Since the enactment of California’s two landmark green chemistry laws in September 2008 (AB 1879 and SB 509), significant effort has been made to develop their implementing regulations. This process has proven to be difficult and controversial, because a compromise must be reached between numerous competing concerns, most notably the legislative mandate to protect human health and the environment, and the significant costs to be imposed on companies manufacturing and selling consumer products in California. The process has also come under intense nationwide scrutiny, because California's Green Chemistry Initiative is considered a possible model for national chemical policy reform.
State regulators at the Department of Toxic Substances Control (DTSC) have until January 1, 2011 to enact the final version of the green chemistry regulations, known as the Safer Consumer Products Alternatives (SCPA) regulations. An informal rulemaking process has been used to shape the regulatory framework and extensive public comment has been received from stakeholders, including the scientific community, industry and environmentalists. The most recent draft of the SCPA regulations was released on June 23, 2010 and public comments were accepted through July 15, 2010.
California’s green chemistry laws are intended to completely refocus the regulation of chemicals in consumer products on the beginning of the product life cycle – the design phase. This approach will enable determinations to be made about which chemicals should be used in which products, and weighing the potential effects of those products on human health and the environment before they occur. Drafting the regulations to accomplish this goal, however, has prompted much debate throughout the informal rulemaking process, which has intensified as the SCPA regulations have taken shape, and has focused on six main issues: (1) scope of the regulations; (2) prioritizing chemicals of concern; (3) alternatives analysis; (4) confidential business information; (5) conflicting and duplicative regulations; and (6) the cost of implementation. This post summarizes the status of these issues.
- How wide to cast the net – a threshold issue is how to balance the goal of regulating chemicals in consumer products to reduce their potentially harmful effects with the financial burden imposed on the regulated community, particularly in this challenging economy. For instance, some wish to maximize the number of chemicals addressed and populate the public clearinghouse mandated by SB 509 with a great deal of data in a very short period of time. However, the burdens of this approach must also be recognized, which include the enormously time consuming and expensive tasks of identifying all the chemicals used in the broad array of consumer products sold throughout the State, followed by preparing life cycle assessments for each one of them.
Early versions of the SCPA regulations were strongly criticized for borrowing "lists of lists" of chemicals from other regulatory programs and adopting broad categories of loosely defined consumer products. The Green Chemistry Alliance warned that unless chemicals and products are selected and prioritized based upon real life exposure risk, the green chemistry initiative will collapse under its own weight. The current draft relies on this approach to a lesser degree, and instead applies a lengthy list of prioritization factors to chemicals in consumer products that exhibit hazard traits. Nevertheless, the number of chemicals covered at the outset – which include all 800+ listed under California's Proposition 65 – is still an ambitious first step.
- Prioritizing chemicals of concern – An effective mechanism is needed to prioritize the chemicals addressed, but various stakeholders have advocated for different criteria to govern that process. Industry’s position is that a policy automatically equating any amount of exposure with harm is not only contrary to AB 1879, but would also put an onerous burden on manufacturers to develop, gather and analyze vast amounts of data on hazard traits and exposure in very little time, and in some cases without good reason. Scientists, including those on the Green Ribbon Science Panel, are concerned that without an effective prioritization mechanism, the green chemistry program will fall victim to “paralysis by analysis.” Environmentalists are similarly concerned that if the regulations do not take effect quickly enough, the primary goal of the program – to avoid adverse human health and environmental impacts – will be thwarted.
The current draft of the SCPA regulations uses a mechanism of funneling down those chemicals and consumer products to be regulated. Chemicals and consumer products are first "considered" based on their volume, toxicity and exposure potential, and then the highest priority products containing the highest priority chemicals are selected for further regulatory analysis. However, there are currently no deadlines for completing the various steps of this subsequent funneling process, which will follow DTSC's January 1, 2011 deadline to specify the threshold hazard traits to be regulated.
- Alternatives analysis – The process by which manufacturers will be required to study potential alternative chemicals for use in consumer products remains the subject of much debate. Of particular concern to all involved is who will perform those assessments – industry, third parties working for industry, independent third parties, regulators, or some combination of those entities. Manufacturers prefer to conduct their own alternatives analyses, given the complexity of evaluating chemical uses and exposures, the risks associated with being bound by others’ decisions, and the desire to control the dissemination of confidential information. Assemblyman Feuer, the author of AB 1879, has commented on the need to counter the “adverse incentives” that would result if industry could sidestep regulation by failing to develop data upon which regulatory decisions could be based, e.g., by purposefully neglecting to fill critical "data gaps." Similarly, environmentalists insist that the data considered must be completely transparent to the public and subject to DTSC oversight.
Another criticism of the alternatives analysis process is the lack of deadlines to force industry to complete the various steps involved. DTSC's Acting Director Maziar Movassaghi has acknowledged that the timeframe under the current regulations is variable and that it could take years to find suitable alternatives for certain chemicals currently in use.
- Confidential business information (CBI) – CBI is a hotly disputed issue and is closely tied to the alternatives analysis process. That process requires industry to provide detailed information about chemicals of concern (COC) and potential alternatives, including their identity, composition and performance characteristics, as well as redesign of COC-containing products, redesign of associated manufacturing processes, and manufacturers' customer lists. Much of this information is typically considered by industry to be proprietary CBI to protect substantial investments made in research and development, and its public disclosure would have severe economic consequences. Industry is also concerned that publicizing information about chemical and product design alternatives will pave the road for product liability lawsuits.
While the draft regulations do protect trade secrets identified by industry, they also: restrict the scope of data for which such protection can be claimed; reserve for DTSC the discretion to accept or reject claims of trade secret status; allow for disclosure of trade secrets in cases of "substantial need" as determined by DTSC; fail to specify the precise measures to be used to protect such confidential information; and do not impose legal liability against DTSC employees who fail to safeguard such information.
- Conflicting and duplicative regulations – Faced with a new, all-encompassing system of chemical regulation, industry is concerned about how that system will overlap, and perhaps conflict, with the existing patchwork of chemical and product regulations already in effect on the federal and state level. For example, federal agencies could regulate a particular public health or environmental risk under their existing authority that could conflict with the regulatory actions taken under the draft SCPA regulations. Moreover, due to the perceived sluggish operation of the current SCPA regulations, lawmakers are currently considering the need for additional chemical-specific bans, the elimination of which was a goal of the green chemistry laws. The draft regulations allow for the exemption of COCs regulated in a similar manner under other laws, but leave exemption determinations to DTSC's discretion and do not specify the criteria to be considered when making such determinations.
- Cost of implementation – Perhaps the one thing that all parties involved – scientists, industry, activists and regulators – appear to agree on is that implementing the new SCPA regulations will require significant funding and staffing resources. While much of this burden appears destined to fall on industry, a substantial role must also be played by the regulators to administer and enforce the program. However, the source of government funding remains unclear amidst the State’s budget crisis and service cutbacks.
Thus, while progress has been made in developing the SCPA regulations, there is much disagreement about whether this progress is headed in the right direction. For instance, industry representatives have recently commented that DTSC’s latest draft of the SCPA regulations may overreach the agency’s authority under the green chemistry laws and appear to be considering grounds for challenging the regulations in court. However, DTSC has not yet issued a final draft of the SCPA regulations, which will trigger further hearings and a 45-day public comment period under the formal rulemaking process. Consequently, there is still time and opportunity for further debate and revision of the SCPA regulations.