By Clare Bienvenu and Mary E. Wilke
The California Department of Toxic Substances Control (“DTSC”) recently issued its ninth draft of the Green Chemistry Initiative regulations (“Regulations”) with the final rules expected later this year. The following are six key changes set forth in the ninth draft: (1) companies are only required to make changes to ingredients included on DTSC’s list of chemicals of concern (“COC”); (2) companies are no longer required to hire a certified assessor to perform an Alternative Analysis (“AA”) but may conduct the AA themselves, while also undergoing a public notice and comment period; (3) companies from the same industry are allowed to form a nonprofit group to fund disposal of certain products as part of the end-of-life management program; (4) companies are allowed to assert “trade secret” protection over information required to be submitted; (5) the regulations will distinguish between companies that make products and those that assemble products, rather than define them all as manufacturers; and (6) an exemption is provided for products regulated by other laws that provide public health and environmental protections that are equivalent to the Green Chemistry Initiative or stricter.
With respect to the second key change, under the Regulations, Priority Products must undergo an AA, or an evaluation and comparison of the product to product alternatives. Alternatives may include removing the COC from the product, replacing the COC with a substitute chemical, reformulating/redesigning the product to reduce or eliminate the COC, or using another material to restrict exposure to the COC. Earlier versions of the Regulations allowed DTSC to make changes to any ingredients in their products instead of limiting DTSC’s authority to addressing ingredients on DTSC’s list of COCs. The prior version of the Regulations also required that AAs be performed by certified assessors. Under the latest revised version, while affected entities will be able to conduct their own AAs, those AAs must undergo a public notice and comment period of 45 days, with public comments to be sent directly to the company as well as DTSC. In the Final AA Report, the company must summarize and address the public comments received.
With respect to the third key change, manufacturers of a Priority Product or a selected alternative that must be managed as a hazardous waste in California at the end of its useful life are required to establish “end-of-life” management programs for such products. The new revisions allow manufacturers to join together to form and fund a non-profit third-party stewardship organization to fulfill the end-of-life management program requirements. Under previous versions, each manufacturer was required to individually fund the program within one year of issuance of a notice of compliance for the Final AA Report.
With respect to the fourth key change, the newly revised Regulations allow companies to assert “trade secret” protection over information required to be submitted. In doing so, the company must submit a complete copy of the documentation, including the information for which trade secret protection is claimed, and a redacted copy of that same documentation. The revised Regulations, however, provides an exception to the submission of the complete copy where federal law or a nondisclosure agreement expressly prohibits the release of the information. Additionally, while the regulations generally prohibit trade secret protection for hazard trait submissions, the new draft allows for companies to at least temporarily mask the precise identity of a chemical in the hazard trait submission if the chemical is an alternative considered in the AA and a patent application for the chemical or its use is pending.
With respect to the fifth key change, the Regulations now define manufacturer as “any person who manufactures a product that is subject to the requirements of this chapter, or any person that controls the manufacturing process for, or has the capacity to specify the use of chemicals in, such a product.” The definition of manufacture has also been revised and now states that “manufacture does not include acts that meet the definition of ‘assemble.’” Assemble is defined as to “fit, join, put, or otherwise bring together components to create a consumer product.” If the manufacturer of a Priority Product component does not comply with applicable requirements, assemblers who use that component have the same option as retailers. The assembler can comply with the requirement themselves or cease ordering the Priority Product component.
With respect to the sixth key change, an upfront exemption has been created for products regulated by other laws that provide public health and environmental protections that are equivalent to the Green Chemistry Initiative or stricter.
While it appears that the ninth draft of the regulations provides some relief to the regulatory burden imposed on companies who use targeted materials, with public comments recently closed, it will shortly be seen how the business and environmental communities receive these changes. The answer may come in the form of final rules, as this draft of the regulations is believed to be DTSC’s last version prior to its issuance of the final rules. DTSC has indicated that it will identify the first five Priority Product categories to which to apply these regulations, this year, with the likely categories being articles for personal care and for children/infants.