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

     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

   1333 North CaSfemiaBIwt,
   Suite 600
   P.O. Box 8025
   Walnut Creek, CA
   (925) 256-2700
                                         August 1, 2000


   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
                  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
                         Sweet potato, yarn, artichoke
                         Peppers, eggplant
                         Carrots, radish, turnip
                         Leaves of root vegetables
                         Celery, Swiss chard
                         Cantaloupe, watermelon
                         Squash, cucumber, pumpkin
 Submitted 6/1997, peading
Submitted 1/1999. pending
Submitted 1/2000, pending