E9-30300. National Toxicology Program (NTP); Report on Carcinogens (RoC) Center: Request for Public Comments on the RoC Expert Panel's Recommendation on Listing Status for Formaldehyde and the Scientific Justification for the Recommendation

AGENCY:

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

ACTION:

Request for comments.

SUMMARY:

The NTP invites public comment on the recommendation from an expert panel on the listing status for formaldehyde in the 12th RoC and the scientific justification for the recommendation. The recommendation and scientific justification for formaldehyde are available electronically in Part B of the Expert Panel Report (http://ntp.niehs.nih.gov/​go/​29682 Formaldehyde, Expert Panel Report Part B) or in printed text from the RoC Center (see FOR FURTHER INFORMATION CONTACT below). The RoC Center convened a ten-member expert panel of scientists, plus four technical scientific experts, from the public and private sectors on November 2-4, 2009, in Research Triangle Park, NC. The panel was asked (1) to apply the RoC listing criteria to the relevant scientific evidence and make a recommendation regarding 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 RoC and (2) to provide the scientific justification for their recommendation.

DATES:

The Expert Panel Report (Part B) for formaldehyde will be available for public comment by December 18, 2009. Written comments should be submitted by February 8, 2010.

ADDRESSES:

Comments should be sent to Dr. Ruth Lunn, Director, RoC Center [NIEHS, P.O. Box 12233, MD K2-14, Research Triangle Park, NC 27709; FAX: [phone]; or [e-mail]. Courier address: NIEHS, Room 2006, 530 Davis Drive, Morrisville, NC 27560].

FOR FURTHER INFORMATION CONTACT:

Dr. Ruth Lunn, RoC Center, 919-316-4637 or [e-mail].

SUPPLEMENTARY INFORMATION:

Background

Formaldehyde is a high-production chemical that has 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. 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 to manufacture products such as adhesives and binders for wood products, pulp and paper, plastics, synthetic fibers, in textile finishing and other 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.

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 this process, the NTP announced availability of the draft background document for formaldehyde, invited public comments on the draft background document, and announced the formaldehyde expert panel meeting (74 FR 15983, http://ntp.niehs.nih.gov/​go/​29682). On November 2-4, 2009, the RoC Center convened a ten-member expert panel of scientists from the public and private sectors to evaluate formaldehyde for possible listing in the 12th RoC. Four additional, non-voting, expert scientists were also in attendance to respond to technical concerns from the panel. The expert panel met in a public forum at the Hilton Raleigh-Durham Airport Hotel at Research Triangle Park, NC. The panel was charged to peer review the draft background document for formaldehyde and then to make a recommendation on its listing status in the 12th RoC and to provide a scientific justification for that recommendation. Details about the meeting, including public comments received and the expert panel reports, are available on the RoC Web site (http://ntp.niehs.nih.gov/​go/​29682). The expert panel report for formaldehyde contains two parts: Part A has the peer-review comments on the draft background document and Part B has the recommendation on listing status and its scientific justification. The expert panel recommended that formaldehyde be listed in the 12th RoC as known to be a human carcinogen.

Request for Comments

The RoC Center invites written public comments on the expert panel's recommendation on listing status for formaldehyde and the scientific justification for the recommendation. All comments received will be posted on the RoC Web site and the commenter identified by name, affiliation, and sponsoring organization, if applicable. 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). The deadline for submission of written comments is February 8, 2010.

Next Steps

The RoC Center is in the process of finalizing the background document for formaldehyde based upon the expert panel's peer review comments and public comments on the draft document. Persons can register free-of-charge with the NTP listserv (http://ntp.niehs.nih.gov/​go/​231) to receive notification when the final background document is posted on the RoC Web site . As part of the RoC review process, two government groups will also conduct reviews of formaldehyde; these meetings are not open to the public. Upon completion of these reviews, the NTP will (1) draft a substance profile for formaldehyde that contains its listing recommendation for the 12th RoC and the scientific information supporting that recommendation, (2) solicit public comment on the draft substance profile, and (3) convene a meeting of the NTP Board of Scientific Counselors to peer review the draft substance profile.

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. The RoC follows a formal, multi-step process for review and evaluation of selected chemicals. 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 review process is available on its Web site (http://ntp.niehs.nih.gov/​go/​roc) or by contacting Dr. Lunn (see FOR FURTHER INFORMATION CONTACT above).

Dated: December 9, 2009.

John R. Bucher,

Associate Director, National Toxicology Program.