Document ID: OSHA-H005C-2006-0870-1269
Agency: osha
Document Type: Supporting & Related Material
Title: 
Posted Date: 2015-08-07T04:00Z

Request for Peer Review of NIOSH Manuscripts

	Last week, OSHA received permission from the NIOSH Division of
Surveillance, Hazard Evaluations, and Field Studies (DSHEFS) to
distribute two important unpublished manuscripts to OSHA peer reviewers.
 The document NIOSH Schubauer-Berigan cohort mortality 8-2010.pdf is a
follow-up of a previous NIOSH cohort mortality study of over 9000
beryllium exposed workers from seven beryllium processing plants (Ward
et al., 1992).  The Ward et al. cohort is discussed on page 83-84 of the
OSHA Health Effects Evaluation.  The Schubauer-Berigan et al. study
extends the cohort cause-specific mortality findings from an additional
17 years of observation focusing on three plants with quantitative
exposure estimates.  The principal mortality outcome was lung cancer but
other outcomes of interest were also studied.  This manuscript and its
appendix have been accepted in the Journal of Occupational and
Environmental Medicine and are now in press.  

The companion manuscript, NIOSH Schubauer-Berigan cohort risk
3-2010.pdf, by the same group of authors examines quantitative
relationships between different exposure metrics and lung cancer from a
subset of the Ward et al. cohort.  The study uses various risk models to
project excess lifetime lung cancer risk.  This document is still
undergoing journal peer review.  NIOSH DSHEFS requests that both
manuscripts be kept confidential.  

Since the new NIOSH cohort study and analysis could impact how OSHA
deals with the lung cancer risk assessment, reviewers are being asked to
review the manuscripts and provide written comment to the following
additional charge question.

Please provide your comments on manuscripts NIOSH  Schubauer-Berigan
cohort mortality 8-2010.pdf and NIOSH Schubauer-Berigan cohort risk
3-2010.pdf, including an assessment of their strengths and weaknesses. 
Do these studies address the shortcomings cited in the OSHA preliminary
risk assessment discussion of lung cancer (see pages 3-7)?  Do
they substantially improve upon the previously available data for
quantitative risk assessment for lung cancer?  In light of the
availability of these studies, is the Agency's rationale for choosing to
establish its risk findings for the proposed rule on its analysis for
beryllium sensitization and CBD reasonable?