Calif. Chemical Reg Changes Could Affect Many Products
Sen. Ben Allen, the chair of the California Senate's Environmental Quality Committee, recently introduced Senate Bill 392, which proposes the most significant modifications to California's Safer Consumer Products program since its inception more than a decade ago. SB 392, should it advance through the legislative process in its current form and become law, will therefore impact all types of consumer product manufacturers selling products in California.
In 2008, California lawmakers passed two bipartisan measures that sought to create a new, science-based framework for regulating chemicals in consumer products. The Green Chemistry Initiative, authorized by AB 1879 and SB 509, was the product of a collaborative effort by legislators, the administration of Gov. Arnold Schwarzenegger and stakeholders to give the California Department of Toxic Substances Control, or DTSC, the authority to regulate potentially hazardous substances in consumer products.
The primary purpose of the initiative was to eliminate the adoption of piecemeal legislation regulating chemicals one at a time, in favor of one comprehensive regulatory framework based on scientific judgment. After 11 iterations, DTSC finalized the implementing regulations in October 2013.
The regulations, which established the Safer Consumer Products Program, immediately established a list of approximately 1,200 candidate chemicals based on the work already done by other authoritative organizations. The regulations further specified a process for DTSC to identify additional chemicals as candidate chemicals.
Not all consumer products containing candidate chemicals are subject to the regulations. Only manufacturers of so-called "priority products" – those products specifically targeted by DTSC that contain one or more candidate chemicals – fall within the ambit of regulation.
A candidate chemical that serves as the basis for a product being listed as a priority product is designated as a chemical of concern, or COC, for that product. Instead of banning the use of COCs without knowing the availability or safety of alternatives, the regulations provide manufacturers with an opportunity to determine whether the chemical is necessary and whether a safer alternative exists.
To this end, manufacturers of priority products must either remove the COC from the marketplace or conduct what is called an "alternatives analysis" – a process that compares the existing priority product with potential alternatives, using 13 factors evaluated at each stage of the product's life cycle to determine how to best limit exposure to, or the level of adverse public health and environment impacts imposed by, the COCs in the product.
After evaluating the final alternatives analysis report, DTSC is required to select what the regulations refer to as a "regulatory response" for a priority product, or choose an alternative product to replace the priority product. Possible regulatory responses include, but are not limited to, use restrictions, product sales prohibitions, engineering or administrative controls, or end-of-life product management.
Since 2013, DTSC has established a list of candidate chemicals, finalized the listing of three chemical-product combinations as priority products, and proposed the listing of four chemical-product combinations as priority products. To date, no manufacturer has prepared an alternatives analysis under the program, and thus DTSC has issued no regulatory responses.
2018 Public Health Institute Report
In October 2018, the Public Health Institute issued a report titled "California's Green Chemistry Initiative at Age 10: An Evaluation of its Progress and Promise" which evaluated the "strengths and challenges" of the Safer Consumer Products Program. To guide the Public Health Institute in its efforts, experts from business, nonprofit, academic and government perspectives were interviewed to elicit strengths and challenges of the current program.
According to the report, three significant areas of weakness have impaired the ability of the program to live up to its potential:
- The pace of implementation has been slow, with relatively few priority products identified for action to date;
- The program suffers from unclear authority to collect data on chemicals in products, and struggles with broader data gaps on exposure and toxicity; and
- California's overall efforts and investment have so far not been sufficient to foster robust research and development of safer product chemistry.
The report made numerous recommendations to expedite the program to address these issues, including amending the statute to allow expedited action on certain product-chemical combinations, clarify and strengthen data call-in authority, and streamline and support Alternatives Analyses.
The report was discussed at length during a Feb. 12, 2019, joint hearing of the Senate Committee on Environmental Quality and the Assembly Committee on Environmental Safety and Toxic Materials. Witnesses at the hearing included representatives from DTSC, the National Resources Defense Council and the Chemical Industry Council of California. Gina Solomon, the primary author of the report, also testified at the hearing.
Only a week after the hearing, Sen. Allen introduced SB 392, with backing from the Natural Resource Defense Council and other environmental health groups.
SB 392 adopts many of the recommendations outlined in the Green Chemistry 10-year report, including strengthening data call-in authority and establishing a procedure for bypassing alternatives analyses. But the legislation goes even further than the recommendations contained in the report by, for example, proposing to expand the list of candidate chemicals.
Expanding the Candidate Chemicals List
SB 392 would expand the candidate chemicals list under the Safer Consumer Products Program for the first time. Specifically, the bill instructs DTSC to revise the candidate chemical list by 2021 to include:
- Fragrance allergens listed by the European Union in Annex III of Regulation (EC) 1223/2009;
- Asthmagens for which the American Conference of Governmental Industrial Hygienists has established threshold limits for asthma;
- Chemicals identified under the California Environmental Contaminant Biomonitoring Program; and
- Endocrine disrupting chemicals identified by the Office of Environmental Health Hazard Assessment (OEHHA).
This means that products containing chemicals on such lists could potentially become priority products subject to regulation under the program.
Strengthening Data Call-In Authority
SB 392 would also strengthen the data call-in authority of DTSC by requiring a manufacturer to provide information about the "ingredients and use" of consumer products to DTSC upon request and within the timeframe provided by DTSC. DTSC would be authorized to request information including: (1) ingredient chemical identity, concentration and functional use data; (2) information about the use of consumer products by sensitive subpopulations; and (3) sales data.
If a product manufacturer does not have the requested ingredient information, and cannot obtain the information from the chemical manufacturer, the product manufacturer must certify so in writing to DTSC and provide DTSC with contact information for the chemical manufacturer. DTSC may then require the chemical manufacturer to provide this information.
Additionally, the bill provides for significant fines for failure to comply with information requests – $70,000 per violation, or per day of violation for continuing violations.
Establishing a Procedure for Bypassing Alternatives Analyses
Under SB 392, DTSC may rely on "all or part of one or more publicly available" alternatives analysis for a chemical of concern, rather than requiring the completion of an alternatives analysis. This aspect of the proposal is an apparent attempt to expedite the program.
If DTSC intends to rely on an existing alternatives analysis, it must provide public notice and an opportunity for comment. Following the notice and opportunity for comment, DTSC may proceed to a regulatory response (including prohibiting the use of the chemical in the consumer product, imposing labeling requirements or imposing end of useful life requirements).
DTSC may only rely on an existing alternatives analysis if it is issued by a government agency or "credible institution with relevant expertise and without financial conflicts of interest," or if it is published in a peer-reviewed scientific publication.
Limiting Availability of the Informal Dispute Resolution Process
If DTSC provides public notice and an opportunity for comment prior to the adoption of regulation priority product, the bill provides that the dispute resolution procedures currently available in the regulations would be prohibited. Therefore, in these circumstances, if a responsible entity disagrees with DTSC's adoption of a priority product, the entity must appeal that decision to the Director of DTSC pursuant to existing available procedures.
Adding Requirements for Priority Product Work Plans
The legislation would also impose on DTSC additional requirements for its Priority Product Work Plans. These plans are required to be adopted every three years to identify the scope of products subject to potential future regulation.
Beginning with the 2021-2023 work plan, DTSC would be required to include (in addition to previously required information):
- Any information DTSC has available at the time of publication about chemicals of concern in each category or subcategory of consumer products;
- Additional ingredient information needed to assess the safety of consumer products and how DTSC intends to collect this information; and
- Timelines (not to exceed five years) for the completion of the Safer Consumer Products Program process for at least five categories or subcategories of consumer products.
In assessing information needed to evaluate the safety of a consumer product and the appropriate regulatory response for a chemical-product combination, DTSC must consider the chemicals that are likely to be substituted into products in place of the chemical of concern to ensure that the substitutes are not also on the candidate chemical list.
Key Takeaways and Next Steps
SB 392, should it be signed into law in its current form, would significantly impact consumer product companies throughout the supply chain. First, the proposed expansion of DTSC's candidate chemical list to include fragrance allergens, asthmagens and endocrine disruptors will mean that products that would not have otherwise fallen within the purview of the program could be subject to future regulation. Businesses should therefore assess their product inventory to determine whether any product ingredients are included on these new lists.
Second, given SB 392 would allow DTSC to use "all or part of one or more publicly available" alternatives analysis in lieu of going through the existing alternatives analysis process, businesses should keep apprised of alternatives analyses processes at government agencies or credible institutions with relevant expertise, as DTSC may rely on those analyses – rather than those prepared by manufacturers of priority products – to determine what regulatory response it will issue, if any.
And finally, businesses should pay close attention to DTSC's Priority Product Work Plans, as the new plans under SB 392 would be required to include timelines for the completion of at least five categories of consumer products. These timelines may inform manufacturers of products within the scope of a work plan regarding whether engagement with DTSC may be appropriate.
SB 392 has been referred for hearings in the Senate Environmental Quality Committee and Senate Judiciary Committee. Given the magnitude of the legislation, the earliest it would likely make it to the governor's desk is August or September.