U.S. policy on the regulation of genetically engineered animals evolves with steps by FDA and USDA

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The United States’ regulation of genetically engineered (GE) animals recently advanced with two new developments from the U.S. Department of Agriculture (USDA) and U.S. Food and Drug Administration (FDA). First, the FDA’s Center for Veterinary Medicine (CVM) approved an application for an intentional genomic alteration (IGA) in a line of domestic pigs, called “Gal Safe Pigs,” and the meat and tissues from the pigs may be used for human food. Second, the USDA’s Animal and Plant Health Inspection Service (APHIS) and Food Safety and Inspection Service (FSIS) issued an advance notice of proposed rulemaking (ANPR) seeking comment on the prospect of transitioning from FDA to USDA the regulation of GE animals that are considered amenable to FSIS inspection. Animals not subject to FSIS jurisdiction would remain under FDA’s jurisdiction under the framework outlined in the ANPR.

Collectively, the FDA and USDA actions, although unrelated, mark gradual but continued progress in further developing the federal regulatory framework for GE animals. Companies interested in developing products or investing in this space should follow these developments carefully, as they could be important for the pathway to market.

CVM’s approval of Gal Safe Pigs

On 14 December 2020, the FDA’s CVM approved a new animal drug application (NADA 141-542) for the use of “Gal Safe Pigs,” an IGA in a line of domestic pigs, for food and human therapeutics. This is the first time FDA has approved an IGA in an animal for both human food consumption and as a source for therapeutic uses. Importantly, the “Gal Safe Pigs” themselves are not a drug and not subject to FDA approval; rather, it is the IGA that is the regulated article subject to the FDA’s review as a new animal drug.

“Gal Safe Pigs” contain an IGA that was accomplished by inserting an additional piece of genetic material, known as rDNA, into the genome. In particular, the rDNA insertion disrupts the part of the genome that codes for an enzyme responsible for production of the alpha-gal sugar found on biological surfaces of the pigs. As such, “Gal Safe Pigs” do not contain any detectable alpha-gal sugar on their cells, tissues, or organs. Pigs containing the IGA also pass the trait to their offspring through conventional animal breeding.

The lack of detectable alpha-gal sugar has implications for people who suffer from alpha-gal syndrome (AGS), an allergy to red meat from food producing animals. This allergy occurs in certain people who are bitten by a Lone Star tick that can transmit alpha-gal sugar molecules into the person’s body. Food products made from “Gal Safe Pigs” do not contain detectable alpha-gal sugar and may provide a red meat option for people with AGS. They can also potentially provide a source of porcine-based materials to produce human medical products that are free of detectable alpha-gal sugar such as the blood-thinning drug heparin.

As part of the review, the FDA has evaluated human food safety for the general population (not specially for people with AGS) and concluded there is reasonable certainty of no harm for people to consume food products from “Gal Safe Pigs.” The FDA reasoned the safety of food products made from “Gal Safe Pigs” is no different than the safety of food products made from conventional pigs. The FDA also noted in the approval that it is the USDA who has regulatory oversight over the labelling and processing of food products made from “Gal Safe Pigs.”

USDA’s ANPR

The USDA has issued an ANPR seeking comments on a tentative proposal to transfer oversight from FDA to USDA of GE animals considered “amenable” to FSIS inspection. Importantly, the proposed changes would apply only to amenable species used for agricultural purposes (e.g., not medical or pharmaceutical purposes); other food-producing animals would remain under the existing regulatory framework for GE animals, and the FDA would retain its jurisdiction over foods like dairy products and table eggs.

Under the framework envisioned in the ANPR, the FDA’s regulatory oversight role for animal biotechnology would be transitioned to the USDA, which would consult with the FDA when performing its reviews. As discussed above, the FDA currently regulates IGAs in animals as animal drugs under the Federal Food, Drug and Cosmetic Act. The contemplated change would house all pre-market reviews and post-market oversight for these species within the USDA, except when the species are used for medical or pharmaceutical purposes.

Under the contemplated regulatory scheme, the APHIS, drawing on its authority granted under the Animal Health Protection Act (AHPA), would conduct a safety assessment of organisms developed using genetic engineering that may increase the animal’s susceptibility to pests or diseases of livestock, including zoonotic diseases, or ability to transmit those pests or diseases. Under its authority granted by the Federal Meat Inspection Act (FMIA) and Poultry Products Inspection Act (PPIA), FSIS would conduct a pre-slaughter food safety assessment to ensure that the slaughter and processing of animals developed using genetic engineering would not result in a product that is unsound, unhealthful, unwholesome, or otherwise unfit for human food.

For purposes of the framework under consideration, the term “genetic engineering” would mean “techniques that use recombinant, synthesized, or amplified nucleic acid to modify or create a genome.” It would not include conventional breeding methods.

The USDA would not regulate GE amenable species intended for non-agricultural purposes (e.g., medical or pharmaceutical uses). The FDA would continue its review of IGAs in these amenable species when used for non-agricultural purposes. The FDA would also continue to regulate dairy products, table and shell eggs, and animal food (feed) that are derived from amenable species. In addition, the FDA would continue its review of IGAs in animals and the animal food products derived from them that are not subject to the FMIA or PPIA and not previously determined by the FDA to be low risk.

The ANPR follows an Executive Order President Trump issued in 2019 on agricultural biotechnology, which directed federal agencies to modernize the regulatory framework for agricultural biotechnology products by establishing regulatory approaches proportionate to the product’s risks, avoid unjustified distinctions across similar products, and promote future innovation and competitiveness. To that end, the revised regulatory framework the USDA is contemplating is intended to provide developers, in most cases, with a “one-stop-shop” for their products at the USDA.

At this time, the contemplated framework is only preliminary in nature, and the USDA is seeking feedback on its proposal. Comments on the ANPR are due 26 February 2021. The agencies did not provide an anticipated timeframe for promulgating proposed regulations to establish the contemplated framework. It remains to be seen whether this initiative aligns with the incoming administration’s priorities or how the change in administration may affect the timeline or prospects for this initiative.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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