40 CFR 152.81 - Applicability.
(a) Except as provided in paragraph (b) of this section, the requirements of this subpart apply to:
(1) Each application for registration of a new product.
(2) Each application for amended registration of a currently registered product.
(3) Each submission in response to a Data Call-In under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) section 3(c)(2)(B) for an existing registration, including but not limited to, a product subject to reregistration under FIFRA section 4 or registration review under FIFRA section 3(g). If the Data Call-In establishes procedures for protection of data submitters' rights, recipients must comply with the specific requirements of the Data Call-In rather than the generic procedures set forth in §§ 152.85 through 152.96.
(b) This subpart does not apply to any of the following:
(1) An application for registration submitted to a State under FIFRA section 24(c).
(2) An application for an experimental use permit (EUP) under FIFRA section 5.
(3) An application for an emergency exemption under FIFRA section 18.
(4) A request for cancellation of a registration, or a request for deletion of one or more existing uses, under FIFRA section 6(f).
(5) A modification to registration of a currently registered product that may be accomplished under the notification or non-notification provisions of § 152.46 and any procedures issued thereunder. Notwithstanding the preceding sentence, compliance with this subpart is required if the Administrator has, by written notice under § 152.46, determined that the modification may not be accomplished by notification or non-notification.
(6) Any type of amendment if the Administrator determines, by written finding, that Agency consideration of data would not be necessary in order to approve the amendment under FIFRA section 3(c)(5).
(7) Compliance with Agency regulations, adjudicatory hearing decisions, notices, or other Agency announcements that unless the registration is amended in the manner the Agency proposes, the product's registration will be suspended or canceled, or that a hearing will be held under FIFRA section 6. However, this paragraph does not apply to amendments designed to avoid cancellation or suspension threatened under FIFRA section 3(c)(2)(B) or because of failure to submit data.