The United States is the largest grower of commercial crops that have been genetically engineered in the world, but not without domestic and international opposition.
[2][3][4]) In 1983, environmental groups and protestors delayed the field tests of the genetically modified ice-minus strain of P. syringae with legal challenges.
The plaintiff also alleged that the FDA did not follow the Administrative Procedures Act in formulating and disseminating its policy on GMO's.
The federal district court rejected all of those arguments and found that the FDA's determination that GMO's are generally recognized as safe was neither arbitrary nor capricious.
Diamond v. Chakrabarty, 447 U.S. 303 (1980), was a United States Supreme Court case dealing with whether genetically modified organisms can be patented.
Groups such as the Center for Food Safety, the nonprofit science advocacy group Union of Concerned Scientists, Greenpeace and the World Wildlife Fund have expressed concerns about the FDA's lack of a requirement for additional testing for GMO's, lack of required labeling and the presumption that GMO's are "generally recognized as safe" (GRAS).
[14] The notification procedure is a streamlined process for the simplest or most familiar genetically engineered plants that meet six criteria (is not a noxious weed, the function of the genetic material is known and characterized, stable integration, no significant risk of creating new viruses and that no animal or human pathogen sequences are present).
[18] For field trials of organisms that contain pharmaceutical or industrial compounds, inspections are carried out more frequently (five times during establishment and twice yearly after that).
If the regulations are not being adhered to the inspectors will issue a Notice of Non-Compliance requesting that the deviations be fixed, or for more serious breaches a warning letter requiring a written response and corrective action to be taken within a given time frame.
[18] Formal investigations are carried out on developers who may not be adhering to regulations, permit conditions, or other requirements, which can result in civil penalties or criminal charges.
[19] APHIS will prepare at least two documents (an Environmental Assessment and a determination of non-regulatory status) under the NEPA while considering the application.
[14] APHIS initially lost all four cases, with the judges ruling they failed to diligently follow the NEPA guidelines.
[22][23] The FDA is responsible for the safety and security of human and animal food and drugs, including any that are genetically modified.
When evaluating new GM foods or feed the FDA looks for the presence of any new or altered allergens and toxicants and examines changes in the levels of nutritional and anti-nutritional substances.
As of 2007, the FDA has not identified any genetically modified foods with unexpected changes in the nutrient composition or levels of allergens or toxic substances.
Pioneer Hi-Bred inserted a gene from the Brazil nut into transgenic soybean resulting in soy with an enhanced nutritional profile.
[29] The FDA also has extra guidelines that apply to genetically modified animals that will be used in the manufacturing and testing of therapeutic products and xenotransplantation.
[29] The FDA guidance documents do not establish legally binding laws and are viewed as recommendations, unless specific regulatory or statutory requirements are cited.