National toxicology program: Carcinogens Report, Ninth Edition— Agents, substances, mixtures, and exposure circumstances for listing or delisting,

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Federal Register: March 19, 1998 (Volume 63, Number 53)NoticesPage 13418-13421From the Federal Register Online via GPO Access [wais.access.gpo.gov]

DOCID:fr19mr98-80

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.

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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.

\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.

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FR Doc. 98-7183Filed3-18-98; 8:45 amBILLING CODE 4140-01-M

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