On August 23, 2013, the California Department of Toxic Substances Control (DTSC) released changes to the near final Safer Consumer Products Regulations (SCPR). These game-changing regulations took effect October 1, 2013. This column broadly outlines the rule and summarizes the changes.
SCPR: An Overview
In 2008, California passed "green chemistry" legislation directing DTSC to adopt regulations establishing "a process for evaluating chemicals of concern in consumer products, and their potential alternatives, to determine how best to limit exposure or to reduce the level of hazard posed by a chemical of concern." The regulations, which originally were to be issued by January 1, 2011, must prioritize chemicals of concern in consumer products and establish procedures for evaluating safer alternatives to toxic chemicals through a science-based approach.
The state's Office of Environmental Health Hazard Assessment (OEHHA) specified hazard traits, environmental and toxicological endpoints, and other relevant data for inclusion in a state Toxics Information Clearinghouse. DTSC will use information from the clearinghouse to help identify chemicals of concern in consumer products.
In broad terms, within 30 days after the SCPR becomes effective (later this year), DTSC is required to establish a "candidate chemicals" list. The term "chemical of concern" remains in the regulations, as a candidate chemical is the basis for a product being listed as a priority product (PP) that will be designated by DTSC as a chemical of concern for that product. DTSC plans to release a list containing approximately 1,200 candidate chemicals. The current draft would exclude approximately 500 chemicals now used only in pesticides and drugs. DTSC must develop a list of PPs for which alternatives analyses must be conducted.
Within 60 days after a product is placed on the Priority Products List, "responsible entities" will be required to provide notification to DTSC stating that their products are PPs, unless they submit "alternative notifications." Responsible entities include manufacturers, importers and retailers who sell products in California. The alternatives assessment (AA) is central to the regulations. Each AA must be conducted in two stages and a report must be sent to DTSC at the end of each stage. In the first stage, product criteria are identified. Next, alternatives to the use of the chemical of concern must be identified and screened, and a work plan proposed for the second stage.
The second stage requires a more detailed AA. The product and each alternative must be evaluated for key factors and potential exposure pathways and lifecycle segments. Possible regulatory responses triggered by DTSC's findings and determinations include use restrictions and prohibitions on sales, among other options.
The recent changes relate principally to how trade secret information is managed. They would extend the period of confidentiality to allow DTSC to review the information and allow the entity submitting information time to appeal a decision. The changes aren't expected to delay issuance of the final rule, and have been generally praised.
California's SCPRs are expected to redefine the way consumer products are designed, formulated, distributed and marketed. For this reason, implementation of the program will have impact far beyond California. Because the state represents a large market, manufacturers likely will need to conform their specifications for all consumer products to California's SCPR criteria. The alternative is to create different product specifications for California and the rest of the country and world, which is regarded widely as commercially infeasible and a legal non-starter.
Watch for the issuance of the final rule, and review it carefully if products your company manufactures or sells in California are within the SCPR scope. Even if direct application of the program isn't immediately relevant, given the precedential impact of the regulations, consumer product manufacturers may wish to review the rule as California's approach likely will be seen as a template for the regulation of consumer products elsewhere and thus may be adopted by other regulatory bodies.
LYNN BERGESON is Chemical Processing's Regulatory Editor. You can e-mail her at email@example.com
Lynn is managing director of Bergeson & Campbell, P.C., a Washington, D.C.-based law firm that concentrates on conventional, biobased, and nanoscale chemical industry issues. She served as chair of the American Bar Association Section of Environment, Energy, and Resources (2005-2006).