US Environmental Protection Agency
Office of Pesticide Programs
Petition for Indoxacarb
October 16, 2007
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DuPont Crop Protection
Stine-Haskeli Research Center
P.O. Box 30
Newark. DE 19T14-OQ30
October 16,200?
BY
Document Processing Desk-(REGFEE)
Attn: John Hebert
Office of Pesticide Programs (7504P)
U, 8. Environmental Protection Agency
One Potomac Yard
2777 S. Crystal Drive
Arlington" VA
Subject: Request for Extension of Exclusive Use Period for Products Containing .
Indoxacarb Per FIFRA §3(c)(l)(F)(ii)
Dear John:
On October 30,2000, EPA granted the first registrations for products containing
indoxacarb as the active ingredient, including DuPont™ Avaunt® and DuPont™
Steward® Insecticides (EPA Reg, Nos. 352-597 and 352-598). In 1996, the Food Quality
Protection Act (FQPA) became law. This act included a provision which states "The
period of exclusive use... shall be extended 1 additional year for each 3 minor uses
registered after the date 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..." "Minor Uses" are defined in FIFRA (§
2(11)(2)) as meeting one of 4 criteria:
1. There are insufficient efficacious alternative registered pesticides available
for the use,
2. The alternatives to the minor use pesticide pose greater risks to the
environment or human health
3. The minor use pesticide plays or will play a significant part in managing
pest resistance, or
4. The minor use pesticide plays or will play a significant part in an
integrated pest management program.
The exclusive use provision for minor uses provision of FIFRA §3(c)(l)(F)(ii) contains
these identical criteria, i.e. - a use identified as a minor use under FIFRA § 2{li)(2) meets
at least one of these 4 criteria.
DuPont hereby requests the Agency to approve an extension of the exclusive use
period for an additional 3 years based on the following information:
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October 16,2007
Crops Submitted As Part of the Initial Registration
o DuPont received Reduced Risk classification for all proposed uses as part
of the original submission (see Tab 1 in the Supporting Information
volume which accompanies this letter)
o DuPont supplied residue data for 9 minor crops as part of the original
submission. These include:
« Cabbage,
« Broccoli,
-» Toma.tpes7" '
« Peppers,
• Head lettuce,
» Leaf lettuce,
* Apples, -
• Pears and
" Sweet corn
o Criterion 2 (above) is fulfilled for all 9 crops since these minor crops were
all classified as "Reduced Risk" and indoxacarb was identified as an
alternative to organophosphate pesticides as part of that action (see
highlighted section on page 4 of Tab 2 In the Supporting Information
volume which accompanies this letter - "U.S. EPA, Office of Pesticide
Programs, Reduced Risk/Organophosphate Alternative Decisions for
Conventional Pesticides, updated 8/10/07,
(http://www.epa.gov/opprdOOl/workplan/completionsportrait.pdf),.
Crops, Sub_mitted_Subsfqacntly
o Subsequent to the Initial registration, the IR-4 Program has submitted
tolerance petitions for indoxacarb on numerous minor crops since the
initial registration. Residue data, jointly developed by DuPont and IR-4,
were submitted for the following 13 crops:
* Mint
" Southern pea
• Cranberry
» Mustard greens
» Plum
• Peach
• Cherry, sweet
• Cherry, sour
» Summer squash
• Cucumber
» Cantaloupe
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October 16, 200?
* Spinach
• Celery
The Agency has recently established upon data (72
FR 37633-37641, July 11, 2007).
All Cropsjpn.Indoxacarb Product Labels
o Because of the need for indoxacarb as an alternative insecticide on these
and other minor use crops, IR-4 requested that DuPont consider labeling
of crop groups resulting in additional uses on the indoxacarb product
labels. IR-4 collaborated with DuPont in the submissions which resulted in
EPA approvals. Current crop groups on the indoxacarb label include,
brassica leafy vegetables, cucurbit vegetables, leafy green vegetables, leafy
petiole vegetables, porne fruit, stone fruit and tuberous and corm
vegetables.
o By virtue of the fact that the IR-4 program - whose Mission is to "provide
pest management solutions to growers of fruits, vegetables and other
minor use crops" was involved with these minor use registrations means
that these crops clearly meet the definition of "minor uses" as defined by
FIFRA § 2(11). In other words, registration of a minor use for a pesticide
should be sufficient to establish that at least one of these 4 criteria have
met for that use,
o The website for the Regional Integrated Pest Management (IPM) Centers
(established by the Cooperative State Research, Education, and Extension
Service, United States Department of Agriculture) references-ind-Qxacar-fe-' ;
as an important tool to be used for insect control a^part of IPM programs;
for all crops labeled prior to the recent tolerance approvals (see enclosed "
printout of National Information System for the Regional 1PM Centers);
several printouts showing the importance of indoxacarb in IPM programs
are also enclosed.
(See http://www.ipmcenters.org/cropprofiles/cp_form.cfm and search
for "indoxacarb") These documents support the vital role indoxacarb
plays in an effective IPM program (Criteria 4) (See highlighted
information in Tabs 4 - 8 in the Supporting Information volume which
accompanies this letter.
o In 2002 a Section 18 emergency exemption was granted for use of
indoxacarb on cranberries in Massachusetts, In 2003 a Section 18
emergency exemption was granted for use of indoxacarb on collards in
Georgia. In both cases the Section 18 requests were renewed over several
consecutive years. This clearly displays that use of indoxacarb on these 2
minor crops provided efficacious insect control that was not currently
available in the marketplace. (Criteria 1)
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October 16,200?
Q In 2003 an Experimental Use Permit was granted for the use of indoxacarb'
in stone fruit. This EUP was sponsored by the EPA, USDA's Risk
Avoidance and Mitigation Program (RAMP) and DuPont. The EUP was
administered by several leading stone fruit University researchers. The
goal of the RAMP Is to enhance development and implementation of
innovative integrated pest management strategies for multi-crop food
production systems. The primary emphasis of RAMP applications is crop
productivity and profitability while addressing critical environmental
quality and human health issues. As demonstrated in the EUP report,
Indoxacarb met the criteria set forth by the RAMP effort. Indoxacarb is
clearly a helpful tool in an 1PM program in stone fruit. This meets the
requirements set forth in Criteria 4,
o The California Department of Pesticide Regulation has recently issued a
document entitled "ENVIRONMENTAL FATE OF INDOXACARB" (copy
enclosed). In part, the document states:
"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,
corn earworrn, diamondback moth, fall army worm, imported
cabbageworm, southern armyworm, tomato pinworrn, and tomato
fruitworm (DuPont, 2006; California Department of Pesticide
Regulation, 2006).
"Many insects have developed resistance 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 Leptdoptera pests, as well as certain
Homoptera and Coleoptera pests."
This passage supports criteria 3 & 4, above.
The provision for the extension of the exclusive use period in the Food Quality
Protection Act "was intended to be an Incentive for registering more minor uses."
("Report on Minor Uses of Pesticides", EPA's Minor Use Team and Public Health
Steering Committee in cooperation with the United States Department of Agriculture,
October 9,2001). DuPont has pursued minor crop uses in cooperation with the IR-4
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October 16,2007
program with the understanding that the Agency would deliver on the promise made
in this statute.
Based on the evidence outlined above for meeting the criteria outlined in the
FQPA registration of minor use provision, DuPont Crop Protection requests an
additional 3 years of exclusive tise for the data supporting indoxacarb registrations.
Please contact me at 302-451-4517 if you have any questions regarding this
request
Sincerely,
. . ,
> •• i
Richard A, Carver, Ph.D.
Sr, Product Registration Manager
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