Recent Biden administration initiatives to boost the "bioeconomy" acknowledge an important fact: the government's current biotechnology regulatory policies impose an unnecessary burden that slows the development of important products. A proposal to shift oversight of genetically engineered food animals to the Department of Agriculture, instead of its currently shared responsibility with the FDA, would help ease that burden.
Struggling with other responsibilities, the FDA has nevertheless exerted control over "genetically altered" agricultural animals, irrespective of risk, for decades. It's hard to see a compelling reason for that other than turf-building. The 1986 Coordinated Framework for the Regulation of Biotechnology designated the USDA as the responsible agency and called for regulation of only "unreasonable" risks.
To assert jurisdiction over genetically engineered animals, the FDA has expansively interpreted its statutory responsibilities for regulating animal drugs. The agency declared that genetically altered DNA in an animal counts as a chemical intended to change the animal's "structure and function," and thus fits the legal definition of a drug. But animal scientists and breeders have a long history of safely crafting important genetic improvements in animals—using crude, pre-genetic engineering techniques—without government involvement.
The FDA's animal-drug regulations were designed for the testing of traditional small-molecule drugs, but the breeding and genetic modification of farm animals is fundamentally different. The high costs of compliance with FDA regulations would be prohibitive, especially for academic researchers. More to the point, those regulatory requirements are unnecessary: FDA research restrictions would not allow research animals to be used for food, which is routinely permitted when they present no risk. And despite asserting authority over all genetically altered animals, the FDA concedes that not all pose an unreasonable risk.
Using its "enforcement discretion," the agency says that it will make "low-risk determinations" based on flexible standards and allow some genetically altered animals to be marketed without formal approval. However, even that process could be lengthy and expensive for researchers, and it is fraught with uncertainty.
The current system creates large opportunity costs. Many genetically altered farm animals have been developed, raised to adulthood through several generations, and then abandoned because the costs of bringing them to market were too high. One academic study documents the "lost innovation" from some 15 years of FDA oversight.
Moreover, little is known about FDA oversight of genetically altered animals. The agency has never reported the number of genetically altered animals that it has under review, whether that number has declined over time and the percentage approved or otherwise allowed.
After years of the FDA's inept efforts, only two farm animals have received regulatory approval. The first, the AquAdvantage fast-growing salmon, was approved in 2015 after a 20-plus-year review and only recently has become commercially available. The second, the GalSafe pig, modified to be less allergenic to certain people, was approved in 2020. Several other genetically altered animals have been approved to provide medical products, and the FDA has exercised enforcement discretion for a large number of genetically engineered laboratory animals, for the ornamental GloFish, and for cows with short, slick coats that help them withstand hot weather.
Will the FDA relinquish control? The USDA issued an Advanced Notice of Proposed Rulemaking (ANPR) in December 2020 for a regulatory regime appropriately tailored to animal research, development, and production. A month later, the USDA and HHS, the parent agency of FDA, signed a Memorandum of Understanding specifying that the FDA would defer regulation of genetically altered farm animals to the USDA, though President Donald Trump's FDA commissioner refused to sign it.
President Biden's USDA reissued the 2020 ANPR on March 8, 2021. Nothing had been heard subsequently about the proposal until last December, when the administration requested public comments by February 3, 2023, on "Identifying Ambiguities, Gaps, and Uncertainties in the Coordinated Framework for the Regulation of Biotechnology."
Industry groups, including the National Pork Producers Council, have argued that "for the tremendous potential of gene editing to be safely and readily available to U.S. farmers, regulatory authority for all agricultural applications of these new technologies has to be consolidated at the USDA." We agree.
It's past time to cut the red tape. American animal breeders, farmers, and consumers would all be best served by ceding to the USDA exclusive jurisdiction over animals genetically engineered for food.
John J. Cohrssen is an attorney who served as counsel to the White House working group that issued the Coordinated Framework for the Regulation of Biotechnology. Henry I. Miller is a physician and molecular biologist, the Glenn Swogger Distinguished Fellow at the American Council on Science and Health, and was the founding director of the FDA's Office of Biotechnology.