A review and critique of U.S. EPA's risk assessments for asbestos.

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  • Additional Information
    • Source:
      Publisher: Informa Healthcare Country of Publication: England NLM ID: 8914275 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1547-6898 (Electronic) Linking ISSN: 10408444 NLM ISO Abbreviation: Crit Rev Toxicol Subsets: MEDLINE
    • Publication Information:
      Publication: London : Informa Healthcare
      Original Publication: Boca Raton, Fla. : CRC Press, c1980-
    • Subject Terms:
      Asbestos, Amphibole/*standards ; Asbestos, Amphibole/*toxicity ; Inhalation Exposure/*adverse effects ; Occupational Exposure/*adverse effects ; United States Environmental Protection Agency/*legislation & jurisprudence; Aluminum Silicates/toxicity ; Endpoint Determination ; Humans ; Lung Neoplasms/chemically induced ; Lung Neoplasms/pathology ; Mesothelioma/chemically induced ; Mesothelioma/pathology ; Ohio ; Risk Assessment ; Risk Factors ; Smoking/adverse effects ; United States
    • Abstract:
      U.S. Environmental Protection Agency (EPA) recently conducted a risk assessment for exposure to Libby amphibole asbestos that is precedent-setting for two reasons. First, the Agency has not previously conducted a risk assessment for a specific type of asbestos fiber. Second, the risk assessment includes not only an inhalation unit risk (IUR) for the cancer endpoints, but also a reference concentration (RfC) for nonmalignant disease. In this paper, we review the procedures used by the Agency for both cancer and nonmalignant disease and discuss the strengths and limitations of these procedures. The estimate of the RfC uses the benchmark dose method applied to pleural plaques in a small subcohort of vermiculite workers in Marysville, Ohio. We show that these data are too sparse to inform the exposure-response relationship in the low-exposure region critical for estimation of an RfC, and that different models with very different exposure-response shapes fit the data equally well. Furthermore, pleural plaques do not represent a disease condition and do not appear to meet the EPA's definition of an adverse condition. The estimation of the IUR for cancer is based on a subcohort of Libby miners, discarding the vast majority of lung cancers and mesotheliomas in the entire cohort and ignoring important time-related factors in exposure and risk, including effect modification by age. We propose that an IUR based on an endpoint that combines lung cancer, mesothelioma, and nonmalignant respiratory disease (NMRD) in this cohort would protect against both malignant and nonmalignant disease. However, the IUR should be based on the entire cohort of Libby miners, and the analysis should properly account for temporal factors. We illustrate our discussion with our own independent analyses of the data used by the Agency.
    • Contributed Indexing:
      Keywords: Libby; United States Environmental Protection Agency; amphibole asbestos; benchmark dose; inhalation unit risk; localized pleural thickening; pleural plaques; reference concentration; risk assessment
    • Accession Number:
      0 (Aluminum Silicates)
      0 (Asbestos, Amphibole)
      1318-00-9 (vermiculite)
    • Publication Date:
      Date Created: 20140509 Date Completed: 20150128 Latest Revision: 20140627
    • Publication Date:
      20221213
    • Accession Number:
      10.3109/10408444.2014.902423
    • Accession Number:
      24806876