February 2013 Volume 9 Number 6

FDA and Regulation of GMOs

By Ramona Bashshur, JD, MJ, CFPH, Ann Arbor, MI

AuthorGenetically engineered or genetically modified organisms (“GMO”s, or “GM foods”) are defined as those in which “the genetic material (“DNA”) has been altered in such a way that does not occur naturally.”1 This methodology is then used “to create GM plants – which are then used to grow GM food crops”.2 The use of these GMOs in the nation’s food supply has received increasing media attention due to growing concerns regarding their safety. For example, Proposal 37 in California, which was narrowly defeated in November 2012, would have required manufacturer labeling of these food products,.3 Opposition donors poured 45 million into the campaign, 8 million alone donated by the Monsanto Company, equal to the entire amount contributed by supporters.4 While the measure was defeated, 6 million voting in favor suggests that a level of awareness has been created on the subject. Similar initiatives are underway in other states such as New Mexico,5 Washington,6 Oregon,7 and Vermont8 as well as a national campaign.9

Consumer, environmental and farmer organizations have raised objections not only regarding the GM food products,10 but also the safety of the chemicals applied to GM crops.11 Concerns include the potential effects on human health,12 contamination of non-GM crops due to cross pollenization,13 and escalating toxicity from increasing use of the chemicals, in turn caused by increasing weed resistance.14 The manufacturer of the pesticide used on these crops has maintained the safety of its product while contradictory findings continue to emerge.15 As the debate continues regarding risks to human health, questions have arisen as to whether the Food and Drug Administration (“FDA”), tasked with regulating food safety, should act to assess the risks of these foods separately from non GM foods and in the interim, require labeling so that consumers are informed of whether GM ingredients are present and are empowered to make purchasing decisions accordingly.

FDA Oversight

The FDA regulates GM foods as part of the “coordinated framework” of federal agencies that also includes the Environmental Protection Agency (“EPA”) and the United States Department of Agriculture (“USDA”).16 This framework, which has been the subject of critical analysis and calls for redesign,17 is available online18 and contains a searchable database that covers “genetically engineered crop plants intended for food or feed that have completed all recommended or required reviews.”19 The FDA policy (unchanged since 1992)20 places responsibility on the producer or manufacturer to assure the safety of the food, explicitly relying on the producer/manufacturer to do so: “Ultimately, it is the responsibility of the producer of a new food to evaluate the safety of the food and assure that the safety requirement of section 402(a)(1) of the act is met.”21 So it is the company, not any independent scientific review, providing the research that is relied on to assert safety. FDA guidance to industry issued in 1997 covered voluntary “consultation procedures,” but still relied on the developer of the product to provide safety data.22 There is currently no regulatory scheme requiring GM food to be tested to see whether it is safe for humans to eat.23

The FDA approach can be understood as the result of having a dual mission. In addition to its mission to protect food safety, the FDA was charged with promotion of the biotech industry.24

Health Concerns Continue

However, some studies have called to question the safety of these foods. The chemical herbicides applied are poisons engineered specifically for the purpose of killing plant life, and their use is increasing.25 Crops which result from genetic modifications, resistant to the chemicals, are classified as safe with no long term studies available to provide an evidence base.26 The American Academy of Environmental Medicine (“AAEM”) released a position paper calling for a moratorium on GM foods pending independent long term studies to investigate the role of GM foods on human health.27 The authors asserted that “there is more than a casual association between GM foods and adverse health effects.”28 The paper also cited numerous animal studies showing adverse effects and posited that the biological plausibility, as defined by Hill’s criteria, in light of this data is that adverse health effects are also caused in humans.29 A 2011 study found maternal/fetal exposure associated with GM crops in Quebec.30 A well publicized study,31 sharply criticized by industry32 found that rats fed GM corn developed tumors and organ damage.33 Moreover, new questions continue to emerge.34 The nature of these concerns have manifested in repeated calls for new food labeling regulations containing GM ingredients.35 However, the FDA has expressed no interest in revisiting its policy. Moreover, a 2002 study by the U.S. General Accounting Office (since renamed the Government Accountability Office and referred to as “GAO”)) asserted that it is not feasible to assess long term effects of GMOs because it is so difficult to assemble a control group without labels on GM food.36

Labeling Controversy

The FDA position on labeling is consistent with its original 1992 policy that these foods are not materially different.37 The FDA did not believe that “the method of development of a new plant variety (including the use of new techniques including recombinant DNA techniques) is normally material information within the meaning of 21 U.S.C. 321(n) and would not usually be required to be disclosed in labeling for the food.”38 Hence, FDA’s 2001 guidance to industry logically rejects any implication of inferior quality in GM foods: “Therefore, a label statement that expresses or implies that a food is superior (e.g., safer or of higher quality) because it is not bioengineered would be misleading.”39 The FDA made it clear the policy is unchanged: “FDA is therefore reaffirming its decision to not require special labeling of all bioengineered foods.”40 The FDA did recognize public concern by stating that “While the use of bioengineering is not a material fact, many consumers are interested in the information, and some manufacturers may want to respond to this consumer desire.”41 To that end, the FDA described a comprehensive set of examples as to what would constitute unfair or misleading labeling.42 However, if the overarching FDA concern is truth in labeling, it is difficult to reconcile the statement that GM foods are not materially different when there is so much scientific disagreement.43 The FDA stated further that the “certified organic” label assures consumers that the food product is not produced via bioengineering:

The national organic standards would provide for adequate segregation of the food throughout distribution to assure that non-organic foods do not become mixed with organic foods. The agency believes that the practices and record keeping that substantiate the "certified organic" statement would be sufficient to substantiate a claim that a food was not produced using bioengineering.44

However, this sidesteps the issue of direct labeling sought by consumers and restricts marketplace choice. It is possible that a product be GM free and not be certified organic, for example. Moreover, despite the FDA statement on “adequate segregation,” there exists a real issue of organic crop contamination by GM crops.45 Well publicized cases of conventionally grown crops that were contaminated by GM corn, not approved for human consumption, highlight the difficulty of containing a GM plant strain due to the ease of contamination.46 These cases were discussed in a 2008 GAO study which specifically addressed the problem of “unauthorized releases.”47

The landmark case on labeling, where the plaintiffs sued to require mandatory labeling of GM foods was Alliance for Bio-Integrity, et. al. v. Shalala.48 Among its holdings, the U.S. District Court refused to find the FDA's determination (that a genetically engineered food component was safe) to be arbitrary or capricious, stating that consumer demand was not a basis for requiring a food label: “the court deferred to FDA's interpretation that special labeling for genetically engineered foods is not required under section 201(n) of the Act if the sole justification for such a requirement is consumer demand.”49 Not only did the court defer to the agency finding of what constituted a material difference, the court explained that because of that finding, the FDA did not have any basis with which to require labeling.50 The court rejected all plaintiff arguments and made it clear that subsequent plaintiffs would have scant ground for a similar lawsuit.


These issues will continue to be brought to the FDA’s attention as consumers continue to mobilize on the labeling issue and state legislatures begin to address it. Further, as awareness builds, farmers and consumers are increasingly turning to non-GM products, especially since GM corn has not lived up to promises.51 As a result it may be time to revisit FDA policy on GM foods.

120 questions on genetically modified foods, World Health Organization (2002) http://www.who.int/foodsafety/publications/biotech/20questions/en/index.html, retrieved 12/1/2012.






Link to source.


http://naturalsociety.com/next-prop-37-new-mexico-law-calls-for-mandatory-labeling-of-gmos/#ixzz2HW0St0xp Retrieved 1/12/13.


http://www.labelitwa.org/ Retrieved 1/12/13.


http://www.gmofreeoregon.org/right_to_know Retrieved 1/17/13.


http://www.vtrighttoknow.org/ Retrieved 1/17/13. The Vermont bill also addresses the vague term “natural” and would restrict its use on GM foods. See “learn more” then “lessons of 2012.”


Id. See also http://truthinlabelingcoalition.org/; http://www.organicconsumers.org/gelink.cfm.

11Glyphosate Summary, Pesticide Action Network Asia & the Pacific, November 2009, http://www.panap.net/sites/default/files/monograph_glyphosate.pdf Retrieved 12/13/12. This summary covers toxicity as well as environmental effects.

Are Genetically Engineered Foods Promoting Autism? http://www.responsibletechnology.org/autism.

13Geertson Seed Farms v. Johanns, 570 F.3d 1130 (9 th Cir. 2009).

Dr. Charles Benbrook, “ Impacts of genetically engineered crops on pesticide use in the U.S. -- The first sixteen years” October 2012, http://www.enveurope.com/content/24/1/24/abstract. See also, Aaron J. Gassmann, Jennifer L. Petzold-Maxwell, Ryan S. Keweshan, and Mike W. Dunbar

“Field-Evolved Resistance to Bt Maize by Western Corn Rootworm”



GMO Myths and Truths Report, http://earthopensource.org/index.php/3-health-hazards-of-gm-foods/3-1-myth-gm-foods-are-safe-to-eat Retrieved 1/26/13. See also, Pesticide and Environmental Update, http://www.ghorganics.com/Roundup&weeds.htm Retrieved 12/14/12. See also, Union of Concerned Scientists, “Risks of Genetic Engineering” http://www.ucsusa.org/food_and_agriculture/our-failing-food-system/genetic-engineering/risks-of-genetic-engineering.html Retrieved 1/6/13. See also note 11 supra.


United States Regulatory Agencies unified Biotechnology Website, http://usbiotechreg.epa.gov/usbiotechreg/ Retrieved 12/1/12.


Gregory N. Mandel, TOWARD RATIONAL REGULATION OF GENETICALLY MODIFIED FOOD http://www.scujil.org/sites/default/files/volumes/v4_MandelArticle.pdf (2005).

18Note 16 supra.
20http://www.fda.gov/Food/Biotechnology/default.htm (Links to guidance documents available).

Guidance to Industry for Foods Derived from New Plant Varieties, Section V (B) and (C).


22Consultation Procedures under FDA's 1992 Statement of Policy - Foods Derived from New Plant Varieties Guidance on Consultation Procedures (June 1996; Revised October 1997) page last updated 2/22/10.

Peter Melchett, Thepro-GM lobby's seven sins against science http://www.soilassociation.org/motherearth/viewarticle/articleid/4752/the-pr 12/2012.

See this article also for explanation of why science behind GM approvals may be flawed.

24Emily Marden, Risk and Regulation: U.S. Regulatory Policy on Genetically Modified Food and Agriculture, 44 B.C.L. Rev. 733 (2003), http://lawdigitalcommons.bc.edu/bclr/vol44/iss3/2. This article gives historical overview of FDA role in regulation of biotech foods.
25Note 14 supra.
26Scientific American, “Do Seed Companies Control GM Crop Research?” http://www.scientificamerican.com/article.cfm?id=do-seed-companies-control-gm-crop-research Retrieved 12/5/12.
27American Academy of Environmental Medicine Calls for Immediate Moratorium on Genetically Modified Foods, position paper http://aaemonline.org/gmopost.html, and press advisory, http://www.aaemonline.org/gmopressrelease.html Retrieved 12/12/12.
29Id. Also see this note for explanation of Hill’s criteria, a commonly accepted group of factors deemed necessary to determine causation in epidemiologic studies.

Aziz Aris, Samuel Leblanc  “ Maternal and fetal exposure to pesticides associated to genetically modified foods in Eastern Townships of Quebec, Canada” Volume 31, Issue 4, May 2011, pp. 528–533, available at

http://www.sciencedirect.com/science/article/pii/S0890623811000566 Discussion of findings that the pesticide known as Bt toxin, used on GM corn, was detected in pregnant women and their fetuses, meaning that the toxin persisted and was not eliminated by the digestive process.

31Gilles-Eric Séralini, Emilie Clair, Robin Mesnage, Steve Gress, Nicolas Defarge, Manuela Malatesta, Didier Hennequin, Joël Spiroux de Vendômois Long term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize Food and Chemical Toxicology 50 (2012) 4221–4231 available at http://gmoseralini.org/wp-content/uploads/2012/11/GES-final-study-19.9.121.pdf.
33Note 31 supra.
34Don Huber, “GMOs, Glyphosate & Tomorrow” available at organiconsumers.org/artman2/uploads/May_2011Huber.pdf Discussion regarding the recent discovery of a new infectious agent present in GM crops. Retrieved 12/2012.
35Note 10 supra.
36GENETICALLY MODIFIED FOODS Experts View Regimen of Safety Tests as Adequate, but FDA's Evaluation Process Could Be Enhanced (May 2002) http://www.gao.gov/assets/240/234718.pdf at p.34.
37Genetically Engineered Plants for Food and Feed, FDA's Biotechnology Policy http://www.fda.gov/Food/Biotechnology/default.htm page last updated 10/22/2012.
3857 FR 22984 (May 29, 1992) available at this link. See Section 6, Labeling.

Guidance for Industry: Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed Using Bioengineering; Draft Guidance Contains Nonbinding Recommendations (January 2001).

page last updated 5/22/09.

42Note 39 supra. For example, the FDA considers it misleading if a manufacturer were to label green beans ‘not produced through biotechnology” when there are no GM green beans on the market. It would not be misleading if the label stated, “Green beans are not produced using biotechnology” so as to not imply that one brand of green beans is superior to another.”
43Craig Holdrege, Should Genetically Modified Foods Be Labeled?http://www.southerncrossreview.org/19/gmcrops.htm Retrieved 1/4/13.
44Note 39 supra.
45See Geertson Seed Farms, et al., v Mike Johanns, 541 F.3d 938 (9 th Cir. 2008), Geertson Seed Farms v. Johanns, 570 F.3d 1130 (9 th Cir. 2009), Monsanto v. Geertson Seed Farms, 130 S. Ct. 2743, 2756 (2010).
46Bratspies, Rebecca M., Myths of Voluntary Compliance: Lessons from the Starlink Corn Fiasco. William & Mary Environmental Law and Policy Review, Vol. 27, p. 593, 2003. Available at SSRN:http://ssrn.com/abstract=421700 or http://dx.doi.org/10.2139/ssrn.421700. This article describes the StarLink corn contamination in detail and calls for a new regulatory scheme for bioengineered foods.
47GENETICALLY ENGINEERED CROPS Agencies Are Proposing Changes to Improve Oversight, but Could Take Additional Steps to Enhance Coordination and Monitoring (November, 2008) http://www.gao.gov/assets/290/283060.pdf.
48Alliance for Bio-Integrity v Shalala, 116 F.Supp.2d 166 (D.D.C. 2000).
49Id. Also see discussion of this case on FDA website at this link.


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