US Environmental Protection Agency
Office of Pesticide Programs


Petition for Pyriproxyfen

April 11, 2002

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08/20/2003 WED 01:43   FAX                                                                     ilOOl/004
      1333 North California Blvd.                               , J(KB __
      Suit* 600                                         Ua *m 75|<
      P.O. Box 8025
      Walnut Creek. CA 94596-8025
      (925)256-27                                      April 11,2002

                                                      Extension of the Period of Exclusive Data
                                                      Use For the Active Ingredient
      Mr. Marion Johnson
      Product Manager Team 10
      Office of Pesticide Programs (H7505C)
      Document Processing Desk (AMEND)
      U.S. Environmental Protection Agency
      Room 266A, Crystal City Mall 2
      1921  Jefferson Davis Highway
      Arlington, Virginia 22202

      Dear  Mr. Johnson,

      Valenl U-S-A. Corporation is in the seventh year of a ten-year period of exclusive data use for the
      active ingredient pyriproxyfen. The ten-year exclusivity statute is established under FTFRA Section
      3(c)(l)(FXi). Valent U.S.A. is eligible for and requests extension of the exclusivity period for an
      additional  three  years  as estabUshed  under PIFRA Section 3(cXlXF)(ii). The extension is
      determined by the number of minor use registrations for the active ingredient, with one additional
      year of exclusivity granted for every 3 minor use registrations, up to a maximum of three years. At
      this time, Valent U.S.A.  has twelve minor use registrations as defined by the  statute, with an
      additional six minor use registrations  on the OPP registration Work Plan to be completed by June
      2002. Therefore, pyriproxyfen  qualifies  for  an  additional three  years  of exclusive  use data
      protection.

      Current Pyriproxyfen Registrations

      Pyriproxyfen was fust granted U.S. registration-on September 15, 1995 (Sumilarv Technical Grade,
      EPA  Reg. No. 10308-11), and  is the active ingredient contained in the following Valenl  U.S.A.
      end-use products:

      End  Use Product                        EPASegJVa..

      Knack Insect Growth Regulator             59639-95
      Distance Insect Growth Regulator          59639-96
      Esteem Insect Growth Regulator           59639-104
      Esteem Ant Bait                          59639-114
      Esteem 35 WP Insect Growth Regulator     59639-115
      Valent U.S.A. Corporation

                                                                                  08/20/2003   10:58AM

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      Mr. Marion Johnson	Eagfi?.of.4	April!!. 2QQ2

      Criteria Used to Determine the Number of Minor Use Registrations for Pyriproxyfen

      In determining the total number of minor use registrations to be applied toward the pyriproxyfen
      exclusivity extension, the following criteria were used:

      A, One minor use registration for which data has been provided may be counted.
      B. One minor vise for each representative crop under a registered crop poup may be counted. If the
         representative crop is major, a minor crop may be substituted and therefore counted,
      C. A minor use registration may be counted regardless of a tolerance requirement. For example, a
         minor use registration for ornamentals is counted toward exclusivity, even though a tolerance is
         not required for the ornamental crop registration.

      Summary of Minor Use Registrations for Pyriproxyfen

      Number of
      Minor ()aes   flritmfi    ._.   	Crop / Knd T Ise Pmdnct / Ratifroilg	

          3        A & B     Citrus crop group^ Knack IGR, Esteem IGR, Esteem 35 WP IGR,
                              Esteem Ant Bait. Three representative crops. Minor uses include lemon,
                              grapefruit and tangerines (substitution for orange).
          3        A & B     Fruiting vegetable crop group- Knack IGR, Esteem IGR. Three
                              representative crops.  Minor uses include pepper, jalapeoo and eggplant
                              (substitution for tomato).
          2        A & B     Tree nut crop group-  Knack TOR, Esteem IGR, Esteem 3 5 WP IGR,
                              Esteem Ant Bait Two representative crops. Minqr uses include walnut
                              and Brazil nut (substitution for almonds).
          1           A      Pear- Knack IGR, Esteem IGR, Esteem 3 5 Wp IGR, Esteem Ant Bait.
          1           C      Ornamentals-Distance IGR.
          1           A      Pistachio (bearing)- Esteem Ant Bait. SLN CA-010029.
          1           C      Olive (non-bearing)-  Esteem Ant Bait.

      Total: 12

      Pending Pyriproxyfen Minor Use Registrations

      EPA's third quarter work plan, which is due for completion by June  2002, includes pyriproxyfen
      rcgislTdlion on stone fruit, which includes three representative crops (all minor), guava lychee and
      blueberries.  If  completed  as scheduled,  the  pending  registrations  would add six minor  use
      registrations toward the exclusivity extension.

      Additional Requirements

      In addition  to  meeting the  minor  use registration requirements, pyriproxyfen also  meets the
      chemical  characteristics  and  use requirements set forth under  FIFRA Section 3(c)(I)(F)(ii).
      Pyriproxyfen is  a reduced risk compound, providing control of insect species with no known toxic
     valent U.S.A. Corporation

                                                                                 08/20/2003   10:58AM

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08/20/2003  WED 01:43  FAX
                                                     HQ03/004
      Mr Marinn
. Page. 1 of 4
                                                                               April
      effects to humans, other mammalian species or endangered species. Pyriproxyfen poses a reduced
      risk to the environment as well, with low use rates, rapid degradation in the environment, and low
      leacMng potential.  With its unique mode of action  as a juvenile hormone mimic in insects,
      pyriproxyfen end-use products are an integral part of both integrated pest management programs
      and pest resistance management programs in minor crops.

      Independent support for the value of pyriproxyfen in pest management programs for minor crops
      may be found through inspection of Pest Management Strategic Plans (PMSFs) which have been
      facilitated by USDA's Office  of Pest Management  Policy.   Of the minor uses  listed above,
      PMSPs have been finalized for peaches (FT,,  GA, MI,  NC, NJ, PA, SC, CA), tart cherry (MI) and
      blueberry (MI).

      The PMSP for peaches hi FL, GA, MI, NC, NJ, PA, and SC noted a critical need for scale insect
      control, and a regulatory need for reduced-risk products with multiple modes of action, especially
      in light of current Agency scrutiny of existing organophosphate tools.  This PMSP also identifies
      Oriental Fruit Moth  as  the key pest in peach production  in the  Midwest and Northeast.
      Pyriproxyfen provides excellent control of San Jose Scale and Lecanium Scale, and suppression
      of Peach Twig Borer and Oriental Fruit Moth, with a unique and reduced-risk mode of action.
      Finally, the California peach  PMSP identifies registration of pyriproxyfen specifically as the
      number one critical need in California peach production "in order to better manage San Jose
      scale and reduce dependence on organophosphates."

      In addition to the above-mentioned PMSPs, USDA  has developed "Crop Profiles" describing
      production practices for many crops in many states, Although the Crop Profiles do not provide
      direct recommendations for pest  management needs  as do the PMSPs, they are instructive in
      describing  current pest management practices  which could benefit from  the introduction of
      pyriproxyfen.  Following  is a table with a sampling of minor use crops, states, and current
      chemical controls, which are listed for use to control pests on the pyriproxyfen label.  In some
      cases pyriproxyfen itself is already listed.  All information  presented  in the  table was excerpted
      from USDA Crop Profiles published at hiip:/Avwm
CROP
Bedding Plants
Bell Pepper
Chrysanthemum
Citrus


STATE
WA
CA
OH
CA
CA
AZ
PEST
Fungus gnats
Silverleaf
Whiteflv
Whiteilies,
fungus gnats
California
Red Scale
Cottony
Cushion Scale
Woolly
Whitefly
CHEMICAL CONTROLS
bifcnthrin
Dirnethoate, endosulfan, naled, oxamyl
Imidacloprid, acephate, chlorpyrifos, endosulfan,
bifenthrin, fcnpropathrin, azadirachtin,
diflubcnzuron. S-kinoprene, sulfotepp, nicotine
Pyriproxyfen*, buprofezin, chlorpyrifos*, carbaryl,
methidathion, oil f*also in AZD
Pyriproxyfen, buprofezin, malathion,
meinidaihion
pyriproxyfen
      Valerll U.S.A. Corporation
                                                                               08/20/2003   10:58ftM

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                                                                                              i!004/004
      Mr. Marinn
                                                                                pril


Citrus (minor)
Eggplant
Olive
Ornamentals
Pear


Plum
CA
CA
FL
FL
CA
FL
CA
CA
OR
CA
Black Scale
Southern Fire
Anl
Scales
SUverleaf
Whiteflv
Black Scale
Whiteflies,
scales, fungus
j?nats
Pear Psvlla
Codline Moth
Sam Jose
Scale
San Jose
Scale
Methidathion, carbaryl, oil
Chlorpyrifos, avermectin
Bthion, Chlorpyrifos, malathion, methidathioa,
azadiraehtiri
Imidacloprid, endosulfan, permethrin
Carbarvl. rnethidathion, oil
Imidacloprid, acephate, diazinon, dimethuale,
Chlorpyrifos, endosullan, bifenthrin,
fenpropathrin. azadirachtin. S-kinopreoe. oil
avennectin. csfcnvalcratc. pcimcttein, amitraz, oil
Azinphos-methvl, methvl parathion, phosmet
OP + oil ai dormat growth .stage
CMorpyrifos, diazinon, carbaryl, methidatMon,
methyl pamthion, phosmet
      Thank  you  for  youi-  consideration of ow  three-year  exclusive use  extension  request fof
      pyriproxyfen. If you have any questions, please contact me at (925)  256-2852 or Eric Maurer,
      located at Valent U,S,A,'s Washington, D.C. office, at (202) 872-4682.

                                                  Sincerely.
                                                 Harry Radke
                                                 Project Manager' Pyriproxyfen
                                                 Registration and Regulatory Affairs
     Valent U.S.A. Ctxp(xaUon
                                                                               08/20/2003   10:58ftM

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