EPA Publishes Proposed Rule on Plant Breeding Innovation Policy

On Tuesday, September 1, the U.S. Environmental Protection Agency (EPA) announced a proposed rule “to streamline the regulation of certain plant-incorporated protectants (PIPs) that pose no risks of concern to humans or the environment.” The proposed rule will be available for public comment for 60 days. The action is pursuant to President Trump’s 2019 Executive Order which called for EPA, USDA and FDA to work together to streamline regulatory policies around products of agriculture biotechnology.

ASTA appreciates the work of EPA in taking this important step to provide clarity and work towards cross-agency alignment around plant breeding innovation policies. Through its committee and working group process, ASTA will review the proposed rule and provide comments on the proposal. The association remains committed to continuing to work closely with the administration, industry and the broader public and private plant breeding community to ensure commercial viability and widespread access by producers to the latest plant breeding tools, both here and around the globe.

Under the proposal, EPA is calling for an exemption under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) and the Federal Food, Drug and Cosmetic Act (FFDCA) for certain PIPs created through biotechnology. The Agency has preliminarily determined that these substances meeting the exemption criteria have no risks of concern to humans or the environment. EPA would require developers of PIPs to submit either a self-determination letter or a request for EPA confirmation that their PIP meets the criteria for exemption; a developer could also submit both.

“Over the history of plant breeding, breeders have reliably integrated evolving techniques with long-established practices to safely and effectively meet the changing needs of farmers, consumers, and the environment,” said ASTA President & CEO Andy LaVigne. “Today, we face unprecedented challenges that threaten the future of our planet and food supply; and it’s more critical than ever that U.S. farmers have access to the latest innovations, like gene editing, to keep pace with the challenges of today and the future.”

For more information, visit the EPA website.