40 CFR 152.83 - Definitions.

§ 152.83 Definitions.
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]
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§ 152.83 Definition of exclusive use study.

A study is an exclusive use study if it meets the conditions of either paragraph (a) or paragraph (b) of this section.

(a) Initial exclusive use period. A study submitted to support the registration of a product containing a new active ingredient (new chemical) or a new combination of active ingredients (new combination) is an exclusive use study if all the following conditions are met:

(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, or an application to amend such registration to add a new use.

(3) Less than 10 years have passed (or up to 13 years, if the period of exclusive use protection has been extended under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) section 3(c)(1)(F)(ii)) since the issuance of the registration for which the data were submitted.

(4) The study was not submitted to satisfy a data requirement imposed under FIFRA section 3(c)(2)(B).

(b) Exclusive use period for certain minor use data. A study submitted by an applicant or registrant to support an amendment adding a new minor use to an existing registration that does not retain any period of exclusive use under paragraph (b)(1) of this section is an exclusive study under FIFRA section 3(c)(1)(F)(vi) if all the following conditions are met:

(1) The study relates solely to a minor use of a pesticide.

(2) The applicant or registrant at the time the new use is requested has notified the Administrator that any exclusive use period for the pesticide has expired and that the study is eligible for exclusive use treatment.

(3) Less than 10 years have passed since the study was submitted to EPA.

(4) The study was not submitted to satisfy a data requirement imposed under FIFRA section 3(c)(2)(B).

(5) The minor use supported by the data has not been voluntarily canceled nor have such data been used to support a non-minor use.

[79 FR 6825, Feb. 5, 2014]

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