July 22, 2019

July 19, 2019

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President Trump Issues Executive Order to Streamline Regulation of Genetically Modified Food

On June 11, President Trump issued an Executive Order Modernizing the Regulatory Framework for Agricultural Biotechnology Products.  The purpose of the Executive Order (EO) is to employ a science-based regulatory system that evaluates products based on human health and safety and potential benefits and risks to the environment with an ultimate goal of facilitating innovation, ensuring coordination across regulatory agencies (the United States Department of Agriculture (USDA), Food and Drug Administration (FDA), and Environmental Protection Agency (EPA)), and fostering public confidence in the oversight of such products.

Six specific policy objectives are listed, with additional elaboration on each:

  • Base regulatory decisions on science and, as appropriate and consistent with law, economic factors;
  • Review applications for products of agricultural biotechnology quickly and efficiently;
  • Ensure transparency, predictability, and consistency in the regulation of products;
  • Involve the public in guidance and regulation development;
  • Use a risk-based decision-making process; and
  • Promote a science- and risk-based regulatory approach with trade partners.

The heads of USDA and the Department of Health and Human Services (HHS; the Department in which FDA sits) have issued press releases regarding the EO.  Both Agencies applauded the EO and both indicated that currently ongoing efforts at each Agency would continue in support of the EO.  These ongoing efforts include FDA’s Plant and Animal Biotechnology Innovation Action Plan, Veterinary Innovation Program, and Plant Biotechnology Consultation Program and USDA’s non-regulation of plants that could otherwise have been developed through conventional breeding techniques (consistent with the Bioengineered Food Labeling Rule).

The EO’s push for streamlined regulation of genetically modified organisms can be contrasted with recent increases in regulation in Europe.

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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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