California Releases Draft Regulations for Safer Consumer Product Alternatives
The California Department of Toxic Substances Control (CDTSC) released on June 23, 2010, the draft regulations for safer consumer product alternatives. CDTSC states that the draft regulations “would prioritize toxic chemicals and products, require manufacturers to seek safer alternatives to toxic chemicals in their products, and create tough governmental responses for lack of compliance.” Under the draft regulations, CDTSC would create a list of chemicals that it deems toxic and believes could harm people or the environment. Products containing those chemicals would be prioritized based upon such factors as the volume in commerce, the extent of public exposure, and how the product is eventually disposed. Manufacturers of those products would be required to perform an “alternatives assessment” to determine if a viable safer alternative is available. CDTSC will hold two half-day public workshops, on July 7 and July 8, 2010. Comments on the draft regulation are due July 15, 2010. CDTSC states that, following the July workshops, it “intends to begin the formal Administrative Procedures Act (APA) rulemaking process which it plans on completing by the end of this calendar year.” More information is available online.
According to CDTSC’s Frequently Asked Questions (FAQ), the draft regulations call for three phases: (1) the prioritization process, during which CDTSC will identify and prioritize chemicals of concern and products that contain them; (2) for those priority products identified in Phase 1, an alternatives assessment, conducted by the product manufacturers, to identify safer alternatives; and (3) CDTSC will impose various regulatory response actions to address any remaining concerns raised by the alternatives selected by manufacturers for implementation, and to move manufacturers toward designing safer products.
CDTSC states that draft regulations will first identify chemicals that pose public health and environmental threats, and are most prevalent in consumer products found in the marketplace. CDTSC will narrow the list of chemicals under consideration to a list of chemicals of concern, which will be a priority list of chemicals that pose the greatest threat to the public and environment. Once CDTSC establishes the final chemicals of concern list, CDTSC will create two product lists. The first is the “Products under Consideration” list, which includes products that pose public health and environmental threats because they contain chemicals of concern. From that list, CDTSC will identify and list as “Priority Products” those products that are of the highest priority based on the relative degree of public health and environmental threats posed by the product due to the chemical of concern contained in the product. According to CDTSC, it will use a number of factors to make this determination, including the chemical in the product, current use, distribution, end-of-product-life issues, and potential use by and exposure to the public, including sensitive subpopulations.
As CDTSC develops and updates the list of chemicals of concern, CDTSC will require manufacturers to submit information describing the types, categories, and classes of products containing chemicals of concern. CDTSC states that it will supplement this information with “market research [that] DTSC will conduct.” CDTSC will post on its website the list of chemicals of concern, the priority product list, and the list of manufacturers that are required to perform alternatives assessments for each listed product. DTSC states that it will create an online database providing data on chemical toxicity and hazard traits, and it will also publish on its website “a list of manufacturers and their product types that are out of compliance with the regulation.” The draft regulations would require manufacturers to notify retailers if CDTSC has determined that their product cannot be sold in California.
Once CDTSC identifies a product as a priority product, the manufacturer must perform an alternatives assessment, a process that evaluates toxicity and other information concerning the chemicals of concern in the product, and compares that data to alternative chemicals or product redesigns that may make that product safer. After the alternatives assessment is complete, if the product alternative selected by the manufacturer still contains a chemical of concern, and CDTSC determines there is a safer alternative “that is functionally equivalent, and technologically and economically feasible,” CDTSC will impose a sales ban on that product within two years. The manufacturer would first have a one-year opportunity to submit a revised alternatives assessment.
According to CDTSC, the list of chemicals under consideration will include chemicals that pose public health or environmental threats, “but are not of as a great a concern as the threats posed by chemicals listed as chemicals of concern.” The availability and nature of scientific information to substantiate the threats posed by a chemical will also be a factor that determines whether a chemical is listed as a chemical under consideration or a chemical of concern. In the FAQs, CDTSC states the list of chemicals under consideration will “encourage many manufacturers to proactively seek safer alternatives for products that contain these chemicals, knowing that these chemicals may eventually move to the Chemicals of Concern category.”
Under the draft regulations, manufacturers would be able to sell products that contain chemicals under consideration. Manufacturers would be able sell products that contain chemicals of concern while the chemical and product are going through the prioritization and alternatives assessment phases of the regulation, “as long as the manufacturer remains in compliance with the regulatory requirements that apply to the product, as specified.” Once the alternatives assessment is complete, if the product alternative selected by the manufacturer still contains a chemical of concern, and CDTSC determines there is a safer alternative that is functionally equivalent, and technologically and economically feasible, CDTSC will impose a sales ban on that product within two years. The manufacturer would first have a one-year opportunity to submit a revised alternatives assessment.
Unlike CDTSC’s October 1, 2009, straw proposal for safer alternative regulations, the draft regulations do not designate any chemicals for inclusion on the lists of chemicals under consideration or chemicals of concern. Under the draft regulations, CDTSC would be required to review and revise the lists of chemicals under consideration and chemicals of concern at least every three years.
Concerns with the Proposal
There are many concerns with the proposal. First, on a purely administrative level, the deadline for submitting comments is short and fast approaching — July 15, 2010. We note, however, that there may be another opportunity for comment. According to the CDTSC website, CDTSC “may revise the draft regulation based on comments received and will release the revised draft following the July 15 comment deadline. The formal Administrative Procedures Act (APA) rulemaking process will begin with the release of that draft.” The APA process calls for public hearings and a 45-day public comment period. CDTSC states that it will announce specific information about the APA process “when the final draft regulation is available for review.”
Second, the breadth of the criteria for identifying chemicals of concern and products of concern virtually ensure that few chemicals will be excluded from the process.
Third, the prioritization process includes factors to be considered that are inherently open-ended and subject to broad interpretation. For example, factors to consider in making the determination of what is a “priority product” include the chemical, its current uses, distribution, end-of-product life issues, and potential use by and exposure to the public, including sensitive subpopulations.
Fourth, the “alternatives assessment process” is equally open-ended and fraught with challenging and ambiguous factors. For example, an alternatives assessment report must include a product life cycle analysis that takes into account product function and performance, human health and environmental impacts, materials and resource consumption, economic impacts, and “other information as needed.” None of these criterion is well-defined, and the application of each in an alternatives assessment analysis could lead to materially different results depending upon how the criterion is calibrated and applied.
Fifth, not surprisingly, “trade secret” status will be difficult to achieve and the information being submitted under the regulation is presumptively public unless proven otherwise.
Sixth, interestingly, “nanoscale” is defined to mean one or more dimensions of the order of 1,000 nanometers or less, a definition unlike virtually all other definitions of nanoscale propounded by regulatory or standard-setting organizations.
There are many important issues raised by the draft regulations. Because this is a precedent-setting initiative, it will have significant national and international product marking implications and stakeholders are urged to review the proposal carefully and provide comment on it as appropriate.