[Federal Register Volume 64, Number 105 (Wednesday, June 2, 1999)]
[Notices]
[Pages 29641-29643]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-13795]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-00599; FRL-6079-4]


Pesticides; Draft Guidance on Mandatory/Advisory Labeling 
Statements

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 Mandatory and Advisory 
Labeling Statements.'' This draft notice provides guidance to the 
registrant for improving the clarity of labeling statements in order to 
avoid confusing directions and precautions and to prevent the misuse of 
pesticides.

DATES: Written comments, identified by docket control number OPP-00599, 
should be submitted by August 2, 1999.

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'' section of 
this document. To ensure proper receipt by EPA, your comments must 
identify docket control number OPP-00599 in the subject line on the 
first page of your response.

FOR FURTHER INFORMATION CONTACT: Jeff Kempter, Environmental Protection 
Agency (7509C), 401 M St., SW., Washington, DC 20460, telephone number: 
(703) 305-5448; fax: (703) 305-6920; e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does This Notice Apply to Me?

    You may be potentially affected by this notice if you manufacture 
or formulate pesticides. Potentially affected categories and entities 
may include, but are not limited to:

 
------------------------------------------------------------------------
                                                         Examples of
           Categories                   NAICS            potentially
                                                      affected entities
------------------------------------------------------------------------
Pesticide Producers                     32532        Pesticide
                                                      manufacturers
                                                     Pesticide
                                                      formulators
------------------------------------------------------------------------

     This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed could also be affected. If 
available, the North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this notice affects certain entities. If you have any 
questions regarding the applicability of this announcement to you, 
consult the person listed in the ``FOR FURTHER INFORMATION CONTACT'' at 
the beginnng of this document.

B. How Can I Get Additional Information or Copies of This Document or 
Other Documents?

    1. Electronically. You may obtain electronic copies of this 
document and the draft PR Notice from the EPA Home Page at http://
www.epa.gov/. On the Home Page select ``Laws and Regulations'' 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 to receive a faxed copy of this 
document, as well as supporting information, by using a faxphone to 
call (202) 401-0527 and selecting item 6120. You may also follow the 
automated menu.
    3. In person or by phone. If you have any questions or need 
additional information about this action, you may contact the 
appropriate technical person identified in the ``FOR FURTHER 
INFORMATION CONTACT'' at the beginning of this document. In addition, 
the official record for this document and the draft paper listed in the 
``SUMMARY'' at the beginning of this document, including the public 
versions, has been established under docket control number OPP-00599 
(including comments and data submitted electronically as described 
below). This record not only includes the documents that are physically 
located in the docket, but also includes all the documents that are 
referenced in those documents. A public version of this record, 
including printed, paper versions of any electronic comments, which do 
not include any information claimed as Confidential Business 
Information (CBI), is available for inspection in 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 Public 
Information and Records Integrity Branch 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, you must identify 
docket control number OPP-00599 in the subject line on the first page 
of your response.
    1. By mail. Submit written comments to: Public Information and 
Records Integrity Branch, Information Resources and Services Division 
(7502C), Office of Pesticide Programs, Environmental Protection Agency, 
401 M St., SW., Washington, DC 20460.
    2. In person or by courier. Deliver written comments to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, Rm. 119, Crystal Mall #2, 1921 Jefferson Davis 
Highway, Arlington, VA.
    3. Electronically. Submit your comments and/or data electronically 
by e-mail to: [email protected]. Do not submit any information 
electronically that you consider to be CBI. Submit electronic comments 
as an ASCII file, avoiding the use of special characters and any form 
of encryption. Comments and data will also be accepted on standard 
computer disks in WordPerfect 5.1/6.1 or ASCII file format. All 
comments and data in electronic form must be identified by the docket 
control number. Electronic comments on this notice may also be filed 
online at many Federal Depository Libraries.

D. How Should I Handle CBI Information That I Want to Submit to the 
Agency?

     You may claim information that you submit 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

[[Page 29642]]

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 CBI must be submitted for inclusion in the public 
record. Information not marked confidential will be included in the 
public docket by EPA without prior notice. If you have any questions 
about CBI or the procedures for claiming CBI, please call the Public 
Information and Records Integrity Branch telephone number is (703) 305-
5805.

E. What Should I Consider As I Prepare My Comments for EPA?

    EPA invites you to provide your views on the draft PR Notice. 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 solid technical information and/or data to support your 
views.
     4. If you estimate potential burden or costs, explain how you 
arrived at the estimate.
     5. Indicate what you support, as well as what you disagree with.
     6. Provide specific examples to illustrate your concerns.
     7. Make sure to submit your comments by the deadline in this 
notice.
     8. At the beginning of your comments (e.g., as part of the 
``Subject'' heading), be sure to properly identify the document you are 
commenting on. You can do this by providing docket control number OPP-
00599, along with the name, date and Federal Register citation.

II. Background

     The Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) 
section 2(ee) defines ``to use any registered pesticide in a manner 
inconsistent with its labeling'' (misuse) as use of ``* * * any 
registered pesticide in a manner not permitted by the labeling * * *,'' 
and goes on to list a number of exceptions to the term. Use includes 
storage, transportation, handling, pre-application activities, mixing 
and loading, worker notification and worker protection, application, 
post-application activities and disposal.
     Statements on the pesticide labeling may be interpreted by users 
different from what the registrant or EPA intended when the labeling 
was accepted. If EPA believes that misuse has occurred, a court may 
have to decide whether a product's labeling statements are clear enough 
for the user to understand how to lawfully use the product. Pesticide 
labeling needs to clearly identify what is required of the user to 
handle and apply a pesticide safely. The Agency is engaged in numerous 
efforts to improve labels in general (e.g., the Consumer Labeling 
Initiative), as well as specific areas of the labeling of pesticide 
products (e.g., bee precautionary labeling and pesticide drift 
labeling).

III. Summary of Draft PR Notice

     Following is an excerpt from draft PR Notice which summarizes its 
key points:

     Mandatory statements, which commonly use imperative verbs such 
as ``must'' or ``shall,'' either require action or prohibit the user 
from taking certain action. Advisory statements simply provide 
information, either in support of the mandatory statements or about 
the product in general. To ensure that the intent of each labeling 
statement is clear, mandatory statements need to be clearly 
distinguishable from advisory statements.

     Currently, labeling provisions are enforced by taking into 
consideration all the information presented on the label and reading 
advisory statements in the context of the entire label. Problems can 
arise when advisory statements are either vague or ambiguous in 
meaning, or are inconsistent with other labeling. In the past, advisory 
statements have commonly used suggestive verbs such as ``should,'' 
``may,'' or ``recommend'' to help the user achieve the directed 
behavior, but sometimes these statements can be unclear as to whether 
they are mandatory or advisory. In a recent misuse enforcement action, 
for example, the person charged with the violation argued that advisory 
statements misled him into taking action which was inconsistent with 
the mandatory statements.
     The Agency seeks to improve mandatory and advisory labeling 
statements by providing guidance (see Appendix to the PR Notice) on how 
they can best be written. This guidance consists of two steps. First, 
mandatory statements are generally written in imperative or directive 
terms (such as ``shall,'' ``must,'' ``do this,'' ``do not'') so that a 
typical user will understand that these statements direct the user to 
take or avoid certain actions. Second, advisory statements are best 
written in descriptive or nondirective terms to support the mandatory 
statements or provide information. Suggestive terms such as ``should,'' 
``may,'' or ``recommend'' may be confusing or ambiguous, or potentially 
conflict with mandatory labeling statements; thus, they are to be 
avoided whenever possible. EPA realizes that the use of descriptive 
terms for advisory statements is not appropriate for every situation 
and that there are times where it may be necessary to use ``should,'' 
``may,'' ``recommend,'' or similar words. However, in most cases it is 
best to state advisory labeling statements in straightforward, 
descriptive language.

IV. Questions/Issues for Comment

     While comments are invited on any aspect of the draft PR Notice, 
EPA is particularly interested in comments on the following questions:
    1. Are the descriptions of mandatory and advisory labeling 
statements clear and complete? If not, how should they be changed?
    2. Is the basic policy that mandatory and advisory statements 
should be distinguishable from each other clear and adequate? If not, 
how can this policy be better expressed?

V. Policies Not Rules

     The draft PR Notice discussed in this notice is intended to 
provide guidance to EPA personnel and decision-makers, and to the 
public. As a guidance document and not a rule, this policy is not 
binding on either EPA or any outside parties. Although this guidance 
document provides a starting point for EPA decisions, EPA will depart 
from this policy where the facts or circumstances warrant. In such 
cases, EPA will explain why a different course was taken. Similarly, 
outside parties remain free to assert that this policy is not 
appropriate for a specific pesticide or that the specific circumstances 
demonstrate that this policy should be abandoned.
     EPA has stated in this notice that it 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, not a rule. 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. In the course of 
commenting on this guidance document, EPA would welcome comments that 
specifically address how the guidance document can be structured so 
that it provides meaningful guidance without imposing binding 
requirements.

[[Page 29643]]

VI. Contents of Docket

    Documents that are referenced in this notice will be inserted in 
the docket under the docket control number OPP-00599.

List of Subjects

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, pesticides and pests.

    Dated: May 21, 1999.

Marcia E. Mulkey,
Director, Office of Pesticide Programs.

[FR Doc. 99-13795 Filed 6-1-99; 8:45 am]
BILLING CODE 6560-50-F