The Food and Drug Administration's Policy on Genetically Modified Foods

As discussed in my previous article, the Food and Drug Administration (“FDA” or “Agency”) has regulatory jurisdiction over, among other things, food and food additives. In 1992, the FDA announced its policy with respect to genetically modified foods.[i]The 1992 policy provides that foods developed through genetic modification are not inherently dangerous and, except in rare cases, should not require extraordinary premarket testing and regulation.[ii] In other words, under the FDA’s 1992 policy genetically modified foods are regulated as ordinary foods, and not food additives, unless they contain substances or demonstrate attributes that are not usual for the product.[iii] The FDA’s regulatory approach thus focuses on the end product, rather than the process used to create genetically modified foods.[iv] In short, the FDA regards GM products as “generally regarded as safe,” (“GRAS”) and does not subject GM food products to food additive review (which would otherwise require a safety review of all ingredients that have not been granted the GRAS status).[v]

The 1992 Policy also established a voluntary process under which producers could consult with the Agency about safety and regulatory issues prior to marketing food derived from biotechnology.[vi] Typically, the developer of the product initiates a consultation with FDA, submits summary information about the safety and nutritional assessment of the product, and makes a scientific presentation to FDA scientists.[vii]

Even though the FDA argued that one of the benefits of the voluntary consultation process was that it would permit the identification of unresolved safety issues without going through the food additive regulatory process,[viii] many critics believed that the “voluntary” nature of the consultation was precisely the problem (among many others) with the FDA’s regulatory scheme. Furthermore, the consultation process was shrouded in secrecy as there was no provision for mandatory disclosure of information regarding GM foods. [ix] The only part of the process that would be transparent to the public was the letter that the agency sent “not objecting” to the voluntary consultation.[x] Furthermore, under the voluntary consultation process the manufacturer, not the FDA, makes the determination of safety; therefore, the burden of proof regarding safety remains with the manufacturer.[xi]

Granted, the industry may have intellectual property rights concerns with respect to any disclosure of information concerning GM products. These reasons are insufficient to justify keeping the public out of the discussion especially when there could have been ways to provide the public with pertinent information while addressing the industry’s concerns. As the system stands now, I am not at all surprised that to many critics the process appears nothing more than a rubber stamping mechanism. But this is only one of the problems with the U.S. regulatory regime of genetically engineered foods and crops. Many people continue to question its adequacy especially as we enter the era of second generation of genetically modified organisms where plants are engineered to express several desired traits and fields are sown to grow biocrops and not food.

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

[ii] Board on Agriculture and Natural Resources, Genetically Modified Pest-Protected Plants: Science and Regulation, p. 147 (2000), available at (last visited on August 23, 2009).

[iii] Id.; see alsoEmily Marden, Risk and Regulation: U.S. Regulatory Policy On Genetically Modified Food and Agriculture, 44 B.C.L.R., 733, 745 (2003) (stating that the “FDA observed that with a few modest exceptions, food derived from new plant varieties – through traditional breeding techniques such as hybridization – are not routinely subjected to scientific tests for safety, and it proposed to treat genetically modified plants in the same way.”) (internal citations omitted).

[iv]Marden, supra note iii at 748.

[v]Sophia Kolehmainen, Precaution Before Profits: An Overview of Issues on Genetically Engineered Food and Crops, 20 Va. Envtl. L.J. 267, 289 (2001); see also Judson O. Berkey, The Regulation of Genetically Modified Foods (1999), American Society of International Law, available at (last visited on August 18, 2009).

[vi] Pew Initiative on Food and Biotechnology, Guide to U.S. Regulation of Genetically Modified Food and Agricultural Biotechnology Products (2001), at 20-21, available at (last visited on August 18, 2009).

[vii] Id.

[viii] Id.

[ix]Mardin, supra note iii at 751.

[x] Id.

[xi] Pew Initiative, supra note vi at 21.