§ 69506.2. Supplemental Information and Regulatory Response Revisions.

(a) Supplemental Information for Selection of Regulatory Response(s). Prior to imposing any regulatory response for a product, the Department may require the responsible entity to obtain or develop, and provide to the Department within a specified time frame, any information supplementary to the AA Report that the Department determines is necessary to select and ensure implementation of one or more regulatory responses.

(b) Information-Generation for Revision of Regulatory Response(s).

(1) When imposing one or more regulatory responses for a product, the Department may include a requirement that the responsible entity provide information to the Department to fill one or more information gaps identified in the AA Report under section 69505.7(i)(2), if the Department determines this information is necessary to re-evaluate one or more of the other initial regulatory responses.

(2) Following receipt of information required to be provided under paragraph (1), the Department may, based on this new information, revise the initial regulatory response(s) imposed for the product in accordance with the procedures set forth in section 69506.1. Any revisions to the initial regulatory responses shall be noticed for public review and comment no later than ninety (90) days after receiving the information required to be provided under paragraph (1).

(c) Regulatory Response Revisions for Revised AA Reports. In addition to the circumstances described in subsection (b), the Department may revise the initial regulatory response(s) imposed for a product in response to a revised AA Report submitted by a responsible entity under section 69505.4(e), within ninety (90) days after issuing the notice of compliance or notice of disapproval for the revised AA Report.

HISTORY

1. New section filed 8-28-2013; operative 10-1-2013 (Register 2013, No. 35).

Note

Note: Authority cited: Sections 25253 and 58012, Health and Safety Code. Reference: Section 25253, Health and Safety Code.