As used in this subpart, the following terms shall have the meanings set forth in this section:
Data gap means the absence of any valid study or studies in the Agency's files which would satisfy a specific data requirement for a particular pesticide product.
Data Submitters List means the current Agency list, entitled “Pesticide Data Submitters by Chemical,” of persons who have submitted data to the Agency.
Exclusive use study means a study that meets each of the following requirements:
(1) The study pertains to a new active ingredient (new chemical) or new combination of active ingredients (new combination) first registered after September 30, 1978;
(2) The study was submitted in support of, or as a condition of approval of, the application resulting in the first registration of a product containing such new chemical or new combination (first registration), or an application to amend such registration to add a new use; and
(3) The study was not submitted to satisfy a data requirement imposed under FIFRA section 3(c)(2)(B) ;
Provided that, a study is an exclusive use study only during the 10-year period following the date of the first registration.
Original data submitter means the person who possesses all rights to exclusive use or compensation under FIFRA section 3(c)(1)(F) in a study originally submitted in support of an application for registration, amended registration, reregistration, or experimental use permit, or to maintain an existing registration in effect. The term includes the person who originally submitted the study, any person to whom the rights under FIFRA section 3(c)(1)(F) have been transferred, or the authorized representative of a group of joint data developers.
Valid study means a study that has been conducted in accordance with the Good Laboratory Practice standards of 40 CFR part 160 or generally accepted scientific methodology and that EPA has not determined to be invalid.
[49 FR 30903, Aug. 1, 1984, as amended at 73 FR 75595, Dec. 12, 2008]
Title 40 published on 2012-07-01
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