§ 69505.7. Alternatives Analysis Reports.

(a) General Requirements.

(1) Preliminary and Final AA Reports and Abridged AA Reports must each include all of the applicable information specified in subsections (b) through (k).

(2) The responsible entity shall include in the AA Reports sufficient information for the Department to determine:

(A) Compliance with the substantive and administrative requirements of this article; and

(B) The appropriate due date for submission of the Final AA Report, and the appropriate due date for any regulatory response(s) required under article 6.

(3) The responsible entity shall identify and explain in the Final AA Report all differences in the information and analyses presented in the Preliminary AA Report and the Final AA Report. The responsible entity must identify in the Final AA Report the information sources used to support changes from the Preliminary AA Report to the Final AA Report.

(4) The responsible entity shall maximize the scope of information in the AA Report that can be made available to the public, while maintaining protection of legitimate trade secrets.

(A) If the AA Report contains information claimed by the responsible entity to be a trade secret, a separate publicly available AA Report shall be submitted to the Department that excludes claimed trade secret information only to the extent necessary to protect its confidential nature.

(B) If the Department subsequently rejects a trade secret claim and/or the nature and/or extent of redaction, the responsible entity shall, at the Department's request, submit a revised publicly available AA Report and executive summary within thirty (30) days of the request to add any information for which a trade secret claim or redaction is rejected.

(b) Executive Summary. AA Reports must include a publicly available executive summary sufficient to convey a general understanding of the scope and results of the AA and the rationale for the AA selection decision. The executive summary must be organized in conformance with the organization of the AA Report and must include for each section of the AA Report a detailed summary of the information presented. Information for which trade secret protection is claimed must not be included in the executive summary.

(c) Preparer Information. This section of the AA Report must include:

(1) The name of, and contact information for, the person submitting the AA Report;

(2) If applicable, the name of, and contact information for, all responsible entities on whose behalf the AA Report is being submitted; and

(3) The names of the parties that were involved in funding, directing, overseeing, preparing, and/or reviewing the AA.

(d) Responsible Entity and Supply Chain Information. This section of the AA Report must include:

(1) The name of, contact information for, and headquarters location of the manufacturer(s) and importer(s), if applicable, and, if the AA Report is prepared on behalf of a consortium of manufacturers or other persons in the Priority Product's supply chain, a list of the participants along with their contact information;

(2) The name of, and contact information for, any person(s) identified on the Priority Product label as the manufacturer, importer, or distributor;

(3) The name of, and contact information for, all persons in California other than the final purchaser or lessee to whom the manufacturer or importer directly sold the Priority Product within the prior twelve (12) months; and

(4) Identification and location of the manufacturer's and/or importer's retail sales outlets where the manufacturer and/or importer sold, supplied, or offered for sale the Priority Product in California, if applicable.

(e) Priority Product Information. This section of the AA Report must include:

(1) The brand name(s) and product name(s) under which the Priority Product is placed into the stream of commerce in California;

(2) If the Priority Product is a component of one or more assembled products, a description of the known product(s) in which the component is used;

(3) Identification of the Chemical(s) of Concern for the Priority Product;

(4) Any Material Safety Data Sheets and/or Safety Data Sheets related to the Priority Product; and

(5) The information specified in paragraphs (1) and (2) of section 69505.5(a).

(f) Scope of Relevant Comparison Factors. Each AA Report must identify which factors and, when applicable, associated exposure pathways and life cycle segments were determined to be relevant, under sections 69505.5(c) and 69505.6(a), for evaluation and comparison of the Priority Product and its alternatives. For each factor, and exposure pathway and life cycle segment, if applicable, determined not to be relevant, the AA Report must explain the rationale and identify, and explain the pertinent findings of, the supporting information for this determination.

(g) Scope and Comparison of Alternatives. The AA Reports must identify and describe the alternatives chosen to be evaluated and compared, and explain the rationale for selecting and screening out specific alternatives at each stage of the alternatives comparison process. For any alternative that is screened out because it is determined that its adverse impacts are equal to or greater than those of the Priority Product, the responsible entity shall describe in the AA Report the method used to determine equal or greater adverse impacts, including the method used to compare the multiple factors associated with the impacts, and the rationale for any trade-offs made among the factors.

(1) Each Preliminary AA Report and Abridged AA Report must include the information collected and the comparison conducted under section 69505.5 for the Chemical(s) of Concern and the alternative replacement chemical(s). This must include a matrix, or other summary format, that provides a clear visual comparison that summarizes the information collected regarding the relevant adverse impacts, and their associated relevant exposure pathways and life cycle segments, for the Chemical(s) of Concern and each alternative replacement chemical being considered, and the comparative results of evaluating this information.

(2) The Final AA Report must include the information collected and the comparison conducted under sections 69505.5 and 69505.6 for the Priority Product and its alternatives, including:

(A) A matrix, or other summary format, that provides a clear visual comparison that summarizes the information collected regarding the relevant comparison factors, and their associated relevant exposure pathways and life cycle segments, for the Priority Product and each alternative considered, and the comparative results of evaluating this information; and

(B) Identification and description of how any relevant safeguards provided by other federal and California State regulatory programs were considered in the AA.

(3) The responsible entity shall demonstrate in the Final AA Report that all of the requirements of section 69505.6 have been met.

(h) Methodology. The AA Report shall identify and describe the analytical tools, models, and software used to conduct the AA, and discuss any of their limitations. The AA Report shall also identify any published methodologies and/or guidelines used, and any deviations from those methodologies and/or guidelines.

(i) Supporting Information.

(1) All information used as supporting information in performance of the AA and preparation of the AA Reports must be cited in the AA Reports and made available to the Department upon request. The AA Reports must include a brief summary of the information reviewed and considered under section 69505.1(d).

(2) The Final AA Report must identify information that is not currently available but, if it were available, could be used to:

(A) Validate information used for purposes of sections 69505.5 and 69505.6; and/or

(B) Address any uncertainties in the analyses conducted under sections 69505.5 and 69505.6.

(j) Selected Alternative(s).

(1) The Preliminary AA Report must identify and describe the alternatives selected for further evaluation in the second stage of the AA, and explain the rationale for the selection decision.

(2) The Final AA Report must identify and describe the alternative(s), if any, selected to replace the Priority Product. The description of the selection decision must include an analysis that evaluates and compares the selected alternative(s) against the Priority Product and a detailed list and explanation of the reasons for the selection decision, or, alternatively, for the decision not to select and implement an alternative to the Priority Product. The Final AA Report must also include:

(A) The product function and performance information specified in section 69505.6(a)(2) for the selected alternative(s). If no alternative is selected, this information must be provided in the Final AA Report or Abridged AA Report, as applicable, for each alternative considered.

(B) An explanation of the rationale for retaining the Chemical(s) of Concern or using the alternative replacement chemical(s), if section 69505.5(a)(3)(B) applies, and one or more selected alternatives retains the Chemical(s) of Concern or uses one or more replacement chemicals.

(C) A list of all chemicals known, based on available information, to be in the selected alternative(s) that are Chemicals of Concern, that differ from the chemicals in the Priority Product, or that are present in the selected alternative(s) at a higher concentration than in the Priority Product relative to other chemicals in the Priority Product other than the Chemical(s) of Concern. The following information, to the extent available, must be provided for those chemicals:

1. Environmental fate;

2. Hazard trait and environmental and toxicological endpoint information that has not already been provided to the Department under this chapter;

3. Information about the chemical purity, meaning the relative absence of extraneous matter, and identification of known impurities and additives in the chemical;

4. Physicochemical properties; and

5. Substance identification information, including all of the following that are applicable:

a. Chemical abstract services number;

b. Structural formula;

c. Molecular weight;

d. Synonyms;

e. International Union of Pure and Applied Chemistry name;

f. European Commission number;

g. Registry of Toxic Effects of Chemical Substances number;

h. International Union of Biochemistry and Molecular Biology number;

i. Japan Ministry of International Trade and Industry number;

j. Number assigned by the United Nations Experts on the Transport of Dangerous Goods;

k. North America Department of Transportation number;

l. European Inventory of Existing Commercial Chemical Substances number;

m. European List of Notified Chemical Substances number;

n. European Commission Directive 67/548/EEC No Longer Polymers number; and

o. Other commonly recognized substance identification system numbers.

(k) Next Steps.

(1) Work plan. The Preliminary AA Report must include the work plan and proposed implementation schedule for completion of the second AA stage required to be prepared under section 69505.5(f)(1).

(A) The work plan and implementation schedule must specify the proposed submission date for the Final AA Report and must ensure that the Final AA Report or progress report, if applicable, will be submitted to the Department no later than twelve (12) months after the Department issues a notice of compliance for the Preliminary AA Report. If the Department approves an extended due date under section 69505.9(b)(4), the responsible entity shall provide a yearly progress report until the Final AA Report is submitted. The first yearly progress report shall be submitted no later than twelve (12) months after the Department issues a notice of compliance for the Preliminary AA Report. Each progress report must include:

1. Preparer information specified in subsection (c);

2. Priority Product information specified in subsection (e);

3. A summary of achievements since the last progress report;

4. A summary and discussion of issues that have arisen and their resolutions;

5. A summary of work that is pending; and

6. An assessment of whether the milestones in the schedule set forth in the Preliminary AA Report or Alternate Process AA Work Plan are anticipated to be completed on time and any contingency plans to ensure timely completion.

(B) The responsible entity may request an extended due date for submittal of the Final AA Report. Any requested extension shall not exceed twenty-four (24) months from the date the Department issues a notice of compliance for the Preliminary AA Report, unless additional time is needed to conduct regulatory safety and/or performance testing on multiple alternatives prior to making an AA selection decision, in which case the requested extension shall not exceed thirty-six (36) months. The extended due date request must include a detailed explanation of why additional time is needed.

(2) Implementation of selected alternatives. The Final AA Report must include a detailed plan for implementing any selected alternative(s).

(A) The implementation plan must include key milestones and dates for implementing the selected alternative(s), if applicable, and identify steps that will be taken to ensure compliance with applicable federal, state, and/or local laws.

(B) The implementation plan may also include the identification of and implementation plan(s) for any regulatory response(s) that the responsible entity wishes to propose that would best limit exposure to, or reduce the level of adverse impacts or adverse waste and end-of-life effects posed by, any Chemical(s) of Concern or replacement Candidate Chemical(s) that will be in the selected alternative(s) or the Chemical(s) of Concern that is/are in the Priority Product if the decision resulting from the AA is to retain the Priority 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.