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PubMed1995

A compilation of Good Laboratory Practice questions and (where to get the) answers.

Since the inception of the Food and Drug Administration's Good Laboratory Practice Regulations and Environmental Protection Agency's Good Laboratory Practice Standards, many "questions and answer" documents have been produced. Our purpose in this presentation is to pull together some of these reference documents and provide a cross-reference index to sort through the many topics and questions. The combined reference resource and index provide the quality assurance professional a useful Good Laboratory Practice information tool.

Facility Regulation and Control↗
PubMed1998

Synthetic risks, risk potency, and carcinogen regulation.

This article analyzes a comprehensive sample of over 350 chemicals tested for carcinogenicity to assess the determinants of the probability of regulation. Controlling for differences in the risk potency and noncancer risks, synthetic chemicals have a significantly higher probability of regulation overall: this is due to the greater likelihood of U.S. Food and Drug Administration (FDA) regulation. Measures of risk potency increase the probability of regulation by the U.S. Environmental Protection Agency (EPA), have a somewhat weaker positive effect on regulation by the U.S. Occupational Safety and Health Administration (OSHA), and decrease the likelihood of regulation by the FDA. The overall regulatory pattern is one in which the FDA targets synthetic chemicals and chemicals that pose relatively minor cancer risk. The EPA particularly performed more sensibly than many critics have suggested.

Carcinogens↗
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

Efficacy testing of disinfectants.

The U.S. Environmental Protection Agency's (EPA) Office of Pesticide Programs (OPP) has the responsibility for regulating antimicrobial products, including sporicides, used to treat and decontaminate inanimate surfaces. In response to the anthrax (Bacillus anthracis) attacks of 2001 and the associated need for verifying the performance of chemicals for building decontamination, the EPA initiated research in late 2003 to evaluate and improve efficacy test methods for sporicides. The OPP Microbiology Laboratory located at the Environmental Science Center, Ft. Meade, MD is the lead laboratory. Through funding provided by EPA's Office of Research and Development (Safe Buildings Program), a collaborative research plan has been established to address several key issues. Research is currently being conducted on 2 fronts: (1) the evaluation of quantitative methodology for assessing the efficacy of sporicides, and (2) the development and comparative testing of selected modifications to improve the AOAC Sporicidal Activity Test (AOAC Method 966.04). Future studies will include the evaluation of candidate surrogates of B. anthracis using a quantitative method, and a multilaboratory validation study of a quantitative method-surrogate combination. The General Referee is serving as the Principal Investigator for all research described in this report, and has the overall responsibility for the technical conduct of the projects. In cases where the General Referee has oversight of projects that involve official collaborative studies and validation support from AOAC INTERNATIONAL, AOAC officials and the Committee Chair will determine the appropriate mechanism for formal study review. The 2003 General Referee report provides the background on the development and direction of the research projects. The preliminary data, general conclusions, next steps, and recommendations are provided in this report.

Bacillus subtilis↗
PubMed2005

Lessons Learned for the Study of Childhood Asthma from the Centers for Children's Environmental Health and Disease Prevention Research.

The National Children's Study will address, among other illnesses, the environmental causes of both incident asthma and exacerbations of asthma in children. Seven of the Centers for Children's Environmental Health and Disease Prevention Research (Children's Centers), funded by the National Institute of Environmental Health Sciences and the U.S. Environmental Protection Agency, conducted studies relating to asthma. The design of these studies was diverse and included cohorts, longitudinal studies of older children, and intervention trials involving asthmatic children. In addition to the general lessons provided regarding the conduct of clinical studies in both urban and rural populations, these studies provide important lessons regarding the successful conduct of community research addressing asthma. They demonstrate that it is necessary and feasible to conduct repeated evaluation of environmental exposures in the home to address environmental exposures relevant to asthma. The time and staff required were usually underestimated by the investigators, but through resourceful efforts, the studies were completed with a remarkably high completion rate. The definition of asthma and assessment of disease severity proved to be complex and required a combination of questionnaires, pulmonary function tests, and biologic samples for markers of immune response and disease activity. The definition of asthma was particularly problematic in younger children, who may exhibit typical asthma symptoms sporadically with respiratory infections without developing chronic asthma. Medications confounded the definition of asthma disease activity, and must be repeatedly and systematically estimated. Despite these many challenges, the Children's Centers successfully conducted long-term studies of asthma.

Asthma↗
PubMed2001

Methodologies for estimating emissions for the U.S. EPA's NOx SIP call, CER rule, and other complexities.

Emissions inventories play an important role in many air quality decisions, and the importance of obtaining correct emissions data challenges the emissions inventory community to continuously improve its estimation techniques. The Clean Air Act Amendments of 1990 requires states with ozone nonattainment areas (NAAs) to submit periodically a comprehensive, accurate, and actual inventory of ozone precursor emissions until the areas are redesignated to attainment. They require the states with NAAs to report peak ozone season daily and annual estimates of the inventories for the counties that are in nonattainment. The recently proposed U.S. Environmental Protection Agency's (EPA) NO(x) SIP call and the Consolidating Emissions Reporting (CER) rule are more demanding still. The CER rule requires the states to report statewide point source inventories, 3-yr cycle inventories, and NO(x) SIP call inventories by county for all source types, regardless of the attainment status; the estimating periods are peak ozone season daily, 5-month ozone season, and annual estimates. Furthermore, complexities in emissions inventories such as estimating the emissions with different seasonal and multiple controls exist. These complexities and methodologies for estimating emissions for different time periods are not addressed sufficiently either by the EPA's procedure manuals or by the Emissions Inventory Improvement Program guidance documents. This paper presents methodologies for estimating emissions for different time periods and multiple controls. These methodologies will help the EPA, state, and local government agencies to meet the evolving demands of emissions inventories and the reporting requirements of the NO(x) SIP call and the CER rules.

Air Pollutants↗
PubMed2006

Antepartum seafood consumption and mercury levels in newborn cord blood.

OBJECTIVE: The purpose of this study was to determine the level of fetal mercury exposure by measuring mercury levels in newborn cord blood and to analyze the association with fish consumption during pregnancy. STUDY DESIGN: A total of 308 women who met the eligibility criteria were enrolled in the study. Of these, 275 women completed a dietary survey; after delivery, cord blood was collected and analyzed for mercury levels. RESULTS: The mean mercury level in cord blood was 4.82 microg/L; 28.3% of the participants had measured mercury levels above the US Environmental Protection Agency's recommended reference dose (5.8 microg/L). A significant relationship was noted between the amount of fish consumed during pregnancy and rising mercury levels in cord blood. CONCLUSION: In an island state with high levels of fish consumption, women were 3 times more likely to have elevated cord blood mercury levels, compared with the national average.

Adult↗
PubMed2002

QSARs for identifying and prioritizing substances with persistence and bioconcentration potential.

From the 8511 chemicals with 1998 production volumes reported to the U.S. Environmental Protection Agency (U.S. EPA), the TSCA Interagency Testing Committee's (ITC's) Degradation Effects Bioconcentration Information Testing Strategies (DEBITS) was used to identify 56 chemicals. The DEBITS Quantitative Structure-Activity Relationships (QSARs) and the U.S. EPA's PBT profiler QSARs were used to predict the persistence and bioconcentration factors of these 56 chemicals. Partial order ranking was used to prioritise the chemicals based on persistence and bioconcentration potential.

Biological Availability↗
PubMedDate not supplied

An inventory of human exposure-related data bases.

An inventory of Federally-sponsored data bases, which either have been or could be used to estimate human exposures to environmental agents, was compiled through a joint effort by the Environmental Protection Agency (EPA), the National Center for Health Statistics (CDC-NCHS), and the Agency for Toxic Substances and Disease Registry (ATSDR). The inventory includes sixty-seven exposure-related data systems that meet the following criteria: cover a relatively large geographical area (e.g., national, state); provide reasonable access to information; and are supported, at least in part, by Federal funds. Findings allow for comparison of data bases according to 1) exposure estimators (e.g., emission estimates, environmental measurements), 2) sample types (e.g., air, water soil, food, human tissue), 3) measured/observed parameters (e.g., pesticides, PCBs, microorganisms), 4) geographic scope (e.g., national, regional, state), 5) sample collection frequency (e.g., yearly, quarterly, daily), and 6) sample location identifiers (e.g., latitude/longitude, zip code, county). Results indicate that existing data bases were established for a variety of reasons (e.g., regulatory compliance, research, monitor environmental conditions, legal requirements) and contain information which varies widely in terms of quality, relevance, and availability. Although the inventory identifies many potential sources of information, it also highlights significant shortcomings in the available systems, including an almost complete absence of data on contact between people and environmental agents (human exposure) and on the amount of the agent that is absorbed into the body (dose).

Data Collection↗
PubMed2000

The removal of lead from gasoline: historical and personal reflections.

Tetraethyllead (TEL) was first fabricated for use in gasoline in 1923. Shortly after manufacture began, workers at all three plants began to become floridly psychotic and die. A moratorium on TEL production was put into place, but was lifted in 1926. Between 1926 and 1965, the prevailing consensus was that lead toxicity occurred only at high levels of exposure and that lead in the atmosphere was harmless. Most of the data on lead toxicity issued from a single source, the Kettering Laboratory in Cincinnati. In 1959, the first warnings of adverse health effects of lead at silent doses were raised by Clair Patterson, a geochemist. In hearings before the Senate Committee on Public Works, Senator Edward Muskie raised the question of adverse health effects from airborne lead. As new data accumulated on health effects of lead at lower doses, the movement to remove lead from gasoline gained momentum, and the Environmental Protection Agency examined the question. The removal of lead would take place over the next 25 years, and its accomplishment would require a severe change in the federal stance regarding its hazard. This article details the interaction of various forces, industrial, regulatory, judicial, public health, and public interest, that were engaged in this contest and estimates the value of this step.

Air Pollutants↗
PubMed1999

Performance assessment in support of the 1996 compliance certification application for the Waste Isolation Pilot Plant.

The conceptual and computational structure of a performance assessment (PA) for the Waste Isolation Pilot Plant (WIPP) is described. Important parts of this structure are (1) maintenance of a separation between stochastic (i.e., aleatory) and subjective (i.e., epistemic) uncertainty, with stochastic uncertainty arising from the many possible disruptions that could occur over the 10,000-year regulatory period that applies to the WIPP, and subjective uncertainty arising from the imprecision with which many of the quantities required in the analysis are known, (2) use of Latin hypercube sampling to incorporate the effects of subjective uncertainty, (3) use of Monte Carlo (i.e., random) sampling to incorporate the effects of stochastic uncertainty, and (4) efficient use of the necessarily limited number of mechanistic calculations that can be performed to support the analysis. The WIPP is under development by the U.S. Department of Energy (DOE) for the geologic (i.e., deep underground) disposal of transuranic (TRU) waste, with the indicated PA supporting a Compliance Certification Application (CCA) by the DOE to the U.S. Environmental Protection Agency (EPA) in October 1996 for the necessary certifications for the WIPP to begin operation. The EPA certified the WIPP for the disposal of TRU waste in May 1998, with the result that the WIPP will be the first operational facility in the United States for the geologic disposal of radioactive waste.

Geological Phenomena↗
PubMed2000

Fitting second-order finite mixture models to data with many censored values using maximum likelihood estimation.

Finite mixture models, that is, weighted averages of parametric distributions, provide a powerful way to extend parametric families of distributions to fit data sets not adequately fit by a single parametric distribution. First-order finite mixture models have been widely used in the physical, chemical, biological, and social sciences for over 100 years. Using maximum likelihood estimation, we demonstrate how a first-order finite mixture model can represent the large variability in data collected by the U.S. Environmental Protection Agency for the concentration of Radon 222 in drinking water supplied from ground water, even when 28% of the data fall at or below the minimum reporting level. Extending the use of maximum likelihood, we also illustrate how a second-order finite mixture model can separate and represent both the variability and the uncertainty in the data set.

Algorithms↗
PubMed1991

Hazard communication/right-to-know for health care facilities.

This manual is intended to provide useful information on the various new and pending health and safety regulations that affect hospitals. The governing bodies promulgating these regulations are the Occupational Safety and Health Administration (OSHA), the Environmental Protection Agency (EPA), and state and local governments. The majority of this document is dedicated to the OSHA Hazard Communication Standard (or federal Employee Right-to-Know Law) and the EPA Superfund Amendment Reauthorization Act (SARA) Title III Regulations (or federal Community Right-to-Know Law).

Communication↗
PubMed1997

Sulfobutylether-beta-cyclodextrin-mediated capillary electrophoresis for separation of chlorinated and substituted phenols.

Cyclodextrin-mediated capillary electrophoresis has been developed for separation and analysis of chlorinated as well as substituted phenolic compounds. The procedure used a negatively charged sulfobutylether-beta-cyclodextrin (SB-betaCD) to effect differential partitioning of the phenols between the buffer and CD phases. In 50 mM phosphate buffer containing as low as 1 mM SB-betaCD, 25 phenolic compounds including 11 Environmental Protection Agency (EPA) priority phenols were separated with theoretical plate numbers well above 100,000, for 50 cm of effective length in most cases. An equilibrium complexation model was used for investigating the effect of pH as well as different cyclodextrin concentrations on the electrophoretic mobility. The cyclodextrin-mediated capillary electrophoresis system was also applicable for separating and quantifying the level of pentachlorophenol in contaminated soil samples.

Chlorophenols↗
PubMed1993

The U.S. EPA Geographic Information System for mapping environmental releases of Toxic Chemical Release Inventory (TRI) chemicals.

This study characterizes the environmental releases of toxic chemicals of the Toxic Chemical Release Inventory (TRI) in the southeastern United States by using the U.S. Environmental Protection Agency (EPA) Geographic Information System (GIS) to map them. These maps show that the largest quantities of TRI releases in the Southeast are usually near densely populated areas. This GIS mapping approach takes the first steps in defining those areas in the region which may be potential exposure zones and which could be strategic targets for future risk screening efforts in this geographic area.

Animals↗
PubMed2004

Analysis of polycyclic aromatic hydrocarbons in contaminated soil by Curie point pyrolysis coupled to gas chromatography-mass spectrometry, an alternative to conventional methods.

Curie point pyrolysis gas chromatography-mass spectrometry (Py-GC-MS) has been compared with classical extraction procedures (Soxhlet, sonication, KOH digestion, microwave-assisted) followed by GC-MS analysis for the determination of polycyclic aromatic hydrocarbons (PAHs) in contaminated soil. In each case, the efficiency of the technique was examined for 16 PAHs included in the US Environmental Protection Agency Priority Pollutant List. The results indicate that the recovery of PAHs is dependent on the extraction technique. The highest recoveries of PAHs were obtained with Curie point pyrolysis and KOH digestion. Py-GC-MS appeared to be interesting alternative method for the determination of PAHs in contaminated soil. The results were validated by certified soil (CRM 104) analysis.

Gas Chromatography-Mass Spectrometry↗
PubMed1989

A risk assessment for selected lead-induced health effects: an example of a general methodology.

The research described here is part of a larger risk assessment project to aid the U.S. Environmental Protection Agency (EPA) in its review of the primary National Ambient Air Quality Standard for lead. The methodology can be applied to many situations in which a policy decision about a toxic substance is required in the face of incomplete data. Numerical results are presented for three potentially adverse lead-induced effects of interest to EPA: elevated erythrocyte protoporphyrin (EP), hemoglobin (Hb) decrement, and intelligence quotient (IQ) decrement.

Air Pollutants↗
PubMed1989

Toxic air pollution across a state line: implications for the siting of resource recovery facilities.

Massive volumes of solid waste are produced in the United States. Options for disposal are limited. Incineration and recycling are frequently proposed solutions. However, incinerators and waste recovery facilities, such as scrap smelters, generate hazardous air pollutants and toxic ash. Their potential hazards to health have not been adequately assessed. To illustrate the policy issues surrounding waste incineration and resource recycling, we examine the case of U.S. Metals, a scrap metals recovery plant in Carteret, New Jersey. This plant emitted 20 kilograms of dioxin in its 25 years of operation. It also released 86 tons of lead annually; nearby air lead levels were repeatedly in violation of standards. Construction of a tall stack caused export of toxic emissions from the plant to Staten Island, New York; high concentrations of lead were documented in surface soil on Staten Island. Because neither the State of New Jersey nor the U.S. Environmental Protection Agency were willing to regulate emissions from the plant, New York, the downwind state, was forced to sue U.S. Metals in federal court. The suit resulted ultimately in closing the plant. The case illustrates the difficulties in regulating pollution across state lines, a difficulty compounded by the abdication of responsibility by state and federal agencies. Further, the episode appears paradigmatic of a disturbing trend by state and local governments to locate waste combustion facilities at sites which will resolve problems of solid waste by encouraging export of airborne pollutants across regulatory boundaries.

Air Pollutants↗