\       UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
       ? •                   WASHINGTON, D.C. 20460   '
                                     •  ;               "•.-..'- OFFICE OF   »
                                 Julv29  1998     i             PREVENTION. PESTCIDES AND
                                  M*   '                           tOXIC SUBSTANCES
                 PESTICIDE REGISTRATION (PR) NOTICE 98-6

         NOTICE TO MANUFACTURERS, PRODUCERS, FORMULATORS
                AND REGISTRANTS OF PESTICIDE PRODUCTS
ATTENTION:   Persons Responsible for Federal Registration and Reregistration of
  ,           -  Pesticide Products    -

SUBJECT:     Flammability Labeling Requirements for Total Release Fogger
               Pesticides  '
      This notice describes new labeling requirements for total release foggers and
provides the procedures and time frame for compliance. It ONLY affects total release "
foggers containing a-propellant with a flash point at or below 20 degrees Fahrenheit.

I.     BACKGROUND
              '.                                  .•••:.•
  -..'  On.February 23, 1998, EPA issued a regulation (40'CFR part 156.10) requiring
additional Jabeling for total release fogger pesticides [63 FR 9077].  This rule .was*
effective on April 24,1998. These new requirements add/modify the precautionary
statements and directions for use on total release foggers. This1 PR Notice provides
guidance on how to comply with the new rule.                    '

II-    APPLICABILITY    ;

      The rule defines a total release fogger as an aerosol pesticide product designed
to automatically release the total contents in one operation, for the purpose of creating
a permeating fog within a confined space to deliver the pesticide throughout the space.
This PR Notice applies to all pesticide products which are total release foggers
containing a propellant with a flash point at or below 20 degrees Fahrenheit.  Products
that have a "dual action" valve that allows the product to be used as a space spray pr
as a total release fogger are subject to this notice.
          Rocycled/Recyclabfo". Prn.jeo wir- Vegeiaofe Oil Based Inks on 100% Recyciea Paoer (4C% Postconsumer\

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                                                                                        I

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       EPA records indicate that approximately 220 products meet the definition of a
 total release fogger.  About sixty-five registrants hold these registrations.

       If you hold a registration for a product that is subject to this notice, continue
 reading and follow the instructions as shown below.
                                           • ,    \          • •           •      '
 III.     WHAT YOU NEED TO DO

       A.    Changes to the Physical or Chemical Hazard statement:
                  r

       Retain the existing Physical or Chemical Hazard statements and add the
following statement to the "Physical or Chemical Hazard" section on your label:

       This product contains a highly flammable ingredient. It may cause a fire
       or explosion if not used properly. Follow the."Directions for Use" on this
       label very carefully.

       In addition to this required language, a graphic symbol such as illustrated below
or an equivalent symbol, must be displayed adjoining the "Physical or Chemical
Hazard" statement. The graphic symbol must be no smaller than twice the size of the
first character of the human hazard signal word. Also, the two phrases shown below
must be presented near the graphic symbol.
                          Highly Flammable Ingredient
                        Ingrediente Altamente Inflamable

      B.    Changes to the Directions for Use:

      Add the following label text to the Directions for Use section:

      DO NOT use more than one fogger per room. DO NOT use in small,
      enclosed spaces such as closets, cabinets or under counters or tables.'
      Do not use in a room 5 ft. x 5 ft. or smaller; instead, allow fog to enter from
      other rooms, Turn off ALL ignition sources such as pilot lights (shut off gas
      valves), other open flames or running electrical appliances that cycle off
      and on  (i.e., refrigerators, thermostats, etc.).  Call your gas utility or
      management company if you need assistance with  your pilot lights.

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       Review the existing language on your label and remove any conflicting or
 redundant statements to the above required language.

 IV.    RECOMMENDED PRESENTATION

       The Agency recommends that the information necessary for safe use of foggers
 (including the above required labeling) be presented in a manner that most effectively
 conveys necessary information to the user. Therefore, registrants are encouraged to
 use contrasting color (use of different colors for text), bolding, all caps and large fonts
 for certain text,  and intrusive borders (bold, thick lines) to segment information on
 labeling. The Agency further recommends that the sentence "Turn off ALL ignition
 sources such as pilot lights (shut off gas valves), other open flames or running electrical
 appliances that cycle off and on (i.e., refrigerators, thermostats, etc.)" in the above
 required text be printed on the label in bold type, or in some other way as to highlight
 the text as very important.         .

       Also, illustrations can enhance the user's comprehension and understanding of the
 directions for safe use. Specifically, illustrations (pictures, graphics or drawings) that depict
 the right and wrong way to use the product are suggested as-a means of enhancing user
 understanding.  The illustrations depicting the wrong way should be shown with a  large X
 or a standard slash mark (/) superimposed  over the illustration.
             '''._'          "         .          :         •<'•'.
       Registrants are encouraged to contact the individual shown at the end of this notice
 for additional guidance regarding the presentation?of the necessary information on the
 label.          '    "..'••        .     .              *

 V.     HOW TO COMPLY

       In order to remain in compliance with FlFRA, registrants of products subject to this
 notice should take either of the following actions:

       (a)    If you adopt the label .statements exactly (word for word) as specified in this
 notice, you may submit a notification (according to PR Notice 95-2 or the current guidance
 on submitting notifications) for each product. Submit a copy of the label with a completed
Application for Registration form (EPA  Form 8570-1). A photocopy of the EPA application
form is acceptable. The application should bear the following statements:         .

             "Notification of label change per PR Notice 98-6.  This notification is
           .-  consistent  with the  provisions' of PR Notice 98-6  and  EPA
             regulations at 40 CFR 156.10 and 40  CFR  152.46, and no  other
             changes have  been made  to the labeling or the  confidential
             statement of formula of this product.   I understand  that it is a

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             violation of 18 U.S.C. Sec. 1001 to willfully make any false statement
             to EPA. I further understand that if this notification is not consistent
             with the terms of PR Notice  98-6, 40 CFR 156.10 and 40 CFR
             152.46, this  product may be  in  violation of FIFRA and I may be
             subject to enforcement action  and penalties under sections 12 and
             14 of FIFRA."

      (b)     You may propose an alternative approach or design (not wording) for
adding flammability warning language to your product label(s). Any alternative
approach or design must distinctly warn the  user of a fire or explosion hazard and
provide clear user directions for reducing the hazard in order to be accepted. Your
cover letter or amendment form must justify  your approach.  EPA will determine the
acceptability of alternative approaches and designs on a case-by-case basis. You
should allow sufficent time for the processing of amendments. If you wish to change
your label in this manner, submit an application for amended registration.  This
application should include the following items: a completed EPA application form 8570-
1, three copies of the draft label, and your justification for the alternative approach on
the application, in addition to, "Amended in accordance with  PR Notice 98-6."

      If you believe that your particular type of total release fogger product should be
given special consideration for a variance from the required language as stipulated in
the rule, you may submit an application or amendment for such consideration as
explained above. EPA will consider such requests on a case-by-case basis, however,
EPA believes very few foggers should  not be labeled in accordance with the rule.

      You should send notifications and /or applications for amendment to one of the
appropriate following addresses.

U:S. Postal Service Deliveries

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

      Document Processing Desk (AMEND) or. (NOTIF) [as applicable]
      Office of Pesticide Programs (7504C)
      U.S. Environmental  Protection Agency
      401 M Street, S.W.        .                     .    -   ,
      Washington, D.C. 20460-0001

Personal/Courier Service Deliveries

      The following address should be used for all correspondence or data
submissions that are hand-carried or sent by courier service Monday through Friday,

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from 8:00 AM to.4:30 PM, excluding Federal holidays:

      Document Processing Desk (AMEND) or (NOTIF) [as applicable]
      Office of Pesticide Programs (7504C) -,              ,
      U.S. Environmental Protection Agency
      Room 266A, Crystal Mall 2
      1921 Jefferson Davis Highway
      Arlington, Virginia 22202
VI.  PAPERWORK REDUCTION ACT
     11     ' -~" ~"-"  . —'' ~-  •  ~ "          -       ~          •* •         r .'--"     •

    The Office of Management and Budget (OMB) has approved the information
collection requirements contained in the rule under the provisions of the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq. and has assigned OMB control number
2070-0060.                         -                                    ;

    The public reporting burden for this collection of information is estimated to
average 0.85 hours per product, including time for reviewing instructions, searching
existing data sources, gathering and maintaining the data needed, and completing and
reviewing the collection information. However, by using this guidance the time burden
for compliance may be reduced.                                    '

    Send comments regarding the burden estimate or any other aspect of this
collection of information,  including suggestions for reducing this burden, to Chief,  OPPE
Regulatory Information Division;  Environmental Protection Agency (2137),, 401 M St.,
S.W., Washington, DC 20460; and to the Office of Information and Regulatory Affairs,
Office of Management and Budget, Washington, DC 20503, marked "Attention: Desk
Officer for EPA."    '. ,   ,               .      :       ;    •"'...•'.;

VII.  COMPLIANCE DATES

       A.     Existing Products.

       Registrants of currently registered total release foggers subject to this notice must
submit revised labels by either of the methods.indicated in Section V. All  total release
foggers subject to this notice released for shipment by registrants .after'October  1,1999
should  bear labeling that  is consistent with this notice.  After that, EPA may  initiate
cancellation proceedings under FIFRA section 6, or an enforcement action for misbranding
under FIFRA,12(a)(1)(E), for any total release fogger registration not in compliance with
the requirements of FIFRA and the final rule.
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       B.    New Registrations

       Effective immediately, the Agency will not approve a registration for a total release
fogger within the scope of this notice unless  the label  complies with these labeling
requirements.
VIII.  FOR ADDITIONAL INFORMATION

       If you have questions regarding this Notice, contact Jim Downing of the Labeling
Team at (703) 308-9071.
                                           (/James Jones, Director -
                                            Registration Division (7505C)
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