Federal Register / Vol. 65, No. 122 / Friday, June 23, 2000 / Notices 39147

Aquatic, Vegetative and Wildlife Habitat

Improvement Activities,

Implementation, Coeur d’Alene River

Ranger District, Idaho Panhandle

National Forests, Kootenai and

Shoshone Counties, ID.

Summary: EPA expressed objections

based on the potential adverse impacts

to water quality and wildlife. EPA

recommends that the final EIS present

more discussion on the relative merits

of passive and active restoration to meet

project objectives.

ERP No. DS–COE–E36167–FL Rating

EO2, Central and Southern Florida

Project for Flood Control and Other

Purposes, Everglades National Park

Modified Water Deliveries, New

Information concerning Flood

Mitigation to the 8.5 Square Mile Area

(SMA), Implementation, South Miami,

Dade County, FL.

Summary:

EPA expressed environmental

objections to Alternative 1 since its

structural approach maximizes internal

surface water and wetland drainage.

EPA had no objection with Alternative

5 since it restores the area to its natural

conditions. In addition, EPA requested

that all internal surface waters within

any leveed area must be treated to

marsh-ready levels before delivery into

the Everglades National Park and that

zoning within the protected area must

be enforced to reduce water quality

degradation.

Final EISs

ERP No. F–AFS–J65296–MT Swamp

Timber Sales Project, Implementation,

Kootenai National Forest, Fortine

Ranger District, Lincoln County, MT.

Summary:

EPA continues to express

environmental concerns with the

preferred alternative in comparison to

alternative D, the environmentally

preferred alternative. However, the

preferred alternative did include many

beneficial features such as road

reconstruction, decommissioning and

access restrictions, and riparian buffers

and fencing, and harvest prescriptions

to mitigate impacts.

Dated: June 20, 2000.

Joseph C. Montgomery,

Director, NEPA Compliance Division, Office

of Federal Activities.

[FR Doc. 00–15979 Filed 6–22–00; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

[OPP–00591A; FRL–6589–8]

Pesticides; Policy Issues Related to

the Food Quality Protection Act

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice of availability.

SUMMARY: EPA is announcing the

availability of the revised version of the

pesticide science policy document

entitled ‘‘Guidance for Refining

Anticipated Residue Estimates For Use

in Acute Dietary Probabilistic Risk

Assessment.’’ The Agency has also

incorporated into this policy document

two other policy documents that were

issued for public comment: ‘‘Guidance

for the Conduct of Bridging Studies for

Use in Acute Dietary Probabilistic Risk

Assessment’’ and ‘‘Guidance for the

Conduct of Residue Decline Studies for

Use in Acute Dietary Probabilistic Risk

Assessment.’’ This notice is the

seventeenth in a series concerning

science policy documents related to the

Food Quality Protection Act of 1996 and

developed through the Tolerance

Reassessment Advisory Committee.

FOR FURTHER INFORMATION CONTACT:

Kathleen Martin, Environmental

Protection Agency (7509C), 1200

Pennsylvania, Ave., NW., Washington,

DC 20460; telephone number: (703)

308–2857; fax number: (703) 305–5147;

e-mail address:

martin.kathleen@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be potentially affected by

this action if you manufacture or

formulate pesticides. Potentially

affected categories and entities may

include, but are not limited to:

Categories NAICS

Examples

of potentially affected entities

Pesticide

producers

32532 Pesticide

manufacturers

Pesticide

formulators

This listing is not intended to be

exhaustive, but rather provides a guide

for readers regarding entities likely to be

affected by this action. Other types of

entities not listed could also be affected.

The North American Industrial

Classification System (NAICS) codes

have been provided to assist you and

others in determining whether or not

this notice affects certain entities. If you

have any questions regarding the

applicability of this action to a

particular entity, consult the person

listed under ‘‘FOR FURTHER

INFORMATION CONTACT.’’

B. 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, the

science policy documents, and certain

other related documents that might be

available from the Office of Pesticide

Programs’ Home Page at http://

www.epa.gov/pesticides/. On the Office

of Pesticide Programs’ Home Page select

‘‘FQPA’’ and then look up the entry for

this document under ‘‘Science

Policies.’’ You can also go directly to the

listings at the EPA Home Page at http:/

/www.epa.gov. On the Home Page select

‘‘Laws and Regulations’’ and then look

up the entry to this document under

‘‘Federal Register—Environmental

Documents.’’ You can go directly to the

Federal Register listings at http://

www.epa.gov/fedrgstr/.

2. Fax-on-Demand. You may request

a faxed copy of the science policy

documents, as well as supporting

information, by using a faxphone to call

(202) 401–0527. Select item 6063 for the

document entitled ‘‘Guidance for

Refining Anticipated Residue Estimates

For Use in Acute Dietary Probabilistic

Risk Assessment.’’ Select item 6064 for

the document entitled ‘‘EPA’s

Responses to Public Comments on the

Draft Policy Documents: Data for

Refining Anticipated Residue Estimates

Used in Dietary Risk Assessments;

Guidance for the Conduct of Bridging

Studies for Use in Acute Dietary

Probabilistic Risk Assessment; and

Guidance for the Conduct of Residue

Decline Studies for Use in Acute Dietary

Probabilistic Risk Assessment.’’ You

may also follow the automated menu.

3. In person. The Agency has

established an official record for this

action under docket control number

OPP–00591A. In addition, the

documents referenced in the framework

notice, which published in the Federal

Register on October 29, 1998 (63 FR

58038) (FRL–6041–5) have also been

inserted in the docket under docket

control number OPP–00557. The official

record consists of the documents

specifically referenced in this action,

and other information related to this

action, including any information

claimed as Confidential Business

Information (CBI). This official record

39148 Federal Register / Vol. 65, No. 122 / Friday, June 23, 2000 / Notices

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 official record does not include any

information claimed as CBI. The public

version of the official record, which

includes printed, paper versions of any

electronic comments submitted during

an applicable comment period is

available for inspection in the Public

Information and Records Integrity

Branch (PIRIB), Rm. 119, Crystal Mall

#2, 1921 Jefferson Davis Highway,

Arlington, VA, from 8:30 a.m. to 4 p.m.,

Monday through Friday, excluding legal

holidays. The PIRIB telephone number

is (703) 305–5805.

II. Background Information About the

Tolerance Reassessment Advisory

Committee

On August 3, 1996, the Food Quality

Protection Act of 1996 (FQPA) was

signed into law. Effective upon

signature, the FQPA significantly

amended the Federal Insecticide,

Fungicide, and Rodenticide Act (FIFRA)

and the Federal Food, Drug, and

Cosmetic Act (FFDCA). Among other

changes, FQPA established a stringent

health-based standard (‘‘a reasonable

certainty of no harm’’) for pesticide

residues in foods to assure protection

from unacceptable pesticide exposure;

provided heightened health protections

for infants and children from pesticide

risks; required expedited review of new,

safer pesticides; created incentives for

the development and maintenance of

effective crop protection tools for

farmers; required reassessment of

existing tolerances over a 10-year

period; and required periodic reevaluation of pesticide registrations and

tolerances to ensure that scientific data

supporting pesticide registrations will

remain up-to-date in the future.

Subsequently, the Agency established

the Food Safety Advisory Committee

(FSAC) as a subcommittee of the

National Advisory Council for

Environmental Policy and Technology

(NACEPT) to assist in soliciting input

from stakeholders and to provide input

to EPA on some of the broad policy

choices facing the Agency and on

strategic direction for the Office of

Pesticide Programs (OPP). The Agency

has used the interim approaches

developed through discussions with

FSAC to make regulatory decisions that

met FQPA’s standard, but that could be

revisited if additional information

became available or as the science

evolved. As EPA’s approach to

implementing the scientific provisions

of FQPA has evolved, the Agency has

sought independent review and public

participation, often through

presentation of the science policy issues

to the FIFRA Scientific Advisory Panel

(SAP), a group of independent, outside

experts who provide peer review and

scientific advice to OPP.

In addition, as directed by Vice

President Albert Gore, EPA has been

working with the U.S. Department of

Agriculture (USDA) and another

subcommittee of NACEPT, the

Tolerance Reassessment Advisory

Committee (TRAC), chaired by the EPA

Deputy Administrator and the USDA

Deputy Secretary, to address FQPA

issues and implementation. TRAC

comprised more than 50 representatives

of affected user, producer, consumer,

public health, environmental, states,

and other interested groups. The TRAC

met seven times as a full committee

from May 27, 1998, through April 29,

1999.

The Agency worked with the TRAC to

ensure that its science policies, risk

assessments of individual pesticides,

and process for decision making are

transparent and open to public

participation. An important product of

these consultations with TRAC was the

development of a framework for

addressing key science policy issues.

The Agency decided that the FQPA

implementation process and related

policies would benefit from initiating

notice and comment on the major

science policy issues.

The TRAC identified nine science

policy issue areas they believed were

key to implementation of FQPA and

tolerance reassessment. The framework

calls for EPA to provide one or more

documents for comment on each of the

nine issues by announcing their

availability in the Federal Register. In

accordance with the framework

described in a separate notice published

in the Federal Register of October 29,

1998 (63 FR 58038), EPA has been

issuing a series of draft science policy

documents concerning nine science

policy issues identified by the TRAC

related to the implementation of FQPA.

This notice announces the availability

of the revised version of the science

policy document identified in the

‘‘SUMMARY.’’

III. Summary of Revised Science Policy

Guidance Document

This science policy document

provides guidance to registrants, other

test sponsors and interested parties, and

data reviewers on the extent and quality

of pesticide residue and ancillary data

needed to support the use of more

refined ‘‘anticipated residues’’ in acute

dietary probabilistic exposure

assessments. The purpose of this

guidance document is to outline the

types of data OPP can use to refine

residue estimates for pesticides and

explain when and how EPA may use

these data. Such data can include (as is

further discussed in the science policy

document) information from cooking

studies, processing studies, and market

basket surveys conducted on individual

produce items. In addition, such data

can include information from

‘‘bridging’’ studies used to support the

use of typical application rates in

probabilistic risk assessments or residue

decline data used to support the use of

typical preharvest intervals (PHI) in

probabilistic risk assessments. This

guidance also provides information on

how risk-mitigation activities (e.g.,

increasing PHIs and lowering maximum

label rates) can be considered in OPP

risk assessments and used to adjust

tolerance levels.

It should be noted that the guidance

in this science policy document is not

intended to limit or restrict the type of

data that may be submitted in support

of risk-mitigation measures, and that

OPP will consider other data or

information as long as they would

provide a scientifically sound basis for

determining residues at typical

application rates for risk mitigation

purposes.

EPA published a draft version of this

science policy document on April 7,

1999 (64 FR 16967) (FRL–6071–1) and

comments were filed in docket control

number OPP–00591. In addition, EPA

issued two related draft science policy

documents entitled, ‘‘Guidance for the

Conduct of Bridging Studies for Use in

Acute Dietary Probabilistic Risk

Assessment’’ and ‘‘Guidance for the

Conduct of Residue Decline Studies for

Use in Acute Dietary Probabilistic Risk

Assessment,’’ on August 4, 1999 (64 FR

42371) (FRL–6093–2). Comments for

these documents were filed in docket

control number OPP–00616. The

Agency received comments from several

organizations and interested

individuals. All comments on these

three draft science policy documents

were considered by the Agency in

producing the revised version of the

science policy document and the

response-to-comments document

described in this notice.

Many of the comments were similar

in content, and pertained to general

issues concerning the proposed policy

or specific sections within the draft

science policy document. The Agency

grouped the comments according to the

nature of the comment and the issue or

section of the document which they

addressed. The Agency’s response to the

Federal Register / Vol. 65, No. 122 / Friday, June 23, 2000 / Notices 39149

comments is available as described in

Units I.B.1. and I.B.2.

IV. Policies Not Rules

The policy document discussed in

this notice is intended to provide

guidance to EPA personnel and

decision-makers, and to the public. As

a guidance document and not a rule, the

policy in this guidance is not binding on

either EPA or any outside parties.

Although this guidance provides a

starting point for EPA risk assessments,

EPA will depart from its policy where

the facts or circumstances warrant. In

such cases, EPA will explain why a

different course was taken. Similarly,

outside parties remain free to assert that

a policy is not appropriate for a specific

pesticide or that the circumstances

surrounding a specific risk assessment

demonstrate that a policy should be

abandoned.

List of Subjects

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests.

Dated: June 15, 2000.

Susan H. Wayland,

Acting Assistant Administrator for

Prevention, Pesticides and Toxic Substances.

[FR Doc. 00–15917 Filed 6–22–00; 8:45 am]

BILLING CODE 6560–50–F

FEDERAL HOUSING FINANCE BOARD

Sunshine Act Meeting: Announcing an

Open Meeting of the Board

TIME AND DATE: 10 a.m., Friday, June 23,

2000.

PLACE: Board Room, Second Floor,

Federal Housing Finance Board, 1777 F

Street, N.W., Washington, D.C. 20006.

STATUS: The entire meeting will be open

to the public.

MATTERS TO BE CONSIDERED DURING

PORTIONS OPEN TO THE PUBLIC: 

• Final Rule: Amendments to

Membership Regulation and Advances

Regulation.

• Final Rule: Election of Federal

Home Loan Bank Directors.

• Resolution Required by Section 608

of the Federal Home Loan Bank

Modernization Act Certifying that

Withdrawal of Bank System Members

will not cause the Bank System to fail

to meet its REFCorp Obligations.

CONTACT PERSON FOR MORE INFORMATION:

Elaine L. Baker, Secretary to the Board,

(202) 408–2837.

William W. Ginsberg,

Managing Director.

[FR Doc. 00–16009 Filed 6–20–00; 4:59 pm]

BILLING CODE 6725–01–P

FEDERAL HOUSING FINANCE BOARD

Sunshine Act Meeting: Announcing an

Open Meeting of the Board

TIME AND DATE: 2 P.M., Thursday, June

29, 2000.

PLACE: Board Room, Second Floor,

Federal Housing Finance Board 1777 F

Street, N.W., Washington, D.C. 20006.

STATUS: The entire meeting will be open

to the public.

MATTERS TO BE CONSIDERED DURING

PORTIONS OPEN TO THE PUBLIC: 

• Final Rule: Federal Home Loan

Bank Acquired Member Assets, Core

Mission Activities, Investments and

Advances.

• Final Rule: Amendments to

Advances and Other Regulations to

Implement Gramm-Leach-Bliley Act

Collateral Provisions and Make Related

Revisions.

CONTACT PERSON FOR MORE INFORMATION:

Elaine L. Baker, Secretary to the Board,

(202) 408–2837.

William W. Ginsberg,

Managing Director.

[FR Doc. 00–16010 Filed 6–20–00; 4:59 pm]

BILLING CODE 6725–01–P

FEDERAL RETIREMENT THRIFT

INVESTMENT BOARD

Employee Thrift Advisory Council;

Amended Meeting

FR.00–14739 appearing on page

36906 in the Federal Register of

Monday, June 12, 2000, change the time

of the meeting from 10 a.m. to 2 p.m. on

Tuesday, June 27, 2000. Everything else

remains the same.

Dated: June 20, 2000.

Elizabeth S. Woodruff,

General Counsel, Federal Retirement Thrift

Investment Board.

[FR Doc. 00–15958 Filed 6–22–00; 8:45 am]

BILLING CODE 6760–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Office of the Secretary

Research Integrity Office Findings;

Lingxun Duan, M.D.

AGENCY: Office of the Secretary, HHS.

ACTION: Notice.

SUMMARY: Notice is hereby given that

based on oversight by the Office of

Research Integrity (ORI) and decision by

the Assistant Secretary for Health, the

U.S. Public Health Service has taken

final action in the following case:

Lingxun Duan, M.D., Thomas

Jefferson University: The U.S. Public

Health Service (PHS) alleges that Dr.

Duan, former Research Assistant

Professor of Medicine, Division of

Infectious Diseases, Department of

Medicine, Jefferson Medical College,

Thomas Jefferson University, engaged in

scientific misconduct by reporting

research that was inconsistent with

original data or could not be supported

because original data were not retained.

The research in question was supported

by a National Institute of Allergy and

Infectious Diseases (NIAID), National

Institutes of Health (NIH), grant, R01

AI36552, entitled ‘‘Intracellular

antibodies and HIV 1.’’

Specifically, the research in question

was reported in an NIAID, NIH, grant

application; in an FDA-approved phase

I gene therapy investigational new drug

(IND) application entitled ‘‘Intracellular

immunization against HIV—1 infection

using an anti-rev single chain variable

fragment (SFV);’’ and in two

publications: (1) Duan, L., Bagasra, O.,

Laughlin, M.A., Oakes, J.W., &

Pomerantz, R.J., ‘‘Potent inhibition of

human immunodeficiency virus type I

replication by an intracellular anti-Rev

single chain antibody,’’ Proc. Natl.

Acad. Sci. USA 91:5075–5079, 1994;

and (2) Levy-Mintz, P., Duan, L., Zhang,

H., Hu, B., Dornadula, G., Zhu, M.,

Kulkosky, J., Bizub-Bender, D., Skalka,

A.M., and Pomerantz, R.J., ‘‘Intracellular

expression of single-chain variable

fragments to inhibit early stages of the

viral life cycle by targeting human

immunodeficiency virus type 1

integrase,’’ J. Virol. 70:8821–8823, 1996.

Dr. Duan denies all allegations of

scientific misconduct and contends that

some of his original data is missing.

Both Dr. Duan and PHS are desirous of

concluding this matter without further

expense of time and other resources.

Thus, Dr. Duan has entered into a

Voluntary Exclusion Agreement

(Agreement) with PHS, in which Dr.

Duan has voluntarily agreed: