C.F.R. » Title 40 » CHAPTER I—ENVIRONMENTAL PROTECTION AGENCY › SUBCHAPTER E—PESTICIDE PROGRAMS › PART 152—PESTICIDE REGISTRATION AND CLASSIFICATION PROCEDURES › Subpart E—Satisfaction of Data Requirements and Protection of Data Submitters' Rights

40 C.F.R. § 152.83

Definition of exclusive use study

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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]
Notes of Decisions
Cited in 2 cases, 2002–2006 · leading case: Syngenta Crop Prot., Inc. v. United States Env't Prot. Agency, 444 F. Supp. 2d 435 (M.D.N.C. 2006).
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Syngenta Crop Prot., Inc. v. United States Env't Prot. Agency, 444 F. Supp. 2d 435 (M.D.N.C. 2006). “20 40 C.F.R. § 152.83 (c). Syngenta alleges that on March 14, 1997, EPA issued a conditional registration for S-metolachlor as a new active ingredient under FIFRA § 3(c)(7)(A) and that upon further review of the data package submitted for the S-metolachlor application, EPA…”
Syngenta Crop Prot., Inc. v. United States Env't Prot. Agency, 202 F. Supp. 2d 437 (M.D.N.C. 2002). “In order to more fully define the exclusive use provision, the EPA promulgated 40 C.F.R. § 152.83 (c). Section 152.83(c) sets out the three criteria necessary for data to be considered “exclusive use study” material as is required under 152.”
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