80 FR 27178 - Draft Report on Carcinogens Monograph on Cobalt and Certain Cobalt Compounds; Availability of Document; Request for Comments; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 91 (May 12, 2015)

Page Range		27178-27179
FR Document		2015-11355

The notice announces a meeting to peer review the Draft Report on Carcinogens (RoC) Monograph on Cobalt and Certain Cobalt Compounds. This document was prepared by the Office of the Report on Carcinogens (ORoC), Division of the National Toxicology Program (DNTP), National Institute of Environmental Health Sciences (NIEHS). The peer-review meeting is open to the public. Registration is requested for both public attendance and oral comment and required to access the webcast. Information about the meeting and registration is available at http:// ntp.niehs.nih.gov/go/38853.

Federal Register, Volume 80 Issue 91 (Tuesday, May 12, 2015)

[Federal Register Volume 80, Number 91 (Tuesday, May 12, 2015)]
[Notices]
[Pages 27178-27179]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-11355]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

Draft Report on Carcinogens Monograph on Cobalt and Certain
Cobalt Compounds; Availability of Document; Request for Comments;
Notice of Meeting

SUMMARY: The notice announces a meeting to peer review the Draft Report
on Carcinogens (RoC) Monograph on Cobalt and Certain Cobalt Compounds.
This document was prepared by the Office of the Report on Carcinogens
(ORoC), Division of the National Toxicology Program (DNTP), National
Institute of Environmental Health Sciences (NIEHS). The peer-review
meeting is open to the public. Registration is requested for both
public attendance and oral comment and required to access the webcast.
Information about the meeting and registration is available at http://ntp.niehs.nih.gov/go/38853.

DATES:
Meeting: July 22, 2015, 9:00 a.m. Eastern Daylight Time (EDT) to
adjournment.
Document Availability: Draft monograph will be available by June 5,
2015, at http://ntp.niehs.nih.gov/go/38853.
Written Public Comments Submissions: Deadline is July 8, 2015.
Registration for Attendance and/or Oral Comments: Deadline is July 15,
2015. Registration to view the meeting via the webcast is required.

ADDRESSES: Meeting Location: Rodbell Auditorium, Rall Building, NIEHS,
111 T.W. Alexander Drive, Research Triangle Park, NC 27709.
Agency Meeting Web page: The draft monographs, draft agenda,
registration, and other meeting materials will be posted at http://ntp.niehs.nih.gov/go/38853.
Webcast: The URL for viewing the webcast will be provided to those
who register.

FOR FURTHER INFORMATION CONTACT: Dr. Lori White, NTP Designated Federal
Official, Office of Liaison, Policy and Review, DNTP, NIEHS, P.O. Box
12233, MD K2-03, Research Triangle Park, NC 27709. Phone: (919) 541-
9834, Fax: (301) 480-3272, Email: whiteld@niehs.nih.gov. Hand Delivery/
Courier: 530 Davis Drive, Room 2136, Morrisville, NC 27560.

SUPPLEMENTARY INFORMATION:
Background: The RoC is a congressionally mandated, science-based,
public health report that identifies agents, substances, mixtures, or
exposures (collectively called ``substances'') in our environment that
pose a cancer hazard for people in the United States. The NTP prepares
the RoC on behalf of the Secretary of Health and Human Services.
The NTP follows an established, four-part process for preparation
of the RoC (http://ntp.niehs.nih.gov/go/rocprocess). A RoC monograph is
prepared for each candidate substance selected for review for the RoC.
A draft RoC monograph consists of (1) a cancer evaluation component
that reviews all information that may bear on a listing decision,
assesses its quality and sufficiency for reaching a listing decision,
applies the RoC listing criteria to the relevant scientific
information, and recommends a listing status for the candidate
substance in the RoC and (2) a substance profile that contains the
NTP's preliminary listing recommendation and a summary of the
scientific evidence considered key to reaching that recommendation.
Cobalt was selected as a candidate substance following solicitation
of public comment, review by the NTP Board of Scientific Counselors on
April 16--18, 2014, and approved by the NTP Director (http://ntp.niehs.nih.gov/go/9741). This meeting is planned for peer review of
the Draft RoC Monograph on Cobalt and Certain Cobalt Compounds.
Cobalt is a naturally occurring metallic element that exists in
different forms. It occurs in the environment in ores where it is
combined with other elements such as arsenic and sulfur. Pure cobalt is
a grey metal and there are numerous inorganic and organic cobalt
compounds, with varying valence states and water solubility. The RoC
evaluation includes cobalt metal and certain cobalt compounds--both
water soluble and poorly soluble compounds--that can release cobalt
ions in biological fluids. One cobalt compound that releases cobalt
ions, cobalt sulfate, is listed in the 13th RoC as reasonably
anticipated to be a human carcinogen (http://ntp.niehs.nih.gov/go/roc13). The RoC evaluation does not include cobalt forms that have
confounding exposures, such as cobalt carbides, alloys and radioactive
forms of cobalt or cobalt compounds. It also does not include Vitamin
B12, which does not release cobalt ions in vivo. Cobalt-
tungsten carbide: powders and hard metals is listed in the 13th RoC as
reasonably anticipated to be a human carcinogen and is not included in
this evaluation.
Major uses of cobalt include the production of cemented carbides,
diamond tools, and superalloys and other alloys used in a variety of
commercial, industrial, medical and military applications. Some cobalt
compounds are used as pigments for coloring glass, ceramics, and
pottery. A more recent use of cobalt is in green energy (e.g.,
rechargeable batteries for electric vehicles and consumer electronics).
People are exposed to cobalt in workplaces that process cobalt metals
and produce cobalt alloys; exposure to cobalt in their everyday lives
may also result from implanted medical devices, consumption of food and
drinking water and, to a lesser extent, from breathing contaminated
air. Additional information about the review of cobalt and certain
cobalt compounds for the RoC is available at http://ntp.niehs.nih.gov/go/730697.
Meeting and Registration: This meeting is open to the public with
time set aside for oral public comment. The public may attend the
meeting at NIEHS, where attendance is limited only by the space
available, or view the webcast. Registration is required to view the
webcast; the URL for the webcast will be provided in the email
confirming registration. Individuals who plan to provide oral comments
(see below) are encouraged to register online at the meeting Web site
(http://ntp.niehs.nih.gov/go/38853) by July 15, 2015, to facilitate
planning for the meeting.
The preliminary agenda and draft monograph should be posted on the
NTP Web site (http://ntp.niehs.nih.gov/go/38853) by June 5, 2015.
Additional information will be posted when available or may be
requested in hardcopy, see FOR FURTHER INFORMATION CONTACT. Following
the meeting, a report of the peer review will be prepared and made
available on the NTP Web site. Registered attendees are encouraged to
access the meeting Web page to stay abreast of the most current
information regarding the meeting.
Visitor and security information is available at http://www.niehs.nih.gov/about/visiting/index.cfm. Individuals with
disabilities who need accommodation to participate in this event should
contact Ms. Robbin Guy at

[[Page 27179]]

phone: (919) 541-4363 or email: guyr2@niehs.nih.gov. TTY users should
contact the Federal TTY Relay Service at (800) 877-8339. Requests
should be made at least five business days in advance of the event.
Request for Comments: The NTP invites written and oral public
comments on the draft monograph. The deadline for submission of written
comments is July 8, 2015, to enable review by the peer-review panel and
NTP staff prior to the meeting. Registration to provide oral comments
is by July 15, 2015, at http://ntp.niehs.nih.gov/go/38853. Public
comments and any other correspondence on the draft monographs should be
sent to the FOR FURTHER INFORMATION CONTACT. Persons submitting written
comments should include their name, affiliation, mailing address,
phone, email, and sponsoring organization (if any) with the document.
Written comments received in response to this notice will be posted on
the NTP Web site, and the submitter will be identified by name,
affiliation, and/or sponsoring organization.
Public comment at this meeting is welcome, with time set aside for
the presentation of oral comments on the draft monograph. In addition
to in-person oral comments at the meeting at the NIEHS, public comments
can be presented by teleconference line. There will be 50 lines for
this call; availability will be on a first-come, first-served basis.
The lines will be open from 9:00 a.m. until adjournment on July 22,
2015, and oral comments will be received only during the formal public
comment period indicated on the preliminary agenda. Each organization
(sponsoring organization or affiliation) is allowed one time slot. At
least 7 minutes will be allotted to each speaker, and if time permits,
may be extended to 10 minutes at the discretion of the chair.
Persons wishing to make an oral presentation are asked to register
online at http://ntp.niehs.nih.gov/go/38853 by July 15, 2015, and if
possible, to send a copy of their slides and/or statement or talking
points at that time. Written statements can supplement and may expand
the oral presentation. Registration for in-person oral comments will
also be available at the meeting, although time allowed for
presentation by on-site registrants may be less than that for
registered speakers and will be determined by the number of speakers
who register on-site.
Background Information on the RoC: Published biennially, each
edition of the RoC is cumulative and consists of substances newly
reviewed in addition to those listed in previous editions. The 13th
RoC, the latest edition, was published on October 2, 2014 (available at
http://ntp.niehs.nih.gov/go/roc13). The 14th RoC is under development.
For each listed substance, the RoC contains a substance profile, which
provides information on: cancer studies that support the listing--
including those in humans, animals, and studies on possible mechanisms
of action--information about potential sources of exposure to humans,
and current Federal regulations to limit exposures.
Background Information on NTP Peer-Review Panels: NTP panels are
technical, scientific advisory bodies established on an ``as needed''
basis to provide independent scientific peer review and advise the NTP
on agents of public health concern, new/revised toxicological test
methods, or other issues. These panels help ensure transparent,
unbiased, and scientifically rigorous input to the program for its use
in making credible decisions about human hazard, setting research and
testing priorities, and providing information to regulatory agencies
about alternative methods for toxicity screening. The NTP welcomes
nominations of scientific experts for upcoming panels. Scientists
interested in serving on an NTP panel should provide a current
curriculum vita to the FOR FURTHER INFORMATION CONTACT. The authority
for NTP panels is provided by 42 U.S.C. 217a; section 222 of the Public
Health Service (PHS) Act, as amended. The panel is governed by the
Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), which
sets forth standards for the formation and use of advisory committees.

Dated: May 6, 2015.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. 2015-11355 Filed 5-11-15; 8:45 am]
BILLING CODE 4140-01-P

Document Created: 2015-12-16 07:55:30
Document Modified: 2015-12-16 07:55:30

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
Dates		Meeting: July 22, 2015, 9:00 a.m. Eastern Daylight Time (EDT) to adjournment.
Contact		Dr. Lori White, NTP Designated Federal Official, Office of Liaison, Policy and Review, DNTP, NIEHS, P.O. Box 12233, MD K2-03, Research Triangle Park, NC 27709. Phone: (919) 541- 9834, Fax: (301) 480-3272, Email: [email protected] Hand Delivery/ Courier: 530 Davis Drive, Room 2136, Morrisville, NC 27560.
FR Citation		80 FR 27178

80 FR 27178 - Draft Report on Carcinogens Monograph on Cobalt and Certain Cobalt Compounds; Availability of Document; Request for Comments; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 80, Issue 91 (May 12, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health