Federal Register / Vol. 65, No. 81 / Wednesday, April 26, 2000 / Notices 24495

Dated: April 20, 2000.

LaVerne Y. Stringfield,

Director, Office of Federal Advisory

Committee Policy.

[FR Doc. 00–10411 Filed 4–25–00; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Public Health Service

National Toxicology Program; Meeting

of the NTP Board of Scientific

Counselors

Pursuant to Public Law 92–463,

notice is hereby given of a meeting of

the National Toxicology Program (NTP)

Board of Scientific Counselors, U.S.

Public Health Service, in the Rodbell

Auditorium, Building 101, South

Campus, National Institute of

Environmental Health Sciences

(NIEHS), 111 T.W. Alexander Drive,

Research Triangle Park, North Carolina,

on May 24, 2000.

The NTP Board of Scientific

Counselors is composed of scientists

from the public and private sector. The

Board provides primary scientific

oversight to the NTP.

Agenda

The meeting is open to the public

from 8:30 a.m. to adjournment with

attendance limited only by space

available. A draft agenda with a

tentative schedule is provided below.

There are three primary agenda topics:

(1) An update on the NTP Center for the

Evaluation of Risks to Human

Reproduction (CERHR) including a

discussion of its progress, the phthalates

review, and its procedures for

nomination, selection and review of

chemicals; (2) presentations about

current initiatives for NTP toxicology

studies; and (3) recommendations of

substances by the Interagency

Committee for future NTP studies. Also

in the afternoon, there will be reports on

activities of the Report on Carcinogens

and Technical Reports Review

Subcommittees. The Board will review

a concept proposal for the continued

use of a contract mechanism to perform

NTP toxicology and carcinogenesis

studies.

Information about the CERHR

including the chemicals currently under

consideration for Expert Panel

evaluation and the evaluation process

are described in a Federal Register

notice [March 20, 2000, Volume 65,

Number 54, pages 14997–14998]. The

opportunity for submission of written

public comments on those candidate

chemicals is provided through May 4,

2000. A copy of this notice is available

on-line at the NTP web site (http://ntpserver.niehs.nih.gov) and CERHR web

site (http://cerhr.niehs.nih.gov) or by

contacting the Executive Secretary

(address given below). The chemicals

under consideration include: 1-

Bromopropane, 2-Bromopropane,

Dimethyl Methyl Phosphonate, Ethylene

glycol, Glycol ethers, Glyphosate,

Methanol, Nicotine, Phenol,

Thimerosal, and Toluene. This meeting

provides an additional opportunity for

the public to present any comments to

the NTP Board of Scientific Counselors

and NTP staff. However, if written

comments were submitted in response

to the March 20th Federal Register

announcement they are being

considered and do not need to be

resubmitted or readdressed.

The NTP has a broad mandate to

provide toxicological characterization

for chemicals and agents of public

health concern and strives to balance

the selection of agents for study. Current

NTP initiatives include water

disinfection by-products, DNA-based

products, herbal/dietary supplements,

phototoxicology studies and

occupational exposures and mixtures.

Information about substances

nominated to the NTP for toxicology

studies and recommendations for testing

by the NTP Interagency Committee for

Chemical Evaluation and Coordination

(ICCEC) are provided in the Federal

Register notice dated March 2, 2000

(Volume 65, Number 42, Pages 11329–

11331). The opportunity for submission

of written public comments on those

candidate chemicals is provided

through April 30, 2000. Substances

currently under consideration include:

Substances recommended for testing: 1-

Bromopropane and 2-Bromopropane,

Chitosan, DNA-based products, Juglone,

Potassium ferricyanide, and Radio

frequency radiation emissions of

wireless communication devices;

Substances for which no testing is

recommended at this time: Cafestol and

Plumbagin; Substances for which a

testing recommendation is deferred

pending receipt and consideration of

additional information:

Ethylenebis(tetrabromo-phthalimide),

Terpinolene, Tetrabromophthalic

anhydride, and Texanol benzyl

phthalate. Testing recommendations

from the ICCEC are given in the

referenced Federal Register notice. This

meeting provides an additional

opportunity for the public to comment

to the NTP Board and staff. However, if

written comments were submitted in

response to the March 2nd Federal

Register announcement, they are under

consideration and do not need to be

resubmitted or readdressed.

Public Comment Encouraged

Public input at the meeting is

welcome and time is set aside in the

agenda for presentation of public

comments on any agenda topic. Seven

minutes are allotted for each formal oral

presentation. To facilitate planning for

the meeting, persons interested in

providing formal written or oral

comments are asked to notify the

Executive Secretary, Dr. Mary S. Wolfe,

NIEHS, P.O. Box 12233 MD A3–07,

Research Triangle Park, NC 27709

(telephone 919/541–3971, fax 919/541–

0295, and email wolfe@niehs.nih.gov).

Written comments submitted for

consideration by the Board and NTP

staff prior to the meeting must be

received by May 15, 2000. Persons

wishing to register to make a formal

presentation during a public comment

period are asked to notify the Executive

Secretary preferably no later than May

22, 2000, and, if possible, to provide a

copy of the statement in advance of the

meeting for distribution to the Board

and NTP staff. Individuals will also be

able to register to give oral public

comments on-site at the meeting.

However, if registering on-site and

reading from written text, please bring

25 copies of the statement to the

meeting for distribution to the Board

and NTP staff and to supplement the

record. Persons registering to make oral

comments or submitting written

comments are asked to provide their

name, affiliation, mailing address,

phone, fax, e-mail, and sponsoring

organization (if any).

Additional Information About Meeting

Prior to the meeting, a copy of the

agenda and a roster of the Board

members will be available from the

Executive Secretary. Following the

meeting, summary minutes will be

prepared and available upon request to

Central Data Management, NIEHS, P.O.

Box 12233 MD E1–02, Research Triangle

Park, NC 27709; telephone 919/541–

3419; fax 919/541–3687; and email

CDM@niehs.nih.gov.

24496 Federal Register / Vol. 65, No. 81 / Wednesday, April 26, 2000 / Notices

Dated: April 19, 2000.

Samuel H. Wilson,

Deputy Director, National Institute for

Environmental Health Sciences.

Draft Agenda; National Toxicology

Program (NTP) Board of Scientific

Counselors

May 24, 2000

Rodbell Auditorium, Building 101,

South Campus, National Institute of

Environmental Health Sciences

(NIEHS), Research Triangle Park, North

Carolina

8:30 a.m.—Welcome

8:50 a.m.—NTP Update

9:00 a.m.—NTP Center for the

Evaluation of Risks to Human

Reproduction (CERHR)

• Role of CERHR in meeting the goals

of the NTP

• Response to last years Board

Review of CERHR

9:30 a.m.—CERHR Processes and

Criteria

• Nomination and selection of agents

for review

• Evaluation of selected agents

• Communication with public

10:00 a.m.—Break

10:15 a.m.—Public Comments

10:30 a.m.—Board Discussion

11:00 a.m.—Perspectives on the Process

(e.g. Phthalates Review)

• Expert Panel

• Regulatory Agencies

• NTP Board of Scientific Counselors

• Public Comments

Noon—Lunch

1:00 p.m.—Current Trends in NTP

Toxicology Testing

• Water disinfection by-products

• DNA-based products

• Herbals/dietary supplements

2:15 p.m.—Break

2:30 p.m.—Current Trends in NTP

Toxicology Testing (continued)

• Phototoxicology studies and the

NTP Center

• Occupational chemicals and

mixtures

3:20 p.m.—Concept Review

• Board Discussion and ACTION

3:50 p.m.—Testing Recommendations

from the Interagency Committee for

Chemical Evaluation and

Coordination

• Public Comments

• Board Discussion

4:35 p.m.—NTP Board Subcommittee

Reviews—Updates

• Report on Carcinogens

• Technical Reports

• Board Discussion

5:20 p.m.—Adjourn

Substances Nominated to the NTP for

Study and Testing Recommendations

Made by the ICCEC on December 13,

1999

TABLE 1.—SUBSTANCES RECOMMENDED FOR TESTING

Substance [CAS No.] Nominated by ICCEC recommendations Study rationale; other information

1-Bromopropane [106–94–5] and 2-

Bromopropane [75–26–3].

OSHA

NIOSH

1-Bromopropane .........................

—Carcinogenicity ........................

—Reproductive and developmental toxicity.

—Toxicokinetics ..........................

—Mechanistic studies .................

—Neurotoxicity ...........................

—Genotoxicity ............................

—Exposure studies in workers ...

Reported increasing production and use in

many industrial applications as an alternative to ozone depleting substances;

available data from limited repeat dose

studies indicate toxicity to multiple organ

systems.

2-Bromopropane is a contaminant in reagent grade.

1-Bromopropane with known reproductive

toxicity.

2–Bromopropane ........................

—Subchronic toxicity.

Chitosan [9012–76–4] .................................... NCI —Mechanistic studies to evaluate vitamin E and mineral depletion.Significant human exposure through use as

a dietary supplement and other commercial applications; potential for toxicity from

interference with dietary fat absorption.

DNA-based products ...................................... FDA —Establish joint NIEHS/FDA

program to evaluate long-term

toxicity in anticipation of regulatory needs.

Rapidly growing market for DNA-based

therapeutic agents and a lack of adequate mechanisms and methodologies for

evaluating safety.

Juglone [481–39–0] ........................................ NCI —Mechanistic studies .................

—Metabolism studies .................

—Mouse lymphoma assay .........

—Mammalian mutagenicity ........

—Carcinogenicity testing pending results of preliminary studies.

Potential human exposure resulting from

use of walnut-based products as dietary

supplements and natural dyes and stains;

suspicion of carcinogenicity based on quinone structure.

Potassium ferricyanide [13746–66–2] ............ NCI —Genotoxicity ............................

—Subchronic toxicity ..................

Potential consumer and worker exposure

resulting from use in photographic processing; suspicion of toxicity based on potential for redox cycling; inadequate toxicity information available.

Radio frequency radiation emissions of wireless communication devices.FDA —Establish interagency program

to design studies assessing

cancer and non-cancer health

effects to fulfill regulatory

needs.

Widespread consumer and worker exposure; available data is inadequate to

properly assess safety.

Federal Register / Vol. 65, No. 81 / Wednesday, April 26, 2000 / Notices 24497

TABLE 2.—SUBSTANCES FOR WHICH NO TESTING IS RECOMMENDED AT THIS TIME

Substance [CAS No.] Nominated by Nominated for Rationale for not testing

Cafestol [469–83–0] and Kahweol [6894–43–

5].

Private individual.—Toxicity and carcinogenicity

testing.

Anti-carcinogenic effects demonstrated in

animal studies; limited data indicate low

potential for toxicity; other natural products with higher potential for toxicity and

human exposure exist; ongoing research

efforts as opposed to new testing may

provide basis for determining relevance

of metabolic modulatory effects to chronic

toxicity.

Plumbagin [481–42–5] ................................... NCI ................. —Mechanistic studies .................

—Metabolism studies .................

—Mouse lymphoma assay .........

—Mammalian mutagenicity ........

—Carcinogenicity ........................

Structurally similar to Juglone which is selected for study; low magnitude and/or

prevalence of human exposure; adequate

evidence of acute and reproductive toxicity.

TABLE 3.—SUBSTANCES FOR WHICH A TESTING RECOMMENDATION IS DEFERRED PENDING RECEIPT AND CONSIDERATION

OF ADDITIONAL INFORMATION

Substance [CAS No.] Nominated by Nominated for Additional information needed

Ethylenebis(tetrabromo-phthalimide) [32588–

76–4].

NIEHS —Toxicity and carcinogenicity

testing.

Ongoing and planned industry testing efforts; better characterization of uses and

potential human exposures.

Terpinolene [586–62–9] ................................. NIEHS —Toxicity and carcinogenicity

testing.

Ongoing and planned industry testing efforts; better characterization of uses and

potential human exposures; study results

for structurally related compounds.

Tetrabromophthalic anhydride [632–79–1] .... NIEHS —Toxicity and carcinogenicity

testing.

Ongoing and planned industry testing efforts; better characterization of uses and

potential human exposures.

Texanol benzyl phthalate [16883–83–3] or

[32333–99–6].

NIEHS —Toxicity and carcinogenicity

testing.

Ongoing and planned industry testing efforts; better characterization of uses and

potential human exposures.

[FR Doc. 00–10414 Filed 4–25–00; 8:45 am]

BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Substance Abuse and Mental Health

Services Administration

Notice of Meetings

Pursuant to Public Law 92–463,

notice is hereby given of a joint meeting

of the Substance Abuse and Mental

Health Services Administration

(SAMHSA) five advisory committees

(SAMHSA National Advisory Council,

Center for Mental Health Services

National Advisory Council, Center for

Substance Abuse Prevention National

Advisory Council, Center for Substance

Abuse Treatment National Advisory

Council, and the Advisory Committee

for Women’s Services) in May 2000.

The organizing theme of the Year

2000 Joint Council Meeting is ‘‘Spirit of

Collaboration from Prevention through

Treatment.’’ The session on May 10 will

be open and will include presentations

by several representatives from the

Department of Health and Human

Services Programs. On May 11, there

will be presentations by the U.S.

Department of Education and the

Department of Justice, a presentation on

the effects of the Olmstead Decision and

its relationship to the Institute for

Mental Disease exclusion, a

presentation on economic analysis and

depression and an update on the

National Congress for Hispanic Mental

Health.

Attendance by the public will be

limited to space available. Public

comments are welcome, and interested

persons may present information or

views, orally or in writing, on issues

pending before the committees. Those

desiring to make formal presentations

should contact Toian Vaughn, Executive

Secretary, Office of Extramural

Programs, SAMHSA, 5600 Fishers Lane,

Room 12C–06, Rockville, Maryland

20857, prior to April 28, 2000, and

submit a brief statement of: the general

nature of the information or arguments

they wish to present, the names,

addresses, and telephone number of

proposed participants, identification of

organizational affiliation, and an

indication of the approximate time

required to make their comments. Time

for presentations may be limited by the

number of requests. Photocopies, up to

five pages of material, may be

distributed at the meeting through the

SAMHSA National Advisory Council

Executive Secretary, if provided by

April 28.

A summary of the meeting and/or a

roster of committee members may be

obtained from Toian Vaughn, Executive

Secretary, SAMHSA National Advisory

Council, 5600 Fishers Lane, Room 17–

89, Rockville, Maryland 20857.

Telephone (301) 443–4266, e-mail:

tvaughn@samhsa.gov.

Substantive program information and

information pertaining to special

accommodations for persons with

disabilities may be obtained from the

contact whose name and telephone

number are listed below.

Committee Names: Substance Abuse and

Mental Health Services Administration

National Advisory Council, Center for Mental

Health Services National Advisory Council,

Center for Substance Abuse Prevention

National Advisory Council, Center for

Substance Abuse Treatment National