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NIOSH Responses to Public Review Comments August 16, 2016 Public Comments Are Available in Full As Submitted at CDC-2013-0023

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NIOSH Responses to Public Review Comments August 16, 2016 Public Comments Are Available in Full As Submitted at CDC-2013-0023 NIOSH CIB 68: NIOSH Chemical Carcinogen Policy NIOSH Responses to Public Review Comments August 16, 2016 Public comments are available in full as submitted at www.regulations.gov, CDC-2013-0023. Commenter/Topic Public Comment NIOSH Response Federal Register Questions: Question #1: Are the proposed carcinogen policies consistent with the current scientific knowledge of toxicology, risk assessment, industrial hygiene, and occupational cancer? IARC The proposed carcinogen policy is reasonable and consistent with current NIOSH appreciates IARC support for its scientific knowledge. Given the large number of agents used in commerce and chemical carcinogen classification policy. the rapid pace at which new ones are introduced, a robust, yet efficient method of identifying agents that represent a cancer hazard to workers is an important step toward cancer prevention. The proposed policy would accomplish this goal for many agents by drawing on existing evaluations by other agencies, including the IARC Monographs. It is also appropriate for NIOSH to make a determination of occupational relevance, since some of the agents that have been evaluated by other agencies may not involve significant exposure to workers in the United States. The process proposed by NIOSH would normally assign agents to the highest category of hazard assigned by NTP, EPA, or IARC. This is appropriate because differences in the level hazard recognised by various agencies often reflect evolution of the state of knowledge over time; thus more recent evaluations incorporating new studies tend to lead to upgrading the level of hazard. Moreover, reconciling potential differences among hazard evaluations in favour of providing greater protection to workers is prudent and consistent with best practice for cancer prevention. Commenter/Topic Public Comment NIOSH Response Diane Brown, AFSCME supports updating NIOSH’s carcinogen policy. NIOSH’s views and As stated in the document, "Because there is (AFSCME) policy are an important resource in our efforts to protect workers from no safe level of exposure to occupational exposure to harmful agents. An updated policy must reflect current scientific carcinogens, NIOSH will continue to evidence and technologies as necessary to protect workers from carcinogens recommend reduction of exposure to an at the same level as the general public. occupational carcinogen according to the hierarchy of controls through elimination or AFSCME agrees that relying on carcinogen classifications of National substitution and implementation of Toxicology Program (NTP), the Environmental Protection Agency (EPA), and engineering controls, if practical, and the use the International Agency for Research on Cancer (IARC) is consistent with of administrative controls before use of current scientific knowledge. However, in accordance with occupational safety personal protective equipment (PPE). When and health principles, the policy should place more emphasis on substitution. exposures to carcinogens cannot be In addition, choosing 1/1000 or any other risk level is a policy decision, not a eliminated, NIOSH will also (1) calculate a scientific one. range of risk estimates, from 1 excess cancer case in 100 workers to 1 excess cancer case in 1 million workers over a 45-year working lifetime when the data permit, and (2) set a risk management limit for carcinogens (RML- CA). When data permit NIOSH to complete a quantitative risk assessment (QRA), NIOSH will use the results of the QRA to perform both tasks." In addition, "NIOSH will set the RML-CA for an occupational carcinogen at the concentration corresponding to the 95% lower confidence limit of the 1 in 10,000 (10-4) risk estimate when analytically possible to measure." Commenter/Topic Public Comment NIOSH Response Anna Fendley, For the most part, the proposed policy update is consistent with current NIOSH appreciates USW's support for its (USW) scientific knowledge. However, as noted above, USW disagrees that NIOSH chemical carcinogen policy. As stated in the should be setting RELs using a target risk level of 1 in 1000. It is widely document, "Historically, NIOSH issued recognized in the occupational safety and health community that there is no recommended exposure limits (RELs) for safe level of exposure to carcinogens, and 1 in 1000 leaves workers at a high carcinogens based on an excess risk level of 1 level of excess risk. in 1,000 (10-3), while acknowledging that there is no safe level of exposure to a carcinogen. This level of risk was recommended because it could be analytically measured and achieved in many workplaces. However, in the last 25 years, advances in exposure assessment, sensor and control technologies, containment, ventilation, risk management, and safety and health management systems have made it possible, in many cases, to control occupational chemical carcinogens to a lower exposure level. Therefore, in order to incrementally move toward a level of exposure to occupational chemical carcinogens that is closer to background, NIOSH will begin issuing recommendations for RML-CAs that would advise employers to take additional action to control chemical carcinogens when workplace exposures result in excess risks greater than 10-4. Commenter/Topic Public Comment NIOSH Response Darius Sivin, PhD, The UAW agrees that relying on carcinogen classifications of National NIOSH appreciates UAW's support of its UAW Toxicology Program (NTP), the Environmental Protection Agency (EPA), and chemical carcinogen classification policy. As the International Agency for Research on Cancer (IARC) is consistent with stated in the document, "NIOSH has current scientific knowledge. However, as elaborated below, the policy should established the terminology RML-CA instead place more emphasis on substitution. In addition, choosing 1/1000 or any of REL to bring the language used for NIOSH other risk level is a policy decision, not a scientific one. As explained in the recommendations into conformity with the answer to question 6, it would be best for NIOSH not to choose a particular recognition that there is no safe level of risk level. exposure to carcinogens. NIOSH will continue to recommend that employers reduce worker exposure to occupational carcinogens as much as possible through the hierarchy of controls, most importantly elimination or substitution of other chemicals that are known to be less hazardous, and engineering controls. Administrative controls, such as work practice controls, are also an important way to minimize workers’ exposures but are lower in the hierarchy. Personal protective equipment is the last line of defense, used when other methods do not adequately reduce exposures. Therefore, exposures should be kept below a risk level of 1 in 10,000, if practical. Finally, several public commenters urged NIOSH to provide only the exposure limits that correspond to various risk levels, such as 1 in 1,000, 1 in 10,000, 1 in 100,000, or 1 in 1,000,000. Many of these commenters objected that NIOSH should not “recommend” one specific exposure level and should leave Commenter/Topic Public Comment NIOSH Response such a policy decision to OSHA. These commenters observed that NIOSH is a scientific research agency and that OSHA is the agency that is charged with making decisions about acceptable risks and feasibility. NIOSH agrees that it should provide information on the exposure levels that correspond to various levels of risk; however, NIOSH will continue to provide a health-based RML-CA to guide employers who seek to reduce exposures to occupational carcinogens to better protect their workers." Commenter/Topic Public Comment NIOSH Response Deborah Proctor The proposed carcinogen policies are not consistent with the state of the As stated in the document, "NIOSH believes of ToxStrategies, science of risk assessment. There are several areas that require further carcinogen classification should employ a Inc. and Marc consideration and discussion. Specifically, NIOSH should incorporate current systematic methodology for critically Kolanz, CIH, scientific knowledge and practices regarding the use of Mode of Action (MOA) assessing and interpreting a body of scientific Materion Brush in risk assessment. Although MOA assessment is mentioned in the document, information. This methodology should include Inc. its use is not adequately described or consistent with the state-of the-science. specific steps for the evaluation and integration of scientific information: defining The Draft Cancer Policy does not contain adequate details regarding the use of a question or stating a problem of interest MOA information for low dose extrapolation, and it does not appear that (causal question definition); creating a review NIOSH will use the current state of the science in its risk assessments to set protocol; identifying and selecting relevant RELs. It is unclear whether (1) NIOSH will conduct formal weight-of-evidence information; evaluating individual studies reviews and human relevance evaluations to reach MOA determinations or (2) (review of individual studies); assessing and NIOSH will rely upon assessments that have been conducted by other integrating evidence across studies and regulatory agencies. providing an overall synthesis (data integration and evaluation); and As noted in the policies, MOA is important for determining the most interpretation of findings (drawing scientifically valid method for low-dose extrapolation. NIOSH should describe conclusions based on inferences) [Rhomberg how it will conduct MOA
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