After a failed attempt at the end of the Schwarzenegger Administration, under current Governor Jerry Brown, California is now pushing forward with its new “green chemistry” approach to the regulation of chemicals in consumer products. These regulations are likely to be formally unveiled early this year and will require extensive risk and life cycle analyses for prioritized products, which are likely to initially include children’s products, personal care products, and household cleaning products.
The Envisioned Process
The revised California green chemistry regulations will establish a four-step process to identify safer consumer product alternatives.
1. Chemicals: The State will publish an initial list of Chemicals of Concern (COCs), likely involving close to 3,000 substances.
2. Priority Products: Next, it will develop a list of Priority Products based on its evaluation of products that contain the identified COCs, as well as the distribution, use, and disposal patterns.
3. Business Duty to Notify and Evaluate: Responsible entities will be required to notify the State when their product is listed as a Priority Product and to perform an Alternatives Assessment.
4. Product/Chemical Limits/Regulations: California will identify and impose a “Regulatory Response” to limit potential adverse public health and environmental impacts.
As drafted, the regulations will eventually apply to all consumer products containing a COC that are sold, offered for sale, supplied, distributed, or manufactured in California. There are limited exemptions for:
• Products exempted by law (specified medical and dental devices, “dangerous” prescription drugs, food, and pesticides) and products used solely to manufacture a product exempted by law;
• Products manufactured, stored in, or transported through, California, solely for out-of-state use; and
• Products regulated by other federal or California state regulatory programs or international trade agreements, where the program or agreement provides an equivalent or greater level of protection of public health and the environment than would be provided if the product were listed as a Priority Product (no examples are specified, but EU programs seem likely candidates).
There are de minimis exemptions for products with COCs at concentrations equal to:
• 0.01% by weight for chemicals exhibiting one of nine specified hazard traits (carcinogenicity, developmental toxicity, reproductive toxicity, endocrine toxicity, genotoxicity, immunotoxicity, neurotoxicity, bioaccumulation, or environmental persistence);
• 0.1% by weight for chemicals that do not exhibit any of the nine specified hazard traits and environmental and toxicological endpoints; or
• A lower or higher concentration if specified by DTSC in the Priority Products list.
The regulations apply to any “responsible entity,” which includes the manufacturer, or, if the manufacturer does not comply, the importer or retailer.
This assessment remains at the heart of the Green Chemistry regulations. Each must be conducted in two stages, with a report sent to State regulators at the end of each stage.
Necessity/Identification of Alternatives: In the first stage, product criteria are identified (e.g., by function, performance, technical, and legal requirements). A statement must be provided on whether the COC or a substitute chemical is necessary to meet the product’s requirements. Next, alternatives to the usage of the COC must be identified and screened, and a work plan proposed for the second stage.
Detailed Assessment of Alternatives: The second stage requires a more detailed assessment of alternatives. The product and each alternative must be evaluated with respect to relevant factors and associated exposure pathways and life cycle segments. At this stage, the responsible entity selects an alternative that will replace or modify the Priority Product or decides not to modify the Priority Product (or discontinue the distribution of the product in California).
At a minimum, product information will be required to be provided to consumers if a Priority Product contains a COC above the de mimimis level. Additional possible regulatory responses include mandating implementation of engineered safety measures designed to control access or limit exposure to the COC in a Priority Product and, at the extreme, a potential prohibition on sale of the Priority Product within California.
With reform of the Toxic Substances Control Act stalled in Congress, Governor Brown’s Administration appears more determined than its predecessor to take the lead in product stewardship and chemical regulation through California’s so-called “green chemistry” initiative.