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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↗
PubMed1982

Hazardous waste management system: standards applicable to generators of hazardous waste and standards applicable to owners and operators of hazardous waste treatment, storage, and disposal facilities--Environmental Protection Agency. Proposed rule.

The Environmental Protection Agency (EPA) is today proposing amendments to its hazardous waste regulations under Subtitle C of the Resource Conservation and Recovery Act (RCRA). These amendments would replace the annual reporting requirements for hazardous waste generators and owners and operators of hazardous waste treatment, storage, ad disposal (TSD) facilities with a biennial survey of representative samples of those populations. This approach will provide verifiable data on a wider range of topics, better serve EPA's long term regulatory needs under RCRA, and reduce significantly the information burden on the regulated community.

Refuse Disposal↗
PubMed2002

Is the U.S. Environmental Protection Agency brownfields assessment pilot program environmentally just?

In the early 1990s, the U.S. Environmental Protection Agency (U.S. EPA) started a grant program to assist communities redevelop brownfields, which are abandoned or underutilized sites that have real or perceived contamination. In addition to determining if the communities receiving the grants were the most distressed cities in the United States, we also evaluate the U.S. EPA program in terms of environmental justice at the macro scale. Using 1990 U.S. Census of Housing and Population data and a matched-cities methodology, we compared the brownfields pilot cities to other communities in the United States. We found that regardless of intent, the U.S. EPA program is environmentally just by disproportionately awarding grants to the most economically distressed cities. We also found that the cities that received funding in the early years of the program were more economically distressed than cities receiving the funding more recently.

Cities↗
PubMed1982

Standards applicable to owners and operators of hazardous waste treatment, storage, and disposal facilities: liability requirements. Environmental Protection Agency. Revised interim final rule.

The Environmental Protection Agency is today revising regulations of January 12, 1981, on liability coverage requirements for hazardous waste facility owners or operators. Under these requirements, owners or operators must demonstrate liability coverage for bodily injury and property damage to third parties resulting from facility operations. The major revisions are: addition of the option of a financial test as a means of demonstrating liability coverage to satisfy the requirements; addition of the option of submitting a certificate of insurance as evidence of insurance; and changes in the requirements for the endorsement and certificate. In a future document, EPA will propose to delete two provisions of the January 12, 1981 regulations. These provisions are: the procedure to obtain a variance for liability coverage requirements; and the provision allowing an owner or operator to use State assumption of legal responsibility for liability coverage to satisfy the liability requirements. The January 12, 1981, regulations were issued under an accelerated schedule imposed by a court order. The revisions that are being made today are necessary to eliminate unworkable aspects of the previous regulations, improve their effectiveness, and allow reasonable flexibility in satisfying the requirements.

Insurance, Liability↗
PubMed1981

Container and waste pile standards for owners and operators of hazardous waste facilities: consolidated permit regulations--Environmental Protection Agency. Amendments to interim final rule.

The Environmental Protection Agency (EPA) is today promulgating amendments to the hazardous waste management regulations regarding the management of hazardous waste in containers and piles and associated permit regulations (40 CFR Part 264, Subparts I and L, and Part 122, Subpart B). These amendments better tailor the standards to the particular type of hazard posed by specific situations. The standards for containers are amended to waive the containment system requirements for wastes that do not contain free liquids, provided that the wastes are protected from contact with accumulated liquid. The standards for waste piles are amended to waive the containment system requirements for wastes that do not contain free liquids, provided that the pile is protected from precipitation by a structure and from surface water run-on and wind dispersal of the waste by the structure or some other means. The Agency believes these amendments believes these amendments will not reduce the level of protection of human health and the environment.

Refuse Disposal↗
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↗
PubMed1999

Assessment of the U.S. Environmental Protection Agency methods for identification of hazards to developing organisms, Part II: The developmental toxicity testing guideline.

BACKGROUND: The effects of toxins on developing animals depend not only on the nature of the chemical but also on the timing of exposure and assessment of outcomes. This complicates the task of regulatory agencies such as the U.S. Environmental Protection Agency (EPA), which must comply with the 1996 Food Quality Protection Act to ensure that their standards and policies protect infants and children from environmental toxins. For this task, the Agency relies heavily on scientific data obtained by manufacturers of industrial chemicals and pesticides following protocols collected under EPA's Health Effects Test Guidelines. METHODS AND RESULTS: This article reviews the protocols included in the EPA guidelines to assess developmental toxicity, which are required for food-use pesticides under the core testing battery. We reviewed these protocols on the basis of their adequacy for identifying hazards to infants and children. Our analysis found limitations in the protocols that hinder their potential for identifying developmental hazards. CONCLUSIONS: Methods that the EPA currently depends upon to identify developmental toxicity of chemicals have limitations that impede obtaining complete and reliable data on which to base regulatory decisions that protect children. Other methodological approaches need to be explored as alternatives or supplements to the current protocols. Until more accurate testing protocols become available, it may well be necessary under existing laws to employ safety factors that are more protective of the health of children at all stages of development.

Animals↗
PubMed1981

Guidelines for development and implementation of state solid waste management plans and criteria for classification of solid waste disposal facilities and practices--Environmental Protection Agency. Final rule.

This rule modifies the Environmental Protection Agency's Guidelines for the Development and Implementation of State Solid Waste Management Plans (40 CFR Part 256) and the Criteria for the Classification of Solid Waste Disposal Facilities and Practices (40 CFR Part 257). The Guidelines are being amended to expand public participation opportunities in the planning process and provide for expedited approval of certain portions of the State plans. The Criteria are being amended to modify the groundwater, surface water and air protection criteria. EPA is taking this action as part of a settlement agreement reached with industrial groups which have challenged these regulations in Federal Court.

Environmental Pollution↗
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↗
PubMed1981

Consolidated permit regulations and hazardous waste management system: Environmental Protection Agency. Notice of issuance of regulation interpretation memorandum.

The Environmental Protection Agency (EPA) is issuing today a Regulation Interpretation Memorandum (RIM) which provides official interpretation of the issue of whether a generator who accumulates hazardous waste pursuant to 40 CFR 262.34, may qualify for interim status after November 19, 1980. This issue arose when the requirements for submitting a Part A permit application (one of the prerequisites to qualifying for interim status) were amended on November 19, 1980. The provisions interpreted today are part of the Consolidated Permit Regulations promulgated under Subtitle C of the Solid Waste Disposal Act, as amended by the Resource Conservation and Recovery Act, as amended (RCRA).

Refuse Disposal↗
PubMed1996

Evaluation of the mass balance model used by the Environmental Protection Agency for estimating inhalation exposure to new chemical substances.

The U.S. Environmental Protection Agency (EPA) is responsible for assessing the potential for unacceptable human health and environmental risks of new chemical substances prior to commercialization. Estimates of potential inhalation exposure to workers during manufacture, processing, and use of a new chemical substance are key elements of these assessments. However, the available information with which to assess the potential for exposure is often limited for new chemicals. One approach used by EPA to develop screening level estimates of inhalation exposure to vapors in the absence of data is the use of a mass balance model to predict the airborne concentration for various activities such as drumming and sampling. The mass balance model was evaluated by comparing the exposure estimates for specific operations with monitoring data reported in selected studies from the available literature. In general the estimated exposures based on the midpoint of the range of default input values were well within one order of magnitude of the measured exposures. Selection of more conservative (i.e., protective) model input values overestimated exposures by one or more orders of magnitude. There are many simplifying assumptions inherent in the model and many variables that influence exposure that are not considered. Uncertainty analyses of the model demonstrated that values selected for the ventilation flow rate and generation rate greatly influence the estimate of exposure and should be carefully chosen. Additional research is recommended, and ultimately, model validation should be completed to further improve and refine the model.

Air Pollutants↗
PubMed1981

Hazardous waste management system: identification and listing of hazardous waste--Environmental Protection Agency. Interim final rule and request for comments.

The Environmental Protection Agency [EPA] is today revising the regulations for hazardous waste management under the Resource Conservation and Recovery Act to exempt certain categories of mixtures of solid wastes and hazardous wastes from the presumption of hazardousness presently contained in the regulations. EPA is taking this action because the Agency believes that the risk posed to human health and the environment from the management of these waste mixtures is not substantial, so that automatically defining these waste mixtures as hazardous is inappropriate. This amendment will substantially reduce the regulatory burden to those persons who would otherwise have applied the regulations for hazardous waste management to these mixtures.

Hospitals↗
PubMed1996

U.S. Environmental Protection Agency guidelines for carcinogen risk assessment: past and future.

The U.S. Environmental Protection Agency (USEPA) recently proposed new guidelines to update and replace the 1986 USEPA Guidelines for Carcinogen Risk Assessment. Today, there is a better understanding of the variety of modes by which carcinogens can operate that did not exist when the 1986 USEPA guidelines were published. Many laboratories are adding new test protocols in their programs directed at questions concerning the mechanisms of action of carcinogens. In response to the evolving science of carcinogenesis, the new guidelines provide an analytical framework for incorporating all relevant biological information and recognizing a variety of situations regarding cancer risk. In addition, the guidelines are flexible enough to allow consideration of future scientific advances.

Animals↗
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↗
PubMed1983

An assessment of the Environmental Protection Agency's asbestos hazard evaluation algorithm.

We performed an exploratory evaluation of the Environmental Protection Agency's algorithm for assessment of risk of exposure to asbestos in buildings. Observers scored five sites using the algorithm. One group (N = 23) conducted their assessments relying only on written instructions, while another (N = 20) was trained in the use of the algorithm. Five professional industrial hygienists, experienced in risk assessment, also used the algorithm on the same sites. A wide range of highly variable results, for both untrained and trained observers coupled with poor comparability with expert's scores raise concern as to the reliability of this assessment tool. The development of a valid and reliable "lay" index of risk is still needed.

Adult↗