The Agriculture Department hasn’t made up its mind on whether to move forward with a Trump-era proposal to take over regulation of biotech animal products, asking Friday for more comments on the subject.
The Animal and Plant Health Inspection Service and Food Safety and Inspection Service have reopened and extended the comment period until May 7 on an advance notice of proposed rulemaking published Dec. 28, which was followed by a Jan. 19 memorandum of understanding signed by then-Secretary of Agriculture Sonny Perdue and then-Public Health Service head Brett Giroir.
The MOU says USDA will use its rulemaking authorities in the Animal Health Protection Act, Federal Meat Inspection Act, and Poultry Products Inspection Act “to develop a regulatory framework that covers the pre-market and post-market evaluation and monitoring of agriculture amenable species developed using genetic engineering.”
However, then-Food and Drug Administration Commissioner Stephen Hahn said after it was issued that FDA did not support it.
"FDA remains undeterred in our steadfast commitment to ensure that animal agricultural biotechnology products undergo independent and science and risk-based evaluation by our career experts," Hahn said.
The meat industry, led by the National Pork Producers Council, has long criticized the current system, which treats “intentional genetic alterations” in animals as new animal drugs, as overly burdensome and unjustified. The industry points in particular to FDA's approval of only two animals bioengineered for food — AquaBounty salmon and GalSafe pigs.
Rep. Glenn "GT" Thompson of Pennsylvania, the top Republican on the House Agriculture Committee, issued a statement saying, "I know [Agriculture] Secretary [Tom] Vilsack has a long history of supporting agricultural innovation. Hopefully this is a sign of continued efforts to build on the work of the last administration that resulted in this proposal and the related MOU."
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The comment period that ended Feb. 26 garnered thousands of submissions, both pro and con. NPPC Science and Technology Counsel Andrew Bailey, for example, said the AHPA “contains all the tools necessary to effectively regulate agricultural animals bred utilizing new genetic technologies. The FMIA and the PPIA contain all the tools needed to ensure that the meat products they produce are safe and wholesome (the USDA can partner with FDA to ensure the safety of dairy and egg products under that agency’s primary purview).”
And the Biotechnology Innovation Organization’s Clint Nesbitt, the group's senior director for science and regulatory affairs, food and agriculture, said “FDA’s insistence on applying to living animals and/or the farms where they are produced regulatory requirements and procedures that are normally applied to conventional veterinary drugs leads to a regulatory system incompatible with the realities of animal agricultural production systems, and comes across as confusing, illogical, and a strong deterrent for research, development, and adoption of new and innovative products.”
The Center for Food Safety, however, criticized the ANPR. “We believe it is absolutely clear that FDA has far more of the expertise and ‘safety first’ perspective needed to regulate novel GE animals,” Policy Director Jaydee Hanson and Senior Scientist William Freese said in CFS’s comments. “Stringent regulation is required not only to ensure safety, but also to avoid blowback from the ‘rush-to-market, consequences be damned’ mentality of some regulation-haters.”
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This story was updated to include Thompson's comments.
