On January 30, 2013, the California Department of Toxic Substances Control (DTSC) released revised proposed Safer Consumer Products Regulations (Revised Proposed Regulations). The Revised Proposed Regulations are subject to a 30-day comment period, ending February 28, 2013. Memoranda providing background information are available online. The Revised Proposed Regulations are available online.
Below is a summary of the core elements of the Revised Proposed Regulations -- Chemicals of Concern (COC), Priority Products (PP), Alternative Assessments (AA), and Regulatory Responses -- and any significant changes from prior proposals.
Scope of Persons and Products Subject to the Regulations
The regulations apply to 'responsible entities' -- including manufacturers, importers, assemblers, and retailers who sell products in California. Manufacturer has been redefined as: 'any person who manufactures a product that is subject to the requirements of this chapter, or any person that controls the manufacturing process for, or has the capacity to specify the use of chemicals in, such a product.' Manufacture and manufacturer are explicitly distinguished from assemble and assembler, with assemble defined as to 'fit, join, put, or otherwise bring together components to create a consumer product' and assembler defined as a person who 'assembles a product containing a component that is a product subject to the requirements' of the Regulations (i.e., a component that is listed as a PP).
As with prior versions of the Regulations, the responsibilities for responsible entities are tiered, such that primary responsibility will lie with the manufacturer, the importer will have responsibility if the manufacturer fails to comply, and retailers will be required to comply only if the manufacturer and importer (if any) fail to comply. The Revised Proposed Regulations clarify that DTSC will inform importers and retailers of such non-compliance by posting the information on a 'Failure to Comply' list on DTSC's website and that assemblers are now in the same position as retailers. Section 69501.2(a)(1). A retailer or assembler who becomes responsible for complying due to non-compliance by the manufacturers and importers may opt out by ceasing to order the product and providing a notification to DTSC. Section 69501.2(b).
In the Revised Proposed Regulations, DTSC has altered those products exempt from the Regulations. Pursuant to Section 69501(b), products exempt continue to include those exempt from the definition of 'consumer product' specified in Health and Safety Code Section 25251 (e.g., dangerous prescription drugs and devices; dental restorative materials; medical devices; pesticides; food; and packaging associated with dangerous prescription drugs and devices, dental restorative materials, and medical devices) and now also include an exemption for a consumer product that DTSC determines is regulated by one or more federal and/or California State regulatory program(s), and/or applicable treaties or international agreements with the force of domestic law, that, in combination:
1. Address the same potential adverse impacts, potential exposure pathways, and potential adverse waste and end-of-life effects that could otherwise be the basis for the product being listed as a Priority Product; and
2. Provide a level of public health and environmental protection that is equivalent to or greater than the protection that would potentially be provided if the product were listed as a Priority Product.
Upfront exemptions have been eliminated for consumer products manufactured or stored in, or transported through, California solely for use out-of-state and products used in California solely for the manufacture of one or more of the products exempted from the definition of consumer product. These factors are now included as factors when DTSC is prioritizing products for consideration as PPs.
DTSC to Develop a 'Candidate Chemicals' List
The first phase of these Regulations is the requirement that DTSC establish, within 30 days after the effective date of the Regulations, a Candidate Chemicals List. In the Revised Proposed Regulations, DTSC has changed the name from 'Chemical of Concern' List to Candidate Chemicals List. The term COC remains in the Regulations, as a Candidate Chemical (CC) that is the basis for a product being listed as a PP that will be designated by DTSC as a COC for that product.
Under Section 69502.2(a), the Candidate Chemicals List would include those substances that exhibit a hazard trait or an environmental or toxicological endpoint (identified through the Office of Environmental Health Hazard Assessment's (OEHHA) development of a Toxics Information Clearinghouse pursuant to Health and Safety Code Section 25256.1). Changes to the sources from which the Candidates Chemical List will be derived include:
- Chemicals classified by the European Union (EU) as Category 1 respiratory sensitizers have been added to the initial list of CCs.
- The list of pollutants identified for California under the federal Clean Water Act has been expanded to include Section 303(d) chemicals in addition to the Section 303(c) chemicals.
- The source for chemicals identified as persistent, bioaccumulative, and toxic by the EU was changed from 'Chemicals that are identified as High Production Volume Persistent Bioaccumulating Toxins by the European Union' to 'Chemicals included as persistent, bioaccumulative and toxic, or very persistent and very bioaccumulative in the candidate list of Substances of Very High Concern in accordance with Article 59 of Regulation (European Commission) 1907/2006.'
The Revised Proposed Regulations establish a process by which DTSC can identify additional chemicals as COCs after considering the potential chemical adverse impacts and potential exposures for which reliable information is available. Section 69502.2(b). While this procedure remains largely the same, the Revised Proposed Regulations eliminate as a factor for consideration that DTSC 'may consider the availability of a safer alternative chemical that is functionally acceptable for one or more common uses of the chemical in consumer products in determining whether to list the chemical as a Chemical of Concern.'
DTSC has retained the provision stating that prior to January 1, 2016, DTSC may list a product as a PP only if the product is being listed on the basis of one or more CCs in the product that meet both of the criteria noted above (exhibit a hazard trait and an environmental or toxicological endpoint), even though a substance can be listed on the Candidate Chemicals List if either criterion can be met. Although not defined as an 'Initial' Candidate Chemicals List, this means that there will continue to be a subset of the Candidate Chemicals List from which DTSC will determine the initial PP listings.
DTSC to Develop a 'Priority Products' List
In prior versions of the Regulations, DTSC set forth the procedure by which it would evaluate and prioritize products that contain COCs to develop a list of PPs for which AAs must be conducted. The Revised Proposed Regulations have been modified to clarify throughout that DTSC will be identifying and prioritizing COC product-chemical combinations when listing PPs. For example, DTSC states the following emphasizing product-chemical combinations:
The Department may identify and list as a Priority Product one or more product-chemical combinations that it determines to be of high priority. The Department's decision to identify and list a product-chemical combination as a Priority Product shall be based on an evaluation of the product-chemical combination to determine its associated potential adverse impacts, potential exposures, and potential adverse waste and end-of-life effects by considering the factors described in paragraphs (1) and (2) [Adverse Impacts and Exposures and Other Regulatory Programs] for which information is reasonably available.
The Revised Proposed Regulations further state:
Any product-chemical combination identified and listed as a Priority Product must meet both of the following criteria:
(1) There must be potential public and/or aquatic, avian, or terrestrial animal or plant organism exposure to the Candidate Chemical(s) in the product; and
(2) There must be the potential for one or more exposures to contribute to or cause significant or widespread adverse impacts.
To determine products of high priority, DTSC will evaluate the potential adverse health and environmental impacts posed by the COCs in each product based on several factors listed in the Revised Proposed Regulations that are somewhat similar to that previously proposed (i.e., adverse impacts, potential exposures, availability of information, and other regulatory programs). Section 69503.2. Another factor added is that DTSC may consider 'product uses, or discharges or disposals, in any manner that have the potential to contribute to or cause adverse waste and end-of-life effects associated with the Candidate Chemical(s) in the product.' DTSC has also reinstated a factor that allows it to consider 'whether there is a readily available safer alternative that is functionally acceptable, technically feasible, and economically feasible.'
When listing chemical-product combinations in PPs, the Revised Proposed Regulations now clarify that PPs will be established and updated through rulemaking pursuant to the Administrative Procedure Act (commencing with Government Code Section 11340) in addition to provisions already in place that DTSC will hold one or more public workshops. Section 69503.5(a)(2).
In any proposed or final PP List, DTSC must now list '[a] description of the product-chemical combination that is sufficient for a responsible entity to determine whether one or more of its products is a Priority Product.' The prior regulations required DTSC to include, if applicable, information about components, homogeneous materials, and/or highly durable goods. The Proposed Revised Regulations change the term from highly durable goods to complex durable goods, and restate that for a complex durable product, DTSC will not list as PPs, in a three-year period, more than ten components contained in that product. DTSC reinstates the term 'assembled product,' and requires DTSC to include a description of the known assembled product(s) in which the component is used if the product-chemical combination is a component of one or more assembled products.
Each responsible entity for a product listed on the PP list must provide to DTSC a PP Notification within 60 days after the product is listed as a PP unless DTSC specifies a later notification date. Alternatives Analysis Threshold (AAT) Exemption Notifications, PP Removal Notifications, or COC Removal Notifications (where the only change is the removal of the COC from the PP without adding a substitute chemical) can be submitted concurrently with a PP Notification, although these notifications can be submitted later in the process in lieu of conducting an AA.
Also significant, DTSC previously changed the term 'de minimis level' with regard to the presence of the COC in the PP to an AAT, defined as a concentration by weight specified by DTSC. DTSC now defines AAT as the 'Practical Quantitation Limit for a Chemical of Concern that is present in a Priority Product solely as a contaminant.' DTSC thus retains its decision to remove any default thresholds (e.g., 0.01 percent by weight), but clarifies the AAT will be the Practical Quantitation Limit (PQL) and will apply only to contaminants. Since the AAT is now the PQL, the sections in the Regulations setting forth the criteria by which DTSC will set the AAT for each COC in a PP and the procedure by which a responsible entity can submit an AAT Exemption Notification to seek an exemption from the requirement to conduct an AA have been eliminated. DTSC does allow for an AAT for a particular intentionally added chemical in a particular product to be addressed in the rulemaking for that PP listing if DTSC determines an AAT is needed.
The Revised Proposed Regulations retain the requirement that DTSC develop, with a new deadline to be within one year of the effective date of the Regulations, an Initial Priority Product Work Plan that 'identifies and describes the product categories that the Department will evaluate to identify product-chemical combinations to be added to the Priority Products list during the three (3) years following the issuance of the work plan.' Section 69503.4(a). The Revised Proposed Regulations include a new provision that will allow DTSC to revise a work plan if it is legally required to take action on a particular chemical or product prior to the expiration of the work plan or if DTSC grants a petition.
DTSC also retained the provision limiting the initial list of PPs to no more than five products. These provisions are now in a new section at Section 69503.6.
Companies to Prepare Alternative Analysis
DTSC will require 'responsible entities' -- including manufacturers, importers, and retailers who sell products in California -- to notify DTSC within 60 days of a PP's listing that its product is a PP, and if applicable, the option of submitting a notification that the responsible entity intends to seek an exemption. Under the tiered system, manufacturers will generally be those that must perform an AA for the listed COC and PP to determine how best to limit potential exposures or the level of potential adverse public health and environmental impacts posed by the COC in the PP. Under the Revised Proposed Regulations (and prior versions), AAs must be conducted in two stages that produce a Preliminary AA Report and then a Final AA Report (Sections 69505.5). The Revised Proposed Regulations retain the two stages with the following changes:
- In lieu of conducting an AA, a manufacturer can submit to DTSC, no later than the due date for submitting a Preliminary AA Report:
- A Chemical Removal Intent and/or Confirmation Notification (certifying that the COC(s) will be/have been removed from the product without the use of any replacement chemical(s)) that complies with Sections 69505.2(b) and (c);
- A Product Removal Intent and/or Confirmation Notification (certifying that the manufacturer will or has ceased fulfilling orders for the product from persons selling or distributing the Priority Product in California) that complies with Sections 69505.2(b) and (d);
- A Product-Chemical Replacement Intent and/or Confirmation Notification (certifying that the COC(s) will be or have been removed from the product and any replacement chemical meets certain criteria) that complies with Sections 69505.2(b) and (e); or
- An AAT Notification that complies with Section 69505.3.
- A very significant change is the elimination of all provisions requiring that the AA be conducted by a 'certified assessor.' In fact, all provisions relating to work conducted by certified assessors or accreditation bodies meeting specified education and experience requirements have been eliminated. Instead, to provide a quality assurance mechanism for the AAs, DTSC will require responsible entities to consider all information and public comments made available on DTSC's website and summarize the consideration of such information and comments in the Final AA Report.
- DTSC states in the first stage that the responsible entity 'shall consider any identified alternative in the AA, or explain in the AA Report why such an alternative is not viable for consideration.' A responsible entity can only eliminate an alternative from consideration as long as the elimination is explained in the Preliminary AA Report and there are alternatives remaining to be evaluated in the second AA stage. Sections 69505.5(b) and (d).
- The Revised Proposed Regulations revise the economic impacts evaluation required in the second stage. This evaluation is now limited to a monetized comparison of public health and environmental costs, and costs to 'governmental agencies and non-profit organizations that manage waste, oversee environmental cleanup and restoration efforts, and/or are charged with protecting natural resources, water quality, and wildlife.' Section 69505.6(a)(2)(C). In addition, the responsible entity must explain in the Final AA Report any alternative selection decision to retain the PP based in whole or in part on internal impact costs. This would include 'a quantified comparison of the internal cost impacts of the Priority Product and the alternatives, including manufacturing, marketing, materials and equipment acquisition, and resource consumption costs.'
The timeframes for compliance with AA Reports remain the same. A Preliminary AA Report must be submitted no later than 180 days after the date the product is listed on the final PP List unless DTSC specifies a different date. The Final AA Report must be submitted no later than 12 months after the date DTSC issues a notice of compliance for the Preliminary AA Report, unless the responsible entity requests, and DTSC approves, a longer period of time not to exceed 24 months (or up to 36 months if regulatory safety and/or performance testing is required for the alternatives being considered). Section 69505.8(b)(4)(A). The Revised Proposed Regulations add that if DTSC approves an extended due date to submit the Final AA Report, the responsible entity shall provide a yearly progress report until the Final AA Report is submitted.
Other issues of note include:
- DTSC Review of AA Reports: Within 60 days of receiving a Preliminary AA Report or Final AA Report, DTSC shall review the Preliminary AA Report for compliance and issue a notice of compliance, a notice of deficiency, or a newly-added notice of disapproval. Section 69505.8(b)(1), (c)(1). A notice of disapproval will be issued if a responsible entity received a notice of deficiency but the revised report or work plan does not fully address the DTSC-identified areas of deficiency, or if a revised report or work plan is not submitted timely.
- Trade Secrets: With respect to documents or information submitted to DTSC, a person may assert a claim of trade secret protection. Section 69509. The information required to substantiate these claims is unchanged from the prior Regulations, although DTSC now states that a copy of the documentation, including the trade secret information, does not need to be submitted with the substantiation when expressly prohibited by federal law, or when there is a nondisclosure agreement whose relevant text is provided to DTSC.
With regard to trade secret protection for information identifying or describing a hazard trait exhibited by a chemical or chemical ingredient, prior versions of the Regulations sought to deny the ability to make any trade secret claims for such information, while the Proposed Regulations provide that a trade secret claim can be made when the claimant can show that the 'chemical that is the subject of the claim is a new chemical or a new use of an existing chemical,' provide certain data, and comply with substantiation requirements. In the Revised Proposed Regulations, DTSC specifies that such a claim can only be made temporarily when a patent application is pending for an alternate chemical or its contemplated use in the product. This 'chemical identity masking' shall be authorized only until the patent application has been granted or denied. Section 69509(g).
DTSC to Identify and Impose Regulatory Responses on Priority Products/Chemicals of Concern
No later than 90 days after DTSC issues a notice of compliance or notice of disapproval for a Final AA Report, DTSC will issue a notice of its proposed determination that one or more regulatory responses is required, or that no regulatory response is required. Section 69506.1(c). DTSC will require implementation of regulatory responses only 'when necessary to protect public health and/or the environment.' DTSC shall seek to 'maximize the use of alternatives of least concern when such alternatives are functionally acceptable, technically feasible, and economically feasible.' Section 69506(a). The previous definition of 'technically and economically feasible alternative' has been decoupled to technically feasible and economically feasible.
In selecting regulatory responses, DTSC has revised the factors it may consider to now comprise:
- The degree to which, and speed with which, the regulatory response can address the adverse public health and/or environmental impacts and/or adverse waste and end-of-life effects of the COC(s) or replacement CC(s);
- The ability of end-users to understand and act upon any regulatory response involving provision of information with respect to the PP;
- Any adverse ecological impacts of the regulatory response on sensitive resources, or unique or additional burdens that the regulatory response would impose upon sensitive subpopulations;
- Existing federal and/or California State regulatory requirements applicable to the COC(s) or replacement CC(s);
- The cost to the responsible entity of the regulatory response(s) relative to the cost of other possible responses;
- The practical capacity of responsible entities to comply with the regulatory response(s);
- The management and clean-up costs imposed on public agencies by the ongoing sale of the PP or a selected alternative;
- DTSC's administrative burden in overseeing implementation of the regulatory response(s); and
- The ease of enforcing the regulatory response(s).
DTSC has limited its scope for regulatory responses by: (1) stating that the basis for, and application of, regulatory responses has been limited to the COCs for the PP and any replacement CCs; (2) eliminating the provision allowing DTSC to impose a regulatory response other than those specified in the regulations; (3) eliminating the provisions allowing DTSC to require a new AA be performed based on receipt of new information; and (4) specifying that only manufacturers will be required to comply with regulatory responses imposed by DTSC related to engineering safer measures and administrative controls, end-of-life management requirements, and advancement of green chemistry and green engineering.
If DTSC determines that additional information is necessary to select and ensure implementation of one or more regulatory responses, it can require a responsible entity to provide such supplementary information. It can also require a responsible entity to 'obtain or develop' information to fill one or more 'information gaps' if DTSC determines such information is needed to reevaluate the initial regulatory response(s) imposed for a selected alternative or a PP that remains in commerce. Section 69506.2
Other regulatory responses discussed in the Revised Proposed Regulations are similar to those previously proposed with the following distinctions.
- Product Information for Consumers: DTSC states that information to be made available to the consumer will apply for: (1) PPs for which an alternative was not selected; (2) PPs that continue to be introduced into commerce in California pending development and distribution of an alternative product for longer than 12 months after DTSC issues a notice of compliance or notice of disapproval for an AA Report; and (3) selected alternative products that retain COCs and/or contain any replacement CCs. This information to be provided is generally the same (e.g., manufacturer's or importer's name, the brand name/product name, the COCs (including common names) in the product, safe handling procedures) with a new requirement to include a 'statement informing consumers that the product must be disposed of or otherwise managed as a hazardous waste at the end of its useful life, if applicable.' Section 69506.3(b).
- Use Restrictions on COCs and PPs: DTSC may impose use restrictions the same as those previously proposed (e.g., restrictions on the amount or concentration of the COC permitted in a product; restrictions on the settings in which a product may be sold or used; restrictions on who may purchase and/or use a product). Section 69506.4. The Revised Proposed Regulations now state that these restrictions can be imposed not only on a COC in a selective alternative but also a replacement CC in a selected alternative or a COC if a PP for which an alternative is not selected.
- Product Sales Prohibition: If a responsible entity decides in a Final AA Report to retain an existing PP or select an alternative that still contains a COC or replacement CC, DTSC will have an opportunity to override effectively a responsible entity based on a determination that a safer alternative exists that does not contain a COC or replacement CC and is functionally acceptable, technically feasible, and economically feasible. Sections 69506.5. If DTSC issues such a notification, the responsible entity can either cease placing the product into the California marketplace, directly or indirectly, or submit to DTSC an AA Report that selects an alternative that does not contain a COC or replacement CC.
- Engineering or Administrative Controls: Under specified conditions, DTSC may require a manufacturer to engineer safety measures that integrally contain or control access to, and/or implement administrative controls to reduce the potential for adverse public health and/or environmental impacts. Section 69506.6. The Revised Proposed Regulations now state that these requirements can be imposed not only on a COC in a selective alternative but also a replacement CC in a selected alternative or a COC if a PP for which an alternative is not selected.
- End-Of-Life Management: A responsible entity must establish, maintain, and fund an end-of-life product stewardship program, and provide product information to consumers, if the alternative product (or the PP, if the manufacturer chooses to retain the PP) is required to be managed as a hazardous waste in California at end-of-life. Section 67506.7. The Revised Proposed Regulations state that manufacturers can join to form a non-profit third party product stewardship organization, funded by participating manufacturers, to fulfill these requirements. The comprehensive product stewardship plan required to be developed and maintained -- and now approved -- by DTSC must identify the scope of products and roles and responsibilities of those participating, plus also identify anticipated resources, ensure the program is maintained for sufficient time, and fulfill funding mechanism requirements.
- Advancement of Green Chemistry and Green Engineering: DTSC has kept the regulatory response of requiring manufacturers to initiate research and development products or fund challenge grants to design a safer alternative, improve the performance of a safer alternative, decrease the cost of the safer alternative, or increase the market penetration of a safer alternative. The Revised Proposed Regulations specify that this option is available only '[w]hen a manufacturer concludes that no safer alternative to its Priority product is functionally acceptable, technically feasible, and economically feasible, or a manufacturer selects an alternative that reduces but does not eliminate the use of Candidate Chemicals in the product.' Section 69506.8.
Once a final regulatory response determination notice has been issued, DTSC states that it shall not augment or revise that response unless in response to supplemental information supplied by responsible entities, after a revised AA Report is submitted within 90 days after issuing the notice of compliance or notice of disapproval for the revised AA Report, or as a result of a dispute resolution ruling. Section 69506.1(h).
The core elements and responsibilities for companies with consumer products in the stream of commerce in California remain generally the same under the Revised Proposed Regulations. There are notification requirements if a company's PP is identified, and AAs or other notifications are required to be prepared and submitted. Companies also may need to respond to information requests from DTSC, substantiate claims when information is submitted as trade secret, and potentially utilize the dispute resolution procedures to dispute certain actions taken by DTSC (Section 69507). These responsibilities may be fulfilled by a consortium, trade association, non-profit organization, or other entity, except that notifications required once a PP is listed must be submitted by each affected entity.
DTSC has proposed to revise the Revised Proposed Regulations in response to concerns identified. Several of these changes will improve what is an otherwise complicated and resource-intensive process. The elimination of all requirements pertinent to certified assessors and accreditation bodies is a significant improvement that will help simplify the process without sacrificing how AA Reports are prepared. The process also has been improved by streamlining the notifications that are required to be submitted for identified PP. In addition, DTSC has shown restraint with regard to when certain regulatory responses will be imposed and seemingly has tried to set forth more objective criteria that will streamline the process with regard to AATs and economic impact analysis.
There are still provisions that have been of concern since the Regulations were first proposed, and revisions now proposed that will raise new concerns, including but not limited to restricting any de minimis exemption to the PQL for a contaminant and limiting trade secret claims for chemical identity to those subject to a patent. Although all the comments submitted to DTSC have been posted, DTSC has not yet issued a Response to Comments that would help explain the changes it has proposed, leaving some open questions as to the extent that DTSC considered all the comments and its reasoning for accepting or rejecting submitted commence.