On July 27, 2012, California's Department of Toxic Substances Control (DTSC) released its long-awaited formal draft of its Safer Consumer Products regulations. The state's regulations will require product manufacturers to consider the toxicity of components and raw materials when designing their products. They follow a series of informal proposals made by California regulators pursuant to California's 2008 "Green Chemistry Initiative" law; those proposals were met with heavy criticism by environmental and public health groups, scientists, and industry.
California's latest version narrows the scope of the regulations to include fewer initial Chemicals of Concern (COCs), but also provide fewer exceptions to the regulations.
In 2008, California's legislature passed legislation requiring DTSC to have its regulations in place by January 1, 2011. Previously, an increasing number of chemical-specific bills had been introduced to ban particular chemicals or restrict their use in certain products. The Green Chemistry Initiative regulations attempt to create a systematic regulatory process that potentially addresses all chemicals.
The regulations also attempt to force manufacturers to consider, at the design stage, the toxicity of the components and raw materials used in their products; the hope is that imposing this burden will lead to the manufacture of consumer products that contain fewer toxic substances. Under the law, the regulations must provide a science-based approach for:
- Developing a list of chemicals that pose the greatest risks,
- Identifying products that contain the chemicals, and
- Analyzing safer alternatives.
A Four-Step Process
The formal proposed regulations refine the previously-proposed continuous, science-based, iterative four-step process for identifying safer consumer product alternatives:
- Chemicals of Concern. The regulations establish an immediate list of approximately 1,200 COCs (down from 3,000) that "exhibit a hazard trait or an environmental or toxicological endpoint," or are identified by other authoritative organizations. The regulations also specify a process for DTSC to identify additional chemicals as COCs.
- Product Prioritization. The regulations require DTSC to develop a list of "Priority Products" for which an Alternatives Analysis (AA) must be conducted. DTSC specifically noted that the initial Priority Products list will include no more than five products. If a Priority Product meets the Alternatives Analysis Threshold for the particular COCs in a product, the manufacturer may be exempt from having to conduct an AA. DTSC must specify the Alternatives Analysis Threshold for each COC.
- Responsibility for Compliance. The regulations impose the responsibility for compliance on manufacturers, product retailers, and importers. Responsible entities must notify DTSC when their product is listed as a Priority Product or qualifies for an Alternatives Analysis Threshold Exemption, conduct an AA for any Priority Products, and submit both a Preliminary and a Final AA Report to DTSC.
- Regulatory Responses. The regulations require DTSC to identify and impose regulatory responses to protect public health and the environment, and to maximize the use of alternatives of least concern whenever technically and economically feasible. DTSC may place use restrictions on COCs and Priority Products, or prohibit altogether the sales of Priority Products containing COCs if an alternative exists. DTSC will maintain a "Response Status" list on its website, where it will post, among other things, whether a responsible entity failed to make the information requested available to DTSC within the specified time period, and whether it satisfactorily demonstrated it does not have, and is unable to produce, the requested information. Under the regulations, DTSC is also authorized to conduct audits to determine compliance with the AA and regulatory response requirements.
Following the controversy and criticism surrounding its "informal" draft regulations, DTSC's current formal proposed regulations are the culmination of four years of working with its Green Ribbon Science Panel, business groups, health care advocates, and environmentalists. DTSC will hold a public hearing on the proposed regulations on September 10, 2012. Responsible parties wishing to comment on the regulations must do so before September 11, 2012.
Manufacturers will learn more about how this new regulatory program will work once the DTSC identifies the first batch of Priority Products and how they will be treated. The way they are handled will shed useful light on how manufacturers can best position themselves to comply with the Safer Consumer Products regulations even as they watch for DTSC to identify additional Priority Products.
For More Information
Please contact Timothy J. Coughlin, Heidi B. Goldstein, Fern P. O'Brian, or William J. Hubbard or any member of our Product Liability Litigation practice group for more information.
This advisory may be reproduced, in whole or in part, with the prior permission of Thompson Hine LLP and acknowledgement of its source and copyright. This publication is intended to inform clients about legal matters of current interest. It is not intended as legal advice. Readers should not act upon the information contained in it without professional counsel. This document may be considered attorney advertising in some jurisdictions.