E7-22178. 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 ...

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 [e-mail]. 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: [phone], or [e-mail]. 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, [e-mail].

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, 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.