Draft NIOSH Criteria for a Recommended Standard: 1-Bromopropane

Required Elements for Initial Public Posting

Title: Draft NIOSH Criteria for a Recommended Standard: 1-Bromopropane

Subject: A comprehensive summary of the health risks from exposure to 1-bromopropane.

Purpose: To describe the extent and characteristics of workplace exposures and to provide strategies for preventing exposure at the work site (engineering controls, personal protective equipment, and a recommended exposure limit).

Timing of Review: February - April 2016

Primary Disciplines or Expertise Needed for Review: Risk assessment, toxicology, epidemiology, 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. James V. Bruckner, PhD
   Professor of Pharmacology & Toxicology
   Department of Pharmaceutical & Biomedical Sciences
   College of Pharmacy, University of Georgia
   Areas of expertise: toxicology, pharmacology
   
2. Stephanie Chalupka, EdD, RN, PHCNS-BC, FAAOHN, FNAP
   Associate Dean for Nursing
   Dr. Lillian R. Goodman Department of Nursing
   School of Education, Health and Natural Sciences, Worcester State University
   Area of expertise: occupational medicine
   
3. Gaku Ichihara, MD, PhD
   Department of Occupational and Environmental Health
   Faculty of Pharmaceutical Sciences, Tokyo University of Science
   Area of expertise: toxicology
   
4. Lawrence H. Lash, PhD
   Professor, Department of Pharmacology
   Wayne State University School of Medicine
   Areas of expertise: toxicology, pharmacology
   
5. Jennifer J. Majersik, MD
   Chief, Division of Vascular Neurology
   Clinical Neurosciences Center, University of Utah Neurology
   Area of expertise: neurology
   
6. Xiaozhong Yu, MD, MPH, PhD
   Assistant Professor
   Department of Environmental Health Science
   College of Public Health, University of Georgia
   Areas of expertise: developmental and reproductive toxicology, toxicogenomics

Charge to Peer Reviewers

The overall goal of the peer review is to enhance the scientific quality by ensuring that the scientific and technical analyses support the NIOSH recommendations. The charge to the peer reviewers is to assess the scientific and technical validity of the information, and not matters of style or usage.

As part of the review of this draft criteria document, reviewers are asked to address the following critical questions:

1. Does the draft criteria document accurately identify and characterize the health hazards of occupational exposures to 1–bromopropane (1–BP) based on the current understanding of the scientific literature? Please identify any additional relevant literature that NIOSH should consider when developing its recommendations. Is the risk estimation for 1–BP presented in the draft criteria document a reasonable reflection of the current understanding of the scientific literature? Please describe any changes in the risk estimation that NIOSH should consider and provide supporting scientific literature.
2. Are there other risk assessment methods or health endpoints that NIOSH should consider for estimating risks of 1–BP? Please provide supporting scientific literature or other evidence to support your recommendations.
3. In this draft criteria document, NIOSH proposes a recommended exposure limit (REL) to prevent a risk of one excess cancer in 1000 workers exposed to 1–BP for a 45-year working lifetime. During development of the draft criteria document, NIOSH also considered setting the REL at a level to prevent 1 excess cancer in 10,000 workers for a 45-year working lifetime. Please comment on the excess cancer
   risk level and resulting REL for 1–BP.
4. Is the relationship between exposure to 1–BP and biological activity (toxicity) accurately presented in the draft criteria document?
5. Are the recommended strategies for controlling or preventing exposure to 1–BP (e.g., engineering controls, work practices, personal protective equipment) reasonable and technically feasible?
6. Are there other techniques or technologies capable of controlling workplace exposures to 1–BP that should be discussed in the draft criteria document?
7. Are the exposure measurement methods and the associated challenges in measuring workplace exposures to 1– BP adequately addressed in the draft criteria document?
8. Are there medical screening and surveillance measures, such as specific diagnostic tests, guidelines, and metrics, that should be implemented for workers expected of being exposed to 1–BP that are not discussed in the draft criteria document?
9. Are there biological indices or metrics that should be used to aid in the interpretation of biomonitoring data for 1–BP? What is the most appropriate biomarker that can confirm and quantify occupational exposures to 1–BP?
10. Should acute exposure recommendations, such as a short term exposure limit (STEL), be derived for 1– BP? If so, what data support the development of the STEL?
11. NIOSH provided Globally Harmonized System (GHS) of Classification and Labelling of Chemicals designations for health endpoints evaluated in the criteria document. Please comment on the utility of these classifications for hazard communication. Are these classifications helpful for employers?