Data Requirements
Before pesticides can be marketed and used in the United States, EPA
evaluates them thoroughly to ensure that they will meet federal safety
standards to protect human health and the environment. Pesticides that
meet the requirements are granted a license or "registration" that permits
their distribution, sale, and use according to specific use directions
and requirements identified on the label.
The process of registering a pesticide is a scientific, legal, and administrative
procedure through which EPA examines the ingredients of the pesticide;
the particular site or crop on which it is to be used; the amount, frequency,
and timing of its use; and the appropriate storage and disposal practices.
In evaluating a pesticide registration application, EPA assesses a wide
variety of potential human health and environmental effects associated
with use of the product. The producer of the pesticide must provide data
from tests done according to EPA guidelines.
These tests evaluate whether a pesticide has the potential to cause harmful
effects on humans, wildlife, fish, and plants, including endangered species
and nontarget organisms, as well as possible contamination of surface
water or ground water from leaching, runoff, and spray drift. Potential
human risks range from short-term toxicity to long-term effects such as
cancer and reproductive system disorders.
When EPA approves a particular pesticide for registration, the Agency
has assessed the chemical and found that, when used according to label
directions, it does not pose unreasonable risk to public health and the
environment. A pesticide cannot be legally used if it has not been registered
with EPA's Office of Pesticide Programs.
The data requirements for registration are intended to generate data
and information necessary to address concerns pertaining to the identity,
composition, potential adverse effects and environmental fate of each
pesticide. EPA's requirements for data are listed in the Code of Federal
Regulations, Chapter 40, Part 158. Tables in 158.240-740 give the specifics
of data requirements for various proposed use patterns and provide references
to the guidelines on how the tests are to be conducted.
The following sections describe the reasons for each type of test and
the kind of information EPA obtains from the results of each test.
Residue Chemistry
EPA uses residue chemistry data to estimate the exposure of the general
population to pesticide residues in food and for setting and enforcing
tolerances for pesticide residues in food or feed. The Agency can estimate
the amount and nature of residues likely to be present in food or animal
feed as a consequence of a proposed pesticide usage by evaluating information
on:
- the chemical identity and composition of the pesticide product,
- the amounts, frequency and time of pesticide application, and
- results of test on the amount of residues remaining on or in the treated
food or feed.
Environmental Fate
EPA uses the data generated by environmental fate studies to:
- assess the potential for toxicity to humans from exposure to pesticide
residues remaining after application, either upon reentering treated
areas or from consuming inadvertently-contaminated food
- assess the presence of widely distributed and persistent pesticides
in the environment that may result in loss of usable land, surface water,
ground water, and wildlife resources
- assess the potential environmental exposure of other nontarget organisms,
such as fish and wildlife, to pesticides
- help estimate expected environmental concentrations of pesticides
in specific habitats where threatened or endangered species or other
wildlife populations at risk are found.
Degradation Studies
The data from hydrolysis and photolysis studies are used to determine
the rate of pesticide degradation and to identify pesticides that may
harm nontarget organisms.
Metabolism Studies
Data generated from aerobic and anaerobic metabolism studies are used
to determine the nature and availability of pesticides to rotational crops
and to aid in the evaluation of the persistence of a pesticide.
Mobility Studies
These data requirements pertain to leaching, adsorption/desorption, and
volatility of pesticides. They provide information on the mode of transport
and eventual destination of the pesticide in the environment. This information
is used to assess potential environmental hazards related to:
- contamination of human and animal food;
- loss of usable land and water resources to man through contamination
of water (including ground water); and
- habitat loss of wildlife resulting from pesticide residue movement
or transport in the environment.
Dissipation Studies
The data generated from dissipation studies are used to assess potential
environmental hazards (under actual field use conditions) related to:
- reentry into treated areas;
- hazards from residues in rotational crop and other food sources;
and
- the loss of land as well as surface and ground water resources.
Accumulation Studies
Accumulation studies indicate pesticide residue levels in food supplies
that originate from wild sources or from rotational crops.
- Rotational crop studies are necessary to establish realistic crop
rotation restrictions and to determine if tolerances may be needed for
residues on rotational crops.
- Data from irrigated crop studies are used to determine the amount
of pesticide residues that could be taken up by representative crops
irrigated with water containing pesticide residues.
- These studies allow the Agency to establish label restrictions regarding
application of pesticides on sites where the residues can be taken up
by irrigated crops.
- These data also provide information that aids the Agency in establishing
any corresponding tolerances that would be needed for residues on such
crops.
- Data from pesticides accumulation studies in fish are used to establish
label restrictions to prevent applications in certain sites so that
there will be minimal residues entering edible fish or shell fish.
- These residue data are also used to determine if a tolerance or action
level is needed for residues in aquatic animals eaten by humans.
Hazard to Humans and Domestic Animals
Data required to assess hazards to humans and domestic animals are derived
from a variety of acute, subchronic and chronic toxicity tests, and tests
to assess mutagenicity and pesticide metabolism.
Acute Studies
Determination of acute oral, dermal and inhalation toxicity is usually
the initial step in the assessment and evaluation of the toxic characteristics
of a pesticide. These data provide information on health hazards likely
to arise soon after, and as a result of, short-term exposure. Data from
acute studies serve as a basis for classification and precautionary
labeling. For example, acute toxicity data are used to calculate farmworker
reentry intervals and to develop precautionary label statements pertaining
to protective clothing requirements for applicators. They also:
- provide information used in establishing the appropriate dose levels
in subchronic and other studies;
- provide initial information on the mode of toxic action(s) of a
substance; and
- determine the need for child resistant packaging. Information derived
from primary eye and primary dermal irritation studies serves to identify
possible hazards from exposure of the eyes, associated mucous membranes
and skin.
Subchronic Studies
Subchronic tests provide information on health hazards that may arise
from repeated exposures over a limited period of time. They provide
information on target organs and accumulation potential. The resulting
data are also useful in selecting dose levels for chronic studies and
for establishing safety criteria for human exposure. These tests are
not capable of detecting those effects that have a long latency period
for expression (e.g., carcinogenicity).
Chronic Studies
Chronic toxicity (usually conducted by feeding the test substance to
the test species) studies are intended to determine the effects of a
substance in a mammalian species following prolonged and repeated exposure.
Under the conditions of this test, effects that have a long latency
period or are cumulative should be detected. The purpose of long-term
oncogenicity studies is to observe test animals over most of their life
span for the development of neoplastic lesions during or after exposure
to various doses of a test substance by an appropriate route of administration.
Teratogenicity and Reproduction
Studies
The teratogenicity study is designed to determine the potential of
the test substance to induce structural and/or other abnormalities to
the fetus as the result of exposure of the mother during pregnancy.
Two-generation reproduction testing is designed to provide information
concerning the general effects of a test substance on gonadal function,
estrus cycles, mating behavior, conception, parturition, lactation,
weaning, and the growth and development of the offspring. The study
may also provide information about the effects of the test substance
on neonatal morbidity, mortality, and preliminary data on teratogenesis
and serve as a guide for subsequent tests.
Mutagenicity Studies
For each test substance a battery of tests are required to assess potential
to affect the mammalian cell's genetic components. The objectives underlying
the selection of a battery of tests for mutagenicity assessment are:
- To detect, with sensitive assay methods, the capacity of a chemical
to alter genetic material in cells.
- To determine the relevance of these mutagenic changes to mammals.
- When mutagenic potential is demonstrated, to incorporate these
findings in the assessment of heritable effects, oncogenicity, and
possibly, other health effects.
Metabolism Studies
Data from studies on the absorption, distribution, excretion, and metabolism
of a pesticide aid in the evaluation of test results from other toxicity
studies and in the extrapolation of data from animals to humans. Metabolism
studies are designed to help the Agency understand how the chemical
acts in humans in the context of potential human exposure from the intended
uses of the pesticide.
Reentry Protection
Data required to assess hazard to farm employees resulting from reentry
into areas treated with pesticides are derived from studies on toxicity,
residue dissipation, and human exposure. Monitoring data generated during
exposure studies are used to determine how much pesticide people may
be exposed to after application and to establish how long workers must
wait before re-entering a treated area.
Pesticide Spray Drift Evaluation
Data required to evaluate pesticide spray drift are derived from studies
of the range of droplet sizes and spray drift field evaluations. These
data contribute to development of the overall exposure estimate. Along
with data on toxicity for humans, fish, and wildlife, or plants data
on spray drift are used to assess the potential hazard of pesticides
to these organisms. A purpose common to all these tests is to provide
data to help determine the need for (and appropriate wording for) precautionary
labeling to minimize the potential harm to nontarget organisms.
Hazard to Nontaget Organisms
The information required to assess hazards to nontarget organisms are
derived from tests to determine pesticidal effects on birds, mammals,
fish, terrestrial and aquatic invertebrates, and plants. These tests include
short-term acute, subacute, reproduction, simulated field, and full field
studies arranged in a hierarchial or tier system that progresses from
the basic laboratory tests to the applied field tests. The results of
each tier of tests must be evaluated to determine the potential of the
pesticide to cause harmful effects and to determine whether further testing
is required. A purpose common to all data requirements is to help determine
the need for (and appropriate wording for) precautionary label statements
to minimize the potential harm to nontarget organisms.
Short-term Studies
The short-term acute and subchronic laboratory studies provide basic
toxicity information that serves as a starting point for the hazard
assessment. These data are used to:
- establish acute toxicity levels of the active ingredient to the
test organisms;
- compare toxicity information with measured or estimated pesticide
residues in the environment in order to assess potential effects on
fish, wildlife and other nontarget organisms; and
- indicate whether further laboratory and/or field studies are needed.
Long-term and Field Studies
Additional studies (i.e., avian, fish, and invertebrate reproduction,
lifecycle studies, and plant field studies) may be required when basic
data and environmental conditions suggest possible problems. Data from
these studies are used to:
- estimate the potential for chronic effects, taking into account
the measured or estimated residues in the environment; and
- determine if additional field or laboratory data are necessary to
further evaluate hazards.
- Simulated field and/or field data are used to examine acute and
chronic adverse effects on captive or monitored fish and wildlife
populations under natural or near-natural environments.
Such studies are required only when predictions as to possible adverse
effects in less extensive studies cannot be made, or when the potential
for harmful effects is high.
Product Performance
Requirements to develop data on product performance provide a mechanism
to ensure that pesticide products will control the pests listed on the
label and that unnecessary pesticide exposure to the environment will
not occur as a result of the use of ineffective products. Specific performance
standards are used to validate the efficacy data in the public health
areas, including disinfectants used to control microorganisms infectious
to humans in any area of the inanimate environment and those pesticides
used to control vertebrates (such as rodents, birds, bats and skunks)
that may directly or indirectly transmit diseases to humans.
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