How can the public trust government agenciesÂ to ensure the safety of GMOs if those agencies have a long track record of failure?1 Â Take the United States Department of Agriculture (â€śUSDAâ€ť or â€śAgencyâ€ť) as an example.Â Its regulatory track record, as discussed below and elsewhere at GMO Journal, begs the question of whether it is a government â€śregulatoryâ€ť agency or an industry group.2Â While the specific examples of the Agencyâ€™s failure will be discussed separately, the focus here is on examining the main factors that contributed to regulatory inadequacy.
One of those factors, which also plagues other federal agencies, is that USDAâ€™s regulatory authority over GMOs stems from the Coordinate Framework. The Framework established certain guiding principals which many critics find indefensible.Â For example, under the Framework biotechnology is assumed to pose no risk, only the products of biotechnology are regulated (not the processes), existing laws are used to regulate the products of biotechnology (rather than advising that new laws devised to deal with novel technology be passed), and regulatory gaps, it is presumed, wouldÂ be addressed through coordination among agencies.3Â By assuming that biotechnology is safe and that the focus of regulation should be on the end product and not the process leads to another controversial principle established by the Framework, namely, that GMOs are functionally equivalent to their unmodified counterparts (doctrine of â€śsubstantial equivalenceâ€ť).4Â Despite criticism, these assumptions and principals continue to defineÂ the American GMO regulatory regime. As a result, there is a lack of coherent comprehensive government policies in theÂ United StatesÂ that ensure that new technology is safely explored.5
In this regulatory hodgepodge, the USDA, much like other federal agencies, narrowly focuses on its regulatory GM universe while ignoring overarching questions of safety.6Â Much like its sister agencies, USDA has its own mission and regulatory structure, and regulates under the authority of federal statutes, none of which were enacted to address biotechnology.7
Another factor that contributes to USDAâ€™s failure to adequately regulate GMOsÂ is that, similar to other government agencies,8Â USDA is tainted with the â€śrevolving-door” syndrome where industry members make smooth transitions into key government posts and back.9Â While the concept of appointing industry leaders to government agencies designed to regulate those same industries seems like an obvious conflict of interest to many, apparently government officials appointing industry members to government posts believeÂ differently and have an admirable conviction in the ability of their appointees to conduct themselves objectively.Â The rest of us, however, get to live out the effects of the decisions made by (insider)regulators.Â And as many of us already know, the little personâ€™s interests are often left out of the equation or, if considered, then only as a distant after thought.Â Â Only when those voices combine into an uproarÂ is there a government reaction–but that is democracy 101 and beyond the scope of this article.
In the final analysis, the combination of inadequate regulatory structure, antiquated and ill-designed to deal with the novel questions presented by the new technology, combined with industry sympathizers as regulators, results in a government agency that is less than willing to regulate and more than willing to pass favorable regulation.
- See Rebecca Bratspies, Some Thoughts On the American Approach to Regulating Genetically Modified Organisms, 16 Kan.J.L. & Pub. Pol. 393, 395-98 (2007) (discussing US regulatory agencies and GMOs and noting that â€ś[o]nly when the public believes it has reason to trust that regulators are acting in the public interest will assessments of risks and benefits that underlie regulatory decisions be credible. The most important determinants of trust are a track record of good decisions and an unbiased source.â€ť) (internal citations omitted).
- It is worth mentioning that USDA stands at interesting crossroads. While many believe that the Agencyâ€™s mission is to protect consumers by ensuring food safety, after all, who has not seen the â€śUSDA Inspectedâ€ť label on meat products, the Agency lists as its â€śkeyâ€ť missions, mentioned first, as â€śexpanding markets for agricultural products and support international economic development, further developing alternative markets for agricultural products and activities.â€ť USDA Mission Statement, available atÂ http://www.usda.gov/wps/portal/!ut/p/_s.7_0_A/7_0_1OB?parentnav=ABOUT_USDA&navid=MISSION_STATEMENT&navtype=RT (last visited on November 24, 2009).
- See Bratspies, supra note 1, p. 406; Pew Initiative on Food and Biotechnology, Guide to U.S. Regulation of Genetically Modified Food and Agricultural Biotechnology, pp. 5-6 (2001), available at http://www.pewtrusts.org/uploadedFiles/wwwpewtrustsorg/Reports/Food_and_Biotechnology/hhs_biotech_0901.pdf.
- Initiative, supra note 3, p. i.
- Bratspies, supra note 1, p 407.
- Id.; see also Brian Tokar, Deficiencies in Federal Regulatory Oversight of Genetically Engineered Crops, Institute for Social Ecology Biotechnology Report (June 2006), available at http://environmentalcommons.org/RegulatoryDeficiencies.html (last visited November 15, 2009).
- See e.g., Jeffrey M. Smith, Seeds of Deception, pp.127-159 (2003).
- Philip Mattera, USDA INC: How Agribusiness Has Hijacked Regulatory Policy at The US Department of Agriculture, available at http://www.tradewatch.org/documents/USDAInc.pdf(last visited on November 15, 2009); see also Carol Eisenberg, Revolving Door Between Meat Industry, USDA Raises Consumer Safety Concerns, July 2, 2008; Organic Consumer Association, Take Action: Stop Sidiqqi, available at http://salsa.democracyinaction.org/o/642/campaign.jsp?campaign_KEY=27042 (last visited on November 29, 2009); Mindfully.Org has a good summary aptly called The Revolving Door, available at http://www.mindfully.org/GE/Revolving-Door.htm(last visited on November 29, 2009); Political Friendster created a great chart on Michael Taylor, available at http://www.politicalfriendster.com/showPerson.php?id=2590&name=Michael-Taylo(last visited on November 29, 2009); see generally, Anne C. Mulkern, When Advocates Become Regulators, available at http://www.mindfully.org/Reform/2004/Advocates-Become-Regulators23may04.htm (last visited on November 29, 2009).