DTSC Releases Revised Proposed Safer Consumer Products Regulations
On April 10, 2013, the California Department of Toxic Substances Control (DTSC) released what many believe to be the last revisions to the proposed Safer Consumer Products Regulations (Revised Proposed Regulations). The Revised Proposed Regulations are subject to a 15-day comment period, ending April 25, 2013. Memoranda providing background information are available online. The Revised Proposed Regulations are available online.
In summary, DTSC has not made many significant changes to the Regulations, which were last released and subject to comment earlier this year. The core elements of the Revised Proposed Regulations — Chemicals of Concern (COC), Priority Products (PP), Alternative Assessments (AA), and Regulatory Responses — remain largely the same. Below is a discussion of the substantive changes from the last proposal. DTSC has indicated that it intends to issue final regulations by October 2013.
Scope of Persons and Products Subject to the Regulations
The Regulations continue to apply to “responsible entities” — including manufacturers, importers, assemblers, and retailers who sell products in California. In the last version, manufacturer was redefined as: “any person who manufactures a product that is subject to the requirements of this chapter, or any person that controls the manufacturing process for, or has the capacity to specify the use of chemicals in, such a product.” The current version redefines manufacturer again, this time as “any person who manufactures a product that is subject to the requirements of this chapter, or any person that controls the manufacturing process for, or specifies the use of chemicals to be included in, the product.” DTSC does not explain its removal of the definition that relates to the “capacity” to specify the use of the chemicals in the product, but arguably it was removed because that is not an easily defined term.
As with the prior version, manufacture and manufacturer are explicitly distinguished from assemble and assembler. Assemble was previously defined as to “fit, join, put, or otherwise bring together components to create a consumer product.” DTSC has revised this definition to make it clear that it includes repair and maintenance activities in addition to creation of a new consumer product. The new revised definition of “assemble” is thus to “fit, join, put, or otherwise bring together components to create, repair, refurbish, maintain, or make non-material alterations to a consumer product.”
“Priority Products” List
The procedure by which DTSC would evaluate and prioritize products that contain COCs to develop a list of PPs for which AAs must be conducted remains largely unchanged, with two important changes:
- Reliable Information: During the process to identify and prioritize product-chemical combinations, and specifically when DTSC is evaluating the quality of scientific and other information available to substantiate the existence or absence of potential adverse impacts, potential exposures, and potential adverse waste and end-of-life effects, the Revised Proposed Regulations now include additional information regarding what DTSC must consider. Specifically, the Regulations now state that DTSC must consider: (1) the level of rigor attendant to the generation of the information, including, when relevant, the use of quality controls; (2) the degree to which the information has been independently reviewed by qualified disinterested parties; (3) the degree to which the information has been independently confirmed, corroborated, or replicated; (4) the credentials and education and experience qualifications of the person(s) who prepared and/or reviewed the information; and (5) the degree to which the information is relevant for the purpose for which it is being considered by DTSC.
The definition of “reliable information” also has been revised at Section 69501.1(57) to specify that the type of information that would be reliable is “a scientific study or other scientific information.”
- Alternatives Analysis Threshold (AAT): Perhaps most significant of the proposed changes are the revisions to the definition of AAT. DTSC has revised Sections 69501.1(57) and 69503.5(c) to state that the AAT is not only the practical quantification limit (PQL) for a COC that is present in a PP solely as a contaminant. Now, an AAT also can be another concentration specified by DTSC. DTSC states that this revision is intended to clarify that an AAT concentration can be determined for a COC that is an intentionally added ingredient, as well as an AAT concentration greater than the applicable PQL for any COC that is a contaminant.
Companies to Prepare Alternative Analysis
Under the Revised Proposed Regulations (and prior versions), AAs must be conducted in two stages that produce a Preliminary AA Report and then a Final AA Report. One significant change is that DTSC has moved one of the process steps from stage two to stage one. That process step, now set forth at Section 69505.5(c), involves the identification of factors that are relevant for comparison of a PP and its alternatives.
In the prior version of the Regulations, a very significant change was the elimination of all provisions requiring that the AA be conducted by a “certified assessor” or be reviewed by accreditation bodies. To provide a quality assurance mechanism for the AAs, DTSC wanted to require responsible entities to consider all information and public comments made available on DTSC’s website and summarize the consideration of such information and comments in the Final AA Report. In the Revised Proposed Regulations at Section 69505.8, DTSC has limited the requirement that responsible entities consider “all” information and public comments. Instead, DTSC will provide a public comment period for the Final AA Report, review those comments, and then identify, no later than thirty (30) days after the close of the public comment period, any issues that it determines need to be addressed by the responsible entity in an AA Report Addendum. The due date for the AA Report Addendum will be provided by DTSC, taking into consideration “the scope and complexity of the issues the Department is requiring the person to address.” When providing an AA Report Addendum, the responsible entity must also include any revisions to the Final AA Report or Abridged AA Report “determined necessary based on consideration of the issues identified by” DTSC. If no public comments are received, or if DTSC determines there are no issues to be addressed in an AA Report Addendum, DTSC sets forth timeframes for completing its review of the Final AA Report or Abridged AA Report. Specifically, the review will be completed within sixty (60) days of either: (1) the close of the comment period, if no comments are submitted; or (2) thirty (30) days after the close of the comment period, if comments are submitted but DTSC determines there are no issues that need to be addressed.
With respect to documents or information submitted to DTSC, a person may assert a claim of trade secret protection. With regard to trade secret protection for information identifying or describing a hazard trait exhibited by a chemical or chemical ingredient, the prior version of the regulations provided that a claim with regard to chemical identity could only be made temporarily when a patent application is pending for an alternate chemical or its contemplated use in the product. This “chemical identity masking” shall be authorized only until the patent application has been granted or denied. In the Revised Proposed Regulations, DTSC has modified this provision to state that such masking shall be authorized only until “the information subject to the trade secret is made public through any means, including through publication of the patent application, a foreign counterpart, or an issued patent.” Section 69509(g). Considering the different nature of trade secrets and patents, it is unlikely this change will satisfy those that believe trade secrets are not adequately protected under these regulations.
No later than ninety (90) days after DTSC issues a notice of compliance or notice of disapproval for a Final AA Report, DTSC will issue a notice of its proposed determination that one or more regulatory responses is required, or that no regulatory response is required. Section 69506.1(c). There is only one proposed change to a regulatory response, that for end-of-life management requirements. Section 69506.7(c). In the Revised Proposed Regulations, DTSC has eliminated the requirement for the manufacturer to provide compensation to retailers and others that agree to participate in an end-of-life collection program. DTSC states that this provision was eliminated so that these issues can be addressed by affected parties as part of the agreement process.
The proposed changes to the AAT definition and the reduced requirements for review of public comments are arguably the most helpful to the process. Considering the substantial comments submitted in February 2013 — approximately 650 pages — the changes made by DTSC in this version are relatively modest and perhaps not as much as what industry was hoping to see. As with previous versions, DTSC has posted comments submitted but has not issued a Response to Comments that would help explain the changes it has proposed. The lack of explanation leaves some questions as to the extent that DTSC considered all the comments, and its reasoning for accepting the comments it did. It is widely believed that this is the last opportunity to comment on these Regulations before DTSC issues them in final, estimated to be no earlier than October 2013.