On October 31, 2011, for the third time in two years, the California Department of Toxic Substances Control (DTSC) released a set of draft regulations to regulate the contents and design of consumer products sold in California called the Safer Consumer Products Regulations. (For information on previous draft releases, see our advisories on the November 2010 release and the September 2010 release.)
Who Must Comply?
These regulations apply to manufacturers, importers and retailers of consumer products in California. Compliance rests first and foremost with the manufacturer; only if the manufacturer does not comply is a compliance obligation triggered with the importer and/or retailer. The regulations apply to all consumer products that contain a listed chemical, termed a Chemical of Concern, except for the few products exempted by the Health and Safety Code Section 25251; dangerous drugs, devices, food and pesticides; and products manufactured, stored in or transported through California solely for out-of-state use.
Summary of Regulatory Scheme
In sum, the regulations:
- Establish a Chemicals of Concern list, consisting of roughly 3,000 chemicals, which is based on work done by other organizations, and specify a method for DTSC to identify additional Chemicals of Concern.
- Require DTSC to evaluate and prioritize products that contain chemicals on the Chemicals of Concern list in order to develop a list of “Priority Products” for which an Alternative Assessment (AA) must be conducted.
- Require manufacturers, importers and retailers to notify DTSC if their product is one of those on the “Priority Product” list, so that DTSC can post it on its website (or submit a De Minimis Exemption Notification). Responsible entities then must perform an AA for the product and the Chemicals of Concern to determine how to best limit exposure posed by those chemicals.
- Require DTSC to identify and impose regulatory responses to limit potential adverse public health and/or environmental impacts posed by the product or the chemicals and the proposed alternative product and chemicals (and require the responsible entity to comply with these responses).
The first Chemical of Concern list will be effective on the date of the regulations, which is expected to be in late 2012. The initial Priority Products list will be issued 180 days after. Both lists will be reviewed at least once every three years; however, the regulations allow for a citizen petition process to add chemicals and products to the lists at any time.
Also at any time, DTSC may request a product manufacturer to provide information regarding the toxicity of its ingredients or any other information DTSC determines “is necessary to implement” these regulations, regardless of whether that information exists or must be generated in the first instance. (§ 69501.5.)
Within 60 days after a Priority Product listing, the regulated entity must prepare an AA, which is a complex report evaluating the comparative environmental attributes of alternative product designs throughout the product’s lifecycle. (§§ 69505-69505.6.) A preliminary AA report is due within 180 days, and the final is due within 12 months, unless the regulated entity can show that its product meets the de minimis thresholds and submits a De Minimis Exemption Notification to DTSC.
Based on the AA submitted and DTSC’s independent review, DTSC may require one of a number of regulatory responses. For instance, it may require the regulated entity to provide labeling and web disclosure information to consumers regarding its products containing a Chemical of Concern. Alternatively, it may require a manufacturer to establish, maintain and fund an end-of-life product stewardship program, and provide information on this program to consumers. Additionally, DTSC can impose regulatory bans on sale of the product, order an inventory recall of the product or impose research and development funding requirements, among other regulatory responses.
In addition to the potential regulatory responses at the outcome of the Safer Consumer Products Regulatory process, DTSC may conduct audits to assess compliance with the regulatory process itself. If DTSC determines that any information requirement is not fulfilled for a product, it will issue a notice of noncompliance, and if the noncompliance is not remedied, it will be posted on the Failure to Comply list on DTSC’s website. The draft regulations also include fine and penalty provisions for noncompliance with the information disclosure process.
These draft regulations are open for informal comment by the public until December 30, 2011. DTSC will hold a workshop for the draft regulations on December 5, 2011, at the Cal/EPA Headquarters building in Sacramento from 9:30 a.m. to 3:30 p.m. It is anticipated that, sometime in early 2012, DTSC will formerly propose under the Administrative Procedures Act these draft regulations and any modifications it makes as a result of the comments it receives through the end of the year.
There are many issues presented in this draft and it will be incumbent on those potentially affected to provide detailed comments to DTSC to ensure that compliance with their formal proposed regulations can be feasibly and practically achieved.
For more information on the origins and development of these draft regulations, please see our previous advisories on the topic:
Rare Meeting of the California Environmental Policy Council (CEPC) to Be Convened on October 27,2010, to Consider Whether the DTSC Green Chemistry Regulations — Or Safer Consumer Product Alternatives Regulations — Will Have Multimedia Impacts