[Federal Register: November 13, 2007 (Volume 72, Number 218)]
[Notices]
[Page 63900-63901]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13no07-56]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Toxicology Program (NTP); Report on Carcinogens (RoC);
Availability of the Draft Background Documents for Aristolochic Acid
Related Exposures (Two Candidate Substances: Botanical Products
Containing Aristolochic Acid and Aristolochic Acid) and Riddelliine and
Request for Public Comment on the Draft Background Documents;
Announcement of the Aristolochic Acid Related Exposures and Riddelliine
Expert Panel Meeting
AGENCY: National Institute of Environmental Health Sciences (NIEHS);
National Institutes of Health (NIH), Department of Health and Human
Services (HHS).
ACTION: Request for public comments and meeting announcement.
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SUMMARY: The NTP announces the availability of the draft background
documents for (1) aristolochic acid related exposures (the background
document describes information on two candidate substances: Botanical
products containing aristolochic acid and aristolochic acid) and (2)
riddelliine on November 13, 2007, on the RoC Web site (http://ntp.niehs.nih.gov/go/10091
see aristolochic acid related exposures or
riddelliine) or in printed text from the RoC (see FOR FURTHER
INFORMATION CONTACT below). The NTP invites the submission of public
comments on the two draft background documents (see SUPPLEMENTARY
INFORMATION below). The expert panel will meet on January 24-25, 2008,
at the Chapel Hill Sheraton Hotel, One Europa Drive, Chapel Hill, North
Carolina 27514, to peer review the draft background documents for
aristolochic acid related exposures and riddelliine and, once
completed, make a recommendation regarding the listing status (i.e.,
known to be a human carcinogen, reasonably anticipated to be a human
carcinogen, or not to list) for botanical products containing
aristolochic acid, for aristolochic acid, and for riddelliine in the
12th Edition of the RoC (12th RoC). The RoC expert panel meeting is
open to the public with time scheduled for oral public comments.
Attendance is limited only by the available meeting room space.
Following the expert panel meeting and completion of the expert panel
report, the NTP will post the final version of the background documents
and the expert panel peer review reports on the RoC Web site.
DATES: The expert panel meeting for aristolochic acid related exposures
and riddelliine will be held on January 24-25, 2008. The draft
background documents for these substances will be available for public
comment on November 13, 2007. The deadline to submit written comments
is January 11, 2008, and the deadline for pre-registration to attend
the meeting and provide oral comments at the meeting is January 18,
2008. Persons needing special assistance, such as sign language
interpretation or other reasonable accommodations in order to attend,
should contact 919-541-2475 (voice), 919-541-4644 TTY (text telephone),
through the Federal TTY Relay System at 800-877-8339, or by e-mail to
niehsoeeo@niehs.nih.gov. Requests should be made at least seven
business days in advance of the event.
ADDRESSES: The RoC expert panel meeting on aristolochic acid related
exposures and riddelliine will be held at the Chapel Hill Sheraton
Hotel, One Europa Drive, Chapel Hill, North Carolina 27514. Access to
on-line registration and materials for the meeting is available on the
RoC Web site (http://ntp.niehs.nih.gov/go/29679). Comments on the draft
background documents should be sent to Dr. C. W. Jameson, RoC Director,
NIEHS, P.O. Box 12233, MD EC-14, Research Triangle Park, NC 27709, Fax:
(919) 541-0144, or jameson@niehs.nih.gov. Courier address: Report on
Carcinogens, 79 T.W. Alexander Drive, Building 4401, Room 3118,
Research Triangle Park, NC 27709.
FOR FURTHER INFORMATION CONTACT: Dr. C. W. Jameson, RoC Director, 919-
541-4096, jameson@niehs.nih.gov.
SUPPLEMENTARY INFORMATION:
Background
On April 16, 2007 (72 FR 18999 available at http://ntp.niehs.nih.gov/go/9732
), the NTP announced the RoC review process
for the 12th RoC. An expert panel meeting is being convened on January
24-25, 2008, to review three candidate substances (botanical products
containing aristolochic acid,
[[Page 63901]]
aristolochic acid, and riddelliine) under consideration for possible
listing in the 12th RoC. The available scientific and exposure
information on botanical products containing aristolochic acid and
aristolochic acid overlap is described in one background document
(aristolochic acid related exposures); however, the expert panel will
be asked to make separate recommendations for listing status for each
candidate substance. The draft background documents for aristolochic
acid related exposures and riddelliine will be available on the RoC Web
site on November 13, 2007, or in printed text from the RoC Director
(see ADDRESSES above). Persons can register free-of-charge with the NTP
listserv to receive notification when draft RoC background documents
for other candidate substances for the 12th RoC are made available on
the RoC Web site (http://ntp.niehs.nih.gov/go/231).
Botanical products containing aristolochic acid are used in
traditional folk medicines, particularly in Chinese herbal medicine and
have been used inadvertently as part of a weight-loss regimen.
Aristolochic acid is a generic name for a family of nitrophenanthrene
carboxylic acids that occurs naturally in plants in the
Aristolochiaceae family, primarily of the genera Aristolochia and
Asarum. Riddelliine is a pyrrolizidine alkaloid that occurs in plants
of the genus Senecio that are found in sandy desert areas of the
western United States and other parts of the world. Humans may be
exposed to riddelliine via direct contamination of foodstuffs by parts
of Senecio plants or from indirect introduction of the alkaloid through
products derived from animals that have fed on the plants.
Pyrrolizidine alkaloid residues have been detected in honey.
Request for Comments
The NTP invites written public comments on the draft background
documents on aristolochic acid related exposures and riddelliine. All
comments received will be posted on the RoC Web site prior to the
meeting and distributed to the expert panel and RoC staff for their
consideration in the peer review of the draft background documents and/
or preparing for the expert panel meeting. Persons submitting written
comments are asked to include their name and contact information
(affiliation, mailing address, telephone and facsimile numbers, e-mail,
and sponsoring organization, if any) and send them to Dr. Jameson (see
ADDRESSES above) for receipt by January 11, 2008. Time is set-aside on
January 24-25, 2008, for the presentation of oral public comments at
the expert panel meeting. Seven minutes will be available for each
speaker (one speaker per organization). Persons can register on-line to
present oral comments or contact Dr. Jameson (see ADDRESSES above).
When registering to comment orally, please provide your name,
affiliation, mailing address, telephone and facsimile numbers, e-mail
and sponsoring organization (if any). If possible, send a copy of the
statement or talking points to Dr. Jameson by January 18, 2008. This
statement will be provided to the expert panel to assist them in
identifying issues for discussion and will be noted in the meeting
record. Registration for presentation of oral comments will also be
available at the meeting on January 24-25, 2008, from 7:30-8:30 a.m.
Persons registering at the meeting are asked to bring 25 copies of
their statement or talking points for distribution to the expert panel
and for the record.
Preliminary Agenda, Availability of Meeting Topics and Registration
Preliminary agenda topics include:
Oral public comments on aristolochic acid related
exposures.
Peer review of the background document on aristolochic
acid related exposures.
Recommendation for listing status in the 12th RoC for
botanical products containing aristolochic acid and for aristolochic
acid.
Oral public comments on riddelliine.
Peer review of the background document on riddelliine.
Recommendation for listing status in the 12th RoC for
riddelliine.
The meeting is scheduled for January 24-25, 2008, from 8:30 a.m. to
adjournment each day. The review of riddelliine will immediately follow
the review of aristolochic acid related exposures. A copy of the
preliminary agenda, expert panel roster, and any additional
information, when available, will be posted on the RoC Web site or may
be requested from the RoC Director (see ADDRESSES above). Individuals
who plan to attend the meeting are encouraged to register on-line by
January 18, 2008, to facilitate planning for the meeting.
Background Information on the RoC
The RoC is a congressionally mandated document that identifies and
discusses agents, substances, mixtures, or exposure circumstances
(collectively referred to as ``substances'') that may pose a hazard to
human health by virtue of their carcinogenicity. Substances are listed
in the report as either known or reasonably anticipated human
carcinogens. The NTP prepares the RoC on behalf of the Secretary of
Health and Human Services. Information about the RoC and the nomination
process can be obtained from its homepage (http://ntp.niehs.nih.gov/go/roc
) or by contacting Dr. Jameson (see FOR FURTHER INFORMATION CONTACT
above). The NTP follows a formal, multi-step process for review and
evaluation of selected chemicals. The formal evaluation process is
available on the RoC Web site (http://ntp.niehs.nih.gov/go/15208) or in
printed copy from the RoC Director.
Dated: October 30, 2007.
Samuel H. Wilson,
Acting Director, National Institute of Environmental Health Sciences
and National Toxicology Program.
[FR Doc. E7-22178 Filed 11-9-07; 8:45 am]
BILLING CODE 4140-01-P