March 5, 2021 Update: USDA has reopened the public comment window.  Comments will now be accepted through May 7, 2021.

Key Takeaways

• What Happened: USDA is seeking comment on its intent to transfer portions of the regulatory framework governing agricultural animals modified or produced by genetic engineering from USDA to FDA.
• Who’s Impacted: Companies who produce, distribute, and/or sell animal biotechnology products.
• What Should They Consider Doing in Response: Review the ANPRM document—in in particular, the “Contemplated Regulatory Framework” section—to assess how their products might be regulated under the approaches discussed and determine whether to submit comments. USDA indicated that stakeholders and any other members of the public will have a 60-day opportunity to submit comments, ending on February 26, 2021.

The United States Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) published on December 28, 2020 an advanced notice of proposed rulemaking (ANPRM) outlining and seeking comment on its intent to regulate animals developed using “genetic engineering.” As defined under USDA’s existing regulations at 7 C.F.R. part 340, “genetic engineering” refers to “techniques that use recombinant, synthesized, or amplified nucleic acids to modify or create a genome.”

It is unclear if the incoming Biden administration will support this effort, which will require buy-in from entirely new leadership at USDA and the United States Food and Drug Administration (FDA). If pursued, however, the proposed changes would represent a landmark shift in the longstanding regulatory framework that applies to genetically engineered (GE) animals. Currently, USDA regulates many GE “plant pest” organisms consistent with its authority under the Plant Protection Act, while the FDA separately regulates most GE animals pursuant to its existing “animal drug” authority under the Federal Food, Drug, and Cosmetic Act (FFDCA). According to the FFDCA, a drug includes “articles (other than food) intended to affect the structure or any function of the body of man or other animals.” 21 U.S.C. § 321(g). Historically, FDA has considered each specific genomic alteration to be a separate “new animal drug” to the extent that it is intended to “affect the structure or function” of an animal’s body, and therefore subject to FDA’s new animal drug approval requirements.

When approving a new GE animal under its animal drug authority, FDA ensures that the genomic alteration is safe for the animal, safe for anyone that may consume food from the animal, and effective. FDA also assesses the environmental impacts of approving the application and determines if any potential impacts are significant. Some industry stakeholders have been critical of the FDA process, which can involve years of review and has resulted in approvals for only two GE animals for human consumption, a salmon in 2015, and a pig in December 2020. By contrast, USDA has approved well over a hundred GE crops over the last few decades, and last year promulgated substantial changes to its oversight of GE crops that include allowing developers to “self-determine” that their GE plants fall within an applicable regulatory exemption.

What is the “Contemplated Regulatory Framework”?

As part of the new approach, USDA intends to issue regulations under the Animal Health Protection Act (AHPA), the Federal Meat Inspection Act (FMIA), and the Poultry Products Inspection Act (PPIA) that enable “end-to-end regulatory oversight” meaning pre-market reviews as well as post-market food safety monitoring of GE animals including cattle, sheep, goats, swine, horses, chickens, and other species known as “amenable species” under the FMIA.

According to USDA, the change is needed to facilitate innovation and provide farmers with safe and effective tools. Under the proposal, FDA would retain authority over GE animals developed for nonagricultural purposes, such as medical or pharmaceutical use. FDA also would continue to regulate dairy and eggs, and USDA envisions operating under a Memorandum of Understanding (MOU) with FDA consistent with each agency’s authorities and statutory obligations and informed by the comments received in response to the ANPRM.

The ANPRM proposes that developers would be required to request that USDA conduct safety reviews of GE animals to assess their risk to both human and animal health. Depending on the outcome of the review, the animal may be exempted from permitting requirements for movement and import as well as marked free from adulteration if intended for human consumption. The reviews would be conducted in a two-tiered system: (1) an expedited review for modifications already known to occur in the gene pool, and; (2) a full animal and human health risk assessment for modifications not eligible for an expedited review.

USDA notes that the framework is conceptually similar to its recently updated regulations under 7 C.F.R. part 340 governing the movement of GE organisms (notably plants). One notable difference, however, is that USDA does not intend to provide up-front exceptions from regulation for certain types of GE animal modifications, and would instead require a permit for all species until they have either undergone an expedited safety review or a full risk assessment.

Request for Comments

An ANPRM is a preliminary step in the administrative rulemaking process and an opportunity to provide significant input into the ultimate regulatory proposal. Subject to the policy preferences of the new administration, USDA will still need to formally propose regulations and provide an opportunity for comment on that subsequent proposal. For the ANPRM, USDA is requesting comments on aspects of the contemplated regulatory framework and included specific topics for input, including:

• the scope of the contemplated framework, including the types of species and generic modifications that should or should not be covered;
• the risk assessment process;
• what terms need definitions and how might they be defined; and
• what are the current limits of conventional breeding, and what problems are entities seeking to solve using genetic engineering.

Beveridge & Diamond's Biotechnology and Pesticides Regulation practice group and Agriculture and Biotechnology industry groups help clients develop and commercialize newer, safer, and better ways of achieving animal breeding. We help companies address cutting-edge issues where agriculture, livestock, and biotechnology converge with the law. For more information, please contact the authors.