[Federal Register Volume 65, Number 96 (Wednesday, May 17, 2000)]
[Notices]
[Pages 31313-31315]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-12379]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-00599B; FRL-6553-9]


Pesticides; Guidance for Pesticide Registrants on Mandatory and 
Advisory Labeling Statements

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of availability.

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SUMMARY: The Agency has issued Pesticide Registration (PR) Notice 2000-
5 entitled ``Guidance for Mandatory and Advisory Labeling Statements.'' 
This PR 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.

FOR FURTHER INFORMATION CONTACT: Jeff Kempter, (7505C), Environmental 
Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (703) 305-5448; fax number: 
(703) 305-6920; e-mail address: [email protected].

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 are required 
to register pesticides. Since other entities may also be

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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'' 
and then look up the entry for this document under the ``Federal 
Register--Environmental Documents.'' You can also go directly to 
theFederal Register listings at http://www.epa.gov/fedrgstr.
    2. Fax-on-demand. You may request a faxed copy of the Pesticide 
Registration (PR) Notice entitled ``Guidance for Mandatory and Advisory 
Labeling Statements,'' by using a faxphone to call (202) 401-0527 and 
selecting item 6128. Also, you may select item 6129 for the paper 
entitled ``Responses to Public Comments on Draft PR Notice on 
Mandatory/Advisory Labeling.'' 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-00599B. 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.

II. What Guidance Does this PR Notice Provide?

    This 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. The Federal 
Insecticide, Fungicide and Rodenticide Act (FIFRA) section 2(ee) 
defines the term ``to use any registered pesticide in a manner 
inconsistent with its labeling'' (i.e., misuse) as use of ``. . . any 
registered pesticide in a manner not permitted by the labeling . . . 
.'' For purposes of this notice, the term ``use'' includes storage, 
transportation, handling, pre-application activities, mixing and 
loading, worker notification and worker protection, application, post- 
application activities and disposal. Registrants are not required to 
submit applications in response to this notice, however, EPA will 
review applications in light of the guidance presented here and seek to 
clarify labeling statements that are unclear or ambiguous. Finally, 
registrants may no longer add or change advisory labeling statements to 
existing products by notification as previously permitted by PR Notices 
95-2 and 98-10. This PR Notice supersedes those PR Notices concerning 
the use of notification for adding or modifying advisory statements.

III. Guidance on Mandatory and Advisory Labeling Statements

    Statements on the pesticide labeling may be interpreted by users 
differently from what the registrant or EPA intended when the labeling 
was accepted. If EPA believes that misuse has occurred, an 
administrative law judge or 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 
pesticide product labels in general (e.g., the Consumer Labeling 
Initiative), as well as in specific areas of the labeling (e.g., bee 
precautionary labeling and pesticide drift labeling).
    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 generally 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 of the information presented on the label and by 
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 mandatory labeling 
statements. In the past, advisory statements have commonly used 
suggestive verbs such as ``should,'' ``may,'' or ``recommend'' to 
encourage the user to achieve the directed behavior, but often 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.
    Advisory language using terms such as ``should,'' ``may,'' and 
``recommend'' can create ambiguities as to the intent of the direction 
or precaution. Too often, common everyday speech using the word 
``should'' creeps into mandatory label statements where the imperative 
tense is needed to communicate that certain action is required. Another 
problem is contradictory headings and statements. A set of mandatory 
directions preceded by an advisory heading such as ``Use 
Recommendations'' potentially conflicts as to the nature of the 
intended action. Lastly, the use of words such as ``should'' in 
advisory language can mistakenly imply that an unaccepted use is 
permissible. For example, the direction ``you should remove all food 
articles prior to use'' on a product that is not registered for any 
food uses could be mistakenly read to suggest that it is not mandatory 
to remove all food from the area to be treated.
    The Agency seeks to improve mandatory and advisory labeling 
statements by providing guidance on how they can best be written. 
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, and that failure to follow these 
instructions is a misuse of the product. Advisory statements are 
generally 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

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conflict with mandatory labeling statements; thus, they are to be 
avoided. 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 
craft advisory labeling statements in straightforward, descriptive 
language.
    The PR Notice was developed from a draft document by the same title 
that was released for public comment on June 2, 1999 (64 FR 29641) 
(FRL-6079-4). The Agency received comments from various organizations. 
Each of the commenters offered recommendations for improving the 
document. All comments were extensively evaluated and considered by the 
Agency. This revised version embodies some of the recommendations of 
the commenters. A summary of the public comments, as well as the 
Agency's response to the comments, is being made available as described 
in Units I.B.1. and I.B.2.

IV. Why is a PR Notice Guidance and Not a Rule?

    The 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.

List of Subjects

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

    Dated: May 10, 2000.
Marcia E. Mulkey,
Director, Office of Pesticide Programs.
[FR Doc. 00-12379 Filed 5-16-00; 8:45 am]
BILLING CODE 6560-50-F