June 23, 2019

New Executive Order streamlines ag biotechnology regulations

New Executive Order streamlines ag biotechnology regulations

On June 11, President Trump signed an executive order aimed at modernizing ag biotechnology regulations. The new “Executive Order on Modernizing the Regulatory Framework for Agricultural Biotechnology Products” was based on recommendations from the Administration's Rural Development Taskforce. It directs the U.S. Department of Agriculture, U.S. Food & Drug Administration, and U.S. Environmental Protection Agency to review and streamline their agricultural biotechnology regulatory systems.

The order specifically addresses genetically engineered animals used in production. The order separates animal used in agriculture from “animals, or the products thereof, developed for non- agricultural purposes, such as to produce pharmaceutical or industrial compounds.”

This distinction between agricultural and pharmaceutical uses for animals and animal products appears to help clarify an FDA approach that classified all products of "gene-editing" as pharmaceuticals. As many had pointed out, classifying food animals as pharmaceuticals would subject them to a lengthy and unnecessary animal drug regulatory evaluation.

“Harmonizing the regulations associated with gene editing in food species is imperative to allow both plant and animal breeders access to gene editing tools to introduce useful sustainability traits like disease resistance, climate adaptability, and food quality attributes into U.S. agricultural breeding programs,” wrote Dr. Alison L. Van Eenennaam, an animal scientist at the University of California, Davis, earlier this year.

The new executive order appears to be a step toward changing the FDA approach.

The order also emphasizes that decisions regarding biotechnology should be based on the scientific evidence available. To encourage adoption and acceptance of new technologies, the order encourages the USDA, FDA, and EPA to collaborate on regulations and public awareness programs.

One big project will be the “Unified Biotechnology Web-based Platform,” which the order directs the USDA, FDA, and EPA to work together to design a plan within 180 days. The platform, which would be funded by the USDA, would be a place for an ag-bio producer to submit a question and receive a single, coordinated agency response.

Already, the order has been welcomed by Secretary of Agriculture Sonny Perdue. It has also won praise from the Biotechnology Innovation Organization (BIO) and the National Pork Producers Council (NPPC).

“Today’s executive order paves the way for common sense regulation to keep America first in agriculture so that we remain the global leader in an economic sector that has offset the U.S. trade imbalance for decades and that is so critical for the prosperity of our rural communities,” said David Herring, NPPC president in a statement.