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California Reissues Draft Green Chemistry Regulations for Safer Consumer Products

Beveridge & Diamond, P.C., November 16, 2011

On October 31, 2011, nearly a year after it withdrew its initial Green Chemistry regulatory proposal, the California Department of Toxic Substances Control (“DTSC” or “Department”) released informal Draft Safer Consumer Product Regulations (“Informal Draft Regulations”), as part of its three-year effort to implement the state’s landmark 2008 Green Chemistry legislation.  Manufacturers of consumer products sold in California likely will be significantly impacted if the Informal Draft Regulations are adopted as proposed.  Stakeholders have until December 30, 2011 to comment on the Informal Draft Regulations and have the opportunity to provide comments at a DTSC-sponsored workshop on December 5, 2011.  The formal rulemaking process is planned for some time in 2012.

Background

Since passage of California’s Green Chemistry legislation (A.B. 1879) in 2008, California has sought to reduce or eliminate adverse public health and environmental impacts that may result from the production, use, or end-of-life management of consumer products containing hazardous chemicals.  The enabling statute had imposed a January 1, 2011 deadline for adopting regulations.  In November 2010, DTSC issued proposed regulations (the “November 2010 Proposal”).  But the very next month, the Department halted its efforts, citing the need for additional time to respond to the concerns raised by environmentalists, industry, and the public.  The recently issued Informal Draft Regulations represent the Department’s latest effort to implement the 2008 Green Chemistry legislation.

Overview of the 2011 Proposed Regulations

The Informal Draft Regulations follow the same basic structure and contain many of the elements of the Department’s November 2010 Proposal: 

  1. DTSC would establish a list of Chemicals of Concern.
  2. DTSC would identify Priority Products containing the Chemicals of Concern.
  3. Priority Products would be subject to an Alternatives Assessment, in which responsible entities would be required to study whether there are safer alternatives to Chemicals of Concern in their products and whether it would be feasible to replace them.
  4. DTSC would be able to impose a regulatory response depending on the outcome of the Alternatives Assessment and actions taken by the responsible entity.

The entity with primary responsibility for compliance continues to be the product manufacturer or the entity that controls the product design.  Importers and retailers would also be responsible entities.

Significant Revisions to the November 2010 Draft Regulations

Within each step, however, significant changes have been proposed that alter the scope and timing of the regulations, and the potential impacts upon manufacturers of consumer products.

  • Chemicals of Concern
    • 3,000 Chemicals of Concern would be placed on a Chemicals of Concern list when the regulations are adopted.  This is not only a much larger list of chemicals than contemplated in DTSC’s November 2010 Proposal, it would take effect immediately, rather than over the course of a twelve-month time frame as initially proposed.  This represents a significant acceleration of DTSC’s regulatory efforts.
  • Priority Products
    • All consumer products would be subject to the regulatory requirements of the Informal Draft Regulations unless expressly exempted (e.g., food, pharmaceuticals, medical devices, products regulated by other health and/or environmental regulatory programs).  The November 2010 Proposal limited Priority Products to children’s products, personal products, and household cleaning products in an effort to address “everyday” products that are widely sold and have high exposure potential.  The 2011 Informal Draft Regulations still contemplate prioritization based on these principles but no longer limit prioritization to three discrete categories.  Further, DTSC has stated that it expects only 2-5 products to be subject to the regulations at the outset.
    • Under the Informal Draft Regulations, product manufacturers or other responsible entities would not be required to produce potentially burdensome product information requirements for the product prioritization process.  A frequently criticized component of the November 2010 Proposal had been a requirement that manufacturers disclose certain chemical and product information — chemical ingredients, chemical quantities, and statewide products sales — that potentially constituted confidential business information.   However, under the current proposal, DTSC still would be able to ask for such information and potentially stigmatize a manufacturer by publicly disclosing its failure to respond if the manufacturer elects not to submit such data.
    • Priority Products would be identified by DTSC approximately 6 months after the regulations take effect.  The November 2010 Proposal would have identified Priority Products 24 months after the effective date.  This represents another acceleration of DTSC’s regulatory efforts.
    • Once a Priority Product is listed, a product manufacturer would have approximately 2 months to provide DTSC with notice that it manufactures such a product or that its product does not exceed threshold levels of the Chemical of Concern.  If not, then it must proceed to the Alternatives Assessment.
  • Alternatives Assessment
    • The Informal Draft Regulations would streamline the Alternatives Assessment, which under earlier iterations of the regulations were shaping-up to be expensive, complex, and time-consuming.  For example, the Informal Draft Regulations have eliminated requirements for product manufacturers to fill-in information gaps, which would have required the production and generation of new data before an Alternatives Assessment was finalized, thereby avoiding a potential logjam in the process.
    • The Informal Draft Regulations also would impose clearer deadlines for the completion of Alternative Assessment reports.  Generally, a preliminary report would be due approximately 6 months after a product is listed as a Priority Product; and a final report would be due 1-2 years following DTSC’s approval of the preliminary report.  No hard deadlines were contemplated in the Department’s prior proposal. 
  • Regulatory Response
    • The Informal Draft Regulations would keep DTSC’s regulatory response options largely intact.  As before, DTSC could prohibit the sale of a Priority Product where a product manufacturer elects to leave its product as is.  Product manufacturers or other responsible entities could be required to disclose certain information to consumers or to establish an end-of-life product management program.  DTSC also would be allowed to require no regulatory response in cases where a product manufacturer selects an alternative product that does not contain Chemicals of Concern above threshold levels.

Other Important Areas

  • Exemptions
    • The presence of Chemicals of Concern in Priority Products below threshold levels would continue to provide an exemption from the regulatory scheme for product manufacturers.  The Informal Draft Regulations set the default de minimis level at 0.01% for Chemicals of Concern exhibiting certain hazard traits (carcinogenicity, developmental toxicity, reproductive toxicity, endocrine toxicity, genotoxicity, immunotoxicity, neurotoxicity, bioaccumulation, or environmental persistence), and at 0.1% for all other Chemicals of Concern.  The November 2010 Proposal had set 0.1% as the default de minimis level for all Chemicals of Concern. 
  • Confidential Business Information
    • The Informal Draft Regulations would still require product manufacturers to submit documentation containing claimed trade secrets, and continue to leave great uncertainty with respect to protections of a manufacturer’s trade secrets and other confidential business information.  The November 2010 Proposal had set forth a process by which a manufacturer could attempt to protect its intellectual property but left unclear whether a manufacturer had to prevail on a lawsuit within a short 30-day time frame after receiving notice of DTSC’s disagreement with a trade secret claim in order to prevent disclosure, or whether the filing of the lawsuit itself was enough to prevent the disclosure of claimed trade secrets until a decision on the merits.  To prevent disclosure of a claimed trade secret, the current Informal Draft Regulations still would require a manufacturer to secure some interim order from a court to prevent disclosure if no final decision on the merits is reached within the 30-day period. 
    • Additionally, the Informal Draft Regulations would continue to authorize DTSC to make substantive determinations as to trade secret designations, rather than a third-party arbiter.
  • Program Funding
    • The Informal Draft Regulations continue to be silent regarding funding for the program, which would impose significant burdens on already limited DTSC resources especially in the current context of severe state budget constraints.  It remains open whether additional legislation will be necessary to enact a program fee to carry out the regulatory scheme.  This likely will be an unavoidable issue as the formal rulemaking gets underway, likely next year.

Next Steps

Given the scope of the Informal Draft Regulations and the costs and burdens that may fall on product manufacturers, all members in the regulated community are encouraged to comment.  As noted above, DTSC will be accepting comments on the Draft Regulations until December 30, 2011.  The formal rulemaking process likely will begin in 2012.  When it is initiated, the Proposed Regulations will be subject to the formal rulemaking procedures established by the Administrative Procedures Act and the Office of Administrative Law, which encompass a public review and 45-day comment period before any proposed regulations can be approved and go into effect.

For additional information on California’s Green Chemistry Initiative, please contact Kenneth Finney at kfinney@bdlaw.com, Laura Duncan at lduncan@bdlaw.com, or Ryan Tacorda at rtacorda@bdlaw.com

For a printable PDF, please click here.

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