California’s Department of Toxic Substances Control (DTSC) released a revised version of the Safer Consumer Product Alternatives Regulations (SCPA Regulations) for public comment on November 16, 2010. Once finalized, the SCPA Regulations will implement California’s Green Chemistry Initiative, a new program aimed at refocusing the regulation of chemicals used in consumer products. DTSC will accept comments on these regulations – which were revised in response to extensive comments the agency received on the previous draft published in September – until December 3, 2010. Comments may be submitted only concerning the revised portion of the SCPA Regulations and new documents that DTSC has added to the rulemaking file.
The revisions made to the current draft of the SCPA Regulations are substantial. Significant changes were made to clarify and streamline the regulations, including moving a number of provisions from the body of the regulations to the definitions section and eliminating other elements of the regulations altogether (e.g., the Guiding Principles and tiered alternatives analysis process). The resulting regulations are much easier to understand and apply, and are 30 pages shorter than the previous iteration.
Significant substantive changes were also made to the SCPA Regulations, including:
- While slightly expanding the list of “temporary” hazard traits in effect until the Office of Environmental Health Hazard Assessment (OEHHA) publishes its final list, the categories of products that can be designated as Priority Products have been significantly restricted. Specifically, for the first five years following implementation of the SCPA Regulations (through January 1, 2016), Priority Products can consist only of three categories deemed to pose the greatest threat to human health and the environment: (a) Children’s products; (b) Personal care products; and (c) Household cleaning products. Moreover, nanomaterials have been removed from the scope of the revised regulations completely.
- Certain important regulatory exclusions have been expanded, clarified and the criteria for their application made more objective. For example, the exclusion of chemicals and products regulated by other regulatory programs (the “non-duplication” provision) has been expanded to include international trade agreements, no longer includes the burden of proof by clear and convincing evidence, and is now applied in a more objective manner. Similarly, the exclusion applicable to products containing chemicals that exhibit a hazard trait, but for which there is no exposure pathway posing a threat to public health or the environment, no longer carries a negative presumption (i.e. is no longer presumed not to apply).
- The Chemicals Under Consideration and Products Under Consideration lists have been deleted, eliminating intermediate steps in the prioritization process between initial data assessment and final determination of the chemicals and products to be regulated. Additionally, deadlines have been specified for publishing the initial lists of those chemicals and products to be regulated, i.e., the lists of Chemicals of Concern and Priority Products. The initial list of Chemicals of Concern must be published no later than one year following enactment of the SCPA Regulations (December 31, 2011), and the initial Priority Products list one year later (December 31, 2012).
- Changes to the regulations governing treatment of confidential information, including trade secrets, include removal of the prohibition against the misuse of confidential information by DTSC employees (based on assertion that this provision was duplicative of existing law and DTSC practice), and deletion of a process allowing for DTSC’s independent review of trade secret claims separate from the provisions in Health and Safety Code section 25257(a) governing the same issue.
In addition to the revisions made to the text of the SCPA Regulations, DTSC also added documents to the rulemaking file supporting the enactment of the regulations, which include scientific peer-review documents and a resolution by the California Environmental Policy Council (CEPC) concluding that the regulations would not have any significant adverse impacts on public health or the environment. CEPC’s determination was strongly opposed by industry, based upon the adverse impacts the SCPA Regulations could cause by replacing certain chemicals with other substances that pose an even greater threat. Deferring the analysis of such potential impacts is arguably a violation of the California Environmental Quality Act.
Despite the significant changes reflected in the current version of the SCPA Regulations, those regulations and the underlying green chemistry program remain very controversial. Common criticisms include environmentalists’ persistent claims that the program is not broad enough in scope and would not regulate fast enough, compared to industry’s claims that the program would essentially regulate every product sold in California. Another major area of disagreement is how the regulations treat confidential information, such as trade secret protections. Additionally, complementary regulations drafted by OEHHA to create the toxics information clearinghouse, a key component of the green chemistry program, have also come under fire for potentially exceeding that agency’s authority because they would conclusively link chemicals with specific hazard traits, instead of merely publishing data concerning hazard traits and toxicology for public review.
Although DTSC is legally authorized to issue another revised version of the SCPA Regulations after considering the comments received on the current draft, the time to do so is very short. DTSC has a statutory mandate to enact the SCPA Regulations by January 1, 2011, and releasing another revised draft of those regulations would have to include another 15-day public comment period.