83 FR 47174 - Revised Draft NIOSH Current Intelligence Bulletin: Health Effects of Occupational Exposure to Silver Nanomaterials

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 83, Issue 181 (September 18, 2018)

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the availability of the following draft document for public comment titled Current Intelligence Bulletin: Health Effects of Occupational Exposure to Silver Nanomaterials. To view the notice, document and related materials, visit https://www.regulations.gov and enter CDC-2016-0001 in the search field and click ``Search''.

[Federal Register Volume 83, Number 181 (Tuesday, September 18, 2018)]
[Notices]
[Pages 47174-47175]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-20169]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[CDC-2016-0001; Docket Number NIOSH 260-A]


Revised Draft NIOSH Current Intelligence Bulletin: Health Effects 
of Occupational Exposure to Silver Nanomaterials

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: Notice of draft document available for public comment and 
online public meeting.

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SUMMARY: The National Institute for Occupational Safety and Health 
(NIOSH) of the Centers for Disease Control and Prevention (CDC) 
announces the availability of the following draft document for public 
comment titled Current Intelligence Bulletin: Health Effects of 
Occupational Exposure to Silver Nanomaterials. To view the notice, 
document and related materials, visit https://www.regulations.gov and 
enter CDC-2016-0001 in the search field and click ``Search''.

DATES: The public online meeting will be held on October 30, 2018, 1 
p.m.-4:30 p.m., Eastern Time, or until the last public commenter has 
spoken, whichever occurs first. The public online meeting will be a 
web-based event available only by remote access. Members of the public 
who wish to provide public comments should plan to login to the meeting 
at the start time listed. Members of the public who register with the 
NIOSH Docket Office, [email protected] to attend the public meeting 
will be provided the login information prior to the meeting.

ADDRESSES: Written comments submitted to the docket must be received by 
November 30, 2018. Written comments may be submitted by either of the 
following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments.
     Mail: NIOSH Docket Office, 1090 Tusculum Avenue, MS C-34, 
Cincinnati, Ohio 45226-1998.

FOR FURTHER INFORMATION CONTACT: Charles Geraci, NIOSH/EID/NTRC, Robert 
A. Taft Laboratories, 1090

[[Page 47175]]

Tusculum Avenue, Cincinnati, OH 45226, (513) 533-8339 (not a toll free 
number).

SUPPLEMENTARY INFORMATION: 
    Background: In response to public and peer review comments on the 
NIOSH draft document titled Current Intelligence Bulletin: Health 
Effects of Occupational Exposure to Silver Nanomaterials, NIOSH has 
developed a revised draft document and released it for public comment 
[https://www.regulations.gov]. Regarding the previous draft document, 
notices of a public meeting and comment period were published on 
January 21, 2016 [81 FR 342], and February 10, 2016 [81 FR 7124]. A 
public meeting was held on March 23, 2016, and members of the public, 
stakeholders, and scientific peers were given the opportunity to 
provide comments by April 22, 2016. In the interest of completeness and 
transparency, NIOSH is making available the public and peer reviewer 
comments received on the previous draft document and the NIOSH 
responses to those comments at [https://www.regulations.gov]. NIOSH has 
carefully considered the review comments on the previous draft in 
developing the current draft document. For the current review, NIOSH is 
requesting comments on the August 2018 draft NIOSH document only.
    This revised draft document provides an updated scientific 
literature review of information pertaining to occupational exposure to 
silver nanomaterials. This literature review includes studies on the 
toxicological effects of exposure to silver nanomaterials in 
experimental animal and cellular systems, the effect of particle size 
and other properties on the toxicological effects of silver, and NIOSH 
recommendations on the measurement and control of occupational 
exposures to silver and silver nanomaterials. NIOSH assessed the 
potential health risks of occupational exposure to silver nanomaterials 
by evaluating the scientific literature. Studies in animals have shown 
adverse lung and liver effects associated with exposure to silver 
nanoparticles. Based on an assessment of these data, NIOSH developed a 
recommended exposure limit (REL) for silver nanomaterials. This new 
draft REL applies to processes that produce or use silver 
nanomaterials. In addition, NIOSH continues to recommend its existing 
REL for total silver (metal dust and soluble compounds, as Ag) 
[www.cdc.gov/niosh/npg/npgd0557.html].
    NIOSH further recommends the use of workplace exposure assessments, 
engineering controls, safe work procedures, training and education, and 
established medical surveillance approaches to prevent potential 
adverse health effects from exposure to silver nanomaterials. NIOSH 
proposes research needs to fill remaining data gaps on the potential 
adverse health effects of occupational exposure to silver 
nanomaterials.
    The purpose of the public review of the draft document is to obtain 
comments on whether the proposed NIOSH draft document (1) adequately 
and clearly describes the scientific literature on the potential 
adverse health effects of silver nanomaterials, and (2) demonstrates 
that the NIOSH recommendations on occupational exposure to silver 
nanomaterials are consistent with current scientific knowledge.

Purpose of Public Meeting

    To discuss and obtain comments on the revised August 2018 draft 
NIOSH document, ``Current Intelligence Bulletin: Health Effects of 
Occupational Exposure to Silver Nanomaterials''. Special emphasis will 
be placed on discussion of the following questions for reviewers:
    (1) Does the draft document accurately identify and characterize 
the health hazards of exposures to silver and silver nanomaterials 
based on the available scientific literature?
    (2) Are the risk assessment and dosimetry modeling methods 
presented in the draft document consistent with current scientific 
knowledge and practice?
    (3) Is the relationship between exposure to silver nanomaterials 
and biological activity (toxicity) accurately portrayed in the draft 
document?
    (4) Is the available scientific evidence fully described regarding 
the human health relevance of the adverse health endpoints observed in 
rats associated with exposure to silver nanomaterials?
    (5) Is the proposed recommended exposure limit (REL) well-supported 
by the scientific data presented in the document?
    (6) Are the sampling and analytical methods proposed for silver 
nanomaterials adequate to measure worker exposure?
    (7) Are the recommended strategies for controlling exposure to 
silver and silver nanomaterials (e.g., engineering controls, work 
practices, personal protective equipment) reasonable?
    (8) Are the important data gaps and future research needs complete 
and clearly described?

Online Public Meeting

    The meeting is open to the public, limited only by the number of 
logins available. The Adobe Connect license accommodates approximately 
500 people. In addition, there will be an audio conference for those 
who cannot login through a computer. There is no registration fee to 
attend this public online meeting. However, those wishing to attend are 
encouraged to register via email to NIOSH Docket Office 
[email protected] by October 23, 2018. Registrants will be provided 
with the public meeting login information prior to the meeting. 
Individuals wishing to speak during the meeting may sign up when 
registering. Those who have not signed up to present in advance may be 
allowed to present at the meeting if time allows. Persons wanting to 
provide oral comments will be permitted up to 20 minutes. If additional 
time becomes available, presenters will be notified. Oral comments 
given at the meeting may also be submitted to the docket in writing to 
assure they are accurately recorded by the Agency.
    Priority for attendance will be given to those providing oral 
comments. Other requests to attend the meeting will then be 
accommodated on a first-come basis. Unreserved attendees will be 
admitted as login space allows.
    Instructions: All material submitted to the Agency should reference 
the agency name and docket number [CDC-2016-0001; NIOSH 260-A]. Each 
person making a comment will be asked to give his or her name and 
affiliation, and all comments (including their name and affiliation) 
will be posted without change to https://www.regulations.gov. All 
information received in response to this notice will be available for 
public examination and copying at the NIOSH Docket Office, Room 155, 
1150 Tusculum Avenue, Cincinnati, Ohio 45226-1998.

    Dated: September 12, 2018.
Frank J. Hearl,
Chief of Staff, National Institute for Occupational Safety and Health, 
Centers for Disease Control and Prevention.
[FR Doc. 2018-20169 Filed 9-17-18; 8:45 am]
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