Green Chemistry Initiative: California DTSC Issues Draft Regulation for Safer Consumer Products
In order to implement California’s green chemistry program (Assembly Bill 1879 and SB 509, enacted in 2008), the California Department of Toxic Substances Control (DTSC) has issued its Green Chemistry Draft Regulation for Safer Consumer Products. The green chemistry program is meant to reduce or remove potentially toxic chemicals from a wide variety of consumer products by regulating the design of chemical products and processes. Public comments on this draft are due to DTSC by July 15, 2010.
The draft regulation shows how deep and expansive this program will be. In a nutshell, this regulation requires manufacturers to assess the toxicity and health risks of a product and consider the use of alternative components and ingredients prior to the planned manufacture of the product, in essence prior to its use by and exposure to consumers. Infused with theories of “benign by design,” this program encourages innovation and research while reducing the risks of exposure to harmful chemicals. It will also require manufacturers to assess and possibly replace potentially harmful chemicals and components of consumer products.
DTSC’s new draft regulation describes a process for identifying and prioritizing chemicals in consumer products. The process consists of:
- Alternatives assessment; and
- Regulatory response.
For products already on the market, manufacturers must determine whether safer alternatives exist and, if they do, either reformulate their product or remove it from the market. For new products, manufacturers must look at potential impacts and address them before the product is produced.
DTSC will identify and prioritize the universe of chemical and consumer products, based on an estimate of their risk or toxicity, as follows:
- Create a list of chemicals under consideration;
- Select a shorter list of Chemicals of Concern that includes the highest-priority chemicals;
- Develop a list of products under consideration (the products that contain Chemicals of Concern); and
- Create a list of Priority Products.
In making these determinations, DTSC will consider the product’s current use, distribution, fate, and exposure to the public, including people with sensitivities.
A public or private entity or individual may petition DTSC to evaluate a chemical or consumer product for inclusion. There is no process to petition for removal of a chemical or product from the priority list.
2. Alternatives assessment
The alternatives assessment considers toxicity in identifying safer alternatives to Priority Products. The draft regulation requires manufacturers to prepare analyses that evaluate raw ingredients and product components, manufacturing processes, product uses and ultimate fate, and the product’s total impact on health, the environment, and resources. Alternative chemicals or product redesigns that could decrease potential health and environmental impacts of Chemicals of Concern are considered as part of the alternatives assessment.
Manufacturers of Priority Products must submit an alternatives assessment work plan for review by DTSC. When the work plan is approved, manufacturers must complete the analysis and submit an alternatives assessment report that considers whether alternative formulations or designs would eliminate or reduce Chemicals of Concern in the current product and reduce or mitigate impacts related to health, the environment, and resources. The rationale for the manufacturer’s selected alternative and a timetable for implementation must be submitted to the DTSC. An accredited lead assessor must prepare the alternatives assessment. If the assessor works for the manufacturer, an independent assessor must also verify the alternatives assessment.
3. Regulatory response
DTSC will select the regulatory response based on the alternatives assessments report. Possible responses might include “no further action,” phasing out the product, or recalling products already on the market. DTSC will notify the manufacturer of the regulatory response, and the manufacturer must then issue a regulatory response notification to retailers. The regulation provides that DTSC may conduct audits and take enforcement actions that include injunctive relief and penalties.
Conceptually, thoughtful manufacturing and consideration of alternatives is the key to safe products and minimal chemical exposure. To force such consideration the draft regulation contemplates a complex and expensive centralized program covering a potentially large number of regulated chemicals and an even larger number of products. Alternative assessments may be complicated and time consuming. How the regulatory process will work is anyone’s guess. The potential public availability of process information and design alternatives will also create a trade-secret concern that may further complicate the process.
DTSC may revise the draft regulation based on comments received by the July 15 comment deadline and will release the revised draft shortly thereafter. The formal Administrative Procedures Act (APA) rulemaking process will begin with the release of that draft. The APA process will include public hearings and a 45-day public comment period. DTSC will announce specific information about the APA process when the final draft regulation is available for review.