US Environmental Protection Agency
Office of Pesticide Programs
Petition for Pyriproxyfen
April 11, 2002
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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
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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
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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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