Genetically modified food in the United States

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Genetic engineering in the United States
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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.[1]

Legislation

See Farmer Assurance Provision. (This bill is commonly referred to as the “Monsanto Protection Act” by its critics.[2][3][4])

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.[5]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

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.[6][7](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.[8] 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

Opposition

Numerous organizations based in the U.S. oppose or have concerns about genetic engineering for various reasons. Groups such as the

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.[6]

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,[9] and subsequent evaluations of the Bt trait determined that there is medium risk to human health.[10]

Regulation

The USA is the largest commercial grower of genetically modified crops in the world.[11] United States regulatory policy is governed by the Coordinated Framework for Regulation of Biotechnology.[12] The United States is not a signatory to the Cartagena Protocol on Biosafety.[13] 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.[14] 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.[15] (See Mendocino County GMO Ban)

U.S. Department of Agriculture

The Biotechnology Regulatory Services program of the

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.[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 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.[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.

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.[14] 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.[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.

Four

Environmental Impact Statements for both crops they were deregulated again.[22][23]

Food and Drug Administration

The

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.[14] Food and feed that is identical or nearly identical in composition to current products is deemed to be substantially equivalent[24] and is not required to undergo review by the FDA.[25] 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.[26] 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.[14][27]

The FDA consultation focuses on whether the new food or feed contains any new allergens or toxic substances and whether the nutritional components of the food or feed have increased or decreased.

allergic to Brazil nut the allergenic nature of the protein was discovered.[28] The development of the transgenic soybean expressing a Brazil nut allergen was stopped after these tests. The FDA consultation process is relatively (when compared to the other agencies regulating GM) informal and they do not approve new GM products. Instead they issue a memo stating whether the new food is the same as or different from the non-modified variety.[14]

The Center for Veterinary Medicine of the FDA regulates genetically modified animals in consultation with Centers at the FDA responsible for regulating pharmaceuticals or other medical products derived from biopharm animals.[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. Any relevant federal, State, or local laws and regulations must also be adhered to.[29]

Environmental Protection Agency

The

cisgenic), plants that used physical barriers to prevent the target pest from attaching itself, and plants expressing viral coat proteins to protect against virus infection.[14]
In 2001, rules regarding exemption of cisgenic plants had been finalised. The other two proposed exemptions were still under review in 2010.

The EPA evaluated each submission on a case-by-case basis. The EPA assesses data concerning the characterisation of the end-product of the engineered organism (presently all plants evaluated produce proteins), as well as data on mammalian toxicity, effects on non-target organisms and environmental metabolism.[14] For Bt products the producer must also supply an insect resistance management program. For herbicide resistant plants the EPA co-ordinates with the USDA and FDA, but does not regulate the plant itself. Instead it regulates the herbicide and its use on the new cultivar.[14] The EPA examines the construct used to transform the plant and the biology of recipient plant. The sequence of the resulting protein must be described, expression pattern and intencity verified and any modifications to the protein reported. The EPA considers the potential allergenicity of the product, issues surrounding gene flow into wild species, possible effects on non-target organisms, likelihood of it persisting in the environment and the potential for insect resistance developing when assessing submissions.[14]

See also

References

  1. ^ Feature story - March 7, 2008 (March 7, 2008). "New movie damns Monsanto's deadly sins | Greenpeace International". Greenpeace.org. Archived from the original on April 13, 2010. Retrieved February 1, 2012.{{cite web}}: CS1 maint: numeric names: authors list (link)
  2. ^ Godoy, M. (March 21, 2013). "Did Congress Just Give GMOs A Free Pass In The Courts?". NPR. Retrieved May 29, 2013.
  3. ^ Boerma, L. (March 28, 2013). "Critics slam Obama for "protecting" Monsanto". CBS News. Retrieved May 29, 2013.
  4. ^ "What's Next for the 'Monsanto Protection Act'?". Yahoo! News. April 4, 2013. Retrieved May 29, 2013.
  5. SSRN 1017832
  6. ^ a b 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."
  7. ^ "FDA and Regulation of GMOs". Archived from the original on September 29, 2016. Retrieved January 22, 2016.
  8. ^ Supreme Court Decision on Justia
  9. ^ 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.
  10. ^ "StarLink Corn: What Happened". Ccr.ucdavis.edu. Archived from the original on September 1, 2006. Retrieved February 1, 2012.
  11. ^ Clive James (2009). "ISAAA Brief 41-2009: Executive Summary: Global Status of Commercialized Biotech/GM Crops The first fourteen years, 1996 to 2009".
  12. ^ United States Regulatory Agencies Unified Biotechnology Website Archived November 17, 2012, at the Wayback Machine
  13. ^ "Restrictions on Genetically Modified Organisms". The Law Library of Congress, Global Legal Research Center. March 2014. Retrieved January 25, 2016.
  14. ^
    PMID 17956539
    .
  15. .
  16. ^ Plant Protection Act (PDF), June 20, 2000
  17. ^ "User Guide: Notification" (PDF). USDA-APHIS Biotechnology Regulatory Services. April 8, 2010. Archived from the original (PDF) on April 3, 2011.
  18. ^ a b Animal and Plant Health Inspection Service (June 2008). "Biotechnology Regulatory Services factsheet" (PDF). U.S. Department of Agriculture. Archived from the original (PDF) on November 9, 2011.
  19. ^ "Biotechnology: Petitions". USDA-APHIS. May 7, 2010. Archived from the original on March 10, 2012.
  20. ^ Monsanto 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
  21. ^ 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
  22. ^ Staff (August 7, 2012) Roundup Ready® Sugar Beet News Archived October 13, 2010, at the Wayback Machine USDA Animal and Plant Health Inspection Service, Biotechnology, Retrieved November 5, 2012
  23. ^ USDA - Roundup Ready® Alfalfa Environmental Impact Statement (EIS) Archived September 24, 2008, at the Wayback Machine, United States Department of Agriculture, December 2010. Retrieved November 5, 2012
  24. ^ "Recombinant DNA Safety Considerations" (PDF). Paris: OECD. 1986. Archived from the original (PDF) on August 14, 2011. Retrieved November 15, 2011. {{cite journal}}: Cite journal requires |journal= (help)
  25. ^ "Statement of Policy - Foods Derived from New Plant Varieties". FDA Federal Register. May 29, 1992. Archived from the original on December 8, 2011.
  26. S2CID 16657114. Archived from the original
    (PDF) on December 8, 2011.
  27. ^ "Consultation Procedures under FDA's 1992 Statement of Policy - Foods Derived from New Plant Varieties". FDA. October 1997 [June 1996].
  28. PMID 8594427
    .
  29. ^ a b c Center for Veterinary Medicine (CVM) (January 15, 2009). "Guidance for Industry Regulation of Genetically Engineered Animals Containing Heritable Recombinant DNA Constructs: Final Guidance" (PDF). U.S. Department of Health and Human Services Food and Drug Administration.