69772 Federal Register / Vol. 65, No. 224 / Monday, November 20, 2000 / Notices

Providing Oral or Written Comments at

SAB Meetings

It is the policy of the Science

Advisory Board to accept written public

comments of any length, and to

accommodate oral public comments

whenever possible. The Science

Advisory Board expects that public

statements presented at its meetings will

not be repetitive of previously

submitted oral or written statements.

Oral Comments: In general, each

individual or group requesting an oral

presentation at a face-to-face meeting

will be limited to a total time of ten

minutes. For teleconference meetings,

opportunities for oral comment will

usually be limited to no more than three

minutes per speaker and no more than

fifteen minutes total. Deadlines for

getting on the public speaker list for a

meeting are given above. Speakers

should bring at least 35 copies of their

comments and presentation slides for

distribution to the reviewers and public

at the meeting. Written Comments:

Although the SAB accepts written

comments until the date of the meeting

(unless otherwise stated), written

comments should be received in the

SAB Staff Office at least one week prior

to the meeting date so that the

comments may be made available to the

committee for their consideration.

Comments should be supplied to the

appropriate DFO at the address/contact

information noted above in the

following formats: one hard copy with

original signature, and one electronic

copy via e-mail (acceptable file format:

WordPerfect, Word, or Rich Text files

(in IBM-PC/Windows 95/98 format).

Those providing written comments and

who attend the meeting are also asked

to bring 25 copies of their comments for

public distribution.

General Information—Additional

information concerning the Science

Advisory Board, its structure, function,

and composition, may be found on the

SAB Website (http://www.epa.gov/sab)

and in The FY1999 Annual Report of

the Staff Director which is available

from the SAB Publications Staff at (202)

564–4533 or via fax at (202) 501–0256.

Committee rosters, draft Agendas and

meeting calendars are also located on

our website.

Meeting Access—Individuals

requiring special accommodation at this

meeting, including wheelchair access to

the conference room, should contact the

DFO at least five business days prior to

the meeting so that appropriate

arrangements can be made.

Dated: November 9, 2000.

Donald G. Barnes,

Staff Director, Science Advisory Board.

[FR Doc. 00–29644 Filed 11–17–00; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

[FRL–6904–7]

Draft Benchmark Dose Technical

Guidance Document

AGENCY: Environmental Protection

Agency.

ACTION: Notice of Peer-Review

Workshop and Public Comment Period.

SUMMARY: The U.S. Environmental

Protection Agency (EPA) is announcing

that Eastern Research Group, Inc. (ERG),

an EPA contractor for external scientific

peer review, will organize, convene, and

conduct an external peer-review

workshop to review the draft document

titled: ‘‘Benchmark Dose Technical

Guidance Document’’ (EPA/630/R–00/

001). The EPA is also announcing a 30-

day public comment period for the draft

document. The document was prepared

by an EPA Risk Assessment Forum

Technical Panel. The Technical Panel

will consider the peer-review and

public comment submissions in

finalizing the document.

DATES: The peer-review workshop will

begin on Thursday, December 7, 2000,

at 8:30 a.m. and end at 5:00 p.m., then

reconvene Friday, December 8, 2000,

from 8:00 a.m. to 1:00 p.m. Members of

the public may attend as observers, and

there will be a limited time for

comments from the public. The 30-day

public comment period begins

November 20, 2000, and ends December

20, 2000.

ADDRESSES: The external peer-review

workshop will be held at the Holiday

Inn Capital, 550 C Street SW,

Washington DC 20024. To attend the

workshop register by November 30,

2000 by calling ERG at (781) 674–7374

or send a facsimile to (781) 674–2906.

You may also register on the Internet at

http://www.erg.com/conferences/

index.htm, or by E-mail at

confmail@erg.com. Space is limited, and

reservations will be accepted on a firstcome, first-served basis. There will be a

limited time for comments from the

public during the workshop. Please let

ERG know if you wish to make

comments.

The draft ‘‘Benchmark Dose Technical

Guidance Document’’ is available

primarily via the Internet at http://

www.epa.gov/ncea/bnchmrk/bmds—

peer.htm. A limited number of paper

copies are available from the Technical

Information Staff (8623D), NCEA–W;

telephone: 202–564–3261; facsimile:

202–565–0050. If you are requesting a

paper copy, please provide your name,

mailing address, and the document title,

draft ‘‘Benchmark Dose Technical

Guidance Document.’’ Copies are not

available from ERG. Comments may be

mailed to the Technical Information

Staff (8623D), NCEA–W, U.S.

Environmental Protection Agency, 1200

Pennsylvania Avenue, NW, Washington,

DC 20460, or delivered to the Technical

Information Staff at 808 17th Street,

NW, 5th Floor, Washington, DC 20006;

telephone: 202–564–3261; facsimile:

202–565–0050. Comments should be in

writing and must be postmarked by

December 20, 2000. Please submit one

unbound original with pages numbered

consecutively, and three copies of the

comments. For attachments, provide an

index, number pages consecutively with

the comments, and submit an unbound

original and three copies. Electronic

comments may be emailed to:

nceadc.comment@epa.gov.

Please note that all technical

comments received in response to this

notice will be placed in a public record.

For that reason, commentors should not

submit personal information (such as

medical data or home address),

Confidential Business Information, or

information protected by copyright. Due

to limited resources, acknowledgments

will not be sent.

FOR FURTHER INFORMATION CONTACT: For

workshop information, registration, and

logistics, contact ERG, 110 Hartwell

Avenue, Lexington, Massachusetts

02173; telephone: (781) 674–7374;

facsimile: (781) 674–2906.

For information on the public

comment period, contact Marilyn

Brower, Risk Assessment Forum Staff;

telephone: 202–564–3363; facsimile:

202–565–0062; or email:

brower.marilyn@epa.gov.

SUPPLEMENTARY INFORMATION: The U.S.

EPA conducts risk assessments for an

array of health effects that may result

from exposure to environmental agents

and that require an analysis of the

relationship between exposure and

health-related outcomes. The doseresponse assessment can be approached

as a two-step process, the first being the

definition of a point of departure (POD)

and the second extrapolation from the

POD to low environmentally-relevant

exposure levels. The benchmark dose

(BMD) approach provides a more

quantitative alternative to the first step

in the dose-response assessment than

the current no-observed-adverse-effectVerDate 11<MAY>2000 17:50 Nov 17, 2000 Jkt 194001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 E:\FR\FM\20NON1.SGM pfrm01 PsN: 20NON1
Federal Register / Vol. 65, No. 224 / Monday, November 20, 2000 / Notices 69773

level/lowest-observed-adverse-effectlevel (NOAEL/LOAEL) process for

noncancer health effects and can be

applied to determining the POD

proposed for cancer endpoints (EPA,

1996). As the Agency moves toward

harmonization of approaches for cancer

and noncancer risk assessment, the

dichotomy between cancer and

noncancer health effects is being

replaced by consideration of mode of

action and whether the effects of

concern are likely to be linear or

nonlinear at low doses. Thus, the

purpose of this document is to provide

guidance for the Agency on the

application of the BMD approach in

determining the POD, whether a linear

or nonlinear low dose extrapolation is

used.

The document addresses a number of

issues that must be resolved in order to

apply the BMD approach for doseresponse assessment in a consistent

manner. These issues include: (1)

Determination of appropriate studies

and endpoints on which to base BMD

calculations; (2) selection of the

benchmark response (BMR) value; (3)

choice of the model to use in computing

the BMD; (4) details surrounding

computation of the confidence limit for

the BMD (BMDL); and (5) reporting

requirements for BMD and BMDL

computation.

Since the methods for BMD

computation require appropriate

software, another purpose of this

document is to provide enough

information about preferred

computational algorithms to allow users

to make an informed choice in the

selection of that software. The

document does not advocate use of any

particular software package, although it

is recommended that software with well

documented algorithms, such as the

Agency’s BMD software (BMDS)

package, be used. Nor is this guidance

intended to document any particular

software package, although it will

present examples for illustrative

purposes that use the Agency’s BMDS

package. It is also expected that this

guidance will inform the design of

studies for the computation of BMDs

and dose-response analysis, though this

will not be covered explicitly. The

terminology used in the document is

consistent with the EPA’s BMDS. This

software is available on the Internet at

http://www.epa.gov/ncea/bmds.htm.

The Risk Assessment Forum has been

active in promoting research and

discussion on BMD issues since 1990. In

1993 the Risk Assessment Forum

sponsored a colloquium on the

applications of BMD methods to

noncancer risk assessment. The focus of

this colloquium was to review a Forum

draft report that outlined the techniques

and presented the major questions and

decisions involved in applying the BMD

method. Following this a technical

panel published a background

document on the use of BMD in health

risk assessment (EPA/630/R–94/007). In

the ensuing years the Forum sponsored

several workshops and symposia on the

BMD approach, including a 1996

external peer review on an earlier draft

of the document presently undergoing

review. Following this external peer

review, the Technical Panel will

consider reviewers’ and public

comments in finalizing the document.

This document is intended to be

updated as new information becomes

available that would suggest approaches

and default options alternative or

additional to those indicated here and

should not be viewed as precluding

additional research on modified or

alternative approaches that will improve

quantitative risk assessment.

Dated: November 9, 2000.

William H. Farland,

Director, National Center for Environmental

Assessment.

[FR Doc. 00–29648 Filed 11–17–00; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

[FRL–6902–7]

Proposed Settlement Under Section

122(h) of the Comprehensive

Environmental Response,

Compensation and Liability Act, as

Amended, 42 U.S.C. 9622(h),

CHEMCENTRAL Warehouse Fire

CERCLA Site, Kent, WA

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice of proposed settlement

and request for public comment.

SUMMARY: In accordance with section

122(i) of the Comprehensive

Environmental Response, Compensation

and Liability Act, as amended by the

Superfund Amendment and

Reauthorization Act (‘‘CERCLA’’), notice

is hereby given of a proposed settlement

to resolve a claim against

CHEMCENTRAL Corporation. The

proposed settlement concerns the

federal government’s past response costs

at the CHEMCENTRAL Warehouse Fire

CERCLA Site, Kent, Washington. The

settlement requires the settling party,

CHEMCENTRAL Corporation, to pay

$24,066.34 to the Hazardous Substance

Superfund. For thirty (30) days

following the date of publication of this

document, the Agency will receive

written comments relating to the

settlement. The Agency’s response to

any comments received will be available

for public inspection at the U.S.

Environmental Protection Agency,

Region 10, office at 1200 Sixth Avenue,

Seattle, Washington 98101. A copy of

the proposed settlement may be

obtained from Mary Shillcutt, Regional

Hearing Clerk, EPA, Region 10, 1200

Sixth Avenue, Seattle, Washington

98101, telephone number (206) 553–

2429. Comments should reference the

‘‘CHEMCENTRAL Warehouse Fire

CERCLA Site’’ and EPA Docket No.

CERCLA–10–2001–0006 and should be

addressed to Ms. Shillcutt at the above

address.

FOR FURTHER INFORMATION CONTACT:

Jennifer G. MacDonald, Assistant

Regional Counsel, EPA Region 10,

Office of Regional Counsel, 1200 Sixth

Avenue, Seattle, Washington 98101,

telephone number (206) 553–8311.

Dated: November 8, 2000.

Charles E. Findley,

Acting Regional Administrator, Region 10.

[FR Doc. 00–29357 Filed 11–17–00; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

[OPPTS–51956; FRL–6754–1]

Certain New Chemicals; Correction

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice; correction.

SUMMARY: EPA is issuing this notice to

correct the Test Marketing Exemption

T–00–0006.

FOR FURTHER INFORMATION CONTACT:

Barbara Cunningham, Director, Office of

Program Management and Evaluation,

Office of Pollution Prevention and

Toxics (7401), Environmental Protection

Agency, 1200 Pennsylvania Ave., NW.,

Washington, DC 20460; telephone

number: (202) 554–1404; e-mail address:

TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

This action is directed to the public

in general. As such, the Agency has not

attempted to describe the specific

entities that this action may apply to.

Although others may be affected, this

action applies directly to the submitter

of the premanufacture notices addressed

in the action. If you have any questions