We conclude that state and local jurisdictions should retain the power to address specific problems with GE crops that are not sufficiently addressed by federal regulators.
Does the federal government regulate genetically engineered crops?
No federal laws have been passed to specifically regulate genetically-engineered crops. Since 1986, responsibility for GE foods and crops has been divided among three federal agencies, based upon preexisting statutes:
According to a 2004 peer-reviewed study by William Freese, policy analyst for Friends of the Earth and David Schubert of the renowned Salk Institute,2 "claims regarding the safety of these crops... are founded mostly on unpublished studies conducted by the crop developer."3 Independent scientists are often denied access to proprietary plant material, and researchers who have identified significant problems with GE crop varieties have been subjected to ostracism and loss of academic standing. Thus, regulators are unusually beholden to the developers of GE crops for information regarding their potential consequences. According to Henry Miller, chief of biotechnology regulation at the FDA from 1979-1994, "In this area, the US government agencies have done exactly what big agribusiness has asked them to do and told them to do."4
Because the USDA-APHIS has primary jurisdiction over genetically engineered seeds and plants in the field, this summary will focus mainly on this agency. Deficiencies in FDA and EPA oversight will be summarized in the final section.
How does the USDA oversight of GE crops actually work?
There are three components of USDA's process with respect to GE crops: Notification, Permitting and Deregulation:
Is USDA oversight of GE crops adequate?
Two independent scientific assessments have been commissioned to evaluate the efficacy of the USDA oversight process: a 2002 report by the National Research Council of the National Academy of Sciences,9 and an internal USDA Audit Report, published in 2005.10 Additionally, public interest organizations such as the Consumers Union, Union of Concerned Scientists, Friends of the Earth, and others have assessed various aspects of the USDA's oversight process for genetically engineered crops.
Concerns highlighted in these reports include:
Limits to USDA jurisdiction: The jurisdiction of APHIS is limited to potential plant pests, including noxious weeds. This generally requires "the presence of a previously identified plant pest or genes from a plant pest in the transformed plant."11 Other potential hazards from growing GE varieties do not fall under the agency's jurisdiction, including locally noxious effects that are not listed on the federal noxious weed registry.12 In one instance, the USDA allowed the growing of corn engineered to produce a substance with known toxic properties under its simple 30-day notification process.13
The 2002 National Academy of Sciences report further addressed the lack of regulatory attention to the broad environmental consequences of genetically engineered plants: "There has been no environmental monitoring of these transgenic crops, so any effects that might have occurred could not have been detected. The absence of evidence of an effect is not evidence of absence of an effect."14
Reliability of APHIS risk assessments: The National Academy of Sciences panel also concluded that the APHIS review process for GE crops was neither transparent nor scientifically rigorous. NAS experts pointed to a lack of scientific peer review and public input as well as applicants' failure to clearly present their data, methods, analyses and interpretations.15 APHIS does not rely sufficiently on independent scientific experts, especially in potentially precedent-setting decisions.16 Companies are allowed to hide vast amounts of data as Confidential Business Information (CBI); even the NAS Committee was hampered in its review by excessive CBI. In addition, APHIS is chronically understaffed in the area of ecological analysis.17 Unintended genetic or metabolic effects of the transgene on the host plant go unreported, unless they visibly alter the plant's weediness or fitness.18
The USDA's own Inspector General states that "weaknesses in APHIS regulations and internal management controls increase the risk that regulated genetically engineered organisms will inadvertently persist in the environment before they are deemed safe to grow without regulation,"19 and that "APHIS lacks basic information about the field test sites it approves and is responsible for monitoring, including where and how the crops are being grown, and what becomes of them at the end of the field test."20 For instance, USDA inspectors found that companies frequently only listed their business address, failing to specify the locations of the field trials. The auditors recommended that applicants be required to submit basic field trial protocols to ensure gene containment, and make these available to USDA inspectors, a recommendation that was rejected by APHIS officials.21 By refusing to require submission of these protocols, the auditors concluded that "APHIS is relinquishing its regulatory responsibility in favor of self-certification by the notification applicants."22 In many instances, this may represent a significant risk to public health and the environment.
Lack of post-commercialization testing and monitoring: APHIS considers deregulation to be "absolute," according to the National Academy of Sciences study. Environmental effects, however, are more likely to appear at the scale of a commercial planting as compared to a test plot.23 Many such effects are scale-dependent, including harm to locally important plants and wildlife, and are not considered in the standard application process.24 The National Academy panel proposed a program of ongoing environmental monitoring to assess unanticipated or long-term environmental impacts, as well as "any potential impacts of transgenic plants on regional farming practices or systems in its deregulation assessments."25 This recommendation has not been implemented by USDA. APHIS also does not require holders of permits to grow crops that are engineered to produce pharmaceutical and industrial chemicals to report on the final disposition of these potentially hazardous materials.26 For instance, over two tons of crop material containing plant-produced pharmaceuticals were stored at two locations for over a year without the knowledge of APHIS, much less inspection of the storage facilities or approval of handling procedures.
Weaknesses in inspection and enforcement: The USDA's inspectors reported a lack of coordination between the agency that oversees inspection of permitted field test sites, and the agency that actually carries out inspections. Of the field trials reviewed by the auditors, barely half of the required inspections took place - just 23 of 60 for high-risk pharmaceutical crop field trials. Sites are not selected for inspection based on systematic risk assessment criteria, and violations are often not reported in time to address problems. Of 11 field trial violations found by the auditors, none had been recorded, and USDA's Biotechnology Regulatory Services had taken enforcement action on only one.27 Companies are not held financially responsible for the consequences of unauthorized releases of regulated GMOs, and crops are often allowed to lie in fields for months after harvest, without regard to potential effects on wildlife or human passersby.28
Additional concerns raised by critics of the USDA permitting processes include:
How well do the EPA and FDA address environmental and food safety concerns?
The Environmental Protection Agency (EPA) has jurisdiction over plants that are genetically engineered to produce pesticides, most notably the family of toxin proteins derived from the bacterium Bacillus thuringiensis (Bt). The Agency disavows authority over any aspects of GE plants other than these incorporated pesticides and the pesticides that are sprayed on GE crops. As with the USDA's oversight process, the EPA relies almost entirely on company data, and does not require an approved set of laboratory tests to help assure meaningful results. For example, 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 to detect any possible medium- to long-term health and behavioral effects.36
Meanwhile, the EPA has used its authority under the Federal Food, Drug and Cosmetic Act to exempt the pesticides currently produced by GE plants from any limit on human exposure. At the same time, the agency has agreed to raise the allowable tolerance levels of chemical herbicide residues on crops that are engineered to tolerate exposure to herbicides, thus permitting higher levels of chemical weed killers in our foods. Finally, the EPA does not require any medium or long-term feeding studies with GE products on test animals, as recommended by many experts.
The biotech industry often claims that the safety of their products for human consumption has been certified through a rigorous approval process carried out by the Food and Drug Administration (FDA). The FDA's actual role, however, is far different from this. Whereas chemical food additives regulated under the federal Food, Drug and Cosmetic Act do undergo pre-market review and approval, GE crops are only subject to "voluntary consultations" with companies that choose to consult with the agency about their products. Because the consultations are voluntary, FDA does not specify a required list of studies or test methods, but instead accepts superficial in-house summaries of whatever testing the company has chosen to do. FDA requests for additional data sometimes go unfulfilled.
The result is a system in which companies essentially "self-certify" their GE crops as safe. This is well illustrated by the letter FDA sends companies after a consultation is complete, a typical example of which reads as follows:
"...it is our understanding that Monsanto has concluded that corn products derived from this new variety are not materially different ... from corn currently on the market, and that the genetically modified corn does not raise issues that would require pre-market review or approval by FDA ... as you are aware, it is Monsanto's responsibility to ensure that foods marketed by the firm are safe, wholesome, and in compliance with all applicable legal and regulatory requirements."37
FDA political appointees and other officials essentially ignored the recommendations of agency scientists, who proposed a mandatory system involving required tests for toxicity and other unintended health effects.38 The FDA has likewise ignored numerous recommendations from independent scientists to require rigorous testing of GE foods for mutagenic effects, toxicity, altered nutritional composition, reproductive effects and allergenic properties. Instead, the FDA's consultative process allows for chronic abuses, including: test protocols designed to hide potential problems; substitution of "surrogateproteins," derived from genetically engineered bacteria, for the proteins actually produced by a GE plant; and flouting of widely accepted scientific protocols, such as those recommended by the World Health Organization to identify potential human allergens.39 The FDA does not recommend, much less require, that companies carry out animal feeding trials with the intact GE crop.
In a public statement announcing the comprehensive, peer-reviewed study of federal regulation of GMOs (co-authored with William Freese, policy analyst for Friends of the Earth), Dr. David Schubert of the renowned Salk Institute described the disturbing conclusion of their evaluations:
"One thing that surprised us is that U.S. regulators rely almost exclusively on information provided by the biotech crop developer, and those data are not published in journals or subjected to peer review... The picture that emerges from our study of U.S. regulation of GM foods is a rubber-stamp 'approval process' designed to increase public confidence in, but not ensure the safety of, genetically engineered foods."40
This and numerous other careful studies conclude that present federal oversight is insufficient to address the potential environmental, human health, and economic consequences of experimental genetically engineered crops.
In the absence of sufficient federal oversight, local jurisdictions should retain the ability to monitor genetically engineered plantings, address possible unforeseen consequences, and respond to any emergency conditions that may arise. Local jurisdictions are better able to respond to matters involving local residents' health, safety, and welfare. Thus there should be no new laws limiting the capacity of local jurisdictions to control the use of genetically engineered seeds or crops.
Home | About Us | Local Food | GMOs | Precautionary Principle | Toxics | Resources | Donate | Contact | Sitemap
All content on this website is governed by a Creative Commons License, except where noted.