83_FR_47355 83 FR 47174 - Revised Draft NIOSH Current Intelligence Bulletin: Health Effects of Occupational Exposure to Silver Nanomaterials

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)

Page Range47174-47175
FR Document2018-20169

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 Issue 181 (Tuesday, September 18, 2018)
[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.

-----------------------------------------------------------------------

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]
BILLING CODE 4163-19-P



                                               47174                            Federal Register / Vol. 83, No. 181 / Tuesday, September 18, 2018 / Notices

                                                  Much of CDC’s health communication                               health programs to assess needs related                              testing of technology-based instruments
                                               takes place within campaigns that have                              to initiation of a new program activity,                             and materials, (5) field testing of new
                                               fairly lengthy planning periods—                                    or expansion or changes in scope, or                                 methodologies and materials, (6)
                                               timeframes that accommodate the                                     implementation of existing program                                   investigation of mental models for
                                               standard Federal process for approving                              activities to adapt them to current                                  health decision-making, to inform
                                               data collections. Short term qualitative                            needs. The information collected will be                             health communication messages, and (7)
                                               interviewing and cognitive research                                 used to advise programs and provide                                  organizational needs assessments to
                                               techniques have previously proven                                   capacity-building assistance tailored to                             support development of capacity.
                                               invaluable in the development of                                    identified needs.
                                               scientifically valid and population-                                  Overall, these development activities                                Respondents who will participate in
                                               appropriate methods, interventions, and                             are intended to provide information that                             individual and group interviews
                                               instruments.                                                        will increase the success of the                                     (qualitative, cognitive, and computer
                                                  This request includes studies                                    surveillance or research projects                                    assisted development activities) are
                                               investigating the utility and                                       through increasing response rates and                                selected purposively from those who
                                               acceptability of proposed sampling and                              decreasing response error, thereby                                   respond to recruitment advertisements.
                                               recruitment methods, intervention                                   decreasing future data collection burden                             In addition to utilizing advertisements
                                               contents and delivery, questionnaire                                to the public. The studies that will be                              for recruitment, respondents who will
                                               domains, individual questions, and                                  covered under this request will include                              participate in research on survey
                                               interactions with project staff or                                  one or more of the following                                         methods may be selected purposively or
                                               electronic data collection equipment.                               investigational modalities: (1)                                      systematically from within an ongoing
                                               These activities will also provide                                  Structured and qualitative interviewing                              surveillance or research project. The
                                               information about how respondents                                   for surveillance, research, interventions                            total burden hours for this collection is
                                               answer questions and ways in which                                  and material development, (2) cognitive                              46,516. Participation of respondents is
                                               question response bias and error can be                             interviewing for development of specific                             voluntary. There is no cost to
                                               reduced. This request also includes                                 data collection instruments, (3)                                     participants other than their time.
                                               collection of information from public                               methodological research, (4) usability

                                                                                                                  ESTIMATED ANNUALIZED BURDEN HOURS
                                                                                                                                                                                                          Number of
                                                                                                                                                                                        Number of                       Average hours
                                                                 Type of respondent                                                       Form name                                                     responses per
                                                                                                                                                                                       respondents                      per response
                                                                                                                                                                                                          respondent

                                               General public .................................................   Screener .........................................................         56,840                 1           10/60
                                               Health care providers ......................................       Screener .........................................................         24,360                 1           10/60
                                               General public .................................................   Consent Forms ...............................................              28,420                 1            5/60
                                               Health care providers ......................................       Consent Forms ...............................................              12,180                 1            5/60
                                               General public .................................................   Individual Interview .........................................              4,620                 1               1
                                               Health care providers ......................................       Individual Interview .........................................              1,980                 1               1
                                               General public .................................................   Focus Group Interview ...................................                   2,800                 1               2
                                               Health care providers ......................................       Focus Group Interview ...................................                   1,200                 1               2
                                               General public .................................................   Survey of Individual ........................................              21,000                 1           30/60
                                               Health care providers ......................................       Survey of Individual ........................................               9,000                 1           30/60



                                               Jeffrey M. Zirger,                                                  Control and Prevention (CDC),                                        whichever occurs first. The public
                                               Acting Chief, Information Collection Review                         Department of Health and Human                                       online meeting will be a web-based
                                               Office, Office of Scientific Integrity, Office                      Services (HHS).                                                      event available only by remote access.
                                               of the Associate Director for Science, Office                       ACTION: Notice of draft document                                     Members of the public who wish to
                                               of the Director, Centers for Disease Control                                                                                             provide public comments should plan
                                               and Prevention.
                                                                                                                   available for public comment and online
                                                                                                                   public meeting.                                                      to login to the meeting at the start time
                                               [FR Doc. 2018–20245 Filed 9–17–18; 8:45 am]                                                                                              listed. Members of the public who
                                               BILLING CODE 4163–18–P                                              SUMMARY:    The National Institute for                               register with the NIOSH Docket Office,
                                                                                                                   Occupational Safety and Health                                       niocindocket@cdc.gov to attend the
                                                                                                                   (NIOSH) of the Centers for Disease                                   public meeting will be provided the
                                               DEPARTMENT OF HEALTH AND                                            Control and Prevention (CDC)                                         login information prior to the meeting.
                                               HUMAN SERVICES                                                      announces the availability of the                                    ADDRESSES: Written comments
                                                                                                                   following draft document for public                                  submitted to the docket must be
                                               Centers for Disease Control and
                                                                                                                   comment titled Current Intelligence                                  received by November 30, 2018. Written
                                               Prevention
                                                                                                                   Bulletin: Health Effects of Occupational                             comments may be submitted by either of
                                               [CDC–2016–0001; Docket Number NIOSH                                 Exposure to Silver Nanomaterials. To                                 the following methods:
                                               260–A]                                                              view the notice, document and related                                   • Federal eRulemaking Portal:
                                                                                                                   materials, visit https://                                            https://www.regulations.gov. Follow the
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                                               Revised Draft NIOSH Current                                         www.regulations.gov and enter CDC–                                   instructions for submitting comments.
                                               Intelligence Bulletin: Health Effects of                            2016–0001 in the search field and click                                 • Mail: NIOSH Docket Office, 1090
                                               Occupational Exposure to Silver                                     ‘‘Search’’.                                                          Tusculum Avenue, MS C–34,
                                               Nanomaterials                                                                                                                            Cincinnati, Ohio 45226–1998.
                                                                                                                   DATES: The public online meeting will
                                               AGENCY: National Institute for                                      be held on October 30, 2018, 1 p.m.–                                 FOR FURTHER INFORMATION CONTACT:
                                               Occupational Safety and Health                                      4:30 p.m., Eastern Time, or until the last                           Charles Geraci, NIOSH/EID/NTRC,
                                               (NIOSH) of the Centers for Disease                                  public commenter has spoken,                                         Robert A. Taft Laboratories, 1090


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                                                                         Federal Register / Vol. 83, No. 181 / Tuesday, September 18, 2018 / Notices                                                 47175

                                               Tusculum Avenue, Cincinnati, OH                            NIOSH further recommends the use of                Online Public Meeting
                                               45226, (513) 533–8339 (not a toll free                  workplace exposure assessments,
                                               number).                                                engineering controls, safe work                          The meeting is open to the public,
                                                                                                       procedures, training and education, and               limited only by the number of logins
                                               SUPPLEMENTARY INFORMATION:
                                                                                                       established medical surveillance                      available. The Adobe Connect license
                                                  Background: In response to public
                                               and peer review comments on the                         approaches to prevent potential adverse               accommodates approximately 500
                                               NIOSH draft document titled Current                     health effects from exposure to silver                people. In addition, there will be an
                                               Intelligence Bulletin: Health Effects of                nanomaterials. NIOSH proposes                         audio conference for those who cannot
                                               Occupational Exposure to Silver                         research needs to fill remaining data                 login through a computer. There is no
                                               Nanomaterials, NIOSH has developed a                    gaps on the potential adverse health                  registration fee to attend this public
                                               revised draft document and released it                  effects of occupational exposure to                   online meeting. However, those wishing
                                               for public comment [https://                            silver nanomaterials.                                 to attend are encouraged to register via
                                               www.regulations.gov]. Regarding the                        The purpose of the public review of                email to NIOSH Docket Office
                                               previous draft document, notices of a                   the draft document is to obtain                       niocindocket@cdc.gov by October 23,
                                               public meeting and comment period                       comments on whether the proposed                      2018. Registrants will be provided with
                                               were published on January 21, 2016 [81                  NIOSH draft document (1) adequately                   the public meeting login information
                                               FR 342], and February 10, 2016 [81 FR                   and clearly describes the scientific                  prior to the meeting. Individuals
                                               7124]. A public meeting was held on                     literature on the potential adverse                   wishing to speak during the meeting
                                               March 23, 2016, and members of the                      health effects of silver nanomaterials,               may sign up when registering. Those
                                               public, stakeholders, and scientific                    and (2) demonstrates that the NIOSH
                                                                                                                                                             who have not signed up to present in
                                               peers were given the opportunity to                     recommendations on occupational
                                                                                                                                                             advance may be allowed to present at
                                               provide comments by April 22, 2016. In                  exposure to silver nanomaterials are
                                                                                                       consistent with current scientific                    the meeting if time allows. Persons
                                               the interest of completeness and                                                                              wanting to provide oral comments will
                                               transparency, NIOSH is making                           knowledge.
                                                                                                                                                             be permitted up to 20 minutes. If
                                               available the public and peer reviewer                  Purpose of Public Meeting                             additional time becomes available,
                                               comments received on the previous                                                                             presenters will be notified. Oral
                                                                                                          To discuss and obtain comments on
                                               draft document and the NIOSH                                                                                  comments given at the meeting may also
                                                                                                       the revised August 2018 draft NIOSH
                                               responses to those comments at [https://
                                                                                                       document, ‘‘Current Intelligence                      be submitted to the docket in writing to
                                               www.regulations.gov]. NIOSH has
                                                                                                       Bulletin: Health Effects of Occupational              assure they are accurately recorded by
                                               carefully considered the review
                                                                                                       Exposure to Silver Nanomaterials’’.                   the Agency.
                                               comments on the previous draft in
                                                                                                       Special emphasis will be placed on                       Priority for attendance will be given
                                               developing the current draft document.
                                                                                                       discussion of the following questions for             to those providing oral comments. Other
                                               For the current review, NIOSH is
                                                                                                       reviewers:                                            requests to attend the meeting will then
                                               requesting comments on the August                          (1) Does the draft document
                                               2018 draft NIOSH document only.                         accurately identify and characterize the              be accommodated on a first-come basis.
                                                  This revised draft document provides                                                                       Unreserved attendees will be admitted
                                                                                                       health hazards of exposures to silver
                                               an updated scientific literature review                                                                       as login space allows.
                                                                                                       and silver nanomaterials based on the
                                               of information pertaining to                                                                                     Instructions: All material submitted to
                                                                                                       available scientific literature?
                                               occupational exposure to silver                            (2) Are the risk assessment and                    the Agency should reference the agency
                                               nanomaterials. This literature review                   dosimetry modeling methods presented                  name and docket number [CDC–2016–
                                               includes studies on the toxicological                   in the draft document consistent with
                                               effects of exposure to silver                                                                                 0001; NIOSH 260–A]. Each person
                                                                                                       current scientific knowledge and                      making a comment will be asked to give
                                               nanomaterials in experimental animal                    practice?
                                               and cellular systems, the effect of                                                                           his or her name and affiliation, and all
                                                                                                          (3) Is the relationship between                    comments (including their name and
                                               particle size and other properties on the               exposure to silver nanomaterials and
                                               toxicological effects of silver, and                                                                          affiliation) will be posted without
                                                                                                       biological activity (toxicity) accurately             change to https://www.regulations.gov.
                                               NIOSH recommendations on the                            portrayed in the draft document?
                                               measurement and control of                                                                                    All information received in response to
                                                                                                          (4) Is the available scientific evidence
                                               occupational exposures to silver and                    fully described regarding the human                   this notice will be available for public
                                               silver nanomaterials. NIOSH assessed                    health relevance of the adverse health                examination and copying at the NIOSH
                                               the potential health risks of                           endpoints observed in rats associated                 Docket Office, Room 155, 1150
                                               occupational exposure to silver                         with exposure to silver nanomaterials?                Tusculum Avenue, Cincinnati, Ohio
                                               nanomaterials by evaluating the                            (5) Is the proposed recommended                    45226–1998.
                                               scientific literature. Studies in animals               exposure limit (REL) well-supported by                  Dated: September 12, 2018.
                                               have shown adverse lung and liver                       the scientific data presented in the                  Frank J. Hearl,
                                               effects associated with exposure to                     document?
                                               silver nanoparticles. Based on an                          (6) Are the sampling and analytical                Chief of Staff, National Institute for
                                               assessment of these data, NIOSH                                                                               Occupational Safety and Health, Centers for
                                                                                                       methods proposed for silver
                                               developed a recommended exposure                                                                              Disease Control and Prevention.
                                                                                                       nanomaterials adequate to measure
                                               limit (REL) for silver nanomaterials.                                                                         [FR Doc. 2018–20169 Filed 9–17–18; 8:45 am]
                                                                                                       worker exposure?
                                               This new draft REL applies to processes                    (7) Are the recommended strategies                 BILLING CODE 4163–19–P
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                                               that produce or use silver                              for controlling exposure to silver and
                                               nanomaterials. In addition, NIOSH                       silver nanomaterials (e.g., engineering
                                               continues to recommend its existing                     controls, work practices, personal
                                               REL for total silver (metal dust and                    protective equipment) reasonable?
                                               soluble compounds, as Ag)                                  (8) Are the important data gaps and
                                               [www.cdc.gov/niosh/npg/                                 future research needs complete and
                                               npgd0557.html].                                         clearly described?


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Document Created: 2018-09-18 01:18:26
Document Modified: 2018-09-18 01:18:26
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of draft document available for public comment and online public meeting.
DatesThe 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.
ContactCharles Geraci, NIOSH/EID/NTRC, Robert A. Taft Laboratories, 1090 Tusculum Avenue, Cincinnati, OH 45226, (513) 533-8339 (not a toll free number).
FR Citation83 FR 47174 

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