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:
o 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.
o 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.
o 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:
o 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.
o 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:
o Studies assessing the risks to human health
o Studies assessing risks to nontarget organisms and the environment
o The potential for gene flow
o 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:
o Using sound science
o Ensuring transparency of the decision-making process
o Maintaining consistency and fairness
o Collaborating with our regulatory partners
o 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:
o 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.
o 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:
o Identification of new genetic material and all new proteins;
o Mammalian toxicity testing of all new proteins;
o Comparison of new proteins to known toxins and allergens;
o Toxicity testing on birds, fish, earthworms, and representative insects
such as bees, ladybird beetles, and lacewings;
o Toxicity testing on insects related to target insect pests;
o 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/brs/index.html 
For general information on FDA's role in regulating food and feed developed
with biotechnology, contact:
o 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/
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