EPA, USDA and FDA launch one-stop shop for regulatory actions on agricultural biotechnology products.

January 9, 2020

3 Min Read
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The U.S. Environmental Protection Agency, the U.S. Department of Agriculture and the Food & Drug Administration 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.

In a joint statement, the agencies stated that this new website, launched in recognition of National Biotechnology Month, is a key accomplishment under President Donald Trump’s Executive Order on Modernizing the Regulatory Framework for Agricultural Biotechnology Products.

The Unified Website for Biotechnology Regulation describes the federal review process for certain biotech 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 that Americans continue to enjoy the safest and most affordable food supply in the world and can learn more about the safe use of biotech products, the agencies noted.

“EPA is pleased to be working with our partners at USDA, FDA and across the federal government to implement President Trump’s executive order and launch this new coordinated website,” EPA Administrator Andrew Wheeler said. “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.”

Related:USDA proposes rule to modernize biotech regulations

Agriculture Secretary Perdue added, “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. From producers to consumers, all Americans deserve a government that delivers science-based, commonsense regulations that foster innovation, conserve resources and protect public health, especially when it comes to the food supply. The launch of this unified biotechnology regulation website is proof of President Trump’s commitment to provide the American people with sensible regulations in a clear and transparent manner.”

“This is a time of unprecedented scientific innovation. Agricultural biotechnology promises to bring dynamic new products to the marketplace,” FDA Commissioner Dr. Stephen Hahn said. “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.”

Related:G20 ag ministers commit to biotech sound science

EPA regulates the sale, distribution, use and testing of pesticides to protect public health and the environment. EPA regulates pesticides under the Federal Insecticide, Fungicide & Rodenticide Act. EPA establishes the amount of pesticide chemical residues that may be present in food under Section 408 of the Federal Food, Drug & Cosmetic Act.

Under the Toxic Substances Control Act and regulations implementing that statute, EPA currently regulates biotech 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 Trump’s executive order.

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