Peer Review: Occupational Exposure Banding Process
NIOSH Scientific Information Quality – Peer Review Agenda
The NIOSH Occupational Exposure Banding Process for Chemical Risk Management
- NIOSH Docket 290
- Visit https:www.regulations.govexternal icon, enter CDC-2017-0028 in the search field, and click “Search” to view the Notice and related materials.
Required Elements for Initial Public Posting
Title: Draft NIOSH Occupational Exposure Banding Process: Guidance for the Evaluation of Chemical Hazards
Subject: Documentation of the process of occupational exposure banding to characterize workplace chemical hazards for risk management.
Purpose: The rate at which new chemicals are being introduced into commerce significantly outpaces occupational exposure limit (OEL) development, creating a need for guidance on thousands of chemicals that lack reliable exposure limits. The draft NIOSH occupational exposure banding document provides a validated, consistent, and documented approach to characterizing chemical hazards so timely and well-informed risk management decisions can be made for chemicals lacking OELs.
Timing of Review: March – May 2017; Public meeting May 23, 2017
Primary Disciplines or Expertise Needed for Review: Exposure assessment, toxicology, industrial hygiene
Type of Review: Individual
Number of Reviewers: 5
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: No
- Susan Arnold, PhD, CIH
Assistant Professor, Division of Environmental Health Sciences
Director, Exposure Science and Sustainability Institute
University of Minnesota School of Public Health
Expertise: exposure assessment, industrial hygiene
- Anne Bracker, MPH, CIH
Occupational Hygienist, Connecticut Department of Labor
Division of Occupational Safety and Health
Expertise: industrial hygiene
- Katherine McNamara
Department of Environmental Health Sciences
University of California, Los Angeles
Expertise: industrial hygiene, occupational safety
- Jessica Myers, PhD
Texas Commission on Environmental Quality
Expertise: toxicology, chemical assessment
- Gurumurthy Ramachandran, PhD
Professor, Environmental Health and Engineering
Johns Hopkins Bloomberg School of Public Health
Expertise: exposure assessment
Charge to Peer Reviewers
In reviewing the draft document, you are asked to focus on the technical content and consider the following questions:
(1) If a chemical can cause an immediate effect (necrosis, sensitization, pulmonary edema, CNS effects), should there be special guidelines for assigning a short term OEB or emphasizing the importance of keeping even short duration exposures below the OEB for those types of toxicants?
(2) If a skin toxicant is a corrosive, irritant, or sensitizer, should there be any special designation assigned along with the OEB? Additionally, please comment on the utility of using skin and eye effects to create inhalation based bands.
(3) The comparison of Tier 1 and Tier 2 results for a set of chemicals showed that Tier 1 and Tier 2 produce the same band for 65% of the chemicals tested. Tier 1 is more protective for 17.5% of the chemicals, while Tier 2 is more protective for 17.5% of the chemicals. NIOSH currently recommends that both the Tier 1 and Tier 2 process be completed for a particular chemical. Do you agree with this recommendation? If not, what approach should NIOSH take?
(4) NIOSH has proposed a number of sources of information for the different human health and toxicological endpoints under consideration. The recommended sources of information for each health endpoint are categorized as Rank 1 or Rank 2. Is the rationale for the rankings presented clearly? Is there a need to rank the recommended sources? Are the rankings reasonable? Additionally, are there other sources of information that we should recommend? Are there some sources that should be omitted?
(5) In Tier 1, the NIOSH method does not currently assign chemicals to an OEB based on H335 or H336 (drowsiness and dizziness). Should NIOSH include H335/H336 in the Tier 1 methodology? If so, what criteria should be used for banding and why?
(6) In Section 3.2 the process for assessing whether enough information is available to conduct occupational exposure banding is presented. Please comment on the use of a numerical scale (determinant scores) to document endpoint-specific data availability. Is the rationale for assigning the endpoint determinant score (EDS) for each health endpoint clear? Further, is the minimum value of 30 out of a possible total of 125 for the total determinant score (TDS) a suitable choice for the data sufficiency threshold? Is the relative weight for each score appropriate?
(7) How should NIOSH consider data collected on structural analogs or related chemicals in the banding scheme?
(8) Qualitative and quantitative technical criteria have been adopted for some endpoints. Is this approach adequately justified and suitably explained in the document? If not, how should the explanations be refined?
(9) If a chemical has two forms (vapor or particulate) in the workplace, we have recommended that the most protective OEB take precedence. Please comment on the utility and adequacy of this recommendation.
(10) Acute toxicity information may be presented in an array of different units. We have attempted to address those possibilities in the banding criteria for the acute toxicity endpoint, especially for inhalation exposures. Is this information sufficiently clear? Are suitable rubrics for unit conversions provided?
(11) Does this draft document adequately describe the occupational exposure banding process in a way that supports its use in assigning ranges of exposure concentrations to protect worker health in the occupational setting?
(12) Please provide any feedback you have on the electronic tool for occupational exposure banding, such as its utility and ease of use. The e-tool is available at: https://wwwn.cdc.gov/niosh-oeb/Home/Index