In recognition of National Biotechnology Month, the U.S. Environmental Protection Agency (EPA), the U.S. Department of Agriculture (USDA), and the Food and Drug Administration (FDA) have launched a unified website that provides a one-stop-shop for information about the actions the federal government is taking to oversee the development of agricultural biotechnology products. This new website is a key accomplishment under President Trump’s Executive Order on Modernizing the Regulatory Framework for Agricultural Biotechnology Products.

EPA

“This new website will help provide regulatory certainty and clarity to our nations farmers and producers by bringing together information on the full suite of actions the Trump Administration is taking to safely reduce unnecessary regulations and break down barriers for these biotechnology products in the marketplace,” said EPA Administrator Andrew Wheeler. 

USDA

“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 USDA Secretary 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…”

FDA

“At the FDA, we are committed to fostering flexible, risk-based approaches in this field while upholding our mission of protecting and promoting both human and animal health and animal well-being, for example by reducing their susceptibility to diseases like novel influenzas and resistance to zoonotic or foreign animal diseases. Our approach balances our internationally respected, science-based review standards with our ongoing risk-based regulatory approaches to ensure the safety of our food supply,” said FDA Commissioner Stephen Hahn, M.D. 

The unified website for biotechnology regulation describes the federal review process for certain biotechnology products and allows users to submit questions to the three agencies. The goals of the website are to provide enhanced customer service to innovators and developers, while ensuring Americans continue to enjoy the safest and most affordable food supply in the world and can learn more about the safe use of biotechnology products.

Background

EPA regulates the sale, distribution, use and testing of pesticides to protect public health and the environment. Under the Federal Insecticide, Fungicide and Rodenticide Act, EPA regulates pesticides. Under section 408 of the Federal Food, Drug and Cosmetic Act, EPA establishes the amount of pesticide chemical residues that may be present in food. Under the Toxic Substances Control Act and regulations implementing that statute, EPA currently regulates biotechnology products that are new microorganisms not specifically excluded by the statute (generally those regulated by other statutes). EPA is also actively working through the regulatory process to use its existing statutory authority, as appropriate, to exempt low-risk products of agricultural biotechnology from undue regulation to the extent consistent with the law, as directed under President Trump’s Executive Order. 

For more information: https://www.epa.gov/regulation-biotechnology-under-tsca-and-fifra