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At least 829 records · Page 46Linked to original sources
PubMed2005

Beverages: bottled water. Final rule.

The Food and Drug Administration (FDA) is amending its bottled water quality standard regulations by revising the existing allowable level for the contaminant arsenic. As a consequence, bottled water manufacturers are required to monitor their finished bottled water products for arsenic at least once each year under the current good manufacturing practice (CGMP) regulations for bottled water. Bottled water manufacturers are also required to monitor their source water for arsenic as often as necessary, but at least once every year unless they meet the criteria for the source water monitoring exemptions under the CGMP regulations. This final rule will ensure that the minimum quality of bottled water, as affected by arsenic, remains comparable with the quality of public drinking water that meets the Environmental Protection Agency's (EPA's) standards.

Arsenic↗
PubMed2002

Rationale for a tissue-based selenium criterion for aquatic life.

This paper proposes a national tissue-based criterion for the protection of aquatic life in the United States based on the growing body of selenium literature, but may be of international importance due to the raising global awareness of selenium contamination. A recent peer consultation workshop was undertaken by the US Environmental Protection Agency to address the technical issues underlying the freshwater aquatic life chronic criterion for selenium. The workshop participants discussed concerns associated with three possibilities for a new criterion: a water-based criterion, a tissue-based criterion, and a sediment-based criterion. Since the current national water quality criterion was established in 1987, several publications have reported adverse effects in fish from dietary selenium exposure with waterborne concentrations below the current criterion of 5 microg/l. Based on this literature, a water-based criterion seems unsuitable because of the propensity for selenium to bioaccumulate through the food chain to toxic dietary concentrations. There is little information to support a sediment-based criterion. A tissue-based criterion accounts for selenium's biogeochemical pathways because it integrates the route, duration, and magnitude of exposure, chemical form, metabolic transformations, and modifying biotic and abiotic factors. The convergence of laboratory and field data shows 4 microg/g to be a conservative value for a national tissue-based criterion for selenium.

Animals↗
PubMed2004

Environmental impacts of dispersed development from federal infrastructure projects.

Dispersed development, also referred to as urban growth or sprawl, is a pattern of low-density development spread over previously rural landscapes. Such growth can result in adverse impacts to air quality, water quality, human health, aquatic and terrestrial ecosystems, agricultural land, military training areas, water supply and wastewater treatment, recreational resources, viewscapes, and cultural resources. The U.S. Environmental Protection Agency (U.S. EPA) is charged with protecting public health and the environment, which includes consideration of impacts from dispersed development. Specifically, because federal infrastructure projects can affect the progress of dispersed development, the secondary impacts resulting from it must be assessed in documents prepared under the National Environmental Policy Act (NEPA). The Council on Environmental Quality (CEQ) has oversight for NEPA and Section 309 of the Clean Air Act requires that U.S. EPA review and comment on federal agency NEPA documents. The adverse effects of dispersed development can be induced by federal infrastructure projects including transportation, built infrastructure, modifications in natural infrastructure, public land conversion and redevelopment of properties, construction of federal facilities, and large traffic or major growth generation developments requiring federal permits. This paper presents an approach that U.S. EPA reviewers and NEPA practitioners can use to provide accurate, realistic, and consistent analysis of secondary impacts of dispersed development resulting from federal infrastructure projects. It also presents 24 measures that can be used to mitigate adverse impacts from dispersed development by modifying project location and design, participating in preservation or restoration activities, or informing and supporting local communities in planning.

Cities↗
PubMed2002

Comparing Clean Water Act Section 316(b) policy options.

This paper develops a comparative framework for policy proposals involving fish protection and Section 316(b) of the Clean Water Act (CWA). Section 316(b) addresses the impingement and entrainment of fish by cooling-water intake structures used principally by steam electric power plants. The framework is motivated by examining the role of adverse environmental impacts (AEIs) in the context of Section 316(b) decision making. AEI is mentioned in Section 316(b), but not defined. While various AEI options have been proposed over the years, none has been formalized through environmental regulations nor universally accepted. Using a multiple values approach from decision analysis, AEIs are characterized as measurement criteria for ecological impacts. Criteria for evaluating AEI options are identified, including modeling and assessment issues, the characterization of ecological value, regulatory implementation, and the treatment of uncertainty. Motivated by the difficulties in defining AEI once and for all, a framework is introduced to compare options for 316(b) decision making. Three simplified policy options are considered, each with a different implicit or explicit AEI approach: (1) a technology-driven rule based on a strict reading of the 316(b) regulatory text, and for which any impingement and entrainment count as AEI, (2) a complementary, open-ended risk-assessment process for estimating population effects with AEI characterized on a site-specific basis, and (3) an intermediate position based on proxy measures such as specially constructed definitions of littoral zone, sensitive habitat, or water body type. The first two proposals correspond roughly to responses provided, respectively, by the Riverkeeper environmental organization and the Utility Water Act Group to the U.S. Environmental Protection Agency (EPA)'s proposed 316(b) new facilities rule of August 2000; the third example is a simplified form of the EPA's proposed August 2000 new facilities rule itself. The simplified policy positions are compared using the three dimensions of the comparative policy framework: (1) the role of CWA philosophy or vision, such as the use of technology-forcing rules, (2) regulatory policy implementation, and (3) the role for scientific information and the knowledge base. Strengths and weaknesses of all three 316(b) policy approaches are identified. The U.S. EPA's final new facilities rule of November 2001 is briefly characterized using the comparative policy framework and used to further illustrate the approach.

Animals↗
PubMed2003

Effects of ozone on lung function and lung diseases.

Ozone (O3) is an air pollutant produced by sunlight-driven reactions involving the oxides of nitrogen and volatile organic compounds. The population of many large metropolitan areas in the US is exposed to high levels of O3, particularly in the summer months. Individuals exposed to O3 levels in human experiments at higher than common ambient levels develop reversible reductions in lung function often associated with symptoms, such as airway hyperreactivity and lung inflammation. Animal models have helped characterize potential mechanisms of lung injury from O3 exposure. Defining the adverse effects of chronic exposure to ambient levels of O3 on lung function and disease have been challenging, in part due to the presence of co-pollutants, such as particulate matter. The US Environmental Protection Agency's 1997 revised standard for O3 (0.08 ppm averaged over 8 hours) is designed to provide better protection to susceptible individuals. The revised standard is being implemented following the failure of court challenges.

Air Pollutants↗
PubMedDate not supplied

Accreditation at the US EPA-NEIC. National Enforcement Investigations Center.

The US Environmental Protection Agency-National Enforcement Investigations Center (NEIC) of Denver, Colorado is the specialty technical arm of the Office of Enforcement and Compliance Assurance (OECA) within the US EPA. NEIC is a center for technical support nationwide to state, local, tribal, and federal environmental enforcement and compliance assurance programs. NEIC is a source of expertise for technical analysis, compliance monitoring, engineering evaluations, forensic laboratory activities, information management, computer forensics, and witness testimony. Effective 1 February 2001, NEIC was granted accreditation for overall environmental measurement activities that include field sampling, field measurements and monitoring, and laboratory measurements. NEIC became the first and only environmental forensic center in the United States to be granted this type of accreditation. The accreditation criteria incorporates nationally and internationally accepted forensic and quality management standards. Awarded by the National Forensic Science Technology Center (NFSTC), the NEIC Accreditation Standard was developed for conducting environmental measurements while adhering to forensic requirements in specific areas. The NEIC Accreditation Standard is based on ISO/IEC Guide 25 and ANSI/ASQC E4-1994, and it references specific aspects of the American Society of Crime Laboratory Directors/Laboratory Accreditation Board (ASCLD/LAB) Manual.

Accreditation↗
PubMed1990

Hazard evaluation for complex mixtures: relative comparisons to improve regulatory consistency.

The traditional "absolute decision-making" process used by federal regulatory agencies to derive permissible exposure concentrations for hazardous substances is initiated by an evaluation of the "weight-of-evidence" that a substance is a potential human carcinogen. Subsequent conservative procedures applied variably to noncarcinogens and carcinogens yield exposure limits for individual substances based on "data-sparse, model-intensive" techniques which may lack consistency and have difficulty directly addressing the hazards from complex mixtures. This paper describes how a "relative decision-making" technique applicable to complex mixtures can supplement the "absolute" approach currently used. Estimates obtained through this "data-intensive, model-sparse" technique may be evaluated by comparisons to estimates representing a range of hazards "generally regarded as safe" derived through analyses of chlorinated drinking water, cigarette smoke condensate, and other common human exposures. Comparisons are also used to evaluate the relative degree of consistency in risk estimates between 58 suspect human carcinogens analyzed by the U.S. Environmental Protection Agency Carcinogen Assessment Group and by the authors.

Animals↗
PubMed2004

Using science to assess environmental vulnerabilities.

Beginning in 1995, the U.S. Environmental Protection Agency (U.S. EPA), Office of Research and Development has focused much of its ecological research in the Mid-Atlantic as part of the Mid-Atlantic Integrated Assessment (MAIA). The goal of MAIA is to improve the assessability of scientific information in environmental decision-making. Following the Environmental Monitoring and Assessment Program (EMAP) whose goal is to guide monitoring that effectively reflects current ecosystem condition and trends, MAIA's second, current, phase of research under the Regional Vulnerability Assessment (ReVA) program is designed to target risk management activities using available data and models. The papers presented here are from a conference held in May 2003 that presented results of research in this second phase of MAIA. The conference was organized into the following topics: 1. Assessing Current Impacts and Vulnerabilities 2. Forecasting Environmental Condition and Vulnerabilities 3. Developing Management Strategies to Optimize the Future, and 4. Assessing and Responding to Environmental Vulnerability.

Environmental Monitoring↗
PubMed1990

Mode of action and the assessment of chemical hazards in the presence of limited data: use of structure-activity relationships (SAR) under TSCA, Section 5.

Section 5 of the Toxic Substances Control Act (TSCA) requires that manufacturers and importers of new chemicals must submit a Premanufacture Notification (PMN) to the U.S. Environmental Protection Agency 90 days before they intend to commence manufacture or import. Certain information such as chemical identity, uses, etc., must be included in the notification. The submission of test data on the new substance, however, is not required, although any available health and environmental information must be provided. Nonetheless, over half of all PMNs submitted to the agency do not contain any test data; because PMN chemicals are new, no test data is generally available in the scientific literature. Given this situation, EPA has had to develop techniques for hazard assessment that can be used in the presence of limited test data. EPA's approach has been termed "structure-activity relationships" (SAR) and involves three major components: the first is critical evaluation and interpretation of available toxicity data on the chemical; the second component involves evaluation of test data available on analogous substances and/or potential metabolites; and the third component involves the use of mathematical expressions for biological activity known as "quantitative structure-activity relationships" (QSARs). At present, the use of QSARs is limited to estimating physical chemical properties, environmental toxicity, and bioconcentration factors. An important overarching element in EPA's approach is the experience and judgment of scientific assessors in interpreting and integrating the available data and information. Examples are provided that illustrate EPA's approach to hazard assessment for PMN chemicals.

Animals↗
PubMed2001

Alkylphenol ethoxylate degradation products in land-applied sewage sludge (biosolids).

Alkylphenol ethoxylates, widely used in commercial and household detergents in the United States, can degrade during the wastewater treatment process to more toxic, estrogenic, and lipophilic compounds. These include octylphenol (OP), nonylphenols (NPs), nonylphenol monoethoxylates (NP1EOs), and nonylphenol diethoxylates (NP2EOs). These compounds have received considerable attention due to their acute toxicity and ability to disrupt the endocrine system. In Europe, regulations have been established to control their impact on the environment. In this study, biosolids derived from all 11 U.S. wastewater treatment plants examined contained detectable levels of OP, NPs, NP1EOs, and NP2EOs. Nine exceeded the current Danish land application limit (30 mg/kg; sum of NPs, NP1EOs, and NP2EOs) by 6-33x. NPs were the major component, and their concentrations therein ranged from 5.4 to 887 mg/kg (dry weight). OP, reportedly 10-20x more estrogenic than NP, was detected in these same nine biosolids at levels up to 12.6 mg/kg. Three biosolids were also subjected to the U.S. Environmental Protection Agency Toxicity Characteristic Leaching Procedure Method 1311. NPs and NP1EOs were both detected in the leachate; the former at concentrations from 9.4 to 309 microg/L. On the basis of effect levels published in the literature, alkylphenol ethoxylate degradates in U.S. biosolids may cause adverse environmental impacts.

Biodegradation, Environmental↗
PubMed2000

Toxicology. Mercury report backs strict rules.

The debate, finally, seemed to be settled. After an 18-month review, a panel of the National Academy of Sciences last week weighed in on the health risks of mercury, endorsing strict safety levels proposed by the Environmental Protection Agency in 1995. But already some scientists are contesting the panel's conclusions, and federal agencies are grappling with how to reconcile competing regulations.

Animals↗
PubMed1996

Hispanic environmental health: ambient and indoor air pollution.

Air pollution has serious deleterious effects on health and is a public health matter of the utmost importance. The National Coalition of Hispanic Health and Human Services Organizations (COSSMHO) believes that reducing exposure to air pollution is a priority issue for the Hispanic community because 80% of Hispanics (compared with 65% of non-Hispanic blacks and 57% of non-Hispanic whites) live in nonattainment areas--areas that fail to meet the Environmental Protection Agency ambient air quality standard. Although Hispanics in general live as long as or longer than non-Hispanic whites, what morbidity data are available reveal that the quality of that life is severely impaired by a variety of chronic conditions, such as asthma. This makes environmental health a pressing matter for Hispanic communities, particularly in the area of air pollution. Action items are included.

Adolescent↗
PubMed1991

ASTER: an integration of the AQUIRE data base and the QSAR system for use in ecological risk assessments.

Ecological risk assessments are used by the US Environmental Protection Agency (US EPA) and other governmental agencies to assist in determining the probability and magnitude of deleterious effects of hazardous chemicals on plants and animals. These assessments are important steps in formulating regulatory decisions. The completion of an ecological risk assessment requires the gathering of ecotoxicological hazard and environmental exposure information. This information is evaluated in the risk characterization section to assist in making the final risk assessment. ASTER (ASsessment Tools for the Evaluation of Risk) was designed by the US EPA Environmental Research Laboratory-Duluth (ERL-D) to assist regulators in producing assessments. ASTER is an integration of the ACQUIRE (AQUatic toxicity Information REtrieval system) and QSAR (Quantitative Structure Activity Relationships) systems. ACQUIRE is a data base of aquatic toxicity tests and QSAR is comprised of a data base of measured physicochemical properties, and various QSAR models that estimate physicochemical and ecotoxicological endpoints. ASTER will be available to international governmental agencies through the US EPA National Computing Center.

Animals↗
PubMed2000

Can varying concepts of susceptibility in risk assessment affect particulate matter standards?

The Clean Air Act mandates that sensitive subpopulations be considered in setting standards to protect the public's health. The purposes of this paper are to point out different conceptualizations of susceptibility, examine how it is approached in risk-related processes, and recommend ways it may be more explicitly framed for risk assessment and management purposes. We studied the traditional risk assessment paradigm, the U.S. Environmental Protection Agency (EPA) guidelines and revised PM standard, discussions from recent interdisciplinary meetings, and peer-reviewed literature. Areas of controversy include what factors intrinsic and extrinsic to the host should be incorporated in susceptibility, what health endpoints are of concern, whether susceptibility is deterministic or stochastic, and whether it should be defined on an individual or population scale. Recent discussions about susceptibility applied to PM indicate that it needs to be more clearly defined and evaluated for scientific and policy purposes. We conclude that varying concepts of susceptibility can affect risk-related processes such as PM standard setting. We recommend that susceptibility be clearly defined in the problem statement of risk assessments and be addressed in a specific subsection of risk characterization, integrating all susceptibility findings from the prior three steps in the risk assessment paradigm.

Air Pollution↗
PubMed2005

Mortgaging the future: dumping ethics with nuclear waste.

On August 22, 2005 the U.S. Environmental Protection Agency issued proposed new regulations for radiation releases from the planned permanent U.S. nuclear-waste repository in Yucca Mountain, Nevada. The goal of the new standards is to provide public-health protection for the next million years - even though everyone admits that the radioactive wastes will leak. Regulations now guarantee individual and equal protection against all radiation exposures above the legal limit. Instead E.P.A. recommended different radiation exposure-limits for different time periods. It also recommended using only the arithmetic mean of the dose distribution, to assess regulatory compliance during one time period, but using only the median dose to assess compliance during another period. This piece argues that these two changes - in exposure-limits and in methods of assessing regulatory compliance - have at least four disturbing consequences. The changes would threaten equal protection, ignore the needs of the most vulnerable, allow many fatal exposures, and sanction scientifically flawed dose calculations.

Ethics↗
PubMed1996

Setting exposure standards: a decision process.

Increased emphasis on routine screening of chemicals for potential neurotoxicity has resulted in the development of testing guidelines and standardized procedures. A multiphased, tiered-testing strategy has been proposed by numerous expert panels to evaluate large numbers of chemicals. In a regulatory context, however, a formal tiered-testing approach is not used, mostly because of the constraints of differing regulatory authorities and the potential cost of such a testing strategy. Instead, current regulatory decision making utilizes all available animal and human data to identify a critical adverse effect which is then used for setting standards. Although the current decision-making process does not use a formal tiered-testing approach, it appears to identify chemicals with neurotoxic effects. An analysis of U.S. Environmental Protection Agency integrated risk information system (IRIS) indicates that about 20% of the chemicals having standards or health advisories are based on neurotoxicity.

Algorithms↗
PubMed1989

Formaldehyde. Council on Scientific Affairs.

In response to Resolution 195 (A-87), the medical literature on the adverse health effects of formaldehyde was reviewed, and the potential cancer risk to anatomists and other related health professionals from exposure to the chemical is described. Though the evidence in humans is limited and controversial, both the Environmental Protection Agency and the Occupational Safety and Health Administration, in their consideration of available epidemiologic and toxicological studies, now regard formaldehyde as a possible human carcinogen and will regulate it accordingly.

Anatomy↗