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Regulatory Agencies Launch Unified Website for Biotechnology Regulation

In a coordinated effort, the Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), and the Environmental Protection Agency (EPA) launched a Unified Website for Biotechnology Regulation on January 9, 2020. The website serves to streamline information regarding agriculture biotechnology products, which are regulated by FDA, USDA, and EPA. The implementation of the website is in response to the June 2019 Executive Order issued by President Donald Trump on Modernizing the Regulatory Framework for Agricultural Biotechnology Products. The Unified Website for Biotechnology Regulation complements prior joint actions such as the Coordinated Framework for the Regulation of Biotechnology, an Obama administration effort to reform the biotechnology regulatory process by enhancing transparency, predictability, and efficacy. Mintz has previously covered these coordinated efforts here.   

Agriculture biotechnology products are products created through genetic engineering of plants, animals, and microbes. Each agency has a role in regulating biotechnology products: USDA has authority to approve all releases of genetically modified organisms (GMOs) to ensure they do not create an environmental hazard; EPA must approve all crops that contain insect-killing genes; and FDA is responsible for evaluating whether GMOs are safe to eat. However, because of the interrelatedness of this area, agency regulatory oversight can be disjointed and unclear. Additionally, the advancement of technology can cause confusion in interpreting the regulatory requirements of each agency. Therefore, a primary goal of the website is to enhance customer service by allowing users to submit questions directly to the three agencies, as well as through providing a Frequently Asked Questions page.

The Unified Website for Biotechnology Regulation does not alter the regulatory process concerning agriculture biotechnology products. Instead, the website acts as an interactive archive containing information about the federal review process, while also enabling users to submit questions to the regulatory agencies with the expectation of a coordinated response. According to the FDA Press Release, "[t]he goals of this 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 innovations.”

The website launch follows the October 2018 FDA announcement for its Plant and Animal Biotechnology Action Plan, which provides a risk-based regulatory approach to the oversight of plant and animal-derived products of biotechnology, with a focus on safety and effectiveness. One of the action plan's priorities is to coordinate a new biotechnology approach with EPA and USDA to clarify oversight of genome-edited products. According to FDA Commissioner Stephen Hahn, M.D.: “This is a time of unprecedented scientific innovation. Agricultural biotechnology promises to bring dynamic new products to the marketplace . . . 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.”

While the Unified Website for Biotechnology Regulation is a step towards meeting the goals set in the June 2019 Executive Order, additional efforts are needed to better coordinate biotechnology product regulation as technology continues to advance.

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About this Author

Elizabeth K. Conti Associate Mintz DC FDA Regulatory Health Care Enforcement & Investigations Health Care Compliance, Fraud & Abuse, and Regulatory Counseling Consumer Product Safety
Associate

Elizabeth focuses her practice on regulatory compliance and enforcement defense matters for companies in the pharmaceuticals, medical device, dietary supplement, cosmetics, and food industries as well as pharmacies and distributors.

She advises clients on FDA regulations related to labeling, advertising, importing and exporting, and manufacturing practices. Her practice also encompasses administrative matters and civil litigation related to DEA requirements. On the enforcement defense side of her practice, Elizabeth counsels clients on fraud and abuse compliance and litigation...

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