Authorized by California’s 2008 Green Chemistry statute (Assembly Bill 1879), a final SCPR as it was proposed would constitute the most far-reaching regulation yet of chemicals of concern (COC) by requiring that manufacturers conduct complex analyses of these substances. Such analyses would be intended to reduce the concentration of the COC in a product and/or reduce or restrict public health and/or environmental exposures to the COC.
Companies would be faced with the difficult task of identifying safer alternatives to chemicals they have manufactured for decades. The SCPR would also provide consumers with enhanced information about product ingredients, information that many companies regard as confidential.
The proposal, which was released by California’s Department of Toxic Substances Control (DTSC) in July 2012, has generated an overwhelming negative response from potentially affected industries. At least part of that concern is that finalization of the SCPR as proposed may ease acceptance of the federal Safe Chemicals Act, which mirrors many aspects of the SCPR and has yet to win congressional approval. The federal law as proposed would require that manufacturers demonstrate the safety of existing chemicals and would provide fewer protections for confidential business information (CBI).
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Healthcare Costs
While comments on the proposed SCPR from those who support the action were less voluminous than industry input, they conform much more closely with the DTSC’s own vision. This may result in fewer words carrying more weight when the DTSC composes the final SCPR. A quote from the Sierra Club of California is representative of those who stand by the proposal:
“There are more than 100,000 chemicals currently in commerce, and more than 2,000 new chemicals are added each year. Existing laws do not adequately protect the environment and consumers from unnecessary exposure to toxic levels of these chemicals. According to the Berkeley Center for Green Chemistry, health care costs for California’s children and workers from chemical and pollution-related diseases exceed $2 billion per year. Preventable chronic illnesses, developmental and behavioral disorders such as ADHD, infertility, cancer, and birth defects are linked to exposure to harmful toxins in products. The harm does not just end with consumers. Dangerous substances from products will make their way to the environment where they pollute our water and harm wildlife. Local governments are usually tasked with water treatment and cleanup efforts that cost taxpayers billions of dollars each year.”
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Four-Step Rule
With some exceptions (e.g., dangerous prescription drugs and devices and dental restorative materials), the proposed regulations would apply to all consumer products that contain a COC and are sold, offered for sale, distributed, supplied, or manufactured in California. According to the DTSC, the regulations provide for a four-step continuous, science-based, iterative process to identify safer consumer product alternatives:
• The regulations establish an immediate list of COCs (approximately 1,200) based on work already done by other authoritative organizations and specify a process for the DTSC to identify additional chemicals as COCs.
• The DTSC must evaluate and prioritize product/COC combinations to develop a list of priority products for which alternatives analyses must be conducted.
• Responsible entities (manufacturers, importers, and retailers) must notify the DTSC when their product is listed as a priority product. The DTSC will post this information on its website. Manufacturers (or other responsible entities) of a priority product must perform an alternatives analysis for the product and the COCs in the product to determine how best to limit exposures to or the level of adverse public health and environmental impacts posed by the COCs in the product.
• The DTSC must identify and require implementation of regulatory responses designed to protect public health and the environment and maximize the use of feasible alternatives of least concern. The DTSC may require regulatory responses for a priority product/COC if the manufacturer decides to retain the priority product or for an alternative product/chemical selected to replace the priority product. The DTSC may select from a range of responses, including having the regulated party provide product information for consumers; restricting the use of the COC in consumer products; prohibiting sale of specific products; requiring engineered safety or administrative controls; and requiring end-of-life product management.
See tomorrow’s Advisor to see how the SCPR affects California’s Green Chemistry Initiative.