In the Dec. 28 Federal Register, the U.S. Department of Agriculture published an advance notice of proposed rulemaking, “Regulation of the Movement of Animals Modified or Developed by Genetic Engineering.“
But what exactly is it that USDA is proposing, and how does the plan differ from the Food & Drug Administration’s current regulatory approach? Does the contemplated regulatory framework improve things?
Dr. Alison Van Eenennaam, cooperative extension specialist in the field of animal genomics and biotechnology in the department of animal science at University of California-Davis, explored these questions and the subject overall in a recent series of BIOBEEF blogs, which can be found at https://biobeef.faculty.ucdavis.edu/mostrecentblog/
USDA’s proposal calls for moving the regulation of food animals that are genetically engineered for agricultural purposes, such as human or animal food, fiber and labor, from FDA to USDA. As such, intentional genomic alterations in food animals would no longer be automatically and mandatorily regulated by FDA as “drugs.” That is good news, according to Van Eenennaam because genetic variation between individuals cannot reasonably be considered a drug. “All life is made up of genetic alterations. It is the very foundation of all selection programs, and indeed evolution itself. In some ways it is going back to the future, as APHIS (Animal & Plant Health Inspection Service) oversight of agriculture and forestry products developed by modern biotechnology was envisioned in early discussions of the regulation of biotechnology,” she said.
Under USDA’s proposed framework, APHIS would conduct a safety assessment of animals that have been modified or developed using genetic engineering subject to the Federal Meat Inspection Act, and the Poultry Products Inspection Act, with a specific eye to alterations that may increase the animal’s susceptibility to pests or diseases of livestock, including zoonotic diseases, or ability to transmit the same. The Food Safety & Inspection Service (FSIS) would also conduct a pre-slaughter food safety assessment to ensure that the slaughter and processing of certain animals modified or developed using genetic engineering would not result in a product that is adulterated or misbranded, as they do with animals produced using conventional breeding.
Van Eenennaam said this is a definite improvement over FDA’s approach. That being so, she also pointed out in her blogs that there are some logical inconsistencies in the proposal as it currently stands.
Van Eenennaam, an academic working in livestock improvement, said she has seen the promise of genetic engineering go nowhere, “Regulatory evaluations have included ‘Alice-in-Wonderland’ evaluations that include questions that have no right or wrong answer. If there is no hypothesis to test it is not possible to a power analysis or design a sensible experiment. Studies that product developers have conducted to try to address these questions have been used by groups opposed to the technology to suggest unacceptable risk,” she said, noting that USDA’s proposal is seeking to identifying ‘plausible’ risks.
In contemplating an improved regulatory approach for genetically modified animals, Van Eenennaam suggested that perhaps it is time to ditch the process-based trigger that requires additional regulatory scrutiny of plants and animals that could have been achieved using conventional breeding, and rather take the advice of the 1996 Coordinated Framework, and that is that regulatory review should be confined to organisms deliberately formed to contain an intergeneric combination of genetic material from sources in different genera (aka foreign or transgenic DNA that could plausibly produce a toxin or an allergen), and that oversight should be exercised only where the risk posed by the introduction is unreasonable, that is, when the value of the reduction in risk obtained by additional regulatory oversight is greater than the cost thereby imposed.
The bottom line is that as long as animals produced using genetic engineering, even those that could have been produced using conventional breeding, are subjected to unique regulatory scrutiny not required of identical products produced using conventional breeding, research in food animals using genetic engineering for agricultural applications will be cost-prohibitive in the U.S., Van Eenennaam said.
To comments on USDA’S contemplated regulatory framework, there is a 60-day public comment period that closes Feb. 26, 2021. Comments can be posted Federal eRulemaking Portal at http://www.regulations.gov/#!docketDetail;D=APHIS-2020-0079
Supporting documents and any comments that are received on this Advance Notice of Proposed Rulemaking may be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2020-0079
To view, Van Eenennaam’s blog posts in their entirety: