On April 15, 2010, the California Department of Toxic Substances Control (DTSC) released an Outline of its Draft Regulations for Safer Products. This outline is one step toward the adoption of regulations that are likely to significantly affect manufacturers of consumer products that are sold, manufactured, imported, marketed, or distributed in California. The regulations propose to require manufactures to conduct analyses of products containing specifically identified chemicals and to consider alternatives to using those chemicals. The regulations would also authorize DTSC to implement regulatory responses ranging from requests for information to complete prohibitions on the use of specified chemicals. Because DTSC is still in the early stages of developing regulations, manufacturers now have the opportunity become involved in shaping the regulations in ways that will ensure the regulations are not overly costly or burdensome.
In September 2008, California Governor Arnold Schwarzenegger signed two Green Chemistry framework laws—SB 509 and AB 1879. These laws are designed to reduce hazardous chemicals in consumer products and to stimulate the green design and manufacture of such products.
SB 509 creates an online Toxics Information Clearinghouse—a web-based database, to increase consumer knowledge about the toxicity and hazards of thousands of chemicals used in California. AB 1879 establishes authority for DTSC to develop regulations that create a process for identifying and prioritizing chemicals of concern and to create methods for analyzing alternatives to existing hazardous chemicals. It also allows DTSC to take certain actions based on the alternatives analysis that range from “no action” to “restrictions or bans.”
Under the authority of AB 1879, DTSC has released an Outline of its Draft Regulations for Safer Products and is now seeking public comment before initiating its formal rulemaking process.
Proposed Regulatory Framework
The approach proposed by DTSC in its outline would require DTSC to identify “Chemicals Under Consideration,” “Chemicals of Concern,” “Products Under Consideration,” and “Priority Products.” Under DTSC’s outline, these classifications will affect how products are regulated. The list of Chemicals Under Consideration would be developed based on consideration of a number of factors including adverse impacts on the environment, adverse impacts on sensitive subpopulations, physical properties, and anticipated rates of exposure. From that list, DTSC would develop a list of priority Chemicals of Concern. Products under Consideration are products that contain a Chemical of Concern. Priority Products are products from the list of Products under Consideration that are determined to be of highest priority. Products are identified as Products Under Consideration and Priority Products based on consideration of a number of factors identified in the outline. Additionally, any person may petition DTSC to evaluate a chemical or product during the prioritization process to be added as a Priority Product.
The outline proposes the following regulatory framework:
•Certificate of Compliance: Products listed as Priority Products could only be sold with a certificate of compliance stating that the manufacturer is in compliance with, or is exempt from, the regulations.
•Information Submission: The DTSC would have authority to request extensive information from manufacturers including product marketing data and chemical information submitted to the United States Environmental Protection Agency, the Canadian Environmental Protection Agency, or the European Commission under the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) regulations.
•Alternatives Assessments: Manufacturers of Priority Products would be required to perform an Alternatives Assessment of their product. This process would begin with the preparation of an Alternatives Assessment Work Plan, which would identify the alternatives to be considered and the proposed methodology. DTSC would review the Work Plan for compliance with AB 1879. Once DTSC determined that the Work Plan meets the requirements of AB 1879 and the regulations, the manufacturer would be required to complete an Alternatives Assessment and prepare an Alternatives Assessment Report. Based on this report, DTSC would identify appropriate regulatory responses.
•Regulatory Response: After a manufacturer prepared an Alternatives Assessment Report, DTSC would have authority to determine the most appropriate regulatory response to limit the effect of the Chemical of Concern on public health and the environment. Potential regulatory responses would include: (1) requiring additional information regarding the Chemical of Concern or proposed safer alternative(s); (2) requiring product information disclosure to consumers; (3) placing restrictions on the use of Chemicals of Concern in the consumer product; (4) prohibiting use of Chemical of Concern in the consumer product; (5) imposing safety measures to control access to the Chemical of Concern in the consumer product; (6) requiring end of life management of the product; and (7) requiring research and development with respect to the product. Alternatively, DTSC may determine that no further action is required.
The next step in the regulatory process will be the creation of draft regulations based on the outline already developed by DTSC and any comments received in response to this outline. According to DTSC, the draft regulations will be released in the very near future and will begin a formal rule-making process. Under AB 1879, the regulations must be adopted by January 1, 2011.
Manufacturers who may be impacted by these regulations may want to submit comments to DTSC’s outline, before the formal rulemaking process commences. DTSC is currently accepting feedback on its outline by e-mail at email@example.com. Additionally, interested parties may wish to submit comments during the rulemaking process. To track DTSC’s progress in preparing final regulations, visit DTSC’s Green Chemistry website.
Kristin M Stastny is an Associate in the Regulatory Affairs Department at Dorsey & Whitney, LLP. Please see our web site at www.dorsey.com.