161.30—Timing of the imposition of data requirements.
This part establishes requirements for the types of data which are necessary to support the unconditional registration of a pesticide product under section 3(c)(5) of the Act. While every registered pesticide product must eventually be supported by the data required by part 161, when an applicant or registrant must initially satisfy these data requirements depends on the factors listed below in this section.
(a) Existing Registrations.
A registrant of a currently registered pesticide product is not obligated to satisfy any data requirement in part 161 with respect to that product until he receives a notice under section 3(c)(2)(B) of the Act that additional data are required to support the continued registration of the product, until he applies for an amendment to the registration, or until the product is subject to reregistration.
(b) Applications.
The amount of data required by the Agency to evaluate an application for initial or amended registration depends on whether the product is being reviewed under section 3(c)(5) of the Act (unconditional registration) or section 3(c)(7) of the Act (conditional registration). Refer to § 152.111 of this chapter or consult with the appropriate EPA Product Manager to determine under which section of the Act the application will be reviewed. The following paragraphs identify, for each different type of application, the minimum amount of data that must be available for EPA review to permit EPA to make the statutory risk-benefit determinations required by section 3(c)(5) or 3(c)(7) of the Act. In addition to satisfying these minimum data requirements, applicants may be required to submit or cite additional data, either to permit EPA to assess the safety or efficacy of the product (refer to § 161.75) or to comply with the statutory requirements of section 3(c)(1)(D) of the Act, or both.
(1) Applications for unconditional registration under
EPA will not approve an application for unconditional registration unless all data required by this part which have not been waived are available for EPA to review.
(2) Applications for conditional registration of a new chemical under
EPA will not approve an application for conditional registration of a pesticide containing an active ingredient not contained in any currently registered product unless data required by this part are available for EPA to review except for:
(ii)
Those data for which the requirement was imposed so recently that the applicant has not had sufficient time to produce the data.
(3) Applications for conditional registration of products which are identical or substantially similar to currently registered products under
EPA will not approve an application for conditional registration of a pecticide product which is identical or substantially similar to a currently registered pesticide unless the following data are available for EPA to review:
(4) Applications for conditional registration of new uses of currently registered products under
EPA will not approve an application for registration of a pesticide for a new use of a currently registered pesticide product unless the following data are available for EPA to review:
(iii)
Other data pertaining solely to the new use. The applicant may generally determine which data pertain solely to the new use by comparing the data requirements for all existing uses of all currently registered products containing the same active ingredient(s) with those for all uses including the new use. Any differences are attributable to the new use and must be submitted with the application.