[Federal Register Volume 83, Number 160 (Friday, August 17, 2018)]
[Notices]
[Pages 41093-41095]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-17782]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Draft Report on Carcinogens Monograph on Night Shift Work and
Light at Night; Availability of Document; Request for Comments; Notice
of Peer-Review Meeting
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
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SUMMARY: The National Toxicology Program (NTP) announces a meeting to
peer review the Draft Report on Carcinogens Monograph on Night Shift
Work and Light at Night. NTP has conducted a literature-based
assessment to determine whether night shift work (e.g., working at
least three hours between 12 a.m. and 6 a.m.) and light at night are
cancer hazards and should
[[Page 41094]]
be listed the Report on Carcinogens. The peer-review meeting will be
held at the National Institute of Environmental Health Sciences (NIEHS)
in Research Triangle Park, NC and is open to the public. Registration
is requested for attendance at the meeting either in-person or by
webcast and to present oral comments. Information about the meeting and
registration is available at https://ntp.niehs.nih.gov/go/36051.
DATES:
Meeting: Scheduled for October 5, 2018, 8:30 a.m. to adjournment at
approximately 5:00 p.m. Eastern Daylight Time (EDT). The preliminary
agenda is available at https://ntp.niehs.nih.gov/go/36051 and will be
updated one week before the meeting.
Document Availability: The draft RoC monograph should be available
by August 24, 2018, at https://ntp.niehs.nih.gov/go/36051.
Written Public Comment Submissions: Deadline is September 21, 2018.
Registration for Oral Comments: Deadline is September 21, 2018.
Registration To Attend Meeting In-Person or To View Webcast:
Deadline is October 5, 2018.
ADDRESSES:
Meeting Location: Rodbell Auditorium, Rall Building, NIEHS, 111
T.W. Alexander Drive, Research Triangle Park, NC 27709.
Meeting Web Page: The draft RoC monograph, preliminary agenda,
registration, and other meeting materials will be available at https://ntp.niehs.nih.gov/go/36051.
Webcast: The URL for viewing the peer-review meeting webcast will
be provided to registrants.
FOR FURTHER INFORMATION CONTACT: Kate Helmick, ICF, 2635 Meridian
Parkway, Suite 200, Durham, NC, USA 27713. Phone: (919) 293-1673, Fax:
(919) 293-1645, Email: [email protected].
SUPPLEMENTARY INFORMATION:
Background: The invention of electric light transformed society,
from one in which people's activities and sleep patterns were limited
by the natural light: Dark cycle to a culture in which people now work,
sleep, eat, and receive goods or services throughout the 24-hour day.
Through lifestyle choices, home location, and work schedule, people are
exposed to different patterns and types of light, including electric
light at night (LAN), which may lead to cancer and other adverse health
effects. These health effects may arise from misalignment of daily
physiological and behavioral cycles (i.e., circadian rhythms) with
external stimuli or with each other (i.e., circadian disruption).
Circadian rhythms can include processes and behaviors like sleep-wake
cycles, eating, and body temperature, among others.
NTP has conducted a literature-based assessment and applied the
Report on Carcinogens (RoC) listing criteria to this assessment to
determine whether night shift work (e.g., working at least three hours
between midnight and 6 a.m.) and light at night are cancer hazards. As
circadian disruption is thought to be a key intermediate step, NTP has
also reviewed the literature on this topic.
The monograph assesses the evidence from cancer studies in humans
and experimental animals and mechanistic data and provides NTP's
preliminary recommendation regarding whether night shift work and or
light at night should be listed in the Report on Carcinogens, and if
so, how the two exposure scenarios should be defined. The listing
categories include known or reasonably anticipated to be a human
carcinogen.
Meeting Attendance Registration: The meeting is open to the public
with time set aside for oral public comment; in-person attendance at
the NIEHS is limited by the space available (~100 attendees).
Registration for in-person attendance is on a first-come, first-served
basis. After the first 100 registrants, persons will be placed on a
wait list and notified should an opening become available. Registration
to attend the meeting in-person or view the webcast is by October 5,
2018, at https://ntp.niehs.nih.gov/go/36051. The URL for the webcast
will be provided in the email confirming registration. Visitor and
security information for those attending in person is available at
https://www.niehs.nih.gov/about/visiting/index.cfm. Individuals with
disabilities who need accommodation to view the webcast should contact
Kate Helmick by phone: (919) 293-1673 or email: [email protected].
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.
Public Comment Registration: NTP invites written and oral public
comments on the draft RoC monograph that address scientific/technical
issues. Guidelines for public comments are available at https://ntp.niehs.nih.gov/ntp/about_ntp/guidelines_public_comments_508.pdf.
The deadline for submission of written comments is September 21,
2018. Written public comments should be submitted through the meeting
website. Persons submitting written comments should include name,
affiliation, mailing address, phone, email, and sponsoring organization
(if any). Written comments received in response to this notice will be
posted on the NTP website and the submitter will be identified by name,
affiliation, and sponsoring organization (if any). Comments that
address scientific/technical issues will be forwarded to the peer-
review panel and NTP staff prior to the meeting.
The agenda allows for one oral public comment period (up to 12
commenters, up to 5 min per speaker). Registration to provide oral
comments is September 21, 2018, at https://ntp.niehs.nih.gov/go/36051.
Registration is on a first-come, first-served basis. Each organization
is allowed one time slot. Oral comments may be presented in person at
NIEHS or by teleconference line. The access number for the
teleconference line will be provided to registrants by email prior to
the meeting. Commenters will be notified after September 21, 2018, the
deadline to register for oral public comments, about the actual time
allotted per speaker.
If possible, oral public commenters should send a copy of their
slides and/or statement or talking points to Kate Helmick by email:
[email protected] by September 21, 2018.
Meeting Materials: The draft RoC monograph and preliminary agenda
will be available on the NTP website at https://ntp.niehs.nih.gov/go/36051. The draft RoC monograph should be available by August 24, 2018.
Additional information will be posted when available or may be
requested in hardcopy, contact Kate Helmick by phone: (919) 293-1673 or
email: [email protected]. The preliminary meeting agenda will be
available on the meeting web page and will be updated one week before
the meeting. Individuals are encouraged to access the meeting web page
to stay abreast of the most current information regarding the meeting.
Following the meeting, a report of the peer review will be prepared
and made available on the NTP website.
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. For each
listed substance, the RoC contains a substance profile, which provides
information on cancer studies that support the listing--including those
in humans and animals and studies on possible mechanisms of action,
information about potential sources of exposure to humans, and current
Federal regulations to limit exposures. The 14th RoC, the latest
edition, was published on November 3, 2016
[[Page 41095]]
(available at https://ntp.niehs.nih.gov/go/roc14).
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 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. NTP welcomes
nominations of scientific experts for upcoming panels. Scientists
interested in serving on an NTP panel should provide their current
curriculum vitae to Kate Helmick by email: [email protected]. The
authority for NTP panels is provided by 42 U.S.C. 217a; section 222 of
the Public Health Service 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: August 8, 2018.
Brian R. Berridge,
Associate Director, National Toxicology Program.
[FR Doc. 2018-17782 Filed 8-16-18; 8:45 am]
BILLING CODE 4140-01-P