Title of Regulation: 12VAC5-90. Regulations for Disease Reporting and Control (repealing 12VAC5-90-230, 12VAC5-90-240, 12VAC5-90-250, 12VAC5-90-260, 12VAC5-90-270).

Statutory Authority: § 32.1-35 of the Code of Virginia.

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: January 10, 2018.

Effective Date: January 26, 2018.

Agency Contact: Diane Woolard, PhD, Director, Disease Surveillance, Virginia Department of Health, 109 Governor Street, Richmond, VA 23219, telephone (804) 864-8124, or email diane.woolard@vdh.virginia.gov.

Basis: §§ 32.1-12 and 32.1-35 of the Code of Virginia authorize the State Board of Health to promulgate regulations and empowers the State Board of Health to adopt such regulations as are necessary to carry out provisions of laws of the Commonwealth administered by the Commissioner of the Department of Health.

Purpose: Section 32.1-45.3 of the Code of Virginia that authorized the regulations in this action has been repealed. Therefore, the sections of regulations contained in this regulatory action are no longer authorized, necessary, or applicable to protect public health.

Rationale for Using Fast-Track Rulemaking Process: As the section of the Code of Virginia has already been repealed, the repeal of the regulation is noncontroversial. This regulatory action aligns regulations with statute, and no agency discretion is involved.

Substance: Regulatory language is being repealed in compliance with the Code of Virginia.

Issues: The primary advantage to the public is the removal of potentially confusing regulatory language that no longer applies. This is also the primary advantage to the agency. No disadvantages or other pertinent matters have been identified as this action simply removes these sections of the regulation because they are no longer authorized by the Code of Virginia.

The Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. Pursuant to Chapter 301 of the 2015 Acts of Assembly (Chapter 301),¹ the State Board of Health (Board) proposes to repeal regulatory text concerning HIV testing of gamete² donors.

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

Estimated Economic Impact. Prior to 2015, § 32.1-45.3 of the Code of Virginia required that the Board promulgate regulations establishing an HIV testing protocol for donors of gametes used to treat patients for infertility. Chapter 301 repealed this requirement. Regulations of the U.S. Food and Drug Administration³ require testing and other measures to prevent transmission of HIV and other infections when assisted reproductive technology, including donated gametes, are used to treat infertility and related problems. These federal regulations are more comprehensive than the existing state regulations. Thus the proposed repeal of text from the Virginia Regulations for Disease Reporting and Control would have no impact, beyond potentially reducing confusion, since the federal regulations already apply.

Businesses and Entities Affected. Beyond potentially reducing confusion among readers of the regulation, the proposed repeal of text does not affect any businesses or entities. The subject matter concerns practitioners who treat infertility, their medical practices, and potential donors of gametes.

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

Projected Impact on Employment. The proposed amendments do not affect employment.

Effects on the Use and Value of Private Property. The proposed amendments do not affect the use and value of private property.

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

Small Businesses:

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

Costs and Other Effects. The proposed amendments do not affect costs for small businesses.

Alternative Method that Minimizes Adverse Impact. The proposed amendments do not adversely affect small businesses.

Adverse Impacts:

Businesses. The proposed amendments do not adversely affect businesses.

Localities. The proposed amendments do not adversely affect localities.

Other Entities. The proposed amendments do not adversely affect other entities.

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¹ See http://leg1.state.va.us/cgi-bin/legp504.exe?151+ful+CHAP0301.

² Gametes are either sperm or ova.

³ CFR 21, Chapter 1, Part 1271-Human Cells, Tissues, and Cellular and Tissue-Based Products https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=1271.

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

Summary:

The amendments repeal Part XII of 12VAC5-90 to comply with Chapter 301 of the 2015 Acts of Assembly, which repealed § 32.1-45.3 of the Code of Virginia, the statute that authorized regulations to establish a testing protocol for gamete donors.

Part XII
Human Immunodeficiency Virus (HIV) Testing of Gamete Donors (Repealed)

12VAC5-90-230. Definitions. (Repealed.)

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

"Artificial insemination" means instrumental placement of semen into the vagina, cervical canal, or uterus of a recipient.

"Donor" means an individual who is unrelated by marriage to the recipient and who contributes sperm or ova used in the following procedures: treatment of infertility by artificial insemination; in vitro fertilization; gamete intrafallopian tube transfer; zygote intrafallopian tube transfer or any other gamete, zygote, or embryo transfer; or other intervening medical technology using sperm or ova.

"Embryo" means the product of a fertilized ovum prior to the eighth week of development inside a uterus.

"Gamete" means either sperm or ova.

"Gamete intrafallopian tube transfer" means placement of harvested ova and sperm into the fallopian tube or tubes of a recipient.

"HIV-1" means the retrovirus causing the human immunodeficiency virus infection, type 1.

"HIV-2" means the retrovirus causing the human immunodeficiency virus infection, type 2.

"In vitro fertilization" means placement of a zygote or embryo that has been fertilized outside the body into the uterus of a recipient.

"Zygote" means a fertilized ovum prior to cell cleavage.

"Zygote intrafallopian tube transfer" means placement of a zygote or zygotes into the fallopian tube or tubes of a recipient.

12VAC5-90-240. Excluding donors with high risk factors. (Repealed.)

A. Practitioners using gametes for the treatment of infertility by transfer of such gametes to a recipient shall interview all gamete donors at the time of donation in order to screen for high risk behavior indicating potential exposure to HIV-1 and HIV-2.

B. Any gamete donor reporting infection with HIV-1 or HIV-2 or any of the following risk factors shall be excluded from donating:

1. Men who have had sex with another man within the preceding five years.

2. Persons who have injected drugs for a nonmedical reason in the preceding five years, including intravenous, intramuscular, and subcutaneous injections of recreational or illegal drugs.

3. Persons with hemophilia or related clotting disorders who have received human derived clotting factor concentrates.

4. Persons who have had sex in exchange for money or drugs in the preceding five years.

5. Persons who have had sex in the preceding 12 months with any person described in subdivisions 1 through 4 of this subsection or with any person suspected of being infected with HIV-1 or HIV-2.

6. Persons who have been exposed within the last 12 months to known or suspected HIV-1 or HIV-2 infected blood through percutaneous inoculation (e.g., needle stick) or through contact with an open wound, nonintact skin, or mucous membrane.

7. Current inmates of correctional systems, including jails and prisons, and individuals who have been confined in jail or incarcerated in prison for more than 72 consecutive hours during the previous 12 months.

8. Persons who have had or have been treated for syphilis or gonorrhea during the preceding 12 months.

9. Persons who within 12 months of donation have undergone acupuncture, ear or body piercing or tattooing in which sterile procedures were not used or where it is unknown if sterile procedures were used.

10. Persons who choose to defer from donation whether or not they report any of the above potential exposures to HIV-1 or HIV-2.

12VAC5-90-250. Storage of semen pending negative HIV tests. (Repealed.)

Semen specimens from donors shall be stored and withheld from use for at least 180 days following donation and used only if the donor tests negative for serum antibodies for HIV-1 and HIV-2 on enzyme-linked immunosorbent assay or blood HIV-1 and HIV-2 by polymerase chain reaction at least 180 days after donation.

12VAC5-90-260. Use of ova after negative HIV tests. (Repealed.)

Ova shall be used only if the donor tests negative for serum antibodies to HIV-1 and HIV-2 on enzyme-linked immunosorbent assay or blood HIV-1 and HIV-2 by polymerase chain reaction at the initiation of the cycle during which the ova are harvested.

12VAC5-90-270. Notifying recipients of option to delay transfer. (Repealed.)

Practitioners using ova, embryos, or zygotes for the treatment of infertility or other medical technology involving the transfer of ova, embryos, or zygotes to a recipient shall notify these recipients of the option for having donor ova fertilized and the resultant zygotes frozen and then transferred to the recipient only if the ova donor is negative for serum antibodies for HIV-1 and HIV-2 on enzyme-linked immunosorbent assay or blood HIV-1 and HIV-2 by polymerase chain reaction at least 180 days after donation.