In July, the California Department of Toxic Substances Control (DTSC) released proposed Safer Consumer Products regulations, the newest iteration of the much anticipated regulatory implementation of California's Green Chemistry Initiative, available at http://www.dtsc.ca.gov/upload/SCPProposedRegulationsNoUnderlineJuly2012.pdf. Below is a summary of the core elements of the proposed regulations — chemicals of concern (COC), priority products (PP), alternative analysis (AA), and regulatory responses.
Chemicals of concern: Of critical importance to most companies doing business in California is DTSC's directive to establish, within 30 days after the effective date of the regulations, a COC list. The list would include substances that exhibit a hazard trait or an environmental or toxicological endpoint according to one or more of 14 lists already selected by agencies or organizations, or are identified by one or more of eight lists of certain types of chemicals.
While some of the more-controversial lists from which DTSC will derive its COC roster have been removed in these proposed regulations, the remaining lists contain a large number of chemicals that other agencies or organizations have determined exhibit certain hazard traits (carcinogenicity, reproductive toxicity, mutagenicity, developmental toxicity, endocrine disruption, neurotoxicity or persistent bioaccumulative toxicity) or that appear on exposure indicator lists for water quality, air quality or biomonitoring.
Priority products: DTSC will evaluate and prioritize products that contain COCs to develop a list of PPs requiring AAs. To determine high-priority products, DTSC will evaluate the potential adverse health and environmental impacts posed by the COCs in each product based on several factors listed in the proposed regulations.
Alternative analysis: DTSC will require responsible entities — including manufacturers, importers and retailers that sell products in California — to notify DTSC within 60 days of a PP's listing that a product is a PP or satisfies an exemption. Responsibilities are tiered, such that primary responsibility will lie with the manufacturer (the entity that makes the product or controls the specifications and design of, or use of materials in, the product), the importer will have responsibility if the manufacturer fails to comply, and retailers will be required to comply only if the manufacturer and importer (if any) don't comply and such information is posted on a "Failure to Comply" list on DTSC's website.
Regulatory response: Once DTSC gets and then okays a final AA report it will specify, after considering the complexity of implementing the regulatory response, a proposed deadline for its execution. DTSC will require implementation of regulatory responses "designed to protect public health and the environment, and maximize the use of alternatives of least concern, where such alternatives are technically and economically feasible."
A company with consumer products in commerce in California will need to notify DTSC that its product is a PP (or cease to distribute the product in California) or satisfy another exemption (e.g., AA threshold exemption); perform an AA and prepare a preliminary and final AA report; and comply with any regulatory responses applicable to its product or that DTSC determines are necessary.
DTSC has revised the proposed regulations in response to concerns identified in earlier versions. It has eliminated certain controversial lists upon which the COC list could be derived, revised the prior de minimis exemption so that there's no default concentration, extended to 90 days from 60 days the time for responsible entities to remedy noncompliance notices regarding an AA or regulatory response , and dropped inventory recalls as a regulatory response. The procedure that runs from developing a COC list to determining appropriate regulatory responses remains complicated, with many factors to be applied and evaluated.
Fortunately, DTSC will only subject a small number of PPs to these regulations initially, a fact that may provide interested parties with an opportunity to see how these regulations will be implemented, what AA reports will look like, and what changes or refinements may be needed.
LYNN BERGESON is Chemical Processing's Regulatory Editor. You can e-mail her at firstname.lastname@example.org.
Lynn is managing director of Bergeson & Campbell, P.C., a Washington, D.C.-based law firm that concentrates on chemical industry issues. The views expressed herein are solely those of the author.