[Federal Register Volume 63, Number 53 (Thursday, March 19, 1998)]
[Notices]
[Pages 13418-13421]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-7183]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
National Toxicology Program; Call for Public Comments; Agents,
Substances, Mixtures and Exposure Circumstances Proposed for Listing in
or Removing From the Report on Carcinogens, Ninth Edition
Background
The National Toxicology Program (NTP) solicits final public
comments on its intent to recommend additional agents, substances,
mixtures and exposure circumstances for listing in or delisting from
the Report on Carcinogens, Ninth Edition. This Report is a
Congressionally-mandated listing of known human carcinogens and
reasonably anticipated human carcinogens and its preparation is
delegated to the National Toxicology Program by the Secretary,
Department of Health and Human Services (HHS). Section 301(b)(4) of the
Public Health Service Act, as amended, provides that the Secretary,
(HHS), shall publish a report which contains a list of all substances
(1) which either are known to be human carcinogens or may reasonably be
anticipated to be human carcinogens; and (2) to which a significant
number of persons residing in the United States (US) are exposed. The
law also states that the report should provide available information on
the nature of exposures, the estimated number of persons exposed and
the extent to which the implementation of Federal regulations decreases
the risk to public health from exposure to these chemicals.
In 1997, 14 substances or exposure circumstances were reviewed for
listing in or removal from the Ninth Report. This review included two
Federal and one non-government, scientific peer reviews and public
comment and review. All available data relevant to the criteria for
inclusion or removal of candidate substances or exposure circumstances
in the Report were evaluated by the three scientific review committees.
The criteria used in the review process and the detailed description of
the review procedures, including the steps in the current formal review
process, can be obtained by contacting: Dr. C.W. Jameson, National
Toxicology Program, Report on Carcinogens, MD EC-14, P.O. Box 12233,
Research Triangle Park, NC 27709; phone: (919) 541-4096, fax: (919)
541-2242, email:jameson@niehs.nih.gov.
Public Comment Requested
The NTP will be making a final recommendation for the 14 substances
or exposure circumstances reviewed in 1997, for either listing in,
delisting from, or changing the current listing from reasonably
anticipated to be a human carcinogen to the known to be a human
carcinogen category in the Ninth Report. These nominated substances or
exposure circumstances are provided in the following table with their
Chemical Abstracts Services (CAS) Registry numbers (where available)
and the recommendations from the three scientific peer reviews of the
nominations.
Background documents provided to the review committees and the
interested public and summary minutes of the public peer review by the
NTP Board Subcommittee are available upon request. The NTP will review
the recommendations of each of the review committees and consider the
public comments received throughout the process in making decisions
regarding the NTP recommendations to the Secretary, DHHS, for listing
or removal of the nominated substances and exposure circumstances in
the Ninth Edition of the Report on Carcinogens. The NTP solicits final
public comment to supplement any previously submitted
[[Page 13419]]
comments or to provide comments for the first time on any substance or
exposure circumstances in the following table. Because of the different
recommendations forwarded by the three scientific review groups, the
NTP is especially interested in obtaining additional relevant
information in support of or against the petition to delist Saccharin
from the Report on Carcinogens. The critical areas identified in the
earlier scientific reviews where additional input is solicited include
(1) information that addresses the adequacy of existing epidemiology
data, particularly as it relates to reported increased incidences of
bladder tumor formation in certain small populations; (2) the levels of
human exposure, especially in infants and children; (3) information
addressing the mechanism of urinary bladder tumor formation in male
rats as it relates to other test species (especially female rats and
male and female mice) and to humans; and (4) the adequacy of data for
tumor formation in laboratory animals at target sites other than the
urinary bladder. Comments will be accepted for a period of 60 days from
the date of the publication of this announcement in the Federal
Register. Comments or questions should be directed to Dr. C.W. Jameson
at the address listed above.
Attachment.
Dated: March 12, 1998.
Kenneth Olden,
Director, National Toxicology Program.
Summary of RG1 \1\, RG2 \2\ and NTP Board Subcommittee \3\ Recommendations for the Agents, Substances, Mixtures
of Exposure Circumstances Reviewed in 1997 for Listing in or Delisting From the Report on Carcinogens, 9th
Edition
----------------------------------------------------------------------------------------------------------------
NTP Board
Substance or exposure Primary uses or RG1 action RG2 action Subcommittee
circumstance/CAS No. exposures action
----------------------------------------------------------------------------------------------------------------
DYES METABOLIZED TO BENZIDINE Benzidine-based RG1 voted 7/1 to RG2 voted The Subcommittee
(BENZIDINE DYES AS A CLASS). dyes are used list as known to unanimously to recommended
primarily for be human list as a known unanimously
dyeing textiles, carcinogen. to be human listing as known
paper and leather carcinogen. to be human
products. More carcinogen.
than 250
benzidine-based
dyes have been
reported by the
Society of Dyers
and Colorists.
1,3-BUTADIENE/106-99-0.......... Used primarily as RG1 voted 9/0 with RG2 voted The Subcommittee
a chemical 1 abstention to unanimously to recommended (4
intermediate and upgrade the upgrade the yes votes to 2 no
polymer component current listing current listing votes with 1
in the to known to be to known to be abstention)
manufacture of human carcinogen. human carcinogen. upgrading the
synthetic rubber. current listing
to known to be
human carcinogen.
CADMIUM and CADMIUM COMPOUNDS/ Used in batteries, RG1 voted 7/1 to RG2 voted The Subcommittee
7740-43-9. coating and upgrade the unanimously to recommended
plating, plastic current listing upgrade the unanimously
and synthetic to known to be current listing upgrading the
products and in human carcinogen. to known to be current listing
alloys. human carcinogen. to known to be a
human carcinogen.
CHLOROPRENE/126-99-8............ Used as monomer RG1 voted 7/0 with RG2 voted The Subcommittee
for neoprene 2 abstentions to unanimously to recommended
elastomers, list as a list as a unanimously
industrial rubber reasonably reasonably listing as
products, and as anticipated human anticipated human reasonably
a component of carcinogen. carcinogen. anticipated to be
adhesives in food a human
packaging. carcinogen.
PHENOLPHTHALEIN/77-09-8......... Used as a RG1 voted 9/1 to RG2 voted 7/0 with The Subcommittee
laboratory list as 1 abstention to recommended
reagent and acid- reasonably list as a unanimously
base indicator anticipated to be reasonably listing as
and as a a human anticipated to be reasonably
cathartic drug in carcinogen. a human anticipated to be
over-the-counter carcinogen. a human
laxative carcinogen.
preparations.
SACCHARIN/218-44-9.............. Used primarily as RG1 voted 7/3 to RG2 voted 6/2 to The Subcommittee
a nonnutritive delist from the delist from the recommended (4
sweetening agent. Report on Report on yes votes to 3 no
Carcinogens. Carcinogens. votes) not to
delist from the
Report, and leave
saccharin listed
as reasonably
anticipated to be
a human
carcinogen.
SMOKELESS TOBACCO............... Oral use of RG1 voted RG2 voted The Subcommittee
smokeless tobacco unanimously to unanimously to recommended
products. list as a known list as a known unanimously
to be human to be human listing as a
carcinogen. carcinogen. known to be human
carcinogen.
[[Page 13420]]
STRONG INORGANIC ACID MISTS Sulfuric acid is RG1 voted RG2 voted 7/1 to The Subcommittee
CONTAINING SULFURIC ACID. the one of the unanimously to list as known to recommended
most widely used list as known to be a human unanimously
of all industrial be a human carcinogen. listing as known
chemicals. Used carcinogen. to be a human
in the carcinogen.
manufacture of
fertilizers,
rayon and other
fibers, pigments
and colors,
explosives,
plastics, coal-
tar products such
as dyes and
drugs, storage
batteries,
synthetic
detergents,
natural and
synthetic rubber,
pulp and paper.
TAMOXIFEN/10540-29-1............ Used as an anti- RG1 voted RG2 voted 7/0 with The Subcommittee
estrogen drug and unanimously to 1 abstention to recommended
in the palliative list as known to list as known to unanimously
treatment of be human be a human listing as known
breast cancer. carcinogen with carcinogen with to be a human
the added the added carcinogen, with
statement that statement that the statement
there is also there is also that there is
conclusive conclusive also conclusive
evidence that evidence that evidence that
tamoxifen therapy tamoxifen therapy tamoxifen therapy
reduces the risk reduces the risk reduces the risk
of contralateral of contralateral of contralateral
breast cancer in breast cancer in breast cancer in
women with a women with a women with a
previous previous previous
diagnosis of diagnosis of diagnosis of
breast cancer. breast cancer. breast cancer.
2,3,7,8-TETRACHLORODIBENZO-P- Not used RG1 voted RG2 voted The Subcommittee
DIOXIN (TCDD)/1746-01-6. commercially, unanimously to unanimously to recommended (4
used only as a upgrade the upgrade the yes votes to 3 no
research chemical. current listing current listing votes with 1
to known to be to known to be abstention)
human carcinogen. human carcinogen. upgrading the
current listing
to known to be
human carcinogen.
TETRAFLUOROETHYLENE/116-14-3.... Used in the RG1 voted RG2 voted The Subcommittee
production of unanimously to unanimously to recommended
polytetrafluoroet list as list as unanimously
hylene (Teflon) reasonably reasonably listing as
and other anticipated to be anticipated to be reasonably
polymers. Has a human a human anticipated to be
also been used as carcinogen. carcinogen. a human
a propellant for carcinogen.
food product
aerosols.
TOBACCO SMOKING................. Inhalation of RG1 voted RG2 voted The Subcommittee
tobacco smoke. unanimously to unanimously to recommended
list as known to list as known to unanimously
be a human be a human listing as known
carcinogen. carcinogen. to be a human
carcinogen.
TRICHLOETHYLENE/79-01-6......... Used as an RG1 voted 6/2 to RG2 voted 7/1 to The Subcommittee
industrial list as list as recommended
solvent for vapor reasonably reasonably unanimously
degreasing and anticipated to be anticipated to be listing as
cold cleaning of a human a human reasonably
fabricated metal carcinogen. carcinogen. anticipated to be
parts. Has also a human
been used as a carcinogen.
carrier solvent
for the active
ingredients of
insecticides and
fungicides, as an
anesthetic for
medical and
dental use, and
for caffeine from
coffee.
UV RADIATION.................... Solar and RG1 voted RG2 voted 7/1 in The Subcommittee
artificial unanimously to favor of motion recommended
sources of list Solar to defer action unanimously
ultraviolet Radiation and use on UV Radiation listing Solar
radiation. of Sunlamps and until the Radiation and use
Sunbeds as known Background of Sunlamps and
to be a human Document could be Sunbeds as know
carcinogen. revised to to be a human
address the full carcinogen.
spectrum of UV
Radiation,
including UVA,
UVB, and UVC.
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\1\ The NIEHS Review Committee for the Report on Carcinogens (RG1).
\2\ The NTP Interagency Executive Committee Working Group for the Report on Carcinogens (RG2).
\3\ The NTP Board of Scientific Counselors Report on Carcinogens Subcommittee.
[[Page 13421]]
[FR Doc. 98-7183 Filed 3-18-98; 8:45 am]
BILLING CODE 4140-01-M
