National Toxicology Program (NTP); Report on Carcinogens; Status of Nominations to the 12th Report on Carcinogens (RoC): Request for Comments and Nominations of Scientific Experts, 60548-60554 [05-20729]
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Federal Register / Vol. 70, No. 200 / Tuesday, October 18, 2005 / Notices
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Toxicology Program (NTP);
Report on Carcinogens; Status of
Nominations to the 12th Report on
Carcinogens (RoC): Request for
Comments and Nominations of
Scientific Experts
National Institute of
Environmental Sciences (NIEHS),
National Institutes of Health (NIH),
HHS.
AGENCY:
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Federal Register / Vol. 70, No. 200 / Tuesday, October 18, 2005 / Notices
Request for Comments and
Nominations of Scientific Experts.
ACTION:
SUMMARY: The NTP invites public
comments on an updated list of
nominations proposed for review in the
12th RoC and the nomination of
scientists who have expertise and/or
knowledge relevant to the evaluation of
carcinogenicity for these nominations
(see SUPPLEMENTARY INFORMATION).
Information on the nominations under
consideration for the RoC can be
obtained at the NTP Web site https://
ntp.niehs.nih.gov (select ‘‘Report on
Carcinogens’’) or by contacting Dr. C.W.
Jameson at the address provided below.
DATES: Comments and nominations will
be accepted until November 17, 2005.
ADDRESSES: All correspondence should
be directed to Dr. C. W. Jameson,
National Toxicology Program, Report on
Carcinogens, 79 Alexander Drive,
Building 4401, Room 3118, P.O. Box
12233, Research Triangle Park, NC
27709; phone: (919) 541–4096, fax: (919)
541–0144, e-mail:
jameson@niehs.nih.gov.
SUPPLEMENTARY INFORMATION:
Background
This notice provides an update on the
current status of and/or additions to the
list of nominations identified in earlier
Federal Register notices relevant to the
12th RoC [69FR28940 (May 19, 2004)
and 69FR62276 (October 25, 2004)]. All
but the newly identified nomination of
formaldehyde were announced in
earlier Federal Register notices. Any
additional nominations for the 12th RoC
or modifications to the nominations in
the attached table will be announced in
future Federal Register notices.
Request for Comments on Nominations
to the RoC
The following table identifies the
nominations that the NTP has under
consideration for review as either a new
listing in the RoC or as a change in the
current listing. These nominations are
provided with their Chemical Abstracts
Services (CAS) Registry numbers (where
available) and pending review action.
The NTP solicits public input on these
nominations and asks for relevant
information concerning their
carcinogenicity as well as current data
on production, patterns of use, or
human exposure. The NTP also invites
interested parties to identify any
scientific issues related to the listing of
a specific nomination in the RoC that
they feel should be addressed during the
reviews. Individuals who submitted
comments in response to the May 19,
2004 Federal Register (69FR28940) and/
or the October 25, 2004 Federal Register
notice (69FR62276) need not re-submit
their comments as they are already part
of the public record. Individuals
submitting public comments are asked
to include relevant contact information
[name, affiliation (if any), address,
telephone, fax, and e-mail] and
sponsoring organization, if applicable.
Written submissions will be made
available on the NTP Web site as they
are received (https://ntp.niehs.nih.gov/
select ‘‘Report on Carcinogens’’) and
added to the public record.
Request for Nominations of Scientific
Experts
The NTP solicits nominations of
scientists who have expertise and/or
knowledge relevant to the evaluation of
carcinogenicity for the selected
nominations. These scientists should
have expertise in various aspects of
toxicology, epidemiology,
carcinogenesis, or other relevant areas of
science (e.g., genetic toxicity,
metabolism, etc.) and/or experience
with the agent being reviewed. The
experts may be used to write and/or
review the background documents
prepared on selected nominations.
Nominations of scientists should
include contact information for the
nominee [name, affiliation (if any),
address, telephone, fax, and e-mail], the
specific nominated agent(s) (listed in
the table below) for which they are
being recommended as an expert, and a
curriculum vitae (if possible). Contact
information for the nominator must also
be provided.
Additional Nominations Encouraged
The NTP solicits and encourages the
broadest participation from interested
individuals or parties in nominating
agents, substances, or mixtures for
review for future RoCs. Nominations
should contain a rationale for review.
Appropriate background information
and relevant data [e.g., journal articles,
NTP Technical Reports, International
Agency for Research on Cancer (IARC)
listings, exposure surveys, release
inventories, etc.] that support the review
of a nomination should be provided or
referenced when possible. Contact
information for the nominator should
also be included [name, affiliation (if
any), address, telephone, fax, and email].
Background Information on the Report
on Carcinogens
The RoC is a congressionally
mandated document [Section 301(b)(4)
of the Public Health Services Act, 42
U.S.C. 241(b)(4)], published by the
Secretary of Health and Human Services
(HHS), that identifies agents,
substances, mixtures, or exposure
circumstances (collectively referred to
as ‘‘substances’’) that may pose a
carcinogenic hazard to human health.
The Secretary, HHS, has delegated
responsibility for preparing the draft
report to the NTP. Substances are listed
in the RoC as either known to be a
human carcinogen or reasonably
anticipated to be a human carcinogen.
Review of nominations (substances that
are under consideration for listing or
removing from the RoC) involves a
multi-step scientific review process
with opportunity for public comment.
Dated: October 6, 2005.
Samuel H. Wilson,
Deputy Director, National Institute of
Environmental Health Sciences.
STATUS OF NOMINATIONS TO BE REVIEWED FOR THE REPORT ON CARCINOGENS
Nomination/CAS No.
1 Herbal
remedies containing aristolochic acid.
*Note—this nomination
was previously identified
as ‘‘Aristolochia-Related
Herbal Remedies’’.
VerDate Aug<31>2005
Primary uses or exposures
Nominator
Basis for nomination
Status
Several Aristolochia species (notably A. contorta,
A. debilis, A. fangchi
and A. manshuriensis)
have been used in traditional Chinese medicine
as antirheumatics, as
diuretics, in the treatment of edema, and for
other conditions such as
hemorrhoids, coughs,
and asthma.
NIEHS ...............................
Herbal remedies containing the plant genus
Aristolochia: IARC 2 finding of sufficient evidence
of carcinogenicity in humans (IARC Monograph
Vol. 82, 2002).
Review for possible listing
in 12th RoC.
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Federal Register / Vol. 70, No. 200 / Tuesday, October 18, 2005 / Notices
STATUS OF NOMINATIONS TO BE REVIEWED FOR THE REPORT ON CARCINOGENS—Continued
Nomination/CAS No.
Primary uses or exposures
Nominator
Basis for nomination
Status
Aristolochic Acid ................
Aristolochic acid, the principle extract from
Aristolochia, is a mixture
of nitrophenanthrene
carboxylic acids.
NIEHS ...............................
Review for possible listing
in 12th RoC.
Asphalt fumes ....................
Asphalt is a petroleum
product used in paving
and roofing operations.
Asphalt fumes are a
cloud of small particles
generated after volatilization of asphalt aggregates.
Private Individual ...............
Atrazine (192–24–9) ..........
Atrazine is an herbicide
used to control grass
and broad-leaved
weeds. Atrazine has
been detected at levels
that exceeded or approached the maximum
contaminant level (MCL)
for atrazine in 200 community surface drinking
water systems.
Benzofuran is produced by
isolation from coal-tar
oils. Benzofuran is used
in the manufacture of
coumarone-indene resins, which harden when
heated and are used to
make floor tiles and
other products.
Captafol is a fungicide that
has been widely used
since 1961 for the control of fungal diseases in
fruits, vegetables, and
some other plants. Use
of captafol in the United
States was banned in
1999.
NIEHS ...............................
Naturally occurring mixtures of aristolochic
acids: IARC 2 finding of
sufficient evidence of
carcinogenicity in animals and limited evidence in humans (IARC
Monograph Vol. 82,
2002).
Human epidemiological
studies have reported an
increased risk of lung
cancer among workers
exposed to asphalt
fumes and asphalt
fumes caused skin tumors in experimental
animals. Additionally,
known human carcinogens (polycyclic aromatic hydrocarbons or
PAHs) have been found
in asphalt fumes.
IARC 2 finding of sufficient
evidence of carcinogenicity in animals
(IARC Monograph Vol.
73, 1999).
Cobalt-tungsten carbide
hard-metals are manufactured by a process of
powder metallurgy from
tungsten and carbon
(tungsten carbide), and
small amounts of other
metallic compounds
using cobalt as a binder.
They are used to make
cutting and grinding
tools, dies, and wear
products for a broad
spectrum of industries
including oil and gas
drilling, and mining.
NIEHS ...............................
Benzofuran (271–89–6) .....
Captafol (2425–06–01) ......
1 Cobalt-tungsten
carbide
powders and hard metals.
*Note—This nomination
was previously identified
as ‘‘Cobalt/TungstenCarbide Hard Metal
Manufacturing’’.
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NIEHS ...............................
NIEHS ...............................
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Results of a NTP bioassay
(NTP Technical Report
370, 1989) 3, which reported clear evidence of
carcinogenicity in male
and female mice and
some evidence of carcinogenicity in female
rats.
IARC 2 finding of sufficient
evidence of carcinogenicity in animals
(IARC Monograph Vol.
53, 1991). IARC also
noted that captafol is
positive in many genetic
assays including the invivo assay for dominant
lethal mutation.
Recent human cancer
studies on the hard
metal manufacturing industry showing an association between exposure to hard metals (cobalt tungsten-carbide)
and lung cancer.
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Defer review of nomination
until the 13th RoC.
Defer review of nomination
until the 13th RoC.
Defer review of nomination
until the 13th RoC.
Review for possible listing
in 12th RoC.
Review for possible listing
in 12th RoC.
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Federal Register / Vol. 70, No. 200 / Tuesday, October 18, 2005 / Notices
STATUS OF NOMINATIONS TO BE REVIEWED FOR THE REPORT ON CARCINOGENS—Continued
Nomination/CAS No.
Primary uses or exposures
Nominator
Basis for nomination
Di (2-ethylhexyl) phthalate
(DEHP) (117–81–7).
DEHP is mainly used as a
plasticizer in polyvinyl
chloride (PVC) resins for
fabricating flexible vinyl
products. PVC resins
have been used to manufacture toys, dolls, vinyl
upholstery, tablecloths,
and many other products.
Private Individual ...............
Review for possible removal of listing in 12th
RoC.
Etoposide in combination
with cisplatin and
bleomycin.
Etoposide in combination
with cisplatin and
bleomycin is used to
treat testicular germ cell
cancers.
Etoposide is a DNA
topoisomerase II inhibitor used in chemotherapy for non-Hodgkin’s lymphoma, smallcell lung cancer, testicular cancer, lymphomas,
and a variety of childhood malignancies.
Formaldehyde is primarily
used in the production of
resins that are used in
the production of many
different products including plastics, adhesives
and binders for wood
products, pulp and
paper, synthetic fibers,
and in textile finishing. It
is also used as a disinfectant and preservative and as an intermediate for many industrial chemicals.
NIEHS ...............................
Currently listed in the RoC
as reasonably anticipated to be a human
carcinogen.
IARC 2 reclassification as
not classifiable as to its
carcinogenicity to humans (Group 3) (IARC
Monograph Vol. 77,
2000). IARC stated that
there was sufficient evidence for the carcinogenicity in experimental
animals; however, the
mechanism for liver
tumor involves
peroxisome proliferation
that is not relevant to
humans.
IARC 2 finding of sufficient
evidence of carcinogenicity in humans
(IARC Monograph Vol.
76, 2000).
IARC 2 finding of limited
evidence of carcinogenicity in humans
(IARC Monograph Vol.
76, 2000).
Formaldehyde (gas) is currently listed in the RoC
as reasonably anticipated to be a human
carcinogen. Nominated
for reconsideration
based on the 2004
IACR 2 review, which
concluded that there
was sufficient evidence
for the carcinogenicity of
formaldehyde in humans
(IARC Monograph Vol.
88, 2004).
Review for possible reclassification of listing status
in 12th RoC.
Etoposide (33419–42–0) ...
Formaldehyde (50–00–0) ..
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NIEHS ...............................
NIEHS ...............................
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Status
Review for possible listing
in 12th RoC.
Review for possible listing
in 12th RoC.
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Federal Register / Vol. 70, No. 200 / Tuesday, October 18, 2005 / Notices
STATUS OF NOMINATIONS TO BE REVIEWED FOR THE REPORT ON CARCINOGENS—Continued
Nomination/CAS No.
1 Certain
Glass Wool Fibers.
*Note—This nomination
was previously identified
as ‘‘Glass wool (respirable size): Two nominations: (1) Insulation
glass wool fibers, and
(2) Special purpose
glass fibers’’.
Metalworking Fluids ...........
ortho-Nitrotoluene (88–72–
2).
Oxazepam (604–75–1) ......
Riddelliine (23246–96–0) ..
Styrene (100–42–5) ...........
VerDate Aug<31>2005
Primary uses or exposures
Nominator
Basis for nomination
Status
Glass wool fibers, which
are a type of synthetic
vitreous fibers, are an
inorganic fibrous material manufactured primarily from glass and
processed inorganic oxides. The composition of
these fibers may vary
substantially because of
differences in end-use,
manufacturing requirements, and biopersistence considerations.
The major uses of glass
wool are in thermal,
electrical, and acoustical
insulation, weatherproofing, and filtration
media. Some glass wool
fibers (special purpose
fibers) are used for highefficiency air filtration
media, and acid battery
separators.
Metal working fluids are
complex mixtures that
may contain mixtures of
oil, emulsifiers, anti-weld
agents, corrosion inhibitors, extreme pressure
additives, buffers
biocides, and other additives. They are used to
cool and lubricate tools
and working surfaces in
a variety of industrial
machining and grinding
operations.
ortho-Nitrotoluene is used
to synthesize agricultural
and rubber chemicals,
azo and sulfur dyes, and
dyes for cotton, wool,
silk, leather, and paper.
Oxazepam is a
benzodiazepine used
extensively since the
1960s for the treatment
of anxiety and insomnia
and in the control of
symptoms of alcohol
withdrawal.
Riddelliine is found in
class of plants growing
in western United
States. Cattle, horses,
and sheep ingest these
toxic plants. Residues
have been found in milk
and honey.
Styrene is used in the production of polystyrene,
acrylonitrile-butadienestyrene resins, styrenebutadiene rubbers and
latexes, and unsaturated
polystyrene resins.
North American Insulation
Manufacturers Association nominated glass
wool (respirable size) for
delisting.
NIEHS recommended that
the nomination be defined as ‘‘certain glass
wool fibers’’ because of
the considerable differences in the composition of glass wool fibers.
Glass wool (respirable
size) is currently listed in
the RoC as reasonably
anticipated to be a
human carcinogen.
Insulation glass wool:
IARC 2 finding of limited
evidence of carcinogenicity in animals and
evaluation as not classifiable as to its carcinogenicity to humans
(Group 3) (IARC Monograph Vol. 81, 2002).
Special-purpose glass fibers: IARC 2 finding of
sufficient evidence of
carcinogenicity in animals (IARC Monograph
Vol. 81, 2002).
Review for possible listing
in 12th RoC.
NIEHS ...............................
Recent human cancer
studies of metal working
fluids that show an association between exposure to these materials
and cancer at several
tissue sites.
Review for possible listing
in 12th RoC.
NIEHS ...............................
Results of a NTP bioassay
(NTP Technical Report
504, 2002) 3, which reported clear evidence of
carcinogenicity in rats
and mice.
Results of a NTP bioassay
(NTP Technical Report
443, 1993) 3, which reported clear evidence of
carcinogenicity in male
and female mice.
Review for possible listing
in 12th RoC.
NIEHS ...............................
Results of a NTP bioassay
(NTP Technical Report
508, 2003) 3, which reported clear evidence of
carcinogenicity in male
and female rats and
mice.
Review for possible listing
in 12th RoC.
Private Individual ...............
IARC 2 finding of limited
evidence of carcinogenicity in animals and
limited evidence of carcinogenicity in humans
(IARC Monograph Vol.
82, 2002).
Review for possible listing
in 12th RoC.
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NIEHS ...............................
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Defer review of nomination
until the 13th RoC.
60553
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STATUS OF NOMINATIONS TO BE REVIEWED FOR THE REPORT ON CARCINOGENS—Continued
Nomination/CAS No.
Primary uses or exposures
Nominator
Basis for nomination
Talc (Two nominations) .....
(1) Cosmetic talc ...............
(2) Occupational exposure
to talc.
Talc occurs in various geological settings around
the world. Exposure to
general population occurs through use of
products such as cosmetics. Occupational exposure occurs during
mining, milling, and
processing.
NIEHS ...............................
Teniposide (29767–20–2)
Teniposide is a DNA
topoisomerase II inhibitors used mainly in the
treatment of adult and
childhood leukemia.
Vinyl halides are used in
the production of polymers and copolymers.
Vinyl bromide is mainly
used in polymers as a
flame retardant and in
the production of
monoacrylic fibers for
carpet-backing materials. Vinyl chloride is
used to produce polyvinyl chloride and copolymers. Vinyl fluoride
is used in the production
of polyvinyl fluoride,
which when laminated
with aluminum, steel and
other materials, is used
as a protective surface
for the exteriors of residential and commercial
buildings.
NIEHS ...............................
The NTP deferred consideration of listing talc
(asbestiform and nonasbestiform talc) in the
10th RoC because its
2000 review of talc
found that there has
been considerable confusion over the mineral
nature and consequences of exposure
to talc, both containing
asbestiform fibers and
not containing
asbestiform fibers. It has
become evident that the
literature on both forms
of talc, with a few exceptions, provides an inadequate characterization of the actual materials under study to enable one to reach definitive conclusions concerning the specific substances responsible for
the range of adverse
health outcomes reported.
IARC 2 finding of limited
evidence of carcinogenicity in humans
(IARC Monograph Vol.
76, 2000).
Vinyl fluoride and vinyl
bromide are currently
listed in the RoC as reasonably anticipated to
be a human carcinogen
and vinyl chloride is currently listed in the RoC
as a known to be a
human carcinogen.
Vinyl mono-halides: Structural similarities and
common mechanisms of
tumor formation.
Vinyl Mono-Halides as a
class.
NIEHS ...............................
1 Nomination
Status
Withdrawn from review.
Review for possible listing
in 12th RoC.
Defer review of nomination
until the 13th RoC.
has been redefined based on public comments received from earlier Federal Register notices and/or review of the literature.
Agency for Research on Cancer (IARC). IARC Monographs are available from https://monographs.iarc.fr/.
3 NTP Technical Reports are available at https://ntp.niehs.nih.gov/ see ‘‘NTP Study Reports.’’
2 International
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Federal Register / Vol. 70, No. 200 / Tuesday, October 18, 2005 / Notices
[FR Doc. 05–20729 Filed 10–17–05; 8:45 am]
DEPARTMENT OF HOMELAND
SECURITY
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
Federal Emergency Management
Agency
DEPARTMENT OF HOMELAND
SECURITY
[FEMA–1603–DR]
[FEMA–1607–DR]
Federal Emergency Management
Agency
Louisiana; Amendment No. 4 to Notice
of a Major Disaster Declaration
Louisiana; Amendment No. 7 to Notice
of a Major Disaster Declaration
[FEMA–1605–DR]
AGENCY:
BILLING CODE 4140–01–P
Alabama; Amendment No. 7 to Notice
of a Major Disaster Declaration
Federal Emergency
Management Agency, Emergency
Preparedness and Response Directorate,
Department of Homeland Security.
AGENCY:
ACTION:
Notice.
SUMMARY: This notice amends the notice
of a major disaster declaration for the
State of Alabama (FEMA–1605–DR),
dated August 29, 2005, and related
determinations.
EFFECTIVE DATE:
October 5, 2005.
Federal Emergency
Management Agency, Emergency
Preparedness and Response Directorate,
Department of Homeland Security.
ACTION:
Notice.
This notice amends the notice
of a major disaster declaration for the
State of Louisiana (FEMA–1603–DR),
dated August 29, 2005, and related
determinations.
SUMMARY:
EFFECTIVE DATE:
October 7, 2005.
FOR FURTHER INFORMATION CONTACT:
Magda Ruiz, Recovery Division, Federal
Emergency Management Agency,
Washington, DC 20472, (202) 646–2705.
The notice
of a major disaster declaration for the
State of Louisiana is hereby amended to
include the following areas among those
areas determined to have been adversely
affected by the catastrophe declared a
major disaster by the President in his
declaration of August 29, 2005:
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
Magda Ruiz, Recovery Division, Federal
Emergency Management Agency,
Washington, DC 20472, (202) 646–2705.
The notice
of a major disaster declaration for the
State of Alabama is hereby amended to
include the following area among those
areas determined to have been adversely
affected by the catastrophe declared a
major disaster by the President in his
declaration of August 29, 2005: Marengo
County for Individual Assistance
(already designated for Public
Assistance.)
SUPPLEMENTARY INFORMATION:
(The following Catalog of Federal Domestic
Assistance Numbers (CFDA) are to be used
for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora
Brown Fund Program; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services
Program; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management
Assistance; 97.048, Individuals and
Households Housing; 97.049, Individuals and
Households Disaster Housing Operations;
97.050 Individuals and Households ProgramOther Needs, 97.036, Public Assistance
Grants; 97.039, Hazard Mitigation Grant
Program.)
R. David Paulison,
Acting Under Secretary, Emergency
Preparedness and Response, Department of
Homeland Security.
[FR Doc. 05–20770 Filed 10–17–05; 8:45 am]
All parishes in the State of Louisiana are
eligible to apply for assistance under the
Hazard Mitigation Grant Program.
(The following Catalog of Federal Domestic
Assistance Numbers (CFDA) are to be used
for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora
Brown Fund Program; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services
Program; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management
Assistance; 97.048, Individuals and
Households Housing; 97.049, Individuals and
Households Disaster Housing Operations;
97.050 Individuals and Households
Program—Other Needs, 97.036, Public
Assistance Grants; 97.039, Hazard Mitigation
Grant Program.)
R. David Paulison,
Acting Under Secretary, Emergency
Preparedness and Response, Department of
Homeland Security.
[FR Doc. 05–20769 Filed 10–17–05; 8:45 am]
17:22 Oct 17, 2005
SUMMARY: This notice amends the notice
of a major disaster declaration for the
State of Louisiana (FEMA–1607–DR),
dated September 24, 2005, and related
determinations.
EFFECTIVE DATE: October 7, 2005.
FOR FURTHER INFORMATION CONTACT:
Magda Ruiz, Recovery Division, Federal
Emergency Management Agency,
Washington, DC 20472, (202) 646–2705.
SUPPLEMENTARY INFORMATION: The notice
of a major disaster declaration for the
State of Louisiana is hereby amended to
include the following areas among those
areas determined to have been adversely
affected by the catastrophe declared a
major disaster by the President in his
declaration of September 24, 2005:
Evangeline, Sabine, St. Landry, and Vernon
Parishes for Public Assistance [Categories C–
G] (already designated for Individual
Assistance and debris removal and
emergency protective measures [Categories A
and B] under the Public Assistance program,
including direct Federal assistance.)
De Soto, Natchitoches, and Rapides
Parishes for Public Assistance [Categories C–
G] (already designated for debris removal and
emergency protective measures [Categories A
and B] under the Public Assistance program,
including direct Federal assistance.)
(The following Catalog of Federal Domestic
Assistance Numbers (CFDA) are to be used
for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora
Brown Fund Program; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services
Program; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management
Assistance; 97.048, Individuals and
Households Housing; 97.049, Individuals and
Households Disaster Housing Operations;
97.050 Individuals and Households
Program—Other Needs, 97.036, Public
Assistance Grants; 97.039, Hazard Mitigation
Grant Program.)
R. David Paulison,
Acting Under Secretary, Emergency
Preparedness and Response, Department of
Homeland Security.
[FR Doc. 05–20773 Filed 10–17–05; 8:45 am]
BILLING CODE 9110–10–P
BILLING CODE 9110–10–P
VerDate Aug<31>2005
Federal Emergency
Management Agency, Emergency
Preparedness and Response Directorate,
Department of Homeland Security.
ACTION: Notice.
AGENCY:
BILLING CODE 9110–10–P
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]]>Agencies
[Federal Register Volume 70, Number 200 (Tuesday, October 18, 2005)]
[Notices]
[Pages 60548-60554]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-20729]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Toxicology Program (NTP); Report on Carcinogens; Status
of Nominations to the 12th Report on Carcinogens (RoC): Request for
Comments and Nominations of Scientific Experts
AGENCY: National Institute of Environmental Sciences (NIEHS), National
Institutes of Health (NIH), HHS.
[[Page 60549]]
ACTION: Request for Comments and Nominations of Scientific Experts.
-----------------------------------------------------------------------
SUMMARY: The NTP invites public comments on an updated list of
nominations proposed for review in the 12th RoC and the nomination of
scientists who have expertise and/or knowledge relevant to the
evaluation of carcinogenicity for these nominations (see SUPPLEMENTARY
INFORMATION). Information on the nominations under consideration for
the RoC can be obtained at the NTP Web site https://ntp.niehs.nih.gov
(select ``Report on Carcinogens'') or by contacting Dr. C.W. Jameson at
the address provided below.
DATES: Comments and nominations will be accepted until November 17,
2005.
ADDRESSES: All correspondence should be directed to Dr. C. W. Jameson,
National Toxicology Program, Report on Carcinogens, 79 Alexander Drive,
Building 4401, Room 3118, P.O. Box 12233, Research Triangle Park, NC
27709; phone: (919) 541-4096, fax: (919) 541-0144, e-mail:
jameson@niehs.nih.gov.
SUPPLEMENTARY INFORMATION:
Background
This notice provides an update on the current status of and/or
additions to the list of nominations identified in earlier Federal
Register notices relevant to the 12th RoC [69FR28940 (May 19, 2004) and
69FR62276 (October 25, 2004)]. All but the newly identified nomination
of formaldehyde were announced in earlier Federal Register notices. Any
additional nominations for the 12th RoC or modifications to the
nominations in the attached table will be announced in future Federal
Register notices.
Request for Comments on Nominations to the RoC
The following table identifies the nominations that the NTP has
under consideration for review as either a new listing in the RoC or as
a change in the current listing. These nominations are provided with
their Chemical Abstracts Services (CAS) Registry numbers (where
available) and pending review action. The NTP solicits public input on
these nominations and asks for relevant information concerning their
carcinogenicity as well as current data on production, patterns of use,
or human exposure. The NTP also invites interested parties to identify
any scientific issues related to the listing of a specific nomination
in the RoC that they feel should be addressed during the reviews.
Individuals who submitted comments in response to the May 19, 2004
Federal Register (69FR28940) and/or the October 25, 2004 Federal
Register notice (69FR62276) need not re-submit their comments as they
are already part of the public record. Individuals submitting public
comments are asked to include relevant contact information [name,
affiliation (if any), address, telephone, fax, and e-mail] and
sponsoring organization, if applicable. Written submissions will be
made available on the NTP Web site as they are received (https://
ntp.niehs.nih.gov/ select ``Report on Carcinogens'') and added to the
public record.
Request for Nominations of Scientific Experts
The NTP solicits nominations of scientists who have expertise and/
or knowledge relevant to the evaluation of carcinogenicity for the
selected nominations. These scientists should have expertise in various
aspects of toxicology, epidemiology, carcinogenesis, or other relevant
areas of science (e.g., genetic toxicity, metabolism, etc.) and/or
experience with the agent being reviewed. The experts may be used to
write and/or review the background documents prepared on selected
nominations. Nominations of scientists should include contact
information for the nominee [name, affiliation (if any), address,
telephone, fax, and e-mail], the specific nominated agent(s) (listed in
the table below) for which they are being recommended as an expert, and
a curriculum vitae (if possible). Contact information for the nominator
must also be provided.
Additional Nominations Encouraged
The NTP solicits and encourages the broadest participation from
interested individuals or parties in nominating agents, substances, or
mixtures for review for future RoCs. Nominations should contain a
rationale for review. Appropriate background information and relevant
data [e.g., journal articles, NTP Technical Reports, International
Agency for Research on Cancer (IARC) listings, exposure surveys,
release inventories, etc.] that support the review of a nomination
should be provided or referenced when possible. Contact information for
the nominator should also be included [name, affiliation (if any),
address, telephone, fax, and e-mail].
Background Information on the Report on Carcinogens
The RoC is a congressionally mandated document [Section 301(b)(4)
of the Public Health Services Act, 42 U.S.C. 241(b)(4)], published by
the Secretary of Health and Human Services (HHS), that identifies
agents, substances, mixtures, or exposure circumstances (collectively
referred to as ``substances'') that may pose a carcinogenic hazard to
human health. The Secretary, HHS, has delegated responsibility for
preparing the draft report to the NTP. Substances are listed in the RoC
as either known to be a human carcinogen or reasonably anticipated to
be a human carcinogen. Review of nominations (substances that are under
consideration for listing or removing from the RoC) involves a multi-
step scientific review process with opportunity for public comment.
Dated: October 6, 2005.
Samuel H. Wilson,
Deputy Director, National Institute of Environmental Health Sciences.
Status of Nominations To Be Reviewed for the Report on Carcinogens
----------------------------------------------------------------------------------------------------------------
Primary uses or Basis for
Nomination/CAS No. exposures Nominator nomination Status
----------------------------------------------------------------------------------------------------------------
1 Herbal remedies containing Several NIEHS............. Herbal remedies Review for
aristolochic acid. Aristolochia containing the possible listing
*Note--this nomination was species (notably plant genus in 12th RoC.
previously identified as A. contorta, A. Aristolochia:
``Aristolochia-Related Herbal debilis, A. IARC 2 finding of
Remedies''. fangchi and A. sufficient
manshuriensis) evidence of
have been used in carcinogenicity
traditional in humans (IARC
Chinese medicine Monograph Vol.
as 82, 2002).
antirheumatics,
as diuretics, in
the treatment of
edema, and for
other conditions
such as
hemorrhoids,
coughs, and
asthma.
[[Page 60550]]
Aristolochic Acid............... Aristolochic acid, NIEHS............. Naturally Review for
the principle occurring possible listing
extract from mixtures of in 12th RoC.
Aristolochia, is aristolochic
a mixture of acids: IARC 2
nitrophenanthrene finding of
carboxylic acids. sufficient
evidence of
carcinogenicity
in animals and
limited evidence
in humans (IARC
Monograph Vol.
82, 2002).
Asphalt fumes................... Asphalt is a Private Individual Human Defer review of
petroleum product epidemiological nomination until
used in paving studies have the 13th RoC.
and roofing reported an
operations. increased risk of
Asphalt fumes are lung cancer among
a cloud of small workers exposed
particles to asphalt fumes
generated after and asphalt fumes
volatilization of caused skin
asphalt tumors in
aggregates. experimental
animals.
Additionally,
known human
carcinogens
(polycyclic
aromatic
hydrocarbons or
PAHs) have been
found in asphalt
fumes.
Atrazine (192-24-9)............. Atrazine is an NIEHS............. IARC 2 finding of Defer review of
herbicide used to sufficient nomination until
control grass and evidence of the 13th RoC.
broad-leaved carcinogenicity
weeds. Atrazine in animals (IARC
has been detected Monograph Vol.
at levels that 73, 1999).
exceeded or
approached the
maximum
contaminant level
(MCL) for
atrazine in 200
community surface
drinking water
systems.
Benzofuran (271-89-6)........... Benzofuran is NIEHS............. Results of a NTP Defer review of
produced by bioassay (NTP nomination until
isolation from Technical Report the 13th RoC.
coal-tar oils. 370, 1989) 3,
Benzofuran is which reported
used in the clear evidence of
manufacture of carcinogenicity
coumarone-indene in male and
resins, which female mice and
harden when some evidence of
heated and are carcinogenicity
used to make in female rats.
floor tiles and
other products.
Captafol (2425-06-01)........... Captafol is a NIEHS............. IARC 2 finding of Review for
fungicide that sufficient possible listing
has been widely evidence of in 12th RoC.
used since 1961 carcinogenicity
for the control in animals (IARC
of fungal Monograph Vol.
diseases in 53, 1991). IARC
fruits, also noted that
vegetables, and captafol is
some other positive in many
plants. Use of genetic assays
captafol in the including the in-
United States was vivo assay for
banned in 1999. dominant lethal
mutation.
1 Cobalt-tungsten carbide Cobalt-tungsten NIEHS............. Recent human Review for
powders and hard metals. carbide hard- cancer studies on possible listing
*Note--This nomination was metals are the hard metal in 12th RoC.
previously identified as manufactured by a manufacturing
``Cobalt/Tungsten-Carbide Hard process of powder industry showing
Metal Manufacturing''. metallurgy from an association
tungsten and between exposure
carbon (tungsten to hard metals
carbide), and (cobalt tungsten-
small amounts of carbide) and lung
other metallic cancer.
compounds using
cobalt as a
binder. They are
used to make
cutting and
grinding tools,
dies, and wear
products for a
broad spectrum of
industries
including oil and
gas drilling, and
mining.
[[Page 60551]]
Di (2-ethylhexyl) phthalate DEHP is mainly Private Individual Currently listed Review for
(DEHP) (117-81-7). used as a in the RoC as possible removal
plasticizer in reasonably of listing in
polyvinyl anticipated to be 12th RoC.
chloride (PVC) a human
resins for carcinogen.
fabricating IARC 2
flexible vinyl reclassification
products. PVC as not
resins have been classifiable as
used to to its
manufacture toys, carcinogenicity
dolls, vinyl to humans (Group
upholstery, 3) (IARC
tablecloths, and Monograph Vol.
many other 77, 2000). IARC
products. stated that there
was sufficient
evidence for the
carcinogenicity
in experimental
animals; however,
the mechanism for
liver tumor
involves
peroxisome
proliferation
that is not
relevant to
humans.
Etoposide in combination with Etoposide in NIEHS............. IARC 2 finding of Review for
cisplatin and bleomycin. combination with sufficient possible listing
cisplatin and evidence of in 12th RoC.
bleomycin is used carcinogenicity
to treat in humans (IARC
testicular germ Monograph Vol.
cell cancers. 76, 2000).
Etoposide (33419-42-0).......... Etoposide is a DNA NIEHS............. IARC 2 finding of Review for
topoisomerase II limited evidence possible listing
inhibitor used in of in 12th RoC.
chemotherapy for carcinogenicity
non-Hodgkin's in humans (IARC
lymphoma, small- Monograph Vol.
cell lung cancer, 76, 2000).
testicular
cancer,
lymphomas, and a
variety of
childhood
malignancies.
Formaldehyde (50-00-0).......... Formaldehyde is NIEHS............. Formaldehyde (gas) Review for
primarily used in is currently possible
the production of listed in the RoC reclassification
resins that are as reasonably of listing status
used in the anticipated to be in 12th RoC.
production of a human
many different carcinogen.
products Nominated for
including reconsideration
plastics, based on the 2004
adhesives and IACR 2 review,
binders for wood which concluded
products, pulp that there was
and paper, sufficient
synthetic fibers, evidence for the
and in textile carcinogenicity
finishing. It is of formaldehyde
also used as a in humans (IARC
disinfectant and Monograph Vol.
preservative and 88, 2004).
as an
intermediate for
many industrial
chemicals.
[[Page 60552]]
1 Certain Glass Wool Fibers..... Glass wool fibers, North American Glass wool Review for
*Note--This nomination was which are a type Insulation (respirable size) possible listing
previously identified as of synthetic Manufacturers is currently in 12th RoC.
``Glass wool (respirable size): vitreous fibers, Association listed in the RoC
Two nominations: (1) Insulation are an inorganic nominated glass as reasonably
glass wool fibers, and (2) fibrous material wool (respirable anticipated to be
Special purpose glass fibers''. manufactured size) for a human
primarily from delisting. carcinogen.
glass and NIEHS recommended Insulation glass
processed that the wool: IARC 2
inorganic oxides. nomination be finding of
The composition defined as limited evidence
of these fibers ``certain glass of
may vary wool fibers'' carcinogenicity
substantially because of the in animals and
because of considerable evaluation as not
differences in differences in classifiable as
end-use, the composition to its
manufacturing of glass wool carcinogenicity
requirements, and fibers. to humans (Group
biopersistence 3) (IARC
considerations. Monograph Vol.
The major uses of 81, 2002).
glass wool are in Special-purpose
thermal, glass fibers:
electrical, and IARC 2 finding of
acoustical sufficient
insulation, evidence of
weatherproofing, carcinogenicity
and filtration in animals (IARC
media. Some glass Monograph Vol.
wool fibers 81, 2002).
(special purpose
fibers) are used
for high-
efficiency air
filtration media,
and acid battery
separators.
Metalworking Fluids............. Metal working NIEHS............. Recent human Review for
fluids are cancer studies of possible listing
complex mixtures metal working in 12th RoC.
that may contain fluids that show
mixtures of oil, an association
emulsifiers, anti- between exposure
weld agents, to these
corrosion materials and
inhibitors, cancer at several
extreme pressure tissue sites.
additives,
buffers biocides,
and other
additives. They
are used to cool
and lubricate
tools and working
surfaces in a
variety of
industrial
machining and
grinding
operations.
ortho-Nitrotoluene (88-72-2).... ortho-Nitrotoluene NIEHS............. Results of a NTP Review for
is used to bioassay (NTP possible listing
synthesize Technical Report in 12th RoC.
agricultural and 504, 2002) 3,
rubber chemicals, which reported
azo and sulfur clear evidence of
dyes, and dyes carcinogenicity
for cotton, wool, in rats and mice.
silk, leather,
and paper.
Oxazepam (604-75-1)............. Oxazepam is a NIEHS............. Results of a NTP Defer review of
benzodiazepine bioassay (NTP nomination until
used extensively Technical Report the 13th RoC.
since the 1960s 443, 1993) 3,
for the treatment which reported
of anxiety and clear evidence of
insomnia and in carcinogenicity
the control of in male and
symptoms of female mice.
alcohol
withdrawal.
Riddelliine (23246-96-0)........ Riddelliine is NIEHS............. Results of a NTP Review for
found in class of bioassay (NTP possible listing
plants growing in Technical Report in 12th RoC.
western United 508, 2003) 3,
States. Cattle, which reported
horses, and sheep clear evidence of
ingest these carcinogenicity
toxic plants. in male and
Residues have female rats and
been found in mice.
milk and honey.
Styrene (100-42-5).............. Styrene is used in Private Individual IARC 2 finding of Review for
the production of limited evidence possible listing
polystyrene, of in 12th RoC.
acrylonitrile- carcinogenicity
butadiene-styrene in animals and
resins, styrene- limited evidence
butadiene rubbers of
and latexes, and carcinogenicity
unsaturated in humans (IARC
polystyrene Monograph Vol.
resins. 82, 2002).
[[Page 60553]]
Talc (Two nominations).......... Talc occurs in NIEHS............. The NTP deferred Withdrawn from
(1) Cosmetic talc............... various consideration of review.
(2) Occupational exposure to geological listing talc
talc. settings around (asbestiform and
the world. non-asbestiform
Exposure to talc) in the 10th
general RoC because its
population occurs 2000 review of
through use of talc found that
products such as there has been
cosmetics. considerable
Occupational confusion over
exposure occurs the mineral
during mining, nature and
milling, and consequences of
processing. exposure to talc,
both containing
asbestiform
fibers and not
containing
asbestiform
fibers. It has
become evident
that the
literature on
both forms of
talc, with a few
exceptions,
provides an
inadequate
characterization
of the actual
materials under
study to enable
one to reach
definitive
conclusions
concerning the
specific
substances
responsible for
the range of
adverse health
outcomes reported.
Teniposide (29767-20-2)......... Teniposide is a NIEHS............. IARC 2 finding of Review for
DNA topoisomerase limited evidence possible listing
II inhibitors of in 12th RoC.
used mainly in carcinogenicity
the treatment of in humans (IARC
adult and Monograph Vol.
childhood 76, 2000).
leukemia.
Vinyl Mono-Halides as a class... Vinyl halides are NIEHS............. Vinyl fluoride and Defer review of
used in the vinyl bromide are nomination until
production of currently listed the 13th RoC.
polymers and in the RoC as
copolymers. Vinyl reasonably
bromide is mainly anticipated to be
used in polymers a human
as a flame carcinogen and
retardant and in vinyl chloride is
the production of currently listed
monoacrylic in the RoC as a
fibers for carpet- known to be a
backing human carcinogen.
materials. Vinyl Vinyl mono-
chloride is used halides:
to produce Structural
polyvinyl similarities and
chloride and common mechanisms
copolymers. Vinyl of tumor
fluoride is used formation.
in the production
of polyvinyl
fluoride, which
when laminated
with aluminum,
steel and other
materials, is
used as a
protective
surface for the
exteriors of
residential and
commercial
buildings.
----------------------------------------------------------------------------------------------------------------
1 Nomination has been redefined based on public comments received from earlier Federal Register notices and/or
review of the literature.
2 International Agency for Research on Cancer (IARC). IARC Monographs are available from https://
monographs.iarc.fr/.
3 NTP Technical Reports are available at https://ntp.niehs.nih.gov/ see ``NTP Study Reports.''
[[Page 60554]]
[FR Doc. 05-20729 Filed 10-17-05; 8:45 am]
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