Green Chemistry Regulations:
On Monday, October 31, 2011, the California Department of Toxic Substances Control (DTSC) released an informal draft of its revised green chemistry regulations, the so-called “Safer Consumer Product Alternatives (SCPA) Regulations.” DTSC spent the last year further revising the regulations after some stakeholders decried the proposed final version released for public comment over the Thanksgiving holiday in 2010. Public comments on the lastest informal draft are due by December 30, 2011. The formal rulemaking process will begin in 2012.
On Monday DTSC also released a document setting out the most significant changes from the November 2010 version of the regulations. (For purposes of comparison, a summary of the November 2010 version is available here.) It is clear that DTSC is envisioning a more robust program with shorter timelines and fewer exemptions, ultimately requiring more agency and private resources to implement without a clear benefit from doing so. In light of the poor state of California’s economy, and the relative weakness of the U.S. economy as a whole, one has to wonder why DTSC has chosen its proposed path. According to DTSC, the following are the most significant changes found in the current informal draft.
(1) Many timeframes have been shortened and/or made more specific.
(2) Timing of initial Chemicals of Concern (COC) list — effective date of the regulations.
(3) Timing of initial Priority Products list — 6 months for the proposed list.
(4) Both the chemicals and products lists will be reviewed at least once every 3 years.
Chemical / Product Prioritization
(1) The regulations will establish an immediate robust (~3,000) list of COCs (which DTSC can add onto later), based on work already done by numerous authoritative bodies.
(2) The list of hazard traits has been expanded to include all hazard traits and environmental and toxicological endpoints specified by OEHHA. Additionally, the universe of chemicals considered to be carcinogens and reproductive toxins is no longer limited to only those chemicals listed on a short list of lists.
(3) The regulations no longer limit the product categories that DTSC can consider when listing Priority Products during the first 5 years.
(4) Worker exposure has been added as a prioritization factor.
(5) The requirement for responsible entities to provide chemical and product information during the prioritization process has been eliminated. (DTSC will request this information and list anyone who does not provide the information on a Failure to Respond list.)
(1) The regulations expand the primary responsibility for compliance beyond the product producer to also include: (i) the person who controls the product design; and (ii) the U.S. importer.
(2) The alternatives assessment (AA) process is more specific and structured, but allows for flexibility.
(3) There is no requirement to fill information gaps during the AA — instead DTSC has the option to require this as a regulatory response.
(4) The third-party verification requirement for AAs has been eliminated — instead AAs are required to be conducted by a certified assessor. Also, DTSC will play a greater role in auditing AAs.
(1) The default de minimis level is 0.01% for chemicals with one of 9 specified hazard traits, and 0.1% for all other chemicals — DTSC can set a lower or higher de minimis level.
(2) The exemption for unintentionally-added chemicals has been eliminated. However, these chemicals are a consideration for setting a higher de minimis level.
(3) The “no exposure pathway” exemption has been eliminated. However, exposure potential will still be considered during the chemical/product prioritization process.
Readers wanting more information should check back for future posts on this development, as well as visit the DTSC website. In addition, there will be a public workshop on the draft proposal on December 5, 2011 from 9:30 am to 3:30 pm in Sacramento. The Green Ribbon Science Panel also will dicuss the proposal at the Panel’s meeting on November 14 – 15, also in Sacramento.