The Special Case of Genetically Modified Crops
Pesticidal GMOs Under FIFRA
Pesticidal GMOs are regulated under FIFRA in much the same way as traditional chemical pesticides. The decision to treat GMOs similarly to traditional pesticides is rooted in the early US biotechnology policies of the 1980s. The United States government’s first systematic attempt to address the regulation of biotechnology in a comprehensive fashion was with the publication of the 1984 document entitled “Proposal for a Coordinated Framework for Regulation of Biotechnology.”1 The purpose of this document was “to provide a concise index to US laws related to biotechnology, to clarify the policies of the major regulatory agencies that will be involved in reviewing research and products of biotechnology, to describe scientific advisory mechanisms for assessment of biotechnology issues, and to explain how the activities of the federal agencies in biotechnology will be coordinated.”2 In 1986, the Office of Science and Technology Policy (OSTP) published in the Federal Register “Coordinated Framework for Regulation of Biotechnology: Announcement of Policy and Notice for Public Comment” (Coordinated Framework).3 During the 1980s and early 1990s, the executive branch of the US government was focused on promoting biotechnology as the US’s hope for strong economic future. The feeling at the time was that the US had allowed Japan to beat it in the electronics industry. The federal government was determined to not allow this to happen with the biotech industry. During this time, Vice President Quayle’s Council on Competitiveness became intensively involved in planning for the commercialization of biotechnology. The message was clear that regulatory agencies were not to stand in the way of biotechnology and were not to develop any new regulatory programs.4 For pesticidal GMOs this meant FIFRA. Moreover, a raging debate ensued over whether regulatory agencies should be regulating the “process” of genetic engineering or the “products” of genetic engineering. At that time, it was determined that from a risk standpoint, the process was irrelevant and that agencies should regulate only products of biotechnology. Under the coordinated framework, the regulatory approach taken by US regulatory agencies, including EPA, has been to rely on existing statutes and to focus on the “product” rather than the “process” used to create the product.5
Existing statutes provide a basic network of agency jurisdiction over both research and products; this network forms the basis of this coordinated framework and helps assure reasonable safeguards for the public. This framework is expected to evolve in accord with the experiences of the industry and the agencies, and, thus, modifications may need to be made through administrative or legislative actions.
The application of traditional genetic modification techniques is relied upon broadly for enhanced characteristics of food (e.g., hybrid corn, selective breeding), manufactured food (e.g., bread, cheese, yogurt), waste disposal (e.g., bacterial sewage treatment), medicine (e.g., vaccines, hormones), pesticides (e.g. Bacillus thuringiensis) and other uses. Federal agencies implement an array of laws which seek to ensure the safety of these products …. These laws are product-specific because they regulate certain product uses, such as foods or pesticides. This approach provides the opportunity for similar products to be treated similarly by particular regulatory agencies.
Biotechnology also includes recently developed and newly emerging genetic manipulation technologies, such as recombinant DNA (rDNA), recombinant RNA (rRNA) and cell fusion, that are sometimes referred to as genetic engineering. While the recently developed methods are an extension of traditional manipulations that can produce similar or identical products, they enable more precise genetic modifications, and therefore hold the promise for exciting innovation and new areas of commercial opportunity.
Concerns were raised as to whether products resulting from the recently developed techniques would pose greater risks than those achieved through traditional manipulation techniques. For example, what might be the possible environmental consequences of the many anticipated agricultural and environmental applications that will take place outside the physical constraints of a contained facility? In particular, the environmental application of genetically engineered microorganisms may elicit concern because they are of microscopic size, and some may be able to reproduce, proliferate, and become established.
The underlying policy question was whether the regulatory framework that pertained to products developed by traditional genetic manipulation techniques was adequate for products obtained with the new techniques. A similar question arose regarding the sufficiency of the review process for research conducted for agricultural and environmental applications.
The Administration, recognizing its responsibility to confront these concerns, formed an interagency working group under the former White House Cabinet Council on Natural Resources and the Environment in the spring of 1984. The working group sought to achieve a balance between regulation adequate to ensure health and environmental safety while maintaining sufficient regulatory flexibility to avoid impeding the growth of an infant industry.
Upon examination of the existing laws available for the regulation of products developed by traditional genetic manipulation techniques, the working group concluded that, for the most part, these laws as currently implemented would address regulatory needs adequately.
EPA’s primary authorities for regulating agricultural biotechnology products are found in two statutes: the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)6 and the Federal Food, Drug, and Cosmetic Act (FFDCA).7 Under FIFRA, EPA has the authority to address all environmental and human health issues associated with pesticide use. Under FFDCA, EPA has the authority to set tolerances for pesticide residues in or on food. EPA also regulates biologicals and biotechnology products that are not pesticides, food, or drugs under the Toxic Substances Control Act (TSCA).8 TSCA grants EPA the authority to screen new chemical substances and impose controls to prevent unreasonable risks and, through rulemaking, to acquire information and impose restrictions to prevent unreasonable risks on existing chemical substances. Although some agricultural biotechnology products may fall within the purview of TSCA, the majority of agricultural biotechnology products regulated by EPA are considered pesticides under EPA’s broad definition of the term, and thus, are regulated under FIFRA and FFDCA. For pesticidal GMOs, this means using FIFRA to regulate the “pesticide” rather than targeting regulation at the process by which the pesticide is created. GMOs that are intended to kill, disrupt, repel, or mitigate pests are regulated in much the same way as traditional chemical pesticides under FIFRA. As described above, section 2(u) of FIFRA defines the term “pesticide” as: “(1) any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest, and (2) any substance or mixture of substances intended for use as a plant regulator, defoliator, or desiccant ….” This definition is very broad and can include living organisms and substances produced by living organisms as well as traditional chemical pesticides. The definition of “pesticide” in FIFRA does not depend on the process by which a particular pesticide is produced. EPA has interpreted this definition to include biological pesticides and genetically modified pesticides. Thus, pesticidal GMOs must be registered under FIFRA prior to sale or distribution in the US. The standard for registration is the same for pesticidal GMOs as for traditional chemicals. EPA has developed some data requirements specifically geared to address potential risks from microbial pesticides, including microbial GMOs.9
The Coordinated Framework articulated two major policy choices that set the stage for at least the following 20 years of US regulation of biotechnology. First, the document stated that biotechnology could be adequately regulated under existing legal authorities and that new legal authorities were not necessary to address emerging technologies. The document stated: “Upon examination of the existing laws available for the regulation of products developed by traditional genetic manipulation techniques, the working group concluded that, for the most part these laws as currently implemented would address regulatory needs adequately.”10 Second, the document articulated a policy position that the “products” of biotechnology would be regulated rather than the “process” by which such products were created. The document provides that “[t]he manufacture by the newer technologies of food, the development of new drugs, medical devices, biologics for humans and animals, and pesticides, will be reviewed by FDA, USDA and EPA in essentially the same manner for safety and efficacy as products obtained by other techniques.”11 Specifically, the Coordinated Framework stated that “[t]echniques of biotechnology are not inherently risky in that biotechnology should not be regulated as a process, but rather that the products of biotechnology should be regulated in the same way as the products of other technologies.” 12 This approach was based on a belief that rDNA technology in itself does not create risk.13 Instead, certain types of products of biotechnology may pose risks that can be addressed in the same fashion that regulatory agencies address the risks posed by traditional chemical products. In other words, the Coordinated Framework set forth the position that the potential risks of genetic modification were not dependent on the process by which such modification was made, but instead only depended on the ultimate product that was produced regardless of the process or technology used.
In addition, the Coordinated Framework outlined the relationship and coordination between five federal agencies possessing legal authority in the regulation of biotechnology. These agencies include the Environmental Protection Agency (EPA), the United States Department of Agriculture (USDA), the Food and Drug Administration (FDA), the National Institutes of Health (NIH), and the Occupational Safety and Health Administration (OSHA).14 The two federal agencies identified in the Coordinated Framework as having the primary authority to regulate environmental risks posed by genetically modified organisms are the EPA and the USDA.15 The primary agency identified as having the authority to address risks from GMO food is the FDA.16
To date, EPA’s regulation of GMOs has focused on three categories: (1) the regulation under FIFRA and FFDCA of genetically modified microbial organisms that have pesticidal characteristics; (2) the regulation under FIFRA and FFDCA of genetically modified plants that have pesticidal characteristics; and (3) the regulation under TSCA of genetically modified microorganisms that do not have pesticidal characteristics. EPA does not yet have any rules governing genetically modified animals.
Currently, EPA regulates pesticidal GMOs under FIFRA in much the same way as it does traditional chemical pesticides.17 Thus, for pesticidal GMOs, EPA uses its authority under FIFRA to regulate the “pesticide,” rather than targeting regulation at the process by which the pesticide is created.18
EPA has stated that it recognizes that many of the types of restrictive labeling that it relies on to regulate traditional chemical pesticides may not be appropriate for pesticidal GMOs.19 For example, geographical limitations on the use of the GMO may not be meaningful if the organism that produces the pesticide can reproduce and spread in the environment beyond those geographical limits. Similarly, other use restrictions (e.g., “Do not use within 100 feet of a stream, river, or lake”) may not be particularly useful if seeds from plants that produce the pesticide are saved and planted during subsequent growing seasons. Such seeds would not be labeled, and it is at least possible that farmers using these seeds would not even be aware that the seeds were from plants that had been engineered to produce a pesticide. If a GMO pesticide is found to pose an unreasonable adverse effect on the environment after it is registered and in commerce, FIFRA provides mechanisms for the cancellation of the pesticide registration, or in the case of imminent risk, for the immediate and temporary suspension of the registration.20 As described above, EPA is authorized to cancel or suspend existing registrations based upon certain risk/benefit determinations.
During the 1990s, EPA attempted to develop a comprehensive regulatory program for GMOs. Unfortunately, these efforts were met with controversy, political pressure, scientific uncertainty, and bureaucratic delay, which together resulted in regulations for GMOs with very modest effect. The first EPA GMO final rule was the 1994 final rule on the regulation of GM microorganisms under FIFRA.21 The other significant final regulation was the July 19, 2001 rule for the regulation of GM pesticidal plants, which EPA currently calls “plant-incorporated protectants,” under FIFRA.22 Each of these rules took approximately 10 years to develop. Countless public hearings, scientific advisory council meetings, Congressional hearings and interagency negotiations were held. Despite all of these efforts, however, the resultant rules are quite modest and do not really tackle the complex and novel risks of GMOs. The thrust of the rules is to define the scope of regulation—i.e., to outline what types of pesticidal GMOs EPA believes warrant regulation based on risk/benefit considerations. The rules do not, however, impose any new approaches to regulating pesticidal GMOs. Instead, at least for the foreseeable future, EPA has chosen to rely on the old standby of FIFRA regulation, with the cost/benefit analysis leading to the label restriction.
Microbial GMO Pesticides
The first category of pesticidal GMOs to be regulated by EPA under FIFRA was microbial GMOs. EPA had regulated naturally occurring microbial pesticides, such as Bacillus thuringiensis (B.t.), for many years.23 In the early 1980s, when the pesticide industry began to develop microorganisms that had been genetically modified to impart or enhance a pesticidal characteristic, EPA began to regulate these organisms. Microbial pesticides are regulated in much the same way as traditional pesticides at the large-scale testing and registration stages. However, with regard to small-scale testing of microbials, EPA expressed concerns regarding the potential for adverse effects. Small-scale testing of most traditional pesticides is generally considered to pose very limited risks and thus is typically not regulated by EPA. Because microbial pesticides are living organisms that have the potential to reproduce and spread in the environment, even small-scale testing can present unreasonable adverse effects on the environment.24 Thus, EPA promulgated a rule that requires notification prior to any small-scale testing of certain microbial pesticides, including microbial GMOs.25
Section 5 of FIFRA authorizes EPA to issue experimental use permits (EUPs) for the testing of new pesticides or new uses of existing pesticides if it determines that the applicant needs such a permit to accumulate information necessary to register a pesticide under section 3 of FIFRA.26 EPA generally requires EUPs only for large-scale testing of pesticides.27 A large-scale test under Part 172 includes any terrestrial application on a cumulative acreage of more than 10 acres of land or any aquatic application on more than 1 acre of surface water.28 For traditional pesticides, EPA presumes that tests conducted on 10 acres or less of land or 1 acre or less of water (“small-scale tests”) would not require EUPs. For certain GM microorganisms, however, EPA determined that even small-scale tests warrant an evaluation.
In October 1984, EPA published a policy statement entitled “Microbial Pesticides: Interim Policy on Small Scale Field Testing”.29 In June 1986, EPA reiterated the provisions of the Interim Policy Statement as part of the Office of Science and Technology Policy’s Coordinated Framework for Regulation of Biotechnology.30 These policy statements described EPA’s concern about the potential for adverse effects associated with small-scale environmental testing of certain microbial pesticides. To address the situation, these statements specified that EPA be notified prior to initiation of small-scale testing of all non-indigenous and genetically modified microbial pesticides. The purpose of the notification was to allow EPA to conduct an assessment of these small-scale tests in order to make a determination as to whether or not the test should be carried out under an EUP that allows EPA oversight. In addition, the 1986 Policy stated EPA’s plan for future rulemaking to codify the interpretation set out in the policy. Subsequent to the issuance of the 1986 Policy, a number of documents were issued by EPA or other parts of the federal government having relevance to this final rule, including a Federal Register notice issued by EPA in February 1989,31 requesting comment on issues related to this final rule; Federal Register notices issued by the Office of Science and Technology Policy (OSTP) in July 199032 and February 199233 that addressed issues relating to the appropriate scope of federal oversight of introduction into the environment of modified organisms; and a “Report on National Biotechnology Policy” issued in February 1991 by the Council on Competitiveness. In addition, EPA made available to the public and to its FIFRA Scientific Advisory Panel (SAP) and Biotechnology Science Advisory Committee (BSAC) several draft proposals addressing the notification scheme for small-scale testing of certain genetically modified microbial pesticides. After almost 10 years of deliberation and a series of EPA and federal government-wide policy statements that were made available to EPA’s SAP and the BSAC, on September 1, 1994, EPA promulgated the final rule on experimental use permits and notifications for genetically modified pesticidal microorganisms.34
The rule codifies the early screening procedure first set forth in the Coordinated Framework by requiring notification before the initiation of small-scale field testing of certain microbial pesticides in order to determine whether an EUP is necessary. Under the rule, testing conducted in facilities designed and operated to adequately contain the microbial pesticide would not be subject to the notification requirements. Records describing containment, however, would be required to be developed and maintained.35
The most controversial issue that arose during the lengthy development of this rule was the appropriate scope of regulation. EPA decided to require notification for “microbial pesticides whose pesticidal properties have been imparted or enhanced by the introduction of genetic material that has been deliberately modified.”36 In other words, EPA rejected a “product”-based scope of regulation in favor of a “process”-based one.37
One other issue that was some what controversial was whether EPA should require notification for “non-indigenous” microbial pesticides. Under the 1984 Policy Statement and the 1986 Coordinated Framework, EPA had been requiring notifications to be submitted for all small-scale testing of non-indigenous organisms.38 In the final rule, EPA opted to require small-scale notification only for those non-indigenous microbial pesticides that have not been acted upon by the US Department of Agriculture either by issuing or denying a permit or determining that a permit is unnecessary. In the final rule, testing conducted in facilities designed and operated to adequately contain the microbial pesticide would not be subject to the notification requirements. Records describing containment, however, would be required to be developed and maintained.39 EPA based this decision on its belief that to do otherwise and continue the imposition of the notification requirement on all non-indigenous microbial pesticides would constitute duplicative oversight because the USDA/APHIS already regulates small-scale testing of the vast majority of these organisms. The final rule also contains several provisions that were not very controversial and were not changed significantly from what was proposed.
The final rule also includes provisions that enable EPA to address situations where small-scale testing results in unanticipated and untoward effects. Section 172.57 requires persons using microbial pesticides in small-scale tests to submit any information they obtain concerning the potential for unreasonable adverse effects from the microbial pesticide,40 and section 172.59 enables EPA to take immediate actions to prevent use of a microbial pesticide if such use would create an imminent threat of substantial harm to health or the environment. The final rule also amends 40 C.F.R. § 172.3 to clarify EPA’s rationale for presuming that an EUP is not required prior to small-scale testing with most pesticides. The language of section 172.3 is modified to clarify that the determination of whether an EUP is required would be based on risk considerations, rather than on a definitional presumption about whether a substance is a pesticide. This clarification has general applicability to all pesticides and is not limited to microbial pesticides.41