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NIOSH EVALUATION OF ITS CANCER AND REL POLICIES

Current Intelligence Bulletin 68: NIOSH Chemical Carcinogen Policy

NIOSH 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 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).

NIOSH is in the process of developing an implementation plan for the NIOSH Chemical Carcinogen Policy regarding its application to chemicals that NIOSH evaluates. A prioritized list of chemicals to be evaluated is not available at this time.

Evaluation Efforts

The development of the NIOSH chemical carcinogen policy involved rigorous and transparent processes for public and peer 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 to make presentations to NIOSH. All written comments submitted in response to the announcement, including materials presented at the public meeting and the meeting transcript, have been considered and are made available as part of the public record.

NIOSH reviewed its cancer (carcinogen) and related Recommended Exposure Limit (REL) policies to ensure that they reflect current scientific and risk management practices. A draft NIOSH document was available for public comment until February 13, 2014. A public meeting was held in December 2013 in Washington, DC to allow the public to provide comments and ask questions about the draft document. The public was also provided the opportunity to submit comments about the draft document on regulations.gov, a site for information about Federal regulations and related documents in development.

In 2011 NIOSH published a Request for Information and held a public meeting to receive public input on this topic. NIOSH Docket 240 contains the public submissions received. Additional information about the NIOSH re-evaluation of its cancer and REL policies, including other Federal Register notices and the revised draft policies, will be posted on this page when available.

2013-14 Draft for Public Comment

2013 Public Meeting

2011 Request for Information, Public Meeting

NIOSH Cancer Policy History

1975 NIOSH presents its cancer guidelines at the Conference on Occupational Carcinogenesis, organized by the New York Academy of Sciences. Published in 1976, these guidelines recommend "no detectable exposure levels for proven carcinogenic substances".

Fairchild EJ [1976]. Guidelines for a NIOSH policy on occupational carcinogenesis. Ann NY Acad Sci 271:200-207.

1978 NIOSH testifies on the OSHA Notice of Proposed Rulemaking on the Identification, Classification, and Regulation of Toxic Substances Posing a Potential Occupational Carcinogenic Risk (i.e. the OSHA Cancer Policy). NIOSH commits to cooperating with OSHA in developing and applying this generic standard for potential occupational carcinogens. NIOSH indicates that good public health policy dictates that health risk be the primary consideration in the determination of exposure limits. NIOSH testifies to its general agreement with the definition of "potential occupational carcinogen" as stated in the OSHA Cancer policy:

"“any substance, or combination or mixture of substances, which causes an increased incidence of benign and/or malignant neoplasms, or a substantial decrease in the latency period between exposure and onset of neoplasms in humans or in one or more experimental mammalian species as the result of any oral, respiratory, or dermal exposure, or any other exposure which results in the induction of tumors at a site other than the site of administration. This definition also includes any substance that is metabolized into one or more potential occupational carcinogens by mammals ( 29 CFR 1990.103 , OSHA Cancer Policy)."

NIOSH recommends the following categories for carcinogens:

  • Category I: Probable [or Confirmed] Occupational Carcinogen
  • Category II: Suspect Occupational Carcinogen
  • Category III: Carcinogenic Evidence Inconclusive

NIOSH 1978 Testimony to OSHA on Notice of Proposed Rulemaking of OSHA Cancer Policy

1978 NIOSH uses the term "potential occupational carcinogen" in the NIOSH Criteria for a Recommended Standard: Occupational Exposure to Glycidyl Ethers and other NIOSH documents.

1984 NIOSH reaffirms its support for and adoption of the OSHA Cancer Policy in several Current Intelligence Bulletins including dioxin, 1,3-butadiene, and cadmium, with variations on the following text: “There are several classifications for identifying a substance as a carcinogen. Such classifications have been developed by the U.S. National Institute of Environmental Health Sciences, National Toxicology Program, the International Agency for Research on Cancer, and OSHA. NIOSH considers the OSHA classification the most appropriate for use in identifying carcinogens in the workplace. This classification is outlined in 29 CFR 1990.103.”

1988 NIOSH testifies on the OSHA Proposed Rule on Air Contaminants which includes proposed updates on many OSHA Permissible Exposure Limits (PELs). NIOSH reaffirms its policy that carcinogens should be restricted to the lowest feasible level. NIOSH indicates that OSHA should include carcinogen designations for all chemicals that meet the OSHA definition of “potential occupational carcinogen” as established in the OSHA Cancer Policy.
NIOSH 1988 Testimony to OSHA on the Proposed Rule on Air Contaminants

1995 The current NIOSH REL policy is issued for chemical carcinogens and other safety or health hazards, incorporating advances in science and approaches in risk assessment and risk management. It states that NIOSH RELs "will be based on risk evaluations using human or animal health effects data, and on an assessment of what levels can be feasibly achieved by engineering controls and measured by analytical techniques. To the extent feasible, NIOSH will project not only a no-effect exposure, but also exposure levels at which there may be residual risks. This policy applies to all workplace hazards, including carcinogens, and is responsive to Section 20(a)(3) of the Occupational Safety and Health Act of 1970 ..." NIOSH 1995 REL Policy Statement

"The effect of this new policy will be the development, whenever possible, of quantitative RELs that are based on human and/or animal data, as well as on the consideration of technological feasibility for controlling workplace exposures to the REL. Under the old policy, RELs for most carcinogens were non-quantitative values labeled "lowest feasible concentration (LFC)." [Note: There are a few exceptions to LFC RELs for carcinogens (e.g., RELs for asbestos, formaldehyde, benzene, and ethylene oxide are quantitative values based primarily on analytical limits of detection or technological feasibility). Also, in 1989, NIOSH adopted several quantitative RELs for carcinogens from OSHA's permissible exposure limit (PEL) update.]

... Under the new policy, NIOSH will also recommend the complete range of respirators (as determined by the NIOSH Respirator Decision Logic) for carcinogens with quantitative RELs. In this way, respirators will be consistently recommended regardless of whether a substance is a carcinogen or a non-carcinogen."

NIOSH Pocket Guide to Chemical Hazards - Appendix A - NIOSH Potential Occupational Carcinogens

NIOSH Respirator Use Policy for Protection Against Carcinogens

2011 NIOSH requests public comments on the NIOSH cancer and REL policies. A public meeting is held December 12, in Washington, DC, to obtain public and stakeholder input.

Transcript of the NIOSH Public Meeting, December 12, 2011
Transcript - 12/12/11

Introduction to the NIOSH Public Meeting, Dr. Schulte's Presentation

2013 NIOSH requests public comments on the draft NIOSH Current Intelligence Bulletin: Update of NIOSH Carcinogen Classification and Target Risk Level Policy for Chemical Hazards in the Workplace. A public meeting is held in December in Washington, DC to obtain public and stakeholder input.

Transcript of NIOSH Public Meeting, December 2013

NIOSH Presentation at the Public Meeting, December 2013

2014 NIOSH continues re-evaluating its chemical carcinogen policy with public and stakeholder input. The draft NIOSH Current Intelligence Bulletin: Update of NIOSH Carcinogen Classification and Target Risk Level Policy for Chemical Hazards in the Workplace was available for public comment until February 13, 2014.

NIOSH REL Policy History

NIOSH develops RELs for workplace hazards to prevent and reduce workers’ risk of occupational cancer and other adverse health effects. RELs are intended to limit the concentration of the potential hazard in the workplace air to protect worker health.

1970 The Occupational Safety and Health Act of 1970 , Section 20(a)(3), charges NIOSH to "…describe exposure levels that are safe for various periods of employment, including but not limited to the exposure levels at which no employee will suffer impaired health or functional capacities or diminished life expectancy as a result of his work experience."

1988 NIOSH testifies on the OSHA Proposed Rule on Air Contaminants which includes proposed updates on many OSHA Permissible Exposure Limits (PELs). NIOSH adopts many of the proposed PELs.
NIOSH 1988 Testimony to OSHA on the Proposed Rule on Air Contaminants

Prior to 1995 The RELs developed for most carcinogens were non-quantitative values labeled "lowest feasible concentration (LFC)." Some RELs were established based on the analytic limit of quantitation. Other RELs were based on technologic feasibility, i.e., the capability to reduce exposures through the use of engineering controls.

1995 The current NIOSH REL policy is issued, incorporating advances in science and approaches in risk assessment and risk management. It states that NIOSH RELs "will be based on risk evaluations using human or animal health effects data, and on an assessment of what levels can be feasibly achieved by engineering controls and measured by analytical techniques. To the extent feasible, NIOSH will project not only a no-effect exposure, but also exposure levels at which there may be residual risks. This policy applies to all workplace hazards, including carcinogens, and is responsive to Section 20(a)(3) of the Occupational Safety and Health Act of 1970 ..."
NIOSH 1995 REL Policy Statement

2011 NIOSH requests public comments on the NIOSH cancer and REL policies. A public meeting is held December 12, in Washington, DC, to obtain public and stakeholder input.

Transcript of the NIOSH Public Meeting, December 12, 2011
Transcript - 12/12/11

Introduction to the NIOSH Public Meeting, Dr. Schulte's Presentation

2013 NIOSH requests public comments on the draft NIOSH Current Intelligence Bulletin: Update of NIOSH Carcinogen Classification and Target Risk Level Policy for Chemical Hazards in the Workplace. A public meeting is held in December in Washington, DC, to obtain public and stakeholder input.

Transcript of NIOSH Public Meeting, December 2013

NIOSH Presentation at the Public Meeting, December 2013

2014 NIOSH continues re-evaluating its REL policy with public and stakeholder input to clarify issues such as the target working lifetime risk level and the application of "to the extent feasible" in the REL process. The draft NIOSH Current Intelligence Bulletin: Update of NIOSH Carcinogen Classification and Target Risk Level Policy for Chemical Hazards in the Workplace was available for public comment until February 13, 2014.

NIOSH Occupational Carcinogen Resources

Other U.S. Cancer Policy Resources

International Cancer Policy Resources

Agents Identified as Carcinogens

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