The United States Department of Agriculture (USDA) and U.S. Food and Drug Administration (FDA), two of the U.S. Federal agencies responsible for regulation of agricultural biotech recently announced two comment periods related to products under their jurisdiction.
On March 8, USDA announced an extension of the comment period on its Advance Notice of Proposed Rulemaking discussing the possible transition of jurisdiction over certain genetically engineered animals from FDA to USDA. USDA had initially published the ANPRM on December 28, 2020, with a 60-day comment period that ended February 26. I discussed the USDA ANPRM in a Wiley alert that we published when the ANPRM was first announced.
As discussed in the Wiley alert, USDA is seeking public comment on the notion of transitioning from FDA to USDA regulatory jurisdiction over certain genetically engineered agricultural animals (e.g., catfish, cattle, equines (including horses and mules), goats, hogs and pigs, poultry, and sheep) that USDA would then regulate pursuant to its authorities under the Animal Health Protection Act (AHPA), the Federal Meat Inspection Act (FMIA), and the Poultry Products Inspection Act (PPIA). Currently, FDA regulates intentional genetic alterations of the subject animals as new animal drugs, pursuant to its authorities under the Federal Food, Drug, and Cosmetic Act (FFDCA). The ANPRM discusses a process whereby USDA would promulgate the necessary regulations, and FDA and USDA would clarify their respective regulatory jurisdiction over GE animals via a Memorandum of Understanding.
The ANPRM invited comments generally on the concept of transitioning regulatory jurisdiction over the identified GE animals, and specifically on particular issues discussed by USDA. USDA’s March 8 notice announced that the comment period is now re-opened for an additional 60 days, until May 7. As I noted in the Wiley Alert, the timing of the original ANPRM meant that a regulatory concept put forward at the close of the previous administration would be dealt with in its entirety by the Biden Administration, which meant that the Biden Administration, if it was not well-disposed toward or interested in the transfer of regulatory jurisdiction described in the ANPRM, could have just ignored it. The fact that USDA is now allowing an additional 60 days for comment is a positive indication that the concept of this jurisdictional transition may be a viable option going forward.
I will note again with emphasis that it is important for interested stakeholders to submit concise, substantive, well-supported, and well-documented comments to the administrative docket. In this instance, given the positive prospects that may be portended by the extended comment period, it is important that interested stakeholders use this opportunity to urge the Biden Administration to continue a 21st Century approach to regulating animal ag biotech.
FDA also recently announced a public comment opportunity related to its regulatory activities related to ag biotech. FDA’s June 2006 Guidance for Industry, Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use explains the process whereby technology producers can voluntarily initiate a food safety review by FDA of a “new” protein (i.e., a protein that is a “non-pesticidal protein produced in a new plant variety that is new to the plant species, or is a native protein that has been produced at a significantly elevated level, or is a native protein from a part of a plant that is not normally ingested, and will now be produced in a part of the plant that is normally ingested, and has not been the subject of a completed biotechnology consultation or a completed early food safety evaluation with FDA.”). In compliance with the Paperwork Reduction Act (PRA), on March 4, FDA published a request for comments on the necessity for and burden attendant to information collected related to the Guidance for Industry. Stakeholders interested in providing information relevant to OMB’s PRA review of these FDA information collection activities should take advantage of this opportunity.