E9-20878. National Toxicology Program (NTP): Report on Carcinogens (RoC); Availability of the Draft Background Document for Formaldehyde; Request for Comments on the Draft Background Document; Announcement of the Formaldehyde Expert Panel Meeting

AGENCY:

National Institute of Environmental Health Sciences (NIEHS); National Institutes of Health (NIH).

ACTION:

Availability of background document; request for comments; and announcement of a meeting

SUMMARY:

The NTP announces the availability of the draft background document for formaldehyde by September 3, 2009, on the RoC Web site (http://ntp.niehs.nih.gov/​go/​29679) or in printed text from the RoC (see ADDRESSES below). The NTP invites the submission of public comments on the draft background document for formaldehyde. The expert panel will meet on November 2-4, 2009, at the Hilton Raleigh-Durham Airport at Research Triangle Park, 4810 Page Creek Lane, Durham, NC 27703 to peer review the draft background document for formaldehyde 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 formaldehyde 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 background document and the expert panel report on the RoC Web site.

DATES:

The expert panel meeting for formaldehyde will be held on November 2-4, 2009. The draft background document for formaldehyde will be available for public comment by September 3, 2009. The deadline to submit written comments is October 16, 2009, and the deadline for pre-registration to attend the meeting and/or to provide oral comments at the meeting is October 26, 2009.

ADDRESSES:

The RoC expert panel meeting on formaldehyde will be held at the Hilton Raleigh-Durham Airport at Research Triangle Park, 4810 Page Creek Lane, Durham, NC 27703. Access to on-line registration and materials for the meeting are available on the RoC Web site (http://ntp.niehs.nih.gov/​go/​29679). Comments on the draft background document should be sent to Dr. Ruth M. Lunn, NIEHS, P.O. Box 12233, MD K2-14, Research Triangle Park, NC 27709, FAX: [phone], or [e-mail]. Courier address: Report on Carcinogens Center, 530 Davis Drive, Room 2006, Morrisville, NC 27560. Persons needing interpreting services in order to attend should contact [phone] (voice) or [phone] (TTY). Requests should be made at least seven business days in advance of the meeting.

FOR FURTHER INFORMATION CONTACT:

Dr. Ruth M. Lunn, Director, RoC Center, [phone], [e-mail].

SUPPLEMENTARY INFORMATION:

Background

The NTP announced the RoC review process for the 12th RoC on April 16, 2007, in the Federal Register (72 FR 18999, available at http://ntp.niehs.nih.gov/​go/​15208). As part of that process, an expert panel meeting is being convened on November 2-4, 2009, to review formaldehyde for possible listing in the 12th RoC. The draft background document for formaldehyde will be available on the RoC Web site by September 3, 2009, or in printed text from the RoC Center (see ADDRESSES above). Persons can register free-of-charge with the NTP listserv (http://ntp.niehs.nih.gov/​go/​231) to receive notification when draft RoC background documents for candidate substances and meetings related to the 12th RoC are made available on the RoC Web site.

Formaldehyde is a high production chemical with a wide array of uses. The predominant use of formaldehyde in the United States is in the production of industrial resins (mainly urea, phenol, polyacetal, and melamine resins) that are used primarily to manufacture products such as adhesives and binders for wood products. Other uses include as a chemical intermediate, in agriculture (for example as a fumigant), in the production of paraformaldehyde and chelating agents, embalming and fixative or preservative in the medical and research fields, and as a preservative in numerous consumer products such as cleaning agents and cosmetic products. Formaldehyde has been detected in indoor and outdoor air, surface water and groundwater, soil, and food products and is generally considered to be ubiquitous in the environment. Formaldehyde (gas) is currently listed in the 11th RoC as reasonably anticipated to be a human carcinogen and was nominated for reclassification of its listing status in the 12th RoC.

Preliminary Agenda and Registration

Preliminary agenda topics include:

• Oral public comments on formaldehyde;
• Peer review of the draft background document on formaldehyde;
• Recommendation on the listing status of formaldehyde in the 12th RoC and scientific justification.

The meeting is scheduled for November 2-4, 2009, from 8:30 a.m. to adjournment each day. It is anticipated that the meeting will adjourn by 4 p.m. on November 4, although adjournment may occur earlier or later depending upon the time needed for the expert panel to complete its work. 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 Director of the RoC Center (see ADDRESSES above). Individuals who plan to attend the meeting are encouraged to register on-line by October 26, 2009, to facilitate planning for the meeting.

Request for Comments

The NTP invites both written and oral public comments on the draft background document on formaldehyde. 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. Lunn (see ADDRESSES above) for receipt by October 16, 2009. All written comments identified by the individual's name and affiliation or sponsoring organization (if applicable) 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 document and/or preparation for the meeting.

Time will be set aside at the expert panel meeting for the presentation of oral public comments. Seven minutes will be available for each speaker (one speaker per organization). Persons can register on-line to present oral comments or by contacting Dr. Lunn (see ADDRESSES above). When registering to comment orally, please provide your name, affiliation, mailing address, telephone number, e-mail and sponsoring organization (if any). If possible, send a copy of the statement or talking points to Dr. Lunn by October 26, 2009. 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 November 2-4, 2009, from 7:30-8:30 a.m. Time allowed for comments by on-site registrants may be less than for pre-registered speakers and will be determined by the number of persons who register at the meeting to give oral comments. 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.

Background Information on the RoC

The RoC is a congressionally mandated document [Section 301(b)(4) of the Public Health Services Act, 42 U.S.C. 241(b)(4)], 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 to be 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. Lunn (see For Further Information Contact above). The NTP follows a formal, multi-step process for review and evaluation of selected substances. 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 Center.

Dated: August 21, 2009.

John R. Bucher,

Associate Director, National Toxicology Program.