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Pesticides: Regulating Pesticides
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Data Requirements

Types of Studies

Residue Chemistry
Environmental Fate
Degradation Studies
Metabolism Studies
Mobility Studies
Dissipation Studies
Accumulation Studies

Hazard to Humans and Domestic Animals

Acute Studies
Subchronic Studies
Chronic Studies
Teratogenicity and Reproduction Studies
Mutagenicity Studies
Metabolism Studies
Reentry Protection
Pesticide Spray Drift Evaluation

Hazard to Nontarget Organisms

Short-term Studies
Long-term and Field Studies
Product Performance

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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