By Martin E. Levin

from GeneWatch 29-1 | Jan-May 2016

In 1992, the FDA blew a hole in the U.S. food safety law through which genetically engineered foods have been permitted to pass for the last twenty years. FDA adopted a policy approach toward this new form of agricultural technology that relied primarily on food suppliers' voluntary compliance with their legal duty to ensure the safety of products offered to consumers. FDA largely limited the government's authority to actions that might be taken if foods already on the market were discovered to be unsafe (i.e., "post-market" legal action). In so doing, FDA essentially stripped itself of its additional authority to require producers to prove that foods containing genetically engineered (GE) ingredients could be safely offered to consumers in the first place (i.e., "premarket" proof of safety). Instead, FDA expressly presumed GE foods to be safe. That presumption, and the FDA's accompanying determination that GE foods therefore did not have to be labeled as such, set the U.S. on a course of voluntary self-regulation by the producers of GE foods.

The flaw in this model of food safety regulation is self-evident. Profit-motivated businesses engaged in GE food production determine whether their newly engineered products are safe enough to be offered to consumers. Health problems will only be detected upon consumption, but, because the foods are unlabeled, consumers have no practical way of knowing they are eating the products. And we did not arrive at this place as a result of rigorous independent scientific study of the GE ingredients now in much of the food found on grocery store shelves, but as the result of a legal presumption.

It didn't have to be this way. When FDA was considering whether and how to regulate GE food crops, the then-current GE methods involved insertion of genetic material from one organism into the genome of a different organism (the plant), in a manner that could not be normally accomplished in nature. Such genetic modification produced traits in the plant that it did not naturally possess nor could naturally express. Indeed, it is only because the new form of the plant did not already exist in nature that it could be patented under U.S. law. One common sense application of the U.S. Food, Drug & Cosmetic Act ("FDCA"), America's food nutrition and safety law, would have been to conclude that the artificially added genetic material, as well as any new trait caused by its addition, constituted "food additives" as defined by the statute. Had FDA taken this common sense approach, GE food producers would have been required to prove the safety of such additives for consumption through FDA's food additive petition process. Such proof would have been required before foods containing GE additives could be brought to market (i.e., premarket). Each petition would have to be accompanied by supporting data generated by scientifically accepted methods, and FDA could require submittal of all safety studies, both positive and negative, during the petition process. Based on such data, FDA would have made its own finding whether the additive is sufficiently safe for consumption, and the conditions under which it could be safely consumed. FDA would have given public notice of its safety review in the Federal Register. The public would have had an opportunity to comment, and FDA would have had to consider and respond to such comments. FDA would have published its final findings in rule form, and court review of FDA's action would have been available pursuant to well established legal rights and rules of judicial restraint applicable to the agency's administrative decisions. Inclusion of the additive in a food product would have to be labeled, unless certain exceptions applied.

Had FDA adopted this approach, a quarter century later there would be a public record of what GE products it found safe or unsafe for human consumption and under what conditions, along with detailed chemical, toxicological, allergenicity, nutritional, and other pertinent analyses considered by FDA in reaching its findings. Instead of adopting this transparent approach to the new products of GE technology, FDA announced as "policy" that it would presume that such products fall into a statutory exception to the food additive requirements. This is the exception that applies to foods and additives that are "generally recognized as safe" ("GRAS"). The policy and its underlying presumption were based on FDA's rationale that moving genetic material from one organism to another through genetic engineering amounts to no more than moving around the very ingredients of life itself, "...genetic material (nucleic acids)...," [which] "...are present in the cells of every living organism, including every plant and animal used for food by humans or animals, and do not raise a safety concern as a component of food."[1] Assuming that both the newly introduced genetic material and the new trait(s) produced in the recipient plant would not substantially differ from the material and trait(s) present in foods already on the market, FDA made the policy judgment that GE products should be considered GRAS and need not be labeled.[2]

The 1992 FDA policy did establish a voluntary private consultation process through which GE food producers can submit to FDA a summary of the results of the producer's own research in support of the producer's conclusion that the plant or food is safe. FDA is relegated to review of the summary, and expression of any questions or reservations concerning the developer's conclusion of safety. The producer is not required to submit all research conducted, in its complete form, including the underlying data. FDA does not publish any determination of its own whether the food is safe or unsafe. 

In other words, there is no legally required, independent safety assessment of GE products before they reach the U.S. food market.[3] The policy adopted by FDA had important procedural consequences. Determination of safety could be made exclusively by private sector scientists, such as scientists working for the GE food producer, rather than the FDA. The producer decides what, if anything, it submits to FDA review.  There is no right to public notice and comment on the producer's determination, and no readily available avenue to challenge the safety determination made by the producer. And, except in a few cases in which GE products that were not intended for use as human foods found their way into the American food supply, FDA has conducted no post-market monitoring of GE products in the food supply nor surveillance for potential health impacts caused by those products. Nonetheless, the FDA has essentially advised Americans "not to worry" - because GE foods marketed in the U.S. "are as safe as comparable, non-GE foods."[4]

But now many Americans are worried. They are worried because as GE food consumption has increased, various reports have documented the increasing incidence of health problems associated with diet. These include a growing prevalence of food allergies in children, as well as a number of digestive disorders.[5] Such diet-related concerns are heightened by recent developments suggesting the importance of the gut microbiome to human health, and scientists' acknowledgment of how little is known about dietary impacts. Americans have also become worried as reputable, independent nonprofits and academic researchers have, over the course of the past decade, published reports calling into question a number of the health and environment claims made to promote GE products and the pesticides they have been primarily engineered to deliver.[6]

Correlation does not equate to causation. Neither does shortage of conclusive evidence equate to lack of causation, when premarket safety assessments are made exclusively by industry permitted to cherry-pick which, if any, of its research and resulting data is submitted to the government or published in the scientific literature. Nor has the consuming public been readily able to associate any ill health effects to GE foods, since GE foods have not been labeled as such.

Those who support the current self-regulatory regime for GE foods have nonetheless made broad assertions as to the scientifically established safety of GE foods. They have taken to denigrating proponents of GE food labeling as "science deniers," analogous to those who still deny the existence of global climate change or humankind's contribution to it. Science should, of course, inform public policy when it comes to public health. But the present state of GE food science is like climate science virtually stripped of geological and atmospheric observation as well as the past 165 years of temperature data. The scientific understanding of the effects of genomic modification of complex organisms, and of dietary exposures to such organisms, is like climate science virtually stripped of its knowledge of the effects of greenhouse gases on the atmosphere. Moreover, much of the GE food science conducted to date is like global climate science carried out and/or paid for by the fossil fuel industry.

When it comes to whether GE foods are safe to eat, current science may not compel a particular public policy outcome, but the current state of the law does. Since American consumers are unable to impose independent and transparent safety assessments on GE food producers, they are left with three fundamental choices: accept the producers' own opaque assessments, and don't worry about eating GE foods; accept those producers' assessments sufficiently to try eating GE foods, but conduct their own monitoring for possible health effects; or reject the producers' assessments, and avoid GE foods. Those in the first group can and will proceed as they wish regardless of whether GE foods are labeled. For the many remaining Americans who choose to be more careful about what they eat and feed their families, their choice is difficult to impossible when GE foods are identical in appearance to non-GE foods, and the GE foods are not labeled as such. They are stuck in the hole created by the FDA's policy to presume rather than assess safety before allowing GE foods to be served up to the American public, and FDA's failure to look for evidence of the potential effects of GE foods in the American diet.  That hole in our food safety law needs to be patched, and mandatory labeling is clearly the quickest way to do it.[7]


Martin Levin, J.D., practices law in Framingham, Massachusetts, and is a Senior Fellow with the Council for Responsible Genetics.



1. 57 Fed.Reg. at 22,990.

2. The 1992 policy successfully withstood a legal challenge at the trial court level. Alliance for Bio-Integrity v. Shalala, 116 F.Supp. 2d 166 (D.D.C. 2000). That lower court decision was never reviewed by a higher court, so still stands.

3. The 1992 policy only applied to GE crops. However, its underlying rationale-that GE only involved moving around genetic material already present in every living organism and GE products could therefore be presumed safe-was so broad that it placed FDA in a regulatory corner when it comes to food safety of GE animals. FDA has attempted to escape this corner by applying its "New Animal Drug" authority to GE animals even though the FDCA expressly defines the term "drug" as an article "other than food." 21 U.S.C. §321(g)(1)(C).

4. Consumer Info About Food from Genetically Engineered Plants, FDA, (visited Apr. 7, 2016).

5. See, e.g., Jackson et al., Trends in Allergic Conditions Among Children: United States, 1997-2011, NCHS data brief, no. 121. Hyattsville, MD: National Center for Health Statistics. 2013; Samsel & Seneff, Glyphosate, pathways to modern diseases II: Celiac sprue and gluten intolerance, Interdisciplinary Toxicology (2013) 6(4): 159-184; Peery et al., Burden of Gastrointestinal, Liver, and Pancreatic Diseases in the United States, Gastroenterology (2015) 149(7): 1731-1741.

6. See, e.g., Schubert, Science Supports the Need for GM Food Labeling, GeneWatch (2016) 29(1): 6-9, and references cited therein.

7. This is not to suggest that changes to FDA's approach to premarket food safety assessment and post-market surveillance need not also occur. Indeed, after 1992, the FDA extended to a wide range of additives the laissez-faire approach taken with respect to GE foods, to such an extent that its use of the GRAS exception could be said to have almost entirely swallowed the FDA's food additive safety authority. See, e.g., Kindy, "Food additives on the rise as FDA scrutiny wanes," The Washington Post, Aug. 17, 2014,

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