On August 28, the California Office of Administrative Law approved the "Safer Chemical Products" regulations developed by the California Department of Toxic Substances Control ("DTSC"). The regulations will take effect on October 1.
The regulations implement California's "Green Chemistry" law adopted by the Legislature in 2008 (Cal. Health & Safety Code §§ 25215–25257.1). The statute directs DTSC to identify and prioritize chemical ingredients in consumer products that may be chemicals of concern, and to determine how best to limit or reduce the potential hazards posed by such chemicals. The final regulations are the culmination of several prior drafts and public comment periods.
The final regulations apply to consumer products that are placed into the stream of commerce in California. They establish a three-step process. Under the first step, DTSC will identify "candidate" chemicals of concern and identify and prioritize products containing candidate chemicals. Under the second step, responsible entities, usually the manufacturer, of priority products identified by DTSC must analyze alternatives to eliminate or reduce potential exposure to chemicals of concern in priority products. In the third step, DTSC will respond to the manufacturer's analysis based on criteria set out in the regulations. DTSC's response can include prohibiting the sale and distribution of the product in California.
The following is a brief summary of key provisions of the new regulations. The full text of the regulations can be found at www.dtsc.ca.gov/SCPregulations.cfm.
Chemicals of Concern and Priority Products
The regulations define candidate chemicals of concern by reference to lists of potentially hazardous chemicals that have been developed by international, federal, and California agencies. The lists contain approximately 1,200 chemicals. By November 1, DTSC will post on its website a list of the candidate chemicals from these combined lists. Subsequent to this initial posting, DTSC may add or delete listed chemicals using normal rulemaking procedures (including public notice and comment).
After the initial candidate chemicals have been listed, DTSC must identify and evaluate products that contain candidate chemicals and determine whether additional evaluation of the products is warranted. In evaluating what product-chemical combinations to propose as priority products, DTSC will consider the potential for exposure to the candidate chemical in the product, the potential for that exposure to contribute to or cause adverse health or environmental impacts, and potential adverse effects from disposal of the product. DTSC must propose a list of priority product-chemical combinations for public review and comment no later than 180 days after the effective date of the regulations (April 1, 2014). This initial list may include no more than five priority products.
Within one year after the effective date of the regulations (October 1, 2014), DTSC must issue a priority product work plan identifying the product categories from which DTSC will select additional product-candidate chemical of concern combinations to be added to the priority products list during the three years following issuance of the work plan. Subsequent work plans are to be issued by DTSC no later than one year before the end of the three-year expiration date of the current work plan.
Obligations of Responsible Entities
The manufacturer has the principal duty to comply with the regulations governing its listed priority products. If the manufacturer does not comply, the duty falls on the importer, if any, upon DTSC issuance of a notice of noncompliance to the manufacturer and importer. If neither complies, the duty rests with the assembler or retailer if DTSC provides notice through the Failure to Comply List posted on its website. The retailer or assembler can avoid assuming manufacturer obligations by ceasing to order the product.
Within 60 days after a product-chemical combination has been listed as a priority product, the responsible entity must notify DTSC that its product is on the list. It must then submit to DTSC a Preliminary Alternatives Analysis report no later than 180 days after the date of the product's listing, and a Final Alternatives Analysis report no later than 12 months after the date DTSC approves the preliminary report, subject to potential extensions. A responsible entity can avoid having to prepare an Alternatives Analysis if (i) the chemicals of concern have been removed from the product without the use of any replacement chemicals; (ii) the manufacturer has ceased fulfilling orders for the product from persons selling or distributing the product in California; or (iii) the chemicals of concern have been removed from the product and the replacement chemical is either not on the candidate chemicals list or is a candidate chemical that is already in use to manufacture the same product in lieu of the chemicals of concern by the same or different manufacturer.
Consequences Flowing from Alternatives Analysis Reports
DTSC will review the Final Alternatives Analysis Report to determine if the responsible entity considered and addressed the regulatory requirements and whether the conclusions in the report are based on reliable information. If DTSC accepts the Report, it will determine if additional actions are necessary to protect public health and/or the environment. DTSC will maximize the use of alternatives posing the least concern and will prefer alternatives that avoid or reduce adverse impacts through redesign of a product or process rather than through administrative or engineering controls. Additional factors DTSC must consider include the degree to which the actions can address the product's potential adverse impacts, the ability of end users to understand and act upon information or directions provided by the responsible entity, and the cost of the action to the responsible entity relative to the cost of other possible actions. The regulations identify a number of actions that can be required by DTSC. DTSC can require the responsible entity to provide product information to consumers, it can restrict use of the chemicals of concern or the product itself, it can require safety measures to contain or control access to chemicals of concern in the product, and it can prohibit the sale of the product in California.
While the regulations start out with a maximum of only five products on the initial priority product list, the list has the potential to expand over time to cover a substantially greater number of products. Manufacturers of priority products may decide to either withdraw their product from the California market or find ways to avoid use of the chemicals that resulted in the listing. For those manufacturers that proceed with the alternatives analysis, the result of DTSC review could be a requirement to reformulate the product or a ban on the sale of the product in California.
It will be important for companies to track DTSC's listing of specific candidate chemicals of concern and the development of the priority products list, both of which are required to be posted on DTSC's website. The website will also include other important information, such as notices from manufacturers that their product is a priority product, priority product work plans, alternatives analysis report notices, and proposed and final regulatory response determinations. Retailers should pay particular attention to the Failure to Comply list, which will include the manufacturers and importers that have failed to comply with the regulations (including the brand names of their products).