Peer Review: Update of Carcinogen Classification & Target Risk Level Policy
NIOSH Scientific Information Quality – Peer Review Agenda
- NIOSH Response to Peer Review Comments pdf icon[PDF – 456K]
- NIOSH Response to Stakeholder and Public Comments pdf icon[PDF – 1M]
- NIOSH Docket 240-A
- NIOSH Docket 240
Required Elements for Initial Public Posting
Subject: NIOSH carcinogen and target risk level policies
Purpose: To update the NIOSH policies about chemical carcinogens in the workplace and the NIOSH target risk level policy for chemical carcinogens. This update to the NIOSH carcinogen policy, which was first issued in 1978, reflects advancements in cancer science and stakeholder concerns about the previous policy. The proposed policy outlines an approach that is expected to improve the efficiency of classifying carcinogens by utilizing classifications from relevant federal and international organizations, specifically the National Toxicology Program, the U.S. Environmental Protection Agency, and the International Agency for Research on Cancer.
Timing of Review: Public review November 2013 – February 2014; peer review November 2013 – March 2014
Primary Disciplines or Expertise Needed for Review: Carcinogen policy, toxicology, risk assessment, risk communication, occupational health, occupational cancer, industrial hygiene.
Type of Review: Individual
Number of Reviewers: 6
Reviewers Selected by: NIOSH
Public Nominations Requested for Reviewers: No
Opportunities for the Public to Comment: Yes
Peer Reviewers Provided with Public Comments Before Their Review: Yes
- Elaine Faustman, PhD
Professor, Environmental and Occupational Health Sciences
School of Public Health
University of Washington
Expertise: risk assessment, risk management, risk communication
- Robert Herrick, ScD
Senior Lecturer on Industrial Hygiene
Department of Environmental Health
Harvard School of Public Health
Expertise: industrial hygiene, occupational exposures
- David Kriebel, ScD
Professor, Co-Director, Work Environment
Lowell Center for Sustainable Production
University of Massachusetts at Lowell
Expertise: occupational epidemiology of cancer, public policy
- Nat Rothman, MD, MPH, MHS
Senior Investigator, Head of Molecular Studies
Division of Cancer Epidemiology and Genetics
National Cancer Institute
Expertise: occupational and environmental cancer, molecular epidemiology
- Andy Salmon, MA, PhD
Senior Toxicologist and Chief, Air Toxicology and Risk Assessment Section
Office of Environmental Health Hazard Assessment
California Environmental Protection Agency
Expertise: toxicology, risk assessment, hazard assessment
- Peter Sandman, PhD
Private consultant, risk communication expert
Expertise: risk communication
Charge to Peer Reviewers
- Are the proposed carcinogen policies consistent with the current scientific knowledge of toxicology, risk assessment, industrial hygiene, and occupational cancer? If not, provide specific information and references that should be considered.
- Is there additional scientific information related to the issues of the proposed NIOSH carcinogen policies that should be considered for inclusion? If so, provide information and specify references for consideration. Is there any discussion in the document that should be omitted?
- Is the proposed carcinogen classification policy explained in a clear and transparent manner? Is the basis for the proposed policy adequately explained? If not, specify (section, page, and line number) where clarification is needed.
- Are there issues relevant to the classification of occupational carcinogens that have not been adequately addressed in this proposed policy? If so, provide information and specify references for consideration.
- NIOSH adapted the OSHA Hazard Communication Table Relating Approximate Equivalences among IARC, NTP RoC, and GHS Carcinogenicity Classifications (Appendix F, Part D, OSHA Globally Harmonized System for Hazard Communication) to provide a simple, systematic method of determining GHS cancer hazard categories. However, NIOSH has further considered the GHS carcinogen categories 1B and 2 because NTP classification reasonably anticipated to be a human carcinogen and IARC classification 2B have criteria that overlap the two GHS categories. NIOSH has reviewed the criteria for GHS classification and has determined that chemicals classified by NTP as reasonably anticipated and chemicals classified as IARC 2B ”that have sufficient evidence from animal data” meet the criteria for GHS Carcinogen Category 1B. Chemicals classified by NTP as reasonably anticipated and chemicals classified by IARC as 2B ”that have limited evidence from animal data” meet the criteria for GHS Carcinogen Category 2. NIOSH is requesting comments on the validity of the NIOSH Correspondence table (Table 2) and its usefulness as a guide to determine GHS hazard categories.
- Is the proposed target risk level policy explained in a clear and transparent manner? Is the basis for the proposed policy adequately explained? If not, specify (section, page, and line number) where clarification is needed.
- An analytical feasibility (AF) notation will be used to identify those RELs that are established to reflect the limitations of the sampling and analytical method (i.e., AF) and not the target risk level of 1 in 1,000. Is this notation adequately explained?
- Is the proposed analytical feasibility and technical achievability policy explained in a clear and transparent manner? Is the basis for the proposed policy adequately explained? If not, specify (section, page, and line number) where clarification is needed.