United States and GMO Policies: If it looks like a fruit, smells like a fruit, then it is a fruit!

<<This post is a continuation from previous posts. To read the intorducation to this topic, click here.>>

In regulating GMOs, the US has stuck with the risk-benefit analysis, allowing for a more relaxed approach to GMO regulation. The United States has become the biggest producer of GM corn in the world.[1] The framework for the FDA policy regarding GM foods places responsibility on the producer or manufacturer to assure the safety of that food; “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.”[2] In 1992, the FDA approved the first genetically engineered food/ingredient, which was an enzyme used in the production of dairy products.[3]

In approving the use of this product derived by fermenting genetically modified bacterium, the FDA affirmed that this method was “generally recognized as safe.”[4] Two years later, the FDA enacted a policy dealing with plants developed by methods of genetic modification, establishing that such products are not dangerous and should not require extraordinary testing and regulation before being placed in the market.[5] This policy holds that the FDA should only regulate a particular genetically modified food differently than the traditionally grown product when the product demonstrates some unusual attribute from the standard product.[6] In other words, the FDA considers most GM crops as “substantially equivalent” to non-GM crops, and thus safe, not requiring any premarket approval -- as long as it looks like a tomato, it must be a tomato. In 1997, the FDA issued further guidance for food derived from new plant varieties asking for voluntary “consultation procedures”[7]; however, this policy still relied on the developer of the product to provide safety data and not any independent scientific review by the government.

Today, the United States grows approximately a third of the American corn and cotton crop and more than half of the soybean crop from genetically modified seeds.[8] This represents one of the most rapid adoptions of a new technology in the history of the United States. Although use of GMOs is so prominent, consumer awareness of biotechnology remains low. The FDA introduced GMOs into the market in 1992, but seven years later, still only 33 percent of Americans were aware that supermarkets were selling genetically modified foods and less than 3 percent were aware that soybeans were genetically engineered.[9] The FDA actively worked to promote the introduction of GMOs and created simplified procedures for approving bioengineered foods. For example, on May 18, 1994, the FDA determined that Calgene, Inc.’s FLAVR SAVRTM tomato was “as safe as tomatoes bred by conventional means.”[10] This determination meant that subsequent applications for genetically engineered foods did not have to undergo a comprehensive scientific review simply because they were produced through the process of genetic engineering.

The FDA also determined that labeling was not required for GMOs unless the new food posed a safety problem for consumes. Consumers were not too thrilled with this idea as portrayed by a Time magazine poll in January of 1999, which reported that 81 percent of those surveyed supported mandatory labeling of genetically engineered foods.[11] The FDA held a series of hearings to determine whether GM foods should be considered an additive thus requiring mandatory labeling and whether GMO’s needed further testing to ensure consumer safety.[12] As part of a broader initiative by the Clinton Administration to increase funding for research on the potential risks of genetically engineered crops to both consumers and the environment, the FDA subsequently announced that it would strength its review of bioengineered foods and write guidelines for companies that wanted to label their products as free of GMOs.[13] The FDA also announced plans to reassure consumers about the safety of genetically modified foods by requiring developers to published research and safety data on the Internet.[14] Again, however, these are merely plans.

To compare the US GMO policies with that of the European Union, click here.

[1] See Cultivation of GM Plants: Rapid Increase Worldwide, Cautious Start in Europe, GMO Compass, http://www.gmo-compass.org/eng/agri_ biotechnology/gmo_planting/ (last visited Dec. 6, 2012).

[2] See Guidance to Industry for Foods Derived from New Plant Varieties, Section V (B) and (C), U.S. Food and Drug Administartion, http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Biotechnology/ucm096095.htm

[3] See generally Statement of Policy: Foods Derived From New Plant Varieties, 57 Fed. Reg. 22,984 (May 29, 1992).

[4] Id. See also, 21 U.S.C.A. §§ 321(s), 348.

[5] Id. (establishing that genetically modified foods will be regulated essentially identical to the regulations as applied to foods developed by traditional plant breeding).

[6] Id. at 22984, 22991-23004.

[7] Consultation Procedures under FDA’s 1992 Statement of Policy – Foods Derived from New Plaint Varieties Guidance on Consultation Procedures (June 1996; Revised October 1997) http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/biotechnology/ucm096126.htm.

[8] Mark A. Pollack and Gregory C. Shafffer, When Corporation Fails: The international Law and Politics of Genetically Modified Foods 132 (Jun 2009)

[9] Marian Burros, "Different Genes, Same Old Label," New York Times, September 8, 1999: B12.

[10] Biotechnology of Food, FDA Backgrounder, (May 18, 1994) http://www.biotech.wisc.edu/outreach/fdabackgrounder.html.

[11] . Tracy Samuel "Seeds of Change," Consumer Reports September 1999, p. 46.

[12] D. Vogel, Ships Passing in the Night: GMOs and the Politics of Risk Regulation in Europe and the United States, INSEAD (European Institute of Business Administration) (2002)

[13]Melody Petersen, U.S. Plans Closer Study of Biotech Foods and Will Guide Labeling New York Times A21 (May 2000).

[14] Id.