About the Coordinated Framework

hand holding a plant

History of the Coordinated Framework
In 1986, the White House Office of Science and Technology Policy (OSTP) published the U.S. Coordinated Framework for the Regulation of Biotechnology, describing the comprehensive federal regulatory policy for ensuring the safety of biotechnology products. The framework sought to protect health and the environment without impeding innovation.

In 1992, OSTP issued an update to the framework that set forth a risk-based, scientifically sound basis for the oversight of biotechnology products introduced into the environment or used for human or animal food. The update affirmed that federal oversight should focus on the characteristics of the product and the environment into which it is being introduced, not the process by which the product is created. A more recent update in 2017 is described in more detail below.

Each of the relevant federal regulatory agencies implements its authority under existing laws, resulting in the federal regulatory system assessing and managing health and environmental risks of biotechnology products.

Regulation Under the Coordinated Framework
The three primary agencies with responsibilities for regulation of biotechnology products are the U.S. Environmental Protection Agency (EPA), U.S. Food and Drug Administration (FDA), and U.S. Department of Agriculture (USDA).

Under the framework, these agencies aim to cover the full range of plants, animals and microorganisms derived from biotechnology in an integrated and coordinated manner. Each agency has regulatory programs to achieve the health and environmental protection goals derived from their own statutory authorities (Table 1).

The framework is based on laws governing the regulation of products and their uses. In providing oversight, the agencies employ a rational, scientific evaluation of products. Each agency has developed its own agency-specific regulations or policy documents to establish its regulatory approach to biotechnology products. Below is a general overview of agency responsibilities and links to agency websites.


EPA is responsible for protecting human health and the environment. Under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), EPA regulates pesticides. Under section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA), EPA establishes the amount of pesticide chemical residues that may be present in food. Under the Toxic Substances Control Act (TSCA) and regulations implementing that statute, EPA currently regulates biotechnology products that are new microorganisms not specifically excluded by the statute (generally those regulated by other statutes).


FDA is responsible for protection and promotion of public health. It regulates under laws including the Food, Drug, and Cosmetic Act (FFDCA), and the Public Health Service Act (PHS), which together, among other things, govern the safety of most foods for humans and animals, including those produced using biotechnology; the safety and effectiveness of intentional genomic alterations in animals produced using biotechnology; and the safety and effectiveness of human and animal drugs and the safety, purity and potency of human biologics, including drugs and human biologics from plants and animals produced using biotechnology.


Within USDA, the Animal and Plant Health Inspection Service (APHIS) is responsible for protecting agriculture from pests and diseases. Under the Animal Health Protection Act (AHPA) and the Plant Protection Act (PPA), USDA regulates products of biotechnology that may pose a risk to agricultural plant and animal health. Under the Virus-Serum-Toxin Act (VSTA), USDA has regulatory oversight over products of biotechnology that are included in veterinary biologics, and ensures that veterinary biologics are pure, safe, potent and effective.

In addition, the Food Safety and Inspection Service (FSIS) is the public health agency in USDA that is responsible for ensuring that the United States’ commercial supply of meat, poultry, egg products, and fish of the Order Siluriformes is safe, wholesome, and correctly labeled. Under the Federal Meat Inspection Act (FMIA), Poultry Products Inspection Act (PPIA), and Egg Products Inspection Act (EPIA), FSIS inspects all meat, poultry, and processed egg products in interstate commerce. FSIS uses these authorities to regulate products under its jurisdiction, including those derived using genetic engineering.