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Revised Draft—NIOSH Current Intelligence Bulletin

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Revised Draft—NIOSH Current Intelligence Bulletin This information is distributed solely for the purpose of pre-dissemination peer review under applicable information quality guidelines. It has not been formally disseminated by the National Institute for Occupational Safety and Health. It does not represent and should not be construed to represent any agency determination or policy. Revised Draft NIOSH CURRENT INTELLIGENCE BULLETIN Asbestos Fibers and Other Elongated Mineral Particles: State of the Science and Roadmap for Research June 2008 Department of Health and Human Services Centers for Disease Control and Prevention National Institute for Occupational Safety and Health This information is distributed solely for the purpose of pre-dissemination peer review under applicable information quality guidelines. It has not been formally disseminated by the National Institute for Occupational Safety and Health. It does not represent and should not be construed to represent any agency determination or policy. Foreword Asbestos has been a highly visible issue in public health for over three decades. During the mid- to late-20th century, many advances were made in the scientific understanding of worker health effects from exposure to asbestos and other elongated mineral particles (EMPs), and it is now well documented that fibers of asbestos minerals, when inhaled, can cause serious diseases in exposed workers. Yet, as we enter the 21st century, many questions and areas of scientific uncertainty remain. For instance, because of the complexity of the mineralogy, the scientific literature contains various inconsistencies in the definition and application of the term asbestos for health protection guidance and regulatory purposes. As the federal agency responsible for conducting research and making recommendations for the prevention of worker injury and illness, the National Institute for Occupational Safety and Health (NIOSH) is undertaking a 21st century reappraisal of how to ensure adequate protection of workers from exposure to asbestos fibers and other EMPs. As a first step in this science reappraisal effort, NIOSH convened an internal work group to develop a framework for future scientific research and policy development. The NIOSH Mineral Fibers Work Group prepared an earlier draft of this State of the Science and Roadmap for Scientific Research (Roadmap), which summarized NIOSH's understanding of occupational exposure and toxicity issues concerning asbestos and other EMPs. NIOSH invited comments on the occupational health issues identified and the framework for research suggested in the first draft Roadmap. NIOSH sought other views about additional key issues that need to be identified, additional research that needs to be conducted, and suggested methods to conduct the research. In particular, NIOSH sought input from stakeholders concerning study designs, techniques for generating size-selected fibers, analytic approaches, sources of particular types of EMPs suitable for experimental studies, and worker populations suitable for epidemiological study. As a result of comments received during the public and expert peer review process, NIOSH has revised its first draft and is now disseminating a revised draft of the Roadmap. The purpose of the Roadmap is to outline a research agenda that will guide the development of specific research programs to be conducted by NIOSH and others, as well as within and across disciplines to provide answers to current scientific questions, reduce scientific uncertainties, and provide a sound scientific foundation for future policy development. NIOSH continues to be interested in available and forthcoming research results that can help answer the questions set forth in the Roadmap, as well as information on existing workplace exposure data, health effects, and control technologies. NIOSH recognizes that results from toxicity research on asbestos and other EMPs may impact both occupational as well as environmental health policies and practices. Many of the issues that are important in the workplace are also important to communities and to Revised Draft NIOSH CURRENT INTELLIGENCE BULLETIN June 2008 Asbestos and Other Elongated Mineral Particles: State of the Science and Roadmap for Research Page i This information is distributed solely for the purpose of pre-dissemination peer review under applicable information quality guidelines. It has not been formally disseminated by the National Institute for Occupational Safety and Health. It does not represent and should not be construed to represent any agency determination or policy. the general population. Therefore, NIOSH intends to continue to pursue partnerships with Federal agencies, including the Agency for Toxic Substances and Disease Registry (ATSDR), the Consumer Product Safety Commission (CPSC), the Environmental Protection Agency (EPA), the Mine Safety and Health Administration (MSHA), the National Institute of Environmental Health Sciences (NIEHS), the National Institute of Standards and Technology (NIST), the National Toxicology Program (NTP), the Occupational Safety and Health Administration (OSHA), and the United States Geological Survey (USGS), as well as with labor, industry, academia, practitioners, and other interested parties, including international groups. These partnerships will help to focus the scope of the research that will contribute to the scientific understanding of asbestos and other EMPs, to fund and conduct the research activities, and to develop and disseminate informational materials describing results from the research on EMPs and their implications for occupational and public health policies and practices. John Howard, M.D. Director June 2008 Revised Draft NIOSH CURRENT INTELLIGENCE BULLETIN June 2008 Asbestos and Other Elongated Mineral Particles: State of the Science and Roadmap for Research Page ii This information is distributed solely for the purpose of pre-dissemination peer review under applicable information quality guidelines. It has not been formally disseminated by the National Institute for Occupational Safety and Health. It does not represent and should not be construed to represent any agency determination or policy. CONTENTS Foreword.............................................................................................................................. i Executive Summary……………………………………………………………………. vi Acknowledgements………………………………………………………………………xi NIOSH Mineral Fibers Work Group…………………………………………….……….xi Peer Reviewers…………………………………………………………………………..xii Abbreviations …………………………………………………………………………..xiii 1 REVIEW OF CURRENT ISSUES…………………………………………………….1 1.1 Introduction……………………………………………………………………1 1.2 Minerals and Mineral Morphology……………………………………………2 1.3.Trends in Asbestos Use, Occupational Exposures, and Disease……………...4 1.3.1 Trends in Asbestos Use……………………………………………..4 1.3.2 Trends in Occupational Exposure…………………………………..5 1.3.3 Trends in Asbestos-related Disease…………………………………7 1.3.3.1 Asbestosis…………………………………………………8 1.3.3.2 Malignant Mesothelioma………………………………….8 1.4 Clinical Issues…………………………………………………………………9 1.5 Components of the NIOSH Recommendation for Asbestos ……………..…12 1.5.1 Minerals Covered by the NIOSH REL …………………..………..13 1.5.1.1 Chrysotile………………………………………………...14 1.5.1.2 Amphibole Asbestos and Other Fibrous Mineral………..15 1.5.1.3 Nonasbestiform Analogs of the Asbestos Varieties ……..16 1.5.1.3.1 Rationale for NIOSH Policy…………………...16 1.5.1.3.2 Epidemiological Studies………………………18 1.5.1.3.3 Animal Studies…………………………………28 1.5.1.3.4 Analytical Limitations…………………………30 1.6 Determinants of Particle Toxicity and Health Effects…………………..…..31 1.6.1. Deposition…………………………………………………………31 1.6.2 Clearance and Retention…………………………………………...32 1.6.3 Biopersistence and other Potentially Important Particle Characteristics……………………………………………………...34 1.6.3.1 Biopersistence……………………………………………35 1.6.3.2 Other Potentially Important Particle Characteristics…….38 1.6.4 Animal and In Vitro Toxicity Studies……………………………..38 1.6.5 Thresholds…………………………………………………………51 1.7 Analytical Methods………………………………………………………….54 1.7.1 NIOSH Sampling and Analytical Methods for Standardized Industrial Hygiene………………………………….……….…55 1.7.2 Analytical Methods for Research………………………………….56 Revised Draft NIOSH CURRENT INTELLIGENCE BULLETIN June 2008 Asbestos and Other Elongated Mineral Particles: State of the Science and Roadmap for Research Page iii This information is distributed solely for the purpose of pre-dissemination peer review under applicable information quality guidelines. It has not been formally disseminated by the National Institute for Occupational Safety and Health. It does not represent and should not be construed to represent any agency determination or policy. CONTENTS (CONTINUED) 1.7.3 Differential Counting and Other Proposed Analytical Approaches for Differentiating EMPs ……………………………..…………58 1.8 Basis for the Recommended Exposure Limit………………………………..59 1.8.1 1990 Recommendation ……………………………………………59 1.8.1.1 Comments to OSHA……………………………………..59 1.8.1.2 Testimony at OSHA Public meeting …………………….60 1.8.2 The NIOSH Recommended Exposure …………………………..61 1.8.2.1 Clarification of the Recommended Exposure Limit……..61 1.9 Summary of Key Issues……………………………………………………..62 2 FRAMEWORK FOR RESEARCH…………………….………………………..…64 2.1 Strategic Research Goals and Objectives……………………………………64 2.2 Develop a broader understanding of the important determinants of toxicity for mineral fibers and other EMPs……..…………………….………………….66 2.2.1 Conduct in vitro studies to ascertain what physical and chemical properties influence the toxicity of
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