[Federal Register Volume 84, Number 242 (Tuesday, December 17, 2019)]
[Notices]
[Pages 68935-68936]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27169]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[CDC-2019-0111, NIOSH-332]
Request for Information on Toxicological and Physicochemical Data
of Engineered Nanomaterials To Evaluate in Developing Categorical
Occupational Exposure Limits (OELs)
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 information.
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SUMMARY: The National Institute for Occupational Safety and Health
(NIOSH) of the Centers for Disease Control and Prevention (CDC) intends
to evaluate the scientific data on engineered nanomaterials (ENMs) to
develop categorical occupational exposure limits (OELs) based on the
available scientific evidence regarding the hazard or safety of these
materials.
NIOSH seeks to obtain materials, including published and
unpublished reports and research findings, to evaluate the possible
adverse health risks of occupational exposure to ENMs.
DATES: Electronic or written comments must be received by February 18,
2020.
ADDRESSES: You may submit comments, identified by CDC-2019-0111 and
Docket Number NIOSH-332, by either of the two following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
Mail: NIOSH Docket Office, Robert A. Taft Laboratories,
MS-C34, 1090 Tusculum Avenue, Cincinnati, OH 45226.
Instructions: All information received in response to this notice
must include the agency name and docket number [CDC-2019-0111; NIOSH-
332]. All relevant comments received will be posted without change to
http://www.regulations.gov, including any personal information
provided. All electronic comments should be formatted in Microsoft
Word. Please make reference to CDC-2019-0111 and Docket Number NIOSH-
332.
FOR FURTHER INFORMATION CONTACT: Nathan M. Drew, MS, NIOSH, MS-C14,
1090 Tusculum Avenue, Cincinnati, OH 45226, telephone (513) 533-8352.
SUPPLEMENTARY INFORMATION: In 2017, NIOSH contributed to the
International Organization for Standardization (ISO) technical report
on frameworks for developing OELs for nano-objects [ISO 2016]. In 2019,
NIOSH published a Technical Report on occupational exposure banding
guidance [NIOSH 2019]. The information presented in these Technical
Reports represents the most recent update of the scientific rationale
and methodology for establishing hazard values for chemicals, which
includes ENMs.
The development of an OEL for an individual chemical involves a
critical review of the available scientific data in humans and animals
to identify relevant studies and to characterize the various lines of
evidence that can support the derivation of the OEL. NIOSH requests
information for ENMs to include human, animal, and cellular toxicology
data, including but not limited to: Acute, subchronic, or chronic data;
the physicochemical characterization of those ENMs; and other
information about the biological mechanisms and
[[Page 68936]]
toxicological effects of ENMs. NIOSH is also seeking information on
studies that include evaluating the dose-response relationships between
exposure to ENMs and the development of adverse lung effects including
inflammation, fibrosis, or neoplasia. Supporting information for
published studies should include a full citation. For unpublished
studies please include authors, affiliations, year, and any context on
how the data were collected.
NIOSH will publish a Technical Report which describes the data,
methods, and findings for the development of categorical OELs for ENMs,
which may include relevant information submitted in response to this
request. The draft Technical Report will be made available for public
comment in a subsequent notice.
References
[ISO 2016] Nanotechnologies--Overview of available frameworks for
the development of occupational exposure limits and bands for nano-
objects and their aggregates and agglomerates (NOAAs). International
Organization for Standardization (ISO) Technical Report. ISO/TR
18637, published November 21. ISO, Geneva, Switzerland.
[NIOSH 2019] Technical report: The NIOSH occupational exposure
banding process for chemical risk management. By Lentz TJ, Seaton M,
Rane P, Gilbert SJ, McKernan LT, Whittaker C. Cincinnati, OH: U.S.
Department of Health and Human Services, Centers for Disease Control
and Prevention, National Institute for Occupational Safety and
Health, DHHS (NIOSH) Publication No. 2019-132
John J. Howard,
Director, National Institute for Occupational Safety and Health,
Centers for Disease Control and Prevention.
[FR Doc. 2019-27169 Filed 12-16-19; 8:45 am]
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