“One thing that surprised us is that US regulators rely almost exclusively on information provided by the biotech crop developer, and those data are not published in journals or subjected to peer review… The picture that emerges from our study of US regulation of GM foods is a rubber-stamp ‘approval process’ designed to increase public confidence in, but not ensure the safety of, genetically engineered foods.”

– David Schubert, professor and head, Cellular Neurobiology Laboratory, Salk Institute, commenting on a comprehensive peer-reviewed study of US government’s regulation of GMOs that he co-authored [1,2]


GM foods were first commercialised in the US in the early 1990s. The US food regulator, the Food and Drug Administration (FDA), allowed the first GM foods onto world markets in spite of its own scientists’ warnings that genetic engineering is different from conventional breeding and poses special risks, including the production of new toxins or allergens. [3,4,5,6,7,8]

In line with a US government decision to “foster” the growth of the GM industry,[9] the FDA formed a policy that GM crops and foods do not require special testing or oversight because they are “generally recognized as safe” or GRAS. The FDA justified this claim on the basis of an assumption that the components of a GM plant will be “the same as or substantially similar” to substances found in non-GM foods, such as proteins, fats, and carbohydrates. [10]

The FDA is referring to the concept of substantial equivalence. This concept has been used by the GM lobby and its allies to gain acceptance and regulatory approval for GMOs worldwide.

The creation of the FDA policy on GM foods was overseen by the agency’s deputy commissioner of policy, Michael Taylor, who was appointed to the post in 1991. [11]  Prior to joining the FDA, Taylor had been in private practice at a law firm that represented the GM giant Monsanto. In 1998 Taylor became Monsanto’s vice president for public policy.[12,13] By 2010 he was back at the FDA as its deputy commissioner for foods. [14]

Taylor’s career is often cited as an example of a type of conflict of interest called the revolving door, as he has so frequently moved between regulatory bodies and the industry that those bodies are supposed to regulate. [15]

Contrary to many people’s belief, the FDA does not have a mandatory GM food safety assessment process and has never approved a GM food as safe. It does not carry out or commission safety tests on GM foods.

Instead, the FDA operates a voluntary programme for pre-market review of GM foods. All GM food crops commercialized to date have gone through this review process, but there is no legal requirement for them to do so. Companies that develop GM crops are allowed to put any GMO (genetically modified organism) on the market that they wish without even notifying the FDA, though they can be held liable for any harm to consumers that results from it.

In the USA and all other countries worldwide, GM crops are tested for safety by the same GM seed companies that stand to profit from selling the seed and accompanying chemicals. Generally neither the FDA nor any regulatory agency worldwide does its own independent testing of GM crops.

The outcome of the FDA’s voluntary assessment is not a conclusion, underwritten by the FDA, that the GMO is safe. Instead it consists of the FDA sending the company a letter stating that the company is responsible for placing only safe foods in the market and that if a product is found to be unsafe, the company may be liable. [16]

Clearly, this process does not guarantee – or even attempt to investigate – the safety of GM foods. It does not protect the public, though it may protect the FDA from legal liability in the event that harm is caused by a GM food.

Labelling: GM foods and GM ingredients in products do not have to be labelled in the US.



1.         Tokar B. Deficiencies in federal regulatory oversight of genetically engineered crops. Institute for Social Ecology Biotechnology Project. June 2006. http://environmentalcommons.org/RegulatoryDeficiencies.html

2.         Freese W, Schubert D. Safety testing and regulation of genetically engineered foods. Biotechnol Genet Eng Rev2004: 299-324.

3.         Kahl L. Memorandum to Dr James Maryanski, FDA biotechnology coordinator, about the Federal Register document, “Statement of policy: Foods from genetically modified plants”. US Food & Drug Administration. 8 January 1992. http://www.biointegrity.org/FDAdocs/01/01.pdf

4.         Guest GB. Memorandum to Dr James Maryanski, biotechnology coordinator: Regulation of transgenic plants – FDA Draft Federal Register Notice on Food Biotechnology. US Department of Health & Human Services. 5 February 1992. http://www.biointegrity.org/FDAdocs/08/08.pdf

5.         Matthews EJ. Memorandum to Toxicology Section of the Biotechnology Working Group: “Safety of whole food plants transformed by technology methods”. US Food & Drug Administration. October 28 1991. http://www.biointegrity.org/FDAdocs/02/02.pdf

6.      Shibko SL. Memorandum to James H. Maryanski, biotechnology coordinator, CFSAN: Revision of toxicology section of the “Statement of policy: Foods derived from genetically modified plants”. US Food & Drug Administration. 1992. http://www.biointegrity.org/FDAdocs/03/03.pdf

7.      Pribyl LJ. Comments on the March 18, 1992 version of the Biotechnology Document. US Food & Drug Administration. 18 March 1992. http://www.biointegrity.org/FDAdocs/12/ljpp.pdf

8.      Pribyl LJ. Comments on Biotechnology Draft Document, 2/27/92. US Food & Drug Administration. 6 March 1992. http://www.biointegrity.org/FDAdocs/04/04.pdf

9.      Sudduth MA. Genetically engineered foods – fears and facts: An interview with FDA’s Jim Maryanski. FDA Consumer. January–February 1993; 11–14. http://web.archive.org/web/20090202053904/http://www.fda.gov/bbs/topics/consumer/Con00191.html

10.      US Food and Drug Administration. Statement of policy: Foods derived from new plant varieties. FDA Federal Register. 29 May 1992; 57(104): 229.

11.      Harris G. New official named with portfolio to unite agencies and improve food safety New York Times. 13 January 2010. http://www.nytimes.com/2010/01/14/health/policy/14fda.html

12.      Bittman M. Why aren’t GMO foods labeled? New York Times. 15 February 2011. http://opinionator.blogs.nytimes.com/2011/02/15/why-arent-g-m-o-foods-labeled/

13.      Nestle M. Food Politics: How the Food Industry Influences Nutrition and Health. Revised 15 October 2007: University of California Press; 2002.

14.      US Food and Drug Administration. Meet Michael R. Taylor, J.D., deputy commissioner for foods. 2011. http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/ucm196721.htm

15.      Robin MM. The World According to Monsanto [film]. 2008.

16.      US Food and Drug Administration. Biotechnology consultation agency response letter BNF No. 000001. 27 January 1995. http://www.fda.gov/Food/Biotechnology/Submissions/ucm161129.htm