The U.S. Department of Agriculture is reopening the public review and comment period for an Advance Notice of Proposed Rulemaking (ANPR) regarding whether to establish regulations for the movement of certain animals modified or developed using genetic engineering.
In consultation with FDA, USDA is contemplating regulations that would establish a flexible, risk- and science-based regulatory framework for the regulation of certain animals modified or developed using genetic engineering that are intended for agricultural purposes. In the final days of the Trump administration, USDA and Health and Human Services announced a memorandum of understanding to allow for USDA to have jurisdiction over the regulation of these animals. However, the FDA continued to oppose transferring oversight.
On December 28, 2020, the Animal and Plant Health Inspection Service and the Food Safety and Inspection Service announced the availability of the ANPR for a 60-day public review and comment period, which closed on February 26, 2021. To date, 43,108 comments were received.
In the action announced March 4, APHIS and FSIS are reopening the comment period for 60 days to allow interested persons more time to prepare and submit comments.
Earlier this week, Andrew Bailey, National Pork Producers Council science and technology counsel, says he expects the new administration to take some time to decide which direction to go on the animal biotechnology front in waiting for the full transition team and new officials are fully in place at USDA. He does expect the MOU established between USDA and FDA to continue on.
In a statement, Republican leader of the House Committee on Agriculture Glenn ‘GT’ Thompson says, “I know 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 with FDA.”
Thompson adds, “A risk- and science-based review process that leads to the commercialization of animal biotechnology products is critical to ensuring our livestock producers are equipped to meet the challenges of feeding a growing population while adapting to a changing climate and reducing emissions along the way. I hope after careful evaluation of the comments received on this proposal, USDA will move expeditiously to carry out the steps necessary to fully update and implement this framework.”
In comments filed by NPPC during the first comment period on the rule, the group says it strongly supports the proposed rule. “U.S. pork producers see tremendous potential in gene editing to address significant animal health issues, as well as assisting the industry in making continuous improvement in areas such as food safety, animal welfare, responsible antibiotic use and sustainability. An appropriate and practicable regulatory environment is critical to ensuring that this promise can be realized,” NPPC writes.
Under the contemplated regulatory framework, USDA would use the authorities granted to the department through the Animal Health Protection Act, the Federal Meat Inspection Act, and the Poultry Products Inspection Act to evaluate organisms developed using genetic engineering. Previously, FDA’s handling of the animals as a drug had considerably slowed approvals and acceptance of genetic engineered animals.
USDA’s proposal to regulate under the AHPA, FMIA and PPIA is “very sound and critically needed,” NPPC says. “It will allow the USDA to bring the full breadth of its expertise and authority to bear in ensuring their safe and appropriate use in animals while fostering these new technologies as it has done for plants for years. 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). The FDCA does not have the same tools—nor the FDA the same expertise across the agricultural production chain—to effectively regulate agricultural applications of this technology.”
NPPC’s comments note researchers, developers, producers and markets need regulatory certainty. “FDA is currently asserting regulatory authority over all applications of genetic technology in animals under loose and shifting guidance documents. Moreover, guidance documents that are subject to continuous revision. This does not promote any sense of confidence to the scientific community, technology developers and multipliers, or producers that requirements are fixed, and that applications can move forward under security of a clear approval pathway.
“It does promote a sense that at any moment any provision of the FDCA can be brought to bear; that any aspect of animal and subsequent food production can be treated as the distribution of a drug,” NPPC says.
However, the Center for Food Safety wrote a letter to Secretary of Agriculture Tom Vilsack calling on him to instruct USDA officials to remove the MOU from the APHIS Website and to halt and budgetary, regulatory, organizational or personnel activities.
“We believe it is absolutely clear that FDA has far more of the expertise and ‘safety first’ perspective needed to regulate novel GE animals,” CFS writes. “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. That said, FDA needs to shore up its regulatory regime. Guidance documents for GE animal regulation should be recast as formal regulations capable of addressing, with teeth, the food safety and the environmental safety challenges posed by these new kinds of genetically engineered organisms.”