US EPA proposes to exempt certain plants with biotech traits from FIFRA regulations

In another effort to remove barriers to innovation, the U.S. Environmental Protection Agency (EPA) has proposed a rule that will streamline the regulation of certain plant-incorporated protectants (PIPs) that pose no risks of concern to humans or the environment.

This action - which will be available for public comment for 60 days - delivers on a key directive under President Trump's Executive Order on Modernizing the Regulatory Framework for Agricultural Biotechnology Products.

"This new rule will provide critical new tools for America's farmers as they work to increase agricultural productivity, improve the nutritional value and quality of crops, fight pests and diseases, and boost food safety," said EPA Administrator Andrew Wheeler. "Embracing this technology through a transparent, consistent and science-based process is long overdue, and will secure benefits to American agriculture well into the future."

"Agricultural biotechnology has been and will continue to be an essential tool in helping America's farmers and ranchers feed, fuel, and clothe the world," said U.S. Secretary of Agriculture Sonny Perdue.

"From producers to consumers, all Americans deserve a government that delivers science-based, common-sense regulations that foster innovation, conserve resources, and protect public health-especially when it comes to the food supply. President Trump is committed to harmonizing our regulatory framework for agricultural biotechnology in order to equip our farmers with the tools they need to produce the world's safest, most abundant, and most affordable food supply," said Perdue.

Specifically, EPA is proposing exemptions 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's proposed exemptions for PIPs created through biotechnology seek to facilitate the development of new tools for American farmers to protect their crops and control agricultural pests. By reducing antiquated regulations that restrict access to the market for biotechnology products, science-based innovations to agriculture will become far more accessible to American farmers. These improvements will have the potential to increase America's food supply.

PIPs are pesticidal substances produced by plants and the genetic material necessary for the plant to produce the pesticidal substance. The existing regulatory exemption for PIPs is limited to those created through conventional breeding. The proposed exemption would allow for PIPs created through biotechnology to also be exempt from existing regulations if they 1) pose no greater risk than PIPs that meet EPA safety requirements, and 2) could have been created through conventional breeding.

Under the proposed exemption, 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.