34636 Federal Register / Vol. 66, No. 126 / Friday, June 29, 2001 / Notices

III. What is the Agency’s Authority for

Taking this Action?

Section 6(f)(1) of FIFRA provides that

a registrant of a pesticide product may

at any time request that any of its

pesticide registrations be amended to

delete one or more uses. The Act further

provides that, before acting on the

request, EPA must publish a notice of

receipt of any such request in the

Federal Register. Thereafter, the

Administrator may approve such a

request.

IV. Procedures for Withdrawal of

Request

Registrants who choose to withdraw a

request for cancellation must submit

such withdrawal in writing to James A.

Hollins, at the address given above,

postmarked before December 26, 2001,

unless indicated otherwise. This written

withdrawal of the request for

cancellation will apply only to the

applicable 6(f)(1) request listed in this

notice. If the product(s) have been

subject to a previous cancellation

action, the effective date of cancellation

and all other provisions of any earlier

cancellation action are controlling. The

withdrawal request must also include a

commitment to pay any reregistration

fees due, and to fulfill any applicable

unsatisfied data requirements.

V. Provisions for Disposition of Existing

Stocks

The effective date of cancellation will

be the date of the cancellation order.

The orders effecting these requested

cancellations will generally permit a

registrant to sell or distribute existing

stocks for 1–year after the date the

cancellation request was received by the

Agency. This policy is in accordance

with the Agency’s statement of policy as

prescribed in Federal Register of June

26, 1991 (56 FR 29362) (FRL 3846–4).

Exception to this general rule will be

made if a product poses a risk concern,

or is in noncompliance with

reregistration requirements, or is subject

to a data call-in. In all cases, productspecific disposition dates will be given

in the cancellation orders.

Existing stocks are those stocks of

registered pesticide products which are

currently in the United States and

which have been packaged, labeled, and

released for shipment prior to the

effective date of the cancellation action.

Unless the provisions of an earlier order

apply, existing stocks already in the

hands of dealers or users can be

distributed, sold or used legally until

they are exhausted, provided that such

further sale and use comply with the

EPA-approved label and labeling of the

affected product(s). Exceptions to these

general rules will be made in specific

cases when more stringent restrictions

on sale, distribution, or use of the

products or their ingredients have

already been imposed, as in Special

Review actions, or where the Agency

has identified significant potential risk

concerns associated with a particular

chemical.

List of Subjects

Environmental protection,

Agricultural commodities, Pesticides

and pests.

Dated: June 12, 2001.

Richard D. Schmitt,

Associate Director, Information Resources

and Services Division, Office of Pesticide

Programs.

[FR Doc. 01–16443 Filed 6–28–01; 8:45 a.m.]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

[OPP–00706; FRL–6771–9]

Pesticides; Guidance on Phenol

Resistance Testing for Antimicrobial

Disinfectant and Sanitizer Pesticides

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice of availability.

SUMMARY: The Agency is announcing

the availability of guidance titled

‘‘Elimination of Phenol Resistance

Testing for Antimicrobial Disinfectant

and Sanitizer Pesticides.’’ This final

Pesticide Registration (PR) Notice

provides guidance to registrants

concerning the discontinuation of

phenol resistance testing as a part of

efficacy testing for antimicrobial

disinfectants and sanitizers. Adoption of

this guidance will eliminate

unnecessary testing and will result in

resource savings for both the Agency

and registrants. Responses to public

comments received in response to the

previously issued draft guidance are

also being made available.

FOR FURTHER INFORMATION CONTACT:

Michele Wingfield, Antimicrobials

Division, (7510C), Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460;

telephone number: (703) 308–6349; fax

number: (703) 308–8481; e-mail address:

wingfield.michele@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

This action is directed to the public

in general. Although this action may be

of particular interest to those persons

who manufacture or formulate

pesticides. 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 information in this notice,

consult the person listed under FOR

FURTHER INFORMATION CONTACT.

B. How Can I Get Additional

Information, Including Copies of this

Document and Other Related

Documents?

1. Electronically. You may obtain

electronic copies of this document, the

PR Notice, and the Agency’s response to

public comments from the Office of

Pesticide Programs’ Home Page at http:/

/www.epa.gov/pesticides/. You can also

go directly to the listings from the EPA

Internet Home Page at http://

www.epa.gov/. To access this

document, on the Home Page select

‘‘Laws and Regulations,’’ ‘‘Regulations

and Proposed Rules,’’ and then look up

the entry for this document under the

‘‘Federal Register—Environmental

Documents.’’ You can also 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 Pesticide Registration

(PR) Notice titled ‘‘Elimination of

Phenol Resistance Testing for

Antimicrobial Disinfectant and Sanitizer

Pesticides,’’ by using a faxphone to call

(202) 401–0527 and selecting item 6139.

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–00706. The official record consists

of the documents specifically referenced

in this action, any public comments

received during an applicable comment

period, and other information related to

this action, including any information

claimed as confidential business

information (CBI). This official 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 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

Federal Register / Vol. 66, No. 126 / Friday, June 29, 2001 / Notices 34637

holidays. The PIRIB telephone number

is (703) 305–5805.

II. Background

A. What Guidance Does this PR Notice

Provide?

The PR Notice announces the

discontinuation of phenol resistance

testing as a part of efficacy testing for

antimicrobial disinfectants and

sanitizers. The Agency will now

consider registering or reregistering

antimicrobial disinfectant or sanitizer

pesticides without supporting phenol

resistance testing. All other data in

support of registration or reregistration,

including any required efficacy testing

data, would also need to be submitted

and accepted by the Agency.

Phenol resistance testing is a standard

that has traditionally been used to

estimate the intrinsic resistance or

sensitivity of some test bacteria to

chemical disinfectants and sanitizers.

For years, the Agency has been aware of

the lack of standard and uniform

resistance levels to phenol expressed by

the test cultures used in the existing

Official Methods of Analysis of the

Association of Official Analytical

Chemists (AOAC) test methods.

Historically, the inability to maintain

and propagate test cultures that express

standard and uniform levels of phenol

resistance has been a recognized

scientific problem which has persisted

for at least 70 years. Furthermore, the

inability of many reputable and

competent testing facilities to achieve

consistent test results with the phenol

resistance standard has prompted both

concern and action by the Agency.

On September 10, 1997, after internal

scientific deliberation, the Agency

placed before the Federal Insecticide,

Fungicide, and Rodenticide Act (FIFRA)

Scientific Advisory Panel (SAP) the

following question regarding phenol

resistance:

What scientific direction should be

taken regarding the lack of standard and

uniform resistance levels to phenol of

the test cultures used in the existing

AOAC (Association of Official

Analytical Chemists) efficacy test

methods? Should the Agency:

• Totally eliminate the phenol

resistance requirement; or

• Modify the required phenol

resistance patterns to provide a broader

range of acceptable resistance; or

• Replace the phenol resistance

requirements with some other

procedures that assure hardiness and

equivalence to test cultures, such as

standard, quantitative inoculum level?

Briefly, the SAP responded that there

is no current relevance to requiring the

phenol resistance test and, therefore, the

phenol coefficient method should be

eliminated and new protocols should be

established for defining the conditions

for culturing test microorganisms with

suitable resistance levels to

antimicrobials.

Subdivision G of the Pesticide

Assessment Guidelines, part 91-1,

describes the general product

performance (efficacy) standards for

disinfectants and sanitizers. Subsection

(b)(3)(I) of part 91–1 refers to the AOAC

standard tests that may be used to

satisfy the data requirements of 40 CFR

158.640. In turn, these AOAC tests

include references to phenol resistance

testing.

The Agency concurs with the SAP,

which has engaged in considerable

discussion and deliberation, internally

and with members of the scientific and

regulated communities, on how to best

proceed. Given the inapplicability of a

test organism’s resistance to phenol

when disinfectants or sanitizers are

tested for their efficacy performance, the

Agency no longer requires submission

of testing to demonstrate compliance

with AOAC-specified levels of

expressed phenol resistance by test

microorganisms during the efficacy

evaluation of disinfectants or sanitizers.

However, as an interim measure while

method development research

continues, the Agency recommends a

minimum inoculum level of 104 colony

forming units per carrier for all test

microorganisms when the AOAC carrier

based tests are used.

B. PR Notices are Guidance Documents

The PR Notice discussed in this

notice is intended to provide guidance

to EPA personnel and decision-makers

and to pesticide registrants. This notice

is not binding on either EPA or

pesticide registrants, and EPA may

depart from the guidance where

circumstances warrant and without

prior notice. Likewise, pesticide

registrants may assert that the guidance

is not appropriate generally or not

applicable to a specific pesticide or

situation.

List of Subjects

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests.

Dated: June 19, 2001.

Marcia E. Mulkey,

Director, Office of Pesticide Programs

[FR Doc. 01–16442 Filed 6–28–01; 8:45 am]

BILLING CODE 6560–50–S

EXPORT-IMPORT BANK OF THE

UNITED STATES

Agency Information Collection

Activities: Current Collection;

Comment Request

AGENCY: Export-Import Bank of the

United States.

ACTION: Notice of request for comments.

SUMMARY: In accordance with

requirements of the Paperwork

Reduction Act of 1995, the ExportImport Bank of the United States (Ex-Im

Bank) has submitted to the Office of

Management and Budget (OMB) a

request to review and approve an

extension of a currently approved

collection described below. This notice

is soliciting comments from members of

the public concerning the proposed

information collection.

DATES: Written comments should be

received on or before July 31, 2001 to be

assured of consideration.

ADDRESSES: Direct all written comments

and recommendations concerning the

submission to Mr. David Rostker, Office

of Management and Budget, Office of

Information and Regulatory Affairs,

NEOB, Room 10202, Washington, DC

20503.

FOR FURTHER INFORMATION CONTACT:

Copies of these submissions and any

additional information may be obtained

from Carlista D. Robinson, ExportImport Bank of the U.S., 811 Vermont

Avenue, NE., Room 764, Washington,

DC 20571 (202–565–3351).