CALIFORNIA NOTICE 96-4
      
      
      
      
      TO:      Economic Poison Registrants
      
      SUBJECT: REVISION OF CALIFORNIA'S NOTIFICATION
               PROCESS FOR MINOR CHANGES TO PESTICIDE
                   LABELS AND FORMULATIONS
      
      
      THIS NOTICE SUPERSEDES CALIFORNIA NOTICE 96-2 DATED
      MARCH 8, 1996.  THE PURPOSE OF THIS REVISION IS TO
      ADVISE REGISTRANTS OF THE REVISIONS TO CALIFORNIA'S
      NOTIFICATION PROCESS FOR MINOR CHANGES TO PESTICIDE
      LABELING OR FORMULATION. 
      
      SUMMARY OF THE CHANGES: Section I(D), "Changes in
      Package Size and Net Contents," has been moved from
      notification to nonnotification, with the exception
      of those product packages which are subject to child
      resistant packaging requirements; the Section "Other
      Minor Revisions" was removed; and, Section I(N),
      "Changes in the Stated Nominal Concentration," was
      added.  
      
      The following changes have been made in Section II: 
      "Changes in the name or address of the registrant on
      the label" and "Changes in package size and net
      contents" have been added.  
      
      The heading for Section III has been rewritten. 
      Section III(f) has been added to clarify that
      changes allowed by a U.S. Environmental Protection
      Agency (U.S. EPA) Pesticide Regulation (PR) Notice
      still must be submitted as a label amendment.
      
      Section IV, regarding submission requirements, has
      been changed to reflect the requirement for three
      labels.
      
      Section V(D) has been moved to Section V(E); and,
      Section V(D) has been changed to clarify that a
      registrant or their authorized agent will be
      notified of submissions which do not meet the
      criteria for notification. 
      
      California Notice 96-4
      Page Two
      
      
      
      The Department of Pesticide Regulation's (DPR)
      process is similar to U.S. EPA's notification
      process, but differs in certain areas.  This notice
      will identify those label changes which can be made
      through DPR's notification process, as well as those 
      that do not require notification, and those that
      require full review and evaluation as label
      amendments.
      
      Implementation of this procedure is part of our
      continuing effort to reduce the amount of time and
      effort utilized in processing minor label and
      formulation changes.  This should eliminate delays
      in processing minor changes.
      
      Attached is a revised Notification Form #039-031 to
      be used when submitting minor label or formulation
      changes which meet the notification criteria.  A
      copy of the federal notification document and other
      specified documents are also required to be
      submitted.
      
        I.  LABELING AND FORMULATION REVISIONS WHICH CAN   
            BE MADE BY NOTIFICATION TO DPR.
      
         A.   Deleting Pests or Use Sites.  All other
                    labeling references pertaining to the pest
                    or use site being deleted must also be
                    deleted.  Adding a pest or use site (except
                    indoor nonfood antimicrobial) cannot be
                    made by notification.  Use deletions
                    related to data call-ins are also allowed
                    by notification.
      
         B.   Adding Indoor Nonfood Sites for
                    Antimicrobial Products Provided that:
      
              No additional data (such as efficacy,
                    ecological effects, etc.) are required for
                    the added nonfood site; 
      
              Sites are within an already registered use
                    pattern for the product;
      
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              A directive does not explicitly prohibit
                    addition of nonfood sites;
      
              The technical product label does not
                    prohibit the proposed site;
      
              The dosage, concentration, frequency, or
                    method of application do not change.
      
         C.   Advisory Statements - Addition, Revision,
                    or Deletion.  Statements such as those
                    related to use precautions, efficacy, crop
                    damage, and product incompatibility may be
                    added or revised, provided that they are
                    not mandatory phrases and do not negate or
                    detract from the precautionary statements
                    or other label statements.  The addition,
                    deletion, or revision of statements cannot
                    trigger efficacy, human health, or
                    environmental concerns, and cannot change
                    the dosage, frequency, concentration, or
                    method of application.  The statements
                    cannot be false or misleading and cannot
                    negate or conflict with statements made on
                    any other product label which refers to use
                    of the subject product or chemical.  
      
              Advisory statements may be deleted. 
                    Examples of advisory statements include
                    "Product not recommended on natural marble
                    surfaces" and "This product should not be
                    used with products containing X due to risk
                    of explosive reaction."
      
              If you have questions regarding specific
                    advisory statements, please call the
                    registration specialist assigned to your
                    company.
      
         D.   Changes in Package Size and Net Contents of
                    Products Subject to Child Resistant
                    Packaging Requirements provided all of the
                    following criteria are met:
      
              Dosage, concentration, frequency, or method
                    of application do not change; 
      
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              Exposure is not likely to be increased; 
      
              Product is not a rodenticide.  Changes to
                    rodenticide package size and net contents
                    may not be made through notification, but
                    require submission as label amendment;
      
              No Worker Protection Standard labeling
                    statements are changed;
      
              Package size is not reduced to the point
                    that the net contents of the package is
                    smaller than the dosage required by
                    directions for use;
      
              Container size, net contents, or other
                    characteristics are not changed in a way
                    that violates U.S. EPA-mandated
                    restrictions;
      
              No changes are made to bait stations,
                    control stations, attractant stations, or
                    other packaging that houses the pesticide
                    during its use.
      
         E.   Adding Storage and Disposal Statements. 
                    The statements must be in compliance with
                    U.S. EPA PR Notices 83-3 and 84-1.
      
         F.   Adding Bilingual Labeling.  Labeling may be
                    added even though not required by U.S. EPA. 
                    The foreign text must be a true, complete,
                    and accurate translation of the English
                    text.  Both language versions of the
                    labeling must appear on a container in
                    their entirety.
      
         G.   Adding Symbols and Graphics.  Symbols and
                    graphics cannot substitute for, or conflict
                    with, label text, and cannot be false or
                    misleading.  Examples of acceptable items
                    include arrow diagrams demonstrating how to
                    open product containers; graphics
                    displaying application patterns, such as
                    aerial application, pictograms displaying 
      
      California Notice 96-4
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              various exposure routes, pictures of where
                    the product can be used, and pictures of
                    persons wearing appropriate protective
                    clothing.
      
         H.   Removal of Redundant Labeling Statements. 
                    Statements may be combined to remove
                    redundancy anywhere on the label, provided
                    that statements required by DPR or
              U.S. EPA are not removed or changed. 
      
         I.   Changes in Warranty Statement.  Warranty
                    statements may be revised provided they do
                    not disclaim the performance or safety of
                    the product when used in accordance with
                    label directions, and are otherwise
                    consistent with Food and Agricultural Code
              sections 12853 and 12854.
      
         J.   Changes in Source of Active Ingredient.  A
                    change in the source of an active
                    ingredient is allowed provided that there
                    is no resulting change in inert
                    ingredients.  The alternate source must be
                    U.S. EPA registered.
      
         K.   Correcting Typographical and Grammatical
                    Errors.  This includes typographical and
                    printing errors as well as changes in
                    grammar and phrasing that do not change how
                    the product will be used.
      
         L.   Revision, Addition, or Deletion of
                    Non-FIFRA Related Label Elements, such as
                    the following:
      
              Symbols and graphics required by other
                    governmental agencies (i.e., Department of
                    Transportation);
      
              Change in the analysis of a fertilizer
                    product;
      
              Date of manufacture or label approval;
      
      California Notice 96-4
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              Use of metric units in addition to standard
                    United States units for net contents,
                    dosages, and other numeric expressions.
      
         M.   Redesign of Label Format.  A registrant may
                    redesign a label's format provided the
                    redesign does not modify approved label
                    text and is consistent with state and
                    federal format requirements and policy. 
                    This may include, among other things,
                    changes in color, type size, or style, use
                    of space, configuration or placement of
                    label elements.
      
              N.   Changes in the Stated Nominal
                         Concentration.  A registrant may change the
                         stated nominal concentration of any inert
                         ingredient by notification, provided that:
      
                   The nominal concentration falls within the
                         certified limits for that inert ingredient
                         as listed on the accepted confidential
                         statement of formula (CSF); and 
              
                   The composition of the ingredient is known
                         to the registrant.
      
       II.  CHANGES THAT CAN BE MADE WITHOUT NOTIFICATION  
            TO DPR (NOTE: MAY REQUIRE FEDERAL NOTIFICATION)
      
              The source of an inert ingredient may be
                    changed without notification;
      
              The source of starting materials for
                    integrated systems products may be changed
                    without notification;
      
              The formulation process of a product made
                    by a nonintegrated system may be changed
                    without notification.
      
              Change in the name or address of the
                    registrant on the label provided that:
      
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              The registrant has notified DPR of a
                    change in its company name, address, or
                    designated agent as required by California
                    Code of Regulations sections 6154 and
                    6170.5 before making changes to any
                    registered labels.
      
              Changes in package size and net contents
                    provided all of the following criteria are
                    met:
      
              Dosage, concentration, frequency, or
                    method of application do not change; 
      
              Product is not subject to child resistant
                    packaging before or after the change;
      
              Exposure is not likely to be increased; 
      
              Product is not a rodenticide.  Changes to
                    rodenticide package size and net contents
                    may not be made through notification, but
                    require submission as label amendment;
      
              No Worker Protection Standard labeling
                    statements are changed;
      
              Package size is not reduced to the point
                    that the net contents of the package is
                    smaller than the dosage required by
                    directions for use;
      
              Container size, net contents, or other
                    characteristics are not changed in a way
                    that violates U.S. EPA-mandated
                    restrictions;
      
              No changes are made to bait stations,
                    control stations, attractant stations, or
                    other packaging that houses the pesticide
                    during its use.
      
      III.    CHANGES WHICH MUST BE SUBMITTED TO DPR FOR
                    REVIEW AND APPROVAL AS LABEL AMENDMENTS.
      
         A.  Alternate brand names;
         
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         B.  Addition of any pests;
         
         C.  Any increase or decrease in the percentage                   
             of an active ingredient;
      
         D.  Any inert ingredient change in identity or 
              percentage;
      
         E.   Any change in the name or address of the
                    registrant other than as described in this
                    notice;
      
         F.   Any change as allowed by a U.S. EPA
              PR Notice.
      
       IV.  SUBMISSION PROCESS FOR NOTIFICATION.
      
         The registrant should identify the submission
               with a statement such as "Minor label or
               formulation change per CA Notice 96-4" in the
               cover letter, and attach a completed
               Notification Form, #039-031.
      
         Address submissions to:
      
              Notification Project
              Pesticide Registration Branch 
              Department of Pesticide Regulation
              830 K Street, 9th LL
              Sacramento, CA 95814-3510
      
         Requests may also be hand-carried or courier
               delivered Monday through Friday, 8:00 a.m. to
               4:30 p.m., excluding State holidays.
      
         Attach a copy of the federal notification
               document and any other documents submitted to
               U.S. EPA in support of the federal
               notification.  (There would not be any federal
               documents for California-only products since
               federal registration is not required.)
      
         For label changes, attach three copies of the
               final printed or printer's proof proposed
               label.
      
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         If you are informing us of changes that you
               have made to your formulation, attach one copy
               of the Application for Registration of Economic
               Poisons (Pesticides) form with items 20-29
               filled out.  In lieu of filling out 
               items 20-29, you may attach the federal CSF  
               to the application.  In either case, remember
               to sign and date the application form.  In
               addition, submit any supporting information,
               such as Material Safety Data Sheets, that you
               have for proposed inert ingredients.
      
        V.  ADDITIONAL INFORMATION
      
         A.   A product distributed or sold with a
                    changed label that was changed without
                    following California's notification
                    criteria is considered misbranded and
                    subject to an enforcement action. 
      
         B.   Registrants of California-only products
                    (which do not require federal
                    registration) may utilize the notification
                    process for those label changes which meet
                    the criteria.
      
         C.   When change of a labeling or formulation
                    is permissible by notification, the
                    notification must be received by DPR
                    before the registrant may distribute or
                    sell the product with the changed label or
                    formulation.  Registrants should submit
                    the necessary documentation in a manner
                    that will provide date-specific
                    verification that delivery to DPR has been
                    accomplished.  Submission by registered or
                    certified mail or courier service is
                    recommended.  A product distributed or
                    sold with a changed label before the
                    notification documents and final printed
                    labels are received is misbranded.
      
         D.   The registrant or authorized agent will be
                    notified only if the submission does not
                    meet the criteria for notification.
      
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         E.   If a registrant has an application for
                    amended registration pending with DPR
                    which qualifies for notification pursuant
                    to this notice, the registrant may: 
              (1) send a letter to the registration
                    specialist assigned to its company
                    requesting that the application for
                    amended registration be withdrawn; and 
              (2) submit a Notification Form and all
                    other required information to the address
                    above. 
      
       VI.    QUESTIONS REGARDING THIS NOTICE
      
      If you have questions about this Notice and not
      about your specific products, you may call 
      Mr. Richard Bireley in the Pesticide Registration
      Branch, at (916) 324-3930.  If you have questions
      about your specific products, please contact the
      registration specialist assigned to your company.
      
      Sincerely,
      
      
      
      
      
        Original Signed by                   8-12-96
      _____________________________         _________________
      Barry Cortez, Chief                     Date
      Pesticide Registration Branch
      (916) 445-4377
      
      Attachment: Notification of Minor Changes
      (PDF Format)