The U.S. Environmental Protection Agency 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. 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.

This action – which will be available for public comment for 60 days - is pursuant to President Donald Trump’s 2019 Executive Order which called for EPA, the U.S. Department of Agriculture and Food and Drug Administration to work together to streamline regulatory policies around products of agriculture biotechnology.

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.

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.

The Biotechnology Innovation Organization (BIO) said the rule updates the regulatory treatment of PIPS that are developed using new technologies such as gene editing.

“While we are still reviewing the proposal, BIO applauds the Administration for its continuing efforts to modernize the regulatory framework for agricultural biotechnology products consistent with the Executive Order released last year,” said Clint Nesbitt, BIO’s Senior Director of Science and Regulatory Affairs for Food & Agriculture. “An efficient, risk-based regulatory system fosters innovation and paves the way for global solutions such as crops that require fewer chemical inputs and tolerate extreme weather.”  

The proposed rule released by EPA represents an approach that started with development of the National Bioeconomy Blueprint in 2012. In the eight years since, both the Obama and Trump Administrations have initiated regulatory improvements to maintain oversight while recognizing the economic, environmental, and societal benefits of biotechnology.

“BIO will be submitting comments and looks forward to engaging with the agency as it develops a final rule,” said Nesbitt. “We are also continuing our work with stakeholder partners to make sure that any regulatory reform is accompanied by tangible transparency measures that bolster public confidence.”

The American Soybean Assn. commended EPA for taking this critical step needed to enable innovation in agriculture.

“Innovations in plant breeding, like gene editing, hold immense promise to increase agricultural productivity and sustainability, and strengthen our rural economy,” said American Soybean Association President and soybean grower from Worthington, Minnesota, Bill Gordon. “Clarifying vision from the Environmental Protection Agency on its regulatory approach to these innovations will be essential in providing researchers, developers, growers, and other stakeholders with a greater expectation on what the market pathway will look like for these much-needed tools. ASA welcomes the publication of this proposed rule and looks forward to reviewing it and working with EPA in the days to come to achieve the best possible outcomes to support agricultural innovation.”

The American Seed Trade Assn. said it is reviewing the details of the proposed order. “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. 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. We look forward to providing comments on the proposal, and we remain 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,” said Andy LaVigne, ASTA president and CEO.

American Farm Bureau President Zippy Duvall added, "EPA’s proposed rule encouraging innovation in agriculture builds upon many of the actions of this administration that sets a regulatory framework for a bright future for agriculture. Building upon the President’s Executive Order on Biotechnology last year and USDA’s final SECURE rule earlier this year, we welcome the opportunity to provide input to EPA regarding its proposed PIP rule. Having the best tools and technologies will be critical for farmers to meet the challenges ahead for agriculture.”