Pesticides; Draft Guidance for Pesticide Registrants on Bee Precautionary Labeling

 [Federal Register: November 22, 2000 (Volume 65, Number 226)]
[Notices]
[Page 70350-70352]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22no00-61]

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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Pesticides; Draft Guidance for Pesticide Registrants on Bee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.

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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

[[Page 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

[[Page 70352]]

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
Pesticides; Draft Guidance for Pesticide Registrants on Bee Precautionary Labeling

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