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Lynn L. Bergeson is managing director of Bergeson & Campbell, P.C., a Washington, D.C., law firm focusing on conventional and engineered nanoscale chemical, pesticide, and other specialty chemical product approval and regulation, environmental health and safety law, chemical product litigation, and associated business issues, and President of The Acta Group L.L.C. and The Acta Group EU Ltd. with offices in Washington, D.C., and Manchester, U.K.

DTSC Releases Proposed Safer Consumer Products Regulations

August 7, 2012
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Under the guise of public protection and safety, California continues on with plans to control all chemicals used in consumer products. The comment period is a short 45 days.

On July 27, 2012, the California Department of Toxic Substances Control (DTSC) released proposed Safer Consumer Products Regulations (Proposed Regulations). The proposed regulations, subject to a 45-day comment period, are the newest iteration of the much-anticipated regulatory implementation of California's Green Chemistry Initiative. The proposed regulations have been through several iterations, including an "informal draft" that was released in October 2011, and other drafts released on June 23, 2010, and November 16, 2010. DTSC describes the proposed regulations as 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 that do not threaten human health or persist in the environment." Memoranda providing background information are available online. The proposed regulations are available here online.

DTSC will hold a public hearing on the proposed regulations on Sept. 10, 2012. For written comments to be considered, they must be submitted no later than 5:00 PM on Sept. 11, 2012. After the close of the comment period, if substantial changes are made, the modified full text will be made available for comment for at least 15 days prior to adoption.

The core elements of the proposed regulations include Chemicals of Concern (COC), Priority Products (PP), Alternative Assessments (AA), and regulatory responses.

Companies with consumer products in the stream of commerce in California will need to notify DTSC that its product is a PP (or cease to enter the product in the stream of commerce in California) or satisfy another exemption (e.g., AA threshold exemption); perform an AA and prepare a Preliminary AA Report and Final AA Report; and comply with any regulatory responses applicable to its product or that DTSC determines are necessary. Companies also may need to respond to information requests from DTSC, substantiate claims when information is submitted as trade secret, and potentially utilize the dispute resolution procedures to dispute certain actions taken by DTSC (Section 69507). DTSC provides that these responsibilities may be fulfilled by a consortium, trade association, or other entity, but does not provide in the regulations any conditions or criteria for how issues (e.g., formation, compensation) will be resolved.

DTSC has made some revisions in the proposed regulations in response to concerns identified in earlier versions. Certain controversial lists upon which the COC list could be derived have been eliminated, the prior de minimis exemption has been revised so that there is no default concentration, the time for responsible entities to remedy non-compliance notices regarding an AA or regulatory response is extended from 60 to 90 days, and inventory recalls have been eliminated as a regulatory response. The procedure that runs from developing a COC list to determining appropriate regulatory responses remains complicated, with a large variety of factors to be applied and evaluated at every turn.

Although recognizing that the proposed regulations will have an economic impact on businesses, DTSC states that generally, it "does not expect the regulations to result in cost increases, given the wide variety of comparable safer products readily available at competitive prices." While it is true that many companies already conduct these types of assessments as part of their product stewardship efforts, it remains to be seen whether compliance with these particular regulations will increase costs. The cost to the State of California to administer the program also remains unclear. Companies that conduct thorough and useful assessments of this kind may find it difficult to fit their models into that now required by DTSC. 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.
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