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, 67883-67884 [E9-30300]
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Federal Register / Vol. 74, No. 243 / Monday, December 21, 2009 / Notices
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.
erowe on DSK5CLS3C1PROD with NOTICES
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 (https://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 lunn@niehs.nih.gov.
Courier address: NIEHS, Room 2006,
530 Davis Drive, Morrisville, NC 27560].
FOR FURTHER INFORMATION CONTACT: Dr.
Ruth Lunn, RoC Center, 919–316–4637
or lunn@niehs.nih.gov.
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
VerDate Nov<24>2008
14:14 Dec 18, 2009
Jkt 220001
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 https://
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, https://
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 (https://
ntp.niehs.nih.gov/go/29682). The expert
panel report for formaldehyde contains
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Fmt 4703
Sfmt 4703
67883
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-ofcharge with the NTP listserv (https://
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
E:\FR\FM\21DEN1.SGM
21DEN1
67884
Federal Register / Vol. 74, No. 243 / Monday, December 21, 2009 / Notices
Secretary of Health and Human
Services. Information about the RoC and
the review process is available on its
Web site (https://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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Notice of Re-Designation of the
Service Delivery Area for the Cowlitz
Indian Tribe
Indian Health Service.
Notice.
AGENCY:
erowe on DSK5CLS3C1PROD with NOTICES
ACTION:
SUMMARY: This Notice advises the public
that the Indian Health Service (IHS)
proposes to expand the geographic
boundaries of the Service Delivery Area
(SDA) for the Cowlitz Indian Tribe. The
Cowlitz SDA currently is comprised of
Clark, Cowlitz, King, Lewis, Pierce,
Skamania, and Thurston in the State of
Washington. These counties were
designated as the Tribe’s SDA in 67 FR
46329. It is proposed that Columbia
County, Oregon, and Wahkiakum and
Kittitas Counties, Washington be added
to the existing SDA.
DATES: This notice is effective 30 days
after date of publication in the Federal
Register.
ADDRESSES: Comments may be mailed to
Betty Gould, Regulations Officer, Indian
Health Service, Suite 450, 12300
Twinbrook Parkway, Rockville,
Maryland 20852. Comments will be
made available for public inspection at
this address from 8:30 a.m. to 5:00 p.m.
Monday–Friday beginning
approximately 2 weeks after publication
of this notice.
FOR FURTHER INFORMATION CONTACT: Carl
Harper, Director, Office of Resource
Access and Partnerships, Indian Health
Service, Suite 360, 12300 Twinbrook
Parkway, Rockville, Maryland 20852.
Telephone 301/443–2694 (This is not a
toll free number).
SUPPLEMENTARY INFORMATION: The IHS
currently provides services under
regulations in effect on September 15,
1987 and IHS republished at 42 CFR
part 136, subparts A–C. Subpart C
defines a Contract Health Service
Delivery Area (CHSDA) as the
geographic area within which CHS will
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14:14 Dec 18, 2009
Jkt 220001
be made available by the IHS to
members of an identified Indian
community who reside in the area.
Residence with a CHSDA or SDA by a
person who is within the scope of the
Indian health program, as set forth in 42
CFR 136.12, creates no legal entitlement
to contract health services but only
potential eligibility for services.
Services needed but not available at a
IHS/Tribal facility are provided under
the CHS program depending on the
availability of funds, the person’s
relative medical priority, and the actual
availability and accessibility of alternate
resources in accordance with the
regulations.
As applicable to the Tribes, these
regulations provide that, unless
otherwise designated, a CHSDA shall
consist of a county which includes all
or part of a reservation and any county
or counties which have a common
boundary with the reservation (42 CFR
136.22(a)(6) (2007). The regulations also
provide that after consultation with the
Tribal governing body or bodies of those
reservations included in the CHSDA,
the Secretary may, from time to time, redesignate areas within the United States
for inclusion in or exclusion from a
CHDSA. The regulations require that
certain criteria must be considered
before any re-designation is made. The
criteria are as follows:
(1) The number of Indians residing in
the area proposed to be so included or
excluded;
(2) Whether the Tribal governing body
has determined that Indians residing in
the area near the reservation are socially
and economically affiliated with the
Tribes;
(3) The geographic proximity to the
reservation of the area whose inclusion
or exclusion is being considered; and
(4) The level of funding which would
be available for the provision of contract
health services.
Additionally, the regulations require
that any re-designation of a CHSDA
must be made in accordance with the
Administrative Procedures Act (5 U.S.C.
553). In compliance with this
requirement, we are publishing this
proposal and requesting public
comment.
The purpose of this FR notice is to
notify the public of the request of the
Cowlitz Indian Tribe to expand their
SDA as presented in their 08–3 Tribal
resolution dated January 5, 2008, and
08–56 Tribal resolution, dated
December 06, 2008. The Tribe’s request
will expand their current SDA which
incorporates Cowlitz, Clark, Skamania,
King, Pierce, Thurston and Lewis
Counties in the State of Washington, to
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Sfmt 4703
include Columbia County in the State of
Oregon, and Kittitas and Wahkiakum
Counties in the State of Washington.
Under 42 CFR 136.23 those otherwise
eligible Indians who do not reside on a
reservation but reside within a CHSDA
must be either members of the Tribe or
maintain close economic and social ties
with the Tribe. In this case, the Tribe
estimates the current eligible population
will be increased by 35 individuals’
enrolled Cowlitz members who are
actively involved with the Tribe, but not
eligible for health services.
In applying the aforementioned
CHSDA re-designation criteria required
by operative regulations (43 FR 35654),
the following findings are made:
1. Columbia County, Oregon is
contiguous with Clark County in the
state of Washington. Kittitas County is
contiguous to King County and
Wahkiakum County is contiguous to
Lewis in the State of Washington.
2. These three counties are not part of
any other Tribes CHSDA.
3. It is important for the Cowlitz
Indian Tribe to be able to deliver health
care services to enrolled members
residing in these three counties. The
Tribe believes eligible Tribal members
living in the counties proposed for
expansion should also be eligible for
CHS.
4. Most of the 35 Tribal members use
the Cowlitz Clinic in Longview,
Washington for their health care needs.
It is estimated that members have a 40
minute drive to receive their health
care. These Tribal members do not
currently receive care under the CHS
program.
5. The financial resources required to
meet the immediate needs of the Tribal
members residing in the three counties
will not be substantial as the Tribe will
use existing Federal allocations for
contract health funds.
Since CHS is a critical component of
the Tribes’ overall health care system for
its members, the Tribe feels that the
members residing in the three counties
should be included within the SDA for
the Tribe.
Accordingly, after considering the
Tribes’ request in light of the criteria
specified in the regulations, the IHS is
proposing to re-designate the SDA for
the Tribe to consist of Columbia County
in the State of Oregon and Kittitas and
Wahkiakum Counties in the State of
Washington.
This notice does not contain reporting
or recordkeeping requirements subject
to prior approval by the Office of
Management and Budget under the
Paperwork Reduction Act of 1980.
E:\FR\FM\21DEN1.SGM
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]]>Agencies
[Federal Register Volume 74, Number 243 (Monday, December 21, 2009)]
[Notices]
[Pages 67883-67884]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-30300]
[[Page 67883]]
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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.
-----------------------------------------------------------------------
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 (https://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 lunn@niehs.nih.gov. Courier address:
NIEHS, Room 2006, 530 Davis Drive, Morrisville, NC 27560].
FOR FURTHER INFORMATION CONTACT: Dr. Ruth Lunn, RoC Center, 919-316-
4637 or lunn@niehs.nih.gov.
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 https://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, https://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 (https://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 (https://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
[[Page 67884]]
Secretary of Health and Human Services. Information about the RoC and
the review process is available on its Web site (https://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
