[Federal Register Volume 74, Number 154 (Wednesday, August 12, 2009)]
[Notices]
[Pages 40598-40599]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-19329]


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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 Glass Wool Fibers and the Scientific 
Justification for the Recommendations

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 recommendations from an 
expert panel on the listing status for glass wool fibers in the 12th 
RoC and the scientific justification for the recommendations. The 
recommendations and scientific justification are available 
electronically in part B of the Expert Panel Report (http://ntp.niehs.nih.gov/go/29682) or in printed text from the RoC Center (see 
``FOR FURTHER INFORMATION CONTACT'' below). The RoC Center convened a 
nine-member, scientific expert panel on June 9-10, 2009, that was 
charged (1) To apply the RoC listing criteria to the relevant 
scientific evidence for glass wool fibers and make a recommendation 
regarding its listing status (i.e., known to be a human carcinogen, 
reasonably anticipated to be a human carcinogen, or not to list) in the 
12th RoC and (2) to provide a scientific justification for the 
recommendation.

DATES: The Expert Panel Report for Glass Wool Fibers (part B) will be 
available for public comment by August 3, 2009. The deadline for 
written comments is September 28, 2009.

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, Durham, NC 27713].

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

SUPPLEMENTARY INFORMATION:

Background

    Glass wool refers to fine glass fibers forming a mass resembling 
wool and most commonly used for insulation and filtration. Two 
categories of glass wool based on commercial use are (1) Insulation 
glass wools, which are used for applications such as thermal, 
electrical, and acoustical insulation and in weatherproofing, and (2) 
special-purpose glass fibers, which are used in

[[Page 40599]]

specialized products that include aircraft and aerospace insulation, 
battery separators, and high efficiency filters. Glass wool (respirable 
size) is currently listed in the 11th RoC as reasonably anticipated to 
be a human carcinogen.
    As part of the review process for candidate substances for the 12th 
RoC (available at http://ntp.niehs.nih.gov/go/15208), the RoC Center 
convened a nine-member expert panel of independent scientists to 
evaluate glass wool fibers for possible listing in the 12th RoC. An 
additional, non-voting, scientist was also in attendance to respond to 
technical questions from the panel about glass wool. The expert panel 
met in a public forum at the Sheraton Chapel Hill Hotel, Chapel Hill, 
North Carolina on June 9-10, 2009. The panel was charged to peer review 
the draft background document for glass wool fibers and, once this task 
was completed, to make a recommendation on the listing status of glass 
wool fibers 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 Glass Wool Fibers 
Expert Panel Report 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 decided to separate glass wool fibers into two 
categories for purposes of evaluating for the RoC. They recommended 
that special-purpose glass fibers (physical characteristics: longer, 
thinner, less soluble fibers, e.g., [gteqt] 15 [mu]m length with a 
kdiss of <=100 ng/cm\2\/h) be listed as reasonably 
anticipated to be a human carcinogen in the 12th RoC. The panel 
recommended that glass wool fibers, with the exception of special 
fibers of concern (characterized above), not be listed in the 12th RoC 
either as known to be a human carcinogen or reasonably anticipated to 
be a human carcinogen.

Request for Comments

    The RoC Center invites written public comments on the expert 
panel's two recommendations on the listing status for glass wool fibers 
and the scientific justification for those recommendations. The NTP is 
also particularly interested in comments on the expert panel's decision 
to separate glass wool fibers into two categories for purposes of 
listing in the RoC evaluation and on the set of physical 
characteristics that the panel used to classify the fibers into two 
categories. All comments received will be posted on the RoC Web site 
and identified by the submitters and, if applicable, their affiliation 
and/or sponsoring organization. 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 September 28, 2009.

Next Steps

    The RoC Center is in the process of finalizing the background 
document for glass wool fibers based upon the expert panel's peer 
review comments and the public comments received on the draft 
background document. Persons can register free-of-charge with the NTP 
listserve (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 glass wool fibers; these meetings are not open to the 
public. Upon completion of its review, the NTP will (1) Draft a 
substance profile for glass wool fibers 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 candidate 
substances. 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: August 5, 2009.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. E9-19329 Filed 8-11-09; 8:45 am]
BILLING CODE 4140-01-P