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US Environmental Protection Agency
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	 Office of Pesticide Programs
^ EPA Response to Petition
for S-metholachlor
September 15, 2009

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- PROTt^
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
SEP 1 5 2009
OFFICE OF
PREVENTION, PESTICIDES AND
TOXIC SUBSTANCES
John Abbott
Syngenta Crop Protection, Inc.
410 Swing Road
Greensboro, NC 27419
Re: Petition for Extension of the Exclusive Use Period for Data Protection for
Data Submitted for S-Metolachlor Technical (EPA Reg. 100-815)
Dear Dr. Watson:
This is in response to your request dated February 15, 20051 that data
associated with the original registration of the active ingredient s-metolachlor receive an
extension of their exclusive use protection period. You cited FIFRA section 3(c)(l)(F)(ii)
as the authority for the Agency to make such a determination. The initial registration
date for s-metolachlor was on March 14, 1997 for the product named s-metolachlor
Technical. The Agency denies your petition for extension of exclusive use data
protection for reasons described below.
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 to the exclusivity period.
The first step in determining whether data qualifies for an extension of its
exclusive use period is to ascertain which data currently have exclusive use protection.
FIFRA section 3(c)(l)(F)(i) and its implementing regulations carefully circumscribe the
1 The Agency sent Syngenta an interim request for more information on May 18, 2007. This response
incorporates the new information Syngenta submitted to the Agency in response to the interim request The
novel issues in this petition were finally resolved on June 23, 2009, when EPA issued its Qs & As
addressing the exclusive use statutory provisions.
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set of data that is eligible for exclusive-use protection, A study entitled to exclusive use
protection is defined in 40 C.F.R. 152.8?(c).
Pursuant to 40 CI- R 152.83(c), the following requirements must be met 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) first
registered after Scptembe  30. 1978:
(2)	The study was submitted in support of, or as a condition of
approval of the application resulting in the first registration 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 to satisfy a data requirement
imposed under P1PRA section 3(c)(2)< B):
Provided that, a study is an exclusive use stud} only during the 10-
year period following the date of the first registration,
The following is our analysis for determining whether the data associated with the
registration you have cited contains exclusive use data. First, there are date, associated
with this registration that 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 chemicals The registration you cited was granted on March 14. 1997 and was
the first registration for s-mctolachlor wi.h the product name S-Metolachlcr Technical.
Please note, because exclusive use protection is not available for studies that the
Agency requires to maintain registrat on in effect under rlfRA section 3(c)(2)(B) any
such data associated with this registration will not receive exclusive use orotection under
FJFRA section 3(c)(l )(F)(ii).
2
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 {arid 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
exclusive-use protection, but the protection is limited to data that pertain solely to the nev\ use Thus, for
example, if the new use i> approved after eight years of registration the data supporting d at use would gain
exclusi\ e-use protection for only two years, or the remainder of the original 10-year i:\clusive-use
period. See 49 FR 30884, 30889.
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Now that the Agency has determined there are studies associated with this
registration that are exclusive use studies3, we must determine whether you have met the
criteria for extending the exclusive use protection period pursuant to FIFRA section
3(c)(l )(F)(ii). and if so by how many years.
FIFRA section 3(c)(l)(F)(ii) states, in pertinent part:
The period of exclusive data use provided under clause (j) shall be
extended 1 additional year lor each 3 minor uses registered after the date
oi enactment ot this clause and within 7 years of the commencement of
the exclusive use period, up to a total of 3 additional \ears for all minor
uses registered by the Administrator if the Administrator, in cons .illation
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;
(II)	the alternatives to the minor use pesticide pose greater risks to
the environment or human health;
(III)	the minor use pestic:de plays or will play a significant part in
managing pest resistance; or
(m the minor use pestic de plays or will play a significant part in
an integrated pest managemen. program.
The registration ot a pestxide 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 the product or deletes from the registration the minor
uses which formed ihe basis for the extension of the additional exclusive
use period or if ihe Administrator determines that the registrant is riot
actually marketing the product for such minor uses.
Syngenta requested 3 years extension of exclusive use data protection for
registration of 18 crops. Hlevcn of the minor uses Syngenta requested to be considered
towards extension ot exclusi\e use data orotcetion are FIFRA section 24(c) registrations.
FIFRA 24(c) uses are not eligible to be counted towards extensions. FIFRA section
3(c)(1 )(F)(iis contains the requirements that the minor uses be "registered by the
Administrator." Since 24(c) registrations are granted by a state and are not registered by
3 This response is general in nature. For purposes of this petition, EPA did not determine which data
associated with this registration have/had exclusive use data protection.
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the Administrator they do roi count towards the number of" minor uses necessary to
extend the period of data exclusivity. Therefore, the 1 i minor uses associated with 24(c)
registrations: spinach, horseradish, asparagus, carrots, rhubarb, green onions, Swiss
chard, radish. dr\ bulb onions, cabbage, and peppers, are not eligible to be counted
towards an extension.
As for the uses that were not 24(c) registrations. HPA reviewed its '.lies and found
the following: Ihe initial registration of s-mctolachlor occurred on March 14. 1997. On
April 3. 2003 a I IFRA section 3 registration was granted for tomatoes and on April 7.
2003, FTFRA section 3 registrations were granted tor the following six grasses grown for
seed: ryegrass, bentgrass. Kentucky bluegrass. orchardgrass, tall fescue and line fescue.
As required by statute, the aiorementioncd uses were all registered within he requisite
seven-year period.
Syngenta requested that fresh tomatoes be considered as a minor crop for extension
of the exclusive use data period for s-metolachfor. After reviewing the currently
approved label for s-metolachlor the Agency determined that fresh market tomatoes are
not labeled separately from processing tomatoes. The label permits the use of s-
metolachlor on transplanted and direct-seeded tomatoes. The Agency does not have
enough information to determine if direct-seeded and transplanted tomatoes lit the
definition ot a minor crop and therefore cannot conclude that Svngenta's tomato request
is (or a minor crop. Therefore, fresh tomatoes can not be counted towards the extension
oi exclusive use data protection for s-metolachlor. The six grasses grown "or seed;
ryegrass, bentgrass. Kentucky bluegrass. orchardgrass. tali fescue and line iescue are
considered minor crops and are eligible to be counted towards an extension.
Next, EPA analyzed whether these uses met any of the statutory criteria. "The
Agency reviewed the additional informal .on submitted in support of the petition for
extension ot the exclusive use period for s-melolachlor. Svngenta's petition claims that
s-metolachlor meets two of the criteria: (I) there are insufficient efficacious alternative
registered pesticides available lor the use and (111) the minor use pesticide plays or will
play a significant part in managing pest resistance.
S-metolachlor is a chloroacetamide herbicide and is a Vv'SSA Group 1 5 herbicide.
It is applied preplan! or preemcrgence to control grasses yellow nutsedge and certain
broadleat weeds. As BEAD described in its previous analysis (/inn, 2007,, the registrant
claims that there are no documented resistant biotypes to chloroaeetamides, such as s-
nietolachlor. in the United Stales. The Agency found only one case of resistance to this
mode ot action: tlutenacet (oxyacetarnide)-resistant Italian ryegrass in Idaho (Heap,
2007 ). Other herbicides with the same mode of action include dimethenamid-p and
napropamide.
Criteria Analysis for Grasses Grown for Seed
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S-metolachior is registered for use on established stands of grasses grown for seed
{ryegrass, bentgrass. Kentucky bluegrass, orchardgrass tail fescue and fine fescue) in
Idaho. Oregon and Washington. The label states that s-metolachlor will control or
suppress volunteer seedlings ol the lollowing grasses: perennial ryegrass, fine fescue, tall
fescue, orchardgrass. bentgrass. and Kertucky bluegrass. It will also control or suppress
rat tail fescue, annual bluegrass, Italian ryegrass, California brome. do why brome. and
roughstalk bluegrass. These weeds are in addition to the grass, sedge, and broadleaf
weeds described on the label. The majority of the alternatives are discussed below in the
section "Ryegrass tor Seed." Due to tne similarities in alternatives, onlv differences in
alternatives are discussed for the othei g "asses grown lbr seed.
The Agency reviewed the additional information supplied by the registrant and
found that Syngenta did not make a compelling case to support the resistance
management clami. l or ah the grasses grown for seed, other herbicides with the same
mode ol action {e.g.. dimethenamid-p and/or llulcnaect) arc registered, which Svngenta
acknowledges. Wc do not. have usage data for grasses grown for seed so the extent to
which these herbicides are used is unclear. The Agency is unable to conclude that s-
metolachlor plays a significant role in resistance management.
Ryegrass for Seed
Syngenta describes 20 other herbicides registered for use on ryegrass grown for
seed as not being an alternative, an unacceptable alternative, or a partial alternative.
I he Agency agrees that as post-emergence broadleaf herbicides 2,4-D. MCPA,
clopyralid. bromoxynil, dicamba. carfentra/.one-ethy 1. fluro\\ p\ r. and tribenuron-methyl
are not sufficient alternatives to s-metolachlor. In addition, paraquat, glyphosate, and
gluiosinate have a dillerent use pattern and no residual control and thus are also not
alternatives to s-metolachlor.
Diuron. ethofumesate. melribuzin, oxyfluorfen. and pronamide are described as
unacceptable alternatives. Diuron and ethofumesate do not claim control of volunteer
crop seedlings on the label. The diuron and ethofumesate labels were checked and the
claim was confirmed, for melribuzin, oxyfluorfen, and pronamide. the registrant claims
that the weeds spectrum controlled is limited. In addition, the registrant describes other
limitations, including that melribuzin and o\vfluorfen have the potential to cause crop
injury. According to the pronamide, metribuzin, and oxyfluorfen labels, a limited
spectrum oi weeds is described as controlled or suppressed by these herbit ides. The
Agency agrees that these herbicides are unlikely to be adequate alternatives to s-
metolachlor.
Syngenta describes dimethenamid-p, flufenacet -1- metribuzin, pendimethalin. and
quinclorac as partial alternatives. Pendimethalin, s-metolachior. flufcnacei-metribuzin,
and dimethenamid are used precmergence and described as having their own strengths
and weaknesses {Lies, no date). Therefore, although Syngenta states that none of the
alternatives are complete alternatives, it is not clear that the alternatives are insufficient.
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Both dimethcnamid-p and flufenacet have the same mode of action as s-
mctoiachlor. A comparison of the dime^henamid-p and s-metolachlor labels shows
considerable o\erlap in the weeds controlled, although each label claims control of some
weeds thai the other does not. Ffficacv -atings indicated that both s-metcnachlor and s-
dimcthenamid provide control of similai weeds with similar etficaev (Cokjuhoun et al..
2001). Ihere are some restrictions with use of dimethcnamid-p, including the potential
lor crop injury it applied during cold temperatures. Syngenta claims that c.imelhenamid-p
has less residual activity than s-metolr.chlor, but did not provide references or
documentation to support this claim. Grazing and feeding treated grass 01 other plant
parts to livesioek is restricted lor dinicthenamid-p wheieas s-metolachlor may be grazed
alter a certain period of time {varies depending on location). However, there are three
methods of managing the grass stubble after harvest: thermal (e.g. burning), clean
nonthermal (e.g. baling), and mowing and then leaving it on the field to compost (Lies,
no date). I he extent to which each method is used is not clear. It is unclear to us
whether these restrictions are justification for the efficacy criteria. Also, because
dimethenamid-p and lluienaeet have the same mode oi action, it is not clear how s-
metolachlor plays a significant role in resistance management.
S-metolachlor and the other aecvamide herbicides are described in Thc 1 "nited States
Department of Agriculture (IJSDA) Crop Profile for Ryegrass Seed in Oregon. 2002.
However, they are not included in the description of the standard treatments that are used
lor most established grass seed acreage. Given the lack of usage data, it is difficult to
determine thc extent to which s-metolachlor is used in perennial ry egrass production.
Therefore, we are unable to conclude that s-metolachlor plays a significant role in
resistance management or that there are insufficient efficacious alternatives.
Other Grasses Grown for Seed: Benterass. Kentucky Bluegrass. Orcharderass. Tall
Fescue, and Fine Fescue
The majority of the alternatives arc the same as for perennial ryegrass. There are
some herbicides that are registered for other grasses grown for seed and not for perennial
grasses. Likewise, in some cases, an alternative registered for use on pere;mial ryegrass
may not be available tor another grass grown for seed. Rentgrass grown lor seed has the
fewest alternatives discussed of all the grasses grown for seed described in this document.
Terbacil is registered for use on Kentucky bluegrass grown for seed, tall fescue
grown for seed, and fine fescue grown for seed. Syngenta claims that terbaol has the
potential to cause crop injur) and that .t controls a limited spectrum of broad leaf and
grass weeds. "1 he Agency confirmed these claims with the crop label.
Primisulfuron is registered through SLN labels for use on Kentuckv bluegrass
grown for seed. 1 his herbicide is described as not an alternative because i* has rotational
restrictions, must be applied post-emergence, and only controls a limited spectrum of
broadleaf and i>rass weeds.
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Fluazifop-P-butyl and scthoxvdirn are registered for use on fine fescue grown for
seed. Syngenta describes iluazifop-P-butyl and sethoxydim as noi being alternatives
because they only control grass weeds, are applied post-emergence, and have no residual
activity. The Agency confirmed that there are 24(c) labels for iluazifop-P-buty} and
agree that these herbicides are post-emergence grass herbicides.
The Agency does not believe that these additional alternatives change the
conclusion for grasses grown for seed.
After consulting with USDA, the Agency decided that Syngenta did not make a
compelling case for the efficacy or resistance management criteria for grasses grown for
seed. The Agency denies your request for an extension of the exclusive use period for s~
mctolachlor.
Lois Rossi Director
Registration Division
Office of Pesticide Programs
cc: Dan Kenny
Joanne Miller
Michele K norr
Nicole Williams
Pat Cimino
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REFERENCES
Colquhoun, J., B. Brewster, C. Malloiy-Smith, and R. Burr, 2001, Weed Management in
Grass Seed Production, EM 8788, Oregon State University
Crop Data Management System (CDMS) search. Web address:
Crop Profile lor Ryegrass Seed in Oregcn (Annual and Perennial Ryegrass), 2002, Web
address:
Heap, I., 2007. Ihe International Survey of Herbicide Resistant Weeds, Online, Internet,
February 14, 2007. Web address:
Lies. M., ed.5 High Yield Grass Seed Production and Water Quality Protection
Handbook, Oregon Seed Council.
Zinn, N., 2007. Review of Justification for Extension of Exclusive l.'se Period for S-
metolachlor, Oiliee ot Pesticide Programs, U.S. Environmental Protection Agency.
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