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FDA Issues Request for Comment on Genome Editing in Plants

NEW YORK (GenomeWeb) – The US Food and Drug Administration has sent out a request for comment on the use of genome editing technology to produce plants used to feed both humans and animals.

In a document published Jan. 19 with the Federal Register, the FDA released several questions, chiefly about potential food safety risks and comparison of those risks with other "plant development methods" like hybridization or radiation-induced mutagenesis. The agency is also requesting comment on whether genome editing can be a shortcut to modifications that could also be achieved through traditional breeding, whether it requires separate regulation mechanisms, and how to better interface with smaller firms interested in genome editing in plants.

The announcement comes on the heels of an FDA Voice blog post co-authored by outgoing Commissioner Robert Califf, sketching out the agency's views on regulating genome-edited foods and therapeutic products. In the case of animals used as food, FDA said it would consider the modified portion of the genome to be a drug, but it hasn’t commented yet on how it plans to regulate foods from plants.

The FDA also noted that it continues to consult with developers of genetically engineered plants. "In addition to the information we anticipate gathering from developers in the course of consultations, we recognize that developers, researchers, and other stakeholders may have valuable factual information and data about foods derived from new plant varieties produced using genome editing, which can help inform FDA's thinking of these specific products," the agency said.

According to the agency, this latest request for comment is in keeping with its plan to clarify regulation of genome-edited products, as stated in the White House Office of Science and Technology Policy's "National Strategy for Modernizing the Regulatory System for Biotechnology Products," published Sept. 16, 2016. The FDA added that it intends to follow the principles set forth in the "2017 Update to the Coordinated Framework for the Regulation of Biotechnology."

However, while both documents are available under the Obama White House webpage archives, neither is available under the new Trump Administration White House website. The Office of Science and Technology Policy is a congressionally-established entity, but President Donald Trump has yet to nominate a director for the office.

Comments to the FDA can be submitted electronically or in writing until April 19, 2017.