§ 69505.4. Alternatives Analysis Process and Options.

(a) AA Stages.

(1) An AA must be conducted in two stages.

(2) The responsible entity shall initially complete the first stage of the AA in accordance with section 69505.5, and submit a Preliminary AA Report that complies with sections 69505.1(b)(2)(A) and 69505.7.

(3) The responsible entity shall next complete the second stage of the AA in accordance with section 69505.6, and submit a Final AA Report that complies with sections 69505.1(b)(2)(B) and 69505.7.

(b) Abridged AA Reports. After completing the first five (5) steps of the first stage of the AA under subsections (a) through (e) of section 69505.5, a responsible entity that determines a functionally acceptable and technically feasible alternative is not available may prepare and submit an Abridged AA Report, in lieu of the Preliminary and Final AA Reports, if:

(1) The responsible entity summarizes in the Abridged AA Report the first stage AA findings in compliance with the applicable requirements of section 69505.7;

(2) The responsible entity summarizes in the Abridged AA Report its findings with respect to section 69505.6(a) in compliance with the applicable requirements of section 69505.7;

(3) The responsible entity submits an Abridged AA Report to the Department by the due date specified in section 69505.1(b)(2)(A); and

(4) The responsible entity includes an implementation plan in the Abridged AA Report that specifies the milestones and dates for implementation of proposed regulatory responses, which shall, at a minimum, include the regulatory responses required under sections 69506.3 and 69506.8.

(c) Alternate Process AA.

(1) A responsible entity may use an AA process that differs from the process specified in sections 69505.5 and 69505.6, if:

(A) The responsible entity's alternate process provides the information needed to prepare a Final AA Report that substantially complies with section 69505.7.

(B) The responsible entity's alternate process compares the Priority Product and the alternatives under consideration using, at a minimum, the same relevant factors and, when applicable, associated exposure pathways and life cycle segments specified in sections 69505.5 and 69505.6.

(C) The responsible entity submits an Alternate Process AA Work Plan to the Department with sufficient information to demonstrate that the alternate process complies with subparagraphs (A) and (B), and sufficient information for the Department to specify an appropriate due date for submittal of the Final AA Report.

1. The Alternate Process AA Work Plan shall include the information specified in subsections (c), (d), and (e) of section 69505.7.

2. If the Alternate Process AA Work Plan includes information for which trade secret protection is claimed, the responsible entity shall also submit a redacted copy of the work plan that excludes that information.

3. The Alternate Process AA Work Plan shall be accompanied by an executive summary organized in conformance with the organization of the work plan that is sufficient to convey to the public a general understanding of the work plan, and that excludes any information for which trade secret protection is claimed. If the Department subsequently rejects a trade secret claim, the responsible entity shall, at the Department's request, submit a revised executive summary within thirty (30) days of the request to add any information for which a trade secret claim is rejected and which the Department specifies must be included in the executive summary.

(D) The Alternate Process AA Work Plan is submitted to the Department no later than the due date for the Priority Product Notification for the product.

(E)1. The responsible entity timely submits a Final AA Report to the Department that substantially complies with section 69505.7.

2. The due date for the Final AA Report is eighteen (18) months after the date the Department issues a notice of compliance for the Alternate Process AA Work Plan, unless the responsible entity requests and receives Department approval of an extended due date using the procedures specified for Preliminary AA Reports in section 69505.7(k)(1)(B), or the Department otherwise approves an extended due date under section 69505.9(b)(4). If the Department approves an extended due date, the responsible entity shall provide a yearly progress report until the Final AA Report is submitted. Each progress report must provide all of the information specified in subparagraphs 1. through 6. of section 69505.7(k)(1)(A).

(2) If the Alternate Process AA Work Plan is disapproved by the Department under section 69505.9(b)(3), the responsible entity shall submit a Preliminary AA Report to the Department within 180 days after the Department issues the notice of disapproval.

(d) Previously Completed AAs. A responsible entity may comply with section 69505.1(b) by submitting to the Department a report for a previously completed AA for the Priority Product, if the Department determines that the report is substantially equivalent to the Final AA Report requirements of section 69505.7 and contains sufficient information for the Department to determine any necessary regulatory response(s) under article 6. The previously completed AA may be either an AA conducted or obtained by the responsible entity or a publicly available AA.

(1) A responsible entity submitting a report under this subsection shall submit the report no later than the deadline for submitting a Preliminary AA Report, except that a one-time extension may be requested under section 69505.1(c).

(2) A responsible entity submitting an existing report under this subsection may supplement the report with additional information to render the report substantially equivalent to the Final AA Report requirements of section 69505.7.

(e) Revised Alternative Selection Decision.

(1) If after submitting the Final AA Report, the responsible entity selects one or more alternatives that differ from the alternative(s) identified as the selected alternative(s) in the Final AA Report, the responsible entity shall submit a revised Final AA Report to the Department at least sixty (60) days prior to placing the newly selected alternative product(s) into the stream of commerce in California. The revised Final AA Report must explain the differences from the original Final AA Report, identify the information used to support the revisions to the Final AA Report, and describe the rationale for selecting the different alternative(s). The Department shall review and make a compliance determination with respect to the revised Final AA Report in accordance with the procedures and criteria set forth in section 69505.9.

(2) Paragraph (1) also applies if:

(A) The selection decision in the original Final AA Report was to retain the Priority Product, and the responsible entity later decides to select an alternative to replace the Priority Product; or

(B) The responsible entity later decides to retain the Priority Product in lieu of a previously selected alternative product.

(3) The requirements of this subsection only apply for three (3) years after the date the original Final AA Report is approved by the Department.

(f) Reformulation. Except as provided in section 69505.2, if prior to submitting the Final AA Report for a Priority Product the responsible entity removes, or reduces the concentration of, the Chemical(s) of Concern and uses one or more replacement Candidate Chemicals, the Alternatives Analysis evaluation and comparison shall include consideration of both the Priority Product and the reformulated product.

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: Sections 25252, 25253 and 25257, Health and Safety Code.