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