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Environmental monitoring programs vs Good Laboratory Practice (GLP) programs: differences and similarities.

Environmental monitoring and Good Laboratory Practice programs are similar when looked at empirically. Both address quality issues, human or environmental safety, and have set procedures to assure the concomitant results. However, when compared at the operational level, they can be best described as very different. Good Laboratory Practice programs deal basically with two governmental agencies and their divisions- the Environmental Protection Agency and Food and Drug Administration. These are administered from the federal level involving no state resources. These programs are objective driven with the procedures being defined in study plans, protocols, and standard operating procedures. The environmental monitoring testing programs deal with a profusion of federal legislation including CERCLA (also known as CLP), RCRA, CWA, CAA, SDWA, NPDES and others. These acts require analysis by specific procedures mandated by the statutes. States operate many of these programs and have been given the authority by the federal government. Many of the states require separate certifications to conduct these analyses. Environmental monitoring testing laboratories often must acquire multiple state certifications to participate in multiple state programs. This is not cost effective and often leads to conflicting requirements. Much of the direction for having a national certification program comes from problems associated with these state-operated programs.

Accreditation↗

Risk assessment for asbestos-related cancer from the 9/11 attack on the World Trade Center.

OBJECTIVE: We sought to estimate the lifetime risk of asbestos-related cancer for residents of Lower Manhattan attributable to asbestos released into the air by the 9/11 attack on New York City's World Trade Center (WTC). METHODS: Exposure was estimated from available data and reasoned projections based on these data. Cancer risk was assessed using an asbestos risk model that differentiates asbestos fiber-types and the US Environmental Protection Agency's model that does not differentiate fiber-types and combines mesothelioma and lung cancer risks. RESULTS: The upper limit for the expected number of asbestos-related cancers is less than one case over the lifetime of the population for the risk model that is specific for fiber-types and 12 asbestos-related cancers with the US Environmental Protection Agency's model. CONCLUSIONS: The cancer risk associated with asbestos exposures for residents of Lower Manhattan resulting from the collapse of the WTC is negligible.

Adolescent↗

Human tissue monitoring and specimen banking: opportunities for exposure assessment, risk assessment, and epidemiologic research.

A symposium on Human Tissue Monitoring and Specimen Banking: Opportunities for Exposure Assessment, Risk Assessment, and Epidemiologic Research was held from 30 March to 1 April 1993 in Research Triangle Park, North Carolina. There were 117 registered participants from 18 states and 5 foreign countries. The first 2 days featured 21 invited speakers from the U.S. Environmental Protection Agency, the Centers for Disease Control and Prevention, the National Institute of Environmental Health Sciences, various other government agencies, and universities in the United States, Canada, Germany, and Norway. The speakers provided a state-of-the-art overview of human exposure assessment techniques (especially applications of biological markers) and their relevance to human tissue specimen banking. Issues relevant to large-scale specimen banking were discussed, including program design, sample design, data collection, tissue collection, and ethical ramifications. The final group of presentations concerned practical experiences of major specimen banking and human tissue monitoring programs in the United States and Europe. The symposium addressed the utility and research opportunities afforded by specimen banking programs for future research needs in the areas of human exposure assessment, risk assessment, and environmental epidemiology. The third day of the symposium consisted of a small workshop convened to discuss and develop recommendations to the U.S. Environmental Protection Agency regarding applications and utility of large-scale specimen banking, biological monitoring, and biological markers for risk assessment activities.

Biomarkers↗

Identifying US populations for the study of health effects related to drinking water arsenic.

The US Environmental Protection Agency recently set a new maximum contaminant level (MCL) for arsenic in drinking water of 10 micro g/l. In this paper, we review the completeness and accuracy of drinking water arsenic occurrence data in the United States and identify populations exposed to elevated arsenic concentrations that would be suitable for epidemiological studies of arsenic health effects. Using existing data from the Environmental Protection Agency Arsenic Occurrence and Exposure Database and additional data from state health and environment departments and water utilities, we identified 33 counties in 11 states with an estimated mean drinking water arsenic concentration of 10 micro g/l or greater. A total of 11 of these 'confirmed' counties had an estimated mean arsenic concentration of 20 micro g/l or more and two had an estimated mean arsenic concentration 50 micro g/l or more. Based on census data, between 1950 and 1999 there were approximately 51.1 million person-years of exposure to drinking water arsenic at levels of 10 micro g/l or more, 8.2 million at levels of 20 micro g/l or more arsenic and 0.9 million at levels of 50 micro g/l or more. Mortality and incidence of diseases known to be associated with arsenic exposure can and should be examined in these counties as part of a comprehensive assessment of arsenic health effects in US populations.

Arsenic↗

Two data bases in every garage: information quality systems.

Enterprises, including Federal agencies such as the U.S. Environmental Protection Agency (EPA), are now identifying their information as a strategic resource. As part of a new strategy, enterprises address quality system planning. This technical paper presents some of EPA's approaches and techniques for reconciling quality system considerations for science and technical activities with quality system considerations for information technology and resources. Identification of key information quality indicators, management processes, and assessment processes are addressed.

Environmental Monitoring↗

Linking research and policy to ensure children's environmental health.

The U.S. Environmental Protection Agency (U.S. EPA) has made protecting children's environmental health its highest priority. Data on how and when children may be at risk are vital for accomplishing this goal. Recent examples of the link between research and policy include U.S. EPA actions to carry out the recommendations of the National Academy of Sciences on pesticides in children's food, reduce and prevent childhood lead poisoning, and revise national ambient air quality standards for ozone and particulate matter. Today, the Food Quality Protection Act (FQPA), which makes protecting children from pesticide residues in food a national priority, is contributing to the growing need for data for decision making. Further impetus comes from provisions in the FQPA and 1996 Safe Drinking Water Act Amendments for establishing a screening and testing program for potential risks from endocrine disruptors. Another factor is the analysis that will be required under President William J. Clinton's executive order directing all federal agencies, for the first time, to reduce environmental health and safety risks to children. Success of the U.S. international commitment to protect children is directly tied to the strength and availability of environmental data. To meet such challenges, the U.S. EPA is revising key science policies, expanding research opportunities, and adding to the public's right-to-know tools. In this dynamic climate, there are growing opportunities for the research community to play a greater role in helping ensure the well-being of children living today and in generations to come.

Child↗

Status of scrap (recyclable) dental amalgams as environmental health hazards or toxic substances.

This article presents information garnered after an investigation by the Environmental Protection Agency in 1987 of dentists and others who had sold scrap dental amalgam to refiners who had "arranged for the disposal or treatment ... of hazardous substances," and were responsible for adverse consequences associated with their subsequent management and refining. Information about the health hazard status of scrap dental amalgams was obtained by: interviews with toxicologists, review of published lists of toxic and hazardous materials, and survey of biomedical publications (1977 through 1987) concerning toxicity or health hazards associated with dental amalgams. The conclusions were that scrap dental amalgam is not: a waste substance to be disposed of, but is a product of commercial value; identified or regulated by the Environmental Protection Agency, the Occupational Safety and Health Administration, the Department of Transportation, the Food and Drug Administration, the National Institute of Occupational Safety and Health, the US Public Health Service, or the Centers for Disease Control as an environmental health hazard or toxic substance; identified by toxicologists and persons responsible for solid waste regulation as a toxic substance or environmental health hazard; nor proved by scientific study to be toxic or hazardous in the manner and form in which it is collected and stored by dentists and subsequently sold to metal refiners.

American Dental Association↗

Occurrence and weight-of-evidence risk assessment of alkyl sulfates, alkyl ethoxysulfates, and linear alkylbenzene sulfonates (LAS) in river water and sediments.

Alkyl sulfates (AS), alkyl ethoxysulfates (AES) and linear alkyl benzene sulfonates (LAS) are all High Production Volume (HPV) and 'down-the-drain' chemicals used globally in detergent and personal care products, resulting in low levels ultimately released to the environment via wastewater effluent. Due to their surfactant properties, they preferentially sorb to sediments. Hence, assessment of their levels and potential perturbations on benthos are of interest. The relative levels of AS/AES decreased with distance from the wastewater treatment plant outfall. However, this was not evident for LAS. Short chained AES and especially AS dominated the homologue distribution for AES. There were no evident patterns in LAS homologue distribution. The overall mean margin of exposure (MoE) for AS/AES and LAS is approximately 40 (range: 3 to 100) suggesting no noteworthy perturbation on biota. The findings in this study are in concordance with previous preliminary hazard screening. Comparative sediment contamination analyses principally based on Chapman and Anderson [Chapman PM, Anderson, J. A decision-making framework for sediment contamination. Integr Environ Assess Mana. 2005; 1: 163-173.] and the U.S. Environmental Protection Agency RAPID assessment methods [USEPA. Rapid bioassessment protocols for use in wadeable streams and rivers: Periphyton, benthic, macroinvertebrates, and fish. 1999. Second Edition. U.S. Environmental Protection Agency Office of Water, Washington, D.C. EPA 841-B-99-002.] did not reveal significant correlations between the surfactant concentrations and ecological status of the sampling locations. Several Lines of Evidence (LoE) of the Weight-of-Evidence (WoE) lead to the conclusion of low aquatic risk associated to the monitored compounds.

Alkanesulfonic Acids↗

The tobacco industry's political efforts to derail the EPA report on ETS.

Previously secret tobacco industry documents detailed a multifaceted approach of political strategies aimed to derail the 1993 Environmental Protection Agency (EPA) risk assessment on environmental tobacco smoke (ETS). These pervasive strategies included the following: (1) lobbying the first Bush Administration to approve an executive order that would impose new risk assessment standards for federal agencies, thus delaying the release of the EPA report; (2) having the first Bush Administration transfer jurisdiction over ETS from the EPA to Occupational Safety and Health Administration (OSHA), thus obviating the need for the release of the EPA report; and (3) applying enormous political pressure directly by alleging improper procedure and policy at EPA. Although some of the attempted strategies failed, the political pressure from Congressman Thomas Bliley (R-VA) was a success. This is the first report showing how a single member of Congress in conjunction with his staff, tobacco industry attorneys, and executives worked very aggressively to do the tobacco industry's bidding. These tactics successfully delayed the EPA risk assessment and placed a cloud over its validity that was not fully vindicated until December 2002 when the U.S. 4th Circuit Court of Appeals overturned the tobacco industry's suit against the EPA. The documents show that the industry will expend whatever effort is necessary to protect itself from public health policy that would adversely affect consumption of cigarettes and, therefore, profit.

Humans↗

Development and evaluation of a Macroinvertebrate Biotic Integrity Index (MBII) for regionally assessing Mid-Atlantic Highlands Streams.

The Macroinvertebrate Biotic Integrity Index (MBII) was developed from data collected at 574 wadeable stream reaches in the Mid-Atlantic Highlands region (MAHR) by the U.S. Environmental Protection Agency's (USEPA) Environmental Monitoring and Assessment Program (EMAP). Over 100 candidate metrics were evaluated for range, precision, responsiveness to various disturbances, relationship to catchment area, and redundancy. Seven metrics were selected, representing taxa richness (Ephemeroptera richness, Plecoptera richness, Trichoptera richness), assemblage composition (percent non-insect individuals, percent 5 dominant taxa), pollution tolerance [Macroinvertebrate Tolerance Index (MTI)], and one functional feeding group (collector-filterer richness). We scored metrics and summed them, then ranked the resulting index through use of independently evaluated reference stream reaches. Although sites were classified into lowland and upland ecoregional groups, we did not need to develop separate scoring criteria for each ecoregional group. We were able to use the same metrics for pool and riffle composite samples, but we had to score them differently. Using the EMAP probability design, we inferred the results, with known confidence bounds, to the 167,797 kilometers of wadeable streams in the Mid-Atlantic Highlands. We classified 17% of the target stream length in the MAHR as good, 57% as fair, and 26% as poor. Pool-dominated reaches were relatively rare in the MAHR, and the usefulness of the MBII was more difficult to assess in these reaches. The process used for developing the MBII is widely applicable and resulted in an index effective in evaluating region-wide conditions and distinguishing good and impaired reaches among both upland and lowland streams dominated by riffle habitat.

Animals↗

Toxicological information series, IV. Information resources for chemical emergency response.

The need for rapidly available information by community agencies responding to chemical emergencies (leaks, spills, releases, fires, explosions, etc.) can be met by a number of resources. These resources include local poison control centers, the Toxicology Data Network (National Library of Medicine), the Agency for Toxic Substances and Disease Registry, ATSDR/NLM's ANSWER, the National Chemical Response and Information Center, the National Pesticide Telecommunications Network, The National Response Center (U.S. Coast Guard), the Federal Emergency Management Agency, the U.S. Environmental Protection Agency, the National Safety Council, private-sector database vendors, and textbooks addressing hazardous substances.

Emergencies↗

Inhalation of sidestream cigarette smoke accelerates development of arteriosclerotic plaques.

BACKGROUND: Environmental tobacco smoke has been blamed for approximately 40,000 excess deaths from heart disease annually in the United States. As yet, no pathophysiological process that could be responsible for these deaths has been identified. Environmental tobacco smoke is composed mainly of aged and diluted sidestream smoke but also contains 15% to 20% exhaled mainstream smoke. Carcinogens, including nitrosamines and polynuclear aromatic hydrocarbons, are present in mainstream smoke and sidestream smoke. Carcinogen levels in sidestream smoke, unlike those in mainstream smoke, are not reduced in filtered cigarettes. The US Environmental Protection Agency has designated environmental tobacco smoke as a human (class A) carcinogen. In cockerels, subtumorigenic doses of polynuclear aromatic hydrocarbons carcinogens accelerate aortic arteriosclerotic plaque development. METHODS AND RESULTS: To determine whether sidestream smoke inhalation affects arteriosclerotic plaque development, we exposed cockerels to sidestream smoke (n = 30) or to filtered air (n = 12) in inhalation chambers for 6 hours per day, 5 days a week from 6 to 22 weeks of age (0.4% of projected lifespan). Chamber levels of carbon monoxide, total suspended particulates, and nicotine were measured regularly during the exposures. The abdominal aorta from each cockerel was cut into 10 segments, and the plaque index (mean plaque cross-sectional area [mm2]/mean luminal circumference [mm] x 100) was calculated for each segment. There were no differences in plaque incidence or distribution between sidestream smoke-exposed and control cockerels; however, plaque indexes were significantly greater for sidestream smoke-exposed than control cockerels in all segments. CONCLUSIONS: Thus, relatively brief exposures to sidestream smoke early in life are sufficient to enhance arteriosclerotic plaque development.

Animals↗

[Passive smoking and lung cancer: a new report in perspective].

Recently, a working group of six European scientists published a report on exposure to environmental tobacco smoke and the risk of lung cancer. The report concludes that environmental tobacco smoke is not a primary lung carcinogen. Critical evaluation of the report, however, shows that this conclusion is not justified. Results of recent epidemiologic studies support the earlier conclusion of the American Environmental Protection Agency (EPA) that environmental tobacco smoke does cause lung cancer. Furthermore, the working group fails to present compelling evidence that the results of the epidemiological studies in this field can be explained by bias or confounding, or that the association between environmental tobacco smoke and lung cancer is biologically implausible. Therefore, we see no reason to modify the conclusion of the EPA that passive smoking causes lung cancer.

Environmental Exposure↗

Advances in EPA's indirect exposure modeling methodology.

The Environmental Protection Agency's National Center for Environmental Assessment is currently revising and updating its approach to modeling the health risks from indirect exposure to combustor emissions. The updated method is intended to provide the necessary tools for estimating these health risks and to provide the necessary algorithms for the calculation of contaminant concentrations in water bodies, soil, and the terrestrial and aquatic food chains resulting from the deposition and transfer of atmospheric pollutants. Significant additions to the approach include the expansion of the application of exposure methods at a site, the description of procedures for defining the study population at a site, and ways to develop distributions of individual risk for members of the study population. This paper focuses on the changes in the human exposure scenarios of the update method and presents an overview of the development of an exposure scenario.

Environmental Exposure↗

A case study of tire crumb use on playgrounds: risk analysis and communication when major clinical knowledge gaps exist.

Physicians and public health professionals working with the U.S. Environmental Protection Agency's Region 8 Pediatric Environmental Health Specialty Unit (PEHSU) received several telephone calls requesting information regarding the safety of recycled tire crumb as a playground surface constituent placed below children's play structures. There were no reported symptoms or adverse health effects in exposed children. The literature available on the safety and risk of exposure to crumb rubber constituents was limited and revealed no information quantifying exposures associated with product use. Callers were informed by the PEHSU that no evidence existed suggesting harm from intended use of the product, but gaps in knowledge about the product were identified and communicated. Here the case of crumb rubber on playgrounds is used as a model to present an approach to similar environmental medicine questions. From defining the question, to surveying traditional and nontraditional resources for information, synthesis of findings, and risk communication, the case provides a model to approach similar questions.

Child↗

US EPA's acute reference exposure methodology for acute inhalation exposures.

The US Environmental Protection Agency (EPA) National Center for Environmental Assessment is engaged in the development of a methodology for Agency use to perform risk assessments for non-cancer effects due to acute inhalation exposures. The methodology will provide general guidance for deriving chemical-specific acute exposure benchmarks called acute reference exposures (AREs). Chemical-specific AREs are analogous to reference concentra tions (RfCs) for chronic non-cancer effects and will be incorporated in chemical-specific files in the US EPA's Integrated Risk Information System (IRIS) as they are developed and reviewed. AREs will have wide applicability in assessing the potential health risks of accidental and routine acute releases of chemicals to the environment. The proposed methodology for ARE development provides a framework for choosing an optimal derivation approach, depending on the type of data available, from the no-observed-adverse-effect level (NOAEL), benchmark concentration (BMC), or categorical regression approaches. Uncertainty factors are applied to the point of departure, determined by one of the recommended approaches, to derive the ARE. Due to the capability to use more exposure-response information than the NOAEL approach allows, exposure-response analyses such as BMC and categorical regression are favored as methods to develop the point of departure when the available database will support such analyses. The NOAEL approach is suitable when the data are insufficient to support exposure-response modeling. Applications of the proposed ARE methodology are illustrated by the derivation of example AREs for hydrogen sulfide and hexachlorocyclopentadiene, which showcase the categorical regression and NOAEL approaches, respectively. In addition, a recent review of the proposed ARE methodology by the US EPA Risk Assessment Forum is discussed.

Air Pollutants↗

Lead in residential soil and dust in a mining and smelting district in northern Armenia: a pilot study.

This pilot study of sources of lead exposure in residential settings was conducted in a mining and smelting district in northern Armenia. Samples of exterior soil and dust and interior house dust were collected in and around apartment buildings in Alaverdi where the country's largest polymetallic smelter is located, and in nearby mining towns of Aghtala and Shamlugh. The NITON XL-723 Multi-Element XRF analyzer was used for lead testing. Lead levels in samples from Alaverdi were higher than those in Shamlugh and Aghtala. In all three towns, the highest lead levels were found in loose exterior dust samples, and lead concentrations in yard soil were higher than those in garden soil. Many soil samples (34%) and the majority of loose dust samples (77%) in Alaverdi exceeded the US Environmental Protection Agency standard of 400 mg/kg for bare soil in children's play areas. In addition, 36% of floor dust samples from apartments in Alaverdi exceeded the US Environmental Protection Agency standard of 40 microg/ft(2) for lead loading in residential floor dust. The Armenian Ministry of Health and other interested agencies are being informed about the findings of the study so that they can consider and develop educational and preventive programs including blood lead screening among sensitive populations.

Armenia↗

Mercury exposure and child development outcomes.

Mercury is ubiquitous in the global environment, ensuring universal exposure. Some forms of mercury are especially neurotoxic, including clinical signs at high doses. However, typical human exposures occur at low to moderate doses. Only limited data about neurotoxicity at low doses are available, and scientists differ in their interpretation. Dose-response data on neurodevelopment are particularly limited. Despite or perhaps because of the lack of sufficient or consistent scientific data, public concern about a link between mercury exposure and developmental disabilities has been rising. After reviewing the data, the US Environmental Protection Agency proposed a reference dose (an estimate of a daily dose that is likely to be without a risk of adverse effects over a lifetime) for methyl mercury that is substantially lower than previous guidelines from the World Health Organization, the US Agency for Toxic Substances and Disease Registry, and the US Food and Drug Administration. Some questions have been raised about the Environmental Protection Agency's guidelines, but the issue remains unresolved. Meanwhile, consumer groups have raised questions about the potential link between mercury exposure and autism spectrum disorders as well as other adverse neurodevelopmental outcomes. This hypothesis has prompted some parents to seek regulatory, legal, or medical remedies in the absence of firm evidence. This article reviews what is known about mercury neurotoxicity and neurodevelopmental risk. Our intent is to focus the debate about mercury on 1) additional research that should be sought and 2) defining the principal issues that public policy makers face.

Child↗