70350 Federal Register / Vol. 65, No. 226 / Wednesday, November 22, 2000 / 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 May 21, 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 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, Pesticides

and pests, Product registrations.

Dated: November 13, 2000.

Richard D. Schmitt,

Associate Director, Information Resources

and Services Division, Office of Pesticide

Programs.

[FR Doc 00–29896 Filed 11–21–00; 8:45 a.m.]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

[OPP–00684; FRL–6750–9]

Pesticides; Draft Guidance for

Pesticide Registrants on Bee

Precautionary Labeling

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice of availability.

SUMMARY: The Agency seeks public

comment on a draft Pesticide

Registration (PR) Notice entitled

‘‘Guidance for Pesticide Registrants on

Bee Precautionary Labeling.’’ This draft

notice provides guidance to registrants

and others concerning EPA’s policy on

bee labeling statements for pesticide

products which are toxic to bees, such

as honey bees, alfalfa leaf-cutting bees,

alkali bees, and other native and non–

indigenous pollinating insects that are

important to crop production. The

purpose of the proposed label changes

is to help ensure that pesticide products

used outdoors can be used without

posing unnecessary risks of bee

mortality. EPA believes that these

revisions will make the labeling clearer

and more easily understood by pesticide

users and by regulatory officials who

enforce label provisions.

DATES: Comments, identified by docket

control number OPP–00684, must be

received on or before January 22, 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–00684 in the subject line on the

first page of your response.

FOR FURTHER INFORMATION CONTACT: Jim

Roelofs (7506C), Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460;

telephone number: (703) 308–2964; fax

number: (703) 308–1850; e-mail address:

roelofs.jim@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

This action is directed to pesticide

registrants, pesticide regulatory officials,

beekeepers, pesticide users and to the

public in general. Although this action

may be of particular interest to those

persons who have a specific interest in

precautionary labeling to protect bees,

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.access.gpo.gov/sup—docs/.

2. Fax on demand. You may request

a faxed copy of the draft PR Notice

entitled ‘‘Bee Precautionary Labeling

Statements,’’ by using a faxphone to call

(202) 401–0527 and selecting item PR

2000–6133. 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–00684. 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

Federal Register / Vol. 65, No. 226 / Wednesday, November 22, 2000 / Notices 70351

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–00684 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, CM #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, Suite 8, or ASCII file

format. All comments in electronic form

must be identified by docket control

number OPP–00684. 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 or collection activity.

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

To help determine whether pesticide

products used outdoors pose risks of bee

mortality, the Agency generally requires

acute toxicity data on bees to be

submitted with a registration

application. See e.g., 40 CFR 158.590(a).

Depending on the results of the acute

study, EPA may require additional

residual toxicity data. EPA pesticide

labeling regulations require that

‘‘...pesticides toxic to pollinating insects

must bear appropriate label cautions.’’

40 CFR 156.10(h)(2)(ii)(E). In the 1980s,

the Agency published a policy which

described a set of standard bee

precautionary labeling statements it

believed appropriate where results from

the bee data indicated toxicity. The

most recent version of this policy is

found in the 1996 Label Review Manual

(USEPA, Office of Prevention, Pesticides

and Toxic Substances, Label Review

Manual, 2nd Ed. (EPA 737–B–96–001)

December, 1996). Under the 1980s

policy, where a product displayed

extended residual toxicity to bees, the

label language EPA believed to be

appropriate for precautionary purposes

stated: ‘‘This product is highly toxic to

bees exposed to direct treatment or

residues on blooming crops or weeds.

Do not apply this product or allow it to

drift to blooming crops or weeds if bees

are visiting the treatment area.’’

Controversy has continued for many

years among beekeepers, growers,

commercial applicators and State

regulators about the adequacy of these

statements. For example, many

beekeepers believe that the labeling

statements are not adequately

protective, while many growers believe

that the labeling statements are overly

restrictive and prevent them from

managing pests adequately during the

bloom period. State regulators believe

that the labeling statements need to be

clarified regarding the obligations of

applicators with respect to bees.

III. Summary of the Draft PR Notice

A. What Guidance Does the PR Notice

Provide?

The PR Notice states EPA’s proposed

new policy regarding appropriate

standard label language to protect bees.

This new language would include a

specific statement about the length of

time in hours or days that the residues

of the pesticide product remain a toxic

threat to bees. This new proposed

labeling statement is based on a study

of residual toxicity to bees for a specific

product submitted to the Agency, or, in

the absence of such a study, it states a

default period of toxicity of 24 hours.

The proposed label language provides

two conditions under which pesticide

application would be allowed without

limitation to the label–stated period of

toxic hazard to bees. The first of these

conditions is if the pesticide application

method is such that bees will not be

exposed even if they are visiting the

crop. An example of such a method

would be soil incorporation, which

would not produce pesticide residues

on the foliage, blooms or nectar

producing parts of plants, so that bees

would not be exposed. The other

condition under which use is allowed

during the period of toxicity to bees, is

when the user actively participates in

and meets all the applicable

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: