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Alternatives Analysis Reporting Options

This Fact Sheet is for the Responsible Entity1 subject to the Alternatives Analysis (AA) requirements in the California Safer Consumer Products (SCP) regulations.2 It outlines the different ways to fulfill the requirements of the SCP AA process.

The SCP regulations specify a two-stage process for conducting an AA of a Priority Product. However, the regulations also allow the use of different processes or report options, such as an Abridged AA Report, an Alternate Process AA, or a Previously Completed AA. Each option, as identified in the regulations,3 has unique requirements. Ultimately, the different types of AA reports all include the information needed to compare alternatives and select a preferred option.

Responsible Entities have specific responsibilities under SCP regulations, including to provide an AA for their Priority Product and ensure the analysis complies with the regulations. Responsible Entities should consult the regulations to ensure compliance.

Preliminary/Abridged AA Process: 1) Priority Product (PP) Regulation goes into effect. 2) Conduct First Stage Alternatives Analysis (AA). 3 Feasible Alternative Identified (180 days)? a) If "Yes," then: Submit Preliminary AA Report. b) If "No," then: Submit Abridged AA Report. 4) DTSC Issues a Notice of Compliance. 5) Conduct Second Stage AA. 6) Submit Final AA Report. 5 & 6 timeframe is 12 months. Abridged AA Report

An Abridged AA Report can be prepared in lieu of the Preliminary and Final AA Report if, after completing the first five steps of the first stage AA, the Responsible Entity determines there are no available functionally acceptable and technically feasible alternatives. This option expedites the process toward research and development of safer alternatives by streamlining the AA process when a functionally acceptable and technically feasible alternative is not available.4

A significant difference between an Abridged AA Report versus conducting the two-stage AA is the reduced time for submitting the Abridged AA report to the Department of Toxic Substances Control (DTSC). A complete Abridged AA Report is due 12 months before a Final AA Report.

First 5 steps of the first stage AA

  1. Identification of Product Requirements and Function(s) of Chemical(s) of Concern
  2. Identification of Alternatives
  3. Identification of factors relevant for comparison of alternatives
  4. Initial evaluation and screening of alternative replacement chemicals
  5. Consideration of additional information

When preparing an Abridged AA Report, a Responsible Entity is required to document all findings from the first 5 steps of the first stage AA, including an explanation of why the alternatives under consideration are not functionally acceptable or technically feasible. In addition, a summary of findings with respect to identification of relevant factors for comparison of alternatives must be included in an Abridged AA report.5

The Abridged AA Report must be submitted to DTSC by the same due date as the Preliminary AA Report; 180 days from the date the product is listed on the Priority Products list posted on DTSC’s website.

Alternate AA Process: 1) Priority Product (PP) Regulation goes into effect. 2) Submit Alternate Process AA Workplan (60 days). 3) DTSC Issues a Notice of Compliance. 4) Conduct Alternate Process Alternatives Analysis (AA) (Must provide substantially similar information). 5) Submit Final AA Report. Timeframe for 4 & 5 is 18 months.

Alternate Process AA

The regulations allow the Responsible Entity to use an alternate process that differs from the two-stage AA process.6 This option provides flexibility to the Responsible Entities who use their own assessment protocols which may (1) be more applicable to their product, (2) be more quickly implemented, and (3) reduce duplication of effort and waste of resources. The alternate process Final AA report must include all information needed to substantially comply with the SCP regulations and contain sufficient information for DTSC to determine any necessary regulatory response.7 The Responsible Entity is required to submit an Alternate Process AA Work Plan demonstrating the alternate process fulfills the SCP regulatory requirements.

The Alternate Process AA Work Plan must be submitted to DTSC no later than the due date of the Priority Product Notification for the product, that is, within 60 days after the effective date of the Priority Product listing regulation.

The Responsible Entity must submit a Final AA Report to DTSC that compares the Priority Product and the alternatives under consideration using, at a minimum, the same relevant factors and applicable associated exposure pathways and life cycle segments specified in the SCP regulations. The Final AA Report is due 18 months after the date DTSC issues a notice of compliance for the Alternate Process AA Work Plan.

If DTSC rejects the Alternate Process AA Work Plan, the Responsible Entity will be subject to completing the two-stage AA process and required to submit a Preliminary AA Report within 180 days after the notice of disapproval is issued.

Previously Completed AA: 1) Priority Product Regulation goes into effect. 2) Submit Previously Completed AA Report (180 days) (Modify to fit requirements).Previously Completed AA

A Responsible Entity may submit a Previously Completed AA report for the Priority Product if the report is substantially equivalent to the Final AA Report requirements. The Previously Completed AA may either be an AA conducted (or obtained) by the Responsible Entity or a publicly available AA. This option allows Responsible Entities to use existing information to the extent suitable to expedite the quest for safer alternatives.8

Previously Completed AA report must contain information substantially equivalent to the Final AA Report requirements and contain sufficient information for DTSC to determine any necessary regulatory response.9

If the previously completed AA doesn’t address all the SCP requirements, the Responsible Entity may need to supplement the  Previously Completed AA report. Additional information may be added to ensure the report fulfills all Final AA Report requirements.

A Previously Completed AA report must be submitted to DTSC no later than 180 days after the date the product is listed on the final Priority Products list posted on DTSC’s website.

Reporting by Consortium

A consortium, trade association, public-private partnership, non-profit organization, or other entity may act on behalf or instead of the Responsible Entity. This option gives Responsible Entities the flexibility to obtain the necessary resources, expertise, and partnerships to fulfill their AA obligations in the most effective and cost-efficient manner as they see fit.10

Did you know?

All AA Reports can be submitted through SCP’s Information Management System,
CalSAFER (calsafer.dtsc.ca.gov/).

Questions and Answers

Q: Can a Responsible Entity request an extension to the submission due date for an Abridged AA Report, the Alternate Process Work Plan, or the Previously Completed AA Report?

A: A Responsible Entity may request a one-time extension of up to 90 days past the submission due date for either an Alternate Process AA Work Plan or the Previously Completed AA Report.

For an Abridged AA Report, a Responsible Entity cannot request an extension to the original submission due date for an Abridged AA Report. A Responsible Entity is only eligible to request a one-time extension for resubmission of a revised Abridged AA Report, when DTSC issues a notice of deficiency for the originally submitted Abridged AA Report.

References

1 A “Responsible Entity” may be a manufacturer, importer, assembler, or retailer of a listed Priority Product.

2 Cal. Code Regs., tit. 22, § 69505 et seq

3 Cal. Code Regs., tit. 22, § 69505.4

4 Paraphrased based on language in DTSC, Final Statement of Reasons Safer Consumer Products, R-2011-02, section 69505.4(b), page 241

5 Cal. Code Regs., tit.22, § 69505.4(b)(2)

6 Cal. Code Regs., tit.22, § 69505.4(c)

7 Paraphrased based on language in DTSC, Final Statement of Reasons Safer Consumer Products, R-2011-02, section 69505.4(c)(1), page 243

8 DTSC, Final Statement of Reasons Safer Consumer Products, R-2011-02, section 69505.4(d), page 246

9 Cal. Code Regs., tit.22, § 69505.4(d)

10 Paraphrased based on language in DTSC, Final Statement of Reasons Safer Consumer Products, R-2011-02, section 69501.2(a)(2), page 103

Additional Resources

DTSC has developed the following additional resources to help Responsible Entities:

These resources and more information on AA are available on the Alternatives Analysis web page.

Further Information

Still in need of help? Contact SCP at SaferConsumerProducts@dtsc.ca.gov.

To receive the latest information and updates from the Department, join the SCP Program e-mail list (E-List) (opens new window).

Disclaimer: This Fact Sheet is not a standard or regulation and it creates no new legal obligation. It is advisory in nature, informational in content, and intended to assist the Responsible Entity who is conducting an Alternatives Analysis. It does not alter or determine compliance responsibilities set forth in the current statutory and regulatory requirements.