[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Pesticides; Draft Guidance on Mandatory/Advisory Labeling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:
kempter.carlton@epa.gov.
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: opp-docket@epa.gov. 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
