock-in status and have it removed.

Part XIII

Client Medical Management Program

12VAC30-130-800. Definitions.

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

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

"Abuse by recipients" means practices by recipients which are inconsistent with sound fiscal or medical practices and result in unnecessary costs to the Virginia Medicaid Program.

"Abuse by providers" means practices which are inconsistent with sound fiscal, business, or medical practices and result in unnecessary costs to the Virginia Medicaid Program or in reimbursement for a level of utilization or pattern of services that is not medically necessary.

"Abuse" or "abusive practices" means practices by individuals or providers that are inconsistent with sound fiscal or medical practices and result in unnecessary costs to the Virginia Medicaid program.

"Card-sharing" means the intentional sharing of ~~a recipient~~ an individual's eligibility card for use by someone other than the ~~recipient~~ individual for whom it was issued, or a pattern of repeated unauthorized use of ~~a recipient~~ an individual's eligibility card by one or more persons other than the ~~recipient~~ individual for whom it was issued due to the failure of the ~~recipient~~ individual to safeguard the card.

"Client Medical Management Program ~~(CMM)~~ for ~~recipients~~ individuals" or "CMM Program for individuals" means the ~~recipients~~' individuals' utilization control program designed to prevent abuse and promote improved and cost efficient medical management of essential health care for noninstitutionalized ~~recipients~~ individuals through restriction to one primary care provider, one pharmacy, ~~and one~~ ~~transportation~~ ~~provider,~~ or any combination of these ~~three~~ designated providers. Referrals may not be made to providers restricted through the Client Medical Management Program, nor may restricted providers serve as covering providers for restricted individuals.

"Client Medical Management Program ~~(CMM)~~ for providers" or "CMM Program for providers" means the providers' utilization control program designed to complement the ~~recipient~~ individual abuse and utilization control program in promoting improved and cost efficient medical management of essential health care. Restricted providers may not serve as designated providers for restricted ~~recipients~~ individuals. Restricted providers may not serve as

referral or covering providers for restricted ~~recipients~~ individuals.

"Code of Federal Regulations" or "CFR" means the source where Medicaid federal regulations are located (42 CFR Part 430 through Part 505).

"Contraindicated medical care" means treatment which is medically improper or undesirable and which results in duplicative or excessive utilization of services.

"Contraindicated use of ~~drugs~~ medication" means the concomitant use of two or more drugs whose combined pharmacologic action produces an undesirable therapeutic effect or induces an adverse effect by the extended use of a drug with a known potential to produce this effect.

"Controlled substance" means a substance that has a potential for abuse because physical and psychic dependence and tolerance may develop upon repeated administration and are classified as Schedules I through V drugs.

"Covering provider" means a provider designated by the primary provider to render health care services in the temporary absence of the primary provider.

"DMAS" means the Department of Medical Assistance Services. The Department of Medical Assistance Services is the state agency designated by the General Assembly to administer Title XIX of the Social Security Act.

"Dental services" means covered dental services available to Medicaid/FAMIS eligible children as well as the limited, emergency services available to Medicaid eligible adults.

"Designated ~~provider~~ physician/pharmacy" means the provider who agrees to be the designated ~~primary~~ physician, ~~designated~~ or pharmacy~~, or designated transportation provider~~ from whom the restricted ~~recipient~~ individual must first attempt to seek ~~health care~~ medical or pharmaceutical services. Other providers may be established as designated physician or pharmacy providers with the approval of DMAS.

"Diagnostic category" means the broad classification of diseases and injuries found in the International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) which is commonly used by providers in billing for medical services.

"Diagnosis" means (i) the process of determining by examination the nature and circumstances of a diseased condition; and (ii) the decision reached from such examination.

"Drug" means a substance or medication intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease as defined by the Virginia Drug Control Act (§ 54.1- 3400 et seq. of the Code of Virginia).

"Duplicative medical care" means two or more practitioners are concurrently ~~treat~~ treating the same or similar medical problems or conditions falling into the same diagnostic category, but excluding confirmation for diagnosis, evaluation, or assessment.

"Duplicative medications" means more than one prescription of the same drug or more than one drug in the same therapeutic class.

"Eligibility card" means the document issued to each Medicaid individual listing the name and Medicaid number (either the identification or billing number) of the eligible individual. This document may be in the form of a plastic card magnetically encoded, allowing electronic access to inquiries for eligibility status.

"Emergency hospital services" means those hospital services that are necessary to treat a medical emergency. Hospital treatment of a medical emergency necessitates the use of the most accessible hospital available that is equipped to furnish the required services.

"EPSDT" means the Early and Periodic Screening, Diagnosis, and Treatment Program which is federally mandated for eligible individuals ~~under the age of 21~~ younger than 21 years of age.

"Essential medical services" means quality medical services, including but not limited to preventive care, emergency services, maternity care, hospital and physician services, and prescription drug services as set out in the State Plan for Medical Assistance.

"Excessive medical care" means obtaining greater than necessary services such that health risks to the ~~recipient~~ individual or unnecessary costs to the Virginia Medicaid Program may ensue from the accumulation of services or obtaining duplicative services.

"Excessive medications" means obtaining medication in greater than generally acceptable maximum therapeutic dosage regimens or obtaining duplicative medication from more than one practitioner.

"Excessive transportation services" means obtaining or rendering greater than necessary transportation services such that unnecessary costs to the Virginia Medicaid Program may ensue from the accumulation of services.

"FAMIS" means the Family Access to Medical Insurance Security program as created by Title XXI of the Social Security Act.

"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.

"Health care" means any covered ~~services~~ service, including equipment, or supplies~~, or transportation services,~~ provided by any ~~individual~~ person, organization, or entity that participates in the Virginia Medical Assistance Program.

"Home and community-based services" means a range of community services approved by the Centers for Medicare and Medicaid Services (CMS) pursuant to § 1915(c) of the Social Security Act to be offered to individuals as an alternative to institutionalization.

"Hospice services" means services, pursuant to § 1905(o) of the Act, that are reasonable and necessary for the palliation or management of the terminal illness, if the terminal illness runs its normal course.

"Immunization" means the creation of immunity against a particular disease using a vaccination.

"Individual" means the recipient of Medicaid covered services that are provided under the authority of Title XIX of the Social Security Act.

"Java-Server Utilization Review System" or "JSURS" means a computer subsystem of the Virginia Medicaid Management Information System (VAMMIS) that collects claims data and computes statistical profiles of individual and provider activity and compares them with that of their particular peer group.

"Managed Care Organization" or "MCO" means an entity that meets the participation and solvency criteria defined in 42 CFR Part 438 and has an executed agreement with the department to provide services covered under the Medallion II (pursuant to 12VAC30-120-360 et seq.) and FAMIS (pursuant to 12VAC30-141) programs.

"Medical emergency" means the sudden onset of a medical condition manifesting itself by acute symptoms of sufficient severity (including severe pain) that in the absence of immediate medical attention could reasonably be expected to result in (i) placing the ~~client's~~ individual's health in serious jeopardy, (ii) serious impairment of the individual's bodily functions, or (iii) serious dysfunction of any bodily organ or part.

"Medical management of essential health care" means a case management approach to health care in which the designated primary physician has responsibility for assessing the needs of the patient and making referrals to other physicians and clinics as needed. The designated pharmacy has responsibility for monitoring the drug regimen of the patient.

"Medically necessary" means services that are reasonable and necessary for the diagnosis or treatment of an illness, condition, injury, or to improve the function of a disability, consistent with community standards of medical practice and in accordance with Medicaid/FAMIS policies.

"Noncompliance" means failing to follow Client Medical Management Program policies and procedures, or a pattern of utilization which is inconsistent with sound fiscal or medical practices. Noncompliance includes, but is not limited to, failure to follow a recommended treatment plan or drug regimen; failure to disclose to a provider any treatment or services provided by another provider; requests for medical services or medications which are not medically necessary~~; or~~ ~~excessive use of transportation services~~.

"Not medically necessary" means an item or service which is not consistent with the diagnosis or treatment of the patient's condition or an item or service which is duplicative, contraindicated, or excessive.

Volume 30, Issue 10 Virginia Register of Regulations January 13, 2014

"Pattern" means a combination of qualities, acts, or tendencies that result in duplication or frequent occurrence.

"Practitioner" means a health care provider licensed, registered, or otherwise permitted by law to distribute, dispense, prescribe, and administer drugs or otherwise treat medical conditions.

"Primary care provider" or "PCP" means ~~the designated~~ ~~primary physician responsible for medical management of~~ ~~essential health care for the restricted recipient~~ a physician or nurse practitioner practicing in accordance with state law who is responsible for supervising, coordinating, and providing initial and primary medical care to patients; for initiating referrals for specialist care; and for maintaining the continuity of patient care.

"Provider" means ~~the individual, facility or other entity~~ ~~registered, licensed, or certified, as appropriate, and enrolled~~ ~~by DMAS to render services to Medicaid recipients eligible~~ ~~for services~~ a person, organization, or institution with a current, valid license or certification, as applicable, and participation agreement with DMAS who or which will (i) render service to Medicaid individuals who are eligible for covered services, (ii) submit a claim or claims for the rendered services, and (iii) accept as payment in full the amount paid by the Virginia Medicaid/FAMIS program.

"Psychotropic drugs" means drugs ~~which~~ that alter the mental ~~state~~ activity, behavior, or perception. ~~Such~~ Examples of such drugs include~~, but are not limited to,~~ morphine, barbiturates, hypnotics, antianxiety agents, antidepressants, and antipsychotics.

"Recipient" means the individual who is eligible, under Title XIX of the Social Security Act, to receive Medicaid covered services.

"Recipient eligibility card" means the document issued to each Medicaid enrollee; an individual document issued to each Medicaid recipient listing the name and Medicaid number (either the identification or billing number) of the eligible individual. This document may be in the form of a plastic card magnetically encoded, allowing electronic access to inquiries for eligibility status.

"Renal dialysis services" means services that aid the process of diffusing blood across a semi-permeable membrane to remove substances that a normal kidney would eliminate, including poisons, drugs, urea, uric acid, and creatinine. Renal dialysis services help to restore electrolytes and acid- base imbalances.

"Restriction" means an administrative action imposed on a ~~recipient which~~ an individual that limits access to specific types of health care services through a designated primary provider or an administrative action imposed on a provider to prohibit participation as a designated primary provider, referral, or covering provider for restricted ~~recipients~~ individuals.

"Social Security Act" means the Act, enacted by the 74th Congress on August 14, 1935, which provides for the general welfare by establishing a system of federal old age benefits, and by enabling the states to make more adequate provisions for aged persons, blind persons, dependent and crippled children, maternal and child welfare, public health, and the administration of their unemployment compensation laws.

"State Plan for Medical Assistance" or "the Plan" means the ~~document listing the covered groups, covered services and~~ ~~their limitations, and provider reimbursement methodologies~~ ~~as provided for under Title XIX of the Social Security Act~~ comprehensive written statement submitted by the department to the Centers for Medicare and Medicaid Services (CMS) for approval, describing the nature and scope of the Virginia Medicaid program and giving assurance that it will be administered in conformity with the requirements, standards, procedures, and conditions for obtaining federal financial participation.

"Surveillance and Utilization Review Subsystem (SURS)" or "Automated Exception Analysis (AEA)" means a computer subsystem of the Medicaid Management Information System (MMIS) which collects claims data and computes statistical profiles of recipient and provider activity and compares them with that of their particular peer group.

"Therapeutic class" means a group of drugs with similar pharmacologic actions and uses.

"Under-use" or "under-utilization" means an occurrence where there is evidence that a patient did not receive a service or procedure whose benefits exceeded the risks.

"Utilization control" means the control of covered health care services to assure the use of cost efficient, medically necessary or appropriate services.

12VAC30-130-810. Client Medical Management Program for recipients individuals.

A. Purpose. The Client Medical Management Program is a ~~utilization control program designed to prevent abuse and~~ ~~promote improved and cost efficient medical management of~~ ~~essential health care~~ designed to assist and educate Medicaid individuals in appropriately using medical and pharmacy services. Individuals who use these services excessively or inappropriately, as determined by DMAS, may be assigned to a single physician or pharmacy, or both. CMM also monitors individual compliance with program guidelines.

B. Authority.

1. Federal regulations at 42 CFR 456.3 require the Medicaid agency to implement a statewide surveillance and utilization control program ~~and 42 CFR 455.1 through~~ ~~455.16 require the Medicaid agency to conduct~~ ~~investigations of abuse by recipients~~ that (i) safeguards against unnecessary or inappropriate use of Medicaid services and against excess payments, (ii) assesses the quality of those services, (iii) provides for the control of the utilization of all services provided under the Plan, and

(iv) provides for the control of the utilization of inpatient services.

2. Federal regulations at 42 CFR 431.54(e) allow states to restrict ~~recipients~~ individuals to designated providers when the ~~recipients~~ individuals have utilized services at a frequency or amount that is not medically necessary in accordance with utilization guidelines established by the state. ~~42 CFR 455.16(c)(4) provides for imposition of~~ ~~sanctions for instances of abuse identified by the agency.~~

C. Identification of Client Medical Management Program participants. DMAS shall identify ~~recipients~~ individuals for review from computerized reports such as but not limited to ~~Recipient SURS or AEA~~ individual Java-Server Utilization Review System (JSURS), VAMMIS, Oracle or by written referrals from agencies, health care professionals, or other ~~individuals~~ persons. Certain individuals reviewed may not be restricted when evidence indicates that the prescription or medical service utilization patterns, or both, are for appropriate therapy.

D. ~~Recipient~~ Individual evaluation for restriction.

1. DMAS shall ~~review recipients~~ utilize data as indicated in subsection C of this section to conduct a review of individuals to determine if services are being utilized at a frequency or amount that results in a level of utilization or a pattern of services which is not medically necessary or which exceeds the thresholds established ~~in these~~ ~~regulations~~ by the department. Evaluation of utilization patterns can include but is not limited to review by the department ~~staff~~ of medical records or computerized reports, or both, generated by the department reflecting claims submitted for physician visits, drugs/prescriptions, outpatient and emergency room visits, lab ~~and~~ or diagnostic procedures, or both, and hospital admissions, ~~and referrals~~.

2. Restricted individuals shall have reasonable access to all essential medical services. These restrictions shall not apply to hospital emergency services.

2. 3. Abusive activities shall be investigated and, if appropriate, the ~~recipient~~ individual shall be reviewed for educational intervention or restriction, or both. ~~Recipients~~ ~~demonstrating questionable patterns of utilization or~~ ~~exceeding reasonable levels of utilization shall be reviewed~~ ~~for restriction.~~

a. Lock-in. If DMAS' review determines that an individual's data is either (i) inappropriate, (ii) questionable patterns of utilization exist, or (iii) reasonable levels of utilization are exceeded, then the department shall initiate the individual's restriction to either a physician or pharmacy, or both.

(1) Once an individual is locked-in, this period shall last for 24 months from the enrollment date. During this lock- in period, the individual shall be required to use the

services of the designated physician or pharmacy, or both.

(2) The individual may visit physicians or specialists other those who are designated only by a written referral.

(3) The individual may obtain prescriptions from pharmacies other than the designated pharmacy only in an emergency when the designated pharmacy is closed or when the designated pharmacy does not stock, or is not able to obtain in a timely manner, the required medication.

b. DMAS may restrict an individual if any of the following activities or patterns or levels of utilization are identified. These activities, patterns, or levels of utilization include but shall not be limited to:

(1) Two occurrences of having prescriptions for the same drugs filled two or more times on the same or the subsequent day;

(2) Utilizing services from three or more prescribers and three or more dispensing pharmacies in a three-month period;

(3) Receiving more than a total of 24 prescriptions in a three-month period;

(4) Receiving more than 12 psychotropic prescriptions, more than 12 analgesic prescriptions, or more than 12 prescriptions for controlled drugs that have the potential for abuse, in a three-month period;

(5) Exceeding the maximum therapeutic dosage of the same drug or multiple drugs in the same therapeutic class, which have been prescribed by two or more practitioners, for a period exceeding four weeks;

(6) Receiving two or more drugs, duplicative in nature or potentially addictive (even within acceptable therapeutic levels), dispensed by more than one pharmacy or prescribed by more than one practitioner for a period exceeding four weeks;

(7) Receiving narcotic prescriptions from two or more prescribers without supporting diagnoses indicative of use;

(8) Utilizing three or more different physicians of the same type or specialty in a three-month period for treatment of the same or similar condition or conditions;

(9) Two or more occurrences of seeing two or more physicians of the same type or specialty on the same or subsequent day for the same or similar diagnosis;

(10) One or more providers recommend restriction for medical management because the individual has demonstrated inappropriate utilization practices;

(11) Duplicative, excessive, or contraindicated utilization of medication, medical supplies, medical visits, procedures, diagnostic tests, or appliances dispensed by or prescribed by more than one provider for the time period specified by DMAS;

Volume 30, Issue 10 Virginia Register of Regulations January 13, 2014

(12) Use of emergency hospital services for three or more emergency room visits for non-emergency care during a three-month period;

(13) A pattern of noncompliance or utilization of services that is inconsistent with sound fiscal or medical practices. Noncompliance or inappropriate utilization can be characterized by, for example:

(a) Failure to disclose to a provider any treatment or services provided by another provider;

(b) Failure to follow a drug regimen or other recommended treatment;

(d) Use of hospital emergency services for self-referral, non-acute episodes of care, or solely for non-acute management of chronic diagnoses/symptoms; or

(e) Under-use or under-utilization of medically necessary services that result in higher costs for the management of the medical condition;

(14) One or more documented occurrences of the use of the eligibility card to obtain drugs under false pretenses, which includes, but is not limited to, purchase or attempt to purchase drugs via a forged or altered prescription;

(15) One or more documented occurrences of card- sharing or documented occurrences of alteration of the individual eligibility care, or both; or

(16) One or more documented occurrences of paying cash for controlled substances, analgesic drugs, or psychotropic drugs in addition to the use of the eligibility card to obtain similar or duplicative controlled substances.

3. DMAS may restrict recipients if any of the following activities or patterns or levels of utilization are identified. These activities or patterns or levels of utilization include but shall not be limited to:

a. Exceeding 200% of the maximum therapeutic dosage of the same drug or multiple drugs in the same therapeutic class for a period exceeding four weeks.

b. Two occurrences of having prescriptions for the same drugs filled two or more times on the same or the subsequent day.

c. Utilizing services from three or more prescribers and three or more dispensing pharmacies in a three-month period.

d. Receiving more than 24 prescriptions in a three-month period.

e. Receiving more than 12 psychotropic prescriptions or more than 12 analgesic prescriptions or more than 12 prescriptions for controlled drugs with potential for abuse in a three-month period.

f. Exceeding the maximum therapeutic dosage of the same drug or multiple drugs in the same therapeutic class for a period exceeding four weeks. In addition, such drugs must be prescribed by two or more practitioners.

g. Receiving two or more drugs, duplicative in nature or potentially addictive (even within acceptable therapeutic levels), dispensed by more than one pharmacy or prescribed by more than one practitioner for a period exceeding four weeks.

h. Utilizing three or more different physicians of the same type or specialty in a three-month period for treatment of the same or similar conditions.

i. Two or more occurrences of seeing two or more physicians of the same type or specialty on the same or subsequent day for the same or similar diagnosis.

j. Duplicative, excessive, or contraindicated utilization of medications, medical supplies, or appliances dispensed by or prescribed by more than one provider for the time period specified by DMAS.

k. Duplicative, excessive, or contraindicated utilization of medical visits, procedures, or diagnostic tests from more than one provider for the time period specified by DMAS.

l. Use of emergency hospital services for three or more emergency room visits for nonemergency care during a three-month period.

m. One or more providers recommends restriction for medical management because the recipient has demonstrated inappropriate utilization practices.

n. A pattern of noncompliance which is inconsistent with sound fiscal or medical practices. Noncompliance is characterized by, but not limited to:

(1) Failure to disclose to a provider any treatment or services provided by another provider;

(2) Failure to follow a drug regimen or other recommended treatment;

(3) Requests for medical services or medications which are not medically necessary;

(4) Excessive use of transportation services; or

(5) Use of transportation services with no corresponding medical services.

o. One or more documented occurrences of use of the eligibility card to obtain drugs under false pretenses, which includes, but is not limited to the purchase or attempt to purchase drugs via a forged or altered prescription.

p. One or more documented occurrences of card-sharing.

q. One or more documented occurrences of alteration of the recipient eligibility card.

E. ~~Recipient~~ Individual restriction procedures.

1. DMAS shall advise affected ~~recipients~~ individuals by written notice of the proposed restriction under the Client Medical Management Program. Written notice shall include an explanation of restriction procedures and the ~~recipient's~~ individual's right to appeal the proposed action.

2. The ~~recipient~~ individual shall have the opportunity to select designated physician or pharmacy providers, or both. If ~~a recipient~~ an individual fails to respond by the date specified in the restriction notice, DMAS shall select designated ~~providers~~ physician or pharmacy providers, or both.

3. DMAS shall not implement restriction if a valid appeal, consistent with 12VAC30-110-210, is noted. (See subsection K of this section.)

4. DMAS shall restrict ~~recipients~~ individuals to their designated ~~providers~~ physician or pharmacy, or both, for 36 24 months.

F. Designated providers.

1. A designated ~~primary~~ physician or pharmacy, or both, must be a ~~physician who~~ provider that is enrolled ~~as an~~ ~~individual~~ ~~practitioner~~ in Virginia Medicaid and ~~who~~ that is unrestricted by DMAS.

2. ~~A designated pharmacy provider must be a pharmacy~~ ~~that is enrolled as a community pharmacy and that is~~ ~~unrestricted by DMAS.~~ Physicians or pharmacy providers, or both, who are under the CMM Program for providers shall not serve as designated providers, shall not provide services through referral, and shall not serve as covering providers for restricted individuals.

VOL. 30 ISS. 10 PUBLISHED EVERY OTHER WEEK BY THE VIRGINIA CODE COMMISSION JANUARY 13, 2014

Table of Contents

January 2014 through March 2015

TITLE 18. PROFESSIONAL AND OCCUPATIONAL LICENSING‌

TITLE 4. CONSERVATION AND NATURAL RESOURCES‌

TITLE 12. HEALTH

TITLE 18. PROFESSIONAL AND OCCUPATIONAL LICENSING

TITLE 22. SOCIAL SERVICES

TITLE 4. CONSERVATION AND NATURAL RESOURCES

4VAC10-30-40. Permits.

4VAC10-30-120. Charges.

4VAC10-30-200. Hunting and fishing.

4VAC10-30-210. Fishing.

4VAC20-252-55. Recreational harvest quota.

4VAC20-252-150. Individual commercial harvest quota.

4VAC20-490-41. Commercial catch limitations.

4VAC20-490-10. Purpose.

4VAC20-490-42. Spiny dogfish commercial quota and catch limitations.

60; adding 4VAC20-500-35, 4VAC20-500-45).

4VAC20-500-20. Definition.

4VAC20-500-40. Elvers.

4VAC20-500-50. Minimum mesh size.

4VAC20-500-55. Possession limit.

4VAC20-500-60. Penalty.

4VAC20-900-50; adding 4VAC20-900-26; repealing 4VAC20-900-36).

4VAC20-900-21. License Permit requirements and exemption.

4VAC20-900-25. Commercial fisheries management measures.

4VAC20-900-35. Monitoring requirements.

4VAC20-900-36. Quota allocation. (Repealed.)

4VAC20-900-39. Permit transfers.

4VAC20-900-45. Requirements of authorized agents.

4VAC20-900-50. Penalty.

TITLE 6. CRIMINAL JUSTICE AND CORRECTIONS

6VAC40-50-10. Definitions.

6VAC40-50-20. Authority for approval.

6VAC40-50-30. Request for approval evaluation.

6VAC40-50-40. Notice of approval decision.

6VAC40-50-50. Maintenance of approved status.

6VAC40-50-60. Publication.

6VAC40-50-80. Fees.

TITLE 8. EDUCATION

TITLE 9. ENVIRONMENT

9VAC5-60. Hazardous Air Pollutant Sources (Rev. I13) (amending 9VAC5-60-60, 9VAC5-60-90, 9VAC5-60-100).

9VAC5-50-400. General.

9VAC5-50-410. Designated standards of performance.

9VAC5-60-60. General.

9VAC5-60-90. General.

9VAC5-60-100. Designated emission standards.

TITLE 10. FINANCE AND FINANCIAL INSTITUTIONS

TITLE 12. HEALTH

12VAC5-20-10. Definitions.

12VAC5-20-30. Applicability.

12VAC5-20-40. Policy.

12VAC5-20-50. Review process for department.

12VAC5-20-60. Review process for institutions or agencies funded or licensed by the department.

12VAC5-20-70. Composition of research review committee.

12VAC5-20-80. Elements of committee review process.

12VAC5-20-90. Expedited review of human research projects.

12VAC5-20-100. Informed consent.

12VAC5-20-110. Categories of human research exempt from regulation.

12VAC5-20-120. Committee records.

12VAC5-20-130. Applicability of federal policies.

12VAC5-31-1401. General recertification requirements.

12VAC5-31-1465. Recertification examination requirement. (Repealed.)

12VAC30-130-800. Definitions.

12VAC30-130-810. Client Medical Management Program for recipients individuals.

TITLE 18. PROFESSIONAL AND OCCUPATIONAL LICENSING ‌

TITLE 4. CONSERVATION AND NATURAL RESOURCES ‌