Well Done


On December 14, 2020, the US Food and Drug Administration (FDA) approved GalSafe pigs, which are genetically modified (GM) for use in food production and medical products. At the time, the agency noted in its Consumer Q&A that intentional genomic alterations (IGAs) in animals would be regulated by FDA to “ensure that it is safe for the animal, safe for anyone that consumes food from the animal, and that it is effective, i.e., it does what the developer claims it will do.” The agency also explained that IGAs would be “subject to premarket oversight whether they are intended to be used for food or to produce pharmaceuticals or other useful products” (emphasis added), with the US Department of Agriculture (USDA) being responsible for the labeling of food from GM animals.

However, on yet another show of intra-agency conflict during the Trump administration, just several weeks later the USDA moved to wrest the oversight of GM animals intended for food production from FDA by issuing an Advanced Notice of Proposed Rulemaking (ANPRM), titled Regulation of the Movement of Animals Modified or Developed by Genetic Engineering. Under the ANPRM, the USDA would be responsible for:

  • establishing “a flexible, risk- and science-based regulatory framework for the regulation of certain animals modified or developed using genetic engineering that are intended for agricultural purposes,” in consultation with FDA;
  • determining whether GM animals are safe to eat;
  • monitoring the meat of GM animals as part of the food supply; and
  • reviewing the safety and efficacy of IGAs and their impact on the environment.

Notably, FDA would continue to regulate GM seafood. This proposed regulatory framework is intended to operate under a Memorandum of Understanding (MOU) between the USDA and the US Department of Health and Human Services (HHS).

The MOU was signed by the two agencies on January 13, 2021, just mere days before the change in administration. The MOU transfers the oversight of GM animals “intended for agricultural purposes (i.e., human food, fiber, and labor)” from FDA to the USDA under authorities granted to the USDA by the Animal Health Protection Act, the Federal Meat Inspection Act, and the Poultry Products Inspection Act. Under the MOU, FDA will continue to have authority over IGAs intended for any purpose other than agricultural use, including biopharma, xenotransplantation, and gene therapies. Importantly, if a specific GM animal species is intended for human food supply, FDA must “consult with the USDA on the food safety review to promote consistent food safety reviews and monitoring for all amenable species intended for human food as part of USDA's new program.”

Where Are We Now?

Considering the strong interest in the proposed change in agency oversight by both industry and consumers alike—as well as the Biden-Harris administration’s likely desire to gauge the support and opposition for the plan before making a decision—USDA reopened the comment period for the ANPRM in early March, which was extended to May 7, 2021. Despite strong support from industry, however, animal welfare, public health, and environmental advocates have signed letters urging both Tom Vilsack, Agriculture Secretary, and Xavier Becerra, HHS Secretary, to allow FDA to retain its oversight over GM animals intended for food production, claiming the MOU weakens FDA’s authority to protect public health.

In the meantime, FDA continues to regulate GM animals for both agricultural and medical purposes. Whether USDA’s effort to retain jurisdiction over GM meat intended for the food supply will be successful is unclear. However, it seems there would be some amount of duplication in determining whether a genetic modification to an animal is safe for purposes of producing food, drugs, new cells, or tissue structures for use in humans. Presumably the agencies will share their relevant scientific expertise in assessing the use of this novel technology and its possible effects on humans. Because state agencies are also heavily involved in the regulation of livestock, it is likely that states will have a view on which federal agency they believe is more capable to set appropriate standards and police activity. It remains unclear when a decision on the ANPRM will be issued and whether the Biden-Harris administration will support the proposed rule.