[Federal Register Volume 73, Number 47 (Monday, March 10, 2008)]
[Notices]
[Pages 12736-12737]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-4782]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


National Toxicology Program (NTP); Report on Carcinogens (RoC); 
Request for Public Comments on the RoC Expert Panel's Recommendations 
on Listing Status for Captafol and Ortho-nitrotoluene in the 12th RoC 
and the Scientific Justifications for the Recommendations

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

ACTION: Request for public comment.

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SUMMARY: The RoC Office invites public comment on the recommendations 
from an expert panel on listing status for captafol and ortho-
nitrotoluene in the 12th RoC and the scientific justification for the 
recommendations. The recommendation and scientific justification for 
each candidate substance are available electronically in Part B of the 
Expert Panel Report http://ntp.niehs.nih.gov/go/29682, (see Expert 
Panel Report Part B) or in printed text from the RoC Office (see FOR 
FURTHER INFORMATION CONTACT below). The RoC Office convened a nine-
member expert panel of scientists from the public and private sectors 
on October 15-16, 2007. 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 captafol and for ortho-nitrotoluene in the 12th RoC and (2) 
to provide the scientific justification for the recommendation.

DATES: The Expert Panel Report (Part B) for captafol and for ortho-
nitrotoluene will be available for public comment by March 3, 2008. 
Written comments should be submitted by April 24, 2008.

ADDRESSES: Comments should be sent to Dr. Ruth Lunn, RoC Office [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].

[[Page 12737]]


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

SUPPLEMENTARY INFORMATION:

Background

    Captafol and ortho-nitrotoluene are among the candidate substances 
under review for possible listing in the 12th RoC (see complete list at 
http://ntp.niehs.nih.gov/go/10091). Captafol (CAS RN: 2425-06-1) is a 
broad-spectrum fungicide that was widely used in the United States 
prior to the mid 1980s on fruits, vegetables, and other plants, as well 
as on timber products. In 1999, the U.S. Environmental Protection 
Agency (EPA) revoked all captafol tolerances except those for onions, 
potatoes, and tomatoes. In 2006, EPA revoked specific tolerances and 
tolerance exemptions for captafol, and stakeholders withdrew their 
support for import tolerances. Although many countries have now banned 
its use, captafol is still registered in some countries (such as 
Mexico). The potential exists for past, extensive exposure for U.S. 
workers producing the chemical, as well as for agricultural workers 
because of past production and use of millions of pounds of captafol.
    Ortho-nitrotoluene (CAS RN: 88-72-2) is used to synthesize 
agricultural and organic chemicals, explosives, azo and sulfur dyes, 
and dyes for cotton, wool, silk, leather, and paper. Ortho-nitrotoluene 
is a high production volume chemical, and its U.S. production was 
between 10 million and 50 million pounds for every four-year reporting 
period from 1986 to 2002. Exposure to ortho-nitrotoluene in the United 
States is primarily a result of occupational exposure during the 
production and use of this chemical.
    As part of the RoC review process (available at http://ntp.niehs.nih.gov/go/15208), the NTP announced the availability of the 
draft background documents for captafol and ortho-nitrotoluene in the 
Federal Register (72 FR 41755, July 31, 2007), invited public comments 
on the draft background documents, and announced the captafol and 
ortho-nitrotoluene expert panel meeting. The RoC Office convened a 
nine-member expert panel of scientists from the public and private 
sectors to evaluate these two substances. The expert panel met on 
October 15-16, 2007, in a public forum at the Sheraton Chapel Hill 
Hotel in North Carolina. The panel first addressed captafol and then 
ortho-nitrotoluene in its deliberations. The panel was charged to peer 
review the draft background document for the candidate substance 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 each candidate 
substance contains two parts: Part A contains the peer-review comments 
on the draft background document and Part B is the recommendation on 
listing status and its scientific justification. The expert panel 
recommended that (1) captafol be listed in the 12th RoC as reasonably 
anticipated to be a human carcinogen and (2) ortho-nitrotoluene be 
listed in the 12th RoC as reasonably anticipated to be a human 
carcinogen. The panel's recommendation on listing status and its 
scientific justification are now being released for public comment.

Next Steps

    The RoC Office is in the process of finalizing the background 
document for each candidate substance based upon the expert panel's 
peer review comments and the public comments received (72 FR 41755). 
Persons can register free-of-charge with the NTP listserve (http://ntp.niehs.nih.gov/go/231) to receive notification when the final 
background documents are posted on the RoC Web site (http://ntp.niehs.nih.gov/go/10091).
    As part of the RoC review process, two government groups will also 
conduct reviews of captafol and ortho-nitrotoluene; these meetings are 
not open to the public. Upon completion of these reviews, the NTP will 
(1) draft a substance profile, for captafol and for ortho-nitrotoluene 
which contains its listing recommendation for the 12th RoC and the 
scientific information supporting that recommendation; (2) solicit 
public comment on the draft substance profiles; and (3) convene a 
meeting of the Board of Scientific Counselors to peer review the draft 
substance profiles.

Request for Comments

    The RoC Office invites written public comments on the expert 
panel's recommendations on listing status for captafol and ortho-
nitrotoluene and the scientific justifications for the recommendations. 
All comments received will be posted on the RoC Web site. 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 April 24, 2008.

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 are available on its Web site (http://ntp.niehs.nih.gov/go/roc) or by contacting Dr. Lunn (see FOR FURTHER 
INFORMATION CONTACT above).

    Dated: February 29, 2008.
Samuel H. Wilson,
Acting Director, National Institute of Environmental Health Sciences 
and National Toxicology Program.
[FR Doc. E8-4782 Filed 3-7-08; 8:45 am]
BILLING CODE 4140-01-P