As a result of policies enumerated by the Coordinated Framework, regulatory control over GMOs in the United States was divided among different regulatory agencies. The consequences of such a decision was a myopic, and at times, haphazard regulatory control by each agency over GMOs. For USDA, this raises significant questions as to the agency’s ability to effectively regulate second generation GMOs.
USDA’s Regulatory Structure and Its Limits
The USDA’s GMO regulatory role, pursuant to the Plant Protection Act, is to determine whether GMOs are plant pests, a role carried out by Animal and Plant Health Inspection Agency (“APHIS”), within the USDA. The determination of whether a GMO is a plant pest generally requires the presence of a previously identified plant pest or genes from a plant pest in the transformed plant.12 APHIS, much like other agencies, interprets its regulatory authority narrowly and treats GM crops exactly like their conventional counterparts, evaluating them for the same risks,3 even though by their very nature, GMOs are different than the conventional counterparts. Such jurisdictional limits prevent AHPIS from conducting comprehensive analysis of GMOs.
As a result of APHIS’ limited view of its regulatory role, it has been known, for example, to allow GM plants to be deregulated if field tests show that the GMO will not pose a plant pest risk.4 In so doing, APHIS does not consider whether planting a GM crop modified to be resistant to an herbicide, for example, is likely to spread the trait of resistance more generally, nor does the agency consider the possible contamination that might result from pollen drift from GM plants to unmodified plants.56 In fact, APHIS, like other federal agencies, operates under the agreed upon, but questionable, assumption that products developed through biotechnology are “substantially equivalent” to their conventional counterparts.7 Indeed, the Coordinated Framework, responsible for United States’ GMO policy, expects that in most cases, genetically engineered crops “will be improved, and would therefore not pose any new threat to humans, other animal species, or to the environment.”8 The optimism and idealism in that premise is admirable, albeit, foolhardy, especially since neither at the time when the Framework’s GMO policies were enumerated, nor today, can anyone, independent and unconnected to the biotech industry, earnestly state that anything GM is safe.
USDA’s regulatory limitations became visible shortly after the Coordinated Framework developed the GMO policy. For example, an early analysis conducted by the General Accounting Office (now the Government Accountability Office) (GAO) in 1988, criticized the shortcomings in USDA’s oversight of GMOs, echoing calls by the scientific community that certain regulatory decisions were “scientifically indefensible.”91011 In particular, GAO criticized the decision to exempt certain categories of GMOs from regulatory scrutiny “prior to developing scientific information on the behavior of these organisms in the environment.”12
In addition to the shortcomings of the regulatory structure and its questionable assumptions, another serious concern is AHPIS’ historic inability to implement the laws that are already in place, limited as they may be.
APHIS’ Questionable Enforcement
On several occasions APHIS has come under fire for its lax approach to regulation of GMOs.13 For example, APHIS usually does not require permits for field testing of GM crops but rather allows the party to simply notify the agency that it intends to conduct field tests.1415 Not surprisingly, the notification process is favored by the industry as the requirements that applicants must meet are not as stringent as those for acquiring a permit. Since 1987, APHIS has authorized more than 10,000 field tests of GM crops. Once a GM crop has been field tested, its developer can petition for non-regulated status and approval for commercial sales.16 If a deregulation petition is granted, the subject plant is no longer considered a regulated article and is no longer subject to APHIS’ oversight.1718 More than 60 GMOs have been deregulated under this process.19 Most of these deregulated plants are genetically modified to produce the pesticide Bt or are engineered to be tolerant to herbicide exposure (or both).20
In addition to not requiring permits for field testing, in the last decade court battles involving GM alfalfa, sugar beets and sugar cane growers and USDA exposed serious regulatory failures within the agency, such as, for example, violating the National Environmental Policy Act by failing to conduct an environmental impact statement.
As second generation of GMOs are increasingly developed and grown, the laxness within the USDA is especially worrisome since it is the regulatory agency that will oversee pharma crops. No, FDA will have no regulatory role in overseeing pharma crops because they are are not intended for food, nor will the EPA play a regulatory role because pharma crops do not produce pesticides.21
And in case you are wondering what about pharma crops that is so disconcerting–they are genetically engineering crops designed to endogenously produce specialty pharmaceutical or industrial proteins.22 Many such crops are currently being planted in small test plots throughout the country.23 Once they are fully developed and approved, these pharma crops will be grown in the same agricultural fields that are currently devoted to producing traditional agricultural crops.24
And that is where the problem lies. Pharma crops may be coming to a field near you but you cannot rest assured that the regulatory structure in place is sufficient to protect your food supply, nor whether USDA, the agency entrusted with regulating pharma crops, will enforce the existing laws, no matter how limited they may currently be. USDA is infact ill-equipped to handle this regulatory responsibility. It has, for example, little experience or familiarity with the non-food compounds involved in pharma crops, some of which are known to have deleterious effects on human health.25 As such, a limited “plant pest” analysis will not begin to cover the myriad risks that accompany the new technology of crops.26
The USDA’s inexperience with pharma crops, combined with its historical regulatory laxness, is a dangerous and unhealthy mix and points to, once again, the need for our legislators to revisit the regulatory framework under which GMOs are controlled.
- 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 generally, Board on Agriculture and Natural Resources, Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation, (2002), available at, http://www.nap.edu/openbook.php?record_id=10258&page=1, (last visited on November 5, 2009).
- Rebecca Bratspies, Some Thoughts On the American Approach to Regulating Genetically Modified Organisms, 16 Kan.J.Law & Public Policy 393, 405-07 (2007).
- See also Tokar, supranote 1.
- See Bratspies, supra note 3 at 405-07.
- Id. (quoting the Coordinated Framework).
- Richard Caplan and Skip Spitzer, Regulation of Genetically Engineered Crops and Food in the United States, (2001), p. 8, available at http://www.pirg.org/ge/reports/GERegulations.pdf (last visited on November 9, 2009).
- BANR, supra note 2 at pp. 173-74 (noting that early in the history of permits issued by the USDA, a number of comments were submitted expressing the view that the U.S. regulatory approach was incomplete or had gaps).
- Bratspies, supra note 3 at 412.
- See e.g., Genetic Engineering Case Study: Unapproved GMO Rice Contaminates The Food Supply, http://www.calgefree.org/pdf/Rice_contamination_case_study_2008.pdf
- Id. at 412-13.
- Tokar, supranote 1.
- Bratspies, supra note 3, at 412-13.
- Id. at 413.
- Tokar, supranote 1.
- Bratspies, supra note 3 at 413.
- See Bratspies, supranote 3 at 413.
- Rebecca Bratspies, Consuming (F)ears of Corn: Public Health and Biopharming, American Journal of Law and Medicine (2004), republished here: http://www.allbusiness.com/legal/3587486-1.html (last visited December 16, 2009).
- Id.; see also Union of Concerned Scientists map showing pharma crop approvals in the United States: http://www.ucsusa.org/food_and_agriculture/science_and_impacts/impacts_genetic_engineering/pharma-crop-approvals-in-the.html.
- Bratspies, supra note 21.
- See Bratspies, supra note 3 at 413.