January 1, 2011 is the statutory deadline for California's Department of Toxic Substances Control (DTSC) to adopt its potentially game-changing "Green Chemistry" regulations for companies that produce chemicals or consumer products for use in California. That deadline seemed comfortably distant when AB 1879 was passed in 2008, but is now just around the corner. DTSC's bold "Green Chemistry" Initiative is focused on designing products and processes that will reduce or eliminate the need to manage and control waste at the end of the lifecycle.

Whether DTSC can address the mountain of comments it received from stakeholders during the now-closed comment period for its latest draft regulation, entitled "Safer Consumer Product Alternatives," and issue final regulations by that date remains to be seen. Nonetheless, it is not a question of "if" Green Chemistry regulations will be adopted, only "when" and "what" exactly they will require. As such, companies that produce chemicals or consumer products for use in California should be looking at the potential impacts on their operations and developing a compliance strategy, if they are not doing so already.

Consumer products subject to the Green Chemistry program are very broadly defined to be any product used, bought or leased for use by a person for any purposes, with exceptions provided for certain drugs, devices, food and pesticides. As such, these regulations have a huge potential reach. Not every consumer product will face the full impact of these new regulations and many companies may see little or no impact. However, some companies will face a daunting task in complying with this new regulatory program. Although the statute does not have the "citizen's suit" provision contained in California's other unique consumer product chemical safety law, Proposition 65, the proposed regulations have the potential to be much more intrusive into a company's operations.

For example, the draft regulations call for the identification of a list of "chemicals of concern" and "products of concern" containing those chemicals, leading to a final list of "priority products." Manufacturers of priority products (which can include importers or private label manufacturers whose name appears on products produced by others) will need to perform assessments to evaluate the level of hazard to human health and the environment posed by the presence of the chemical in the product, and identify the potential safer alternatives. These alternatives assessments will be based on a multimedia life cycle analysis, looking at not only exposure associated with the product itself but the whole life cycle of the product, including its manufacturing and final disposal. These alternatives assessments will require review and approval by DTSC. There are a wide range of potential regulatory responses to the alternatives assessment, including; no action required, providing information to the consumer, end-of-life management (manufacturer take-back programs), engineering safety measures, restrictions on use, or even outright prohibitions on product sales.

The final regulations likely will be different than the draft version currently available on DTSC's website at: http://www.dtsc.ca.gov/PollutionPrevention/GreenChemistryInitiative/upload/Safer-Product-Alternative-Regulations-6-23-10.pdf. Nonetheless, substantial elements of the regulatory program are required by the legislation, AB 1879, and even if the non-required elements are revised substantially or removed completely, the statutorily-required elements represent a regulatory regime different in kind than what most companies face currently.

Even if the new regulations are adopted by the January 1, 2011 deadline, the program will take some time to unfold. DTSC will be taking the lead in identifying chemicals of concern and products of concern, which will undoubtedly take substantial time to accomplish. It may be quite a while for alternatives analyses to actually begin. Nonetheless, some of the elements of the program, such as submission of chemical and product information by manufacturers in response to requests from DTSC, will come into play much earlier in the process. Manufacturers could find themselves responding to such information requests, and deciding whether to assert a claim that the submitted information is confidential information, long before the program works its way to the alternatives assessments stage.

Given the fast-track of the regulations, manufacturers, importers and distributors will want to review the available draft regulations and begin to assess the potential impacts on their businesses. Many companies already have sophisticated programs to carefully assess the chemicals that they use in their products and continuously search for the safest alternatives and will be well-positioned to comply with the new regulatory program, whenever it is adopted. Other companies may take comfort in knowing that their products do not contain the types of hazardous or controversial chemicals that are likely to make the list as chemicals of concern. However, many companies will find themselves at least potentially subject to these new rules and should take care to avoid being blindsided by discovery in the future that their product requires an analysis of safer alternatives based on a complete life cycle analysis under this new program.