EPA 730-N-00-002
"V PRO*'
                  UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                                WASHINGTON, D.C. 20460
Fax-On-Demand
Fax Number: (202) 401-0527
Item: 6128
                                                              OFFICE OF
                                                        PREVENTION, PESTICIDES AND
                                                           TOXIC SUBSTANCES
ATTENTION:
SUBJECT:
                      May 10, 2000

   PESTICIDE REGISTRATION (PR) NOTICE 2000-5

    NOTICE TO MANUFACTURERS, PRODUCERS,
FORMULATORS AND REGISTRANTS OF PESTICIDES

     Persons Responsible for Registration and Reregistration of Pesticide
     Products

     Guidance for Mandatory and Advisory Labeling Statements
       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 notpermitted 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.

I.  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).
            Recycled/Recyclable  Printed with Vegetable Oil Based Inks on 100% Recycled Paper (40% Postconsumer)

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        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.
                                                                   I
        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. AnotheY 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.  Consequently, such a statement would
 not be acceptable.

       The Agency seeks to improve mandatory and advisory labeling statements by providing
 guidance (see Appendix) 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 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.

II. How to Change Labels

       Registrants should follow the guidance above and in the Appendix whenever submitting
new or revised labeling to EPA for registration or reregistration.  Registrants of new or existing

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c.
           products should draft their product labels to be consistent with the guidance, and submit them for
           acceptance as follows:                                 ,

                        Registrants may modify or add mandatory or advisory labeling statements for
                         currently registered products only by submitting an application for amended
                         registration. This application must include the following items: a completed
                    --     EPA application form 8570-1, five copies of the draft label, and a description of
                         the intended modification.                ',

                        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.

                         Applicants for registration of new products should follow the guidance in this
                         notice when drafting labeling to be submitted with an application.

                  Because of the importance of maintaining a clear distinction between mandatory and
           advisory statements, and of making these statements as clear as possible to pesticide users, EPA
           will review all new or changed mandatory and advisory labeling statements through the
           amendment process, except for those statements specifically permitted by  other PR Notices
           (other than PR Notice 98-10) to be submitted by notification.

                  Registrants must submit applications for new products and amendment as follows:

                  U.S. Postal Service Deliveries

                  The following official mailing address must be used for all correspondence or data
           submissions sent to OPP by mail:

                  Document Processing Desk (AMEND) or (APPL), as applicable
                  Office of Pesticide Programs (7504C)              :
                  U.S. Environmental Protection Agency
                  Ariel Rios Building
                  1200 Pennsylvania Avenue, N.W.
                  Washington, D.C. 20460-0001

                  Personal/Courier Service Deliveries

                  The following address must be used for all correspondence or data  submissions that are
           hand-carried or sent by courier service Monday through Friday, from 8:00  AM to 4:30 PM,
           excluding Federal holidays:

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       Document Processing Desk (AMEND) or (APPL), as applicable
       Office of Pesticide Programs (7504C)
       U.S. Environmental Protection Agency
       Room 266A, Crystal Mall 2
       1921 Jefferson Davis Highway
       Arlington, Virginia 22202

III. Non-Binding Statement

       This PR Notice provides guidance to EPA and to pesticide registrants.  This notice is not
binding on either EPA or pesticide registrants, and EPA may depart from the guidance provided in
individual circumstances.  Likewise, pesticide registrants may assert that the guidance is not
appropriate for a specific pesticide or situation.

IV. For Further Information

       If you have questions, contact the Labeling Team (703-308-9068/69), the appropriate Product
Manager (Registration  Division and Antimicrobial  Division) or Regulatory Action Leader
(Biopesticides and Pollution Prevention Division) for your product.
i
V
                                        Marcia E. Mulkey, Director
                                        Office of Pesticide Programs
                                          4

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 APPENDIX TO PR NOTICE 2000-5: GUIDANCE FOR WRITING CLEAR LABELING

 A. Mandatory Statements

       Mandatory statements generally relate to the actions that are necessary to ensure the proper
 use of the pesticide and to prevent the occurrence of unreasonable adverse effects, which means any
 unreasonable risk to man or the environment (including all living organisms and non-living things
 such as water,  soil,  air, property, etc.). Mandatory statements include directions for use and
 precautions that direct the user to take or avoid specific actions. The directions and precautions
 specify where,  when and how a pesticide is to be applied.  Mandatory statements are generally
 written in imperative or directive sentences (e.g., "Wash application equipment...," "Do not use...,"
 "Users must...," "Apply to com at a maximum rate of one to two pounds per acre 30 days prior to
 harvest.").  Either EPA or the registrant may develop mandatory labeling statements. When writing
 mandatory statements, both EPA and the registrant need to ensure that such statements meet the
 criterion above  that .the statement is necessary to ensure proper use of a pesticide and to prevent
 unreasonable adverse effects.

       The following directions and precautions are examples of mandatory statements:

       "Keep Out of Reach of Children."
       "Wear chemical resistant gloves."
       "If swallowed, call a doctor."
       "Do not induce vomiting."
       "Do not apply directly to water."
       "Do not apply within 66 feet of wells."
       "Keep away from heat, sparks and open flame."
       "Do not enter into treated areas for 12 hours."
       "Apply immediately after mixing."
       "Do not apply when wind speed exceeds 15 mph."

B.  Advisory Statements

       Advisory statements provide information to the product user on such topics as product
characteristics and how to maximize safety and efficacy while using the product. Such statements
are acceptable as  long as they do not conflict with mandatory statements, and are not false or
misleading.

       Advisory statements are best written in descriptive or nondirective terms. Phrasing advisory
statements  in straightforward, factual terms minimizes the possibility that they will conflict with
mandatory statements.  The use of certain words such as "should," "may" or "recommend" in
advisory statements has the potential to lead the product user to erroneously believe that he/she must
comply with such statements, when in fact such statements do mot have to be followed. These words
may also give the user the erroneous impression that a use that is not recommended is still somehow
permitted (that is, someone could believe that a particular use is permitted because a statement
recommending against such use does not have to be followed). To avoid these potential problems,

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the best way to  express  advisory statements is to use descriptive or nondirective language.
Nevertheless, EPA will allow the use of "should," "may," "recommend" or similar terms as long as
they do not appear to cause these kinds of problems.

       Following are hypothetical advisory statements followed by examples of how they can be
rewritten using descriptive terms, which is EPA's preference. These examples are arranged as
follows:  -'

       a.      A  typical label advisory statement as it may have been written prior to this PR
              Notice.
                                                                   L
       b.      The same advisory statement written in descriptive terms.

Precautionary Statements

1.     a.      Latex gloves are recommended.

       b.      Latex gloves provide the best protection.

Physical and Chemical Hazards

1.     a.      It is preferable to open containers of aluminum phosphide products in open air as
              under certain conditions they may flash upon opening.  Containers may also be
              opened near a  fan or other appropriate ventilation which will rapidly exhaust
              contaminated air.

       b.      Opening aluminum phosphide containers outdoors or indoors near an exhaust fan or
              other ventilation assures that the gas will be rapidly dispersed if the product flashes.

Directions for Use

Mixing

1.     a.      Tank mixtures should be applied immediately after preparation. If for any reason this
              is not possible, ensure that sufficient agitation has been provided to re-mix all
              products and check for complete resuspension prior to application.

       b.      Applying the product immediately after preparation assures that it is in suspension.
              If  application is  delayed, agitation to re-mix the products and checking for
              resuspension ensures proper blending.

Application

1.     a.      Factors such as depth to the drain system, soil type, and degree of compaction should
              be taken into account in determining the depth of treatment.

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       b.      The depth of treatment depends on the depth of the drain system, soil type, and
              degree of soil compaction.

2.     a.      It may be necessary to treat along one side of interior partition walls if there are
              cracks in the slab, plumbing entry points, existing termite infestations, or other
              conditions which would make treatment appropriate.

       b.      Treatment along one side of interior partition walls where there are cracks in the
              slab, plumbing entry points, existing termite infestations, or evidence of other
              means of access prevents further infestation.

3.     a.      Rotary hoeing is recommended for preemergence applications which do not receive
              adequate rainfall or sprinkler irrigation to wet the top 2 inches of soil or to the depth
              of germinating weeds within about 10 days after application.

       b.      If rainfall or sprinkler irrigation does not wet the top 2 inches of soil or depth of
              germinating weeds within 10 days of a preemergence application, rotary hoeing will
              ensure soil incorporation.

4.     a.      The spray mixture should be directed to the soil around base of the cotton plants.
              Care should be taken to prevent the spray from striking the cotton leaves as injury
              will occur.   The  use of leaf lifters or  shields on  application  equipment  is
              recommended to avoid spraying the cotton foliage.

       b.      Directing the spray mixture around the base of the cotton plants and using leaf lifters
              and shields on application equipment will help minimize foliage contact and plant
              injury.

Cleaning

1.     a.      It is recommended that the sprayer be thoroughly  cleaned by  flushing with a
              detergent solution at the end of each work day when any emulsifiable oil, oil
              concentrate, or other emulsifiable formulation has been used either alone or in tank
              mix combinations with other pesticide formulations, even if no obvious problems
              have been encountered. This precaution will ensure a clean sprayer and continued
              trouble-free operation.        .

       b.      If an emulsifiable oil, oil concentrate, or other emulsifiable formulation has been
              used, flushing the sprayer with a detergent solution at the end of the workday will
              ensure a clean sprayer and trouble-free operation.

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