Critique of Regulation of Genetically Modified Foods and Crops in the United States

While more and more GMOs are populating our fields and being imported and transported around the world, and despite concerns from consumer advocate groups and scientists, the United States government consistently promotes its regulatory framework for genetically engineered organisms as comprehensive and strict. Is this a public relations maneuver, wishful thinking or the story of the emperor without clothes? Whichever it is, the fact remains that it is questionable whether the US regulatory framework controls and prevents potential harm from GMOs to animals and the environment.

The Coordinated Framework

The current regulation of GMOs dates back to 1986, when the US government developed the Coordinated Framework for Regulation of Biotechnology.1 The federal agencies in the Coordinated Framework decided that no new laws were needed to regulate the products of biotechnology because the consensus was that existing statutes seem adequate to deal with the emerging processes and products of genetic engineering.2 Interestingly, the policy was based on the assumption that the process of biotechnology itself posed no unique or special risks.3 Many people question whether such an assumption is accurate because it is precisely the process that makes GMOs unique.4 GMOs are organisms that cannot be created using traditional breeding methods.5 The process is imprecise and unpredictable and more often than not, it results in failure.6 Getting a useful product out of that process depends on the use of viral vectors, anti-bacterial markers, promoters, switches and other genetically altered molecules to succeed.7 As a leading professor of cell biology and anatomy stated recently, the industry’s assertion that the outcomes of genetic modification are more predictable than traditional breeding, allegedly because the manipulations are more precise at the DNA level, ignores the findings of cell physiology and evolutionary biology.8 Indeed, it is precisely these process-related molecules that could cause problems and are the basis for some of the safety concerns of other countries and international biosafety protocols.9

The framework thus established by the Coordinate Framework regulates the end product rather than the process. In other words, foods developed via biotechnology would be regulated in the same way as other foods developed through conventional processes,10 even though the two are nothing alike. Likewise, microbial pesticides developed from biotechnology would be regulated in the same manner as other microbial pesticides.11

In the final analysis, what we have is an elaborate patchwork quilt of already existing laws that would regulate GMOs instead of making new laws.12 And while new regulations were issued to try to deal with emerging issues, there were and continue to be difficulties in applying old statutes, written for completely different purposes, to the regulation of completely novel organisms that pose novel risks.13 Furthermore, the three regulatory agencies charged with the oversight operate only under their own legislation without much coordination between the three.14

Still feel safe?

Read the next series of articles which take an in-depth look at the shortcomings of each agency’s role in regulating GMOs.

  1. Pew Initiative on Food and Biotechnology, Guide to U.S. Regulation of Genetically Modified Food and Agricultural Biotechnology Products, p. 1 (2001), available at (last visited on September 18, 2009); see also Richard Caplan and Skip Spitzer, Regulation of Genetically Engineered Crops and Foods in the United States, p. 2 (2001), available at (last visited on September 18, 2009); Doreen Stabinsky, Critique of US Biosafety Regulation and Implementation, Greenpeace International, College of the Atlantic (USA).
  2. Caplan and Spitzer, supra note 1, at p. 2.
  3. See Pew Initiative, supra note 1, at p. 1.
  4. Claire Hope Cummings, Are GMOs Being Regulated or Not? (June 2003), available at (last visited on September 21, 2009).
  5. Id.
  6. Id.
  7. Id.
  8. Stewart A. Newman, Science At The Crossroads: Genetically Modified Foods And The Attack On Nature, Capitalism Nature Socialism, Vol. 20, No. 2, p.27 (June 2009), available at (last visited on September 29, 2009).
  9. See Cummins, supra note 4.
  10. See Pew Initiative, supra note 1, at p. 1.
  11. Id.
  12. See Stabinsky, supra note 1, at p. 1.
  13. Id.
  14. See Cummins, supra note 4.