2019 ASHS Annual Conference

The Federal government has a coordinated, risk-based system to ensure that new biotechnology products are safe for the environment and human and animal health. Established as a formal policy in 1986, the Coordinated Framework for Regulation of Biotechnology describes the Federal system for evaluating products developed using modern biotechnology. The Coordinated Framework is based upon existing laws designed to protect public health and the environment. The U.S. government has written regulations, policies, and guidance to apply these laws to biotechnology-derived products.

The U.S. Government agencies responsible for oversight of the products of agricultural modern biotechnology are the USDA's Animal and Plant Health Inspection Service (USDA-APHIS), the U.S. Environmental Protection Agency (EPA), and the Department of Health and Human Services' Food and Drug Administration (FDA). Depending on its characteristics, a product may be subject to the jurisdiction of one or more of these agencies. Regulatory officials from the three agencies regularly communicate and exchange information to ensure that any safety or regulatory issues that may arise are appropriately resolved.

USDA first issued biotech regulations based on its statutory authority in 1986 and has only made modest revisions since. Major revisions were proposed in 2008 and 2017, however APHIS withdrew both rules in response to public comments and to reengage in a fresh dialogue with stakeholders on the regulation of biotechnology. Work is underway for a third proposed rule that optimistically will be published sometime in 2019.