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At least 19 recordsLinked to original sources
PubMed1992

Regulatory concerns of the United States Environmental Protection Agency.

The US Environmental Protection Agency, under 2 of its legislative mandates, has the authority to require the testing of industrial and pesticide chemicals. Among the testing requirements, particularly in chronic studies, are those relating to hematology, clinical chemistry, and urinalysis. Some of these requirements will be discussed in detail. Comments on the usefulness of the current requirements and recommendations for changes will be solicited from the meeting participants.

Animals↗
PubMedDate not supplied

Tolerance setting process in the U.S. Environmental Protection Agency.

The U.S. Environmental Protection Agency (EPA) is responsible for setting tolerances for pesticide residues in food, under the authority of the Federal Food, Drug, and Cosmetic Act. The residue chemistry data required to set tolerances include metabolism in plants and animals, analytical methods, magnitude of the residue, and concentration in processed foods. A key aspect of tolerance-setting procedures is the identity of the residue in the matrix of concern; without knowledge of the chemical moieties that occur as residues, it is impossible to develop suitable methods or generate meaningful residue data. For new chemicals, EPA carries out a single-laboratory validation of the analytical method needed to generate residue data and to enforce tolerances. Tolerance enforcement methods need to be rapid and inexpensive and to use commercially available equipment and reagents. Methods are more complex for many newer pesticides, which are polar compounds that leave low levels of residue. EPA now requires that the registrants of older pesticides, for which methods are not acceptable by today's standards, must develop better methods.

Animal Feed↗
PubMed1986

The United States Environmental Protection Agency's guidelines for applicator exposure monitoring.

The Environmental Protection Agency (EPA)'s proposed guidelines for studies which estimate worker exposure to pesticides during application and related work activities are discussed. These guidelines are intended to aid pesticide registrants in conducting occupational exposure monitoring studies for pesticide applicators at indoor and outdoor sites. The Agency's rationale for requiring exposure to be monitored with passive dosimetry techniques or by biological monitoring is described. The practical and theoretical advantages and disadvantages of both approaches are also discussed.

Environmental Exposure↗
PubMed1990

The U.S. Environmental Protection Agency's risk assessment guidelines.

This paper has been reviewed by the Office of Health and Environmental Assessment, U.S. Environmental Protection Agency, and approved for publication. Approval does not signify that the contents necessarily reflect the views and policies of the Agency, nor does mention of trade names or commercial products constitute endorsement or recommendation for use. In 1983, the U.S. National Academy of Sciences (U.S. NAS) proposed a framework for the processes of risk assessment and risk management in government agencies (U.S. NAS, 1983). Using the U.S. NAS scheme as an organizing principle, the U.S. Environmental Protection Agency (U.S. EPA) published guidelines pertaining to risk assessment in five areas: estimating exposures, chemical mixtures, mutagenicity, suspect developmental toxicity and carcinogenicity. These guidelines were developed to promote high technical quality and consistent practice of risk assessment Agencywide. This paper will discuss the historical development of the guidelines and their role in the work performed by the Agency. Each of the five (5) guidelines is outlined and anticipated revisions discussed. Related assessment activities and new subject areas are also presented.

Animals↗
PubMed1977

Rationale developed by the Environmental Protection Agency for the assessment of carcinogenic risks.

The intent of the Environmental Protection Agency's "Interim Guideline for Carcinogen Risk Assessment" is to provide an evaluation of the evidence regarding suspect carcinogens that encapsulates judgments on the quality and adequacy of data, the likelihood that the agent is a human carcinogen, and an estimate of the magnitude of the cancer burden that could be ascribed to the agent if no regulatory action were taken. Every effort shoult be made to reduce environmental contamination by carcinogens to the lowest possible level; this view stems from uncertainties about qualitative and quantitative extrapolations from animals to man, the lack of evidence for a dose threshold, the great range of possible interactions among environmental carcinogens and cofactors, and the broad spectrum of human susceptibility. New knowledge in the field of carcinogenesis is developing, and modifications of the Environmental Protection Agency's "Interim Guideline for Carcinogen Risk Assessment" must be made periodically.

Carcinogens, Environmental↗
PubMed1990

The U.S. Environmental Protection Agency's inhalation RfD methodology: risk assessment for air toxics.

The U.S. Environmental Protection Agency (U.S. EPA) has advocated the establishment of general and scientific guidelines for the evaluation of toxicological data and their use in deriving benchmark values to protect exposed populations from adverse health effects. The Agency's reference dose (RfD) methodology for deriving benchmark values for noncancer toxicity originally addressed risk assessment of oral exposures. This paper presents a brief background on the development of the inhalation reference dose (RfDi) methodology, including concepts and issues related to addressing the dynamics of the respiratory system as the portal of entry. Different dosimetric adjustments are described that were incorporated into the methodology to account for the nature of the inhaled agent (particle or gas) and the site of the observed toxic effects (respiratory or extrarespiratory). Impacts of these adjustments on the extrapolation of toxicity data of inhaled agents for human health risk assessment and future research directions are also discussed.

Administration, Inhalation↗
PubMed1992

An analysis of the U.S. Environmental Protection Agency neurotoxicity testing guidelines.

Few of the more than 65,000 chemicals listed in the Environmental Protection Agency (EPA) inventory have been tested for neurotoxicity. The nervous system may be especially vulnerable to toxicants because many compounds can cross the blood-brain barrier and induce irreversible damage. Additionally, the young, the elderly, and other sensitive populations may be particularly susceptible to neurotoxic injury. The EPA has developed guidelines including neurobehavioral, neuropathological, and neurochemical tests for the identification of possible neurotoxicants. In the present review, tests included in the current EPA guidelines for neurotoxicity testing are described and evaluated. The main benefit of the tests is that regulators are familiar with them, thus facilitating interpretation. Additionally, validation data on these tests are available for many known neurotoxicants. These factors make it difficult to introduce new methods that may include in vitro and other techniques. The current in vivo tests can be costly and prolonged and can involve the use of many laboratory animals, making them inappropriate for generalized use on existing chemicals. It is suggested that alternative tests be incorporated for screening of large numbers of chemicals and that testing priority be given to chemicals on the basis of structure/activity relationships, lipophilicity, bioaccumulation, and extent of exposure.

Animals↗
PubMedDate not supplied

An introduction to a series of U.S. Environmental Protection Agency special committee reports on testing approaches for the detection of chemically induced aneuploidy.

A committee of scientists was established by the U.S. Environmental Protection Agency to appraise the current state of aneuploidy test methodology, to compile and analyze published data on the chemical induction of aneuploidy, and to provide guidance for additional test development and validation. The reports that follow in this special issue of Mutation Research, document the urgent need for test method development and validation in this important area of environmental mutagenesis, and provide directions for further research.

Aneuploidy↗
PubMed1989

U.S. Environmental Protection Agency procedures and policies to estimate risk of injury to the male reproductive system.

Risk assessment, as defined by the National Academy of Sciences in 1983, is comprised by the following components: hazard identification, dose-response assessment, exposure assessment, and risk characterization. The U.S. Environmental Protection Agency (EPA) has developed risk assessment guidelines which follow the NAS format for Program Offices to follow in evaluating the potential adverse effects of environmental agents on humans. Guidelines have been published in the Federal Register on cancer, mutagenicity, developmental toxicity, chemical mixtures, and exposure. Proposed guidelines are expected to be published shortly on female and male reproductive toxicity.

Animals↗
PubMed1978

Analytical determination of N-nitroso compounds in pesticides by the United States Environmental Protection Agency--a preliminary study.

Lijinsky, Eisenbrand and others have demonstrated the formation of N-nitroso derivatives of certain secondary amine pesticides under specified experimental conditions. Partly based on these studies and on reports of the industrial discharge of N-nitrosos compounds from several chemical manufacturing facilities the Environmental Protection Agency (EPA) has issued several reports on the nitroso problem, including a report by a special ad hoc committee under the Administrator's Science Advisory Board (1976). Unexpectedly high N-nitrosoalkylamine residues found in several pesticide products (Fine et al., 1976) have prompted EPA to conduct a survey, initially of approximately 70-80 pesticides that potentially were representative of the following three routes of contamination: 1. industrial process formation and carryover; 2. in situ (container) nitrosation and 3. utilization of contaminated amines in the manufacturing process. Environmental formation was not studied in this survey. Duplicate samples were analysed by two different laboratories using GC and HPLC interfaced with Hall, UV and chemiluminescent (TEA) detectors. Results of some analyses of this continuing survey are presented. Based partly on the results of this study, the Agency has decided to conduct risk-benefit analyses on pesticides suspected of containing N-nitroso contaminants, with special consideration given to oncogenic and mutagenic potential. The analytical results of the study are discussed, as is the cooperative effort within the Agency.

Chromatography, Gas↗