Draft-Approaches to Developing Occupational Exposure Limits or Bands for Engineered Nanomaterials: User Guide and Technical Report
| Published date | 13 July 2021 |
| Citation | 86 FR 36748 |
| Record Number | 2021-14801 |
| Section | Notices |
| Court | Centers For Disease Control And Prevention |
Federal Register, Volume 86 Issue 131 (Tuesday, July 13, 2021)
[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
