TESTIMONY OF JANET L. ANDERSEN, Ph.D
JANET L. ANDERSEN, Ph.D
DIRECTOR, BIOPESTICIDES AND POLLUTION
OFFICE OF PESTICIDE PROGRAMS
OFFICE OF PREVENTION, PESTICIDES, AND
U.S. ENVIRONMENTAL PROTECTION AGENCY
COMMITTEE ON SCIENCE
SUBCOMMITTEE ON BASIC RESEARCH
U.S. HOUSE OF REPRESENTATIVES
October 19, 1999
Good morning, Mr. Chairman and members of the Committee. I am pleased to appear before you today to discuss the Environmental Protection Agency's (EPA) role in the assessment and regulation of pesticide products produced through biotechnology which are called genetically modified organisms, or GMOs. I welcome the opportunity to participate on this panel to explain what the Agency is doing in this area. As always, we are working closely with our partner agencies, the U.S. Department of Agriculture (USDA) and the Food and Drug Administration (FDA) to ensure that crop plants created using biotechnology, and food from such plants, are safe to both people and the environment.
Biotechnology has great potential to reduce our reliance on some older, more risky chemical pesticides, and to lower worker and ecological risk. Regulation of these products must ensure that we manage and mitigate any risks posed by these products to assure the protection of public health and the environment. Products of biotechnology are not without controversy, some real--some speculative. Many people, including us, have legitimate concerns and questions, especially in the scope of products EPA regulates, resistance management, and protection of non-target species. The application of the technology is continuing to evolve. There is confusing and often misleading information reported in the press that has also leads to misunderstanding and mistrust.
EPA is taking steps to address the issues and answer the many questions. We are rigorously reviewing plant-pesticides, finalizing rules to allow us to focus regulatory attention on those plant-pesticides presenting higher levels of risk and developing data requirements to ensure protection; we have standards in place to protect children; we are using the latest science and the recommendations of renowned scientific experts; we will take appropriate action to protect non-target and endangered species; and we will continually review these product registrations to make sure we are protecting the public and the environment.
In the early 1980s, companies began to apply the techniques of genetic engineering to agriculture for widespread commercial use. Also at this time, the Federal government began to evaluate its options for regulating products created using biotechnology. In 1986, the Administration released a document entitled the "Coordinated Framework for Regulation of Biotechnology," which laid out a broad approach to regulating biotechnology products. The products of biotechnology would be regulated under existing statutes and in a manner similar to the regulatory approach used for products not produced through this technology. Thus, products that are intended to be used as pesticides would be regulated under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) and the Federal food, Drug and Cosmetic Act (FFDCA). The general Framework has been reaffirmed throughout following Administrations, including the current one.
In general, the Framework established an approach to regulating the products of this new technology, not the process used to create them. Rather than seek new legislative authority, the Administration concluded that it could appropriately regulate these products using existing laws, but also recognized that, for each agency, new regulations may be needed. Congress also considered the possibility of developing new legislative authorities specifically for regulating biotechnology products, but ultimately agreed with the approach put forth in the Framework.
Under the Coordinated Framework, EPA currently regulates genetically engineered non-pesticidal microorganism products under the Toxic Substances Control Act (TSCA), and pesticidal products and their residues under FIFRA and FFDCA, including genetically engineered microorganisms and plant-pesticides products. To tailor existing regulations to adequately address biotechnology products, EPA proposed three sets of rules. To date, EPA has final versions of two of these proposed rules--one deals with field testing of microbial pesticides under FIFRA and the other deals with regulating microbial biotechnology products under TSCA. The third set of rules, addressing plant-pesticides and exempting the majority of them from regulation by EPA, have yet to be finalized. EPA plans to publish the final regulations pertaining to plant-pesticides next year.
EPA'S REGULATORY APPROACH TO PLANT PESTICIDES
To fully understand our regulatory approach to plant-pesticides, some basic information on biotechnology may be helpful. EPA's jurisdiction under the Federal Insecticide, and Fungicide Act (FIFRA) is limited to pesticidal substances. For example, a plant that has been genetically modified to resist disease comes under our FIFRA authority, whereas a plant that has been modified to resist drought does not. The former comes under our authority because the substance produced by the plant acts as a pesticide by affecting a pest. In this later instance, a substance produced by the plant may result in, for example, deeper roots to enable the plant to access more water reserves. This bioengineered plant would be subject to USDA authorities, and any food or feed produced would be subject to FDA authorities.
Up until the last quarter of this century, growers have relied on plant breeders to provide them with hardier and more disease-resistant crop varieties. This is done primarily by transferring pollen from one variety of crop to the flower of another variety, or mating a crop plant with a wild or related plant to produce offspring with the desired trait. It is in this way that we got bigger roses and more robust tomatoes. However, the process involves cross combining genes for numerous traits which can result in undesirable traits as well as the desirable trait in the offspring. It can take years of traditional plant breeding to get an acceptable new variety that can now be done with much more precision through biotechnology.
In the early 1980s, scientists began to move genes selectively through biotechnology techniques, rather than by moving all of the genes contained in the pollen. The transfer of desired traits could now be accomplished more broadly and more rapidly. Science is at the point now where it can move genes between unrelated species. In the case of plant-pesticides, scientists alter plants to produce pesticidal substances from any source, for example, another plant, a bacterium or virus, insect, etc.
The most well known example is the gene that is found in the bacterium Bacillus thuringiensis, or simply Bt. This bacterium, when sprayed on plants, is toxic to certain types of harmful insects that feed on the plant. Through the process of biotechnology, scientists can move the genes that produce the toxic protein from the bacterium and place them in, for example, a corn plant. The corn plant can now synthesize its own bacterial protein and ward off pests on its own. No external spraying is necessary.
The need for federal regulation or oversight became apparent in the mid 1980s as companies asked the Agency for clarification of its existing regulations as they related to genetically engineered microorganisms and plant-pesticides. EPA held public meetings with its scientific advisory committees (the FIFRA Scientific Advisory Panel and the Biotechnology Scientific Advisory Committee). In addition, EPA has sought input from the Office of Pesticide Programs' Pesticide Program Dialogue Committee and interested stakeholders at a number of public hearings and workshops throughout the country. These public meetings and the comments received in association with these meetings helped EPA develop its regulatory approach and the data requirements to address the questions of risks to human health and environment. In 1994, EPA published its final regulations regarding small scale field testing of microbial pesticides. A few months later, in November of 1994, EPA issued proposed regulations outlining how it intended to ensure that new pesticidal substances produced by plants would meet the safety standards of FIFRA and FFDCA. These standards are not based on method of production, but are instead based on the characteristics of the compound. Thus, in its proposal, the Agency clarified its interpretation that the substances plants produce for protection against pests and disease (whether through traditional breeding practices or genetic manipulation) are pesticides according to the definition in FIFRA.
FIFRA, however, also gives EPA the authority to exempt pesticides that it has determined pose a low probability of risk. EPA agrees that traditional plant breeding has a good safety record of ensuring the safety of plant varieties for food production. Based on human experience in breeding, growing, preparing and consuming food from plants containing pesticidal compounds, the Agency is able to exempt from regulation a large portion of plant-pesticides. In the proposed rules, EPA establishes several broad categories to exempt plant-pesticides. These actions significantly reduce the number of plant-pesticides subject to regulatory review. The primary focus of the new regulations is to separate out and exempt from regulation those compounds the Agency believes have a low probability of risk and instead concentrate on plant-pesticides that present new dietary and/or environmental exposures. For example, plant-pesticides introduced from unrelated species of plants, bacterium or virus, insects, etc. These new crop varieties have no long-term established record of safe human consumption. It is incumbent upon the Agency to protect the public from any potential risks stemming from their use by evaluating potential risks, establishing tolerance levels, and registering safe products.
EPA's plant-pesticide rule defines a plant-pesticide and describes how it will regulate these substances under the two pesticide statutes. EPA has carefully crafted an approach for plant-pesticides that would focus regulatory oversight on those products that present novel exposures and more toxic modes of action. The Agency's proposal for plant-pesticides: (1) clarifies the regulatory status under FIFRA and FFDCA of plants and plant-pesticides; (2) stipulates that EPA regulates the plant-pesticide rather than the plant itself; and (3) describes which categories of products are subject to regulation and which categories are exempt. We anticipate that a number of additional exemptions will be granted in the future. EPA plans an extensive outreach program once the rule is final to provide better guidance on what types of products are exempt and what must come to the Agency for approval before commercialization. In addition, EPA has made it clear in the 1994 proposed rule that it is not regulating the whole plant and that it is not proposing to regulate all products of biotechnology. For example, if a trait is moved from one tomato variety to another by traditional breeding or by biotechnology techniques, it would not fall under EPA regulation as now proposed by EPA. EPA does believe that pesticidal substance with new exposure to humans or the environment need to be carefully reviewed before being released into commercial agriculture. We have spent the last five years addressing the over one hundred public comments received in response to the 1994 proposal. It is now in the final stages of the rule-making process and the Agency plans to publish a final plant-pesticide rule next year.
EPA'S REGISTRATION PROCESS
At present, there are established guidelines for testing chemical pesticides, microbial pesticides, and biochemical pesticides published in the Code of Federal Regulation and available from the Agency's web site. Although EPA currently relies on these established guidelines for what data should be evaluated in determining whether a plant-pesticide can be registered, it believes that the unique and novel aspects of plant-pesticides indicate that there should be testing guidelines and data requirements specific for these products. For example, worker exposure is a major risk issue for many chemical pesticides, but because the plant-pesticide may be confined within the plant, the potential for worker exposure is much reduced. On the other hand, cross pollination from crop plants to other crop varieties, or wild or weedy relatives by spread of pollen may present a risk from a plant-pesticide where it would not be a concern from a conventional pesticide.
As described above, EPA has used a public process to develop a risk assessment approach that we have applied to the products going through the registration process. The Biopesticides and Pollution Prevention Division (BPPD) has worked with each company or individual developing plant-pesticide products to determine the appropriate data requirements for the particular product and BPPD registered the first plant-pesticide in 1995.
The Agency plans to begin the process of establishing data requirements and testing guidelines specific for plant-pesticides when it completes the rulemaking process for the series of exemptions proposed in 1994 for these products. In establishing the data requirements, EPA will propose the tests it believes are appropriate, indicating the circumstances under which each test is required, conditionally required, or not required. These proposed data requirements and test guidelines will be widely available for public comment and will be subject to scientific peer review by our Scientific Advisory Panel. Test guidelines and data requirements will continue to evolve, as the science and policies related to biotechnology mature. However, anyone applying for registration of a product may request to waive any particular study provided they also submit a scientific rationale. Public literature may also fill a data requirement.
Until data requirements specifically for plant-pesticides can be established, EPA will continue to handle the data requirements for new plant-pesticides on a case-by-case basis. The potential registrant typically comes in for a meeting with our scientific staff, at which time we decide upon the appropriate data requirements to support the Experimental Use Permit (EUP), or for the full commercial approval and registration. The studies done under the EUP are used to support the application for the full registration. Once the Agency receives a complete package for a new plant-pesticide active ingredient, it typically takes about a year for us to review the data and reach a registration decision.
EPA'S REGISTRATION REQUIREMENTS
For the plant-pesticide products EPA has registered to date, we review data in four categories: product characterization, toxicology, non-target organisms effects, and exposure and environmental fate. Product characterization includes reviewing the source of the gene and how the gene is expressed in a living organism, the nature of the pesticidal substance produced, modifications to the introduced trait as compared to that trait in nature, and the biology of the recipient plant. For toxicology, an acute oral toxicity test of the pesticidal substances on mice is required. At times, it has not been possible to make enough of the substance in the plant itself so EPA has allowed the exact same protein to be produced by bacteria and used for the testing. It should be noted that to date, all of the plant-pesticides reviewed by EPA are proteins plus the genes required to make these proteins within the plant. For these proteins, EPA also required a digestibility test where the amount of time it takes for the protein to break down in gastric and intestinal fluids is determined. EPA also considers the potential of allergenicity. Determination of whether an introduced protein is likely to be an allergen is one of the major challenges for the Federal agencies. EPA and FDA are working on this issue together.
For ecological effects, EPA examines the exposure and toxicity of the plant-pesticide to non-target organisms, such as wildlife and beneficial insects. These tests are unique to the crop and pests involved. For example, during the review of the plant-pesticide, Bt-potato, a test of potential effects of the introduced protein to lady bird beetles was conducted and showed that there were no adverse effects to these predators of the pesky Colorado potato beetles. For Bt-corn, tests were conducted on the potential effects on fish because field corn may be manufactured into commercial fish food. No effects were observed in the tests. EPA also has evaluated the degradation rates of the proteins in soil and plant residues.
If adverse effects or potential adverse effects are observed in the testing, a second or higher tiers of testing is required to allow EPA to evaluate the risks. EPA routinely consults with USDA and FDA on data reviews of these plant-pesticides. EPA, USDA, and FDA have conference calls every other week to insure cooperation and open communication between the agencies.
Since March of 1995, EPA has registered twelve plant-pesticide products (see the attached list). Six of these products are for a Bt protein/gene complex. The crops have included potatoes, cotton, field corn, sweet corn, and popcorn. The Agency has also established tolerance exemptions for pesticidal proteins plus genes from viruses that have been moved via biotechnology techniques to plants like watermelon, cucumber, potato, and papaya. In 1998, EPA registered a protein/gene from the potato leaf roll virus (PLRV). Both the Bt protein and the PLRV protein were combined to provide virus and insect protection in the NatureMark's New Leaf Plus variety of potatoes, introduced this year.
Mr. Chairman, we at EPA think these are promising times for advancing better, lower risk solutions to pest control needs. We believe that these products have great potential, but we are not blindly accepting industry claims as to their safety. We are proceeding cautiously to ensure protection to all citizens and to our environment. At this juncture, I would like to turn the discussion to some of the issues being raised and what EPA is doing to address them.
The Monarch Butterfly
As you know, the monarch butterfly made headlines this year. A study conducted by researchers at Cornell University and published this spring in Nature, suggested that pollen from genetically modified Bt-corn may pose risks to monarch butterfly larvae and other butterfly species that feed on milkweed or other plants. While this study did not reflect corn grown in the field, EPA has taken the preliminary results of this laboratory study very seriously. Before the first Bt plant-pesticide was registered in 1995, EPA evaluated studies of its potential effects on a wide variety of organisms which might be exposed to the Bt toxin but are not target pests, such as birds, fish, honeybees, ladybugs, lacewings, and earthworms. EPA concluded that these species were not harmed. While the Agency was aware of potential adverse effects on some species of butterflies, we did not believe that Bt-crops would threaten the long-term survival of the population of these species. At that time, EPA also concluded that threatened or endangered species of butterflies would not be at risk from Bt corn crops because they would not be exposed to the Bt toxin.
Since the publication of the article in Nature, EPA has taken a number of steps to more fully assess and understand the possible risks to monarch butterflies and other butterflies from Bt-corn pollen. We are working with the researchers at Cornell and Iowa State Universities, and we expect to complete our scientific review of their studies shortly. The authors of those studies acknowledge that it would be inappropriate to draw conclusions about risk to monarch populations in the field based solely on the initial results of their laboratory findings. To help identify actual risks to monarch populations in the field, several research projects are underway, the results of which will be provided to EPA. EPA is consulting with monarch butterfly experts and USDA to better understand the effect of Bt-corn pollen on monarch butterflies. If unreasonable risks are identified, EPA will take appropriate precautionary steps to reduce the risk to the monarch populations.
Insect Resistance Management
As mentioned, Bt insect resistance management (IRM) is of great importance because of the threat insect resistance poses to the future use of Bt pesticides. Consumer groups and organic farmers have expressed concern that the widespread planting of these genetically engineered plants will hasten the development of resistance to the pesticidal Bt toxin.
To address this real concern, the Agency has placed resistance management data and monitoring requirements on the Bt plant-pesticides. Sound resistance management will prolong the life of Bt pesticides, and universal adherence to the plans is to the advantage of researchers, producers, and growers alike. EPA's strategy to address insect resistance is twofold: (1) mitigate any significant potential for pest resistance development in the field, and (2) better understand the mechanisms behind pest resistance.
Since the first Bt registration, the Agency has taken steps to manage insect resistance to Bt, with resistance management plans being an important part of any regulatory decision regarding these plant-pesticides. These mitigation measures include management plans to prevent resistance, field research and monitoring for resistance, establishing refugia (a portion of the total acreage using non-Bt seed), and appropriate changes in the plans as more information becomes available. It is believed that the planting of refugia will delay the development of resistance by maintaining genetic diversity among corn plants. EPA will continue to use science-based decision-making as we reevaluate IRM requirements for Bt crops. The content and implementation of these plans continues to be a focus for EPA, and our stakeholders. Because of our continuing concerns about the potential development of insect resistance to Bt, and in order to ensure that Bt products remain effective for all farmers, EPA, in most cases, requires that a refuge should be established. The issue of refuge size continues to be investigated extensively by a number of groups from industry, academia, consumer advocates and the federal government. We are working with USDA, growers, the pesticide registrants, and consumer advocates to ensure that new genetically modified pesticide products can be used without the development of pest resistance. EPA and the U.S. Department of Agriculture held two public workshops this year to get broad stakeholder input on this important issue. Growers, industry, and public interest groups looked at immediate and long term scenarios, what works and what does not, compliance concerns, and a host of other topics related to implementing effective management plans. In addition, work is underway to ensure that the resistance management programs for the Bt-corn registrations are consistent and effective. EPA is working closely with consumer groups, the agricultural community, and others to ensure that the appropriate resistance management and grower education programs are in place for the 2000 growing season. We believe that the extensive dialogue and increasing knowledge base in this area will help strengthen our decisions for the 2000 growing season and beyond.
EPA is working on several international fronts in an effort to share data and foster collaborative relationships in the field of biotechnology. EPA, in conjunction with USDA and FDA, was instrumental is establishing two working groups within the Environment Policy Committee of the Organization for Economic Cooperation and Development. The two groups are the working Group on Harmonization of Regulatory Oversight in Biotechnology and the Task Force for the Safety of Novel Foods and Feeds. These groups provide information useful to EPA as it performs risk assessments on genetically modified organisms, including plant and microorganisms under three of its jurisdictional statutes, FIFRA, FFDCA, and TSCA. EPA has also participated in the negotiations under the Convention on Biological Diversity of a "Biosafety Protocol." These negotiations have been in progress for several years under the auspices of the United Nations Environment Program (UNEP). Central to the Protocol is an "advanced informed agreement" requirement prior to shipping GMOs across international borders. UNEP plans to continue negotiations on the Protocol next year (2000).
I have presented an overview of EPA's activities to regulate products produced through biotechnology. Our biotechnology program is based on 5 important principles: sound science, transparency in decision making, consistency and fairness, collaboration with regulatory partners, and building public trust. EPA believes that our regulatory system is based on the most rigorous scientific information available, is credible, is defensible, and will serve to protect the environment and public health as we address the challenges associated with biotechnology.
Thank you for the invitation to appear before your committee this morning. I will be happy to answer any questions you may have.