An applicant may comply with this subpart by listing the specific data requirements that apply to his product, its active ingredients, and use patterns, and demonstrating his compliance for each data requirement by submitting or citing individual studies, or by demonstrating that no study has previously been submitted to the Agency. This section summarizes the procedures that an applicant must follow if he chooses the selective method of demonstrating compliance. Sections 152.91 through 152.96 contain specific procedures for citing or submitting a study or claiming a data gap.
(a) List of data requirements.
(1) Each applicant must submit a list of the data requirements that would apply to his pesticide, its active ingredients, and its use patterns, if the product were being proposed for registration under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) section 3(c)(5) for the first time.
(2) The applicant must list the applicable requirements, as prescribed by part 158 of this chapter, as applicable. All required (R) studies, and any studies that could be conditionally required (CR) based upon composition, use pattern, or the results of required studies, are to be listed. The applicant need not list data requirements pertaining to any ingredient which qualifies for the formulators' exemption.
(b) Methods of demonstrating compliance. The applicant must state for each data requirement on the list required by paragraph (a) of this section which of the following methods of compliance with the requirement he is using, and shall provide the supporting documentation specified in the referenced section.
(1) Existence of or granting of a data waiver. Refer to § 152.91.
(2) Submission of a new valid study. Refer to § 152.92.
(3) Citation of a specific valid study previously submitted to the Agency by the applicant or another person, with any necessary written authorizations or offers to pay. Refer to § 152.93.
(4) Citation of a public literature study. Refer to § 152.94.
(5) Citation of all pertinent studies previously submitted to the Agency, with any necessary written authorizations or offers to pay. Refer to § 152.95.
(6) Claim of data gap. Refer to § 152.96.
[49 FR 30903, Aug. 1, 1984, as amended at 72 FR 61028, Oct. 26, 2007; 79 FR 6825, Feb. 5, 2014]