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

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:[email protected].

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

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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. 98-7183 Filed 3-18-98; 8:45 am]

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