National Toxicology Program; Call for Public Comments on 11 Agents, Substances, Mixtures and Exposure Circumstances Proposed for Listing in or Delisting from the Report on Carcinogens, Ninth Edition

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service

National Toxicology Program; Call for Public Comments on 11

Agents, Substances, Mixtures and Exposure Circumstances Proposed for

Listing in or Delisting from the Report on Carcinogens, Ninth Edition

Background

The National Toxicology Program (NTP) solicits final public

comments on 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 the Secretary, Department of Health and Human Services

(HHS) delegates its preparation to the National Toxicology Program.

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

reports 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 decrease the risk to

public health from exposure to these chemicals.

In 1998, 11 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. The three scientific review committee evaluated all

available data relevant to the criteria for inclusion or removal of

candidate substances or exposure circumstances in the Report. 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, 79 Alexander Drive, Room

3217, P.O. Box 12233, Research Triangle Park, NC 27709; phone: (919)

541-4096, fax: (919) 541-2242, email: [email protected]. This

information is also available on the NTP Home Page web site at http://

ntp-server.niehs.nih.gov/

Public Comment Requested

The NTP will be making a final recommendation in 1999 for the 11

substances or exposure circumstances reviewed in 1998, 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 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 comments or to

provide comments for the first time on any substance or exposure

circumstances in the following table. 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: December 4, 1998.

Kenneth Olden,

Director, National Toxicology Program.

Summary of RG1,\1\ RG2 \2\ and NTP Board Subcommittee \3\ Recommendations for the Agents, Substances, Mixtures

or Exposure Circumstances Reviewed in 1998 for Listing in or Delisting from the Report on Carcinogens,\4\ 9th

Edition

----------------------------------------------------------------------------------------------------------------

NTP board

Nomination/CAS No. Primary uses or RG1 action RG2 action subcommittee

exposures action

----------------------------------------------------------------------------------------------------------------

Alcoholic Beverages............. Consumption of RG1 recommended (6 RG2 unanimously The Subcommittee

alcoholic yes votes to 1 no recommended (7 recommended (9

beverages. vote) listing as yes votes to 0 no yes votes to 3 no

known to be a votes) listing as votes with 1

human carcinogen. known to be a abstention)

human carcinogen. listing as known

to be a human

carcinogen.

Boot and Shoe Manufacture and Workers in the RG1 recommended (5 RG2 recommended (6 The Subcommittee

Repair. boot and shoe yes votes to 1 no yes votes to 1 no unanimously

manufacture and vote) that Boot vote) that Boot recommended (10

repair industry. and Shoe and Shoe yes votes to 0 no

Manufacture and Manufacture and votes) to defer

Repair in the Repair in the action on this

United States be United States be nomination

included in the included in the because of the

RoC as having RoC as having lack of exposure

been reviewed but been reviewed but assessment

not formally not formally information.

listed, due to listed, due to

inadequate data. inadequate data.

Diesel Exhaust Particulates..... Diesel engine RG1 defeated a RG2 recommended (6 The Subcommittee

exhaust. motion to list as yes votes to 1 no recommended (9

reasonably vote) to list as yes votes to 0 no

anticipated to be reasonably votes with 3

a human anticipated to be abstentions) to

carcinogen (4 yes a human list as

votes to 5 no carcinogen. reasonably

votes). RG1 anticipated to be

recommended (5 a human

yes votes to 4 no carcinogen.

votes) to list as

known to be a

human carcinogen.

[[Page 68784]]

Environmental Tobacco Smoke..... ``Passive'' RG1 recommended (7 RG2 recommended (5 The Subcommittee

inhalation of yes votes to 0 no yes votes to 2 no unanimously

tobacco smoke vote with 1 votes) to list as recommended (13

from abstention) to known to be a yes votes to 0 no

environmental list as known to human carcinogen. votes) listing as

sources. be a human known to be a

carcinogen. human carcinogen.

Ethyl Acrylate/140-88-5......... Monomer used to RG1 recommended (7 RG2 recommended (6 The Subcommittee

produce polymers yes votes to 2 no yes votes to 1 no recommended (8

and copolymers votes) to delist vote) to delist yes votes to 2 no

for use in latex from RoC. from RoC. votes with 2

paints, textiles, abstentions) to

etc. delist from the

RoC.

Ethylene Oxide/75-21-8.......... Industrial RG1 recommended (6 RG2 unanimously The Subcommittee

chemical used as yes votes to 1 no recommended (7 recommended (6

an intermediate vote) to upgrade yeas votes to 0 yes votes to 5 no

in the to a known human no votes) to votes with 1

manufacture of carcinogen. upgrade to a abstention) to

other chemicals; known human upgrade to a

e.g., ethylene carcinogen. known human

glycol and is carcinogen.

widely used in

the health care

industry as a

sterilant.

Isoprene/78-79-5................ The monomeric unit RG1 unanimously RG2 recommended (6 The Subcommittee

of natural rubber recommended (6 yes votes to 0 no unanimously

and naturally yes votes to 0 no votes with 1 recommended (13

occurring votes) to list as abstention) to yes votes to 0 no

terpenes and reasonably list as votes) to list as

steroids and anticipated to be reasonably reasonably

widely used in a human anticipated to be anticipated to be

the production of carcinogen. a human a human

isoprene- carcinogen. carcinogen.

butadiene

copolymers.

Methyl-t-Butyl Ether/1634-04-4.. Used as an RG1 recommended (4 RG2 voted against The Subcommittee

additive in yes votes to 3 no motion to list as voted against

unleaded gasoline votes) to list as reasonably motion to list as

in amounts up to reasonably anticipated to be reasonably

11%. anticipated to be a human anticipated to be

a human carcinogen (3 yes a human

carcinogen. votes to 4 no carcinogen (5 yes

votes). votes to 6 no

votes with 1

abstention).

Nickel Compounds................ Many industrial RG1 unanimously RG2 recommended (4 The Subcommittee

and commercial recommended (7 yes votes to 3 no unanimously

applications. yes votes to 0 no votes with 1 recommended (12

votes) to upgrade abstention to yes votes to 0 no

to a known human upgrade to a votes) to upgrade

carcinogen. known human to a known human

carcinogen. carcinogen.

Silica, Crystalline (Respirable Exposure from RG1 unanimously RG2 recommended (5 The subcommittee

Size)/7631-86-9. mining and recommended (9 yes votes to 2 no recommended (11

quarrying of coal yes votes to 0 no votes) to upgrade yes votes to 1 no

and other votes) to upgrade to a known human vote) to upgrade

minerals, stone to a known human carcinogen. to a known human

cutting, carcinogen. carcinogen.

production of

glass and

ceramics and in

occupations such

as sandblasting,

polishing and

grinding.

2,3,7,8-TETRACHLORODIBENZ O-P- Not used RG1 unanimously RG2 unanimously The Subcommittee

DIOXIN (TCDD)/1746-01-6. commercially, recommended (10 recommended (8 voted against

found as a yes votes to 0 no yes votes to 0 no motion to upgrade

contaminant in votes) to upgrade votes) to upgrade current listing

the production of to a known human to a known human to known human

some pesticides carcinogen. carcinogen. carcinogen. (5

and other yes votes to 7 no

commercial votes with 1

products. abstention).

----------------------------------------------------------------------------------------------------------------

\1\ The NIEHS Review Committee for the Report on Carcinogens (RG1).

\2\ The NTP Executive Committee* Interagency Working Group for the Report on Carcinogens (RG2).

*Agencies represented on the NTP Executive Committee include: Agency for Toxic Substances and Disease Registry

(ATSDR), Consumer Product Safety Commission (CPSC), Environmental Protection Agency (EPA), Food and Drug

Administration (FDA), National Center for Toxicological Research (NCTR), National Institute for Occupational

Safety and Health (NIOSH), Occupational Safety and Health Administration (OSHA), Department of Health and

Human Services (DHHS), National Institutes of Health (NIH), National Cancer Institute (NCI), National Library

of Medicine (NLM), and National Institute of Environmental Health Sciences/NTP (NIEHS/NTP).

\3\ The NTP Board of Scientific Counselor Report on Carcinogens Subcommittee (the External Peer Review Group).

\4\ RoC-Report on Carcinogens.

[[Page 68785]]

[FR Doc. 98-33090 Filed 12-11-98; 8:45 am]

BILLING CODE 4140-01-M