As previously discussed here at GMO Journal, the Environmental Protection Agency’s (“EPA” or “Agency”) authority in regulating genetically engineered crops stems primarily from the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”), the Federal Food Drug and Cosmetic Act (“FFDCA”), as well as the Toxic Substance Control Act (“TSCA”). These statutes limit EPA’s oversight to only certain genetically modified crops, namely those producing pesticides internally. Yet, even within this limited jurisdiction, the Agency’s oversight is not without criticism. As will be explored more fully below, the Agency is often seen as having industry bias, relying on scientifically questionable industry studies, ignoring adverse impacts on non-target organisms, exempting food crops containing pesticides from any registration requirements and failing to independently monitor GMOs after it has approved them.
Questions Concerning PIPs’ Registration
By way of background, EPA uses its authority under FIFRA to regulate plant incorporated protectants (“PIPs”), or substances produced to control pests.1 In other words, plants that are genetically engineered to produce pesticides are treated as pesticides by the EPA. Such pesticide incorporating plants, like other pesticides, must go through a pre-market registration (or approval) process to examine potential health and environmental effects.2
Registrations of such crops, however, are subject to some of the same shortcomings as registration of conventional pesticides.3 For example, EPA generally relies on research provided, and often conducted, by the industry applicant, potentially compromising its objectivity.4 Tainted industry research in pesticide registration has long been a problem.5
Richard Caplan and Skip Spitzer, for example report that a peer-reviewed report released by EcoStrat, an independent Swiss scientific assessment firm, indicated instances where the Agency accepted inappropriate and scientifically questionable studies in approving the first Bt corn for U.S. growers. In fact, the report states that studies submitted by Novartis and Mycogen to determine the effect of Bt corn on non-target insects were so poorly designed that there was virtually no chance that adverse effects would be observed.6
Given that PIPs are genetically modified plants, and given the nature of plants and the methods of genetic modification used, raises many other significant issues outside the realm of conventional pesticides that EPA has not fully addressed. Compared to conventional pesticides, plants genetically engineered to produce pesticides make risk assessment much more complex. As living engineered organisms, they reproduce and spread their DNA by wind or insect pollination, are extremely difficult to trace, and are impossible to recall.7 It can also be nearly impossible to fully identify how a crop has been modified, since gene insertion may result in unintended changes to an organism’s DNA.8 Some of those modifications may not become known until subsequent generations.
The methods of genetic modification are also highly problematic, despite the industry’s best efforts to downplay all the things that can go wrong when a gene from a distant or foreign species is inserted into a plant. For example, Stewart A. Newman, a professor of cell biology and anatomy, writes that when such a foreign introduction is made into the plant (“transgenesis”), it throws an entirely new component into the biological mix.9 This can potentially change the levels of the hundreds to thousands of potentially toxic molecules every plant is capable of manufacturing.10 Moreover, different insertions of the same “transgene”into the same plant can result in vastly different phenotypes (appearance) due to variations in the position of insertion in the chromosomes.11 In addition, transgenesis can inadvertently induce extensive scrambling of the genome.12 In other words, contrary to industry’s claims, genetic modification is not precise and it is precisely that imprecision which can result in unintended and unanticipated results. While EPA may not necessarily share this view, many people would argue that reason dictates that the uncertainties associated with genetic modification and the methods of plant reproduction, should require that more, and not less, caution be taken when approving a GM product.
The EPA’s less-than-prudent approval process has other ramifications.
EPA, Growth of Superbugs and Adverse Impact on Non-Target Animals
Plants engineered to produce pesticides internally spur the development of pest resistance differently than conventional pesticides. Bt crops generally contain a toxin in every cell, throughout the life of the plant and beyond, regardless of actual need to control pests.13 It is no longer possible to deny that this ever-present pesticide exposure will, and does, create resistant species, “superbugs” and “superweeds”, in a relatively short period. Superweeds are not just a headache for a farmer but they have the potential to disrupt ecosystems that are already under threat from climate change.14 Despite this hazard, EPA is criticized for approving some Bt crops without requiring immediate implementation of resistance management plans, which would require a farmer growing GMOs to allocate a certain percentage of the field to non-gmo varieties.15
Only under pressure exerted by agency watchdogs did EPA eventually mandate management plans in which non-GE crops are required to be grown alongside Bt varieties as insect refuges to slow the development of resistance.16 The EPA has not, however, placed significant emphasis on implementation of the refuge requirements, developed an effective compliance program, or followed advice of their scientific advisory panel on the optimum size of refuges.17 For example, while scientific advisers suggested that up to 20% of cotton fields should be planted with non-Bt cotton, the EPA has required farmers to plant only 5% of the non-GE variety.18 Additionally, there is reason to believe that many growers create smaller-than-prescribed refuges, count their neighbor’s land as part of their own refuge, or ignore the requirement altogether.19
More alarmingly is that even if these management plans were fully implemented, they will only delay the onset of resistance, not prevent it.20 While pest resistance is a common occurrence in our modern, pesticide-laden agriculture, Bt resistance, is of particular concern to organic growers. In its non-GE form, Bt toxin is an extremely valuable pesticide and it would be a considerable loss to squander its effectiveness.21 In fact, Bt biopesticides are of great importance to organic growers, a majority of whom depend on it, at least as a tool of last resort.22 Bt resistance is, to use the proverbial expression, a ticking time bomb for the growing organic sector. Yet EPA registers Bt crops without adequately assessing this potential impact.
The EPA has also failed to adequately address the impact of pesticide crops on non-target insects which are effected in novel ways. Research suggests that pollen of at least some Bt crops may harm lacewings, honey bees and monarch butterflies.23 EPA, however, accepts industry applicants’ reports despite the obvious shortcomings in the studies often presented to the Agency. Brian Tokar, for example, notes that, in one instance, studies of the potential consequences of Bt toxins for non-target insects (e.g., honeybees) were carried out for only a few days, far from sufficient time needed to detect any possible medium- to long-term health and behavioral effects. And yet the EPA approved the Bt toxin anyway.24
In another instance, it was only after the publication in Science magazine of an article demonstrating impacts of Bt corn pollen on Monarch butterflies, that the EPA conducted several field studies to investigate the potential scope of impacts.25 The field studies showed that one variety, Bt176, expressed such high levels of Bt in the pollen that indeed it would be toxic to butterflies at pollen concentrations normally found in the wild.26 Despite this showing, the EPA did not immediately remove Bt176 from the market, but allowed the company to let its permit expire and gave it several years to get rid of existing seed stocks.27
Beneficial soil organisms are also harmed in novel ways by GMOs. For example, when grown in soil in which Bt corn had previously been cultivated, nematode worms, important organisms in soil ecology, had significantly reduced reproduction and growth compared with worms reared on soil from plots of non-GM corn.28 Honeybees whose food was laced with the distinctive protein of Bt corn had disturbed feeding behavior and learning performance.29 Mammals are also vulnerable to GMOs: rats fed over three generations on a diet containing Bt corn experienced pathological changes in their livers and kidneys.30
EPA and Pesticides in Our Food
The EPA also determines how much pesticides we get to eat because the Agency, pursuant to FFDCA, sets tolerance limits (“safe” levels) for pesticides on and in food and feed, or establishes exemptions to tolerance requirements. Don’t be surprised that Bt pesticide food crops, which represent pesticides in our food, are routinely granted exemptions based on the alleged relative safety of conventional Bt pesticides.31 Thus, for example, EPA deems Bt potatoes safe to eat, since conventional Bt pesticides are considered safe.32 Bt potatoes, however, may contain novel or altered proteins due to the imprecision of gene insertion and these may have serious health consequences.33 For example, Arpad Pusztai, a scientist at a Scottish research institute, found that feeding rats with GM potato caused intestinal lesions.34 The Agency has also agreed to raise the allowable tolerance levels of chemical herbicide residues on crops that are engineered to tolerate exposure to herbicides (e.g., roundup ready beets and alfalfa35), thus permitting higher levels of chemical weed killers in our foods.36
The EPA’s failure to adequately regulate GMOs, symbolic of the failure of other federal agencies, leads to an uncomfortable realization that that present federal oversight is insufficient to address the potential environmental, human and animal health, and economic consequences of genetically engineered crops.
- Pew Initiative on Food and Biotechnology, Guide to U.S. Regulation of Genetically Modified Food and Agricultural Biotechnology Products (2001), available at http://www.pewtrusts.org/uploadedFiles/wwwpewtrustsorg/Reports/Food_and_Biotechnology/hhs_biotech_0901.pdf (last visited on September 29, 2009); see alsoDonna U. Vogt and Mickey Parish, Food Biotechnology in the United States: Science, Regulation, and Issues (United Stated Dept of State), available at http://fpc.state.gov/fpc/6176.htm(last visited on September 29, 2009).
- Richard Caplan and Skip Spitzer, Regulation of Genetically Engineered Crops and Foods in the United States, p. 2 (2001), available at http://www.pirg.org/ge/reports/GERegulations.pdf (last visited on September 27, 2009).
- Id. at 4.
- Id. at 4-5.
- Id. at 5.
- 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 http://www.nymc.edu/sanewman/PDFs/CNS_GM_foods_09.pdf (last visited on September 29, 2009).
- See id.
- See Newman, supranote 9 at p. 24.
- Doreen Stabinsky, Critique of US Biosafety Regulation and Implementation, Greenpeace International, College of the Atlantic (USA).
- Id.; see also Caplan and Spitzer, supranote 2 at p. 6.
- See Stabinsky, supra note 15.
- See Caplan and Spitzer, supra note 2 at p. 6.
- See Caplan and Spitzer, supranote 2 at p. 6.
- See id.
- See id.
- Brian Tokar, Deficiencies in Federal Regulatory Oversight of Genetically Engineered Crops, Institute for Social Ecology Biotechnology Project (June 2006), available at http://environmentalcommons.org/RegulatoryDeficiencies.html(last visited on September 29, 2009).
- See Stabinsky, supra note 15.
- See id.
- Newman, supra note 9, p. 24 (citations omitted).
- Id. (citations omitted).
- Id. (citations omitted).
- See Caplan and Spitzer, supra note 2 at p. 7.
- See Newman, supranote 9 at p. 25. Incidentally, Newman notes that Arpad Pusztai was fired by the research institute after his findings of the adverse impacts of genetically modified potato.
- Roundup ready beets present an interesting case study on the divided and disjointed regulatory framework in U.S., demonstrating that the concerns with GMOs are at once regulatory and compliance based. Roundup ready beets would have been subject to both EPA and USDA regulation, with the EPA approving the plants based on the pesticides they contain, and the USDA controlling the crops through its permitting program that grants or denies permits for planting of such crops. Recently, one District Court has found that USDA did not perform an environmental impact statement prior to permitting the cultivation of Roundup Ready beets and ordered that the agency comply with the law, but nothing about the EPA’s regulation was challenged in the suit because the EPA may have technically complied with its regulatory directives, despite the many questions that critics raise with respect to the EPA’s regulation and approval of pesticides containing crops. As such, the US regulatory framework suffers shortcomings with respect to its laws laws, namely, whether they go far enough to protect everyone and everything impacted by GMOs, as well as compliance problems of the agencies in charge of implementing the existing laws, however limited they may be.
- See Tokar, supra note 23.