Genetically modified organisms: US regulatory and advisory bodies 19/7/02. By Deirdre Janson-Smith The US Agencies primarily responsible for regulating the development and exploitation of genetically modified organisms are the Animal and Plant Health Inspection Service (APHIS), the Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA).

These three agencies share responsibility for regulating agricultural biotechnology. APHIS oversees field trials and issues licenses to grow GM crops. EPA has responsibility for ensuring the human and environmental safety of genetically modified organisms with pesticidal or pesticide tolerant properties. FDA oversees the testing and licensing of genetically modified organism products for sale, to ensure their safety.

Most products are licensed as 'biological products' under the Public Health Service Act, but some are approved as 'new drugs' under the Federal Food, Drug and Cosmetic Act (for example, drugs produced by transgenic animals).

The Animal and Plant Health Inspection Service (APHIS)

Within the US Department of Agriculture, APHIS regulates all field trials of genetically engineered plants, and some microbes, and licenses their commercial growth and sale. APHIS also approves and licenses veterinary biological substances, including animal vaccines, produced by biotechnology.

Any scientist wishing to field test or move a biotechnology-derived plant must get APHIS approval first. And its officials can inspect field test sites at any time. APHIS is required to evaluate the possible environmental impacts of the genetically modified organism, including its likely impact on endangered or threatened species (working with FPA).

The Food and Drug Administration (FDA)

Within the Department of Health and Human Service, FDA regulates all foods and feed that comes from new plant varieties. Its policy follows existing food law – genetically engineered foods must meet the same safety standards required of all other foods. This covers transgenic animals as well as plants.

Any genetically engineered substance added to food is treated as a food additive if it is significantly different in structure, function or amount from substances currently found in food. FDA also requires testing and labelling of any product that significantly alters a food's nutritional value, or uses material from a known allergen (peanut, for example).

The FDA Center for Biologics Evaluation and Research (CBER) is responsible for approving all 'biologics' (substances produced from living things rather than by chemical synthesis) for human use. This includes pharmaceutical substances produced by transgenic animals.

The Environmental Protection Agency (EPA)

EPA is responsible for regulating pesticidal substances produced through biotechnology, and also pesticide resistant plants. It works with APHIS to oversees the large scale testing of both, and with FDA on the safety to humans of the plants or their products. EPA must assess the risks to human safety and the fate of the substance in the environment, including effects on 'non-target' species. EPA also sets 'safe' environmental exposure levels and allowable food residue tolerance levels for any novel pesticides.

Image credit: Guy Tear