APHIS seeks comments on biotech regulation

Agency begins work to identify reasonable alternatives in evaluating EIS and redefining term biotechnology.

The U.S. Department of Agriculture published a notice of intent in the Federal Register indicating plans to prepare an environmental impact statement (EIS) on the introduction of biotechnology products. The goal of the notice is to identify “reasonable alternatives and potential issues to be evaluated in the environmental impact statement” as well as to redefine the term “biotechnology.”

This is the first step in beginning USDA’s overhaul of its biotech regulations, since its current processes were developed more than 30 years ago. USDA’s Animal & Plant Health Inspection Service (APHIS) hopes to accelerate the development of new crop traits considered to be of little risk to the environment as well as determine regulatory requirements for specific new breeding techniques, such as gene editing.

New breeding techniques are valuable to breeders as the technology continues to advance, especially to public breeders of wheat who are excited to incorporate the technology into their respective programs. These techniques vastly differ from biotechnology as currently defined, which adheres to strict regulation and serves as one tool of many for a breeder to use when overcoming challenges related to plant pests and nutritional improvements for the consumer.

The USDA notice of intent specifies broadly a process of analyzing new crop traits and determining which class of traits would be subject to regulation. APHIS has asked for public comments to “further define the scope of the alternatives and environmental impacts and issues for APHIS to consider.”

Click here for the Feb. 5, 2016, Federal Register notice. Public comments are due March 7, 2016. APHIS said it will thoroughly review and consider all public input submitted during the 30-day comment period on the notice and use the information as it works to complete and then publish the draft programmatic EIS and the draft proposed rule later this year.

APHIS also announced the dates for two additional public sessions to discuss the President’s memorandum directing a review of the regulatory framework for biotech products by USDA, the Environmental Protection Agency and the Food & Drug Administration.

The second public meeting will be March 9 in Dallas, Texas, and the third will be March 30 in Davis, Cal.

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