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PubMed1990

The COMPLY computer program for demonstrating compliance with national radionuclide air emission standards.

The Environmental Protection Agency (EPA) has proposed national radionuclide air emission standards for a number of source categories. One of these standards applies to Nuclear Regulatory Commission Licensees and non-Department of Energy facilities having the potential to release radionuclides to the atmosphere. Approximately 6000 facilities are subject to the standard, which limits the effective whole-body dose commitment to the maximally exposed individual from radionuclide releases to the atmosphere. A computer program to assist the regulated community in determining compliance has been developed by the EPA's Office of Radiation Programs. The computer program COMPLY calculates the dose to an individual residing outside the facility. The program considers dose from inhalation, ingestion of contaminated food, air immersion, and ground deposition. It is based on models developed by the National Council on Radiation Protection and Measurements (NCRP). Compliance procedures provided in COMPLY are designed to reduce the burden on the regulated community. The approach begins with simple-to-use methods that are very conservative in determining compliance. The methods become progressively less conservative but more complicated at succeeding levels. Each higher level requires the input of site-specific information, but allows a more realistic estimate of dose. This paper describes the COMPLY program, and provides estimates of the work required and the degree of conservatism in the dose computed at each level.

Air Pollution, Radioactive↗
PubMedDate not supplied

Reference dose (RfD): the possible impact of hormesis.

A fictitious US Environmental Protection Agency Administrator in the year 2005 is confronted with making a risk management decision on a chemical that exhibits an unambiguous hormetic effect in an animal system. Dose-response curves for average humans and sensitive humans are derived from the animal data. The question is posed: What should the reference dose (RfD) be in this case? A series of outstanding scientific and policy questions are discussed that have a bearing on the answer. The concept of the 'regulatory dose (RgD)' is revived to address, if not resolve, the issue.

Adaptation, Physiological↗
PubMed2004

Concentrations of dioxin-like PCB congeners in unweathered Aroclors by HRGC/HRMS using EPA Method 1668A.

We have determined the congener compositions of nine commercial Aroclor products of polychlorinated biphenyls (PCBs) to the sub-part-per-million level using high-resolution gas chromatography combined with high-resolution mass spectrometry according to US Environmental Protection Agency (EPA) Method 1668A. These Aroclor composition data should allow improved characterization and risk assessment of PCB contamination at hazardous waste sites, particularly for dioxin-like PCB congeners. By combining the data on the concentrations of each dioxin-like congener with its World Health Organization toxicity equivalency factor, we have established dioxin toxic equivalent concentrations for each pure Aroclor product.

Aroclors↗
PubMedDate not supplied

Management of infectious waste by US hospitals.

In July 1987 and January 1988, forty-six percent (441/955) of randomly selected US hospitals responded to a questionnaire intended to identify their waste disposal practices. Survey responses were received from hospitals in 48 states. United States hospitals generated a median of 6.93 kg of hospital waste per patient per day and infectious waste made up 15% of the total hospital waste. Most hospitals (greater than 90%) considered blood, microbiology, "sharps," communicable disease isolation, pathology, autopsy, and contaminated animal carcass waste as infectious. Other sources of hospital waste that were commonly (greater than 80%) designated infectious were surgical, dialysis, and miscellaneous laboratory waste. The infectious waste was normally (80%) treated via incineration or steam sterilization before disposal, whereas noninfectious waste was discarded directly in a sanitary landfill. Eight-two percent of these US hospitals are discarding blood, microbiology, sharps, pathology, and contaminated animal carcass waste in accordance with the Centers for Disease Control's recommendations, while the compliance rate for the Environmental Protection Agency's recommendations (excluding optional waste) is 75%. No hospital could identify an infection problem (excluding needle-stick injuries) that was attributable to the disposal of infectious waste. While the management of infectious waste by US hospitals is generally consistent with the Centers for Disease Control's guidelines, many hospitals employ overly inclusive definitions of infectious waste.

Centers for Disease Control and Prevention, U.S.↗
PubMed2000

The application of standard methods for the determination of toxaphene in environmental media.

In the United States, it is necessary to analyze for toxaphene using approved, validated methods acceptable to the regulatory agencies. As a result of an interlaboratory study and technical exchanges among the US EPA Region IV (EPA), the State of Georgia Environmental Protection Division (EPD), and Hercules Incorporated, guidelines for the application of SW-846 Method 8080 were developed. Results of analyses for sludge, soil, and water samples agreed within a percent relative standard deviation (% RSD) range of 6.9-20%. Through continued technical interchanges, guidance for the application of SW-846 Method 8081 has been developed. The results of analyses of fourteen split samples of soil and sediment produced a percent relative standard deviation that ranged from 1.6% to 127%, with an average of 38%. When two unusually divergent results were removed from consideration, the average % RSD reduced to 26%. The results of analyses of split samples show agreement between the EPA laboratory and a Hercules contract laboratory. Therefore, the guidance has achieved its purpose of producing agreement among data from different laboratories so that data reviewers may have assurance that the analytical method has been applied correctly and consistently for the determination of toxaphene in environmental samples.

Chromatography, Gas↗
PubMed2006

Characterization of background concentrations of contaminants using a mixture of normal distributions.

We present a Bayesian approach for characterizing background contaminant concentration distributions using data from sites that may have been contaminated. Our method, focused on estimation, resolves several technical problems of the existing methods sanctioned by the U.S. Environmental Protection Agency (USEPA) (a hypothesis testing based method), resulting in a simple and quick procedure for estimating background contaminant concentrations. The proposed Bayesian method is applied to two data sets from a federal facility regulated under the Resource Conservation and Restoration Act. The results are compared to background distributions identified using existing methods recommended by the USEPA. The two data sets represent low and moderate levels of censorship in the data. Although an unbiased estimator is elusive, we show that the proposed Bayesian estimation method will have a smaller bias than the EPA recommended method.

Bayes Theorem↗
PubMed1999

Chloroform: An EPA test case.

In March 1998, the U.S. Environmental Protection Agency (EPA) published a proposal to raise the drinking water maximum contaminant level goal (MCLG) for chloroform, a suspected human carcinogen, from zero to 300 parts per billion. The proposal marked a departure from the agency's traditional reliance on linear dose-response models in performing risk assessment, and reflected the new thinking contained in the 1996 draft update to the agency's cancer risk assessment guidelines. The updated guidelines emphasize mechanisms of action and descriptions of the conditions under which carcinogenic hazards are likely to be expressed.

Animals↗
PubMedDate not supplied

Effect of household preparation on levels of pesticide residues in produce.

In 1993, the National Academy of Sciences released a report on the effects of pesticides in the diets of infants and children, indicating that current tolerances do not take into account the eating habits and metabolism of young children. In response to that report, a study was undertaken to determine pesticide residues in raw agricultural commodities at levels below the tolerances established by the Environmental Protection Agency. The objective of the study was to determine whether normal household washing, peeling, and cooking procedures had any effect on pesticide residue levels. Low levels of pesticide residues were detected in 97 (40%) of the 243 samples analyzed. The number of samples containing detectable residues dropped to 47 (19%) after household preparation. Results indicate that residue levels in most commodities are substantially reduced after household preparation.

Carbamates↗
PubMedDate not supplied

Neurotoxic substances also posing a cancer risk: a warning.

A large proportion of compounds studied for their neurotoxic potential are at the same time suspected or proven carcinogens. This is demonstrated using the International Neurotoxicology Association (INA) Professional Interest Directory and publications from the field of neurotoxicology as examples. In addition to listing these compounds, the classification scheme used by the International Agency for Research on Cancer (IARC), the Commission of the European Communities (EC), the U.S. Environmental Protection Agency (EPA), the German MAK-Commission of the Deutsche Forschungsgemeinschaft (DGF) and the U.S. National Institute of Occupational Safety and Health (NIOSH) to make qualitative risk assessments is explained. Finally, a short initiation to quantitative risk assessment as performed by the US EPA and the World Health Organization (WHO) is given in order to put the reader into a position as to assess the cancer risk incurred by his/her co-workers and by himself.

Carcinogens↗
PubMedDate not supplied

Computer validation in toxicology: historical review for FDA and EPA good laboratory practice.

The application of computer validation principles to Good Laboratory Practice is a fairly recent phenomenon. As automated data collection systems have become more common in toxicology facilities, the U.S. Food and Drug Administration and the U.S. Environmental Protection Agency have begun to focus inspections in this area. This historical review documents the development of regulatory guidance on computer validation in toxicology over the past several decades. An overview of the components of a computer life cycle is presented, including the development of systems descriptions, validation plans, validation testing, system maintenance, SOPs, change control, security considerations, and system retirement. Examples are provided for implementation of computer validation principles on laboratory computer systems in a toxicology facility.

Clinical Laboratory Information Systems↗
PubMed1997

Topics in cancer risk assessment.

The estimation of carcinogenic risks from exposure to chemicals has become an integral part of the regulatory process in the United States within the past decade. With it have come considerable controversy and debate over the scientific merits and shortcomings of the methods and their impact on risk management decisions. In this paper we highlight selected topics of current interest in the debate. As an indication of the level of public concern, we note the major recent reports on risk assessment from the National Academy of Sciences and the U.S Environmental Protection Agency's proposed substantial revisions to its Guidelines for Carcinogen Risk Assessment. We identify and briefly frame several key scientific issues in cancer risk assessment, including the growing recognition of the importance of understanding the mode of action of carcinogenesis in experimental animals and in humans, the methodologies and challenges in quantitative extrapolation of cancer risks, and the question of how to assess and account for human variability in susceptibility to carcinogens. In addition, we discuss initiatives in progress that may fundamentally alter the carcinogenesis testing paradigm.

Animals↗
PubMed1997

Environmental risk harmonization: federal/state approaches to risk assessment and management.

As environmental laws and regulations have evolved in recent years, disparities have arisen in the assessment and management of similar risks by different governmental units. Such inconsistencies have had several adverse impacts. One is that resources may not be used most effectively to reduce risks and a second is that public confidence in government may be eroded and thus support for environmental protection. This article presents a summary of a conference and workshop that was held to address the sources of these disharmonies in risk assessment and risk management and to make recommendations as to how to improve the situation. It includes international, national, and state perspectives and utilizes a case study to illustrate the variety of issues associated with harmonizing risk assessment and risk management among governmental units. The workshop summaries demonstrate that, while there are presently many areas of disagreement, there are also significant issues upon which agreement can be reached and which can serve as the basis for further harmonization efforts.

Environmental Exposure↗
PubMed2006

Prevalence and implementation of IAQ programs in U.S. schools.

In this study, we determined the extent to which U.S. schools are implementing indoor air quality (IAQ) programs. We administered a questionnaire on IAQ programs and practices to a representative sample of schools. Participants were asked to provide information on the use, administration, implementation, challenges, and benefits of the IAQ program in their school. We developed an IAQ Practice Index to determine the level of activity directed toward IAQ in schools. The index was computed based on responses to specific survey questions and was normalized to a range of 0 to 100. Each question was weighted qualitatively according to its contribution to strong IAQ management practices. Forty-two percent of schools in the United States have an IAQ management program, and there has been sustained growth from 1998 through 2002 in the number of schools that have such programs. Nearly half of those schools use the U.S. Environmental Protection Agency's IAQ Tools for Schools program. The IAQ Practice Index scores varied widely for schools with an IAQ management program, suggesting that having a program is not equivalent to implementing effective IAQ policies and procedures. Respondents indicated that their IAQ programs led to improved workplace satisfaction, fewer asthma attacks, fewer visits to the school nurse, and lower absenteeism. When actively supported by the school administration, an IAQ program appears to be a valuable factor in improving the learning environment for U.S. schoolchildren.

Air Pollution, Indoor↗
PubMed2003

Beverages: bottled water. Direct final rule.

The Food and Drug Administration (FDA) is amending its bottled water quality standard regulations by establishing an allowable level for the contaminant uranium. As a consequence, bottled water manufacturers are required to monitor their finished bottled water products for uranium 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 uranium as often as necessary, but at least once every 4 years unless they meet the criteria for the source water monitoring exemptions under the CGMP regulations. FDA will retain the existing allowable levels for combined radium-226/-228, gross alpha particle radioactivity, and beta particle and photon radioactivity. This direct final rule will ensure that the minimum quality of bottled water, as affected by uranium, combined radium-226/-228, gross alpha particle radioactivity, and beta particle and photon radioactivity, remains comparable with the quality of public drinking water that meets the Environmental Protection Agency's (EPA's) standards. FDA is issuing a direct final rule for this action because the agency expects that there will be no significant adverse comment on this rule. Elsewhere in this issue of the Federal Register, FDA is publishing a companion proposed, rule under the agency's usual procedure for notice-and-comment rulemaking, to provide a procedural framework to finalize the rule in the event the agency receives any significant adverse comments and withdraws this direct final rule. The companion proposed rule and direct final rule are substantively identical.

Consumer Product Safety↗
PubMedDate not supplied

Chemical characterization of sanding dust and methylene chloride usage in automotive refinishing: implications for occupational and environmental health.

Surface preparation activities conducted during automotive refinishing present several potential human health and environmental risks. This study examines the chemical composition of vehicle sanding dust and the prevalence of methylene chloride use as a basis for evaluating potential chemical exposures in the work environment, fugitive environmental releases, and take-home toxics. This article reports on the findings of (1) a statewide technology and work practices survey of 353 licensed auto body shops and (2) laboratory analyses of sanding dust representing more than 200 vehicles, 10 commercial body filler compounds, and work shirts worn during vehicle sanding while using nonventilated equipment. Survey data revealed that the majority of shops (78%) do not use ventilated sanding equipment, that most workers (55%) take their work clothes and shoes home at the end of the workday, and that 17% of the respondents used a methylene chloride-based paint stripper as an adjunct to mechanical sanding. Laboratory results showed that Pb, As, Cr, Mn, and Ni were present in the sanding dust at every facility tested. Lead concentrations in sanding dust were found to be highest at facilities that performed complete vehicle refinishing (range 770 to 7300 ppm) and at a collision repair shop that used a high-lead content body filler compound (1800 ppm). Hexavalent chromium also was found in two vocational high school paint dust samples at concentrations of 54 and 710 ppm. When total lead and chromium concentrations reached 7300 and 2300 ppm, respectively, facility sanding dust samples failed the U.S. Environmental Protection Agency's Toxicity Characteristic Leaching Procedure for hazardous waste. Metals found in the sanding dust also were present on the work shirts of technicians-ranging from 0.06 (Cd) to 81 (Mg) microg/inch2 of cloth-who sanded on paint without ventilated equipment. Results suggest that sanding dust and methylene chloride paint strippers used in vehicle resurfacing operations pose a potential hazard to human health and the environment.

Automobiles↗
PubMed1991

How sick a patient? Report of a workshop on cancer risk assessment.

A report by the U.S. Government Office of Management and Budget (OMB) criticized the way health, safety, and environmental regulation of potential cancer causing substances is conducted by federal agencies, especially the Environmental Protection Agency. Cancer risk assessment--this report indicates--is governed by arbitrary policy assumptions and procedures improperly disguised as scientific and is designed to overestimate risk. Unwarranted economic burdens of ensuing regulation may then adversely affect standards of living and ultimately the very health and longevity that regulation is presumed to safeguard. An interdisciplinary workshop generally agreed with the OMB position and sharpened criticism of the procedures and scientific pretensions in the regulation of potential carcinogens. Various options for change were discussed, although it was felt that the success of detailed remedies would require a wider political, administrative, and scientific discourse.

Carcinogens↗
PubMed1997

Toxicity identification of poultry litter aqueous leachate.

Poultry litter is a mixture of excreta, feed, feathers, and bedding material. Poultry litter is useful as a fertilizer due to the presence of nitrogen, phosphorus, and potassium. Litter is commonly used for growing corn, soybeans, potatoes, tomatoes, leafy vegetables, and cover crops. The aqueous leachate of poultry litter has been shown to exhibit toxicity to a variety of indicator organisms. The objective of this research was to identify classes of toxicants in the litter aqueous leachate. The aqueous extract of poultry litter was subjected to toxicity identification tests approved by the United States Environmental Protection Agency that use Ceriodaphnia dubia as the test organism. Tests performed included pH adjustment, filtration, aeration, C18 solid-phase extraction, EDTA addition, sodium thiosulfate addition, and extraction through zeolite. Zeolite extraction, filtration at low pH, and aeration at low pH reduced overall toxicity by 68, 20, and 22%, respectively. The major sources of toxicity appear to be ammonia and anionic organic compounds. Toxicity was apparently not due to the presence of heavy metals or oxidants.

Ammonia↗
PubMed1993

Human health and environmental toxicity issues for evaluation of halon replacements.

The Clean Air Act Amendments of 1990 require the US Environmental Protection Agency (EPA) to phase out production and use of ozone-depleting chemicals--among them, the fire suppressants, halons. As part of its rulemaking efforts EPA must evaluate the potential hazards to human health and the environment that could result from exposure to compounds that may substitute for halons. The EPA bases health hazard assessment on data obtained in studies involving short-term and long-term exposures. The former are used to evaluate potential risks of acute or delayed effects potentially resulting from short exposures at high concentrations, such as might be experienced in episodic emissions in the workplace. Studies with long-term exposure are used to assess potential adverse effects from continued exposure to low ambient concentrations. In addition, reproductive and developmental hazards are evaluated in several animal species. About ten chlorinated-, brominated-, and/or fluorinated-hydrogen-containing hydrocarbons, to be used alone or in combination, have been proposed as halon substitutes. In addition to health and safety, environmental, efficacy, and marketability considerations (Table I) need to be addressed for the selection of proposed halon substitutes. This presentation will discuss current EPA/Office of Air and Radiation thinking on a decision-tree approach for testing the toxicity of halon substitutes under the Significant New Alternatives Policy program.

Air Pollution↗