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PubMedDate not supplied

Sample accountability quality assurance for the "Integrated Air Cancer Project" research program of the U.S. Environmental Protection Agency.

A sample accountability quality assurance (QA) program is described for a field and laboratory research effort which resulted in collection of approximately 2000 samples for analysis by several EPA and contractor laboratories. A QA program was specifically developed for this research program to include sample transfer from collection site to storage maintenance, record development, transfer to researchers, and sample tracking at all stages. A sample identification system and sample custody records are described for field and laboratory application. The functions of a sample coordinator are also described as relating to sample custody, coordination of sample analysis with researchers, and development of computer record files to facilitate research and sample tracking.

Air Pollutants↗
PubMed2006

An evaluation of the US Environmental Protection Agency definition of a risk assessment.

A full presentation of relevant information, including both non-adverse and beneficial effects, of chemicals is important to developing sound and balanced risk assessments. Such considerations are not new. For example, the American Thoracic Society has developed criteria for defining adverse and non-adverse pulmonary effects. Failing to allow risk assessors to even consider non-adverse and beneficial effects will discourage the use of information from developing technologies, such as genomics, and from new understandings of dose-response relationships, as reflected in the hormetic model. Failing to provide such information to risk managers potentially provides a biased perspective on risk.

Dose-Response Relationship, Drug↗
PubMed1987

An approach to identifying specialized batteries of bioassays for specific classes of chemicals: class analysis using mutagenicity and carcinogenicity relationships and phylogenetic concordance and discordance patterns. 1. Composition and analysis of the overall data base. A report of phase II of the U.S. Environmental Protection Agency Gene-Tox Program.

This report of the Gene-Tox Assessment Panel is a compilation of data that documents the chemical testing efforts in genetic toxicology through mid-1979. It thus provides an historical perspective of the major efforts in this field and the utility of test models. The total number of chemicals tested in assays reflects chemical availability, commercial interest in specific structural types, the ease or difficulty in assay performance, as well as methodological development resulting from testing experience. Other factors that have been important in assay selection and utility are the perceptions of relevance to hazard evaluation of chemicals and the role that genetic factors may have in other disease states as well as in heritable defects. The phylogenetic diversity of test systems attests to the tremendous effort that has been applied to the testing and evaluation of the effect chemicals can have on genetic structure. The data also illustrate the fact that certain chemicals have an intrinsic capability to alter the genetic structure of cells of diverse biological origin in an heritable manner, whereas others do not. Any attempt to summarize and analyze a data base of this magnitude is a formidable task that would be almost impossible without a computer capability. A computerized system of analysis has been developed at the Environmental Mutagen Information Center (EMIC) that makes it possible to examine the performance of any particular assay in any of 30 chemical classes and to make comparisons with all the other assays individually or in designated groupings. Components of this system include: A distribution of the 2622 chemicals into 30 chemical classes with results of testing in each class. A tabulation of assay results showing the total numbers of chemicals tested, with their definitive and nondefinitive results. A subdivision of assays and results of testing into four major groups: gene mutation, chromosomal aberrations, other genotoxic effects, and in vitro cell transformation assays. These major groups are further subdivided into phylogenetic categories and type of assay. A system of analysis of results utilizing mutagenicity and carcinogenicity comparisons and phylogenetic concordance and discordance. The major utility and/or benefit of this compilation will be derived from a chemical class by chemical class comparative analysis of individual assay performance. Obviously, the data base will serve as a resource for safety evaluation of chemicals through structural correlations and biological end point analyses.(ABSTRACT TRUNCATED AT 400 WORDS)

Animals↗
PubMed1995

The new chemicals process at the Environmental Protection Agency (EPA): structure-activity relationships for hazard identification and risk assessment.

Section 5 of the Toxic Substances Control Act (TSCA) does not require any toxicity testing as a prerequisite for submission of a Premanufacturing Notice (PMN) for a new chemical. In order to compensate for the lack of actual test data, a process involving structure-activity relationships (SAR) for assessing hazard potential was constructed. The hazard assessment is then coupled with an estimation of potential exposure to determine potential risk. This process involves the use of multiple interdisciplinary teams that work within a 90-day time frame to complete approximately 2000 risk assessments per year.

Animals↗
PubMed1990

The in vivo micronucleus assay in mammalian bone marrow and peripheral blood. A report of the U.S. Environmental Protection Agency Gene-Tox Program.

The protocol recommended for the micronucleus assay in mammalian bone marrow has been revised and simplified. The number of sample times has been reduced to one or two, depending upon the dosing protocol. The minimum number of cells to be scored per treatment group has been increased to 20,000 to increase the ability of the assay to detect a doubling of the control micronucleus frequency. Use of both male and female animals is recommended. Scoring of micronuclei in polychromatic erythrocytes of peripheral blood is included as a variation of the bone marrow assay. Published data on chemicals tested by the micronucleus assay have been reviewed and are summarized.

Animals↗
PubMed1988

A review and analysis of the Chinese hamster ovary/hypoxanthine guanine phosphoribosyl transferase assay to determine the mutagenicity of chemical agents. A report of phase III of the U.S. Environmental Protection Agency Gene-Tox Program.

Published literature on the Chinese hamster ovary cell/hypoxanthine guanine phosphoribosyl transferase (CHO/HGPRT) assay from mid-1979 through June 1986 was reviewed and evaluated. Data from the papers considered acceptable include test results on 121 chemicals belonging to 25 chemical classes. A total of 87 chemicals were evaluated positive, 3 negative, and 31 inconclusive. Mutagenicity data on 49 of the 121 chemicals evaluated could also be compared with in vivo animal carcinogenicity data. 40 of the 43 reported animal carcinogens were considered mutagenic. Caprolactam, the only definitive noncarcinogen in the group of 49, was not mutagenic. The CHO/HGPRT assay was concluded to be an appropriate assay system for use in the screening of chemicals for genotoxicity.

Animals↗
PubMed1982

Standards applicable to owners and operators of hazardous waste treatment, storage, and disposal facilities; liability coverage requirements--Environmental Protection Agency. Final rule and notice of extension of effective date.

The effective date for qualifications of insurers providing liability insurance used to satisfy liability coverage requirements applicable to owners or operators of hazardous waste management facilities, as such requirements are included in 40 CFR Parts 264 and 265, is extended from July 15, 1982, to October 16, 1982. The effective date for the rest of the liability coverage requirements remains July 15, 1982. This extension is being provided to allow 6 months between the date of promulgation and the effective date for the insurer qualification provision, in accordance with Section 3010(b) of the Resource Conservation and Recovery Act of 1976, as amended. During the period between July 15 and October 16, 1982, owners or operators may use certificates of insurance or policy endorsements that do not certify to the qualifications of the insurer.

Insurance, Liability↗
PubMed1983

Cell transformation by chemical agents--a review and analysis of the literature. A report of the U.S. Environmental Protection Agency Gene-Tox Program.

The literature on cell transformation by chemical carcinogens has been critically reviewed. This subject is highly relevant to carcinogenesis in vivo, because the phenotypic changes that are collectively referred to as cell transformation usually involve the acquisition of tumorigenicity on inoculation into suitable rodent hosts. The systems chosen for review fall into 3 categories: cell strains (cells with a limited lifespan); cell lines (cells with an unlimited lifespan); and oncogenic viral-chemical interactions involving cells (Fischer rat embryo cells expressing an endogenous retrovirus, mouse embryo cells expressing the AKR leukemia virus, chemical enhancement of a simian adenovirus, SA7 transformation of Syrian hamster or rat embryo cells). Of the entire literature reviewed, 117 papers have been accepted for data abstraction by pre-defined criteria; these include 41 references to cell strains, 40 in cell lines, and 38 in viral-chemical interactions including cells. Because different systems have been reviewed, it would be meaningless to group all the compounds. The overall summary of the systems is as follows (many compounds have been tested in more than one system and, hence, are duplicated in these totals). (Chart: see text) In general, there is a reasonably good correlation between the results of the cell transformation systems and in vivo carcinogenesis. However, the many deficiencies of the EPA Merged Carcinogen List preclude definitive comparisons. Moreover, a number of 'false negatives' were obtained in systems that did not employ external metabolic activation. Further validation of all systems is required, but it seems very probable that several cell transformation systems will become valuable in assaying (with reasonable time and cost) the carcinogenic potential of environmental chemicals.

Animals↗
PubMed1982

Interim status standards for owners and operators of hazardous waste treatment, storage, and disposal facilities: Environmental Protection Agency. Proposed amendments to rule.

On May 19, 1980, EPA promulgated regulations, applicable to owners and operators of hazardous waste treatment, storage, and disposal facilities during interim status, which prohibited the landfill disposal of most containerized liquid waste or waste containing free liquid on and after November 19, 1981. As a result of issues raised by the regulated community with respect to this prohibition, the Agency is today proposing an amendment to this regulation to allow some containers holding free liquids to be disposed of in a landfill, in some circumstances. In a separate action in today's federal Register, EPA is providing a 90-day extension (from today's date) of the compliance date for the prohibition of landfill disposal of containerized liquid waste and the restrictions on the landfill disposal of liquid ignitable waste to allow time to complete this rulemaking action and to avoid immediately imposing requirements that might be changed as a result of this rulemaking action.

Refuse Disposal↗
PubMedDate not supplied

[Setting priorities for environmental protection from asbestos: ethical aspects].

The allocation of resources destined for environmental rehabilitation of areas contaminated by asbestos requires scientific, political, economical and ethical evaluation. Ethically relevant issues reviewed in this paper include: identification of the populations most expected to benefit from the intervention, risk assessment, effectiveness of different technical approaches, as well as a comparison between populations of current socio-economic standards, level of legal assistance and access to both information and participation in the decision making process. A relevant ethical criterion is minimizing inequalities within and between communities.

Asbestosis↗
PubMed1982

The hazardous waste management system--Environmental Protection Agency. Interim final amendments to interim final and final rules.

The Resource Conservation and Recovery Act (RCRA) requires that EPA set regulatory standards for all facilities which treat, store, or dispose of hazardous waste. In partial implementation of its requirement, on January 23, 1981, EPA set regulatory standards for incinerators that burn hazardous waste. These regulations were issued as "interim final," which means that, although they were issued in final form, the Agency invited public comment on them with a view to future amendment. Today, EPA is amending, on an interim final basis, certain of its regulations applicable to hazardous waste incineration facilities. Today's amendments include revisions to: the general standards for permitting hazardous waste incinerators (Part 264, Subpart O), published in the Federal Register on January 23, 1981; the interim status standards for hazardous waste incinerators (Part 265, Subpart O), revised on January 23, 1981; and the consolidated permit requirements for incinerators (Part 122), published on May 19, 1980 and January 23, 1981.U

Refuse Disposal↗
PubMed1992

Overview of the U.S. Environmental Protection Agency's Hazardous Air Pollutant Early Reduction Program.

Under provision of the Clean Air Act Amendments of 1990 Title III, the EPA has proposed a regulation (Early Reduction Program) to allow a six-year compliance extension from Maximum Achievable Control Technology (MACT) standards for sources that voluntarily reduce emissions of Hazardous Air Pollutants (HAPs) by 90 percent or more (95 percent or more for particulates) from a base year of 1987 or later. The emission reduction must be made before the applicable MACT standard is proposed for the source category or be subject to an enforceable commitment to achieve the reduction by January 1, 1994 for sources subject to MACT standards prior to 1994. The primary purpose of this program is to encourage reduction of HAPs emissions sooner than otherwise required. Industry would be allowed additional time in evaluating emission reduction options and developing more cost-effective compliance strategies, although, under strict guidelines to ensure actual, significant and verifiable emission reductions occur.

Air Pollution↗
PubMed1982

Hazardous waste management system standards for owners and operators of hazardous waste treatment, storage, and disposal facilities and EPA administered permit programs; hazardous waste permit program. Environmental Protection Agency. Interim final amendments to rule.

On May 19, 1980, EPA promulgated regulations applicable to owners and operators of hazardous waste treatment, storage, and disposal facilities which prohibited the landfill disposal of most containerized liquid waste or waste containing free liquid on and after November 19, 1981. Further on June 29, 1981, EPA amended its hazardous waste management regulations so as to extend the compliance date of the restriction on the landfill disposal of containerized liquid ignitable wastes to coincide with the compliance data of the general restriction on landfill disposal of liquids. The Agency is today extending the compliance date on both these requirements until May 26, 1982, and, in a separate action, is proposing amendments to these restrictions. This extension of compliance dates is provided for the sole purpose of allowing time to complete the rulemaking action on today's proposed amendments. The Agency is also today exempting from the requirements of the hazardous waste management regulations, the acts of adding absorbent material to hazardous waste in containers and adding hazardous waste to absorbent material in a container, at the time waste is first placed in the container, in order to reduce the free liquids in a container.

Refuse Disposal↗
PubMed1993

U.S. Environmental Protection Agency's Ozone Epidemiology Research Program: a strategy for assessing the effects of ambient ozone exposure upon morbidity in exposed populations.

The Clean Air Act Amendments of 1990 mandate a future reduction of ambient ozone levels in many areas of the country, the cost of which will be great. In order to assess the current public health burden of ambient ozone exposure and to provide information for assessment of potential health benefits of improved air quality, the Health Effects Research Laboratory of the U.S. EPA has undertaken an Ozone Epidemiology Research Program. The research strategy which will guide this scientific program is described in this paper. Criteria for selection of important research questions as well as issues which cut across all questions and study designs are discussed. In particular, this program emphasizes the study of effects which reflect morbidity in the population. The three questions identified as being of most immediate importance involve the relationship of short-term ambient ozone exposure to acute respiratory illness, the relationship of recurrent exposure to chronic respiratory disease, and the relationship of recurrent exposure to development of acute respiratory illness. Specific research approaches and initial projects to address these three questions are described.

Animals↗
PubMed1997

The L5178Y/tk+/- mouse lymphoma specific gene and chromosomal mutation assay a phase III report of the U.S. Environmental Protection Agency Gene-Tox Program.

The L5178Y/tk+/- (-)3.7.2C mouse lymphoma assay (MLA) which detects mutations affecting the heterozygous thymidine kinase (tk) locus is capable of responding to chemicals acting as clastogens as well as point mutagens. Improvements in the assay to enhance detection of this spectrum of genetic events are summarized, and criteria for evaluating the data are defined. Using these criteria, the Phase III Work Group reviewed and evaluated literature containing MLA results published from 1976 through 1993. The data base included 602 chemicals of which 343 were evaluated as positive, 44 negative, 18 equivocal, 54 apparently inappropriate for evaluation in this test system with the published protocols, and 142 that were inadequately tested, and thus a definitive call could not be made. The overall performance of the assay is summarized by chemical class, and the outcome of testing 260 chemicals in the MLA is compared with Gene-Tox and National Toxicology Program evaluations of rodent carcinogenesis bioassay results for the same chemicals. Based on the Work Group's evaluation of published MLA data for chemicals that were considered adequately tested, it is concluded that for most chemicals the L5178Y/tk+/- mouse lymphoma assay is eminently well suited for genotoxicity testing and for predicting the potential for carcinogenicity.

Animals↗
PubMed2001

Efficacy testing of cosmetic products. A proposal to the European Community by the Danish Environmental Protection Agency, Ministry of Environment and Energy.

BACKGROUND/AIMS: Regulations for cosmetic products primarily address safety of the products that may be used by large populations of healthy consumers. Requirements for documentation of efficacy claims are only fragmentary. This synopsis aims to review and conclude a set of standards that may be acceptable to the European Community, and the cosmetic industry, as a legal standard for efficacy documentation in Europe in the future. METHODS AND RESULTS: Ethical, formal, experimental, statistical and other aspects of efficacy testing are described, including validation, quality control and assurance. The importance of user relevant clinical end points, a controlled randomized trial design and evidence-based cosmetic product documentation, validation of methods, statistical power estimation and proper data handling, reporting and archiving is emphasized. The main principles of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) good clinical practice (GCP) should be followed by the cosmetics industry in a spirit of good documentation standard and scientific soundness, but full GCP is not considered mandatory in the field of cosmetics. Documentation by validated bio-instrumental methods may be acceptable, but efficacy documentation based on information about raw materials, reference to literature and laboratory experiments are only acceptable in exceptional cases. CONCLUSIONS: Principles for efficacy substantiation of cosmetic products in Europe, as described in this synopsis, are officially proposed by the Danish Ministry of Environment and Energy to the European Community as a basis for an amendment to the Cosmetics Directive or otherwise implemented as a European Community regulation.

Clinical Trials as Topic↗
PubMed1983

Unscheduled DNA synthesis tests. A report of the U.S. Environmental Protection Agency Gene-Tox Program.

The utility of unscheduled DNA synthesis (UDS) testing for screening potentially hazardous chemicals was evaluated using the published papers and technical reports available to the UDS Work Group. A total of 244 documents were reviewed. Based on criteria defined in advance for evaluation of the results, 169 were rejected. From the 75 documents accepted, results were reviewed for 136 chemicals tested using autoradiographic approaches and for 147 chemicals tested using liquid scintillation counting (LSC) procedures; 38 chemicals were tested by both approaches to measure UDS. Since there were no documents available that provided detailed recommendations of UDS screening protocols or criteria for evaluating the results, the UDS Work Group presents suggested protocols and evaluation criteria suitable for measuring and evaluating UDS by autoradiography in primary rat hepatocytes and diploid human fibroblasts and by the LSC approach in diploid human fibroblasts. UDS detection is an appropriate system for inclusion in carcinogenicity and mutagenicity testing programs, because it measures the repair of DNA damage induced by many classes of chemicals over the entire mammalian genome. However, for this system to be utilized effectively, appropriate metabolic activation systems for autoradiographic measurements of UDS in human diploid fibroblasts must be developed, the nature of hepatocyte-to-hepatocyte variability in UDS responses must be determined, and the three suggested protocols must be thoroughly evaluated by using them to test a large number of coded chemicals of known in vivo mutagenicity and carcinogenicity.

Animals↗
PubMed1990

Use of mouse liver tumor data in risk assessments performed by the U.S. Environmental Protection Agency.

In summary, the EPA has begun to look critically at the induction of certain types of tumors in certain species, including liver tumors in mice. The controversy over the use of such tumor data in assessing the cancer risk for humans has been going on for some time. The present agency policy is to downgrade the weight of evidence for such data under certain conditions. Review of the cancer risk assessments for the 109 chemicals that the agency has formally verified shows that a variety of chemicals yield liver tumors in mice. However, one group of substances that consistently produced such tumors was chlorinated compounds (84%). Many of these compounds not only induced liver tumors in mice but also induced liver tumors in rats and/or other types of tumors in mice and rats. However, several of the chlorinated compounds produced only mouse liver tumors. Another group of compounds that often induced liver tumors in mice was nitrogen-containing compounds (aromatic amines, hydrazines, nitrosamines). These latter substances tended to not only induce liver tumors in mice but also a variety of other tumor types in a variety of species. Mouse liver tumor data have played a major role in the classification of substances in categories B2 and C. Fifty-six percent of the chemicals in category B2 and 40% in category C were classified based at least partially on the use of mouse liver tumor data. In addition, 21 of the 29 category B2 chemicals that produced liver tumors in mice and 5 of the 8 category C chemicals are chlorinated compounds. These two results indicate the importance of chlorinated compounds to the agency, and therefore, the importance of mouse liver tumor data in agency cancer risk assessments.

Animals↗