WASHINGTON, Sept. 21, 2016 - A White House plan for updating federal regulation of agricultural biotechnology calls for the FDA and EPA to clarify how they will treat products of gene editing. The 19-page plan also says that federal agencies are working to better coordinate in the regulation of genetically engineered mosquitoes and other insects.

The White House announced in July 2015 that it planned to overhaul the federal regulatory system for biotechnology that is largely unchanged since it was first developed under the Reagan administration three decades ago.

The update comes as scientists are increasingly using techniques of genome editing, such as CRISPR-Cas9, to alter crops and food animals rather than moving genes between species. Many in the industry want gene-edited products excluded from federal regulation, smoothing and accelerating their path to market.

USDA’s Biotechnology Regulatory Services already is undertaking an overhaul of its regulatory process and has been considering a sweeping definition of biotechnology that includes gene editing. A proposed rule is expected to move to the Office of Management and Budget for review.

The White House document said FDA’s plan will include clarifying what will be needed for gene-edited animals to comply with “applicable statutory and regulatory requirements.”

FDA also will consider updating its industry guidance for voluntary pre-market consultation. Companies aren’t required to get FDA’s approval for new genetically engineered crop traits but routinely do so on a voluntary basis.

The plan is intended to ensure the government can efficiently assess any risks of new biotech products “supporting innovation, protecting health and the environment, promoting public confidence in the regulatory process, increasing transparency and predictability, and reducing unnecessary costs and burdens,” the document said.

EPA, FDA and USDA are expected to lay out how each will divide up their responsibilities for regulating biotech insects.

As an example, the plan said, EPA would use its authority under the Federal Insecticide, Fungicide and Rodenticide Act to regulate genetically engineered mosquitos when the developer claims they would control population levels. FDA could regulate the mosquitoes under the Food, Drug and Cosmetic Act if the developer claims they would prevent disease such as the Zika virus.

Greg Jaffe, who directs biotechnology policy for the Center for Science in the Public Interest, welcomed the agencies’ commitment to clarifying how they will regulate gene editing and to coordinating their handling of gene-altered insects, but he said FDA needs to seek statutory authority to require pre-market safety reviews of new products.

The Biotechnology Innovation Organization says it is reviewing the plan. “BIO commends the White House for undertaking this effort and for recognizing that coordination between the agencies that oversee the approval of biotech products must be a priority to ensure public confidence in the regulatory system and prevent unnecessary barriers to future innovation and competitiveness, while continuing to protect health and the environment.”


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