US Environmental Protection Agency
Office of Pesticide Programs
EPA Response to Petition for Indoxacarb
September 10, 2009

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^ ;	UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
\	9	WASHINGTON, D.C. 20460
\
OFFICE OF
4	PREVENTION, PESTICIDES AND
SEP 1 0 2009	TOXIC SUBSTANCES
Dr. Richard Carver
DuPont Crop Protection
Stine-Haskell Research Center
P.O. Box 30
Newark, DE 19714-0030
Dear Dr. Carver:
Subject: Request for extension of exclusive use data protection for data submitted
for Indoxacarb Technical (EPA Registration No. 352-594)
The Agency GRANTS your petition for an exclusive use data protection under EPA
Registration No. 352-594 for an additional three (3) years. Exclusive use protection for data
submitted in support of this registration which complies with 40 CFR 152.83(c)) will expire on
October 30, 2013.
This letter is in response to your petition dated October 16, 2007 that data associated with
the registration of the active ingredient indoxacarb receive extensions for the exclusive use
period. You cited FIFRA section 3(c)(l)(F)(ii) as the authority for the Agency to make such a
determination.
The 1996 Food Quality Protection Act (FQPA) amendments to FIFRA incorporated this
subsection under 3(c)(1)(F), the section that provides for protection of certain data submitted in
support of pesticide registrations. FIFRA section 3(c)(l)(F)(ii) sets forth the criteria for
extending the period of exclusive use protection. The period of exclusivity can be extended one
year for every three minor uses registered within the first seven years of an original registration
whose data retains exclusive use protection, with a maximum of an additional three years of
exclusive use protection.
The first step in determining whether data qualifies for an extension of its exclusive use
period is to ascertain which data have exclusive use protection. FIFRA section 3(c)(l)(F)(i) and
its implementing regulations carefully circumscribe the set of data that are eligible for exclusive
use protection. A study entitled to exclusive use protection is defined in 40 CFR 152.83(c).

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Pursuant to 40 CFR 152.83(c). the following requirements must be met for a study to t e
considered an exclusive use study;
(1) Hie stud}" pertains lo a new ac'.ive ingredient (new chemical) or r ev\ combination
of active ingredients (new comaination) first registered after September 30, 1 978;
and.
(2 j The study was submitted in support of. or a condition of approval of. the application
resulting in the first registraiio i of a product containing such new chemical or new
combination (first registration), or an application to amend such registration to add a
new use; and
(3) The study was not submitted lo satisfy a data requirement imposed under FIFRA
Section 3(e){2)< B);
Provided that, a studs' is an exclusive use study only during the 10-year period
following the date of first registration.
The following is our analysis for determining whether the data associated with the
registration you have cited contains exclusive use data. First, the data associated with this
registration do pertain to. or have been derived from testing on. a new active ingredient.
Second, the data must have been submitted in support of the first registration of the new
chemical/ The registration you cited was granted October 30. 2000 and was the first registration
for itidoxacarb with the product name indoxacarb technical.
Please note, because exclusive use protection is not available for studies that the Agency
requires to maintain registration in effect under FIFRA section 3(c)(2)(B) any such data
associated with this registration will not receive exclusive use protection under FIFRA section
3(c)( 1 )(F)(ii).
Now that the Agency has determined that studies associated with this registration are
exclusive use studies", we must determine whether you have met the criteria for extending the
exclusive use protection period pursuant la FIFRA section 3(c)( 1 )(F)(n). and if so by how many
years.
FIFRA section 3{c)(l )(F)(ii) states i l pertinent part:
1 Data are not protected solely because they pertain to the new chemical but because they are submitted in support
of a particular product registration of a new chemical. Thus, data submitted to support an application for the second
(and later) registrations, by whatever applicant, of a product containing the same new chemical acquire no exclusive
use protection, Additionally, data submitted in support of subsequent amendments to add new uses to the first
registration of a product containing the new chemical gain such protection, but the protection is limited to data that
pertain solely to the new use. Thus, for example, i'lfe new use is approved after eight years of registration, the data
supporting that use would gain exclusive use protection for onh two \cars. Sec 49 i-'R 30884. 30889
Because the requestor did not attach a list of data they believe retain exclusive use protection, this response is
general in nature if the Agencj receives an application for registering an identical or substantial^ similar pesticide
during the extension period citing the requestor's data, it will then address whether those data have the extension of
data protection.

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The period of exclusive data use p "ovided under clause (i) shall be extended 1 additional
year lor each 3 minor uses registeieci after the dale of enactment of this clause and within
7 years of the commencement of the exclusive use period, up to a total of 3 additional
years for all minor uses registered by the Administrator if the Administrator, in
consultation with the Secretary of Agriculture, determines that, based on information
provided by an applicant for registration or a registrant, that-
(I)	there are insufficient efficacious alternative registered pesticides available for the
use: or
(II)	the alternatives to the minor use pesticide pose a greater risk to the environment
of human health; or
(III)	the minor use pesticide p a\ s or will play a significant part in managing pest
resistance: or
(IV)	the minor use pesticide plays or will play a significant part in an integrated pest
management program.
The registration of a pesticide for a minor use on a crop grouping established by the
Administrator shall be considered for purposes of this clause 1 minor use for each
representative crop for which data are provided in the crop grouping. Any additional
exclusive use period under this clause shall be modified as appropriate or terminated if
the registrant voluntarily cancels .he product or deletes from the registration the minor
uses which formed the basis for the extension of the additional exclusive use period or if
the Administrator determines that the registrant is not actually marketing the product for
such minor uses.
The initial registration of indoxacarb cccurred on October 30. 2000 and included the
following 9 uses that you petitioned the Age icy to consider towards extension of the exclusive
use period: cabbage; broccoli: tomatoes; peppers: head lettuce; leaf lettuce: apples; pears; sweet
corn. The petition also requested consideration of the following 14 uses w hich were registered
on July 16. 2007: mint; southern pea: cranberry; collards; mustard greens; plum: peach: sweet
cherry; sour cherry; summer squash; cucumber; cantaloupe; spinach and celery. As required by
the statute, the aforementioned uses were all registered within the requisite seven year time
period.
After reviewing the currently approved labeling, the Agency has determined that the
following 22 uses qualifv toward the request for extension of exclusive use da;a protection:
cabbage: broccoli; collards; tomatoes: peppers; head lettuce; leaf lettuce: apples; pears: mint;
southern pea; cranhem: mustard greens; plum; peach: sweet eheiry; tart (sour) cherry; summer
squash; cucumber; cantaloupe: spinach and telen .
The Agency determined that sweet corn does not meet the acreage definition of a minor
crop. i.e.. the total I niteJ States acreage Cor the crop is less than 300,000 acres. See The United
States Environmental Protection Agency Report on Minor I rses of Pesticides, "ound at
. for more information about minor
and major crops. A major crop ma> be counted towards extension of exclusive use protection if

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the data generated to support ihe major crop also support the registration, labeling and marketing
of the product on a minor crop(s) in a crop group. In this case, sweet corn is the only commodity
in the cereal grains crop grouping which h on the indoxacarb label so it is not eligible to be
counted towards an extension oi exclusive use data protection. Apples are considered a major
crop as the}' are grown on more than 300,000 aces. However, in this case the generation of apple
data supported the registration, labeling and marketing ofindoxacarb on the following minor
crops in the pome fruits crop group; crab apple, loquat. ma\haw and quince. There fore the minor
uses associated with the apple data are eligible uses lor extension. The same :s true for tomatoes
which are also grown on o\ er 300.000 acres in the United States. Data gene/ated to support the
registration ol tomatoes also supported the registration, labeling and marketing ofindoxacarb on
the following minor crops, eggplant, grou id cherry, pepino and tomatillo. wh'eh are in the
fruiting vegetable crop group.
In addition to meeting the minor use requirements. FIFRA section 3(e)( 1 )fF)(ii) requires
that one ol the criterions I-1V as staled aho\ e be met. DuPont Crop Protection submitted
information lor criteria i. Ill and IV. The Agenc_\ evaluated the information submitted by
DuPont Crop Protection and determined the following:
In support of criterion I, "there are insufficient efficacious alternative registered pesticides
available for the use," DuPont Crop Protection indicated that FIFRA section 18 emergency
exemptions were granted for use of indoxacarb on cranberries in Massachusetts in 2002 and
col lards in Georgia in 2003. Section 18s are only granted for pesticide uses with no effective
alternatives and in both cases the section 18 requests were lenewed prior to tne use being
registered, ihe Agency believes that the lack of ctheacious alternatives for cranberries and
coltards still exists. The cranberry and collard uses were registered on Juh 1 (:. 2007, within the
requisite sex en year time period. The Agency agrees that this evidence supports criterion 1 for
cranberries and collards.
With regard to criterion 111, "the mino" use pesticide plays or will pla\ a significant part in
managing pest resistance, the Agenc_\ conc.uded that indoxacarb lias a no\el mode of action
which makes it a useful tool for pesticide resistance management for 22 of the eligible uses fall
uses requested except sweet corn). 1 he uses include cabbage, broccoli, tomatoes, peppers, head
lettuce. leaf lettuce, apples, pears, mini, southern pea, cranberry, collards. mustard greens, plum,
peach, sweet cherry, sour eherrv. summer squash, cucumber, cantaloupe, spinach and celery.
The following information submitted by the applicant from the California Department of
Pesticide Regulation also supports the claim that the use of indoxacarb meets criteria III for
apples, pears, tomatoes, broccoli, cabbage, peas, peppers and lettuce,
Many insects have developed resis lance to conventional pesticide chemistries, such as
organophosphates. carbamates, and pyrethroids. To combat these pesticide resistant pests
new chemistries have been developed with novel modes of action unrelated to previous
chemical classes to replace the old chemistries. Indoxacarb is a non-systemic, synthetic
organophosphate replacement insecticide that has good field activity against a number of
l.epidoptera pests, as well as certain Homoptera and Coleoptera pests

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Indoxacarb. a broad spectrum foliar insecticide, is registered for use on a broad range of
crops, which include fruits (apples, pears, and tomatoes), vegetables (bok choy. broccoli,
Brussels sprouts, cabbage, cauliflower, Chinese cabbage, corn, eggplant, kohlrabi, peas,
peppers, potatoes, and lettuce), soybeans, alfalfa, and cotton. It controls or suppresses
many insects, including beet army worm, cabbage looper. com car worm, diamond back
moth, fall armyworm. imported eabhageworm. southern armyworm, tomato pin worm,
and tomato fruitworm.
With regard to criterion IV. lhat indoxacarb plays or will play a significant part in an
integrated pest management program (IPM) for the requested uses, the Agency concluded that
indoxacarb plays a significant pari in 1PM p:o grams for peaches as evidenced by the
Experimental L'se Permit for indoxacarb which was requested by university tree fruit
entomology specialists for their multi-state IPM-hased Risk Avoidance and Mitigation Program
(RAMP) grant. Indoxacarb was found to ,ie an alternative to organophosphatc. carbamate and
synthetic pyrethroid insecticides for control of plum eureulio and suppression of Oriental fruit
moth and a good fit for peach I I'M program; in Pennsylvania and California Indoxacarb use on
peaches was subsequently registered on July. 16, 2007, witnin the requisite seven \ear lime
period.
The Agency concluded that 22 of the requested uses meet criterion III including cabbage,
broccoli, tomatoes, peppers, head lettuce, leaf lettuce, apples, pears, mint, southern pea.
cranberry, collards. mustard greens, plum, peach, sweet chern. sour cherry, summer squash,
cucumber, cantaloupe, spinach and celery, In addition, two uses, collards and cranberries met
criterion I and one use. peaches, met criterion IV. Therefoie. the Agency GRANTS your request
for an extension of exclusive use data protection under EPA registration number 352-594 for an
additional three (?) years. Exclusive use protection for data submitted in support of this
registration which complies with 40 CFR 152.83(c) will expire on October 30. 2013.
cc: Meredith Laws
John 1 lehert
Jennifer Gaines
Michcie Knorr
Nicole Williams
Pat Cimino
Lois Rossi. Director
Registration l)i\ision
Office of Pesticide Programs

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REFERENCES
Reduced Risk Insect Mile Management ir Tree Fruit. May ] I, 2009. The Pennsylvania
Integrated Pes! Management Program. Pennsylvania State University.
Pest Management Strategic Plan for Peach Production in California, 2006, Web address:
htlp: //www, ipmcenters.org/pmsp/pdf/CAPEACI IPM SP ,pdf

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