[Federal Register: August 12, 2009 (Volume 74, Number 154)]
[Notices]
[Page 40598-40599]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12au09-72]
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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 lunn@niehs.nih.gov. Courier address:
NIEHS, Room 2006, 530 Davis Drive, Durham, NC 27713].
FOR FURTHER INFORMATION CONTACT: Dr. Ruth Lunn, RoC Center, 919-316-
4637 or lunn@niehs.nih.gov.
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