13334 Federal Register / Vol. 66, No. 43 / Monday, March 5, 2001 / Notices

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Public Health Service

National Toxicology Program; Call for

Public Comments on 8 Nominations,

Proposed for Listing in or Delisting

From the Report on Carcinogens,

Tenth Edition

Background

The National Toxicology Program

(NTP) solicits final public comments on

agents, substances, mixtures and

exposure circumstances reviewed in

2000 for listing in or delisting from the

Report on Carcinogens, Tenth Edition.

This Report (previously known as the

Annual Report on Carcinogens) 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 (DHHS).

Section 301(b)(4) of the Public Health

Service Act, as amended, provides that

the Secretary, (DHHS), shall publish a

biennial 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 decreases the risk to

public health from exposure to these

chemicals.

In 2000, eight nominations were

reviewed for listing in the Tenth Report.

This review included two Federal and

one non-government, scientific peer

reviews and public comment and

review. The three scientific review

committees evaluated all available data

relevant to the criteria for inclusion of

candidate nominations in the Report.

The criteria used in the review process

and a detailed description of the review

procedures, including the steps in the

current formal review process, can be

obtained from the NTP Home Page web

site at http://ntp-server.niehs.nih.gov/

or 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)

541–0144, email:

jameson@niehs.nih.gov.

Public Comment Requested

The nominations reviewed in 2000

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. The NTP will be making a

final recommendation in 2001 for these

eight nominations for listing in, or

changing the current listing from

reasonably anticipated to be a human

carcinogen to the known to be a human

carcinogen category in the Tenth Report.

Background documents provided to

the review committees and the public

are available on the web in PDF-format

at the address above. Hard copies of

these documents are also available upon

request. The NTP will review the

recommendations from 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 of the

nominated substances in the Tenth

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 in the

following table. Comments will be

accepted for 60 days from the

publication date of this announcement

and should be directed to Dr. C.W.

Jameson at the address listed above.

Individuals submitting public

comments are asked to include relevant

contact information [name, affiliation (if

any), address, telephone, fax, and email].

Attachment

Dated: February 21, 2001.

Kenneth Olden,

Director, National Toxicology Program.

SUMMARY OF RG1,9 RG2 2 AND NTP BOARD SUBCOMMITTEE 3 RECOMMENDATIONS FOR THE AGENTS, SUBSTANCES, MIXTURES OR EXPOSURE CIRCUMSTANCES REVIEWED IN 2000 FOR LISTING IN, DELISTING FROM, OR UPGRADING IN THE

REPORT ON CARCINOGENS,4 10TH EDITION

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

action

Broad Spectrum UV Radiation (UVR) and UVA,

and UVB, and UVC.

Solar and artificial sources

of ultraviolet radiation.

Motion to list UVR as

known to be a human

carcinogen passed by

unanimous vote (6/0).

Motion list UVR as known

to be a human carcinogen passed by

unanimous vote (8/0).

Motion to list UVR as

known to be a human

carcinogen passed by

unanimous vote (10/0).

Motion to list UVA, UVB

and UVC as reasonably

anticipated to be human

carcinogens passed by

unanimous vote (6/0).

Motion to list UVA, UVB

and UVC as reasonably

anticipated to be human

carcinogens passed by

unanimous vote (8/0).

Motion to list UVA as reasonably anticipated to

be human carcinogen

passed by unanimous

vote (10/0).

Motion to list UVB as reasonably anticipated to

be human carcinogen

passed by vote of 7 yes

to 3 no. Negative votes

(3) cast because members felt data meets criteria to list as known

human carcinogen.

Federal Register / Vol. 66, No. 43 / Monday, March 5, 2001 / Notices 13335

SUMMARY OF RG1,9 RG2 2 AND NTP BOARD SUBCOMMITTEE 3 RECOMMENDATIONS FOR THE AGENTS, SUBSTANCES, MIXTURES OR EXPOSURE CIRCUMSTANCES REVIEWED IN 2000 FOR LISTING IN, DELISTING FROM, OR UPGRADING IN THE

REPORT ON CARCINOGENS,4 10TH EDITION—Continued

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

action

Motion to list UVC as reasonably anticipated to

be human carcinogen

passed by vote of 9 yes

to 1 no. Negative vote

(1) cast because member felt insufficient

human data to list as

reasonably anticipated

carcinogen.

Chloramphenicol (56–75–

7).

Chloramphenicol has been

used an antibiotic since

the 1950s.

Motion to list Chloramphenicol as reasonably anticipated to be

human carcinogen

passed by unanimous

vote (7/0).

Motion to list Chloramphenicol reasonably

anticipated to be human

carcinogen passed by

vote of 7 yes to 0 no

with 1 abstention. Abstention (1) was because member felt data

concerning link between

aplastic anemia and leukemia was not compelling.

Motion to list Chloramphenicol as reasonably anticipated to be

human carcinogen

passed by unanimous

vote (10/0).

Estrogens, Steroidal .......... Estrogens are widely used

in post-menopausal therapy and in oral contraceptives for women.

Motion to list Steroidal Estrogens as known to be

a human carcinogen

passed by unanimous

vote (7/0).

Motion to list Steroidal Estrogens as known to be

a human carcinogen

passed by unanimous

vote (8/0).

Motion to list Steriodal Estrogens as known to be

a human carcinogen

passed by a vote of 8

yes to 1 no. Negative

vote (1) cast because

member felt insufficient

human data to list all

steroidal estrogens in

the Report.

Methyleugenol (93–15–2) .. Methyleugenol are flavoring agents used in

jellies, baked goods,

nonalcoholic beverages,

chewing gum, candy,

and ice cream. Also

used as fragrance for

many perfumes, lotions,

detergents and soaps.

Motion to list

Methyleugenol as reasonably anticipated to

be human carcinogen

passed by unanimous

vote (7/0).

Motion to list

Methyleugenol as reasonably anticipated to

be human carcinogen

passed by unanimous

vote (8/0).

Motion to list

Methyleugenol as reasonably anticipated to

be human carcinogen

passed by a vote of 9

yes to 1 no. Negative

vote (1) cast because

member felt insufficient

human data to list in the

Report.

Nickel (metallic) and Certain Nickel Alloys.Metallic Nickel and Nickel

Alloys have been used

in commercial applications for over 100 years.

Motion to list Metallic Nickel and Certain Nickel alloys as reasonability anticipated to be human

carcinogen passed by a

vote of 6 yes to 2 no.

Negative votes (2) cast

because members did

not agree with the use

of term ‘‘certain’’ in the

listing of Nickel alloys.

Motion to list Metallic Nickel as reasonability anticipated to be human carcinogen passed by a

vote of 7 yes to 1 no.

Negative vote (1) cast

because member felt the

animal data not persuasive to list in the Report

as reasonably anticipated human carcinogens because of inappropriate routes of exposure.

Motion to list Metallic Nickel as reasonability anticipated to be human carcinogen passed by a

vote of 7 yes to 3 no.

Negative votes (3) cast

because members felt

that the human and animal data not persuasive

to list in the Report as

reasonably anticipated

human carcinogens.

13336 Federal Register / Vol. 66, No. 43 / Monday, March 5, 2001 / Notices

SUMMARY OF RG1,9 RG2 2 AND NTP BOARD SUBCOMMITTEE 3 RECOMMENDATIONS FOR THE AGENTS, SUBSTANCES, MIXTURES OR EXPOSURE CIRCUMSTANCES REVIEWED IN 2000 FOR LISTING IN, DELISTING FROM, OR UPGRADING IN THE

REPORT ON CARCINOGENS,4 10TH EDITION—Continued

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

action

Motion not to list Certain

Nickel Alloys in RoC

was passed a vote of 6

yes to 2 no. Negative

votes (2) cast because

members felt data meets

criteria to list as reasonably anticipated to be a

human carcinogen.

Motion to list Certain Nickel Alloys as reasonably

anticipated to be human

carcinogen was defeated by a vote of 3

yes to 7 no. in RoC.

Negative votes (7) cast

because members felt

available data not persuasive to list in the Report as reasonably anticipated human carcinogens.

Motion not to list Certain

Nickel Alloys in RoC

was passed by a vote of

9 yes 1 no. Negative

votes (1) cast because

member felt data meets

criteria to list as reasonably anticipated to be a

human carcinogen.

Talc (14807–96–6)

Abestiform and NonAbestiform.

Both Asbestiform talc (i.e.,

talc containing

asbestiform fibers) and

non-asbestiform talc (i.e.

talc not containing

asbestiform fibers) occur

in various geological settings around the world.

Occupational exposure

to both forms occurs

during mining, milling,

and processing. Exposure to non-asbestiform

talc by the general population occurs through

the use of products such

as cosmetics.

Motion to list Talc containing asbestiform fibers as known to be a

human carcinogen

passed by unanimous

vote (7/0).

Motion to list Talc not containing asbestiform fibers as reasonably anticipated to be a human

carcinogen passed by a

vote of 6 yes to 1 no.

Negative vote (1) cast

because member questioned the biological

plausibility of talc using

causing ovarian neoplasms in women.

Motion to list Talc containing asbestiform fibers as known to be a

human carcinogen was

defeated by a vote of 2

yes to 6 no. Negative

votes (6) cast because

members felt human

data were not sufficient

to list as a known

human carcinogen because asbestiform fibers

were not considered to

include asbestos contamination.

Motion to list Talc containing asbestiform fibers as reasonably anticipated to be a human

carcinogen resulted in a

tie vote (5 yes to 5 no).

Negatives votes (4) cast

because members felt

human and animal data

not sufficient to list in

Report. Other negative

(1) cast because member felt action should be

deferred.

Federal Register / Vol. 66, No. 43 / Monday, March 5, 2001 / Notices 13337

SUMMARY OF RG1,9 RG2 2 AND NTP BOARD SUBCOMMITTEE 3 RECOMMENDATIONS FOR THE AGENTS, SUBSTANCES, MIXTURES OR EXPOSURE CIRCUMSTANCES REVIEWED IN 2000 FOR LISTING IN, DELISTING FROM, OR UPGRADING IN THE

REPORT ON CARCINOGENS,4 10TH EDITION—Continued

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

action

Motion to list Talc containing asbestiform fibers as reasonably anticipated to be a human

carcinogen passed by a

vote of 6 yes to 2 no.

Negative vote (1) cast

because member felt

data sufficient to list as

a known human carcinogen. Other negative

vote (1) cast because

member felt evidence

not adequate to list in

the Report.

Motion to list Talc not containing asbestiform fibers as reasonably anticipated to be human

carcinogen passed by a

vote of 7 yes to 1 no.

Negative vote (1) cast

because member felt

animal data not sufficient and human data

confounded because of

the uncertainty of possible contamination of

talc with asbestos.

Motion not to list talc not

containing asbestiform

fibers as reasonably anticipated to be a human

carcinogen passed by a

vote of 7 yes to 3 no.

Negative votes cast either because the member felt that data meets

criteria to list talc not

containing asbestiform

fibers as reasonability

anticipated to be a

human carcinogen or

that ovarian cancer studies should have been

considered in the evaluation. The Subcommittee did not consider the ovarian cancer

studies in the evaluation

of talc not containing

asbestiform fibers because it was unclear if

the talc used in these

studies might have been

contaminated with asbestos.

Trichloroethylene (TCE)

(79–01–6).

Trichloroethylene is widely

used as a solvent with

80–90% used worldwide

for degreasing metals.

Motion to list TCE as

known to be a human

carcinogen passed by

unanimous vote (7/0).

Motion to list TCE as

known to be a human

carcinogen was defeated by a vote of 3

yes to 4 no. Negative

votes (4) cast because

members felt the human

data did not meet the

criteria for listing as a

known human carcinogen because the exposures in the human

studies may not have

been specific for TCE.

Motion that the listing of

TCE should remain as

reasonably anticipated

to be a human carcinogen passed by a

vote of 9 yes to 1 no.

Negative vote (1) because member felt

human data sufficient to

list as a known human

carcinogen.

Wood Dust ......................... It is estimated that at least

two million people are

routinely exposed occupationally to wood dust

worldwide. Non-occupational exposure also occurs. The highest exposures have generally

been reported in wood

furniture and cabinet

manufacture, especially

during machine sanding

and similar operations..

Motion to list Wood Dust

as known to be a human

carcinogen passed by

unanimous vote (80).

Motion to list Wood as

known to be a human

carcinogen passed by

unanimous vote (70).

Motion to list Wood Dust

as known to be a human

carcinogen passed by

unanimous vote (80).

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

2The NTP Executive Committee (Agencies from the NTP Executive Committee represented on RG2 include: Agency for Toxic Substances and

Disease Registry (ATSDR), Consumer Product Safety Commission (CPSC), Environmental Protection Agency (EPA), National Center for Environmental Health of the Centers for Disease Control and Prevention (NCEH/CDC), National Center for Toxicological Research of the Food and

Drug Administration (NCTR/FDA), National Institute for Occupational Safety and Health/CDC (NIOSH/CDC), Occupational Safety and Health Administration (OSHA), National Cancer Institute of the National Institutes of Health (NCI/NIH), and National Institute of Environmental Health

Sciences/NIH(NIEHS/NIH) Interagency Working Group for the Report on Carcinogens (RG2). 3The NTP Board of Scientific Counselors Report on Carcinogens Subcommittee (the External Peer Review Group).

4 RoC—Report on Carcinogens.

13338 Federal Register / Vol. 66, No. 43 / Monday, March 5, 2001 / Notices

[FR Doc. 01–5175 Filed 3–2–01; 8:45 am]

BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Substance Abuse and Mental Health

Services Administration

Current List of Laboratories Which

Meet Minimum Standards To Engage in

Urine Drug Testing for Federal

Agencies

AGENCY: Substance Abuse and Mental

Health Services Administration, HHS.

ACTION: Notice.

SUMMARY: The Department of Health and

Human Services notifies Federal

agencies of the laboratories currently

certified to meet standards of Subpart C

of Mandatory Guidelines for Federal

Workplace Drug Testing Programs (59

FR 29916, 29925). A similar notice

listing all currently certified laboratories

will be published during the first week

of each month, and updated to include

laboratories which subsequently apply

for and complete the certification

process. If any listed laboratory’s

certification is totally suspended or

revoked, the laboratory will be omitted

from updated lists until such time as it

is restored to full certification under the

Guidelines.

If any laboratory has withdrawn from

the National Laboratory Certification

Program during the past month, it will

be listed at the end, and will be omitted

from the monthly listing thereafter.

This Notice is also available on the

internet at the following website:http://

www.health.org/workplace.

FOR FURTHER INFORMATION CONTACT: Mrs.

Giselle Hersh or Dr. Walter Vogl,

Division of Workplace Programs, 5600

Fishers Lane, Rockwall 2 Building,

Room 815, Rockville, Maryland 20857;

Tel.: (301) 443–6014, Fax: (301) 443–

3031.

Special Note: Please use the above address

for all surface mail and correspondence. For

all overnight mail service use the following

address: Division of Workplace Programs,

5515 Security Lane, Room 815, Rockville,

Maryland 20852.

SUPPLEMENTARY INFORMATION:

Mandatory Guidelines for Federal

Workplace Drug Testing were developed

in accordance with Executive Order

12564 and section 503 of Pub. L. 100–

71. Subpart C of the Guidelines,

‘‘Certification of Laboratories Engaged

in Urine Drug Testing for Federal

Agencies,’’ sets strict standards which

laboratories must meet in order to

conduct urine drug testing for Federal

agencies. To become certified an

applicant laboratory must undergo three

rounds of performance testing plus an

on-site inspection. To maintain that

certification a laboratory must

participate in a quarterly performance

testing program plus periodic, on-site

inspections.

Laboratories which claim to be in the

applicant stage of certification are not to

be considered as meeting the minimum

requirements expressed in the HHS

Guidelines. A laboratory must have its

letter of certification from SAMHSA,

HHS (formerly: HHS/NIDA) which

attests that it has met minimum

standards.

In accordance with Subpart C of the

Guidelines, the following laboratories

meet the minimum standards set forth

in the Guidelines:

ACL Laboratories, 8901 W. Lincoln

Ave., West Allis, WI 53227, 414–328–

7840/800–877–7016(Formerly:

Bayshore Clinical Laboratory)

Advanced Toxicology Network, 3560

Air Center Cove, Suite 101, Memphis,

TN 38118, 901–794–5770/888–290–

1150

Aegis Analytical Laboratories, Inc., 345

Hill Ave., Nashville, TN 37210, 615–

255–2400

Alabama Reference Laboratories, Inc.,

543 South Hull St., Montgomery, AL

36103, 800–541–4931/334–263–5745

Alliance Laboratory Services, 3200

Burnet Ave., Cincinnati, OH 45229,

513–585–9000 (Formerly: Jewish

Hospital of Cincinnati, Inc.)

American Medical Laboratories, Inc.,

14225 Newbrook Dr., Chantilly, VA

20151, 703–802–6900

Associated Pathologists Laboratories,

Inc., 4230 South Burnham Ave., Suite

250, Las Vegas, NV 89119–5412, 702–

733–7866/800–433–2750

Baptist Medical Center—Toxicology

Laboratory, 9601 I–630, Exit 7, Little

Rock, AR 72205–7299, 501–202–2783

(Formerly: Forensic Toxicology

Laboratory Baptist Medical Center)

Clinical Laboratory Partners, LLC, 129

East Cedar St., Newington, CT 06111,

860–696–8115 (Formerly: Hartford

Hospital Toxicology Laboratory)

Clinical Reference Lab, 8433 Quivira

Rd., Lenexa, KS 66215–2802, 800–

445–6917

Cox Health Systems, Department of

Toxicology, 1423 North Jefferson

Ave., Springfield, MO 65802, 800–

876–3652/417–269–3093 (Formerly:

Cox Medical Centers)

Dept. of the Navy, Navy Drug Screening

Laboratory, Great Lakes, IL, Building

38–H, P.O. Box 88–6819, Great Lakes,

IL 60088–6819, 847–688–2045/847–

688–4171

Diagnostic Services Inc., dba DSI, 12700

Westlinks Drive, Fort Myers, FL

33913, 941–561–8200/800–735–5416

Doctors Laboratory, Inc., P.O. Box 2658,

2906 Julia Dr., Valdosta, GA 31602,

912–244–4468

DrugProof, Division of Dynacare/

Laboratory of Pathology, LLC, 1229

Madison St., Suite 500, Nordstrom

Medical Tower, Seattle, WA 98104,

206–386–2672/800–898–0180

(Formerly: Laboratory of Pathology of

Seattle, Inc., DrugProof, Division of

Laboratory of Pathology of Seattle,

Inc.)

DrugScan, Inc., P.O. Box 2969, 1119

Mearns Rd., Warminster, PA 18974,

215–674–9310

Dynacare Kasper Medical Laboratories,*

14940–123 Ave., Edmonton, Alberta,

Canada T5V 1B4, 780–451–3702/800–

661–9876

ElSohly Laboratories, Inc., 5 Industrial

Park Dr., Oxford, MS 38655, 662–236–

2609

Express Analytical Labs, 1301 18th Ave

NW, Suite 110, Austin, MN 55912,

507–437–7322

Gamma-Dynacare Medical

Laboratories,* A Division of the

Gamma-Dynacare Laboratory

Partnership, 245 Pall Mall St.,

London, ONT, Canada N6A 1P4, 519–

679–1630

General Medical Laboratories, 36 South

Brooks St., Madison, WI 53715, 608–

267–6267

Integrated Regional Laboratories, 5361

NW 33rd Avenue, Fort Lauderdale, FL

33309, 954–777–0018, 800–522–0232,

(Formerly: Cedars Medical Center,

Department of Pathology)

Kroll Laboratory Specialists, Inc., 1111

Newton St., Gretna, LA 70053, 504–

361–8989/800–433–3823, (Formerly:

Laboratory Specialists, Inc.)

LabOne, Inc., 10101 Renner Blvd.,

Lenexa, KS 66219, 913–888–3927/

800–728–4064, (Formerly: Center for

Laboratory Services, a Division of

LabOne, Inc.)

Laboratory Corporation of America

Holdings, 7207 N. Gessner Road,

Houston, TX 77040, 713–856–8288/

800–800–2387

Laboratory Corporation of America

Holdings, 1904 Alexander Drive,

Research Triangle Park, NC 27709,

919–572–6900/800–833–3984,

(Formerly: LabCorp Occupational

Testing Services, Inc., CompuChem

Laboratories, Inc.; CompuChem

Laboratories, Inc., A Subsidiary of

Roche Biomedical Laboratory; Roche

CompuChem Laboratories, Inc., A

Member of the Roche Group)

Laboratory Corporation of America

Holdings, 4022 Willow Lake Blvd.,

Memphis, TN 38118, 866–827–8042/