[Federal Register Volume 86, Number 131 (Tuesday, July 13, 2021)]
[Notices]
[Pages 36748-36749]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-14801]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Docket Number CDC-2021-0067, NIOSH-342]


Draft--Approaches to Developing Occupational Exposure Limits or 
Bands for Engineered Nanomaterials: User Guide and Technical Report

AGENCY: National Institute for Occupational Safety and Health (NIOSH) 
of the Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Request for comment.

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SUMMARY: NIOSH announces the availability of a draft technical report 
entitled Approaches to Developing Occupational Exposure Limits or Bands 
for Engineered Nanomaterials: User Guide and Technical Report now 
available for public comment. To view the notice and related materials, 
visit https://www.regulations.gov and enter CDC-2021-0067 in the search 
field and click ``Search.''

DATES: Electronic or written comments must be received by September 13, 
2021.

ADDRESSES: You may submit comments, identified by CDC-2021-0067 and 
docket number NIOSH-342, by any of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov 
Follow the instructions for submitting comments.
     Mail: National Institute for Occupational Safety and 
Health, NIOSH Docket Office, 1090 Tusculum Avenue, MS C-34, Cincinnati, 
Ohio 45226-1998.
    Instructions: All information received in response to this notice 
must include the agency name and docket number [CDC-2021-0067; NIOSH-
342]. All relevant comments received will be posted without change to 
https://www.regulations.gov, including any personal information 
provided. All electronic comments should be formatted as Microsoft 
Word. For access to the docket to read background documents or comments 
received, go to https://www.regulations.gov. All information received 
in response to this notice will also be available for public 
examination and copying at the NIOSH Docket Office, 1150 Tusculum 
Avenue, Room 155, Cincinnati, OH 45226-1998.

FOR FURTHER INFORMATION CONTACT: Nathan Drew, National Institute for 
Occupational Safety and Health, Emerging Technologies Branch, 1090 
Tusculum Avenue, MS C-14, Cincinnati, OH 45226, telephone (513) 533-
8352 (not a toll free number).

SUPPLEMENTARY INFORMATION: On December 17, 2019, the National Institute 
for Occupational Safety and Health, Centers for Disease Control and 
Prevention announced in the Federal Register [84 FR 68935] plans to 
evaluate the scientific data on engineered nanomaterials for the 
development of categorical occupational exposure limits. The draft 
NIOSH technical report describing approaches to evaluating these 
scientific data is now available for public comment, Approaches to 
Developing Occupational Exposure Limits or Bands for Engineered 
Nanomaterials: User Guide and Technical Report.
    Background: Most chemical substances, including engineered 
nanomaterials, do not have specific occupational exposure limits. 
Alternative methods are needed to assess the potential occupational 
safety and health hazards of engineered nanomaterials. Categorical 
occupational exposure limits are one approach to estimating exposure 
concentrations for groups of materials with similar toxicological 
effects and/or physicochemical properties. Occupational exposure 
banding is another approach to protect worker health by assigning 
chemical substances into specific categories or ``bands'' based on 
their associated health outcomes and on potency considerations. These 
bands correspond to a range of airborne exposure concentrations to 
inform risk management decisions for substances that do not have 
occupational exposure limits. NIOSH has proposed an evidence-based 
approach to evaluate the scientific information available in order to 
derive occupational exposure limits, or bands, for engineered 
nanomaterials. This proposed approach is described in the draft NIOSH 
technical report available for public comment, Approaches to Developing 
Occupational Exposure Limits or Bands for Engineered Nanomaterials: 
User Guide and Technical Report. This draft report contains two main 
parts: (I) User Guide

[[Page 36749]]

and (II) full Technical Report and Appendixes.
    The purpose of the public comment period is to obtain comments on 
the draft report. Comments are being sought from individuals including 
scientists and representatives from various government agencies, 
industry, labor, and other stakeholders, and also the public. If there 
are errors of fact, unsubstantiated claims, evidence of careless 
experimental work, inclusion of too much information already in the 
literature, or statements that are inaccurate, please note such in your 
review comments.
    The authors ask that special emphasis be placed on technical review 
of the following issues:
    1. Does the draft document adequately describe the process for 
gathering and evaluating the information available on occupational 
exposure limits or bands for engineered nanomaterials?
    2. Does the draft document adequately describe the development of a 
framework for categorizing engineered nanomaterials by potential 
occupational health hazard from inhalation exposure?
    3. Are the clustering and classification modeling methodologies 
reasonable for these data?
    4. Is a revision to current occupational exposure banding guidance 
needed to incorporate a band F?
    5. How useful and practical is the approach described in both the 
user guide and full technical report for deriving categorical 
occupational exposure limits, and what are the opportunities for 
improvement?
    6. Are the current searches and collection of scientific data 
sufficient, and are there additional opportunities for obtaining data 
that were not included?
    7. Would the methods used in the report also be appropriate for a 
future comprehensive dataset of experimental, toxicological, and 
physicochemical information for engineered nanomaterials?
    8. Are there additional comments that you would like to provide?

John J. Howard,
Director, National Institute for Occupational Safety and Health, 
Centers for Disease Control and Prevention.
[FR Doc. 2021-14801 Filed 7-12-21; 8:45 am]
BILLING CODE 4163-18-P