On March 13, 2014, the California Department of Toxic Substances Control (“DTSC”) announced the first set of draft priority products that, if finalized, will be subject to the requirements of the California Safer Consumer Products (“SCP”) Regulations.
Notably, while DTSC had legal authority to identify up to five products, it chose to identify only three draft priority products at this time. The three products are:
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Children’s Foam Padded Sleeping Products containing the flame-retardant chemical, Tris (1,3-dichloro-2-propyl phosphate) or (“TDCCP”). Such products include nap mats and cots, travel beds, bassinet foam, portable crib mattresses, play pens, and other children’s sleeping products. In its press release announcing the draft priority products, DTSC asserted that TDCCP is a known carcinogen, is released from products into air and dust where it can be absorbed, inhaled, or transferred from hand to mouth, and has been found in California waters and sediments. DTSC also noted that there is no legal requirement applicable to these products that would require them to be made with flame retardants. For more information on DTSC’s selection of this draft priority product, click here.
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Spray Polyurethane Foam (“SPF”) Products containing Unreacted Diisocyanates. SPF products are used for home and building insulation, weatherizing and sealing, and roofing. DTSC asserted in its press release that exposure to wet or “uncured” SPF materials can contribute to occupational asthma and noted that unreacted diisocyanates are a “suspected” carcinogen. DTSC expressed its concern for populations using these products that are not protected by Occupational Safety & Health Administration regulations, such as independent contractors and people performing their own home repairs. In its press release, DTSC noted that currently there are no alternatives to unreacted diisocyanates for spray-foam applications. For additional information from DTSC on this draft priority product, click here.
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Paint and Varnish Strippers containing Methylene Chloride. Methylene chloride is a well-known and widely used solvent in paint strippers. According to DTSC, when metabolized, methylene chloride converts to carbon monoxide, which is acutely toxic to the brain and nervous system. DTSC claimed that alternative products without methylene chloride are readily available. For more information on this draft listing, click here.
In announcing the “draft list” of proposed priority products, DTSC emphasized that the naming of these products does not constitute a ban on the products, but rather the initiation of process to examine whether the chemicals of concern used in these products are “necessary” or may be replaced with safer alternatives. To put the draft priority products announcement in context, this announcement begins the second of four steps established by California’s SCP Regulations for identifying, prioritizing, and evaluating the use of chemicals and their alternatives in consumer products. The four steps include:
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Identification of Candidate Chemicals. The final SCP Regulations promulgated by DTSC include an initial list of candidate chemicals (~1,200), which DTSC later pared down to an informational “initial” list of fewer than 200 candidate chemicals that exhibit a hazard trait and/or environmental or toxicological endpoint.
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Identification of Priority Products. The SCP Regulations require DTSC to evaluate and prioritize product/candidate chemical combinations and to develop a list of priority products for which alternatives analyses must be conducted. Once a candidate chemical is the basis for a priority product listing, it is considered a chemical of concern. March 13’s announcement identifies the first product/candidate chemical combinations that DTSC is proposing to subject to the procedural process outlined in the SCP Regulations.
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Alternatives Analysis. Responsible entities of a product listed as a priority product must perform an alternatives analysis to determine how best to limit exposures to, or the level of adverse public health and environmental impacts posed by, the chemicals of concern in the product.
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DTSC Regulatory Response. The SCP Regulations provide a range of potential regulatory responses that DTSC may require after review of the alternatives analysis. These include provision of information for consumers (such as safe handling or instructions to limit exposure), restrictions on the use of chemicals of concern in the products, sales prohibition, engineered safety measures, and end-of-life management requirements. DTSC may require regulatory responses for a priority product (if the responsible entity decides to continue producing and distributing the priority product to the California market), or for an alternative product selected to replace the priority product.
Applicability
The SCP regulatory requirements apply to businesses (“responsible entities”) that manufacture, import, distribute, sell or assemble consumer products[1] identified by DTSC as priority products that are placed into the stream of commerce in California. Responsible entities are defined to include manufacturers, importers, retailers and assemblers. The SCP Regulations assign the principal duty to comply with the requirements to manufacturers. If a manufacturer does not comply with its obligations with regard to a priority product, DTSC may notify an importer, retailer or assembler of its duty to meet the requirements with respect to the priority product. Even if not called on to conduct an alternatives analysis, importers, assemblers and/or retailers of priority products may be impacted by regulatory responses selected by DTSC after the manufacturer’s completion of the alternatives analysis (e.g., if DTSC imposes a sales prohibition or requires additional information to be provided to the consumer at the point of sale) .
Requirements for Responsible Entities
Once the draft priority products are formally proposed and finalized through a public rulemaking process (which may take up to one year), responsible entities will be required to:
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Within 60 days after finalization of the final priority products list, notify DTSC that the responsible entity makes or sells a priority product (DTSC will post information obtained from notifications, including the names of the responsible entities as well as the product names, on its web site);
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Within 180 days after finalization of the final priority products list, prepare a Preliminary Alternatives Analysis[2] to determine how best to limit exposures to, or the level of adverse public health and environmental impacts posed by, the chemicals of concern in the product; and
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Within one year after DTSC issues a Notice of Compliance for the Preliminary Alternatives Analysis, prepare a Final Alternatives Analysis.
Next Steps
Those that manufacture, sell, use, or otherwise have an interest in the draft priority products may wish to submit comments to DTSC as part of the priority product listing process. DTSC will follow a formal rulemaking process to finalize the draft priority products, which will take up to a year after the products are formally proposed. DTSC plans to hold several workshops in May and June of 2014 before publishing the notice of proposed rulemaking and opening the public comment period. Stakeholders will then have the opportunity to weigh in on whether, and how, the proposed priority products will be regulated by DTSC.
If your products were not among the three proposed priority products,stay tuned: By October 1, 2014, DTSC is required to issue a Priority Product Work Plan that identifies and describes the product categories that DTSC will evaluate to select priority products for the three years following the issuance of the Work Plan (roughly from 2015 to 2017). DTSC intends the Work Plan to serve as a signal to consumers and the regulated community as to the categories of products it will examine next.
Once DTSC finalizes the initial priority product listings (anticipated late summer or early fall of 2015), responsible entities will be required to meet a series of deadlines for notification and submission of alternatives analysis reports outlined above. Manufacturers of draft priority products should engage their supply chain partners to evaluate options prior to finalization of the priority product listings. Note that manufacturers that choose to reformulate products prior to finalization of the priority product listing will not be subject to the DTSC notification or alternatives analysis requirements.
[1] “Consumer product” is defined for purposes of the California Safer Consumer Products regulations to mean “a product or part of the product that is used, brought, or leased for use by a person for any purposes.” Cal. Health & Safety Code § 25251(e). Certain limited products, such as dental restorative material or its packaging, prescription drugs or devices and their packaging, medical devices and their packaging, food, and federally registered pesticides, and mercury containing lights are excluded from the definition of consumer product.
[2] DTSC is currently developing an alternatives analysis guidance document to assist responsible entities in carrying out their obligations under the SCP Regulations. As of March 13, 2014, the guidance is still in development. DTSC anticipates that it will be released sometime before the first set of priority products is finalized.