SURROGACY LAWS IN NY: WHAT COUPLES AND CLINICS MUST KNOW ABOUT GAMETE TESTING

Under New York’s tissue bank regulations (10 NYCRR Part 52, Subpart 52-8), the male and female gamete providers in this scenario are considered “donors,” not merely client-depositors, because their embryo will be transferred to a gestational surrogate (a recipient other than themselves or their intimate partner). NYS regulations define a “donor” as “a person who provides reproductive tissue for use in artificial insemination or assisted reproductive procedures performed on recipients other than that person or that person’s regular sexual partner”. A “directed donor” is a donor known to the recipient and who directs their tissue to a specific person – explicitly including “a man providing semen to a surrogate, but who is not the regular sexual partner of the recipient.” In contrast, a “client-depositor” refers to someone who banks reproductive tissue for use “solely on themself or their regular sexual partner.” This client-depositor exception does not apply when the tissue will be used in a third-party surrogate. Because the surrogate is not the spouse/sexual partner of either gamete provider, both the female’s oocyte and the male’s sperm are treated as donations to another person under NYS rules. Accordingly, all donor eligibility screening and testing requirements of Subpart 52-8 apply to this couple’s gametes and embryo, just as they would for any third-party donation.

NYS Testing and Eligibility Requirements for Gamete Donors

New York’s regulations impose comprehensive donor screening and testing for reproductive tissue donations. These requirements are enforced by the NYS Department of Health (Wadsworth Center) for all licensed tissue banks and IVF programs. Key provisions include:

Medical and Genetic History Screening (10 NYCRR §52-8.5): Before any gamete collection, a reproductive tissue bank must obtain a complete personal and family medical history from the donor. This includes screening for heritable conditions and genetic disorders. Donors (both semen and oocyte donors) are evaluated for any history of “major malformations” or “major genetic disorders,” including autosomal dominant, X-linked, or recessive diseases. The donor’s family history (first- and second-degree relatives) is reviewed for serious inherited conditions. The bank’s medical director will assess this history to determine eligibility. Not every condition is automatic grounds for exclusion except certain high-risk factors (e.g. HIV risk – see below), but recipients must be counseled about any relevant risks if a donor with a genetic or medical issue is used. (Notably, NYS regulations even require notifying a recipient’s physician if a sperm donor is over age 44 or an egg donor over age 34, due to potential risks with older donors). Donors are also screened for high-risk behaviors and health issues (e.g. multiple sexual partners, history of STDs, IV drug use, etc.), aligning with U.S. Public Health Service guidelines. Individuals with HIV risk factors must be excluded from anonymous donation under NY law, and in practice any such risk in a directed donor would require informed consent of the recipient. In summary, NYS donor qualification standards demand careful vetting of both infectious disease risk and genetic/hereditary risks prior to donation.
Required Infectious Disease Testing (10 NYCRR §52-8.6): New York mandates specific lab tests for all reproductive tissue donors before use of the gametes/embryo in a recipient. Both the male (sperm) and female (oocyte) donors must undergo infectious disease testing. At minimum, the following tests are required: HIV-1 and HIV-2 antibody, Hepatitis B virus (HBsAg and anti-HBc), Hepatitis C antibody, HTLV (Human T-lymphotropic Virus) antibody, and syphilis serology. In addition, a gonorrhea and chlamydia screening is required: a sample of semen or a urethral swab must test negative for Neisseria gonorrhoeae, and a urine or swab test must be negative for Chlamydia trachomatis. (These STD tests use sensitive methods such as NAAT per standard laboratory practice.) For semen donors, a full semen analysis (volume, count, motility, morphology, etc.) is also done to ensure quality for use.

– Timing and Repeat Testing: Physiocal and social and medical history must be completed “prior to the initial collection of reproductive tissue for clinical use”. However, in December of 2022 the NYS DOH conformed the infectious disease testing for semen donors to those of the FDA which allows for testing of semen donors up to seven days after semen collection. If a donor continues to donate over time (relevant for repeat semen donors), re-testing every 6 months is required under NYS rules.Donor semen in New York is ordinarily quarantined for 6 months and the donor retested before release, to ensure no emerging infection was in the window period. However, since this scenario is a directed donation (the embryo is for a known surrogate), NY regulations allow a waiver of the 6-month quarantine if the recipient (surrogate) consents in writing after being fully informed of the risks.This waiver option is analogous to using fresh embryo transfer in a directed donation. Even with a waiver, all the required infectious disease tests must still be done (including tests close to the donation date).In practice, IVF clinics in NY will test the intended parents for all required diseases around the time of embryo creation and again as needed.

– Exclusion for Positive Results: NYS regulations are strict about excluding infected donors. Any positive/reactive test for HIV-1/2, hepatitis B, hepatitis C, or HTLV (on confirmatory repeat testing) means the donor tissue may not be used for reproduction. Similarly, a positive syphilis test (unless confirmatory testing is negative), or a positive gonorrhea or chlamydia test, will disqualify the donation. In such cases, the tissue must be destroyed or labeled for research use only. There is an emergency exception process in NY for certain special cases – for example, the DOH may grant a case-by-case waiver to use semen from a hepatitis B core antibody-positive directed donor who is proven non-infectious – but generally positive infectious disease markers bar the use of donor gametes in NY). Because the embryo in question is intended for a surrogate, both gamete providers must test negative for all these infectious disease markers before the embryo can be released to the surrogate.

Genetic Disease Carrier Testing: In addition to reviewing family history for genetic disorders, NYS rules explicitly require laboratory genetic screening for certain hereditary diseases based on the donor’s ethnic background. Donors with ethnic or familial risk for conditions like Tay–Sachs disease, thalassemia, sickle-cell anemia, or cystic fibrosis must be tested for those carrier states.For example, an Ashkenazi Jewish donor would be tested for Tay–Sachs, and Caucasian donors often are tested for cystic fibrosis carrier status, among others. The reproductive tissue bank’s medical director (with a medical advisory committee) is responsible for setting policies on any additional genetic tests that should be done based on a donor’s background.In practice, NYS-licensed programs often follow American Society for Reproductive Medicine (ASRM) guidelines for expanded carrier screening. These genetic test requirements go beyond what federal rules mandate; they are aimed at safeguarding the health of resulting offspring by minimizing hereditary disease transmission.
Informed Consent and Records: New York also requires proper informed consent and record-keeping, though those sections (52-8.8, 52-8.9) are beyond the scope of the question. However, it’s worth noting that donors and recipients are entitled to certain information. For instance, the results of all donor tests must be made available to the donor and to the physicians using that donor’s gametes.Accurate donor profiles (e.g. medical/genetic info, characteristics) must be provided to recipients or doctors on request.These provisions ensure transparency for the surrogate and intended parents regarding the donors’ medical suitability.

In summary, both the male and female in our scenario must meet NYS’s donor eligibility criteria. They are treated as directed reproductive donors (not anonymous, but still “donors” since the surrogate is a third-party recipient). The client-depositor exception does not apply, as the law only exempts tissues used in oneself or a sexual partner. Indeed, NYS specifically states that if a client-depositor decides to direct their banked tissue to someone other than their regular partner, they must first undergo full donor testing per §52-8.5 and §52-8.6 (infectious disease panel, etc.), and the specimen must be quarantined 6 months before use.This underscores that in a gestational surrogacy, the gamete providers must be screened/treated just like any other donors under NY law.

FDA Donor Eligibility Requirements (21 CFR Part 1271) – Comparison

The U.S. Food and Drug Administration’s Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P) regulations (21 CFR Part 1271) set federal standards for donor eligibility. These rules focus primarily on preventing the transmission of communicable diseases. In the context of our scenario, the FDA’s requirements align in many ways with NYS’s, but there are important differences in scope and exceptions:

“Sexually Intimate Partner” Exemption: The FDA explicitly exempts reproductive cells donated by a sexually intimate partner for reproductive use from its donor testing/screening requirements.. In other words, if this embryo were intended to be carried by the female partner herself (or the sperm were used to inseminate one’s spouse), the couple would be exempt from FDA’s donor-eligibility rules. However, because a gestational surrogate (a non-intimate third party) is the recipient, this exemption does not apply here. Under federal law the couple’s gametes are considered allogeneic donations to another person, so full FDA donor eligibility determination is required (just as NYS requires). Notably, NYS’s regulations mirror this concept by defining donors as excluding intimate-partner use: in effect both NYS and FDA waive donor requirements for intimate couples, but not for surrogacy situations. (The Child-Parent Security Act in NY, which legalized compensated surrogacy, also mandates that all assisted reproduction providers comply with Part 52 tissue bank requirements in such cases, ensuring consistency with FDA rules.)
Communicable Disease Testing Requirements: FDA-required testing is very similar to NYS’s panel for donors, with a focus on infectious diseases:

HIV, Hepatitis, Syphilis: The FDA requires that all cell/tissue donors (living or cadaveric) be tested for HIV-1, HIV-2, hepatitis B, hepatitis C, and syphilis. These are essentially the same core tests New York mandates. Donor blood must be tested using FDA-licensed test kits, and results must be negative/non-reactive for the donor to be deemed “eligible.” An important difference: FDA does notrequire determining ABO/Rh blood type for reproductive donors (whereas NYS does include ABO/Rh testing for semen donors for identification purposes).
HTLV and CMV: For donors of “viable, leukocyte-rich cells or tissues,” the FDA adds testing for Human T-lymphotropic Virus types I and II (HTLV-I/II), and also requires testing for Cytomegalovirus (CMV). Semen is considered a leukocyte-rich tissue (it can contain white blood cells), so a sperm donor under FDA rules must be tested for HTLV-I/II. New York’s regulation explicitly mentions HTLV-I for semen donors, (though NYS did not explicitly list HTLV-II, the expectation is to test for both types in practice). CMV testing is not specifically mandated in NYS regulations for reproductive donors, but FDA requires labs to at least screen for CMV and have policies on using CMV-positive donations. (A positive CMV doesn’t necessarily disqualify a donor under FDA; it must simply be labeled and managed appropriately – typically, CMV-positive sperm may still be used with informed consent if the surrogate or recipient is CMV-positive or immune.)
Gonorrhea and Chlamydia: FDA regulations uniquely emphasize testing for genitourinary infections in reproductive donors. Per 21 CFR §1271.85(c), donors of reproductive cells/tissues must be tested for Chlamydia trachomatis and Neisseria gonorrhoeae (unless the gamete procurement method precludes contamination). This is fully consistent with NYS requirements – in fact, New York already requires those STD tests on semen/urine samples. So there is no discrepancy on this point; both require negative chlamydia and gonorrhea results for donor gametes.
Retesting and Quarantine: FDA guidance recommends a quarantine and 6-month retesting for anonymous semen donors, similar to the NYS requirement. In fact, 21 CFR §1271.85(d) requires that anonymous semen donors be retested at least 6 months post-donation for the full panel before the specimen can be released. Directed reproductive donors (like known donors to a specific recipient) are excepted from that 6-month retest rule, allowing the use of fresh donations if the recipient accepts the risk. This FDA policy aligns with NYS’s allowance for written waiver of quarantine for directed donations. In our case, the surrogate (as a directed recipient) could waive the 6-month quarantine, but both FDA and NYS would still require all initial infectious disease screening to be done (and both would highly encourage using only disease-negative donors to protect the surrogate and baby).

Donor Eligibility Determination and Exceptions: Under FDA regulations, an “eligible donor” is one who has been screened for risk factors (via a medical history interview similar to NY’s process) and tested negative for all required communicable disease tests. If a donor fails these criteria (e.g. tests positive), they are deemed “ineligible.” FDA prohibits use of HCT/Ps from ineligible donors, except in certain cases. Notably, reproductive cells from a directed donor can still be used even if the donor is ineligible, provided the situation is documented and appropriate warnings/labels are used. This means that under federal law, if (hypothetically) the male or female in our scenario had a positive test or risk factor, the embryo could still be implanted in the surrogate with proper informed consent and labeling (“WARNING: Advise patient of communicable disease risks”). The rationale is to respect patient autonomy in known directed donations – the FDA allows the intended parents and surrogate to proceed at their own risk, after being warned. In contrast, New York’s rules are stricter: the state does not allow use of HIV/HBV/HCV-positive donor gametes at all in reproductive procedures, and an official state variance would be needed even for something like a resolved Hep B infection in a directed donor. In practice, clinics in NYS would refuse to transfer an embryo if a gamete donor tested positive for a disqualifying infectious disease. Thus, one key difference is that FDA provides a mechanism to use ineligible directed donors with proper labeling, whereas NYS regulations outright bar the use of positive-testing donors in nearly all cases (to protect recipients).
Genetic Screening and Other Requirements: The FDA’s donor eligibility rule (21 CFR Part 1271) focuses solely on communicable disease transmission. It does not mandate genetic or hereditary disease screening of donors – those considerations are left to clinical practice or state law. This is a significant difference from New York’s requirements. NYS explicitly compels tissue banks to assess genetic risks (family history of genetic disorders, carrier testing for Tay-Sachs, cystic fibrosis, etc.), whereas the FDA regulations make no mention of genetic disease carrier testing. The FDA is concerned with public health risks(infections), not the genetic traits of the donor. Therefore, NYS imposes additional layers of donor eligibility (genetic fitness) beyond the FDA’s baseline. Another minor difference is that NYS, via its Medical Advisory Committee standards, might impose age limits or other quality criteria (for example, recommending not to use eggs from a donor over 34 without notification,), which are not found in federal law. FDA also doesn’t require providing donor profiles or certain record details to recipients – those are NYS-specific enhancements.

Bottom Line: In a gestational surrogacy at a NY-licensed facility, the male and female of a sexually intimate couple are treated as reproductive tissue donors under NY law, because their embryo will be carried by someone else. They must comply with NYS Subpart 52-8’s testing and screening requirements, including full infectious disease panels (HIV-1/2, Hep B, Hep C, HTLV, syphilis, gonorrhea, chlamydia) and genetic history and carrier screening, as cited above. The “client-depositor” exception does not apply to them in this context.Under FDA regulations (21 CFR Part 1271), the same couple would likewise need to undergo donor eligibility determination(since the surrogate is not a sexually intimate partner) – requiring essentially the same infectious disease tests and donor history evaluation as New York, minus the genetic component. The FDA and NYS frameworks are consistent in requiring protection of the surrogate and any resulting child from communicable diseases. The main differences are that NYS adds genetic screening obligations and has stricter prohibitions on using positive-testing donors, whereas FDA allows certain informed-choice exceptions for directed donors and does not address genetic screening. All relevant federal standards (e.g. 21 CFR §§ 1271.75, 1271.80, 1271.85) and state standards (10 NYCRR Part 52) would be followed by a NY facility in this scenario, as confirmed by NYS Department of Health guidance that tissue banks involved in surrogacy must be licensed and in full compliance with Part 52.

Sources:

N.Y. Comp. Codes R. & Regs. tit. 10, Part 52, Subpart 52-8 – Reproductive Tissue Banks (definitions of donor, directed donor, client-depositor; donor screening and testing requirements),
New York Dept. of Health, Wadsworth Center – Tissue Resources Program Guidance (requirements for donor testing, surrogacy compliance, exceptions),
21 CFR Part 1271 – FDA Donor Eligibility Rules (required infectious disease tests; exceptions for sexually intimate partners; use of directed donors).
NYS DOH Child-Parent Security Act Guidance – Assisted Reproduction Providers must comply with Part 52 tissue bank regulations.