**BLOOD PRODUCTS ADVISORY COMMITTEE MEETING**

**TOPIC III. Human Cells, Tissue and Cellular and Tissue-Based Products:
Risk Factors for Semen Donation**

**December 14, 2001**

**Gaithersburg Hilton, 620 Perry Parkway**

**Gaithersburg, MD 20877**

**SUMMARY OF ISSUE:**

-   FDA is in the process of completing rulemaking and drafting guidance
    aimed at preventing the spread of communicable disease by human
    cells, tissues, and cellular and tissue-based products. These rules
    and guidance will apply to semen banking.

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-   FDA published a proposed rule, entitled \"Suitability Determination
    for Donors of Human Cellular and Tissue-Based Products\" on Sept.
    30, 1999 (64 FR 52696). The comment period closed on July 17, 2000.
    This proposed rule would apply to donors of semen.

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-   FDA has proposed that establishments be required to screen and test
    semen donors who are not intimate sexual partners of the recipients.
    Screening entails asking potential donors specific questions to
    reveal risk factors for and clinical evidence of infection due to
    relevant communicable disease agents or diseases. Although the
    proposed rule did not specify risk factors, commenters anticipated
    that one of the risk behaviors that the agency would identify for
    male donors was having had sex with another man within the previous
    five years.

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-   The proposed rule would require testing for HIV-1 and 2, HBV, HCV,
    syphilis, HTLV-I and II, CMV, Chlamydia trachomatis and Neisseria
    gonorrhea. FDA also proposed to require that donations of
    reproductive cells and tissue that can be reliably stored be
    cryopreserved in quarantine for 6 months, at which time the donor
    would be re-tested. This is consistent with CDC guidelines
    (Guidelines for Preventing Transmission of Human Immunodeficiency
    Virus Through Transplantation of Human Tissue and Organs, May 20,
    1994), and industry\'s voluntary standards (American Society for
    Reproductive Medicine Guidelines for Gamete and Embryo Donation,
    October 1998).

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-   Under the proposed rule, semen donations of anonymous donors (donors
    unknown to the recipient) would be released only if the screening
    and testing results were all negative (i.e., the donor had not
    engaged in risk behaviors, and blood tests taken before and after
    the quarantine period did not show the presence of the infectious
    agents). For directed donors, positive results would not preclude
    donation, provided that the risks were explained to the recipient
    and she gave informed consent.

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-   The agency has received many comments criticizing its proposed
    requirement for six month cryopreservation and quarantine of semen
    from directed donors (a donor who is known and requested by the
    female recipient, but is not her sexually intimate partner), and its
    proposed recommendation that men who have had sex with other men
    within the previous five years not be accepted as anonymous semen
    donors.

-   The September BPAC meeting will include presentations of scientific
    data and information relating to these issues. FDA believes that a
    scientifically rigorous review in a public forum will allow it to
    better evaluate and respond to these comments. Speakers will present
    data on incidence and prevalence of HIV, HBV, and HCV in certain
    risk groups as compared to the general population, current practices
    in semen banking, risks of and actual transmissions of sexually
    transmitted diseases by artificial insemination, HHV-8 as an
    emerging pathogen, window period risk, semen cryopreservation
    techniques, and comparison of pregnancy rates using fresh vs.
    cryopreserved semen for artificial insemination.

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-   Several individuals who submitted comments to FDA will present data
    and information during the open public hearing. Following a public
    discussion, FDA will ask the committee members the following
    questions:

1.  Is safety increased when cryopreserved semen is quarantined and the
    donor is re-tested after at least six months?

2.  As compared with the use of fresh semen, does use of cryopreserved
    semen for artificial insemination reduce pregnancy rates? If so,

> 2a. What is the estimated reduction in pregnancy rates?
>
> 2b. Are there procedures for cryopreservation and/or for insemination
> that can improve the pregnancy rates using cryopreserved semen? If so,
>
> 2c. What are the benefits and risks of these procedures?

3.  Are there existing data that identify subsets of men who have had
    sex with other men, in which the incidence and prevalence rates for
    HIV, HBV, and HCV of the subsets are similar to the population at
    large? If so,

> 3a. Are there questions that could be asked to potential donors that
> would accurately identify members of these subsets to the exclusion of
> all others?