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.
Monsanto, based in Creve Coeur, Missouri, in the United States, is the leading producer of genetically engineered seed; it sells 90% of the world's GE seeds.
Legislation
See Farmer Assurance Provision. (This bill is commonly referred to as the “Monsanto Protection Act” by its critics.)
Lawsuits
Foundation on Economic Trends v. Heckler In 1983, environmental groups and protestors delayed the field tests of the genetically modified ice-minus strain of P. syringae with legal challenges.Rebecca Bratspies (2007) Some Thoughts on the American Approach to Regulating Genetically Modified Organisms. Kansas Journal of Law and Public Policy 16:393 Foundation on Economic Trends v. Heckler, 756 F.2d 143 (D.C. Cir. 1985).
Alliance for Bio-Integrity v. Shalala In this case, the plaintiff argued both for mandatory labeling on the basis of consumer demand, and that GMO foods should undergo the same testing requirements as food additives because they are "materially changed" and have potentially unidentified health risks. 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. The court gave deference to the FDA's process on all issues, leaving future plaintiffs little legal recourse to challenge the FDA's policy on GMO's.(pp. 755–756) Alliance for Bio-Integrity v Shalala, 116 F.Supp.2d 166 (D.D.C. 2000).
Diamond v. Chakrabarty
Diamond v. Chakrabarty, 447 U.S. 303 (1980), was a United States Supreme Court case dealing with whether genetically modified organisms can be patented.Supreme Court Decision on Justia The Court held that a living, man-made micro-organism is patentable subject matter as a "manufacture" or "composition of matter" within the meaning of the Patent Act of 1952. The fact that the organism sought to be patented is alive is no bar to patentability.
Revenue Seed sales Income from GMO crops Genetically modified soybeans are a big part of the US agricultural economy Genetically modified maize (there are also issues with cross-pollination)
Opposition Numerous organizations based in the U.S. oppose or have concerns about genetic engineering for various reasons. 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). Some of these groups have questioned whether the FDA is too close to companies that seek approval for their products.Emily Marden, Risk and Regulation: U.S. Regulatory Policy on Genetically Modified Food and Agriculture 44 B.C.L. Rev. 733 (2003). Quote: "By the late 1990s, public awareness of GM foods reached a critical level and a number of public interest groups emerged to focus on the issue. One of the early groups to focus on the issue was Mothers for Natural Law ("MFNL"), an Iowa-based organization that aimed to ban GM foods from the market....The Union of Concerned Scientists ("UCS"), an alliance of 50,000 citizens and scientists, has been another prominent voice on the issue.... As the pace of GM products entering the market increased in the 1990s, UCS became a vocal critic of what it saw as the agency’s collusion with industry and failure to fully take account of allergenicity and other safety issues."
Health concerns Although there have been no recorded instances of harm to human health due to the consumption of genetically engineered foods, there is concern over their impact on health. One of the largest food recalls in US history, was the Taco Bell GMO recall, where a Bt corn plant not approved for human consumption due its risk as an allergen, had contaminated food products like the tacos at Taco Bell, and a huge percentage of US's seed supply. No health problems were linked to Starlink corn,CDC, National Center for Environmental Health. Investigation of Human Health Effects Associated with Potential Exposure to Genetically Modified Corn: A Report to the U.S. Food and Drug Administration from the Centers for Disease Control and Prevention. Atlanta, GA: Centers for Disease Control and Prevention, 2001. and subsequent evaluations of the Bt trait determined that there is medium risk to human health.
Regulation
The USA is the largest commercial grower of genetically modified crops in the world. United States regulatory policy is governed by the Coordinated Framework for Regulation of Biotechnology.United States Regulatory Agencies Unified Biotechnology Website The United States is not a signatory to the Cartagena Protocol on Biosafety. For a genetically modified organism to be approved for release it is assessed by the USDA, the FDA and the EPA. USDA evaluates the plant's potential to become weeds, the FDA reviews plants that could enter or alter the food supply and the EPA regulates the genetically modified plants with pesticide properties. Most developed genetically modified plants are reviewed by at least two of the agencies, with many subject to all three. Final approval can still be denied by individual counties within each state. In 2004, Mendocino County, California became the first and only county to impose a ban on the "Propagation, Cultivation, Raising, and Growing of Genetically Modified Organisms", the measure passing with a 57% majority. (See Mendocino County GMO Ban)
U.S. Department of Agriculture The Biotechnology Regulatory Services program of the Animal and Plant Health Inspection Service (APHIS) agency within the USDA is concerned with protecting agriculture and the environment from potential pests under the Plant Protection Act of 2000 (part of the Agriculture Risk Protection Act) and the National Environmental Policy Act (NEPA). Each transgenic event is regulated separately as the transgene insertion locus varies even when using identical constructs and host genotypes. This could result in different expression patterns or could affect the function of other endogenous genes within the host. The USDA is responsible for approving field trials of GM plants under either the notification or permit procedures. 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). Most field trials are approved under the notification procedure. The permit procedure is much more elaborate and is required for all genetically engineered organisms that do not meet the notification requirements or any plant-made pharmaceuticals or plant-made industrial products.
APHIS officials are responsible for inspecting the field trials. At least one inspection is carried out for each state listed on a permit, while inspection of field trials authorized by notification is conducted based on the relative risk of each trial. 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 inspectors are satisfied that there are no regulatory concerns they issue a Notice of Compliance. 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. 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.
In 1993, the USDA proposal to remove regulatory oversight from GM organisms deemed environmentally benign was approved and four GM plants (Flavr Savr tomato, virus-resistant squash, bromoxynil-tolerant cotton and glyphosate-tolerant soybean) obtained non-regulatory status that year. Non-regulated status means that permits and notifications are no longer required for introductions of this organism. Applicants can petition APHIS for non-regulated status if the GM organism poses no more of a plant pest risk than an equivalent non-GM organism. APHIS will prepare at least two documents (an Environmental Assessment and a determination of non-regulatory status) under the NEPA while considering the application.
Four federal district court suits have been brought against APHIS challenging their regulation of GM plants. Two involved field trials (herbicide-tolerant turfgrass in Oregon; pharmaceutical-producing corn and sugar in Hawaii) and the other two were the deregulation of GM alfalfa and GM Sugar Beet. APHIS initially lost all four cases, with the judges ruling they failed to diligently follow the NEPA guidelines. However, the Supreme Court overturned the nationwide ban on GM alfalfaMonsanto et al v Geertson Seed Farms et al, Supreme Court of the United States, Decision no 09-475, June 21, 2010, Retrieved November 13, 2011 and an appeal court allowed the partial deregulation of GM sugar beet crops.United States Court of Appeals for the Ninth Circuit. No. 10-17719, D.C. No. 3:10-cv-04038-JSW Filed February 25, 2011, accessed March 14, 2013 After APHIS prepared Environmental Impact Statements for both crops they were deregulated again.Staff (August 7, 2012) Roundup Ready® Sugar Beet News USDA Animal and Plant Health Inspection Service, Biotechnology, Retrieved November 5, 2012USDA - Roundup Ready® Alfalfa Environmental Impact Statement (EIS) , United States Department of Agriculture, December 2010. Retrieved November 5, 2012
Food and Drug Administration The FDA is responsible for the safety and security of human and animal food and drugs, including any that are genetically modified. The FDA was responsible for approving the first commercialized GMO, Genetech's genetically modified human insulin (Humulin) in 1982 and the first commercialized GM whole food, Calgene's Flavr Savr tomato in 1994. 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. Food and feed that is identical or nearly identical in composition to current products is deemed to be substantially equivalent and is not required to undergo review by the FDA. The FDA has been criticized for using substantial equivalence, with a major accusation being that FDA review is essentially voluntary as almost all GM products are substantially equivalent. However, all GM food and feed currently on the US market (as of 2008) have undergone a FDA consultation, where the developer submits the compositional data and FDA scientist compare it to regular food and feed.