Re: Stand up to bullying by the biotech industry (12/3/2008)

NOTE: The article Dr. Gurian-Sherman is referring to is available here http://www.lobbywatch.org/archive2.asp?arcid=8870


Although I agree with much of the gist of this article, it is significantly incorrect concerning U.S. GMO regulation. It is important to get this right, or else critics of GMOs leave themselves open to charges of 'not understanding' how regulation of GMOs works.

First, there are specific laws in the U.S. that cover GMOs, contrary to the authors' assertions. The authors may be confusing the absence of laws with the fact that there were no new laws created specifically for GMOs. Instead, regulation of GMOs is covered by previous food safety and environmental laws that were not enacted with GMOs in mind (because those laws preceded GMOs by decades). Those existing laws are often not well adapted to regulate GMOs. Also, in the case of FDA, the weakest part of food safety law is used for regulating most GMOs. Submission of data by a company is voluntary (although so far all seem to have done so), and the kinds of safety testing is determined largely by, and testing done by, the GMO companies. This is in contrast to regulation of chemical food additives, for example, which FDA must approve as safe, and for which many specific types of safety tests are required.

For environmental safety, the U.S. Department of Agriculture (USDA) approves most experimental GMO field trials through notifications, which are 'acknowledged' by USDA (basically a cursory review requiring no safety data, but which includes information on how the company will contain the crop) or permits (for pharma crops and a few others). For commercialization, USDA goes through a process it calls 'deregulation' (not allowed for pharma crops). Deregulation means that after the USDA determines the GMO will not cause undue harm, it is no longer regulated. But to get to this status, it supposedly must show that the GMO is safe. This is a mandatory approval process, but is very weak. It is based on so-called 'performance standards,' rather than defined safety tests. Essentially, performance standards allow the companies, once again, to determine how to test for safety and prevent contamination. The idea is that the agency determines the performance level - e.g. no contamination (supposedly!) - and the company can come up with the means of meeting that standard (with agency concurrence) in any way it desires. In 2002, our National Academy of Sciences criticized USDA's regulatory oversight of GMOs, saying it was not scientifically rigorous. Recent events show that this has not changed substantially.

Finally, the U.S. Environmental Protection Agency (EPA) regulates both the food and environmental safety of all GMOs that produce pesticidal substances, such as the Bt crops (but not herbicide tolerant crops like roundup ready soybeans). This is also a mandatory safety approval process under U.S. law, but not nearly as strong as for chemical pesticides (also regulated under the same law). EPA requires a handful of human and environmental safety tests for these GMOs, unlike FDA or USDA, but these are few, and mostly of short duration. For example, the main dietary safety test is to feed a single high dose of the GE material to rodents, and follow their health for a month. The further details of these tests are usually left to the companies. So although EPA has the most specific requirements, they also are not very strong.

Overall, it is a very weak regulatory framework that should not be relied upon or emulated by anyone.

- Doug
Doug Gurian-Sherman, Ph.D.
Senior Scientist
Food and Environment
Union of Concerned Scientists
1707 H Street, NW
Suite 600
Washington, DC 20006-3962

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