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California DTSC Releases Draft Outline of Green Chemistry Regulations

05/03/10

Source: McKenna Long & Aldridge Chemicals Advisory
Related Topics: Green Chemistry

The California Department of Toxic Substances Control (“DTSC”) has released its draft outline of regulations implementing AB 1879, the Green Chemistry Initiative law intended to “accelerate the quest for safer products.” This draft outline follows DTSC’s earlier release of its conceptual framework for the regulations, and precedes complete regulatory language that will enter the formal rulemaking process later this year. DTSC continues its call for stakeholder input before any formal regulatory language is presented for public notice and comment, and affected members of industry should be responding to that call now.

Codified at Health & Safety Code section 25252, AB 1879 (also sometimes referred to as the “Safer Alternatives Rule”) requires DTSC to promulgate regulations: (1) identifying and prioritizing chemicals of concern (“COCs’) in consumer products; (2) establishing methods for analyzing safer alternatives to COCs in consumer products; and (3) developing appropriate regulatory responses based on the results of the safer alternatives analyses. DTSC’s draft outline of regulations provides a good insight into what this new regulatory scheme will look like -- and it looks like a complex and costly one.

Significantly, the draft outline confers on DTSC the authority to require entities to submit extensive information regarding chemicals and products, including information submitted to other regulatory agencies (e.g., EPA) and under other regulatory schemes (e.g., REACH) as well as chemical/product marketing data. Although this information certainly would help DTSC implement AB 1879, it is far from clear that AB 1879 establishes the agency’s authority to make such mandatory information requests.

Also significantly, DTSC’s proposed regulatory scheme would prohibit any person from selling or offering for sale a consumer product unless that person has a certificate of compliance from the manufacturer/supplier. The certificate would have to state that the product complies with AB 1879 and identify any regulatory response imposed by DTSC. Although the requirements for such certificates remain unclear, they may well require detailed information regarding the COC and the specific regulatory response imposed (e.g., restrictions on use).

Identification of Chemicals of Concern and Priority Products

AB 1879 targets “chemicals of concern in consumer products.” As part of the new regulatory scheme, DTSC will proceed on parallel tracks, developing lists identifying COCs and identifying consumer products of concern (“priority products”). A petition process also will be put in place under the proposed regulatory scheme, through which any person may petition DTSC to include certain chemicals or products on the lists to be developed by the agency. In a worrisome gap, there appears to be no formal process contemplated for affected members of industry to respond to such petitions.

In addition to the COC list and the priority products list, the agency will publish a “chemicals under consideration” list and a “products under consideration” list. DTSC has stated that the chemicals under consideration list is intended to encompass those chemicals for which data gaps and other uncertainties may exist, and the list effectively is an invitation for industry to provide the agency with relevant chemical information or to seek safer alternatives sooner rather than later -- or else risk having those chemicals ultimately placed on the Chemicals of Concern list.

Safer Alternatives Assessments

The meat of AB 1879 is its safer alternatives assessment requirement for priority products, i.e., specified consumer products containing COCs. Manufacturers will have to submit draft work plans for the safer alternative assessments (which will be posted on DTSC’s website) meeting a long list of specified regulatory criteria. Once DTSC determines that the work plan complies with those criteria, it will assign a deadline for the completion of the assessments, which once finalized also will be posted on DTSC’s website. These safer alternatives assessments may be undertaken by third-party consultants or by manufacturers. Either way, the individuals undertaking these assessments will have to be certified by DTSC as being qualified to do the work.

Regulatory Responses

For each safer alternative identified in the manufacturer’s final safer alternative assessment report, DTSC will determine the most appropriate regulatory response that limits the effect of the COC or safer alternative on public health and the environment. The agency will publish a regulatory response report for public comment and then finalize it. Some of the potential regulatory responses appear below:

  • Require additional information to be generated regarding the COC or proposed safer alternative(s);
  • Require labels providing restrictions on use, identifying of subpopulations that should not use the product or describing safe handling instructions;
  • Impose prohibitions, including phased-in bans; and
  • Require end of life management, such as take-back programs.

The goal of the Green Chemistry Initiative is the creation of a sustainable, toxic-free California economy based at least in part on a new paradigm for chemical regulation. DTSC’s proposed AB 1879 regulatory scheme certainly is a new paradigm, and a potentially very cumbersome and costly one at that. Industry must remain vigilant and establish the necessary dialogue with the agency, before AB 1879 is fully implemented in January 2011, to minimize the burden and cost of complying with this law.







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