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US Environmental Protection Agency
*• Office of Pesticide Programs
%i pmt^ Petition for the Extension of the
Exclusive Use Period for
Carfentrazone Technical
October 4, 2011
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. D.C. 20460
OFFICE OF CHEMICAL SAFETY
AND POLUTION PREVENTION
Ms. Shannon Yanocha
FMC Corporation
" 4 2011
1735 Market St.
Philadelphia, PA 19103
Re: Petition for Extension of the Exclusive Use Data Protection Period for
Carfentrazone-ethyl Technical (EPA Reg. No. 279-3181) Under FIFRA section 3(c)( 1 )(F)(ii)
Dear Ms. Yanocha:
This is in response to your request, dated May, 2010, that data associated with the registration of
the active ingredient carfentrazone-ethyl receive extensions for the exclusive use period protection. 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 new
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 J5r 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 have exclusive use protection. FIFRA section 3(c)(l)(F)(i) and its implementing
regulations carefully circumscribe the set of data that is eligible for exclusive use protection. A study
entitled to exclusive use protection is defined in 40 CFR § 152.83(c).
Pursuant to 40 CFR § 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 September 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 FIFRA section
3(c)(2)(B);
Provided that, a study is an exclusive use study only during the 10-year period following the date of
the first registration.
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The following is our analysis for cetermining whether the data associated with the registration you
have cited contains exclusive use data, Firi;t, 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 sjbmitted in support of the first registration of the new chemical,1
The registration you cited was granted on September 30. 1998. and was the first registration with the
product name Carlentrazone-ethyl (1 8426 Technical.
Lastly, because exclusive use prot:etion is not available for studies that the agency requires to
maintain registration in effect under FIFR V section 3tc)(2)(B). any such data associated wi:h llii>
registration w ill not receive exclusive use )r.>lection under FIFRA section 3 (e){l )(F}(ii).
Now that the Agency has determired that studies associated with this registration are exclusive use
studies", we must determine whether you I ave met the criteria for extending the exclusive use protection
pursuant to FIFRA section 3(cXl){F)(ii), and if so. by how many years.
FIFRA. section 3(c)(i )(F)(ii) states. In pertinent part;
The period of exclusive data use provided under clause (i) shall be extended 1
additional year for each 3 minor ines registered after the date of enactment of this
clause and within 7 years of the ccmmencement of the exclusive use period, up to
a 1 ota 1 of 3 additional uses for ail minor use?, registered by the Administrator if the
Administrator, in consultation win the Secretary of Agriculture, determines that,
based on. information provided by an applicant for registration or a registrant, that;
(I) there are insufficient effie icious alternative registered pesticides available for the use;
(II) the alternatives to the m in ?r use pesticide pose greater risks to the environment or human
health.;
(III) the minor use pesticide plays or will play a. significant part in managing pest resistance; or
{IV) the minor use pesticide play 5 or will play a significant part, in an integrated pest
management program.
I he registration of a pesticide for i minor use on a crop grouping established by the Administrator
shall be considered, for purposes of this cl mse. ' minor use for each representative crop for which data are
provided in the crop grouping. Any additi.M al exclusive use period under this clause shall modified as
appropriate or terminated if the registrant voluntarily cancels the product or deletes from the registration the
minor uses which formed the ba>i s for the extension of the additional exclusive u?.c period, or if the
Administrator determine?, thai the registrant is not actually marketing the product for such minor uses.
1 Data are riot protected solely because they petEiri 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 sup port 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 ise 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.
* This response is general in nature. If the Age ic y receives a me-too application for this pesticide during the extension
period citing FMCdata. it will then address whither those data have the extension of protection.
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Alter reviewing the Agency's Siie;- and FMC's letter dated August 5. 2010. we have confirmed the
following; In April. 2008. !• VIC petitioned the Agency for a three-year extension of the exclusive-use
period for data submitted in support of the carfentra/one-ethyl registration. This request was based on
consideration ol 12 minor uses which wen1 rdded to the Carfentra/one-ethyl Technical label within seven
years of the initial registration. Seven oft icse met at least one of the criteria for the extension of the
exclusive use period. Therefore, in Septenher. 2009. the Agency granted a two-year extension of the
exclusive-use period for data submitted in sipport of the carfcntrazone-ethyl registration. Two more minor
uses are needed tor carfentra/one-ethyl to be qualified for an extension of the exclusi\e use period one
more year, for a total of 3 years. In May. 2010 FMC submitted information on 5 more minor crops, all of
which were registered in 2004: raspberries peaches, okra. garlic and peppers, and requested an extension
of the exclusive data use period for an additional year. After review ing the currently approved label for
i arlentra/one-elhyI 1 cchnical. ihe Agency has determined that the following minor uses qualifv toward the
request for extension of exclusive use protection': garlic and okra. As required by statute, tile
aloremenlioned minor uses associated with ihe crop groupings were ail registered within the requisite seven
sear period.
In addition to meeting the minor requirements, as staled above l-'IFRA section 3(c>(I)(I »;ii)
requires that one of the criteria I - IV be met The Agency determined thai carfentra/one-elhy 1 plays a role
in managing resistant weed biotypes in garlic and okra. meeting the requirements of criterion III, above.
The justification for this is as follows (cxc ented from the memorandum. "Review of Justification for the
Extension of hxclusivc Data l.'?>e Period f< r Carfenlrazone-clhy! (DP #380972)." dated November 10. 2010:
Garlic: According to the l.'SDA c ensus of Agriculture (2007), California ranks first in both the
number of farms growing garlic and in harvested garlic acres. Garlic is a weak competitor and does not
thri\e in weedy fields. Currently. 23 diffeeit biotypes of herbicide-resistant weed species are present in
California (WSSA. 2010). Some of these weeds are resistant to modes of action of widely used herbicides,
such as: glycines (glyphosate). synthetic iuxins (quinclorac). bipyridiliums (paraquat). ACCase
(tcnoxaprop). and ALS inhibitors (halosul \i 'on) s WSSA. 2010). Paraquat, glyphosate. and metam sodium
are used as pre-piant treatments to control established weeds prior to planting garlic. Carfcntrazone-cthvl is
a PPO-inbitor. and is applied as a post-emergence burndown treatment to control broad leaf weed s in middle
rows of garlic fields. Applications of herbicide formulations with different modes of action help in
minimizing the development of herbicide icsisiance in weeds. Carfentrazone-ethyl is available as a stand-
alone product, or a premix with many other herbicide.*,, such as 2,-1 D, V1CPP-P. quinclorac. ghphosjJe.
dicamba, and halosulluron (CDV1S. 2010) Jse of premixed herbicides w ith differing modes of action
minimized development of herbieide-resis ant weeds in garlic production. Additionally, application of
herbicides with longer residual activity als:> plays a major role in enhancing the development of herbicide
resistance in weed species. Compared to r lain a\ailable alternatives, at recommended rates, carfentra/one-
ehtyl has little or no residual activity (New York Department of Environmental Conservation. 1999).
Carfentra/one-ethyl can be considered a h ghly useful tool available for garlic growers to manage the
development of herbicide resistance in wexis found in garlic fields. Therefore, under F1FRA §
3{e)( l)(F)(ii), carfentra/one-ethyl meets Criterion III considered for the extension of Ihe exclusive u>e dala
period.
Okra: Many herbicides are recom nended as pre-emergence and pre-plant treatments in okra:
however, only a few are recommended as w.st-emergencc treatments: sethoxydim. glyphosate. and
carlentra/one-cthy 1. Of these, sethoxydim only controls grass weed species, and has a 14-cay preharvesl
3 Because the statute sets a maximum of a thre; year extension for exclusive use protection provided that 9 minor uses
are added within the seven year period after registration, the Agency did not list more than nine eligible minor uses.
There may be additional uses not listed in this document that also count toward exclusive use protection. The agency
will evaluate those uses for eligibility should the registrant decide to voluntarily cancel or stop marketing any of the 9
uses currently forming the basis of the extension.
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interval. A large number of weed species iave developed resistance to glyphosate (WSSA. 2010). and it
also has a 14-day prcharvest interval in ok -a Carfcntrazonc-ethyl lias a 0-day prcharvest interval, and
therefore has greater application flexibility in okra production. (n addition, only two weed species, tall
waterhemp (Amaranthus tuberculaius) anc common ragweed (Ambrosia artemisiitolia). have developed
resistance to carfentrazone-ethvl in the United States (WSSA, 2010). Furthermore, carfentrazone-ethyl has
little or no residual activity, and with its unique mode of action. it can be used as a stand-alone or tank
mixed product to manage the development of herbicide resistance in weeds found in okra production fields.
Therefore, under FIFRA § 3(c)(! )(F)(ii). cirfentrazonc-ctliy! meets Criterion 111 considered for the
extension of the exclusive use data period.
Garlic and okra qualify as minor-ise crops, and also fulfill Criterion 111 under FII-RA §
3(c)( 1 )(F)(ii). This fulfills the require in en for two additional crops necessary to extend the exclusive use
period for an additional year. The Agenc>. therefore, grants your request for an extension of exclusiv e use
data protection under EPA Registration No. 279-3181 for an additional one (1) year. Exclusive use
protection for data submitted in support of this registration which complies with 40 CFR § 152.83(c) expired
on September 30, 2011.
Lois Rossi. Director
Registration Division
Office of Pesticide Programs
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