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Coordinated Framework for the Regulation of Biotechnology in the U.S. to be Updated

July 23, 2015

The White House recently called on the Food and Drug Administration (FDA), the Environmental Protection Agency (EPA), and U.S. Department of Agriculture (USDA) to update the "Coordinated Framework for the Regulation of Biotechnology" (Coordinated Framework). In a July 2 memorandum to the heads of the these agencies, the White House noted that the existing regulatory framework for biotechnology products, last revised in 1992, has created "unnecessary costs and burdens associated with uncertainty about agency jurisdiction, lack of predictability of timeframes for review, and other processes…."

The Coordinated Framework explains the roles played by the three major agencies involved in the regulation of biotechnology products (which are defined as products developed through genetic engineering). FDA regulates genetically modified organisms (GMOs) under the Federal Food, Drug, and Cosmetic Act and ensures the safety and proper labeling of GMO-derived foods and feed. EPA regulates plant-incorporated protectants—a type of pesticide that is bioengineered into crops—under the Federal Insecticide, Fungicide, and Rodenticide Act and sets tolerance limits or exemptions from tolerance for pesticide residues on or in food and animal feed. EPA also regulates certain biological control organisms under the Toxic Substances Control Act. USDA's Animal and Plant Health Inspection Service regulates GMOs under the Plant Pest Act. APHIS reviews GM crops to determine whether they meet the definition of a "plant pest" and may pose risks to domestic agriculture.

The White House Memo on the Coordinated Framework lists three objectives to be accomplished in the first year of the update process:

  1. Development of an updated CF to clarify the roles and responsibilities of the agencies that regulate the products of biotechnology;
  2. Formulation of a long-term strategy to ensure that the Federal regulatory system is equipped to efficiently assess the risks, if any, associated with future products of biotechnology while supporting innovation, protecting health and the environment, promoting public confidence in the regulatory process, increasing transparency and predictability, and reducing unnecessary costs and burdens; and
  3. Commissioning an external, independent analysis of the future landscape of biotechnology products.