The California Department of Toxic Substances Control (“DTSC”) issued its long awaited draft Safer Consumer Products regulations on July 27, 2012. According to DTSC, the proposed regulations are “among the first comprehensive, state-level efforts to find safer alternatives to hazardous chemicals and are viewed as a possible national model for chemical reform.” DTSC views the regulations as effectively “a preemptive strategy that reduces the use of toxic substances in the design of products and industrial processes with the aim of creating safer and sustainable products.” DTSC will hold a public hearing on the regulations on September 10 and comments on the proposed regulations must be submitted to DTSC by September 11 at 5 pm.
Summary. The proposed regulations require DTSC to identify chemicals of concern and then to identify priority products that contain the chemicals of concern resulting in significant exposures. An alternative assessment must be conducted on such products or the product could cease to be sold for use in California. Manufacturers of identified products would have the primary obligation to respond, but importers would be required to respond in the event the manufacturer fails to comply and, if the importer fails to comply, retailers would be obligated to comply. After DTSC reviews the submissions, it will determine appropriate regulatory action which could include restrictions on the product use.
Background. According to DTSC, more than 80,000 chemicals are approved for use in the United States and 42 billion pounds of chemicals are produced or imported daily into the United States. DTSC has concluded that information on these chemicals is “severely limited” and there is “little to no information on health or environmental effects of many of these chemicals.” DTSC also reported that the average consumer comes into contact with 100 chemicals per day and the United States Centers for Disease Control measured 212 chemicals in blood and urine in a representative population in 2009. DTSC concluded that a federal program will likely be delayed by at least five years. DTSC anticipates that its regulations will result in providing sufficient information to businesses, consumers and public agencies “to choose viable safer alternatives to hazardous chemicals used in consumer products.”
List of Chemicals of Concern. The proposed regulations require DTSC to publish a list of “chemicals of concern.” The initial list is to be established as of the effective date of the regulations and will contain approximately 1,200 chemicals based on lists developed by existing authoritative bodies such as the Proposition 65 list of chemicals. DTSC is authorized to identify additional chemicals based on specific factors such as adverse impacts, exposures, and availability of safer alternatives.
List of Priority Products. DTSC will then evaluate products containing chemicals of concern and give priority to products that have a (i) “significant ability to contribute to or cause adverse” impacts to human health or the environment and (ii) “significant ability” for exposure to humans or wildlife in quantities that would contribute to or cause adverse health or environmental impacts. DTSC may list one or more products determined to be high priority after it reviews existing information on adverse impacts and exposures after determining whether the product is being adequately addressed by other regulatory programs.
The first proposed list of products is to be issued within 180 days of the effective date of the regulations. By January 1, 2014, DTSC must issue a “Priority Product Work Plan” that identifies the product categories to be evaluated to identify products.
The proposed regulations apply to all consumer products for use in California.
Alternate Assessments. The responsible entity for an identified party - the manufacturer, importer or retailer - must notify DTSC when their product is listed as a priority product on the DTSC website. Manufacturers have the primary duty to comply but the importer is responsible if the manufacturer fails to comply. The responsible entity must conduct an alternatives analysis for the product to determine how best to limit exposure to the chemical of concern, apply for an exemption based on the chemical at a concentration below a threshold determined by DTSC, or agree not to manufacture, sell or distribute the product in California. A retailer is only required to comply if neither the manufacturer nor importer complies and DTSC lists the product on the Failure to Comply list. Based on DTSC's review, it will establish a date by which a final alternative assessment report is due. The proposed regulations specify the content of the alternative assessments reports. The alternative assessments may be performed by an entity such as a trade association acting on behalf of the responsible entity. The person performing the alternative assessments must meet specific educational and work experience requirements and, two years after the regulations become effective, the person must also be certified by a DTSC-designated accreditation body.
DTSC will determine if submissions are sufficient. If a responsible entity fails to comply, DTSC will list on its website the product and information about the product on a Failure to Comply list.
Regulatory Response. If a suitable alternative is not feasible, DTSC will determine and propose for public comment a regulatory response based on the alternate assessments which could include use restrictions, sales prohibitions, engineering or administrative controls, or other action to limit exposure to a chemical of concern. After consideration of any comments submitted, DTSC will issue a final determination. The responsible entity will have 30 days to provide a response to DTSC and California retailers of affected products, and the responsible entity must notify DTSC upon completion of the regulatory response and, if applicable, the selected alternative.
Petitions and Dispute Resolution. The proposed regulations provide a process by which one can petition DTSC to add or remove a chemical on the chemicals of concern list and add or remove a product from the priority product list. The proposed regulations also provide a process to dispute actions by DTSC.
Trade Secret Protection. DTSC will be posting information on its website and the proposed regulations provide for the treatment of information for which a claim of trade secret is asserted.