[Federal Register Volume 72, Number 218 (Tuesday, November 13, 2007)]
[Notices]
[Pages 63900-63901]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-22178]


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

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.

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

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 
[email protected]. 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 [email protected]. 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, [email protected].

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