A substantial shift for genetically engineered (“GE”) food regulation may be on the horizon thanks to a USDA proposed rule with a fast closing comment period, which ends on February 26, 2021. The proposed rule strips FDA’s jurisdiction over food-bearing GE livestock and places it within USDA’s purview, thereby granting USDA jurisdiction over pre-market review and post-market safety monitoring of such products. This significant change would create a less burdensome pathway for the regulatory approval of certain GE livestock, which are currently regulated by FDA as a new animal drug. While the Trump Administration endorsed the proposal before leaving office, the Biden Administration has yet to indicate whether it supports or disapproves of the measure.
Genetically engineered (“GE”) food is a signature dish on the regulatory menu as the Food and Drug Administration (“FDA”) and the United States Department of Agriculture (“USDA”) battle for jurisdiction to regulate GE animals for human consumption. The turf war was sparked on December 28, 2020, when the USDA published a proposed rule seeking comment for sixty (60) days regarding transitioning jurisdiction for safety assessments of certain GE agricultural animals away from FDA and into USDA’s purview. Shortly thereafter, the Trump Administration signed an interdepartmental memorandum of understanding, moving the conventionally FDA authority over food-bearing GE livestock to USDA. The proposed change has not gone without contest, as now-former FDA Commissioner Stephen Hahn indicated he had no plans to sign off on the jurisdictional transfer based in part on public health concerns. It is also unclear whether the current head of the USDA supports the measure. Given the comment period for the proposal ends February 26, 2021, the Biden Administration will have the final say on whether the jurisdictional transfer takes place.
Historically, the two agencies have shared jurisdiction over food, with FDA regulating animal biotechnology and USDA overseeing GE crops for protecting agriculture from pests and diseases. Under the new proposal, USDA will be in charge of end-to-end regulation over GE livestock, from pre-market review though post-market safety monitoring, which would change significantly the current regulatory landscape. USDA would receive broad authority over GE animals including cattle, sheep, goats, swine, horses, chickens, and others, while FDA would retain authority over GE animals developed for nonagricultural purposes, such as medical or pharmaceutical use. Currently, FDA regulates most GE animals under the Federal Food, Drug, and Cosmetic Act (“FCA”), pursuant to which FDA has considered each specific genomic alternation to be a “new animal drug” that is subject to FDA’s new animal drug approval requirement. Understandably, FDA’s approval process for GE animals takes a holistic approach that sometimes lasts for years. FDA, however, has approved only two GE animals for human consumption in its history, while USDA has made it possible for hundreds of GE crops to be widely adopted throughout the country. Industry stakeholders have expressed frustrations that the current system is too cumbersome and competitively disadvantageous, as numerous nations have developed gene editing capabilities, which include capabilities to engineer more disease resistant animals designed for human consumption.
It will be interesting to see how the Biden Administration responds. It would not be surprising to see the current administration walk back an attempt to usher in a less rigorous regulatory framework and opt to maintain FDA’s jurisdiction to oversee the health and safety of GE animals used for human consumption. As some commentators have proposed, another alternative to consider is treating GE foods as a new food additive. No longer classifying GE foods as drugs would subject these products to the less restrictive regulatory requirements applicable to food additives. This approach would allow FDA to retain jurisdiction, while simultaneously creating an easier pathway for GE animals to obtain pre-market approval. Food for thought.