US Environmental Protection Agency
Office of Pesticide Programs
EPA Response to Petition for
Fenpropathrin
September 25, 2006
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12:17 ItW
Mi. Eric J.
Valent U.SA, Corporation
2033 1C N.W. Suite 850
Washington, DC
Re: New Exclusive Use
for Submitted
to Support &e "Registration 'of
Danitol 2.4 EC Spray
on
2.4 EC
EPA Reg, No.
DANFFGL
Yow March 15,2005
- - i - ' i** u ; •".,! ••
Dear Mr. • ; '. •/-, . . . .
I am in reply to your 15, fte U.S.
Agency (EPA) for exclusive use for data
to EPA in ©f amendments what you to be new uses
to the 2.4 EC Spray). In your you that
use for feipropatiiiifl expired on 22S that this
registration does not cturenfly retain any «se5 and that the
following data, as by MRID number, are aa 10 yeara of
exclusive use data Nos, 45668700,45317200, 45454701
45439801, 46385302,46385303, and "
46385306. For the provided Wow, EPA has that date at* not ,
eligible for the use 'protection sought by Yakut
for extending ve use to 'date in of a new
minor use feat does not intern-exclusive use protection a such an
to its and that camples with
3(cXl)(F)(¥i). section 3(eXt)(F)(vi)
, •' . 'bttWMtMdmn(URL)a
FtaMiMlhVBg^^
10/27/2006 10:18PM
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to data attar the date dause by
or to support an a new use to an
that does not any use, if
suet data solely to a minor use of a data shaO not,
of the data f»e by
fee to support an application for a Me by
flic of 10 years the date of
sod! date. The or at the time the new
shall fie that to the best
the use fa the las and that the data
to the use of a Is tor the
As to what a "minor use/9 section 2(11) minor use as "the use
of a on an on a commercial crop or site, or for to
of where— •
(1) lie total for the crop is 1ms flaa
..;or
(2) the in c»nsultati0n with to
on ffifbrmatian by an for
or a tie use does not
to the ©r of a
for use and—
(A) are iMufficiot
for the use;
(B) the to the use risk to
the or human health;'
, ^ (C) the minor use play or will a
in resistance; or
(D) the minor use plays or will play a
in an pest program,
In this we need took no farther than Ae in
3
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From: 10/27/200612:18 »095 P.003/003
Having declined your request in full, the Agency nonetheless, for instructional
purposes only, would like to note some additional problems with your request First
some of the new uses being added do not, in fact, appear to be minor uses. For instance
the new uses associated with MRID No. 46385301 are all crop groups, and not minor
uses. Similarly, in connection with MRID Nos, 46385302 and 46385306, neither
almonds nor pecans meet the acreage definition of a minor crop. See The United States
Environmental Protection Agency Report on Minor Uses of Pesticides, found at
http://www.epa.Rov/pesticides/minoruse/minor usa rptpdf Accordingly, even if Valent
had timely made its request for exclusive use protection, it is questionable whether this
particular data would be eligible for such protection.
Second, because the studies identified as MRID Nos. 45317200,45454700, and
45919601 were generated in connection with Interregional Research Project No 4 (IR4)
an initiative funded by the federal government, Valent would not be entitled to exclusive'
use rights for any of this data even if Valent had timely made its request for exclusive use
protection in the first place. See 40 CFR 152.94(b) ("In no circumstances does
submission of a public literature study or government-generated study confer any rights
on the data submitter to exclusive use of data or compensation....") Similar concerns
potentially apply to MRID No. 45454701, which is characterized as an unpublished study
prepared by the University of Maryland.
If you have any questions concerning EPA's determination that the data identified
by MRID Nos. 45668700,45317200,45454700,45454701,45439801,45919601
46385310, 46385302,46385303, 46385304,46385305, and 46385306 are not eligible for
the exclusive use protection sought by Valent, please contact George LaRocca at (703)
-jU3"OlOO,
5is A. Rossi, Director
Registration Division
cc: Marion Johnson, OPP
George LaRocca, OPP
Chris Kaczmarek
10/27/2006 10:18ftM
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