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PubMed2006

Comments on article "Applying mode-of-action and pharmacokinetic considerations in contemporary cancer risk assessments: an example with trichloroethylene" by Clewell and Andersen.

In their 2004 article, Clewell and Andersen provide their perspective on the application of mode-of-action (MOA) and pharmacokinetic considerations in contemporary cancer risk assessment using trichloroethylene (TCE) as a case example. TCE is a complex chemical toxicologically, with multiple metabolites, multiple sites of observed toxicity, and multiple potential MOAs. As scientists who are responsible for revising the U.S. Environmental Protection Agency's draft risk assessment of TCE, we welcome input of the quality to which the Agency is held accountable. However, in our view, Clewell and Andersen do not present a sufficiently current, complete, accurate, and transparent review of the pertinent scientific literature. In particular, their article would need to incorporate substantial recently published scientific information, better support its conclusions about MOA and choice of linear or nonlinear dose-response extrapolation, and increase its transparency as to quantitative analyses in order to make a significant contribution to the scientific discussion of TCE health risks.

Animals↗
PubMed2004

Worker exposure standard for phosphine gas.

The 1998 U.S. Environmental Protection Agency Office of Pesticide Programs (OPP) re-registration eligibility decision (RED) for phosphine fumigants has generated much interest in defining safe levels of exposure for workers and worker bystanders. This report summarizes the pertinent literature on phosphine toxicity, including animal inhalation studies and human epidemiology studies, and also describes a margin-of-exposure (MOE) analysis based on available worker exposure data. In addition, a safe occupational exposure limit is estimated using typical OPP assumptions, after determination of appropriate uncertainty factors, based on quality of data in the principal study and pharmacokinetic considerations. While a conservative 8-hour time-weighted average (TWA) of 0.1 ppm was calculated, the overall weight of evidence, from a risk-management perspective, supports a conclusion that an occupational TWA of 0.3 ppm provides adequate health protection. In addition, a 15-minute short-term exposure limit (STEL) of 3 ppm was estimated. Finally, in contrast to the MOE analysis described in the OPP's phosphine RED, the MOE analysis described herein does not indicate that fumigation workers are currently being exposed to unacceptable levels of phosphine. Collectively, these findings support the occupational exposure limits of 0.3 ppm (8-hour TWA) and 1 ppm (STEL) established in the updated applicator's manuals for phosphine-generating products, which recently received approval from OPP.

Administration, Inhalation↗
PubMedDate not supplied

European Union bans atrazine, while the United States negotiates continued use.

Atrazine is a common agricultural herbicide with endocrine disruptor activity. There is evidence that it interferes with reproduction and development, and may cause cancer. Although the U.S. Environmental Protection Agency (EPA) approved its continued use in October 2003, that same month the European Union (EU) announced a ban of atrazine because of ubiquitous and unpreventable water contamination. The authors reviewed regulatory procedures and government documents, and report efforts by the manufacturer of atrazine, Syngenta, to influence the U.S. atrazine assessment, by submitting flawed scientific data as evidence of no harm, and by meeting repeatedly and privately with EPA to negotiate the government's regulatory approach. Many of the details of these negotiations continue to be withheld from the public, despite EPA regulations and federal open-government laws that require such decisions to be made in the open.

Atrazine↗
PubMed2004

Development of freshwater water-quality criteria for perchlorate.

The anion perchlorate (ClO4-) is an oxidizing component commonly used in solid propellants for rockets and missiles; in explosives, flares, fireworks, chemical processes, and automobile air-bag inflators; and for other assorted uses. With recent advances in analytical detection capability, perchlorate has been found in a variety of ground and surface waters throughout the United States. Because perchlorate has been associated with thyroid problems in humans and may have similar effects on wildlife, it is desirable to develop a water-quality criterion to assist in identifying concentrations of perchlorate in water likely to pose an ecological health risk. In the present study, we compiled all available data regarding the effects of perchlorate to aquatic organisms, and we performed additional toxicity and bioconcentration tests as required by the U.S. Environmental Protection Agency (U.S. EPA) for the development of water-quality criteria for aquatic life. A criterion maximum concentration of 20 mg/L and a criterion continuous concentration of 9.3 mg/L were calculated based on the test results. Although these are not formal Clean Water Act Section 304(a) criteria, which must be published by the U.S. EPA, these criteria may be useful in the determination of remedial action levels for contaminated sites, for National Pollutant Discharge Elimination System permit limits, and other water-quality management practices.

Animals↗
PubMed1995

U.S. EPA challenges and review--highlights of the Fiscal Year 1994 Inspection Program and EPA's laboratory accreditation considerations.

The reorganization and consolidation of the United States Environmental Protection Agency's (EPA's) Headquarters Enforcement and Compliance programs into a new Office of Enforcement and Compliance Assurance (OECA) is now complete. The Good Laboratory Practice (GLP) inspection program is now part of the Office of Compliance, one of the principal offices in this new organization. The role of the Office of Compliance and the implications of these changes for the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and Toxic Substances Control Act (TSCA) GLP programs are addressed. Highlights of the fiscal year 1994 inspection program are reviewed. The status of the Agency's consideration of laboratory accreditation is discussed.

Accreditation↗
PubMedDate not supplied

Modeling for health care and other policy decisions: uses, roles, and validity.

The role of models to support recommendations on the cost-effective use of medical technologies and pharmaceuticals is controversial. At the heart of the controversy is the degree to which experimental or other empirical evidence should be required prior to model use. The controversy stems in part from a misconception that the role of models is to establish truth rather than to guide clinical and policy decisions. In other domains of public policy that involve human life and health, such as environmental protection and defense strategy, models are generally accepted as decision aids, and many models have been formally incorporated into regulatory processes and governmental decision making. We formulate an analytical framework for evaluating the role of models as aids to decision making. Implications for the implementation of Section 114 of the Food and Drug Administration Modernization Act (FDAMA) are derived from this framework.

Chlorofluorocarbons↗
PubMedDate not supplied

An innovative blood lead screening program for Indian children.

There is little information on the lead levels of Indian children nationally. In the late 1990s, members of the Chippewa and Cree tribes living on the Rocky Boy Reservation near Box Elder, Montana, were concerned about environmental pollution and how it might be affecting the health of their children. With financial assistance from the Environmental Protection Agency, the tribes designed and implemented an innovative lead screening program for young children. Because most children on the reservation participated in WIC and Head Start, those programs were used to identify and screen close to 100% of young children on the reservation. The average blood lead level for children ages 1-5 on the Rocky Boy reservation was 2.4 micrograms/dL, which is not significantly different from that of children of the same age nationally. The project showed that Indian families will participate readily in screening programs that may improve their children's health.

Age Factors↗
PubMed1999

Emergency planning and the acute toxic potency of inhaled ammonia.

Ammonia is present in agriculture and commerce in many if not most communities. This report evaluates the toxic potency of ammonia, based on three types of data: anecdotal data, in some cases predating World War 1, reconstructions of contemporary industrial accidents, and animal bioassays. Standards and guidelines for human exposure have been driven largely by the anecdotal data, suggesting that ammonia at 5,000-10,000 parts per million, volume/volume (ppm-v), might be lethal within 5-10 min. However, contemporary accident reconstructions suggest that ammonia lethality requires higher concentrations. For example, 33,737 ppm-v was a 5-min zero-mortality value in a major ammonia release in 1973 in South Africa. Comparisons of secondary reports of ammonia lethality with original sources revealed discrepancies in contemporary sources, apparently resulting from failure to examine old documents or accurately translate foreign documents. The present investigation revealed that contemporary accident reconstructions yield ammonia lethality levels comparable to those in dozens of reports of animal bioassays, after adjustment of concentrations to human equivalent concentrations via U.S. Environmental Protection Agency (EPA) procedures. Ammonia levels potentially causing irreversible injury or impairing the ability of exposed people to escape from further exposure or from coincident perils similarly have been biased downwardly in contemporary sources. The EPA has identified ammonia as one of 366 extremely hazardous substances subject to community right-to-know provisions of the Superfund Act and emergency planning provisions of the Clean Air Act. The Clean Air Act defines emergency planning zones (EPZs) around industrial facilities exceeding a threshold quantity of ammonia on-site. This study suggests that EPZ areas around ammonia facilities can be reduced, thereby also reducing emergency planning costs, which will vary roughly with the EPZ radius squared.

Air Pollution↗
PubMed2003

Source reduction for prevention of methylene chloride hazards: cases from four industrial sectors.

BACKGROUND: Source reduction, defined as chemical, equipment and process changes that intervene in an industrial process to eliminate or reduce hazards, has not figured as a front-line strategy for the protection of workers' health. Such initiatives are popular for environmental protection, but their feasibility and effectiveness as an industrial hygiene approach have not been well described. METHODS: We investigated four cases of source reduction as a hazard prevention strategy in Massachusetts companies that had used methylene chloride, an occupational carcinogen, for cleaning and adhesive thinning. Three cases were retrospective and one was prospective, where the researchers assisted with the source reduction process change. Data were collected using qualitative research methods, including in-depth interviews and site visits. RESULTS: Motivated by environmental restrictions, a new worker health standard, and opportunity for productivity improvements, three companies eliminated their use of methylene chloride by utilizing available technologies and drop-in substitutes. Aided by technical assistance from the investigators, a fourth case dramatically reduced its use of methylene chloride via process and chemistry changes. While the companies' evaluations of potential work environment impacts of substitutes were not extensive, and in two cases new potential hazards were introduced, the overall impact of the source reduction strategy was deemed beneficial, both from a worker health and a production standpoint. CONCLUSION: The findings from these four cases suggest that source reduction should be considered potentially feasible and effective for reducing or eliminating the potential hazards of methylene chloride exposure. Especially when faced with a hazard that is both an environmental and worker health concern, companies may chose to change their processes rather than rely on local exhaust ventilation equipment or personal protective equipment that might not be as effective, might transfer risk and/or not be integrated with financial goals. However, technical assistance sensitive to environmental and health and safety impacts as well as production issues should be provided to guide companies' source reduction efforts.

Adult↗
PubMed1990

Comparison of water quality criteria and health advisories for 2,4,6-trinitrotoluene.

The U.S. Environmental Protection Agency (USEPA) has recently recommended health advisories (HAs) for 2,4,6-trinitrotoluene (TNT). The purpose of this brief article is to present these values so that the reader can compare them with the water quality criteria that have been proposed in another article (M. G. Ryon and R. H. Ross, 1990, Regul. Toxicol. Pharmacol. 11, 104-113). In that article, a water quality criterion of 140 micrograms/liter for TNT in drinking water was proposed, and in the present article the methodology by which USEPA calculated a lifetime HA of 2 micrograms/liter is presented. The reasons why the water quality criterion and the HA differ are discussed.

Humans↗
PubMed1991

Burning of hazardous waste in boilers and industrial furnaces--EPA. Final rule: corrections; technical amendments.

On February 21, 1991, the Environmental Protection Agency (EPA) published a final rule to regulate air emissions from the burning of hazardous waste in boilers and industrial furnaces (56 FR 7134). Today's notice corrects typographical and editorial errors that appeared in the regulatory text, including corrections to appendices II and III, and adds two appendices, appendix IX and appendix X, to part 266. Appendices IX and X were not ready at the time of publication; therefore, a note was placed in the appropriate location in the rule to inform readers that these appendices were to be published at a later date. Copies of these appendices were, however, made available to the public through the RCRA Docket maintained at EPA and through the National Technical Information Service (NTIS).

Air Pollution↗
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↗
PubMed1989

Critical assessment of motor activity as a screen for neurotoxicity.

Motor activity consists of a large number of motor behaviors not placed under stimulus control. The Environmental Protection Agency defines motor activity in terms of "activity counts," and has incorporated it in the guidelines for the assessment of neurotoxicity. While motor activity testing has some enticing operating characteristics, a dose-related change in activity counts can reflect an effect on the nervous system only in the absence of systemic toxicity. Furthermore, when a motor activity effect has been documented, ancillary data or further testing is needed to determine whether this effect is indeed adverse. In addition, the results of a motor activity test do not usually provide information about either the origin of the problem, or the follow-up tests that need to be conducted.

Animals↗
PubMed2005

Community-based participatory research: lessons learned from the Centers for Children's Environmental Health and Disease Prevention Research.

Over the past several decades there has been growing evidence of the increase in incidence rates, morbidity, and mortality for a number of health problems experienced by children. The causation and aggravation of these problems are complex and multifactorial. The burden of these health problems and environmental exposures is borne disproportionately by children from low-income communities and communities of color. Researchers and funding institutions have called for increased attention to the complex issues that affect the health of children living in marginalized communities--and communities more broadly--and have suggested greater community involvement in processes that shape research and intervention approaches, for example, through community-based participatory research (CBPR) partnerships among academic, health services, public health, and community-based organizations. Centers for Children's Environmental Health and Disease Prevention Research (Children's Centers) funded by the National Institute of Environmental Health Sciences and U.S. Environmental Protection Agency were required to include a CBPR project. The purpose of this article is to provide a definition and set of CBPR principles, to describe the rationale for and major benefits of using this approach, to draw on the experiences of six of the Children's Centers in using CBPR, and to provide lessons learned and recommendations for how to successfully establish and maintain CBPR partnerships aimed at enhancing our understanding and addressing the multiple determinants of children's health.

Child↗
PubMed2002

Introduction--the methyl parathion story: a chronicle of misuse and preventable human exposure.

In the fall of 1994, Lorain County, Ohio, became the site of the first investigation of several large-scale incidences in which the organophosphate pesticide methyl parathion was illegally applied to private residences. The extent of potential human exposure to this pesticide led the Ohio Department of Health to formally request technical assistance from the Centers for Disease Control and Prevention (CDC). This article describes the initial investigation of 64 homes in Ohio and introduces the method of using both biological markers of exposure (p-nitrophenol levels in human urine samples) and environmental markers of contamination in dust and air samples when making public health decisions about the cleanup of homes sprayed with methyl parathion. The results of the CDC rapid investigation led the U.S. Environmental Protection Agency to declare the contaminated homes in Lorain County a Superfund cleanup site. Seven years after the Lorain incident, and after subsequent Superfund actions had been implemented in Illinois and Mississippi, researchers participated in an expanded session devoted to methyl parathion at the 11th Annual Meeting of the International Society of Exposure Analysis held in Charleston, South Carolina, in the fall of 2001. The articles included in this monograph are based on presentations at that meeting. They report previously unpublished data that tell the methyl parathion story from different perspectives, each providing in-depth information about separate aspects of this multistate, multiagency, and multimillion dollar chemical exposure. This monograph is the methyl parathion story.

Biomarkers↗
PubMed2001

Comparison of operational design criteria for subsurface flow constructed wetlands for wastewater treatment.

Many communities are investigating the use of constructed wetlands as a simple, viable alternative to poorly operating on-site wastewater treatment. Currently, the most popular design models in the U.S.A. for subsurface flow units are the US Environmental Protection Agency (EPA) and the Tennessee Valley Authority (TVA) methods. However, there has been limited data verifying if the operating performance is up to design standards. In order to address this problem, this paper documents the performance of such treatment systems over a broad range of conditions in North Alabama. The operational data is used to determine a best-fit value of reaction rate constant and proposes improved input parameters for both design models. According to this data, the average plug-flow reaction rate constant was calculated to be 0.70 d-1 for the EPA method, while the recommended organic loading criterion is 11.4 m2/kg BOD5 per day into the wetland for the TVA method.

Algorithms↗
PubMed1992

An evaluation of the role of epidemiology in assessing current and future disinfection technologies for drinking water.

Six members of the International Society for Environmental Epidemiology provide a discussion of the presentations of the authors of six studies dealing with the potential chronic disease side effects of water disinfection. This symposium, which was jointly sponsored by the Society and the United States Environmental Protection Agency (EPA) also involved state epidemiologists and engineers from state drinking water programs. This article summarizes the results of the studies and the comments about them. There was a general consensus that the recent EPA sponsored studies of cancer endpoints have strengthened the evidence linking bladder cancer with long term exposure to chlorinated drinking water. The evidence for links with colon cancer is not convincing and that for serum lipid changes is quite weak. Any risks, if real, are low when compared to the risk of infection from not disinfecting water. This is particularly true for small water systems where chlorination may be the only practical option.

Chloramines↗
PubMed2000

Variability in pesticides residues--the US experience.

The evolution of US Environmental Protection Agency's (EPA) process for estimating potential health risks from pesticide residues in or on food is examined in light of changes in US Legislation and the variability of residue data and assumptions used to estimate dietary exposure. In the 86 years since enactment of the Insecticide Act, pesticide laws have become progressively more health-based. Passage of the 1996 Food Quality Protection Act (FQPA) requires EPA to place particular emphasis on assessing potential risk from pesticides to infants and children. Primary factors affecting the actual pesticide residues in food include frequency of application, percentage of crop treated, and the interval from treatment to harvest. Primary factors affecting the estimated pesticide residues in food include the source of the residue data, calculation techniques for non-detected residues, and the availability of data reflecting post-harvest treatments. Risk assessors must thoroughly consider these factors when assessing dietary risk to pesticides. Risk managers will need to consider these factors as a means of mitigating dietary risk from pesticides.

Adult↗