US Environmental Protection Agency
Office of Pesticide Programs

EPA Response to Petition for

September 25, 2006

                                                              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

                 2.4 EC
       EPA Reg, No.


       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
                                                                 10/27/2006  10:18PM


                   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

        (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
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)
                                                  5is A. Rossi, Director
                                                Registration Division
         cc:    Marion Johnson, OPP
               George LaRocca, OPP
               Chris Kaczmarek
                                                                             10/27/2006   10:18ftM