Abstract
AquAdvantage Salmon, produced by AquaBounty Technologies, Inc., is the first genetically engineered (GE) fish to be considered for commercial production and human consumption in the United States. Its application is currently under review by the Food and Drug Administration (FDA). Although private companies around the world are working on developing at least 35 species of GE fish and shellfish—including catfish, carp, oysters, and trout—no country has yet approved any of them for commercial production or human consumption.
This is a preview of subscription content, log in via an institution to check access.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Similar content being viewed by others
Notes
- 1.
Although transgenic and genetically modified are other terms used interchangeably, this chapter refers only to genetically engineered (GE) animals.
- 2.
Center for Food Safety (2015a).
- 3.
AquaBounty Technologies (2010), p. 13 [noting that AquAdvantage salmon have an “enhanced growth rate compared to non-transgenic Atlantic salmon”].
- 4.
AquaBounty Technologies (2010), p. 12.
- 5.
See Food and Drug Administration Center for Veterinary Medicine (2010), p. 110.
- 6.
AquaBounty Technologies (2010), p. 12.
- 7.
Bratspies (2008), p. 5.
- 8.
- 9.
FAO (2014), p. iii.
- 10.
Ibid., pp. iii–iv.
- 11.
Ibid., p. 7.
- 12.
National Research Council (2002), p. 16.
- 13.
Logar and Pollock (2005), p. 17.
- 14.
www.fao.org/newsroom/en/news/2008/1000930/index.html, accessed 11/10/2010.
- 15.
Logar and Pollock (2005), p. 18.
- 16.
Food and Drug Administration Center for Veterinary Medicine (2010), p. 128.
- 17.
Pew Initiative on Food & Biotechnology (2004), preface.
- 18.
Ibid.
- 19.
Ibid.
- 20.
Ibid.
- 21.
21 U.S.C.A. §§ 360(a)(1), 360(a)(3).
- 22.
Food and Drug Administration Center for Veterinary Medicine (2012).
- 23.
Food and Drug Administration (2012), p. 3.
- 24.
Ibid., p. 4.
- 25.
Upton and Cowan (2014), p. 13 citing U.S. Congress, Senate Committee on Health, Education, Labor, and Pensions, Protecting the Public Health: Examining FDA’s Initiatives and Priorities, 113th Cong., 2nd sess., March 13, 2014.
- 26.
Voosen (2010).
- 27.
Bratspies (2008), p. 6.
- 28.
Ibid., p. 10.
- 29.
McEvilly (2013), pp. 415–416.
- 30.
Bratspies (2008), p. 10.
- 31.
Bratspies (2008), p. 11.
- 32.
Van Eenennaam et al. (2013).
- 33.
Ibid.
- 34.
AquaBounty Technologies (2014c).
- 35.
- 36.
AquaBounty Technologies (2010), p. 15.
- 37.
Based on a 2012 inspection Panama recently fined AquaBounty for failing to secure necessary permits, particularly around its use of water and pollution of the local environment. See Biron (2014).
- 38.
Schwab (2013), p. 12.
- 39.
Cartagena Protocol on Biosafety to the Convention on Biological Diversity (2000), p. 3.
- 40.
Ibid., p. 4.
- 41.
Ibid., p. 4.
- 42.
Ibid., p. 1.
- 43.
Ibid., pp. 1–19.
- 44.
Cartagena Protocol on Biosafety to the Convention on Biological Diversity (2000), p. 14.
- 45.
Ibid., p. 4.
- 46.
Ibid., p. 14.
- 47.
Ibid., p. 1.
- 48.
Bratspies (2008), p. 5.
- 49.
GMO Compass (2015).
- 50.
Bratspies (2008), p. 5.
- 51.
EUROPA (2006) (explaining the European Union’s approach).
- 52.
Ibid.
- 53.
Codex Alimentarius, (2015), http://www.fao.org/fao-who-codexalimentarius/about-codex/en/
- 54.
Food and Drug Administration (2009) (“[t]he information needed to establish food safety for food from GE animals under an NADA is consistent with that described in the Codex Guidelines.”)
- 55.
World Health Organization & Food and Agriculture Organization of the United Nations (2009), p. 60.
- 56.
Ibid., p. 70.
- 57.
World Health Organization & Food and Agriculture Organization of the United Nations (2009), p. 67.
- 58.
Food and Water Watch, Consumers Union, and The Center for Food Safety (2012), p. 7.
- 59.
“The food and feed safety step of the hierarchical review process addresses the issue of whether food or feed from the GE animal poses any risk to humans or animals consuming edible products from GE animals compared with the appropriate non-transgenic comparators.” Food and Drug Administration (2010d), p. 5.
- 60.
- 61.
European Union Deliberate Release Directive 2001/18/EC and Regulation 1829/2003.
- 62.
Commn. Reg. 641/2004/EC on genetically modified food and feed, OJ L 102/1 (2004); Reg. 1829/2003/EC on genetically modified food and feed, OJ L 268/6-7 (2003); Reg. 1830/2003/EC concerning the traceability and labeling of genetically modified organisms, OJ L 268/24–25 (2003).
- 63.
- 64.
Austrl. N.Z. Food Stands. Code—Stand. 1.5.2 (2011), http://www.comlaw.gov.au/Details/F2011C00118.
- 65.
Ibid., p. 1.
- 66.
Ibid., pp. 1–2.
- 67.
Ibid., p. 9.
- 68.
Carter and Gruere (2003), p. 2 (see discussion on labeling guidelines for GM foods in Japan, the United States, Australia, New Zealand, European Union, Canada, Argentina, South Korea, and Indonesia).
- 69.
Varela (2013), p. 526.
- 70.
National Research Council (2002), p. 4.
- 71.
Food and Drug Administration Center for Veterinary Medicine (2009). Note that the FDA’s definition is similar to the Cartagena Protocol’s definition of an living modified organism is any “living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology.” Cartagena Protocol on Biosafety to the Convention on Biological Diversity (2000), p. 4.
- 72.
Upton and Cowan (2014), p. 5.
- 73.
Cowx et al. (2010), p. 3.
- 74.
Upton and Cowan (2014), p. 5.
- 75.
Ibid.
- 76.
51 Fed. Reg. 23302.
- 77.
The EPA reviews the potential effects on human health and the environment of pesticidal substances produced by plants, under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA; 7 USC § 136 et seq.) and the pesticide residue provisions of the federal Food, Drug, and Cosmetic Act (FDCA; 21 USC § 346a). The role of the EPA, although relevant to the regulation of GE plants, is beyond the scope of this chapter. However, the FDA’s 2009 Guidance recognized that the EPA may also assert jurisdiction over certain GE animals, such as insects, and that FDA was discussing with it “the best approach for oversight.” Food and Drug Administration Center for Veterinary Medicine (2009), p. 5, fn. 1.
- 78.
See Coordinated Framework for Regulation of Biotechnology, 51 Fed. Reg. at 23,304 (stating that the agencies involved have “extensive experience with products that involve living organisms” and that new developments will be reviewed by the FDA, USDA, and EPA in the same manner for safety).
- 79.
Pew Initiative on Food & Biotechnology (2001), p. 6 (“[T]he application of existing statutes to biotechnology led to significant questions about overlapping authorities among the agencies, as well as uncertainties about whether the agencies would follow consistent approaches in using these authorities.”).
- 80.
Coordinated Framework for Regulation of Biotechnology, 51 Fed. Reg. at 23,303.
- 81.
See Pew Initiative on Food & Biotechnology (2004), pp. 10–11.
- 82.
Ibid.
- 83.
National Research Council (2002).
- 84.
21 U.S.C. §301 et seq.
- 85.
42 U.S.C. §201 et seq.
- 86.
21 U.S.C. §321; Food and Drug Administration Center for Veterinary Medicine (2009), p. 5.
- 87.
Food and Drug Administration Center for Veterinary Medicine (2009), p. 4.
- 88.
Ibid., pp. 4 and 6.
- 89.
21 U.S.C.A. §§ 360(a)(1), 360(a)(3).
- 90.
Food and Drug Administration Center for Veterinary Medicine (2009), pp. 20–25.
- 91.
Ibid., p. 24.
- 92.
Ibid.
- 93.
Ibid.
- 94.
42 U.S.C. 4321.
- 95.
Section 514.1(b)(14).
- 96.
Food and Drug Administration Center for Veterinary Medicine (2009), p. 12.
- 97.
Actions that, based on an agency’s past experience with similar actions, have no significant impacts are categorically excluded from the requirement to prepare an EA or EIS. 21 C.F.R. §514.1(b)(14). Because approval of GE salmon is unprecedented, the FDA was required to prepare an EA.
- 98.
2009 Guidance, p. 18. The EA becomes public when the animal is approved.
- 99.
In cases where significant impacts are anticipated, the federal agency may decide to prepare an EIS without first preparing an EA. CFR at 4.
- 100.
See 21 U.S.C. § 331(j) (2006) (prohibiting information acquired under the authority of several sections related to the Animal Drug approval process from being revealed).
- 101.
21 C.F.R. § 514.11 (2012).
- 102.
Upton and Cowan (2014), p. 5.
- 103.
7 U.S.C. §8301 et seq.
- 104.
Food and Drug Administration (2008), p. 54408.
- 105.
21 U.S.C. §151–159.
- 106.
7 U.S.C. §2131 et seq.
- 107.
United States Department of Agriculture, Office of Inspector General (2011), pp. 10–11.
- 108.
Food and Drug Administration (2008), p. 54408.
- 109.
United States Department of Agriculture, Office of Inspector General (2011), p. 11.
- 110.
Ibid.
- 111.
Food and Drug Administration Center for Veterinary Medicine (2009), p. 6, fn 1.
- 112.
United States Department of Agriculture, Office of Inspector General (2011), pp. 12 and 14.
- 113.
AquaBounty Technologies (2010), p. 10.
- 114.
Ibid.
- 115.
Food and Drug Administration Center for Veterinary Medicine (2010), p. 117.
- 116.
AquaBounty Technologies (2010), p. 46.
- 117.
Ibid., p. 63.
- 118.
Food and Drug Administration Center for Veterinary Medicine (2010), p. 123.
- 119.
Ibid.
- 120.
See Food and Drug Administration Center for Veterinary Medicine (2009), p. 5.
- 121.
Ibid., p. 12.
- 122.
Ibid.
- 123.
Food and Drug Administration (2010d). See Food and Drug Administration (2010b), asking the VMAC to address four questions: (1) Do the data and information demonstrate that the rDNA construct is safe to AquAdvantage salmon? (2) Do the data and information demonstrate that there is a reasonable certainty of no harm from consumption of foods derived from AquAdvantage salmon? (3) Do the data indicate that AquAdvantage Salmon grow faster than their conventional counterparts? (4) Are any potential environmental impacts from AquAdvantage Salmon production adequately mitigated by AquaBounty Technologies’ proposed conditions of use?
- 124.
Opponents of the AquaBounty application have argued that more experts in fisheries and ecology should have been included on the committee. Upton and Cowan (2014), p. 14.
- 125.
Food and Drug Administration (2010) Background Document.
- 126.
Senior (2010).
- 127.
Food and Drug Administration Center for Veterinary Medicine (2012).
- 128.
Food and Drug Administration (2012).
- 129.
Ibid.
- 130.
In 2007, legislation was passed to require the FDA to consult with the National Marine Fisheries Service and to produce a report on any environmental risks associated with genetically engineered seafood products, including the impact on wild fish stocks.21 U.S.C. §2106. According to FDA, the two agencies have consulted on this matter, but this report has not been developed and no target date for its completion has been specified.
- 131.
16 U.S.C.1531 et seq.
- 132.
78 Federal Register 10620–10621 (February 14, 2013).
- 133.
Goldenberg (2013a, b). Two Canadian environmental groups—Ecology Action Centre (NS) and Living Oceans Society (BC)—filed a judicial review application with the Federal Court on Dec. 23, 2013 to decide if the federal government violated its own law when it permitted the manufacture of the AquAdvantage salmon. The legal challenge asserts that the approval is unlawful because it failed to assess whether the GE salmon could become invasive, potentially putting ecosystems and species such as wild salmon at risk. Ecology Action Centre (2014).
- 134.
Upton and Cowan (2014), p. 13 citing U.S. Congress, Senate Committee on Health, Education, Labor, and Pensions, Protecting the Public Health: Examining FDA’s Initiatives and Priorities, 113th Cong., 2nd sess., March 13, 2014.
- 135.
AquaBounty Technologies (2014a).
- 136.
National Research Council (2004).
- 137.
Food and Water Watch, Consumers Union, and The Center for Food Safety (2012), p. 3.
- 138.
Ibid.
- 139.
Senior (2010).
- 140.
Food and Drug Administration (2013).
- 141.
Ibid. (2012).
- 142.
Food and Water Watch, Consumers Union, and The Center for Food Safety (2012).
- 143.
21 U.S.C. §201(s), 21 U.S.C. §321.
- 144.
Food and Water Watch, Consumers Union, and The Center for Food Safety (2012), p. 16.
- 145.
Ibid., p. 6.
- 146.
Ibid., p. 4.
- 147.
Food and Drug Administration (2010d), pp. 290–291 (noting that risk of potential allergenicity was 20 % higher in AquAdvantage Salmon, but that this figure was not statistically significant because the sample size was only six fish).
- 148.
Food and Drug Administration (2010d), p. 293 (noting that the analysis of IGF levels looked at only two studies—a peer-reviewed publication from 1992 and an AquaBounty study from 2004—and the analysis of allergen potency focused on a 2006 study furnished by AquaBounty).
- 149.
Food and Drug Administration (2010d), p. 366.
- 150.
National Research Council (2004).
- 151.
Food and Drug Administration Center for Veterinary Medicine (2012).
- 152.
Upton and Cowan (2014), p. 15.
- 153.
Schwab (2013), p. 9; see Hauter et al. (2014), p. 1 asking the FDA “to deny the new animal drug application (NADA) for AquaBounty Technonlogies’ AquAdvantage Salmon in light of the disastrous environmental record of AquaBounty.” Because “AquaBounty has admitted fault in breaching environmental regulations in Panama and has experienced at least one major security accident involving “lost” salmon. It is also now public record that AquaBounty’s production platform in Panama has changed dramatically from the production platform described by AquaBounty and the FDA in the NADA and draft Environmental Assessments (EA), which presents another basis for FDA abandoning AquaBounty’s NADA.” AquaBounty (2014b) responded to the letter and press release by stating that they are “appalled at the irresponsible and untruthful attacks contained in the activists’ press release and letter. The Company has been in complete control of its Panama facility and at no time was the safety of the fish or the environment at risk.”
- 154.
- 155.
Food and Drug Administration Center for Veterinary Medicine (2012), p. 142.
- 156.
Ibid.
- 157.
Varela (2013), p. 525.
- 158.
Wodder et al. (2010).
- 159.
Food and Drug Administration Center for Veterinary Medicine (2012), p. 91.
- 160.
Ibid.
- 161.
Upton and Cowan (2014), p. 19.
- 162.
See Center for Food Safety (2015a).
- 163.
- 164.
- 165.
See, e.g., Schwab (2013).
- 166.
Upton and Cowan (2014), p. 16.
- 167.
- 168.
See 21 U.S.C. § 331(j) (2006) (prohibiting information acquired under the authority of several sections related to the Animal Drug approval process from being revealed).
- 169.
21 C.F.R. § 514.11 (2012).
- 170.
21 C.F.R. § 514.11(d).
- 171.
Ibid.
- 172.
Consumers Union (2008), p. 2.
- 173.
Ibid.
- 174.
Food and Drug Administration (2010c).
- 175.
Food and Drug Administration (2010d), p. 282.
- 176.
Ibid., pp. 297 and 311 (“Until the release of the [environmental assessment] two weeks ago, the public has had no opportunity to learn more about, assess, or raise questions about potential impacts.”).
- 177.
O’Halloran (2013).
- 178.
See, e.g., Logar and Pollock (2005) (citing data that “Americans’ attitudes towards genetic engineering and biotechnology generally show a decline in support for such technologies over past 5–15 years”).
- 179.
Pew Initiative on Food & Biotechnology (2001), p. 2.
- 180.
Kopicki (2013).
- 181.
Ibid.; See also Thomson Reuters (2010).
- 182.
Food Safety News (2014).
- 183.
Van Eenennaam et al. (2013), quoting Gemma Arjo, Manuel Portero, Carme Pinol, Juan Vinas, Xavier Matias-Guiu, Teresa Capell, Andrew Bartholomaeus, Wayne Parrott & Paul Christou, Plurality of Opinion, Scientific Discourse and Pseudoscience: An In Depth Analysis of the Séralini et al. Study Claiming that Roundup Ready Corn or the Herbicide Roundup Cause Cancer in Rats, Transgenic Reseach, 2013 (22), pp. 255–267.
- 184.
21 U.S.C. §§301 et seq.
- 185.
P.L. 89-755;15 U.S.C. §§1451 et seq. The Nutrition Labeling and Education Act of 1990 (P.L. 101-535; 21 U.S.C. §343), which amended the Federal Food, Drug, and Cosmetic Act, requires most foods to carry nutrition labeling and requires food labels with claims about nutrient content or certain health messages to comply with specific requirements.
- 186.
Food and Drug Administration (2010a). Companies may label their foods as not containing bioengineered products, if they can definitively show that the foods do not contain GE products.
- 187.
Food and Drug Administration (1992).
- 188.
Ibid., (2010a).
- 189.
- 190.
See Nature Biotechnology (2014), p. 1169.
- 191.
AK Food & Drug Code §17.20.040 (2005).
- 192.
Kimbrell and Tomaselli (2011), pp. 100–101.
- 193.
Upton and Cowan (2014), p. 20.
- 194.
AquaBounty Technologies (2011).
- 195.
Kimbrell and Tomaselli (2011), p. 100.
- 196.
21 C.F.R. § 514.8(b)(2).
- 197.
Ibid.
- 198.
Kimbrell and Tomaselli (2011), p. 100.
- 199.
See Center for Food Safety (2013).
- 200.
Cal. Fish & Game Code § 15007.
- 201.
Wash. Admin. Code § 220-76-100 (2012).
- 202.
Cal. Code Regs. tit. 14, §671.1 (2013).
- 203.
Fla. Admin Code r. 5 L-3.004 (2013).
- 204.
Mich. Comp. Laws Ann. § 324.41301-41325.
- 205.
Mich. Comp. Laws Ann. § 324.45901-45908.
- 206.
Mich. Comp. Laws Ann. § 324.48701-48740.
- 207.
16-2 R.I. Code R. § 300.11 (2012).
- 208.
Upton and Cowan (2014), p. 23 citing Letter from Don Young et al. to Dr. Margaret Hamburg, Commissioner, FDA, April 24, 2013, and Letter from Senator Mark Begich et al. to Dr. Margaret Hamburg, April 24, 2014.
- 209.
Upton and Cowan (2014), p. 24. Such a report was required under Section 1007 of the Food and Drug Administration Amendments Act of 2007. 21 U.S.C. 2106.
- 210.
Upton and Cowan (2014), p. 24, citing H.R. 584, H.R. 1699, S. 248, and S. 809.
- 211.
Upton and Cowan (2014), p. 24.
- 212.
Ibid.
- 213.
Center for Food Safety (2015a).
- 214.
See, e.g., Pew Initiative on Food & Biotechnology (2004), p. 125.
- 215.
Bratspies (2005), pp. 503–504.
- 216.
Mandel (2004), p. 2243.
- 217.
See Mandel (2004), p. 2243 (noting that as a result of the Framework’s flawed paradigm, there have been “multiple failures on the part of regulatory agencies to recognize that genetically modified products sometimes do create new and different issues than those raised by the conventional products they routinely regulate”).
- 218.
Van Eenennaam et al. (2013).
- 219.
Ibid.
- 220.
Food and Water Watch, Consumers Union, and The Center for Food Safety (2012).
- 221.
FFDCA, Section 201(s).
- 222.
21 U.S.C. § 348(a) (2006).
- 223.
21 U.S.C. §321.
- 224.
Food and Water Watch, Consumers Union, and The Center for Food Safety (2012).
- 225.
Ibid., p. 22.
- 226.
Food and Drug Administration (2011).
- 227.
McEvilly (2013), pp. 413 and 427–428.
- 228.
Van Eenennaam et al. (2013).
- 229.
Ibid.
- 230.
Ibid.
- 231.
See Upton and Cowan (2014), p. 17.
- 232.
Upton and Cowan (2014), p. 26.
References
AquaBounty Technologies (2010) Environmental assessment for AquAdvantage Salmon. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/VeterinaryMedicineAdvisoryCommittee/UCM224760.pdf. Accessed 19 Jan 2015
AquaBounty Technologies (2011) Interim results for the six months ended 30 June 2011. http://aquabounty.com/wp-content/uploads/2014/02/2011-09.23-Interim-Results.pdf. Accessed 16 Jan 2015
AquaBounty Technologies (2014a) AquAdvantage® Salmon DNA Animations. http://aquabounty.com/press-room/video-b-roll-animation/. Accessed 16 Jan 2015
AquaBounty Technologies (2014b) AquaBounty responds to anti-gm organizations’ letter and press release. http://aquabounty.com/wp-content/uploads/2014/11/2014-11.20-AquaBounty-responds-to-anti-GM-organizations-letter-and-press-release-Finalx.pdf. Accessed 16 Jan 2015
AquaBounty Technologies (2014c) First edible genetically engineered fish still awaiting approval. http://aquabounty.com/first-edible-genetically-engineered-fish-still-awaiting-approval/. Accessed 16 Jan 2015
Biron C (2014) GM salmon company Aquabounty fined by Panama. The Guardian. http://www.theguardian.com/lifeandstyle/2014/oct/29/panama-regulators-could-slow-us-approval-of-gm-salmon
Bratspies R (2005) Glowing in the dark: how America’s first transgenic animal escaped regulation. Minn J Law Sci Technol 6:457
Bratspies R (2008) Farming the genetically modified seas—the perils and promise of transgenic Salmon. American Fisheries Society Symposium. http://www.bioeng.fisheries.org/proofs/igfe/bratspies.pdf. Accessed 2 Jan 2015
Cartagena Protocol on Biosafety to the Convention on Biological Diversity (2000) http://www.cbd.int/doc/legal/cartagena-protocol-en.pdf. Accessed 23 Jan 2015
Carter C, Gruere G (2003) International approaches to the labeling of genetically modified foods. http://www.agmrc.org/media/cms/cartergruere_929BEB69BA4EE.pdf. Accessed 23 Jan 2015
Center for Food Safety (2013) GE fish and the environment. http://www.centerforfoodsafety.org/issues/309/ge-fish/ge-fish-state-regulations#. Accessed 16 Jan 2015
Center for Food Safety (2015a) Genetically engineered fish. http://www.centerforfoodsafety.org/issues/309/ge-fish. Accessed 16 Jan 2015
Center for Food Safety (2015b) International labeling laws. http://www.centerforfoodsafety.org/issues/976/ge-food-labeling/international-labeling-laws. Accessed 16 Jan 2015
Consumers Union (2008) Comments on Docket No. FDA-2008-D-0394, “Draft Guidance for Industry: Regulation of Engineered Animals Containing Heritable rDNA Constructs”. http://www.consumersunion.org/pub/pdf/FDA-comm-DNA-1108.pdf. Accessed 16 Jan 2015
Cowx IG et al (2010) Environmental risk assessment criteria for genetically modified fishes to be placed in the EU market. European Food Safety Authority. http://www.efsa.europa.eu/en/supporting/doc/69e.pdf. Accessed 7 Jan 2015
Ecology Action Centre (2014) Salmon trials. https://www.ecologyaction.ca/content/GM-Salmon-Trial-Release. Accessed 19 Jan 2015
EUROPA (2006) Europe’s rules on GMOs and the WTO. http://europa.eu/rapid/pressReleasesAction.do?reference=MEMO/06/61&format=HTML&aged=0&language=EN&guiLanguage=en. Accessed 7 Jan 2015
Food and Agriculture Organization of the United Nations (2014) State of world fisheries and aquaculture. http://www.fao.org/3/a-i3720e.pdf. Accessed 19 Jan 2015
Food and Drug Administration (1992) Statement of policy: foods derived from new plant varieties. 57 Federal Register 22984
Food and Drug Administration (2008) Guidance for industry: regulation of genetically engineered animals containing heritable rDNA constructs; Availability, 73 Federal Register 54407, September 19, 2008, http://edocket.access.gpo.gov/2008/pdf/E8-21917.pdf. Accessed 19 Jan 2015
Food and Drug Administration (2010a) Background document: public hearing on the labeling of food made from the AquAdvantage Salmon. http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm222608.htm
Food and Drug Administration (2010b) Charge to the VMAC for the AquAdvantage Salmon Meeting. http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/VeterinaryMedicineAdvisoryCommittee/ucm226083.htm. Accessed 19 Jan 2015
Food and Drug Administration (2010c) Veterinary Medicine Advisory Committee, Notice of Meeting, 75 Fed. Reg. 52,605 (Aug. 26, 2010)
Food and Drug Administration (2010d) VMAC Meeting: AquAdvantage Salmon. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/VeterinaryMedicineAdvisoryCommittee/UCM230469.pdf. Accessed 19 Jan 2015
Food and Drug Administration (2011) FDA’s response to public comments. http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/GeneticEngineering/GeneticallyEngineeredAnimals/ucm113612.htm. Accessed 20 Jan 2015
Food and Drug Administration (2012) Preliminary finding of no significant impact, http://www.fda.gov/downloads/AnimalVeterinary/DevelopmentApprovalProcess/GeneticEngineering/GeneticallyEngineeredAnimals/UCM333105.pdf. Accessed 9 Jan 2015
Food and Drug Administration (2013) Key facts commonly misunderstood. http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/VeterinaryMedicineAdvisoryCommittee/ucm226223.htm. Accessed 16 Jan 2015
Food and Drug Administration Center for Veterinary Medicine (2009) Guidance 187, Guidance for industry regulation of genetically engineered animals containing heritable recombinant DNA constructs, http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM113903.pdf. Accessed 7 Jan 2015
Food and Drug Administration Center for Veterinary Medicine (2010) Briefing packet. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/VeterinaryMedicineAdvisoryCommittee/UCM224762.pdf. Accessed 19 Jan 2015
Food and Drug Administration Center for Veterinary Medicine (2012) AquAdvantage Salmon, Draft Environmental Assessment. http://www.fda.gov/downloads/AnimalVeterinary/DevelopmentApprovalProcess/GeneticEngineering/GeneticallyEngineeredAnimals/UCM333102.pdf. Accessed 19 Jan 2015
Food and Water Watch, Consumers Union, and The Center for Food Safety (2012) Petition to deem ABT technologies’ genetically engineered AquaAdvantage Salmon an unsafe food additive. http://www.centerforfoodsafety.org/files/fdafoodadditivepetitiongesalmon.pdf. Accessed 19 Jan 2015
Food Safety News (2014) Kroger, safeway will Nix GMO Salmon regardless of FDA decision. http://www.foodsafetynews.com/2014/03/kroger-safeway-turn-down-gmo-salmon-regardless-of-fda/#.VLleyCvF_eI. Accessed 10 Jan 2015
Goldenberg S (2013a) Canada approves production of GM salmon eggs on commercial scale. The Guardian. http://www.theguardian.com/environment/2013/nov/25/canada-genetically-modified-salmon-commercial. Accessed 19 Jan 2015
Goldenberg S (2013b) GM salmon global HQ – 1,500 m high in the Panamanian rainforest. The Guardian. http://www.theguardian.com/environment/2013/apr/24/genetically-modified-salmon-aquabounty-panama-united-states. Accessed 19 Jan 2015
GMO Compass (2015) Cartagena protocol. http://www.gmo-compass.org/eng/glossary/. Accessed 7 Jan 2015
Hauter W, Hanson J, Perls D (2014) Letter to Dr. Margaret A. Hamburg, FDA Commissioner. http://www.centerforfoodsafety.org/files/abt_fda_sec_ciam_final_16457.pdf. Accessed 20 Jan 2015
Kapuscinski A, Sundstrom F (2010a) Actual oral comments delivered on environmental assessment for AquAdvantage Salmon and briefing packet on AquAdvantage Salmon for the Veterinary Medicine Advisory Committee. https://www.dartmouth.edu/~ark/images/stories/actualoral.pdf. Accessed 19 Jan 2015
Kapuscinski A, Sundstrom F (2010b) Comments on environmental assessment for AquAdvantage Salmon and briefing packet on AquAdvantage Salmon for the Veterinary Medicine Advisory Committee. http://www.dartmouth.edu/~ark/images/stories/kapuscinski_sundstrom_comments_sent16sept10.pdf. Accessed 19 Jan 2015
Kapuscinski A, Sundstrom F (2013) Comments on Docket No. FDA-2011-N-0899, draft environmental assessment for AquAdvantage Salmon and preliminary finding of no significant impact. http://www.dartmouth.edu/~ark/images/stories/kapuscinski_sundstrom_comments_2012draftea_aas.pdf. Accessed 19 Jan 2015
Kimbrell G, Tomaselli P (2011) A “Fisheye” lens on the technological dilemma: the specter of genetically engineered animals. Animal Law 18:75
Kopicki A (2013) Strong support for labeling modified foods. NY Times. http://www.nytimes.com/2013/07/28/science/strong-support-for-labeling-modified-foods.html?_r=1&. Accessed 10 Jan 2015
Mandel G (2004) Gaps, inexperience, inconsistencies, and overlaps: crisis in the regulation of genetically modified plants and animals. William Mary Law Rev 45:2216
Logar N, Pollock L (2005) Transgenic fish: is a new policy framework necessary for a new technology? Environ Sci Policy 8:17–27
Ocean Conservancy et al (2011) Citizen petition regarding AquaBounty Technologies’ application for approval of genetically engineered Salmon, citizen petition before the U.S. Food and Drug Administration. http://earthjustice.org/sites/default/files/FinalGESalmonCitizenPetition.pdf
O’Halloran S (2013) Consumers not interested in genetically modified salmon. Food Engineering. http://www.foodengineeringmag.com/articles/90611-consumers-not-interested-in-genetically-modified-salmon. Accessed 16 Jan 2015
McEvilly M (2013) Lack of transparency in the premarket approval process for Aquadvantage Salmon. Duke Law Technol Rev 11:413–433
National Research Council (2002) Animal biotechnology: science-based concerns. National Academy Press, Washington, DC. http://www.nap.edu/catalog/10418/animal-biotechnology-science-based-concerns. Accessed 10 Jan 2015
National Research Council (2004) Safety of genetically engineered foods: approaches to assessing unintended health effects. National Academies Press, Washington, DC. http://books.nap.edu/openbook.php?record_id=10977&page=R1. Accessed 10 Jan 2015
Nature Biotechnology (2014) Label without a cause. Nat Biotechnol 32:1169. http://www.nature.com/nbt/journal/v32/n12/pdf/nbt.3094.pdf
Pew Initiative on Food & Biotechnology (2001) Guide to U.S. regulation of genetically modified food and agricultural biotechnology products. www.pewtrusts.org/uploadedFiles/wwwpewtrustsorg/Reports/Food_and_Biotechnology/hhs_biotech_0901.pdf. Accessed 10 Jan 2015
Pew Initiative on Food & Biotechnology (2004) Issues in the regulation of genetically engineered plants and animals. http://www.pewtrusts.org/en/research-and-analysis/reports/0001/01/01/issues-in-the-regulation-of-genetically-engineered-plants-and-animals. Accessed 10 Jan 2015
Rossiter S (2013) See inside a genetically modified salmon farm in Panama. The Guardian. http://www.guardian.co.uk/environment/video/2013/apr/25/gm-salmon-panama-video
Schwab T (2013) Is FDA ready to regulate the world’s first biotech food animal? Food Drug Policy Forum 3
Senior D (2010) VMAC, Chairman’s Report, Food and Drug Administration, VMAC Meeting, September 20, 2010. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/VeterinaryMedicineAdvisoryCommittee/UCM230467.pdf. Accessed 14 Jan 2015
Thomson Reuters (2010) National Survey of Healthcare consumers: genetically engineered food, PULSETM Healthcare Survey. http://www.justlabelit.org/wp-content/uploads/2011/09/NPR_report_GeneticEngineeredFood-1.pdf. Accessed 10 Jan 2015
United Nations (2010) Resumed review conference on the agreement relating to the conservation and management of straddling fish stocks and highly migratory fish stocks. http://www.un.org/depts/los/convention_agreements/reviewconf/FishStocks_EN_A.pdf. Accessed 19 Jan 2015
United States Department of Agriculture, Office of Inspector General (2011) Controls over genetically engineered animal and insect research. http://www.usda.gov/oig/webdocs/50601-16-TE.pdf. Accessed 19 Jan 2015
Upton H, Cowan T (2014) Genetically engineered Salmon, congressional research service. http://www.fas.org/sgp/crs/misc/R43518.pdf. Accessed 23 Jan 2015
Van Eenennaam A, Muir W, Hallerman E (2013) Is unaccountable regulatory delay and political interference undermining the FDA and hurting American competitiveness? Food Policy Forum 3(13). http://www.isb.vt.edu/news/2013/Nov/FDLI.pdf. Accessed 23 Jan 2015
Varela J (2013) FDA is ready to authorize GM Salmons but is the market ready for them? Eur J Risk Regul 4:521–526
Voosen P (2010) Panel advises more aggressive FDA analysis of engineered Salmon. N.Y. TIMES, September 21. http://www.nytimes.com/gwire/2010/09/21/21greenwire-panel-advises-more-aggressive-fda-analysis-of-71171.html?pagewanted=all
World Health Organization & Food and Agriculture Organization of the United Nations (2009) Codex Alimentarius Commission: Foods derived from modern biotechnology. ftp://ftp.fao.org/docrep/fao/011/a1554e/a1554e00.pdf. Accessed 10 Jan 2015
Wodder R et al (2010) Letter to Margaret Hamburg, M.D., Commissioner, FDA. http://www.foe.org/sites/default/files/EnvironmentalGroupLettertoFDA-GESalmonEnvironmentalReview.pdf. Accessed 19 Jan 2015
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2017 Springer International Publishing Switzerland
About this chapter
Cite this chapter
Negowetti, N. (2017). Perspectives and Predicaments of GMO Salmon. In: Steier, G., Patel, K. (eds) International Farm Animal, Wildlife and Food Safety Law. Springer, Cham. https://doi.org/10.1007/978-3-319-18002-1_14
Download citation
DOI: https://doi.org/10.1007/978-3-319-18002-1_14
Published:
Publisher Name: Springer, Cham
Print ISBN: 978-3-319-18001-4
Online ISBN: 978-3-319-18002-1
eBook Packages: Law and CriminologyLaw and Criminology (R0)