By Randy Gordon, President
The U.S. Food and Drug Administration (FDA) on Oct. 29 announced its intent to update its policies and issue several new guidance documents over the next year outlining the agency’s approach to providing regulatory oversight of plant and animal biotechnology, including the application of such plant breeding innovation techniques as gene (genome) editing.
The agency outlined its approach in a five-page “Plant and Animal Biotechnology Innovation Action Plan” available here. The unveiling of FDA’s plan follows the agency’s 2017 request for public comments on its future regulatory oversight to ensure new plant breeding innovation techniques being used in plants and animals are safe and effective.
“This new plan advances policy priorities that FDA will pursue to clarify (its) science- and risk-based approach for product developers; avoid unnecessary barriers to future innovation in plant and animal biotechnology; and advance safety and our public health mission,” stated FDA Commissioner Scott Gottlieb and Deputy Commissioner for Policy, Planning, Legislation and Analysis Ana Abram.
Plant Biotechnology: For plant biotechnology, FDA’s action plan states that the agency will “clarify” its policy approach for genome editing based upon its “25 years of experience overseeing the safety of foods” produced using transgenic engineering. For transgenic-engineered products (which can involve the introduction of a “foreign” gene that is not part of the plant’s genus), FDA has strongly encouraged technology developers and providers to engage in voluntary premarket consultations with the agency and to provide data and information that can be used to demonstrate the safety of human and animal food derived from plants developed through use of such technology.
FDA’s new plan said it will publish draft guidance in “early 2019” that will be subject to public comment explaining how the agency’s current regulatory policy for foods derived from new plant varieties applies to foods produced using genome editing. FDA said it intends to begin updating its existing procedures for voluntary premarket consultations over the next two years. The agency long has maintained it does not have the legal authority to mandate such consultations. But it has used its “bully pulpit” to strongly encourage such dialogue by technology developers, and developers of transgenic engineered traits routinely have done so.
“FDA has evaluated the safety of food from more than 180 varieties of genetically engineered plants,” Gottlieb and Abram said in a joint statement. “The guidance will provide the clarification necessary to help small- and medium-size firms understand their responsibilities under (FDA’s) regulatory framework so that they’re better able to navigate the regulatory pathway toward bringing safe, innovative plant biotechnology products to market.
“We believe our actions in plant biotechnology regulation will further establish FDA as a global leader in the regulation of plant biotechnology products, while also positioning (the agency) to set the standard in discussions with our international partners regarding appropriate oversight of plant biotechnology food products,” Gottlieb and Abram said.
Animal Biotechnology: FDA also signaled its intent in 2019 to publish new guidance to “clarify” its approach to regulating intentional genomic alterations in animals, including through genome editing. FDA said such a regulatory approach would be characterized by risk-based categories that include: 1) an FDA decision not to enforce approval requirements with no prior review; 2) an FDA decision not to enforce approval requirements following a review of data that address specific risk questions; and 3) an FDA decision to review for approval with data requirements proportionate to the risk associated with the particular product. “This regulatory approach includes flexibility to transfer products across these categories based on specific conditions as we gain familiarity with different product risk profiles,” FDA said.
FDA also said it plans to issue a second, complementary draft guidance document “to clarify its regulatory approach for categories of intentionally genetically altered animals used in research,” as well as to articulate a risk-based approach for when it intends to utilize enforcement discretion or, conversely, enforce its current requirement that the technology developer submit a new animal drug application. “Such clarification will enhance regulatory predictability for developers,” the agency said. FDA currently regulates the use of animal biotechnology as animal drugs because of its ability to alter the structure and function of the animal (which is a key element of the agency’s definition of a drug).
Regarding animal biotechnology, FDA also said it intends to list on its website the specific animals or animal categories for which genome alterations have been made and for which FDA has issued risk-based determinations to exercise its enforcement discretion not to require premarket approvals.
The agency also outlined these other initiatives it plans to pursue in the coming year:
- Strengthened Outreach and Communication: Engagement with domestic and international partners, as well as the U.S. Department of Agriculture and the Environmental Protection Agency, on oversight of genome-edited plant and animal products. “The FDA will also support international regulatory alignment on risk-based genome-editing policies and provide leadership in international forums,” the plan said.
- Pilot Program on Veterinary Products: A “Veterinary Innovation Program” – a pilot program to offer technical and program assistance to developers of certain innovative veterinary products, including animal biotechnology. The pilot program is to include a set of tools to guide sponsors through the regulatory process; options to develop alternative strategies for generating necessary evidence; pre-submission reviews of data packages; and cross-disciplinary and coordinated FDA review.
- Webinar on Animal Genome Editing: A Dec. 3 webinar on FDA’s regulatory approach for genome editing in animals. FDA said the webinar is an initial step in FDA’s public communication strategy to help innovators understand how FDA regulatory oversight applies to their products.
NGFA’s Crop Technology Committee (formerly Biotechnology Committee) met with FDA officials on Oct. 11, prior to the most recent announcement, and will be deeply involved as the NGFA develops and provides feedback to the agency on its new plan and guidance documents. NGFA’s primary focus will be on the new plan and guidance documents’ potential impact on the marketability of U.S. grains, oilseeds, processed commodities and animal proteins in domestic and international markets, and the importance of retaining consumer confidence in the safety of the U.S. food and feed supply.