US Environmental Protection Agency
Office of Pesticide Programs
ppo^ Petition for Acetamiprid
August 11, 2008
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C2
NISSO AMERICA INC.
45. BROADWAY, SUITE 2120
NEW YORK, NY 10006
PHONE: |212) 490-0350 FAX: (212) 972-9361
August 11, 2008
Pat Cimino
Specialty Crops Advisor
Office of Pesticide Programs [7503P]
US Environmental Protection Agency
1200 Pennsylvania Avenue, NW
Washington, DC 20480
Venus Eagle
PM Team 1
Insecticide/Rodenticide Branch
Office of Pesticide Programs [7505PJ
US Environmental Protection Agency
1200 Pennsylvania Avenue, NW
Washington, DC 20460
Meredith Laws
Branch Chief
Insecticide/Rodenticide Branch
Office of Pesticide Programs [7505P]
US Environmental Protection Agency
1200 Pennsylvania Avenue, NW
Washington, DC 20460
Robert Perils
EPA- Office of General Council [2333A]
1200 Pennsylvania Avenue, NW
Washington, DC 20460
ATTENTION: Minor Use - Exclusive Use Request
Re: Request for Extension of Exclusive Use Data Protection for Acetamiprid
Dear Ms. Cimino, Ms. Eagle, Ms. Laws, and Mr. Pedis,
Nippon Soda Co., Ltd. (Nisso), the sole registrant of the proprietary insecticide,
acetamiprid, is hereby petitioning the Environmental Protection Agency for an extension
of the exciusive use data protection under FIFRA § 3{c)(1)(F)(ii) for agricultural products
containing acetamiprid.
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NtSSO AMERICA INC.
Based on both the residue data generated by Nissc on 28 minor use food crops (twelve
of which were categorized as "reduced-risk'' uses; as well as the use on non-food
gre<=~' - -- omampntak that are currently on ihe acetamiprid product labels
¦ registered on or a >, 2002, Nisso is formally petitioning to extend the
data exclusivity period for acetamiprid for an additional three (3) years.
The current registrations held by Nisso for acetamiprid products used in the agriculture
sector that are subject to extended exclusive use data protection are as follows:
Product Name EPA Reg. No.
Acetamiprid Technical 8033-20
Acetamiprid RTU Insecticide 8033-21
TriStar 70 WSP Insecticide 8033-22
Assail 70 WP Insecticide 8033-23
Assail 30 SG Insecticide 8033-36
TriStar 30 SG Insecticide 8033-94
Acetamiprid 50 FS Insecticide Seed Treatment 8033-95
As mentioned previously, the active ingredient acetamiprid was originally approved by
US EPA on iV: • it was registered as a reduced-nsk, organophosphate
replacement product under the Agency's "Safer Pesticide Policy" that was in place at
the time. The original registration included use on the following crop groups containing
minor use crops: dirts, fruiting veoefeNps (c-cept cucurbits), testy vegetables, pome
fruit (excluding sopiesV and cole crops. Additionally the compound was initially
approved for insect control on greenhouse and outdoor ornamentals that are consider '
another minor use area.
Since the original registration, Nisso has expanded the labe! to include uses in the stone
fru'* cucurbit, tree- nut, bulb ve^el-aLfe, hw'es, and succulent legume crop groups, all of
which contain crops fitting the definition of minor use. Minor crop growers find the
acetamiprid labels very useful due to the flexibility offered by the range of approved crop
groupings.
Because the current acetamprid labels allows use on nine (9) crop groups containing
minor use crops arid is based on residue data eif nnated tn vn fr>«*viffuai
representative minor use- food crops, Nisso petitions the Agency to extend the exclusive * f*
use data protection for the acetamiprid registrations listed above for an additional three .
(3) years beyond the standard 10 year exclusive use period. x H
Attached Table 1 provides a summary list of the following: 1) the currently registered
food crop or crop group on Ihe acetamiprid labels, 2) the representative commodity on / yv ' ;
which residue data were generated, 3) the minor use determination (i.e., < 300,000 . .
acres), 4) the registration date, 5) the "reduced-risk" status, and 6) the MRID number of x 1
the study that contains the residue data on the minor use crops. This concise tabular
format allows for an expeditious review of this petition as it summarizes all pertinent
information for the Agency.
aW
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NISSO AMERICA INC,
Alternative products used on the minor use crops approved on the acetaniprid labels
include various compounds in the organophosphate, carbamate, and pyrethroid classes
of chemistry, fn general, these chemistry classes are considered to pose greater risk to
man and the environment than acetamiprid. Also acetamiprid is consider 3d to be an
"azinphos-methyl replacement product" and exhibits broad spectrum of activity against
various insect pests.
Likewise, being a neonicotinoid, acetamiprid products are used in spray rotation
programs with other mode of action chemistry and thereby reduce the possibility of
insect rested »-v > v .^Uvnent.
Lastly, aside from providing an alternative mode of action, acetamiprid is known to be
"soft" on beneficial insect? and therefore plays an important role in integrated pest
management programs.
For reasons addressed above, Nisso believes that acetamiprid has fully met and
exceeded the statutory minimum number of required minor use registrations. We look
forward to receiving the additional three years of exclusive use data protection under
FIFRA § 3(c)(1)(F)(ii) for acetamiprid products.
Please contact me directly at 212-490-0351 should you have any questions or wish
further detail regarding our request. Thank you in advance for your review of this
petition.
Sincerely,
John J. Wrubei
Regulatory Affairs Director
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NISSO AMERICA INC. Table 1.
Acetamiprid Crop Registrations and Minor Use Determination
For Extension of the Exclusive Use Data Protection Period
Crop
or Crop
Group
Commodity
<300K
Acres1
Registration
Date2
Reduced
Risk
MUD
Brassieas
Bfor.cHi
3/15/02
~
h4-9K: b0~
Cnbbage
~
w
/
4498R808
Mustard nreens
~
u
~
WSSPOQ
Citrus
Grapefruit
y
3/15/02
~
4408??11
.--,"nher
4ROR<;70-)
44
46285701
Legumes4
•- ^~ns
11/15/07
4p7Pcrrv/5
C- em peas
*
4fi7t>rr;f) 4
Lima beans
./
U
4rt70Cfi04
4^7".f.r^
Prr- *n
V
H
Stone fruit
Prt.r.fl
/
11/15/07
4R?65702
"46265702""""
PftlSV
~
Sweet cherry
~
*ie;wo2
T. i cherry
~
4C265702
V, vj1 i v>
4P7ffer^n^
tree nuts4
Almond
11/15/07
Pi-can
M
Berries4
"frrfcberry
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