USDA, EPA and FDA announced a joint plan Wednesday that lays out steps the agencies are taking to further streamline the regulation of genetically modified plants, animals and microorganisms.
The three agencies have varied oversight roles for biotechnology, with USDA taking the lead on plants, while FDA handles animals. EPA regulates plants that are engineered to protect themselves against pests.
The agencies’ 16-page plan, which followed up on an executive order issued by President Joe Biden in 2022, “incorporates processes and timelines to implement regulatory reform, such as identifying guidance and regulations to update, streamline, or clarify, and identifying the potential need for new guidance or regulations. The plan supports a whole-of-government approach to the regulation of biotechnology products,” according to a press release.
As part of the plan, USDA is looking at how to streamline its regulatory review process to hit the target timeframes laid out in the department’s biotechnology regulations.
To cut the time required to prepare documents on plant biology, USDA is revising the review process “to allow developers to submit publicly available materials related to plant biology and mechanisms of action, engaged the National Agricultural Library to deliver staff training related to literature searches and support development of standard search queries, and received approval to test a narrow language learning model to facilitate the rapid identification of literature to support regulatory reviews,” the plan says.
USDA also is looking at eliminating a requirement for interstate movement permits for some plants, and creating alternative permit categories for plants “with streamlined processes and permit conditions, while retaining inspection and recordkeeping requirements.”
EPA, meanwhile, is writing guidance documents covering the common data it needs for assessing plant-incorporated protectants, or PIPs. The data cover the three areas the agency focuses on assessing the risk of the plant traits: molecular characterization, human health assessment, and ecological assessment.
“Providing clear guidance as to what data are typically needed, and when scientific rationale could likely be used in place of data, will result in a more consistent, streamlined review process,” the plan says.
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USDA also is streamlining the process for updating the list of foods covered by the disclosure requirements for bioengineered foods.
The plan says FDA and USDA intend “to collaborate to consider mechanisms for stewardship of food crops engineered to produce substances that could cause food safety concerns, or other food crops where stewardship may be important, if they inadvertently enter the food supply.”
The plan says the agencies have noticed “an increased interest in using genetic engineering to produce, in food crops, ingredients intended for specific food uses that may pose food safety issues if they enter the general food supply (e.g., allergenic ingredients not previously produced by those crops) as well as other food crops where stewardship may be important.”
The plan also notes that FDA and USDA recently released a memorandum of understanding outlining how they plan to communicate and collaborate on oversight of genetically altered animals, settling a years-long debate. FDA will continue to take the lead in regulating genetically modified animals.
In addition, FDA and USDA plan to issue guidance on the regulation of cell-cultured products. “FDA and USDA staff routinely meet to discuss new information on market and technical developments and considerations related to coordination of field oversight in dual jurisdiction food facilities where animal cell culture occurs,” the plan says.
The Biotechnology Innovation Organization welcomed the release of the plan.
“We have been waiting for the administration to put tangible policy behind the commitments outlined in President Biden’s Executive Order 14081, including reducing regulatory ambiguities, increasing interagency coordination and improving communication to reduce inefficiencies," the group said in a statement.
“Developers of plant, animal and microbial biotechnology are innovating rapidly to meet the challenges we face, from addressing climate change to ensuring we can feed a growing world. We need a regulatory process that works at the speed of today’s innovation. The agencies lay out in this report a plan to update existing guidance, develop new guidance and streamline processes.
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