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The New Biotechnology Regulatory Regime

A review of the U.S. agricultural biotechnology regulatory review process by the U.S. Department of Agriculture (USDA), the U.S. Environmental Protection Agency (EPA) and the U.S. Food and Drug Administration (FDA) has the potential to impact biotechnology research work and the end-uses of that work, as well as the landscape of international trade. 

The potential challenges and opportunities generated by reviewing and updating that regulatory process, which President Trump set in motion with an Executive Order on June 11, were examined at the Farm Foundation^® Forum on Tuesday, July 23, 2019, at the National Press Club, Washington, D.C. Panelists for this discussion were:

• Fan-Li Chou, Ph.D., Biology Coordinator in the Office of Pest Management Policy at USDA;
• Mike Mendelsohn, Chief of the Emerging Technologies Branch of the Biopesticides and Pollution Prevention Division in the Office of Pesticide Programs at EPA;
• Laura Epstein, Senior Policy Analyst in the Center for Veterinary Medicine at FDA; and
• Stanley Abramson of Arent Fox LLP.

“This review and update has implications for both crop and livestock producers, as well as for public and private research organizations,” says Megan Provost, Farm Foundation Vice President of Policy and Programs. “This Forum explored what the short- and long-term impacts of a streamlined regulatory regime may be for the research process, crop and livestock producers, and the international trade environment.”

The Executive Order Modernizing the Regulatory Framework for Agricultural Biotechnology Products instructs the Secretary of the U.S. Department of Agriculture (USDA), the Administrator of the U.S. Environmental Protection Agency (EPA) and the Commissioner of the U.S. Food and Drug Administration (FDA) to examine regulatory changes that can help streamline the review process for agricultural biotechnology. This review of regulations and the creation of guidance documents is to be completed within six months. The order also calls for regulatory decisions to be science-based and consistent with legal and economic factors, and to involve the public in guidance and regulation development.

Farm Foundation organizes these public forums to engage all stakeholders in informed dialogue on food, agricultural and rural policies. Participants examine current policies, explore and analyze alternative policy options, and give voice to new proposals.