On September 6, 2012, the California Department of Toxic Substances Control (DTSC) Director Debbie Raphael spoke during the Safer Consumer Products Summit regarding the proposed Safer Consumer Products Regulations (Proposed Regulations). Memoranda providing background information on the Proposed Regulations are available online. The Proposed Regulations are available online.
Points raised during the Summit include:
Timing: DTSC will hold a public hearing on the Proposed Regulations on September 10, 2012. The comment period was extended from September 11, 2012, to October 11, 2012. Raphael stated that DTSC was not inclined to provide any further extensions of the comment period. Although DTSC has previously stated that if substantial changes are made to the regulations the modified full text will be made available for comment for at least 15 days prior to adoption, Raphael stated that DTSC expects to provide a second comment period for which the timing for comment submission will be more than 15 days. DTSC is planning on adopting final regulations in early 2013.
“Chemicals of Concern” (COC) List: Raphael confirmed that the list of 1,200 COCs will not be posted until the regulations are issued in final. DTSC will also at that time publish a list of approximately 185-200 COCs where DTSC will focus its attention before January 1, 2016, in prioritizing Priority Products (PP). The list of 1,200 COCs is derived from several existing lists that list chemicals on the basis of exhibiting at least one of seven hazard traits or one of three exposure indicators. The list of 200 COCs from which DTSC will prioritize and evaluate PPs will be those COCs that exhibit one of the hazard traits and one of the exposure indicators. Section 69503.3(g).
Alternatives Analysis Threshold: DTSC has removed any specific default thresholds (e.g., 0.01 percent by weight) or “de minimis level” with regard to the presence of the COC in the PP and instead uses an “Alternatives Analysis Threshold,” defined as a concentration by weight specified by DTSC. DTSC chose this approach based on comments that defaults needed more flexibility and expects to seek public comments on what a threshold should be. Raphael clarified that these thresholds will not be limited to intentionally added substances. There were some comments during the Summit that suggested that public comments on a threshold may politicize the issue and that a default threshold, with the possibility of arguing to increase or decrease the threshold may be a better approach (and one that is used in other regulatory regimes, including the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH)). In response to questions posed, Raphael stated that it was not DTSC’s intent consistently to make the threshold the minimum detection limit and that this point could be clarified in a response to any written comments submitted on this issue.
Alternative Analysis (AA): Raphael emphasized that AAs must focus not only on identifying alternatives to COCs but on identifying safer alternatives and avoiding regrettable substitutes. DTSC expects to release guidance to assist companies in identifying alternatives, weighing the alternatives against 13 different regulatory criteria, and selecting an alternative. Many acknowledged that weighing criteria, assessing trade-offs, and making these determinations could be one of the most challenging aspects of these Proposed Regulations. Representatives from several companies discussed the different mechanisms by which they now conduct AAs and the problems they encounter, including but not limited to data gaps that make chemical comparisons difficult and selecting alternatives that will not later be restricted (thus starting the process again).
Regulatory Responses: Raphael noted that the range of regulatory responses that DTSC can take in response to an AA and its active participation is perhaps the most “groundbreaking” element of the Proposed Regulations. One point that Raphael clarified is that in cases where product information must be communicated to consumers, there is no requirement that this must be done through labeling.