Current Intelligence Bulletin 68: NIOSH Chemical Carcinogen Policy

The National Institute for Occupational Safety and Health of the Centers for Disease Control and Prevention published a final document entitled “Current Intelligence Bulletin 68: NIOSH Chemical Carcinogen Policy” on December 27, 2016. Underlying this policy is the recognition that there is no known safe level of exposure to a carcinogen, and therefore that reduction of worker exposure to chemical carcinogens as much as possible through elimination or substitution and engineering controls is the primary way to prevent occupational cancer. Accordingly, this policy no longer uses the term recommended exposure limit (REL) for chemical carcinogens; rather NIOSH will only recommend an initial starting point for control, called the Risk Management Limit for Carcinogens (RML-CA). For each chemical identified as a carcinogen, this level corresponds to the 95% lower confidence limit of the risk estimate of one excess cancer case in 10,000 workers in a 45-year working lifetime. Keeping exposures within the risk level of 1 in 10,000 is the minimum level of protection and striving for lower levels of exposure is recommended. When measurement of the occupational carcinogen at the RML-CA is not analytically feasible at the 1 in 10,000 risk estimate, NIOSH will set the RML-CA at the limit of quantification (LOQ) of the analytical method. In addition, NIOSH will continue to evaluate available information on existing engineering controls and also make that information available when publishing the RML-CA.

The foundation on which the NIOSH chemical carcinogen policy is built is cancer hazard classification. To avoid government duplication and to utilize transparent and systematic assessments, NIOSH will rely on existing cancer hazard assessments completed by the U.S. Department of Health and Human Services (HHS) National Toxicology Program (NTP), the U.S. Environmental Protection Agency (EPA) Integrated Risk Information System (IRIS), and the World Health Organization International Agency for Research on Cancer (IARC).

The development of the NIOSH chemical carcinogen policy involved rigorous and transparent processes for public, peer, and stakeholder review. A public review period and public meeting provided opportunities and a forum for discussion about the draft document, as well as opportunities to solicit feedback and comments, and to allow stakeholders and the public to make presentations to NIOSH. All written comments submitted in response to the external review, including materials presented at the public meeting and the meeting transcript, have been considered and are made available as part of the public record.

To view the notice and related material visit http://www.regulations.gov, enter CDC-2013-0023 in the search field, then click “Search”.

Peer review

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

Peer Reviewers

1. Elaine Faustman, PhD
   Professor, Environmental and Occupational Health Sciences
   School of Public Health
   University of Washington
   Expertise: risk assessment, risk management, risk communication
2. Robert Herrick, ScD
   Senior Lecturer on Industrial Hygiene
   Department of Environmental Health
   Harvard School of Public Health
   Expertise: industrial hygiene, occupational exposures
3. 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
4. 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
5. 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
6. Peter Sandman, PhD
   Private consultant, risk communication expert
   Expertise: risk communication

Charge to Peer Reviewers

1. 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.
2. 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?
3. 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.
4. 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.
5. 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.
6. 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.
7. 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?
8. 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.