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)
Centers for Disease Control and Prevention
Federal Register Volume 83, Issue 181 (September 18, 2018)
| Page Range | 47174-47175 | |
| FR Document | 2018-20169 |
[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] ----------------------------------------------------------------------- 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
daltland on DSKBBV9HB2PROD with NOTICES
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
VerDate Sep<11>2014 19:14 Sep 17, 2018 Jkt 244001 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 E:\FR\FM\18SEN1.SGM 18SEN1](https://thefederalregister.org/doc/83_FR_47355/page/1.svg)
![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
daltland on DSKBBV9HB2PROD with NOTICES
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?
VerDate Sep<11>2014 19:14 Sep 17, 2018 Jkt 244001 PO 00000 Frm 00052 Fmt 4703 Sfmt 9990 E:\FR\FM\18SEN1.SGM 18SEN1](https://thefederalregister.org/doc/83_FR_47355/page/2.svg)
Document Created: 2018-09-18 01:18:26
Document Modified: 2018-09-18 01:18:26
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of draft document available for public comment and online public meeting. | |
| 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. | |
| Contact | Charles Geraci, NIOSH/EID/NTRC, Robert A. Taft Laboratories, 1090 Tusculum Avenue, Cincinnati, OH 45226, (513) 533-8339 (not a toll free number). | |
| FR Citation | 83 FR 47174 |
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