US Environmental Protection Agency
Office of Pesticide Programs
EPA Response to Petition for
Clethodim
September 27, 2000
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WASHINGTON, D.C,
SEP 27
OFFICE OF
GENERAL COUNSEL
Eric Mauer
Valent USA Corporation
Federal Registration Manager
2033 K Street, N.W. Suite 850
Washington, D.C. 20005
Dear Mr, Mauer:
This is in response to your April 28S 2000 letter in which you requested that the exclusive"
use penod on Clethodira be extended by three years. The response also takes into consideration
Jim Pensyl's August, 2000 facsimile.
Your request to section 3(c)(l)(F)(H) of which states, in pertinent part
Ltjne period of exclusive data use provided under clause (i) shall be 1 additional year
tor each 3 minor uses registered after the date of enactment clause and within 7 years of
the commencement of the exclusive use period, up to a total of 3 years for all minor
uses registered by the Administrator if the Administrator, ia consultation with the Secretary of
Agriculture, determines that, based on information provided by an applicant for registration or a
registrant,.. . ."
• ™nox e fo!!owin« facts'First'the ten y«r exclusive use period for Clethodim ends
in 2002 and Vatent is pursuing new minor crops, but registration has not been granted Second
section 3(c)(I)(F)(«) of FffRA was an amendment through FQPA and therefore, Valent had three
years to fulfill the requirements set forth in that section, instead of the seven years stated in the
statute, Third, you argue that although Valent did not receive its registrations in the seven year
penod, it did submit the application with supporting data. Lastly, you state that Valent should
receive an additional three years of exclusive use, because it did everything in its power to fulfill
the requirements, but the Agency could not complete the registration action in time.
_ The language in Section 3(c)(l)(F}(ii) of is clear. Congress expressly stated that a
registration must be granted within the seven years of the commencement of the relevant
exclusive use period in order to extend that exclusive use period. Congress did not state that the
submission of data in support of registration would give rise to an extension of the exclusive use
penod.
Primed on Recycled Paper
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_ Throughout section 3(c)(I)ff) of FIFRA, Congress whether data rights attach at
registration or at suteissicm of data. In section 3Ce)0}(F)(ii)3 it is dear that Congress made the
determination that the pesticide must be registered in order to take advantage of this clause I
understand your argument as to the time It has taken the Agency to review the .data submitted by
Valent, but m this case, EPA believes It is acting reasonably In reviewing this registration taking
into account the many other priority actions before the Agency.
Please feel free to contact me for further information at 202-564-5631,
Mchele L, Knorr
Attorney
Pesticides and Toxic
Substances Law Office
cc: Jim Pensyl
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