23022 Federal Register / Vol. 66, No. 88 / Monday, May 7, 2001 / Notices

Point-to-Point Service Agreement

between ATCLLC and Aquila Energy

Marketing Corporation. ATCLLC

requests an effective date of March 26,

2001.

Comment date: May 16, 2001, in

accordance with Standard Paragraph E

at the end of this notice.

Standard Paragraph

E. Any person desiring to be heard or

to protest such filing should file a

motion to intervene or protest with the

Federal Energy Regulatory Commission,

888 First Street, N.E., Washington, D.C.

20426, in accordance with Rules 211

and 214 of the Commission’s Rules of

Practice and Procedure (18 CFR 385.211

and 385.214). All such motions or

protests should be filed on or before the

comment date. Protests will be

considered by the Commission in

determining the appropriate action to be

taken, but will not serve to make

protestants parties to the proceeding.

Any person wishing to become a party

must file a motion to intervene. Copies

of these filings are on file with the

Commission and are available for public

inspection. This filing may also be

viewed on the Internet at http://

www.ferc.fed.us/online/rims.htm (call

202–208–2222 for assistance).

Comments, protests, and interventions

may be filed electronically via the

internet in lieu of paper. See, 18 CFR

385.2001(a)(1)(iii) and the instructions

on the Commission’s web site at http:/

/www.ferc.fed.us/efi/doorbell.htm.

David P. Boergers,

Secretary.

[FR Doc. 01–11340 Filed 5–4–01; 8:45 am]

BILLING CODE 6717–01–P

ENVIRONMENTAL PROTECTION

AGENCY

[OPPTS–42212C; FRL–6778–2]

Endocrine Disruptor Screening

Program; Establishment of an

Endocrine Disruptor Methods

Validation Subcommittee under the

National Advisory Council for

Environmental Policy and Technology;

Request for Nominations for

Membership

AGENCY: Environmental Protection

Agency (EPA).

ACTIONS: Notice; request for

nominations for membership.

SUMMARY: As mandated by the Federal

Food, Drug, and Cosmetic Act, as

amended by the Food Quality Protection

Act of 1996, EPA is implementing an

Endocrine Disruptor Screening Program

(EDSP). This notice proposes the

establishment of an Endocrine Disruptor

Methods Validation Subcommittee

(EDMVS) as a Subcommittee under the

National Advisory Council for

Environmental Policy and Technology

(NACEPT), and requests nominations

for members of the EDMVS from

interested organizations. NACEPT is a

chartered federal advisory committee

subject to the provisions of the Federal

Advisory Committee Act. Through

NACEPT, the EDMVS will provide

technical advice an recommendations to

EPA regarding validation of the Tier 1

Screening and Tier 2 Testing methods

for its Endocrine Disruptor Screening

Program (EDSP). Background

information regarding the Agency’s

Endocrine Disruptor Screening Program

(EDSP) and the mission of the EDMVS

are discussed in Unit IV. of

SUPPLEMENTARY INFORMATION. This

information is being provided to allow

interested organizations to review the

scope of proposed activities to nominate

qualified individuals for membership on

the EDMVS.

DATES: Nominations must be received

on or before June 6, 2001.

ADDRESSES: Nominations for

membership may be submitted by mail,

electronically, or in person. Please

follow the detailed instructions for each

method as provided in Unit III. of the

SUPPLEMENTARY INFORMATION. To ensure

proper receipt by EPA, your request

must identify docket control number

OPPTS–42212C in the subject line on

the first page of your response.

FOR FURTHER INFORMATION CONTACT: For

general information contact: TSCA

Hotline, Environmental Assistance

Division (7408), Office of Pollution

Prevention and Toxics, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. Telephone:

202–554–1404; TDD: 202–554–0551; email: TSCA-Hotline@epa.gov.

For technical information contact:

Anthony Maciorowski, Senior Technical

Advisor, Office of Prevention, Pesticides

and Toxic Substances; telephone: 202–

260–3048; e-mail address:

maciorowski.anthony@epa.gov or

Gary Timm, Senior Technical

Advisor, Office of Prevention, Pesticides

and Toxic Substances; telephone: 202–

260–1859; e-mail address:

timm.gary@epa.gov.

SUPPLEMENTARY INFORMATION:

I. Does This Notice Apply to Me?

This action is directed to the public

in general. You may be interested in

nominating members to the

subcommittee set forth in this notice if

you produce, manufacture, use,

consume, work with, or import

pesticide chemicals, substances that

may have an effect cumulative to an

effect of a pesticide, or substances found

in sources of drinking water. To

determine whether you or your business

may have an interest in this notice you

should carefully examine section 408(p)

of the Federal Food, Drug, and Cosmetic

Act (FFDCA), as amended by the Food

Quality Protection Act (FQPA) of 1996

(Public Law 104–170), 21 U.S.C. 346a(p)

and amendments to the Safe Drinking

Water Act (SDWA) (Public Law 104–

182), 42 U.S.C. 300j–17. Since other

entities may also be interested, the

Agency has not attempted to describe all

the specific entities that may be affected

by this action. If you have any questions

regarding the applicability of this action

to a particular entity, consult the

technical persons listed under FOR

FURTHER INFORMATION CONTACT.

II. How Can I Get Additional

Information, Including Copies of This

Document or Other Related Documents?

1. Electronically. You may obtain

electronic copies of this document, and

certain other related documents that

might be available electronically, from

the EPA Internet Home Page at http://

www.epa.gov/scipoly. To access this

document, on the Home Page select

‘‘Endocrine Disruptors’’ which will take

you to the OSCP Endocrine Disruptor

Screening Program web site.

2. In person. The Agency has

established an administrative record for

the EDMVS under docket control

number OPPTS–42212C. The

administrative record consists of the

documents specifically referenced in

this notice, any public comments

received during an applicable comment

period, and other information related to

the Endocrine Disruptor Methods

Validation Subcommittee

Organizational Meeting. This

administrative record includes the

documents that are physically located in

the docket, as well as the documents

that are referenced in those documents.

The public version of the administrative

record, which includes printed, paper

versions of any electronic comments

that may be submitted during an

applicable comment period, is available

for inspection in the TSCA

Nonconfidential Information Center,

North East Mall Rm. B–607, Waterside

Mall, 401 M St., SW., Washington, DC.

The Center is open from noon to 4 p.m.,

Monday through Friday, excluding legal

holidays. The telephone number of the

Center is (202) 260–7099.

Federal Register / Vol. 66, No. 88 / Monday, May 7, 2001 / Notices 23023

III. How Can I Nominate Potential

Members to the Endocrine Disruptor

Methods Validation Subcommittee?

You may nominate technically

qualified persons for membership to the

Endocrine Disruptor Methods

Validation Subcommittee through the

mail, in person, or electronically.

Nominations for membership should be

submitted by the nominating

organization, and must include a

curriculum vitae of the nominee

detailing his or her specific area of

relevant scientific expertise. Members of

the EDMVS will be selected on the basis

of their relevant scientific expertise and

diversity of perspectives on mammalian,

ecological, and in vitro endocrine

disruptor screening and testing methods

and procedures, toxicity test methods

standardization and validation, and

chemical and pesticide regulatory

processes. Members will be appointed

for 2 years. Subcommittee members

shall be appointed with balanced

representation from among the

following sectors: the agrichemical and

commodity chemical industries;

environmental/public interest

organizations; public health

organizations; animal welfare

organizations; Federal agencies; State,

local and tribal governments; academia;

consumers, and the public. Your

nomination must be received by EPA on

or before June 6, 2001. To ensure proper

receipt by EPA, it is imperative that you

identify docket control number OPPTS–

42212C in the subject line on the first

page of your request.

1. By mail. You may submit a written

nomination to: Document Control Office

(7407), Office of Pollution Prevention

and Toxics (OPPT), Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460.

2. In person or by courier. You may

deliver a written nomination to: OPPT

Document Control Office (DCO) in the

East Tower Rm. G-099, Waterside Mall,

401 M St., SW., Washington, DC. The

DCO is open from 8 a.m. to 4 p.m.,

Monday through Friday, excluding legal

holidays. The telephone number for the

DCO is (202) 260–7093.

3. Electronically. You may submit

your nomination electronically by email to: oppt.ncic@epa.gov. Use

Wordperfect 6.1/8.0 or ASCII file format

and avoid the use of special characters

and any form of encryption. All

comments in electronic form must be

identified by docket control number

OPPTS–42212C.

IV. Background

A. Authorities

Two laws enacted in 1996 authorize

the Agency to screen pesticides and

other chemicals found in food or in

drinking water sources to determine

whether they may cause estrogenic or

other endocrine effects in humans. The

impetus for development of EPA’s

Endocrine Disruptor Screening Program

was an amendment to FFDCA,

contained in the FQPA of 1996 (Public

Law 104–170). The FFDCA (21 U.S.C.

346a(p) as amended requires EPA to:

develop a screening program, using

appropriate validated test systems and other

scientifically relevant information, to

determine whether certain substances may

have an effect in humans that is similar to an

effect produced by a naturally occurring

estrogen, or such other endocrine effect as

the Administrator may designate.

21 U.S.C. 346a(p)(3), also states that in

carrying out its screening program, EPA

(A) shall provide for the testing of all

pesticide chemicals and (B) may provide for

the testing of any other substance that may

have an effect that is cumulative to an effect

of a pesticide chemical if the Administrator

determines that a substantial population may

be exposed to such a substance.

Additionally, Congress amended the

SDWA (42 U.S.C. 300j–17) authorizing

EPA to provide for the testing under the

screening program authorized in the

FFDCA

. . .of any other substance that may be

found in sources of drinking water if the

Administrator determines that a substantial

population may be exposed to such

substance. (42 U.S.C. 300j–17).

Through the amended FFDCA, Congress

directed EPA to develop an endocrine

disruptor screening program using

appropriate validated test systems and

other scientifically relevant information

by August 3, 1998, implement the

program by August 3, 1999, and report

progress to Congress by August 3, 2000.

EPA may rely upon FIFRA and TCSA

testing authority. Under FIFRA section

3(c)(2)(B), if EPA determines that

additional data are required to maintain

in effect an existing pesticide

registration, it can require pesticide

registrants to provide EPA with

additional data in support of the

registrant. Likewise, TSCA section 4

provides EPA authority to require

testing of certain industrial chemicals.

B. Development of EPA’s Endocrine

Disruptor Screening Program

Prior to the passage of the FQPA and

SDWA, the Agency initiated several

endocrine disruptors investigations

including: the development of a special

report and effects assessment (Ref. 6); a

series of endocrine disruptor methods

workshops funded by the World

Wildlife Fund, Chemical Manufacturer’s

Association, and the Agency (Refs. 1, 3,

and 7); and co-sponsorship (with the

National Institute of Environmental

Health Sciences and Department of the

Interior) of an independent critical

analysis of the literature on hormonally

active agents in the environment by the

National Academy of Sciences (Ref. 5).

The foregoing activities coincided with

the establishment and deliberationsof

the Endocrine Disruptor Screening and

Testing Advisory Committee (Ref. 2).

The complexity of the scientific and

regulatory issues surrounding the

endocrine disruptor issue led EPA to

seek broad expert advice and counsel

beyond the Agency. EPA held a public

meeting in May of 1996 requesting

advice on how to develop a

scientifically defensible, pragmatic

approach to endocrine disruptor

screening and testing. The stakeholder

feedback indicated that a broad based

multi-sector stakeholder committee

should be established under the Federal

Advisory Committee Act. Following a

second public meeting and analysis of

stakeholder interests (Keystone Center

Convening Report, see www.epa.gov/

scipoly/oscpendo), the Agency

chartered the Endocrine Disruptor

Screening and Testing Advisory

Committee (EDSTAC).

EDSTAC was charged with providing

advice and recommendations to the

Agency regarding a strategy for testing

chemical substances to determine

whether they may have an effect in

humans similar to an effect produced by

naturally occurring hormones. EDSTAC

consisted of 39 representatives from

industry, environmental and public

health advocacy groups, state

government, other Federal agencies, and

academic scientists. Over a 2–year

period, EDSTAC held eight meetings. To

facilitate regional public comment on

the process, the meetings were held in

different parts of the country (Chicago,

San Francisco, New York, Houston,

Orlando, Baltimore and Washington)

and provided opportunities for public

comment. In its final report, EDSTAC

(Ref. 2, available at www.epa.gov/

scipoly/oscpendo) provided 71

consensus recommendations regarding

an endocrine disruptor screening

program. Considering the EDSTAC’s

diverse membership, EPA found its

consensus recommendations compelling

and scientifically rigorous. Therefore,

EPA closely followed EDSTAC’s advice

and recommendations in developing its

Endocrine Disruptor Screening Program

(EDSP).

23024 Federal Register / Vol. 66, No. 88 / Monday, May 7, 2001 / Notices

EPA’s EDSP is outlined in the August

11, 1998 Federal Register (63 FR 42852)

(FRL–6021–3), and further developed as

a proposed statement of policy in the

December 28, 1998 Federal Register (63

FR 71542) (FRL–6052–9), available at

www.epa.gov/fedrgstr/EPA-TOX/1998/

December/Day-28/t34298.htm). The

EDSP proposed statement of policy,

including public comments, was

subsequently reviewed by a joint panel

of the FIFRA Scientific Advisory Panel

(SAP) and the EPA Science Advisory

Board (SAB) in May 1999. Like Gray et

al. (Ref. 3), EDSTAC (Ref. 2) and the

NRC (Ref. 5), the SAP/SAB (Ref. 8) final

report concluded that a tiered approach

relying on a combination of in vivo and

in vitro screens for Tier 1 and a set of

in vivo Tier 2 tests was scientifically

reasonable. This conclusion was based

upon each group’s assessment of the

current state-of-the-science on the

evaluation of agents impacting the

endocrine system. Another consistent

conclusion was the need to validate the

individual screens and tests in EDSP.

The validation and peer review are

science-based process steps, which are

prerequisite to the final development

and approval of test guidelines for

regulatory use (Ref. 4).

EPA also received public comments

on the proposed statement of policy

which were considered by the SAP/SAB

joint panel review. The Agency will

respond to these public comments in a

future Federal Register notice and final

statement of policy prior to requiring

regulatory testing.

C. Implementation of EPA’s Endocrine

Disruptor Screening Program

EPA’s ongoing implementation of

Endocrine Disruptor Screening Program

(EDSP) is science-driven, and based on

the recommendations and comments of

EDSTAC (Ref. 2), the FIFRA SAP/SAB

Joint Panel (Ref. 8), and the NAS (Ref.

5). In keeping with its FFDCA-mandated

deadline, the Agency forwarded a

Report to Congress in August 2000,

providing the Agency’s progress on

implementation of the EDSP. The above

referenced Federal Register Notices,

SAB/SAP report, Endocrine Disruptor

Screening Program Report to Congress,

and other EPA EDSP-related

information are available at

www.epa.gov/scipoly/oscpendo. The

Agency’s Implementation is currently

proceeding on two fronts. EPA is

completing development of the

Endocrine Disruptor Priority Setting

Database and the compartment-based

approach that the Agency will use to

establish priorities for screening

chemicals at a later stage of

implementation. EPA has also initiated

prevalidation and validation studies on

some of the of Tier 1 and Tier 2 assays

that are likely to be part of the EDSP.

The Endocrine Disruptor Methods

Validation Subcommittee will provide

advice and comment on both the

ongoing and new studies necessary to

validate the EDSP assays.

1. Priority setting. Priority setting

processes will not be included in the

mission statement to the EDMVS, but

EPA’s ongoing activities are briefly

summarized here for background

information purposes. As many as

87,000 chemicals may be sorted into

categories for priority setting. However,

EPA anticipates that tens of thousands

of chemicals will be exempted from

screening. Priority setting tools and

processes are being developed by EPA,

its contractors and cooperators. Until

the Agency completely finalizes its

priority setting tools and process,

accurate estimates of how many

chemicals may actually be candidates

for screening remain premature. Yet,

EPA expects that 10% or less of the

universe of chemicals will undergo

actual screening.

Public review and comment during

development of the EDSP priority

setting process has been provided

through two public workshops held in

January 1999 and June 2000 (Federal

Register notices and workshop reports

are available at www.epa.gov/scipoly/

oscpendo). The priority setting

approach is based on development and

application of a relational database

titledThe Endocrine Disruptor Priority

Setting Database (EDPSD). The EDPSD

consolidates existing information and

data on exposure and effects to rank

chemicals. The chemicals are ranked

within compartments. A number of

compartments may be configured on the

basis of exposure and effects

characteristics, separately or in

combination. The current version of the

EDPSD may be examined at http://

www.ergweb.com/endocrine.

Recognizing that little relevant effects

information for endocrine disruption

exists for the vast majority of chemicals,

the Agency is considering approaches

for providing additional information to

assist priority setting. Initially, high

throughput pre-screening (HTPS)

technology was viewed as an approach

to provide information on the ability of

a chemical to bind with hormone

receptors, thereby improving the

assignment of a high screening priority

for endocrine active chemicals. An

HTPS feasibility study was completed

by the Agency in 1999. Following

external scientific peer review by the

FIFRA SAP/EPA SAB Joint Panel (Ref.

8), the HTPS reporter gene methods

used in the feasibility study were

deemed unreliable for routine regulatory

use. Presently, EPA is not conducting

any Agency-sponsored studies on HTPS.

The Agency is continuing discussions

with the Japanese Government on the

development of a different reporter gene

based HTPS system. However, the

Japanese studies remain ongoing, and

must await completion and scientific

evaluation before being further

considered.

EPA has also engaged in the

development of QSAR models to predict

endocrine receptor binding activity from

the molecular structure of chemicals.

The Agency is presently working with

the Food and Drug Administration to

refine and validate two-dimensional

pharmacophore screening models and

three-dimensional CoMFA (comparative

molecular field analysis) models, as

well as the Unversity of Bourgas on

three dimensional COREPA (Common

Reactivity Pattern) models. The Agency

is developing estrogen and androgen

receptor binding data to verify the

model results. The QSAR model

approaches have the potential to be

incorporated in the EDPSD, provided

they prove to be reliable upon

completion of ongoing studies and

scientific peer review.

Priority setting is not part of the

charge to the EDMVS. However, the

Agency will keep the subcommittee

informed of these activities, in that the

results have implications for the

development of in vitro screening and

pre-screening methods. The latter will

be part of the charge to the

subcommittee.

2. Validation of EDSP assays. The

EDSP assays that EPA is developing and

validating on a priority basis are

identified below:

Tier 1 Screening Battery Methods

• Estrogen (ER) and androgen receptor

(AR) binding assays

• ER and AR assays with w/

transcriptional activation

• Steroidogenesis assay

• Uterotrophic assay

• Hershberger assay

• Pubertal female assay w/thyroid

endpoints

• Frog metamorphosis

• Fish reproductive screening assay

Tier 1 Screening Battery Alternate

Methods

• Pubertal male assay w/thyroid

endpoints

• Aromatase assay

• Rodent in utero through lactation

assay

Tier 2 Testing Battery Methods

• Two-generation mammalian

reproductive toxicity study with

endocrine endpoints

Federal Register / Vol. 66, No. 88 / Monday, May 7, 2001 / Notices 23025

• Two-generation avian reproductive

toxicity study with endocrine endpoints

• Two-generation fish reproductive

study with endocrine endpoints

• Two-generation mysid shrimp

reproductive study with endocrine

endpoints

3. The Validation Process. As a

charter member and co-chair of the

Interagency Coordinating Committee on

the Validation of Alternative Methods

(ICCVAM), EPA (and the EDMVS) will

follow the interagency validation

framework outlined in Validation and

Regulatory Acceptance of Toxicological

Test Methods (Ref. 4) for validating the

EDSP screening and testing methods.

The National Institute of Environmental

Health Sciences (NIEHS) established

ICCVAM as a standing committee of

Federal agencies to coordinate and

facilitate interagency validation,

acceptance, and harmonization of

toxicological test methods with an

emphasis on reducing animal use,

refining procedures involving animals

to make them less stressful and

replacing animals where scientifically

appropriate.

The ICCVAM validation process was

designed as a flexible, adaptable

framework applicable to conventional

and alternative methods, and to meet

the needs of diverse test sponsors,

Federal agencies and regulatory

processes. The framework provides a

number of stages and outcomes

including research, methods

development, prevalidation, validation,

peer review, and regulatory acceptance.

All stages and outcomes are part of the

interagency ICCVAM process. However,

as indicated in Validation and

Regulatory Acceptance of Toxicological

Test Methods: ‘‘ICCVAM does not

ordinarily address methods applicable

to only one agency’’ (Ref. 4, p. 46); and

‘‘test method sponsors may elect to

arrange for independent peer review by

third parties prior to submission of a

method to an agency or ICCVAM’’ (Ref.

4, p. 47). Regulatory approval of test

guidelines remains the sole

responsibility of each regulatory agency.

Although there is widespread interest

in EPA’s EDSP, the screening and

testing methods are being developed

and validated with the specific goal of

developing test guidelines for EPA

regulatory use. The test guidelines will

ultimately be used by chemical

manufacturers, pesticide registrants, and

other entities to develop data for

submission to EPA in support of the

Agency’s statutorily mandated chemical

risk management programs.

EPA will manage the validation

process for the EDSP with substantial

involvement of ICCVAM personnel.

EPA and ICCVAM have mutually agreed

to this administrative arrangement to

ensure that EDSP validation meets

ICCVAM interagency validation

principles (Ref. 4), as well as EPA

guideline development, review, and

regulatory approval processes for EPA’s

chemical risk management programs.

EPA will manage the process set forth

by ICCVAM for the validation of all of

the specific in vitro and in vivo EDSP

methods. ICCVAM and the National

Toxicology Program will manage and

peer review a background review

document and summarize literature

derived performance criteria into a

generic guidance document that could

be used for validating estrogen receptor

and androgen receptor binding/reporter

gene assays.

In addition to EPA’s domestic EDSP

validation program, certain screening

assays and tests for international use are

also being conducted by the

Organization for Economic Cooperation

and Development (OECD) Test

Guidelines Program. EPA is an active

member of the OECD Test Guidelines

Program activities, as well as the latter’s

Endocrine Disruptor Testing and

Assessment Workgroup. EPA will rely

upon the OECD mechanism for

validating those EDSP screens and tests

of international interest. The OECD,

EPA and ICCVAM have also mutually

agreed to this administrative

arrangement to ensure that all

appropriate validation and peer review

steps are achieved in both domestic and

international efforts.

4. Studies initiated to date by EPA. A

number of studies have been initiated

by EPA to provide the data necessary for

the validation of individual methods.

The results of these ongoing studies, as

well as advice regarding the design of

new studies will be the primary work of

the EDMVS. A summary of studies that

have been initiated by EPA is shown

below.

Assays/tests Literature review Initial protocol

demonstration Prevalidation studies Validation studies

ER/AR binding assay ••• •

Uterotrophic assay ••• •

Hershberger assay ••• •

Pubertal female assay •••

Pubertal male assay •••

Frog metamorphosis assay •

Fish reproductive screen •

Mammalian 2-generation test •

Avian 2-generation test •

Invertebrate 2-generation test •

23026 Federal Register / Vol. 66, No. 88 / Monday, May 7, 2001 / Notices

V. Endocrine Disruptor Methods

Validation Subcommittee Mission

Statement

A. Purpose and Authority

This mission statement establishes the

Endocrine Disruptor Methods

Validation Subcommittee (EDMVS) in

accordance with the Federal Advisory

Subcommittee Act (5 U.S.C. App. 2

section 9(c)). The EDMVS is being

established as a subcommittee under the

auspices of EPA’s National Advisory

Council for Environmental Policy and

Technology. The purpose of the EDMVS

is to provide advice and counsel to the

EPA on scientific issues associated with

the conduct of studies necessary for

validation of Tier 1 and Tier 2 methods

for the EPA’s Endocrine Disruptor

Screening Program (63 FR 71542). The

EDMVS will provide advice and

recommendations regarding: the

development of initial protocols;

prevalidation study designs; validation

study designs; and synthesis of

prevalidation and validation study

results for the EDSP Tier 1 and Tier 2

methods into documents suitable for

external peer review. The EDMVS

advice and recommendations will be

forwarded to the Agency through

NACEPT. Taking into account this

advice and recommendations, EPA will

manage and conduct prevalidation and

validation laboratory studies.

B. Objectives

EDMVS provides independent advice

and counsel to the Agency through

NACEPT, on scientific and technical

issues related to validation of EDSP Tier

1 and Tier 2 methods, including the

reduction of animal pain suffering and

use. Following validation of the

individual screening methods, the

collective data will be integrated and

evaluated to optimize the configuration

of the Tier 1 screening battery. EDMVS

may also examine new or innovative

methods that may be applicable for

inclusion in a second phase of

validation. Specific areas for advice and

counsel include:

1. Initial protocol development. The

development and/or review of

Endocrine Disruptor Screening Program

(EDSP) initial protocols based on

existing information and experience

(past and current research). The initial

protocols will serve as the starting point

for all subsequent prevalidation studies.

EPA will prepare a Background Review

Document (BRD) addressing all critical

areas outlined in Validation and

Regulatory Acceptance of Toxicological

Test Methods (Ref. 4) will be prepared

for each method to summarize, explain,

and document decisions regarding the

relevant principles, methods and

techniques for the initial protocol.

2. Prevalidation studies. The further

development and optimization of

specific EDSP initial protocols through

targeted investigations. The targeted

investigations will be designed to

address questions necessary for an

optimized, transferable protocol suitable

for inter-laboratory validation studies.

3. Validation studies. The design and

interpretation of comparative interlaboratory studies to establish the

reliability and relevance of the EDSP

optimized transferable protocols.

Following validation, the optimized

transferable protocols will provide the

basis for endocrine disruptor test

guidelines for regulatory use.

4. Preparation of EDSP Method

Validation documents for external peer

review. All EDSP methods must be peer

reviewed prior to approval for

regulatory use. With advice and

recommendations of the EDMVS, EPA

will synthesize and interpret data and

information generated in protocol

development, prevalidation studies and

validation studies into EDSP methodspecific documents suitable for external

peer review. External scientific peer

review of the EDSP methods will be

arranged by EPA through an Agencyapproved external scientific peer review

panel.

C. Scope of the Activity

The EDMVS and NACEPT will

provide a forum for a diverse group of

individuals representing a broad range

of interests and backgrounds from

across the country to consult with and

make recommendations to the Agency

on matters relating to the validation and

external scientific peer review of

endocrine disruptor screening and

testing methods. The subcommittee will

analyze issues, review data and

protocols, compile information, make

recommendations to the Agency, and

undertake other activities necessary to

meet its responsibilities.

D. Composition

The EDMVS shall be composed of 25

members approved by the

Administrator. Members will be

selected on the basis of their relevant

scientific expertise and diversity of

perspectives on endocrine disruptor

screening and testing methods and

procedures, toxicity test methods

standardization and validation, and

chemical and pesticide regulatory

processes. Members will be appointed

for 2 years. Subcommittee members

shall be appointed with balanced

representation from the following

sectors: The agrichemical and

commodity chemical industries;

environmental/public interest

organizations; public health

organizations; animal welfare

organizations; Federal agencies; State,

local and tribal governments; academia;

consumers, and the public. The Agency

will appoint a Chair and Deputy Chair

for the Subcommittee.

E. Workgroups and Ad Hoc Teams

Workgroups and ad hoc teams may be

established on an as-needed basis

consisting of EDMVS members, or

supplemented with specialists qualified

in the technical area of the workgroup

or team appointed by the Agency. Such

teams will develop in-depth technical

issues or analyses that may be necessary

for the EDMVS to conduct its

deliberations.

F. Meetings

The EDMVS will hold up to six

meeting a year. A regular employee of

EPA will act as the Designated Federal

Officer who will be present or

represented at all meetings and is

authorized to adjourn any such

meetings whenever the official

determines it to be in the public

interest. All EDMVS meetings will be

called, announced, and held in

accordance with FACA and NACEPT

rules, which require open meetings and

an opportunity for interested persons to

file comments before or after meetings,

or to make statements during the public

meetings to the extent time permits. The

date, time, location and any public

participation instructions for each

meeting will be announced in the

Federal Register at least 30 days before

the meeting date. Each meeting shall be

conducted in accordance with an

agenda approved in advance by the

Designated Federal Officer. The meeting

information and agenda will be posted

on the Agency’s web site as soon as it

is available, and no later than 15 days

before the meeting date.

VI. References

1. Ankley, G. T. et al. 1998. Overview

of a workshop on screening methods for

detecting (anti)-estrogenic/androgenic

chemicals in wildlife. Environmental

Toxicology Chemistry. 17: 68-87.

2. Endocrine Disruptor Screening and

Testing Advisory Committee: Final

Report. 1998. U. S. Environmental

Protection Agency, Office of Prevention,

Pesticides, and Toxic Substances,

Washington, DC.

3. Gray. L. E. et al. 1997. Endocrine

Screening Methods Workshop Report:

Detection of Estrogenic and Androgenic

Hormonal and Antihormonal Activity

for Chemicals that Act via Receptor or

Federal Register / Vol. 66, No. 88 / Monday, May 7, 2001 / Notices 23027

Steroidogenic Enzyme Mechanisms.

Reproductive Toxicology 11:719-750.

4. National Institute of Environmental

Health Sciences. 1997. Validation and

Regulatory Acceptance of Toxicological

Test Methods: A report of the ad hoc

Interagency Coordinating Committee on

the Validation of Alternative Methods.

NIH Publication No. 97-3981, NIEHS,

Research Triangle Park, NC,105 pp.

5. National Research Council.

Hormonally Active Agents in the

Environment. National Academy Press,

Washington, DC, 429 pp.

6. U. S. EPA. 1997. Special Report on

Environmental Endocrine Disruptors:

An Effects Assessment and Analysis. U.

S. Environmental Protection Agency,

Office of Research and Development,

EPA/630/R-96/012, Washington, DC,

116 pp.

7. U.S. EPA. 1997. Screening Methods

for Chemicals that Alter Thyroid

Hormone Action, Function, and

Homeostasis. U. S. Environmental

Protection Agency, Office of Research

and Development, EPA/6000/R-98/057,

Washington, DC, 44 pp.

8. U. S. EPA. 1999. Review of the

EPA’s Proposed Environmental

Endocrine Disruptor Screening Program.

U. S. Environmental Protection Agency,

Science Advisory Board, EPA-SAB-EC99-013, Washington, DC, 35 pp.

List of Subjects

Environmental protection.

Dated: April 24, 2001.

Stephen L. Johnson,

Acting Assistant Administrator, Office of

Prevention, Pesticides and Toxic Substances.

[FR Doc. 01–11412 Filed 5–4–01 8:45 am]

BILLING CODE 6560–50–S

FEDERAL COMMUNICATIONS

COMMISSION

Notice of Public Information

Collection(s) Being Reviewed by the

Federal Communications Commission

April 30, 2001.

SUMMARY: The Federal Communications

Commission, as part of its continuing

effort to reduce paperwork burden

invites the general public and other

Federal agencies to take this

opportunity to comment on the

following information collection(s), as

required by the Paperwork Reduction

Act of 1995, Public Law 104–13. An

agency may not conduct or sponsor a

collection of information unless it

displays a currently valid control

number. No person shall be subject to

any penalty for failing to comply with

a collection of information subject to the

Paperwork Reduction Act (PRA) that

does not display a valid control number.

Comments are requested concerning (a)

whether the proposed collection of

information is necessary for the proper

performance of the functions of the

Commission, including whether the

information shall have practical utility;

(b) the accuracy of the Commission’s

burden estimate; (c) ways to enhance

the quality, utility, and clarity of the

information collected; and (d) ways to

minimize the burden of the collection of

information on the respondents,

including the use of automated

collection techniques or other forms of

information technology.

DATES: Written comments should be

submitted on or before June 6, 2001. If

you anticipate that you will be

submitting comments, but find it

difficult to do so within the period of

time allowed by this notice, you should

advise the contact listed below as soon

as possible.

ADDRESSES: Direct all comments to Judy

Boley, Federal Communications

Commission, Room 1–C804, 445 12th

Street, SW., DC 20554 or via the Internet

to jboley@fcc.gov.

FOR FURTHER INFORMATION CONTACT: For

additional information or copies of the

information collection(s), contact Judy

Boley at 202–418–0214 or via the

Internet at jboley@fcc.gov.

SUPPLEMENTARY INFORMATION:

OMB Control No.: 3060–0029.

Title: Application for TV Broadcast

Station License.

Form No.: FCC Form 302–TV.

Type of Review: Revision of a

currently approved collection.

Respondents: Business or other forprofit and not-for-profit institutions.

Number of Respondents: 83.

Estimated Time Per Response: 4–10

hours (1–2 hours for respondent; 2–6

hours for consulting engineer).

Frequency of Response: On occasion

reporting requirement.

Total Annual Burden: 224 hours.

Total Annual Cost: $61,390.

Needs and Uses: FCC Form 302–TV is

used by licensees and permittees of TV

broadcast stations to obtain a new or

modified station license, and/or to

notify the Commission of certain

changes in the licensed facilities. The

data is used by FCC staff to confirm that

the station has been built to terms

specified in the outstanding

construction permit and to ensure that

any changes made to the station will not

have an impact on other stations and the

public. Data is extracted from FCC Form

302–TV for inclusion in the license to

operate the station.

OMB Control No.: 3060–0978.

Title: Compatibility with E911

Emergency Calling Systems, Fourth

Report and Order.

Form No.: N/A.

Type of Review: Extension of a

currently approved collection.

Respondents: Business or other forprofit.

Number of Respondents: 4,000

respondents; 16,000 responses.

Estimated Time Per Response: 8

hours.

Frequency of Response: Quarterly

reporting requirement.

Total Annual Burden: 32,000 hours.

Total Annual Cost: N/A.

Needs and Uses: The Fourth Report

and Order mandates that digital wireless

E911 service providers must be capable

of transmitting 911 calls made using

TTY devices by June 30, 2002. In order

to ensure that carriers comply with this

rule and to keep the Commission

informed of technological advancements

in this regard, the Fourth Report and

Order requires that carriers file a

quarterly TTY progress report, either

individually or through an industry

forum.

OMB Control No.: 3060–0970.

Title: Section 90.621(e)(2), Selection

and Assignment of Frequencies.

Form No.: N/A.

Type of Review: Extension of a

currently approved collection.

Respondents: Business or other forprofit and state, local or tribal

government.

Number of Respondents: 1,000.

Estimated Time Per Response: .5

hours.

Frequency of Response: On occasion

reporting requirement.

Total Annual Burden: 500 hours.

Total Annual Cost: N/A.

Needs and Uses: Section 90.621

requires applicants proposing to modify

operations to use channels for

commercial purposes in certain

frequency bands in 800 MHz to provide

written notice of the modification to all

Public Safety licensees within 70 miles

of the site of the channels for which the

authorization for commercial use is

sought that operate within 25 kHz of the

center of those channels. This

requirement seeks to avoid the potential

of interference that could result from the

modification of a Private Land Mobile

radio facility to commercial use. If the

information were not available there

would be an increased risk of

interference in this band.

Federal Communications Commission.

Magalie Roman Salas,

Secretary.

[FR Doc. 01–11328 Filed 5–4–01; 8:45 am]

BILLING CODE 6712–01–U