[Federal Register Volume 74, Number 243 (Monday, December 21, 2009)]
[Notices]
[Pages 67883-67884]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-30300]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES


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.

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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: 919-541-0144; or [email protected]. Courier address: 
NIEHS, Room 2006, 530 Davis Drive, Morrisville, NC 27560].

FOR FURTHER INFORMATION CONTACT: Dr. Ruth Lunn, RoC Center, 919-316-
4637 or [email protected].

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

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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.
[FR Doc. E9-30300 Filed 12-18-09; 8:45 am]
BILLING CODE 4140-01-P