70352 Federal Register / Vol. 65, No. 226 / Wednesday, November 22, 2000 / Notices

requirements of a state–approved bee

protection program.

The Agency believes that label

precautions should be supplemented by

additional efforts to protect bees, and

that state programs are appropriate to

this purpose. EPA does not intend to set

specific criteria or approve state bee

protection programs. The PR Notice

recommends that state pesticide

regulatory agencies consider a variety of

regulatory and non–regulatory measures

to include in bee–protection efforts.

EPA believes that state agencies are in

the best position to understand the

localized crop–pesticide combinations

and other factors that pose the greatest

risks to bees, and can implement

appropriate measures to mitigate those

risks under varying local and geographic

conditions.

B. What Questions/Issues Should You

Consider?

Commenters are free to raise any

issue, but the following questions are of

particular interest to the Agency, and

comments on them are invited.

1. Should the precautionary labeling

language in the new policy allow for an

exception from bee precautions for

wide–area public health spray

programs? In a number of

communications to the Agency, officials

involved in public health programs have

noted that strict interpretation of the

current bee precautionary labeling could

prevent effective wide–area pest control

in an emergency situation. The Agency’s

proposed new labeling language could

also be very restrictive of wide–area

spraying, for example, if a state had no

bee protection program, or could not

operate the program during an

emergency. The suggestion has been

made that the label language include a

clause to the effect that precautions

apply ‘‘...except when applications are

made to prevent or control a declared

public health threat.’’ The Agency

requests comment on whether such an

exception on the label is necessary or

appropriate, and if it is appropriate,

what authority could invoke the

exception. Should an exception be

applicable to treatments intended to

prevent possible disease outbreaks, or

limited to significant emergencies like

the aftermath of flooding or a proven

outbreak of human or animal disease?

2. Should the new policy described in

the PR Notice allow a 24 hour period of

toxicity statement on labels in the

absence of data as a permanent option,

or only temporarily until registrants

submit residual toxicity data?

3. From the commenter’s perspective

as a pesticide user, bee keeper, state

regulator, or other interested party,

would a specific time period of toxicity

to bees on the label be more or less

useful than the current policy which

includes a label prohibition on

applications while bees are visiting the

treatment area?

4. Is the label condition that

pesticides can be applied if the user

participates in a state bee protection

program likely to encourage bee–

protection efforts? From the

commenter’s perspective, is such a

condition more or less useful in

achieving bee protection that the current

label prohibition against application

when bees are visiting the treatment

area?

C. What is the Scope of this PR Notice?

The draft PR Notice discussed in this

notice is intended to provide guidance

to pesticide registrants, EPA personnel,

state regulatory personnel, and to the

public. As a guidance document, this

policy is not binding on either EPA or

any outside parties, and EPA may

depart from the guidance where

circumstances warrant and without

prior notice. Registrants and applicants

may propose alternatives to the

recommended labeling statements

described in the Notice and the Agency

will assess them for appropriateness on

a case–by–case basis. If a product does

not meet the requirements of 40 CFR

Part 156, the Agency may find the

product to be misbranded. As stated

above, the Agency believes that the

statements outlined in the Notice

should reduce the potential for adverse

effects to the environment and are

‘‘appropriate’’ within the meaning of 40

CFR 156.10(h)(2)(ii)(E).

EPA will make available revised

guidance after consideration of public

comment. Public comment is not being

solicited for the purpose of converting

this guidance document into a binding

rule. EPA will not be codifying this

policy in the Code of Federal

Regulations. EPA is soliciting public

comment so that it can make fully

informed decisions regarding the

content of this guidance.

The revised guidance will not be an

unalterable document. Once a revised

guidance document is issued, EPA will

continue to treat it as guidance.

Accordingly, on a case–by–case basis

EPA will decide whether it is

appropriate to depart from the guidance

or to modify the overall approach in the

guidance.

List of Subjects

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests.

Dated: November 9, 2000.

Marcia Mulkey,

Director, Office of Pesticide Programs

[FR Doc. 00–29815 Filed 11–21–00; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

[OPP–00674; FRL–6736–9]

Pesticides; Elimination of Phenol

Resistance Testing for Antimicrobial

Disinfectant and Sanitizer Pesticides

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice of availability.

SUMMARY: The Agency seeks public

comment on a draft Pesticide

Registration (PR) Notice titled

‘‘Elimination of Phenol Resistance

Testing for Antimicrobial Disinfectant

and Sanitizer Pesticides.’’ This draft

notice provides guidance to registrants

concerning the discontinuation of

phenol resistance testing as a part of

efficacy testing for antimicrobial

disinfectants and sanitizers.

DATES: Comments, identified by docket

control number OPP–00674, must be

received on or before January 8, 2001.

ADDRESSES: Comments may be

submitted by mail, electronically, or in

person. Please follow the detailed

instructions for each method as

provided in Unit I.C. of the

SUPPLEMENTARY INFORMATION. To ensure

proper receipt by EPA, it is imperative

that you identify docket control number

OPP–00674 in the subject line on the

first page of your response.

FOR FURTHER INFORMATION CONTACT:

Ibrahim Barsoum, Antimicrobials

Division (7510C), Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460;

telephone number: (703) 308–6417; fax

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

barsoum.ibrahim@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. Potentially affected

categories and entities may include, but

are not limited to:

Federal Register / Vol. 65, No. 226 / Wednesday, November 22, 2000 / Notices 70353

Categories NAICS

Examples of potentially affected

entities

Pesticide

Producers

32532 Pesticide manufacturers

Pesticide formulators

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 and

the PR Notice 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 draft 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 6132. 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–00674. 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

holidays. The PIRIB telephone number

is (703) 305–5805.

C. How and to Whom Do I Submit

Comments?

You may submit comments through

the mail, in person, or electronically. To

ensure proper receipt by EPA, it is

imperative that you identify docket

control number OPP–00674 in the

subject line on the first page of your

response.

1. By mail. Submit your comments to:

Public Information and Records

Integrity Branch (PIRIB), Information

Resources and Services Division

(7502C), Office of Pesticide Programs

(OPP), Environmental Protection

Agency, 1200 Pennsylvania Ave., NW.,

Washington, DC 20460.

2. In person or by courier. Deliver

your comments to: Public Information

and Records Integrity Branch (PIRIB),

Information Resources and Services

Division (7502C), Office of Pesticide

Programs (OPP), Environmental

Protection Agency, Rm. 119, Crystal

Mall #2, 1921 Jefferson Davis Highway,

Arlington, VA. The PIRIB is open from

8:30 a.m. to 4 p.m., Monday through

Friday, excluding legal holidays. The

PIRIB telephone number is (703) 305–

5805.

3. Electronically. You may submit

your comments electronically by E-mail

to: opp-docket@epa.gov, or you can

submit a computer disk as described

above. Do not submit any information

electronically that you consider to be

CBI. Avoid the use of special characters

and any form of encryption. Electronic

submissions will be accepted in

Wordperfect 6.1/8.0 file format or ASCII

file format. All comments in electronic

form must be identified by docket

control number OPP–00674. Electronic

comments may also be filed online at

many Federal Depository Libraries.

D. How Should I Handle CBI That I

Want to Submit to the Agency?

Do not submit any information

electronically that you consider to be

CBI. You may claim information that

you submit to EPA in response to this

document as CBI by marking any part or

all of that information as CBI.

Information so marked will not be

disclosed except in accordance with

procedures set forth in 40 CFR part 2.

In addition to one complete version of

the comment that includes any

information claimed as CBI, a copy of

the comment that does not contain the

information claimed as CBI must be

submitted for inclusion in the public

version of the official record.

Information not marked confidential

will be included in the public version

of the official record without prior

notice. If you have any questions about

CBI or the procedures for claiming CBI,

please consult the person identified

under FOR FURTHER INFORMATION

CONTACT.

E. What Should I Consider as I Prepare

My Comments for EPA?

You may find the following

suggestions helpful for preparing your

comments:

1. Explain your views as clearly as

possible.

2. Describe any assumptions that you

used.

3. Provide copies of any technical

information and/or data you used that

support your views.

4. If you estimate potential burden or

costs, explain how you arrived at the

estimate that you provide.

5. Provide specific examples to

illustrate your concerns.

6. Offer alternative ways to improve

the notice.

7. Make sure to submit your

comments by the deadline in this

notice.

8. To ensure proper receipt by EPA,

be sure to identify the docket control

number assigned to this action in the

subject line on the first page of your

response. You may also provide the

name, date, and Federal Register

citation.

II. Background

A. What Guidance Does this PR Notice

Provide?

The draft PR Notice announces the

discontinuation of phenol resistance

testing as a part of efficacy testing for

antimicrobial disinfectants and

sanitizers. When the PR Notice is issued

in final form, the Agency will 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

then 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

70354 Federal Register / Vol. 65, No. 226 / Wednesday, November 22, 2000 / Notices

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 questions 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 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

and 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 will no longer require

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 generally will

expect 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 draft 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 or not applicable to

a specific pesticide or situation.

List of Subjects

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests.

Dated: November 9, 2000.

Marcia E. Mulkey,

Director, Office of Pesticide Programs.

[FR Doc. 00–29895 Filed 11–21–00 8:45 a.m.]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

[FRL–6905–2]

Notice of Proposed Prospective

Purchaser Agreement Pursuant to the

Comprehensive Environmental

Response, Compensation and Liability

Act of 1980, as Amended by the

Superfund Amendments and

Reauthorization Act

AGENCY: Environmental Protection

Agency.

ACTION: Notice; Request for public

comment.

SUMMARY: In accordance with the

Comprehensive Environmental

Response, Compensation, and Liability

Act of 1980, as amended by the

Superfund Amendments and

Reauthorization Act of 1986,

(‘‘CERCLA’’), 42 U.S.C. 9601–9675,

notice is hereby given that a proposed

prospective purchaser agreement

(‘‘Purchaser Agreement’’) associated

with the Fischer & Porter Superfund

Site in Warminster Township, Bucks

County, Pennsylvania was executed by

the Environmental Protection Agency

and the Department of Justice and is

now subject to public comment, after

which the United States may modify or

withdraw its consent if comments

received disclose facts or considerations

which indicate that the Purchaser

Agreement is inappropriate, improper,

or inadequate. The Purchaser

Agreement would resolve certain

potential EPA claims under Sections

106 and 107 of CERCLA, 42 U.S.C. 9606,

9607, against Blue Marlin Associates

(‘‘Purchasers’’). The settlement would

require the Purchasers to, among other

things, reimburse the Environmental

Protection Agency $15,000.00 for

response costs incurred and to be

incurred at the Site.

For thirty (30) days following the date

of publication of this notice, the Agency

will receive written comments relating

to the Purchaser Agreement. The

Agency’s response to any comments

received will be available for public

inspection at the U.S. Environmental

Protection Agency, Region III, 1650

Arch Street, Philadelphia, PA 19103.

DATES: Comments must be submitted on

or before December 22, 2000.

AVAILABILITY: The Purchaser Agreement

and additional background information

relating to the Purchaser Agreement are

available for public inspection at the

U.S. Environmental Protection Agency,

Region III, 1650 Arch Street,

Philadelphia, PA 19103. A copy of the

Purchaser Agreement may be obtained

from Suzanne Canning (3RC00),

Regional Docket Clerk, U.S.

Environmental Protection Agency, 1650

Arch Street, Philadelphia, PA 19103, or

‘‘Canning.Suzanne@epamail.epa.gov’’.

Comments should reference the

‘‘Fischer & Porter Superfund Site,

Prospective Purchaser Agreement’’ and

‘‘EPA Docket No. CERC–PPA–2000–

0007,’’ and should be forwarded to

Elizabeth Lukens at the address below.

FOR FURTHER INFORMATION CONTACT:

Elizabeth B Lukens (3RC44), Senior

Assistant Regional Counsel, U.S.

Environmental Protection Agency, 1650

Arch Street, Philadelphia, PA 19103,

Phone: (215) 814–2661.

Dated: November 15, 2000.

Thomas C. Voltaggio,

Acting Regional Administrator, U.S.

Environmental Protection Agency, Region III.

[FR Doc. 00–29878 Filed 11–21–00; 8:45 am]

BILLING CODE 6560–50–P