The California Department of Toxic Substances Control has finalized the California Safer Consumer Products Regulation, also known as California's Green Chemistry regulation. The regulation will become effective on October 1, 2013, making California the first of the United States to codify a green chemistry approach that requires extensive alternatives analyses and end-of-life product management.
This Briefing provides a high-level overview of the final regulation. To download a white paper describing this regulation in greater detail, click here.
The regulation contains four components: (1) DTSC's identification of "Candidate Chemicals"; (2) DTSC's identification of "Priority Products" containing those Candidate Chemicals; (3) "Responsible Entity" (manufacturer, importers, assemblers, or retailers) notification and alternatives analysis; and (4) DTSC's imposition of regulatory responses to address hazards of the product or alternatives.
The regulation draws its initial Candidate Chemical list from a defined list of existing state, federal, and international laws and regulations that identify substances with hazard traits or environmental or toxicological end points, including carcinogens, reproductive toxins, mutagenic toxins, neurotoxins, endocrine disruptors, toxic air contaminants, and water pollutants. Currently, there are approximately 1,200 Candidate Chemicals. The regulation authorizes DTSC to revise the Candidate Chemicals after the publication of the initial list.
DTSC will identify Priority Products by assessing potential human, animal, or environmental exposure to Candidate Chemicals from a product during the product's lifecycle. DTSC will also assess the potential for that exposure to have widespread adverse impacts on public health or the environment. The initial list will consist of products that contain Candidate Chemicals that have been the focus of regulation by various California agencies. The initial list may contain no more than five Priority Products. Using these criteria, DTSC has narrowed the universe of Candidate Chemicals down to approximately 230 for the first Priority Products list. The regulation requires DTSC to issue a work plan to develop the initial list of Priority Products within one year of its effective date, and to finalize the list of Priority Products over the next three years. Once a Candidate Chemical is associated with a Priority Product, it is referred to as a Chemical of Concern, or COC. DTSC must develop a new work plan to designate new products over the following three years within one year of the expiration of the prior plan, resulting in a four-year product listing process. DTSC expects to have a final list of the potential Candidate Chemicals for the initial Priority Products list by September 2013 and a draft Priority Products list by April 2014.
Once DTSC lists a Priority Product, "Responsible Entities" (starting with manufacturers, but potentially including importers, distributors, or retailers) must notify DTSC of the product and begin the assessment process. A Responsible Entity may either cease new distribution of the product in California, remove the COC from the product, or begin an alternatives analysis. If choosing either of the first two options, the Responsible Entity must notify DTSC and certify the removal. While the regulation places the compliance obligation on manufacturers, downstream entities are responsible to comply if the manufacturer does not, either by stepping into the shoes of the manufacturer, or ceasing new orders of the product in California. The regulation contains no sell-through deadline for inventory already in stores.
The alternatives analysis process is divided into two phases: the preliminary alternatives analysis, which the regulation refers to as a "Preliminary AA," and the final alternatives analysis, referred to as the "Final AA." The Preliminary AA seeks to identify potential alternatives, based on a variety of factors, including product performance requirements, legal requirements, and feasibility. If the Responsible Entity completes the Preliminary AA and determines no alternative is less hazardous than the current product, it may conclude the AA process. However, it must notify consumers of the COC in the product and initiate research to develop alternatives. If the Responsible Entity completes the process and determines some alternatives exist, it must submit the Preliminary AA to DTSC, get DTSC approval, and then complete the Final AA process.
The Final AA process involves the quantitative and qualitative assessment of the alternatives as compared to the original product. The assessment includes comparison of health and environmental impacts, product function and performance, economic impacts, and exposure factors. Based on the results of the Final AA, the Responsible Entity must develop a work plan to implement the selected alternatives. DTSC must review and approve the Final AA and work plan.
In conjunction with approval of the Final AA, DTSC may also impose regulatory responses, which may include consumer notification of the COC or alternative, use restrictions, prohibitions, safety measures and administrative controls, end-of-life management requirements, and research and development requirements.
DTSC will enforce the regulation primarily through publication of non-compliant Responsible Entities and products on its website, but it may also initiate enforcement actions under the hazardous waste provisions of the California Health & Safety Code, which authorize criminal and civil penalties of up to $25,000 per violation.