The U.S. food regulatory system enjoys a high degree of public confidence as a result of rigorous scientific reviews within a decision-making framework entirely open to public participation. This approach to regulation provides full access to documents on which decisions are based and is carried out completely in the public eye as required by law.

Biotechnology products in the United States are regulated according to a system put in place by the White House Office of Science and Technology Policy in 1986. Deriving its mandate from existing laws to regulate the safety of food and agriculture, it assigns lead responsibility for biotechnology products to the appropriate regulatory agency, and sets out principles for coordinated and cooperative reviews in areas where responsibilities or authorities adjoin or overlap.

Within the U.S. Department of Agriculture, the Animal and Plant Health Inspection Service (APHIS) governs the field testing of agricultural biotechnology crops. A petition for non-regulated status must be granted by USDA-APHIS prior to commercial growth and sale of any genetically modified crop.

The Environmental Protection Agency (EPA) has regulatory authority for insect-protected crops because they produce their own protection against pests. EPA regulates environmental exposure to these crops to ensure there are no adverse effects to the environment or any beneficial, nontargeted insects and other organisms.

Foods developed through biotechnology face the same regulatory requirements the U.S. Food and Drug Administration uses to safeguard all foods in the marketplace under the Federal Food Drug and Cosmetic Act. They are judged on their individual safety and nutrition, not the methods used to produce them.

The FDA may require that genetic modifications that significantly alter the nutritional value of a food using genetic material from outside the traditional food supply or use known allergens be subject to strict pre-market testing and regulatory oversight.
The FDA also requires that any genetically modified food product that significantly alters a food's nutritional value or uses material from a known allergen be clearly labeled. For example, any product that used a gene from a peanut, which is a potential allergen, would be subject to testing and labeling requirements.

The FDA also has the authority to order unsafe products off the market. Legal responsibility rests squarely with the food company to ensure the safety of any product it places into commerce.

According to the FDA's own "Q&A" on biotechnology:

"We are confident that food derived from plants developed by new biotechnology will be just as safe as those produced by traditional biotechnology."