The recent workshop held by DTSC demonstrated that the state still needs input from the community and industry in order to finalize these proposed regulations that will potentially have a huge impact on everyone.

On Dec. 5, 2011, the California Department of Toxic Substances Control (DTSC) held a workshop to review DTSC’s “informal draft” Safer Consumer Products Regulations (SCPR) released on Oct. 31, 2011. Bergeson & Campbell, P.C.’s (B&C) memoranda providing background information on SCPR are available online.

DTSC began by reviewing the elements of the regulation – the Chemicals of Concern (COC) List; the prioritization of products; the quality assurance of alternative assessments (AA); and DTSC’s regulatory responses – and providing its explanation for why DTSC made certain choices in developing the regulations. DTSC stated that its decision to develop a COC List of approximately 3,000 COCs is intended to send immediate signals to the marketplace of those substances that have been flagged as potential concerns, accelerate implementation by allowing DTSC to immediately commence work to identify priority products (PP) containing one or more COCs, and to focus DTSC resources on PPs and AAs by using available information on chemicals. DTSC also defended its decision to use a narrative standard (instead of a specific or weighted standard) for adding chemicals to the COC List and for selecting PPs. DTSC believes a narrative standard is forward-thinking, flexible and allows DTSC to take advantage of scientific advances. The full presentation DTSC gave at the workshop is available online.

Comments provided from stakeholders varied widely. For example, while several industry representatives argued that such a large COC List will overwhelm DTSC and be too costly for industry to monitor so many substances, non-governmental organization (NGO) representatives stated that the COC List seems reasonable or even too small considering all the chemicals in commerce. Other topics that generated multiple comments included whether the de minimis level was too restrictive, whether the timeframe within which AAs must be prepared is too short, and whether the regulations adequately took all necessary factors into account for preparing AAs (e.g., safety functions, cost to industry, consumer acceptance). Comments of particular interest included the following:

• When asked if DTSC has established a metric for determining the economic impacts of the regulation, DTSC responded that an economic impact analysis had been prepared and was in the process of being reviewed to determine if any changes are needed based on changes made with the “informal draft” regulations. DTSC further stated that the AA process includes a cost assessment so any economic impacts are for the manufacturer, not DTSC, to determine and quantify.
• In response to a question requesting clarification on how nanomaterials are impacted, DTSC stated that it considered nanomaterials to be within the scope of the regulations but would accept comments on whether the regulation language is adequate.
• When discussing the trade secret protections, DTSC stated that it did not intend to create any new law but instead to provide protection based on existing trade secret law.
• With regard to any small business exemption, DTSC stated that there had been a provision in the early draft regulation and DTSC’s authority to treat small businesses differently had been questioned. DTSC stated that without conceding its authority to develop a provision for small business, DTSC decided not to include a specific provision in the “informal draft” regulations. DTSC noted that small businesses may be provided assistance through guidance to be developed by DTSC, other resources that DTSC will make available on its website, and by joining consortia.
• In response to a question whether DTSC would allow AAs posted on DTSC’s website to be copied by other companies without providing compensation to the company/consortia that prepared the AA, DTSC’s initial response was that such a practice would be permissible. DTSC retracted its statement somewhat later on, however, noting that some materials in the AA could be redacted as trade secret, which could make it difficult for other companies to copy and rely upon.

As far as implementation, DTSC provided the following schedule:

• Dec. 8, 2011: The Assembly Environmental Safety and Toxic Materials Committee is holding a special hearing on California’s Green Chemistry Initiative.
• Dec. 30, 2011: The public comment period on the “informal draft” regulations ends.
• Approximately February 2012: The proposed regulations will be issued and the Administrative Procedure Act process begins.
• Fall 2012: The final regulations will be adopted and the first COC List will be issued as of the effective date of the regulations.

Many, many questions still remain over the content, tone, operation and scope of the “informal draft” regulations. It would seem DTSC is in serious need of guidance from interested stakeholders. Its open-ended request for comment on whether the draft language is sufficient regarding the scope of the draft regulation over nanoscale materials is telling, and provides nano stakeholders a clear opportunity to propose an approach. It also seems clear that the data compensation implications, as well as the scope of confidential business information assertions over data claimed as proprietary, are fluid and unsettled, providing another opportunity for industry stakeholders to step up and propose a sensible approach. It would also seem that DTSC is somewhat ambivalent on the issue of whether and how small business is to be covered under the program. Given the significant and almost certain adverse implications of the program on small business, this seems like another area where thoughtful comment and careful consideration is needed. As noted, the comment period closes on Dec. 30, 2011.