US Environmental Protection Agency
Office of Pesticide Programs
Petition for Clethodim
April 28, 2000
-------
2033 K Street, N.W., Suite 850
Washington, B.C.
Tel: (202) 872-4688
Fax: (202) 872-4689
April 28,
Ms. Michelle Knorr
Office of General Counsel
U.S. Environmental Protection Agency
1200 Pennsylvania Avenue, N.W.
Washington, DC
Dear Ms. Knorr:
As you know, the attempts to minor crop by enabling
registrants to gain an additional year of exclusive use of a for every
three minor crop registration. Specifically, the amendment that minor crop
registrations, period for exclusive use of data for new active
ingredients for one year for each three minor uses after
enactment within the first seven years of the exclusive use up to a total of
three years. For pesticides, it affords ten of data for
addition of a minor use."
The ten year exclusive period for clethodim ends In Currently, is
actively pursuing many new minor crops through the and IR-4 although
registration was not achieved within the seven year However, we
feel there are two which may enable us to take of this
amendment.
First, the PR announcing this incentive for IR-4 did not
publish until Thus, Valent had only three years to fulfill requirements
instead of the seven years stated in the FQPA,
Second, Vatent did submit these data for registration in this time but they
were obviously not registered. We feel that even though both IR-4 and the
Agency were to complete these registration actions in we still did
everything in our power to fulfill these requirements.
-------
Considering the Agency is placing an emphasis on the of products for
use on minor we feel these points should show to grant
additional of exclusivity once these new uses are (3rt quarter
With Best
Eric J. Maurer
Federal Registration Manager
Valent USA Corporation
202-872-4882
-------
1333 North CaSfemiaBIwt,
Suite 600
P.O. Box 8025
Walnut Creek, CA
(925) 256-2700
August 1, 2000
VIA FACSIMILE
Ms, Mkhele Knoir
Office of General Counsel
U.S. Environmental Protection Agency
1200 Pennsylvania Avenue, N.W,
Washington, DC 20004
ME; OF USE FOR
Dear Ms.
On April 28, 200Q. Mr. Eric Maurer of Valent U.S.A. Coloration sent a tetter to yon regarding
fe extension of crehwve «e period for cletfaodim, la tbat letter, Mr. Mawer proposal that
tf m f 1 rdmf re^Strf °m m ma°06 "^ cr°Ps» to Vate^ isPentitIed to
f0f Cleth0dfa ^ ~ Wl* <* -*"* « -P
Tie extension of the exclusive use period is extremely vital to Valenf s business interests
ESS £ ^ °n in less ta one year and the exclusive use
Lrii ^ff T fwould 1±e to do whateve^ w caH to expedite yow consldemtion of o-ur
propoS' ^ Wntmg tMS Iete t0 PrOVWe additional supporting our
Qethodim, the active ingredient In Select 2 EC Herbicide, was first registered in 1992
S^JS- \eXCi^V! "* Peri°d f°r data sWP°rt«i to commeiiced in 1992."
Since 1996, when FQPA was enacted, clethodini has been developed for use on three (3) minor
crops and five (5) crop groupings that include minor crops. These crops or crop groups, and the
status of the regtstratroa of each are listed in Table I (attached).
fiA ' * defiaitio° of use Pce, as
defined m the FQPA amendment. That definition requires that, to qualify as a minor ose
pesiicide, the pesticide must be used on a crop gr0wn on less than 300,000 acres I he
amendment also states that the following criteria must also be met:
» There are Insufficient efficacious alternatives for the use
• The alternatives greater risks
• The minor use is significant in managing pest resistance; or
• The minor use plays a significant part in integrated pest management
Vatont USA, Corpoatlon
-------
Ms.MfebefeKnotr August!, 2000
"age 2
All of the crops listed in Table ! are grown on less than acres Also the need for
deOodim registrations on these products Is supported by tie fact that Tk fcse IOB
registrations were developed by IR-4. While Valent did anything in its power to stipport the
registration of ctehodim for these uses (financial, analytical, administrative support) each of
y E €OUn1y °r University se™^ or a local co^7d%
registration of elethocfim for these uses If other, equally effective, products v^nriMM*1**0
Sc^e£lTT^rQ«t txJendf ft "^ ^ re8istrati°m sMe,S that a K&5^™ of a
r eac nree minor registered after the date of enactment of the new Act and
seven years of the commencement of the ten year exclusive use period.,.",
Valent believes that Ae three minor crop registration and the five crop group registrations
(which each count as three crops per the FOPA amendmenti th»t a» „«,*„„ LJ; ^ ^
e P« -e
aacwionaJ teee (3) years of exclusive use. Although none of these registrations have been
grwtod to date, the registration submissions were ^ade within (or nearly 4hk) to seTen year
t^,0f *6 T ^^ r Peri°d * required ^ *e FQPA ^dmeM A£
we televe that the followmg factors shoold be considered whea deciding whether these
registrations qualify under the minor use incentive amendment:
6me AnUdingfte^norusetac^^^^
left Valeirt with only ttoee years to fiilfill the requirement of Ae
^^ While
heA 1 F eVefmg mitS ^^ !° SUpp0rt ^ in makin8 tese submissions, 1R-4'S
schedule for submissions is not within Vaient's control
t JtT! NteS d°n? r Iyfl?n8 ^ MS PWer !° 6Xpedite Ae
°f ^ regIStoti0nS ^ EPA'S
reglstatioas « ^ted scheduled for Ist
D^ee^ear BXtensiM «f fl» «ctoSive use should also be granted.
f vrss" with to proposai We "^ Aat *« pen*^
- °f the FQPA «nendn«^ ** was enacted to encourage fee
^ 6S f°r USC OT mkor Cr°ps' Became of «* i»Portaiice of this Sue to
a buBiness interests and the urgency caused by the patent expiration
e y e patent expraton ventuM
3SST °" ^ "^ " Tn ES POSSMe- ^ y°« fc ^ «^Si oTtMs
proposal. If you have any questern. please feel free to call me at (925) 256-2786 or Mr Eric
Maurerui our Washington, IX office at (202) 872-4682.
ct Manager
Registrations & Regulatory Affairs
-------
Ms, fCnonr
August 1,2000
Page 3
I
Chronology of
Crop/Crop Crops
Crop Subgroup 1-D
Crop Group 8
Crop Subgroup 1-B
Crop Group 2
Crop Subgroup 4-B
Crop Subgroup 9-A
Crop Subgroup 9-B
Cranbeny
Strawberry
Clover
Sweet potato, yarn, artichoke
Peppers, eggplant
Carrots, radish, turnip
Leaves of root vegetables
Celery, Swiss chard
Cantaloupe, watermelon
Squash, cucumber, pumpkin
Cranberry
Strawberry
Clover
Submitted 6/1997, peading
Submitted 1/1999. pending
Submitted 1/2000, pending
------- |