A large number of chemicals are used on land at shore facilities, in the air in combat and reconnaissance aircraft, on seas around the world in surface vessels, and in submarine vessels by the navy and marine corps. Although the chemicals used are for the large part harmless, there is a significant amount of chemicals in use that can be health hazards during specific exposure circumstances. The Navy Environmental Health Center (NEHC) is primarily tasked with assessing these hazards. The NEHC completes its tasks by reviewing toxicological and related data and preparing health-hazard assessments (HHAs) for the different chemicals. Since the NEHC is continually asked to develop these HHAs, the National Research Council (NRC) was asked to assess independently the validity and effectiveness of NEHC's HHA process, in order to determine whether the process as implemented provides the Navy with the best, comprehensive, and defensible evaluations of health hazards and to identify any elements that might require improvement. The task was assigned to the Board on Environmental Studies and Toxicology's Committee on Toxicology's (COT's) Subcommittee on Toxicological hazard and Risk Assessment. Review of the U.S. Navy Environmental Health Center's Health-Hazard Assessment Process presents the subcommittee's report. The report is the work of expertise in general toxicology, inhalation toxicology, epidemiology, neurotoxicology, immunotoxicology, reproductive and developmental toxicology, pharmacology, medicine, risk assessment, and biostatistics. It is based on its review of documents provided by NEHC, presentations by NEHC personnel, and site visits to NEHC in Norfolk, Virginia and an aircraft carrier in San Diego, California.
The United States Navy has been concerned for some time with protecting its military and civilian personnel from reproductive and developmental hazards in the workplace. As part of its efforts to reduce or eliminate exposure of Naval personnel and their families to reproductive and developmental toxicants, the Navy requested that the National Research Council (NRC) recommend an approach that can be used to evaluate chemicals and physical agents for their potential to cause reproductive and developmental toxicity. The NRC assigned this project to the Committee on Toxicology, which convened the Subcommittee on Reproductive and Developmental Toxicology, to prepare this report. In this report, the subcommittee recommends an approach for evaluating agents for potential reproductive and developmental toxicity and demonstrates how that approach can be used by the Navy. This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the NRC's Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We wish to thank the following individuals for their review of this report: James Chen (National Center for Toxicological Research), George Daston (Procter and Gamble Company), Jerry Heindel (National Institute of Environmental Health Sciences), Grace Lemasters (University of Cincinnati), and John Young (National Center for Toxicological Research).
Ignition of upholstered furniture by small open flames from matches, cigarette lighters, and candles is one of the leading causes of residential-fire deaths in the United States. These fires accounted for about 16% of civilian fire deaths in 1996. On average, each year since 1990, about 90 deaths (primarily of children), 440 injuries, and property losses amounting to 50 million dollars have resulted from fires caused by the ignition of upholstered furniture by small open flames. Certain commercial seating products (such as aircraft and bus seats) are subject to flammability standards and sometimes incorporate FR-treated upholstery cover materials, but there is no federal-government requirement for residential upholstered furniture, and it is generally not treated with FR chemicals. It is estimated that less than 0.2% of all U.S. residential upholstery fabric is treated with flame-retardant (FR) chemicals. The Consumer Product Safety Act of 1972 created the U.S. Consumer Product Safety Commission (CPSC) as an independent federal regulatory agency whose mission is to protect the public from unreasonable risks of injury and death associated with consumer products. CPSC also administers the Flammable Fabrics Act, under which it regulates flammability hazards and the Federal Hazardous Substances Act (FHSA), which regulates hazardous substances including chemicals. In 1993, the National Association of State Fire Marshals petitioned CPSC to issue a performance-based flammability standard for upholstered furniture to reduce the risk of residential fires. The Commission granted that portion of the petition relating to small open flame ignition risks. In response to concerns regarding the safety of FR chemicals, Congress, in the fiscal year 1999 appropriations report for CPSC, requested that the National Research Council conduct an independent study of the health risks to consumers posed by exposure to FR chemicals that are likely to be used in residential upholstered furniture to meet a CPSC standard. The National Research Council assigned the project to the Committee on Toxicology (COT) of the Commission on Life Sciences' Board on Environmental Studies and Toxicology. COT convened the Subcommittee on Flame-Retardant Chemicals, which prepared this report. Subcommittee members were chosen for their recognized expertise in toxicology, pharmacology, epidemiology, chemistry, exposure assessment, risk assessment, and biostatistics. Toxicological Risks of Selected Flame-Retardant Chemicals is organized into 18 chapters and two appendices. Chapter 2 describes the risk assessment process used by the subcommittee in determining the risk associated with potential exposure to the various FR chemicals. Chapter 3 describes the method the subcommittee used to measure and estimate the intensity, frequency, extent, and duration of human exposure to FR chemicals. Chapters 4-19 provide the subcommittee's review and assessment of health risks posed by exposure to each of the 16 FR chemicals. Data gaps and research needs are provided at the end of these chapters.
To guide mission planning, military decision makers need information on the health risks of potential exposures to individual soldiers and their potential impact on mission operations. To help with the assessment of chemical hazards, the U.S. Army Center for Health Promotion and Preventive Medicine developed three technical guides for characterizing chemicals in terms of their risks to the mission and to the health of the force. The report reviews these guides for their scientific validity and conformance with current risk-assessment practices. The report finds that the military exposure guidelines are appropriate (with some modification) for providing force health protection, but that for assessing mission risk, a new set of exposure guidelines is needed that predict concentrations at which health effects would degrade the performance of enough soldiers to hinder mission accomplishment.
Methyl bromide is gaseous pesticide used to fumigate soil, crops, commodity warehouses, and commodity-shipping facilities. Up to 17 million pounds of methyl bromide are used annually in California to treat grapes, almonds, strawberries, and other crops. Methyl bromide is also a known stratospheric ozone depleter and, as such, is scheduled to be phased out of use in the United States by 2005 under the United Nations Montreal Protocol. In California, the use of methyl bromide is regulated by the Department of Pesticide Regulation (DPR), which is responsible for establishing the permit conditions that govern the application of methyl bromide for pest control. The actual permits for use are issued on a site-specific basis by the local county agricultural commissioners. Because of concern for potential adverse health effects, in 1999 DPR developed a draft risk characterization document for inhalation exposure to methyl bromide. The DPR document is intended to support new regulations regarding the agricultural use of this pesticide. The proposed regulations encompass changes to protect children in nearby schools, establish minimum buffer zones around application sites, require notification of nearby residents, and set new limits on hours that fumigation employees may work. The State of California requires that DPR arrange for an external peer review of the scientific basis for all regulations. To this end, the National Research Council (NRC) was asked to review independently the draft risk characterization document prepared by DPR for inhalation exposure to methyl bromide. The task given to NRC's subcommittee on methyl bromide states the following: The subcommittee will perform an independent scientific review of the California Environmental Protection Agency's risk assessment document on methyl bromide. The subcommittee will (1) determine whether all relevant data were considered, (2) determine the appropriateness of the critical studies, (3) consider the mode of action of methyl bromide and its implications in risk assessment, and (4) determine the appropriateness of the exposure assessment and mathematical models used. The subcommittee will also identify data gaps and make recommendations for further research relevant to setting exposure limits for methyl bromide. This report evaluates the toxicological and exposure data on methyl bromide that characterize risks at current exposure levels for field workers and nearby residents. The remainder of this report contains the subcommittee's analysis of DPR's risk characterization for methyl bromide. In Chapter 2, the critical toxicological studies and endpoints identified in the DPR document are evaluated. Chapter 3 summarizes DPR's exposure assessment, and the data quality and modeling techniques employed in its assessment are critiqued. Chapter 4 provides a review of DPR's risk assessment, including the adequacy of the toxicological database DPR used for hazard identification, an analysis of the margin-of-exposure data, and appropriateness of uncertainty factors used by DPR. Chapter 5 contains the subcommittee's conclusions about DPR's risk characterization, highlights data gaps, and makes recommendations for future research.
Standing Operating Procedures for Developing Acute Exposure Guideline Levels for Hazardous Chemicals contains a detailed and comprehensive methodology for developing acute exposure guideline levels (AEGLs) for toxic substances from inhalation exposures. The book provides guidance on what documents and databases to use, toxicity endpoints that need to be evaluated, dosimetry corrections from animal to human exposures, selection of appropriate uncertainty factors to address the variability between animals and humans and within the human population, selection of modifying factors to address data deficiencies, time scaling, and quantitative cancer risk assessment. It also contains an example of a summary of a technical support document and an example of AEGL derivation. This book will be useful to persons in the derivation of levels from other exposure routesâ€"both oral and dermalâ€"as well as risk assessors in the government, academe, and private industry.
Formed in 1995 by EPA, several other federal and state agencies, and several private organizations, the National Advisory Committee on Acute Exposure Guideline Levels for Hazardous Substances (referred to as the NAC) develops, reviews, and approves acute exposure guideline levels (AEGLs) for up to 400 extremely hazardous substances (EHSs). AEGLs have a broad array of potential applications for federal, state, and local governments and for the private sector. They are necessary for prevention and emergency-response planning for potential releases of EHSs, either from accidents or as a result of terrorist activities. This report includes an assessment of the NAC's draft AEGLs documents for the following 10 chemicals: 1, 4-dioxane; chloroform; carbon tetrachloride; sulfur dioxide; cis, trans 1,-2 dichloroethylene; monochloroacetic acid; carbon monoxide; fluorine; methanol; and phenol.
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