EPA's Regulation of Biotechnology for Use in Pest Management

June 2003

Biotechnology is the science of modifying the genetic composition of plants, animals, and microorganisms. Historically, biotechnology has relied on conventional plant and animal breeding practices to modify genetic composition.

Modern biotechnology relies on newer techniques, such as genetic engineering, to incorporate genetic material from one living organism into another. Products of biotechnology include medications, human insulin, and enzymes used in laundry detergents and cheese-making. More recently, the use of biotechnology has led to new pesticide products that control a variety of pests. These biologically produced pesticides, which use the inherent pest-fighting abilities of many existing plants and microbes, have properties that distinguish them from those of conventional chemical pesticides. When these products have unique biological properties, they may also pose unique regulatory challenges.

To address these challenges, the Environmental Protection Agency (EPA), the U.S. Department of Agriculture (USDA), and the Food and Drug Administration (FDA) have shared responsibility for regulating agricultural biotechnology in the United States. In particular, EPA regulates pesticides created through biotechnology as a part of its regulatory jurisdiction over all pesticides marketed and used in the United States. As such, EPA has tailored its basic regulatory framework to fit the distinctive characteristics of these genetically engineered biological pesticides.

Applying Modern Biotechnology to Pest Management

Through the use of biotechnology, scientists produce biological pesticides by harnessing the pest-fighting abilities of existing plants and microbes. Biotechnology has been applied to enhance pest control in a number of ways, including the following:

Plant-Incorporated Protectants (PIPs)
Some plants and other organisms naturally contain proteins or other chemicals that serve as a natural defense against pests. Such chemicals and proteins can also be introduced to plants either through the conventional breeding of sexually compatible plants or through techniques of modern biotechnology. For example, by transferring specific genetic material from a bacterium to a plant, scientists can create plants that produce pesticidal proteins or other chemicals that the plant could not previously produce. Using this technology, scientists have modified corn, cotton, and potatoes to produce a pesticidal protein that is toxic when ingested by specific insect pests. In this case, the plant-incorporated protectants are chemicals produced by plants whose DNA has been modified, as well as the DNA that produces the chemicals. The plant's modified DNA now expresses pesticidal properties by producing a bacterial protein that will protect the plant from specific insects. Since March 1995, EPA has registered 12 PIPs.
Genetically Modified Microbial Pesticides
Genetically modified microbial pesticides are either bacteria, fungi, viruses, protozoa, or algae, whose DNA has been modified to express pesticidal properties. The modified microorganism generally performs as a pesticide's active ingredient. For example, certain fungi can control the growth of specific types of weeds, while other types of fungi can kill certain insects. To date, EPA has registered eight such products, which contain a modified microorganism and inert ingredients. These products are typically applied in a spray solution.
Herbicide-Tolerant Crops
Weed control is one of the farmer's biggest challenges in crop production, because poorly controlled weeds drastically reduce crop yield and quality. To control weeds, farmers often use broad-spectrum herbicides, which kill nearly all kinds of plants. For this reason, scientists have applied biotechnology to create crops that are resistant to certain herbicides. Herbicide tolerant crops contain new genes that allow the plant to tolerate these herbicides. The most common herbicide-tolerant crops (cotton, corn, soybeans, and canola) are those that are resistant to glyphosate, an effective herbicide used on many species of grasses, broadleaf weeds, and sedges. EPA does not regulate these crops, however. Rather, USDA regulates the crops and EPA regulates the herbicide.

EPA's Regulatory Role

EPA regulates pesticides, including genetically engineered pesticides, under the following two laws:

Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
This act provides the legal requirements for EPA's registration process for all pesticides. With regard to biotechnology, EPA's jurisdiction under FIFRA covers regulation of the new substance and DNA in the plant when it is pesticidal in nature. For example, the substance produced by a plant that has been genetically modified to resist disease comes under FIFRA authority, whereas the substance produced by a plant that has been modified to resist drought does not.
Federal Food, Drug, and Cosmetics Act (FFDCA), as amended by the Food Quality Protection Act (FQPA).
FFDCA requires EPA to set tolerances, or exemptions from tolerances, for the allowable residues of pesticides that are applied to food and animal feed.

Before a pesticide can be marketed and used in the United States, FIFRA requires that EPA evaluate the proposed pesticide thoroughly to ensure that the pesticide will not pose unreasonable risks of harm to human health or the environment. In the case of genetically modified plants, EPA considers many factors regarding the PIP, including the following, which are mentioned in greater detail below:

Studies assessing the risks to human health
Studies assessing risks to nontarget organisms and the environment
The potential for gene flow
The need for insect resistance management plans

Pesticides that pass EPA's evaluation under FIFRA are granted a license or "registration" that permits their sale and use according to the requirements set by EPA to protect human health and the environment. In making regulatory decisions, EPA evaluates the risks of pesticide use and balances these risks with the benefits derived from pesticide use.

EPA's Five Principles

EPA's biotechnology regulatory program is based on five important principles that guide our decision-making policy:

Using sound science
Ensuring transparency of the decision-making process
Maintaining consistency and fairness
Collaborating with our regulatory partners
Building public trust

Regulatory Partnerships

EPA is one of three Federal agencies responsible for regulating agricultural biotechnology in the United States. Along with EPA, these Federal agencies include:

U.S. Department of Agriculture (USDA).
USDA's Animal and Plant Health Inspection Service (APHIS) is responsible for protecting American agriculture against pests and diseases. APHIS regulates the field testing of genetically engineered plants and certain microorganisms and also approves and licenses veterinary biological substances, including animal vaccines, that may be the products of biotechnology. USDA's Food Safety and Inspection Service (FSIS) ensures the safety of meat, poultry, and eggs consumed as food. USDA's regulatory jurisdiction includes the regulation of herbicide-tolerant crops, which do not fall under EPA's jurisdiction because these crops do not produce pesticides.
Food and Drug Administration (FDA).
A part of the Department of Health and Human Services, FDA assesses food safety and nutritional aspects of new plant varieties. FDA bases its biotechnology policy on existing food law and requires that genetically engineered foods meet the same rigorous safety standards required of all other foods. FDA also sets labeling standards for foods and enforces the tolerances of allowable pesticide residues that EPA establishes.

See table on the types of biotech products each agency regulates.

Setting Tolerances

For any pesticide used in producing food, EPA regulates the amount that may remain in or on foods by setting limits, or tolerances, for pesticidal residues under the FFDCA. In setting a tolerance, EPA must find, based on evaluation of health and safety information, that there is a reasonable certainty of no harm from exposure to the pesticide residues. EPA may also exempt pesticides from the tolerance requirement in cases where such exemptions are found to meet the same standard of reasonable certainty of no harm. EPA must review toxicity and exposure data just as the Agency does when setting a tolerance. EPA has established tolerance exemptions for registered genetically modified microbial pesticides and plant-incorporated protectants because, based on a thorough scientific evaluation, EPA has found that the tolerance exemptions are safe. In the case of herbicide-tolerant crops, EPA establishes tolerances for the allowable amount of herbicide residues that may remain on the crop.

Plant-Incorporated Protectant (PIP) Rules

Because PIPs raise certain novel regulatory circumstances for the Agency, EPA has issued new rules, commonly referred to as the PIP rules, that clarify the relationship between plants and plant-incorporated protectants and their regulatory status under FIFRA. In these rules, the Agency has determined that, in regulating plant-incorporated protectants, the new protein and its genetic material are regulated by EPA; the plant itself is not regulated.

FIFRA also gives EPA the authority to exempt pesticides that it has determined pose a low probability of risk to human health and the environment. EPA has accepted additional public comment on certain suggested exemption proposals related to specific aspects of the proposed rule that were not completed in the PIP rules, and is currently examining these comments. For more information on these proposals and other aspects of the plant-incorporated protectant rules, visit the Web site: http://www.epa.gov/pesticides/biopesticides/pips/index.htm.

Currently Registered Plant-Incorporated Protectants

A table of Currently Registered PIP Products is available.

Testing Requirements to Assess Risks to Human Health and the Environment

Before making a regulatory decision about a pesticide, EPA requires data on a range of subjects to ensure that the product meets Federal safety standards. For all pesticide products, including genetically engineered pesticides, EPA requires testing of product composition and chemical properties, human health effects, environmental effects on non-target pests, and the fate of the pesticide in the environment. Where appropriate, EPA also examines a pesticide's potential to trigger allergenic responses. Specifically for genetically engineered pesticides, EPA routinely examines the following types of information and data:

Identification of new genetic material and all new proteins;
Mammalian toxicity testing of all new proteins;
Comparison of new proteins to known toxins and allergens;
Toxicity testing on birds, fish, earthworms, and representative insects such as bees, ladybird beetles, and lacewings;
Toxicity testing on insects related to target insect pests;
Length of time required for the new proteins to degrade in the environment.

Toxicity testing will be conducted with a range of doses and concentrations 10 to 100 times higher than those expected in environmental conditions. EPA also consults literature and other sources of supporting information related to any aspect of the proteins and the organisms from which they are derived.

Insect Resistance Management

EPA also closely evaluates the potential for pest resistance to a Bt plant-incorporated protectant (PIP). The Agency recognizes that natural selection favors the survival of pests that are not affected by the PIP, and that surviving pests may pass their resistant genes on to subsequent generations. Insect resistance could affect the long-term viability of the PIP itself and also that of related conventional biopesticides like microbial Bt sprays. Thus, the Agency has looked for methods to minimize the likelihood that an insect will develop resistance to the Bacillus thuringiensis (Bt) PIPs. The strategy of the program focuses on the level of the PIP produced and the planting of refuges (areas set within or close to a field of the genetically modified crop where unmodified versions of the same crops are planted). By setting these crops close to each other, the refuge encourages the interbreeding of resistant and nonresistant insects, reducing the likelihood of pesticide-resistant offspring.

Evaluating Potential of Genes Moving to Other Plants

EPA closely evaluates the potential transfer of a new pesticidal trait to wild relatives and weeds. Known as gene flow, cross-pollination of wild relatives can disrupt a local ecosystem by changing the makeup of local plants, crowding out related species, and changing the local habitat. Less risk of cross-pollination exists in the United States than in tropical countries where the wild relatives of most of these crops are found. In the case of genetically modified Bacillus thuringiensis (Bt) cotton, where the potential for gene flow did exist, EPA restricted the planting of this crop in order to mitigate the risk.

The Process of Scientific Peer Review

EPA's risk assessments are based on these types of data and undergo extensive public comment and peer review by scientists within and outside of the Agency. EPA solicits input from the scientific community through the Scientific Advisory Panel (SAP), an independent group of medical and scientific experts. Under the mandate of FIFRA, the SAP regularly convenes to examine pesticide science issues. Between March 1999 and September 2001, EPA consulted with the SAP six times for advice on issues related to EPA's biotechnology program. For more information on the panel's proceedings, reviews, and advisory meetings, visit the SAP Web site at: http://www.epa.gov/scipoly/sap/.

Selected Terms and Definitions

Herbicide tolerant crop: A crop plant that is resistant to an herbicide. The herbicide tolerant trait occurs naturally in some plants, while others have this trait introduced through conventional breeding or through the use of modern biotechnology.

Host Plant: A plant on which an insect pest lives or by which it is nourished.

Insect Resistance Management: A scheme for managing plants expressing insect control proteins that will provide economically important control of the pest and insure that the target insect pest remains susceptible to the trait. The IRM plan often includes growing plants that are not insect resistant in close enough proximity to provide susceptible insects. These susceptible insects will mate with any rare resistant pests, dilute out the resistance gene and prevent the selection of significant resistant populations.

Microbial Pest Control Agent: A microorganism that is usually used to infect and kill a target pest or to compete with undesirable microbial pests in the environment.

Plant-Incorporated Protectant (PIP): A pesticidal substance that is intended to be produced and used in living plants, or in the produce thereof, and the genetic material necessary for the production of such a pesticidal substance. A plant-incorporated protectant also includes any inert ingredient contained in the plant or produce thereof.

Refuge: A portion of cropland devoted to harboring susceptible pest insects. These susceptible insects can reduce the appearance of resistant pest insects by diluting out the resistance gene in the pest population.

Tolerance: The maximum permissible levels for pesticide residues allowed in or on commodities for human and animal consumption.

For More Information

For information about EPA's role in regulating biotechnology's use in pest management, contact:

Brian Steinwand,
Communications Officer,
Biopesticides and Pollution
Prevention Division,
Office of Pesticide Programs,
(703) 305-7973
or visit the Web site: http://www.epa.gov/pesticides/biopesticides

For information about the USDA's role in regulating biotechnology's use in pest management, contact:

James L. White, PhD.,
Senior Operations Officer,
Management Team,
Plant Protection and Quarantine,
Animal and Plant Health
Inspection Service,
(301) 734-5940
or visit the Web site: http://www.aphis.usda.gov/biotechnology/index.shtml

For general information on FDA's role in regulating food and feed developed with biotechnology, contact:

Center for Food Safety and Applied Nutrition (HFS-206)
Food and Drug Administration
200 C Street, SW
Washington, DC 20204
(202) 418-3101
or visit the Web site: http://www.cfsan.fda.gov/~lrd/biotechm.html

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