Sperm donation plays a crucial role in assisted reproductive technology (ART), often being utilized in methods such as in vitro fertilization (IVF), surrogacy arrangements, and intrauterine insemination (IUI). However, despite its importance, the sperm donation industry operates with minimal federal regulation, creating concerns of exploitation and malpractice by both doctors and donors, prompting the need for greater oversight.

The repercussions of unchecked sperm donations extend beyond individual cases of fraud or misconduct, posing broader societal risks, particularly in terms of consanguinity. Consanguinity, the breeding of closely related individuals, carries inherent genetic risks, including an increased likelihood of inherited disorders and health complications in offspring.[i] Of new concern, with donor-conceived individuals starting families, is the possibility that donor-conceived individuals may unknowingly use the same donor for their own conception or conceive with another donor-conceived individual from the same donor.[ii] Furthermore, limitless donations by a single donor can lead to donor-conceived individuals discovering the existence of hundreds of half-siblings.[iii]

Only five sperm banks supply seventy-five to eighty percent of the total sperm distributed in the United States; however, despite this oligopolistic structure, there are no regulations mandating transparency regarding the number of children born from each donor or limiting the number of offspring per donor.[iv] While some individual sperm banks have implemented their own guidelines to address these issues, the lack of a cohesive regulatory framework at the state or federal level undermines the effectiveness of such efforts.[v] Moreover, the lack of uniform regulations creates opportunities for donors to bypass limits through fraudulent practices or by donating to multiple banks, further exacerbating the risks of consanguinity and genetic overlap.

Current federal regulation of sperm donations is minimal. The regulatory oversight provided by the Food and Drug Administration (FDA) focuses primarily on conducting a medical record review and screening donors for communicable and infectious diseases, such as HIV and Hepatitis C, and requires the clinics to register with the FDA. [vi] While these measures address some health-related risks associated with sperm donation, they do not encompass broader ethical and genetic considerations. Professional organizations, like the American Society for Reproductive Medicine (ASRM) and the Society for Assisted Reproductive Technology (SART), have attempted to regulate donation clinics by establishing voluntary standards for clinic accreditation. [vii] However, only a small number of clinics have elected to participate in the voluntary accreditation process.[viii] As such, this lack of accreditation raises concerns about the consistency and reliability of practices across clinics, as well as the adequacy of safeguarding the interests of donors, recipients, and donor-conceived individuals.

In response to these regulatory gaps and harms that have occurred as a result of these gaps, Congressman Jacobs introduced House Bill 8307, “Steven’s Law,” in 2022.[ix] This proposed legislation aimed to impose stricter requirements on egg and sperm donors, mandating donors provide certain medical information.[x] However, the bill did not survive referral to the House Committee on Energy and Commerce.[xi]

As such, there remains a pressing need for federal regulation, preferably similar to that of the recently enacted Colorado law “Donor-Conceived Persons and Families of Donor-Conceived Persons Protection Act.”[xii] This legislation sets a precedent for the regulation of sperm donation practices, calling for not only medical information disclosure but also educational requirements and limits on donor usage. [xiii]

The Colorado law mandates that beginning in 2025, donors and recipients receive educational materials on sperm donation, ensuring informed decision-making and mitigating potential risks.[xiv] Moreover, it imposes strict limits on the use of a donor’s sperm, prohibiting one donor from being used by more than twenty-five recipient families. Additionally, the law requires licenses for fertility banks and clinics, enhancing oversight and accountability in the industry.[xv]

Currently proposed in the House of Representatives and Senate, related to the use of ART, is the Access to Infertility Treatment and Care Act, which aims to require health insurance coverage for the treatment of infertility, treatments that may require the use of sperm donations.[xvi]

While the goal of the act is commendable, aiding individuals and families suffering from infertility, as access to infertility treatments becomes more widespread due to mandated insurance coverage, there is a foreseeable rise in the demand for sperm donations to facilitate these treatments. However, without parallel increases in regulatory oversight of sperm donation practices, this surge in demand may exacerbate existing concerns regarding consanguinity and genetic diversity.

With the expanded utilization of sperm donations, there is a heightened risk of unintentional consanguineous relationships, especially if donors are not subject to federal regulations and are limited in the number of offspring a donor can be used to conceive. Public policy against consanguinity demands that the federal government regulate the number of children conceived by a single donor to lower the chances of half-siblings becoming romantically and sexually involved.[xvii] To effectively address these challenges, it is imperative that in a bill seemingly increasing the use of and access to sperm donations, policymakers incorporate provisions that mandate comprehensive oversight of sperm donation practices.

By drawing upon the successes and lessons learned from state-level initiatives like the Colorado law, federal policymakers can create a regulatory framework that promotes ethical conduct, protects genetic identity, and ensures the integrity of assisted reproductive practices on a national scale. This may include establishing strict guidelines for donor eligibility, implementing limits on the number of offspring a donor can conceive, and connecting clinics to prevent donor fraud in evading limits. Furthermore, coordination between federal agencies such as the FDA and the Department of Health and Human Services is essential to enforce and monitor compliance with regulatory standards across all aspects of assisted reproduction, including sperm donation.

Recent Supreme Court decisions have underscored the delicate balance between federal and state authority in regulating matters of reproductive health.[xviii] As the Court has affirmed the states’ rights to regulate certain aspects of abortion, it remains unknown how the Court would rule on federal regulation on other reproductive health issues, here the regulation of sperm donation. However, continuing with the decentralized approach currently employed by the Court, individual states maintaining their own registries for sperm donors poses significant challenges in addressing overarching concerns such as consanguinity and the prevention of limitless donations.

In an increasingly mobile society, the lack of a centralized federal registry renders state-level regulations insufficient in preventing consanguinity and ensuring responsible donor practices.[xix] Furthermore, the disparities among state regulations regarding sperm donation will exacerbate the inconsistencies and loopholes in donor oversight. A patchwork of regulations not only undermines efforts to maintain genetic diversity and minimize health risks but also creates confusion for individuals seeking reproductive assistance across state borders.

While the Supreme Court’s stance on federal versus state regulation of reproductive health issues remains uncertain, the need to address the shortcomings of the current decentralized system cannot be overstated. By advocating for federal intervention in the establishment of sperm donation regulations, the rights and interests of all stakeholders—donors, recipients, donor-conceived individuals, and society—are safeguarded.

[i] See Consanguinity, Legal Dictionary, https://legaldictionary.net/consanguinity/ (last visited Mar. 11, 2024) (“The term “consanguinity” is often used in relation with marriages or sexual relations between relatives, and whether they are prohibited by law.”).

[ii] See Vanessa L. Pi, Regulating Sperm Donation: Why Requiring Exposed Donation Is Not the Answer, 16 Duke J. Gender L. & Pol’y 379, 389 (2009) (“[I]t is entirely possible that one sperm donor can be the biological parent of numerous children. This concern is compounded when one considers that these children may well grow up in the same geographic area surrounding the bank where their mothers obtained the sperm used in the ART.”).

[iii] See Joshua Zitser, A serial sperm donor who has fathered 550 children is being sued for increasing the risk of accidental incest, Business Insider (Mar. 28, 2023, 9:34AM), https://www.businessinsider.com/sperm-donor-fathered-550-children-sued-reduce-incest-risk-lawsuit-2023-3 ([A]lleging that Meijer donated sperm to at least 13 clinics [in the Netherlands]…. But he has continued to donate his sperm abroad, including in Denmark and Ukraine….”).

[iv] See Ashley Rogers, Swimming Free of Regulation: The Need for a National Regulatory System for Sperm Donation, 35 J. Am. Acad. Matrimonial Law. 757, 760 (2023) (“Five of twenty-six sperm banks supply 75-80% of the total sperm distributed in the United States…. The absence of state and federal laws to regulate the number of children born to each donor has resulted in some sperm banks creating their own regulations to tackle this issue….”).

[v] See id.

[vi] See What You Should Know – Reproductive Tissue Donation, FDA (Nov. 5, 2010) https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/what-you-should-know-reproductive-tissue-donation (“Donated reproductive tissue (eggs or sperm) are regulated as human cells, tissues, and cellular and tissue-based products (HCT/Ps).  Any establishment that performs one or more manufacturing steps for HCT/Ps (recovery, processing, storage, labeling, packaging or distribution of products) must register with FDA….”).

[vii] See Oversight of Assisted Reproductive Technology, ASRM https://www.asrm.org/advocacy-and-policy/media-and-public-affairs/oversite-of-art/ (last visited Mar 11, 2024) (ASRM…administer a reproductive laboratory accreditation program for embryology labs to assure that they conform to high national standards of quality. ASRM also produces ethics and practice guidelines. Its affiliate, [SART], strictly monitors member clinics for adherence to ASRM guidelines, accreditation of their embryology labs….”).

[viii] See Rogers, supra note iv at 759 (“ASRM and SART struggle to objectively review the few clinics that do comply with recommended standards due to their corporate relations.”).

[ix] Steven’s Law, H.R. 8307, 117th Cong. (introduced July 7, 2022) (“[T]o require certain medical information related to donors of reproductive tissue be made available to recipients of such tissue and persons conceived using such tissue, and for other purposes.”).

[x] See id.

[xi] See id.

[xii] Donor-Conceived Persons and Families of Donor-Conceived Persons Protection Act, S. 22-224, 73d Gen. Assemb., Reg. Sess. (Co. 2022) (signing into law an act aimed to educate and protect stakeholders in sperm donations, to beginning Jan. 2025).

[xiii] See Ellen Trachman, Federal Legislation Introduced to Require Egg and Sperm Donor Background Verifications, Above The Law (July 27, 2022, 1:59PM), https://abovethelaw.com/2022/07/federal-legislation-introduced-to-require-egg-and-sperm-donor-background-verifications/ (“[S]tarting in 2025, the Colorado law eliminates anonymity…requires educational materials for both donors and recipients, and limits use of any given donor’s tissue to no more than 25 recipient families. The Colorado legislation also requires licensure for all applicable gamete banks, gamete agencies, and fertility banks.”).

[xiv] See id.

[xv] See id.

[xvi] See Access to Infertility Treatment and Care Act, S. 2386, 118th Cong. (introduced July 19, 2023) (mandating health insurance coverage for the treatment of infertility, including the usage of ARTs).

[xvii] See Rogers, supra note iv at 761 (“Public policy against consanguinity demands that the federal government regulate the number of children conceived by a single donor to lower the chances of half-siblings becoming romantically and sexually involved.”).

[xviii] See Dobbs v. Jackson Women’s Heath Org., 597 U.S. 215, 300 (2022) (“It follows that the States may regulate abortion for legitimate reasons, and when such regulations are challenged under the Constitution, courts cannot ‘substitute their social and economic beliefs for the judgment of legislative bodies.’”).

[xix] See U.S. Const. art. IV, § 2 (protecting fundamental rights of individual citizens and restrains state efforts to discriminate against out-of-state citizens).