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

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WASHINGTON, D C, 20460
%	UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
^ PRQ^N
OFFICE OF
PREVENTION, PESTICIDES AND
_ _ - .nnn	rncvcn I lull, rCOM^ILJCO
SEP 1 0 2009	TOXIC SUBSTANCES
Sherry Movassaghi, Ph.D.
Registration Product Manager
Bayer CropScience
Research Triangle Park
P.O. Box 12014
RTP, NC 27709
Re: Petition for Extension of the Exclusive Use Period for Data Submitted for Spiromesifen
Technical (EPA Reg. 264-718)
Dear Dr. Movassaghi:
The Agency GRANTS your petition for an extension of exclusive use data protection for
EPA Registration No. 264-718 for an additional three (3) years. The initial registration of
spiromesifen occurred on May 3, 2005. Exclusive use protection for data submitted in support of
this registration which complies with 40 CFR 152.83(c) will expire on May 3, 2018.
This letter is in response to your petition dated Novermber 14, 2007 that data associated
with the registration of the active ingredient spiromesifen receive an extension to their 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 Ci R 152.83(c). ti e following requirements mast be net for a study to be
considered an exclusive use study:
(1)	The study pertains to a new active ingredient (new chemical) or new combination
of active ingredients (new combination) lirsi registered after September 30. 1978;
and
(2)	The stud\ was submitted in support of, or a condition of approval of, the application
resulting in the first registration of a product containing such ne w chemical or new
combination (first registration), or an application to amend such registration to add a
new use: and
(3)	The sttidv was not submitted to satisfy a dam requirement imposed under FIFRA
Section 3(c)(2)(B);
Provided that, a study is an exclusive use study only during the 10-year period
following the date ol"first registration.
1 he following is our analysis for determining whether the data associated with the
registration >ou have cited contains exclusive use data. First, the data associated with this
registration do pertain to. or have been cerived 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 May 3. 2005 and was the first registration for
spiromesi fen with the product name Spiromesi fen 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 net receive exclusive use protection under FIFRA section
3(c)(l)(F)(tt),
Now that the Agency has determined that studies associated \vit/i this registration are
exclusive use studies", we must determine whether you have met the criteria lor extending the
exclusive use protection period pursuan: to FIFRA section 3(c)( 1 >(lr)(ii). and if so by how many
years.
FIFRA section 3(c){1)(F)(ii) states in 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, if the new use is approved after eight years of registration, the data
supporting that use would gain exclusive use protection for only two years. See 49 FR 30884, 30889
2	Because the requestor did not attach a list of data they believe retain exclusive use protection, this response is
general in nature. If the Agency receives an application for registering an identical or substantially similar product
during the extension period citing your data, it will then address whether those data have the extension of data
protection.
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The period of exclusive data use provided under clause (i) shall be evlended 1 additional
year for each 3 minor uses registered after the date of enactment of -his clause and within
7 years of the commencement of Lie 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 plays 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 lor 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 the product or deletes from the legislation the minor
uses which formed the basis for the extension of the additional exclusi v e use period or if
the Administrator determines thai the registrant is not actually marketing the product for
such minor uses.
Bayer CropScience requested 3 veais extension of exclusive use data protection based on
the registration of 1 1 minor crops. After reviewing the Agency's files we have found the
following: On May 3. 2005 the following minor crops were registered for spiromesifen:
strawberries; tuberous and corni vegetab es (f PA crop subgroup 1-C): vegetables - leafy greens
subgroup (I-PA crop subgroup 4-A): vegetables bras sic a head and stem subgroup (fPA
subgroup 5-B); fruiting -vegetables (EPA crop group 8): and cucurbit vegetables and melons
(HPA crop group 9). Residue data were generated by Bayer CropScience to support these
registrations and were conducted on: strawberries: head lettuce: leaf lettuce: spinach; broccoli;
cabbage: mustard greens: peppers: can aloupe: cucumbers and summer squash. The initial
registration of spiromesifen occurred on Mav 3. 2005 and as required by the statute, the
aforementioned minor uses associated with the crop groupings were all registered within the
requisite seven-year period.
After reviewing the currently approved label for spiromesifen the Agency has determined
that the following 11 minor uses qualify toward the request for extension of exclusive use data
protection: strawberries: head lettuce: leaf lettuce; spinach; broccoli: cabbage: mustard greens:
peppers; cantaloupe; cucumbers; and summer squash.
In addition to meeting the minor use requirements. FIPRA section 3(c)(l)(F)(ti) requires
that one of the criterions J-IV as stated above be met. Bayer CropScience submitted information
lbr all four criteria. The Agency reviewed the information submitted b\ Bayer CropScience and
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elected to evaluate for criterion III, '"llie minor use pesticide plays or will play a significant part
in managing pes! resistance". The Agency concluded that criterion III has been met for all of the
crops in the petition and the main target pests, Bemisia whiteflies and two-spotted spider mites.
I he Agenev concluded that spiromesilen is a new active ingredient that belongs to the
chemical class of cvclic tetronie acid derivatives diseo\ered b\ Ba\er CropScienee during the
1990s (Nauen and RreiSchneider. 2002: Brctschneider. et al., 2003). Spiromesi fen inhibits lipid
biosynthesis {foapania et al.. 2003: Prajhaker and foscano, 2007). According to Brust (2006).
spiromesilen exhibits a translaminar activ ty that allows it to penetrate the leaf surface and mo\e
through the leaf cells. Spiromesifen shows no cross-resistance to currently available insecticides
and aeancides (i oapanta et al.. 2003; P'abhaker and Toscano. 2007). Spiromesifen is registered
for control of two-spoiled spider mites and whiteflies on strawberries, mustard greens, peppers,
cantaloupe, cucumbers and summer squash. On leaf and head lettuce, spinach, broccoli and
cabbage it is labeled only for whitefly control.
In the Agency s analysis, the two species of Bemisia, B tahuci (sweet potato whitefly) and
B argeiuiiolii (silverleaf whitefly) are treated as a single species since, until recently, the
silverleal whitelly was considered the "IV" biolvpe of the sweet potato whitelly and not a
separate species (Baker. 2006). Reportedly. the silverleal' whitelly has displaced the sweet
potato whitelly in most of its former range (IX' Pest Management Guide! nes. 2005). Although
Bemisia whiteJlies are found throughou1 the southern United States, they appear to be especially
damaging in the hot. desert areas of Ca'i forma. Arizona and 1 exas (USDA-Crop Profile for
broccoli in California. 1999). The host range of the silverleal* whitellv is known to extend to 500
species of plants (Fasulo, 2007).
The Agency used the Michigan State University's Arthropod Pesticide Resistance
Database (o evaluate the resistance incidences of the two species of Bemisia whiteflies and two-
spotted spider mites, fhc Database indicates that these pests have developed resistance to
numerous active ingredients and chemistries worldwide. In the U.S.. two-spotted spider miles
and Bemisia whitellies have developed resistance to 28 and 18 inseeticidal active ingredients,
respectively. On a worldwide basis, the corresponding numbers are 86 and 45. respective!v. At
present, pesticide resistance in Bemisia whiteflies appears to be limited to California. Arizona
and Hawaii. Resistant populations of two-spotted spider mite are found primarily in the eastern
half of the U.S.. as well as in California .md Washington.
The two-spotted spider mite is a serious pest of strawberries in California and Arizona and
on peppers in the western United States. Bemisia whiteHlies are serious pests of head and leaf
lettuce in Arizona and California where :hey cause direct damage to plants as well as vector plant
viruses. Bemisia whitellies are also serious pests in Arizona spinach, western peppers and
brassicas and cucurbit crops in the southeast and western United States.
These pests have demonstrated a historv of resistance to pesticides in (he U.S. and
worldwide. The classic method for slowing the development of pest resistance to pesticides is to
rotate different classes of chemistry during the spray season. This works only when there are
several different and effective pesticide products available for control of the resistance-prone
pests which have different modes of action. Spiromesilen has a unique mode of action and is
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effective in controlling Bemisia whitefiics and two-spotted spicier mile. 1 he Agetic\ concluded
that spiromesifen is a novel chemistry that can be rotated with the few available and effective
chemistries for control of Bemisia whi tellies and two-spotted spider mites to slow the
development of resistance to pesticides by these pests.
1'he Agency concluded thai all :1 of the requested uses meet criteria III. The uses are
strawberries, head lettuce, leaf lettuce, spinach, broccoli, cabbage, mustard greens, peppers,
cantaloupe, cucumbers, and summer squash. The Agency, therefore. GRANTS your request for
an extension of exclusive use data protection under EPA registration No. 264-718 for an
additional three (3) years. Hxclusive use protection for data submitted in support of this
registration which complies with 40 CFR 152.83(e) will expire on May 3. 2018.
cc: Meredith Laws
John Hebert
Jennifer Gaines
Miehele knorr
Nicole Williams
Pat Cimino
Lois Rossi, Director
Registration Division
Office of Pesticide Programs
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