Regulatory Developments

DTSC Releases Revised “Informal Draft” Safer Consumer Products Regulations

November 2, 2011

On October 31, 2011, the California Department of Toxic Substances Control (DTSC) released an "informal draft" Safer Consumer Products Regulations (SCPR). DTSC proposed these regulations after ten months of meetings following the California Secretary for Environmental Protection's instructions to DTSC to stop working on issuing proposed regulations and instead "take additional time to be responsive to the concerns raised and revisit the proposed regulations." Memoranda providing background information are available online. Concerns raised at that time included, among others, the proposed exemption of certain chemicals; the decision to focus the first five years on children's products, personal care products, and household cleaning products; and the process by which "chemicals of concern" (COC) and "priority products" (PP) were identified and alternative assessments (AA) conducted. In the revised regulations, DTSC has removed exemptions for unintentionally added chemicals and chemicals for which there is "no exposure pathway," eliminated the initial focus for certain types of products, and expanded the criteria and processes by which COCs and PPs are identified and prioritized and AAs are conducted. In addition, while there had been a contemplated exemption for nanomaterials in the prior regulations, there is no mention of nanomaterials or any specific exemption for nanomaterials in these informal draft regulations. To the extent that any nanomaterials have not yet been identified by regulatory agencies on the lists from which DTSC will derive the COC list, the nanomaterials will not, at least initially, be subject to these requirements.

The regulations are available online. The regulations will be discussed by DTSC's Green Ribbon Science Panel on November 14-15, 2011. In addition, a workshop to discuss these regulations will be held on December 5, 2011; details can be found online. Comments on the regulations are due December 30, 2011.

The informal draft regulations anticipate implementing the core provisions of the program in stages, as follows:

  • DTSC to Establish a "Chemical of Concern" List: The first step will be for DTSC to establish, within 30 days after the effective date of the regulations, a COC List. DTSC states that list will include approximately 3,000 COCs, defined in Section 69502.2(a) as a substance that exhibits a hazard trait or an environmental or toxicological endpoint as identified by OEHHA pursuant to Health and Safety Code Section 25256.1 and meets one or more of the following criteria:
    • The chemical is identified as exhibiting a hazard trait on one or more of 15 different lists already selected by other agencies and organizations (e.g., Prop 65, European Union (EU) Directive on Dangerous Substances Category 1 Carcinogens and Category 1 Reproductive Toxins; International Agency for Research on Cancer (IARC) Groups 1, 2A, and 2B Carcinogens; U.S. Environmental Protection Agency (EPA) Toxics Release Inventory Persistent, Bioaccumulative, and Toxic Chemicals);
       
    • The chemical is identified by one or more of four lists based on exposures or environmental or toxicological endpoints (e.g., National Report on Human Exposure to Environmental Chemicals, Center for Disease Control; OSPAR List of Chemicals for Priority Action; OSPAR List of Substances of Possible Concern; and EPA National Waste Minimization Program list of Persistent and/or Bioaccumulative and Toxic Priority Chemicals); or
       
    • The chemical is identified by one or more of three sources of "reliable" information (Grandjean & Landrigan Identification of Neurotoxicants; National Toxicology Program, Office of Health Assessment and Translation reports; and EPA Integrated Risk Information System (IRIS) identification of carcinogens).
       
    This initial COC list is a significant development that is different from the prior regulations. DTSC has stated that developing this "immediate robust" list of COCs will send "immediate signals to the marketplace," but also states that a larger list is "much less likely to motivate early (sometimes regrettable) chemical substitutions."
     
    Exempt Products: While the regulations do not exempt any chemical per se, the following products are exempt from these regulations pursuant to Section 69501(b):
     
    • Products exempt by law (Health and Safety Code Section 25251), including 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.
       
    • Products manufactured or stored in, or transported through, California solely for use out-of-state.
       
    • Products that DTSC determines are regulated by one or more federal and/or other California State regulatory program(s), and/or applicable international trade agreements, that, in combination: (1) address the same adverse public health and environmental impacts and exposures pathways that would otherwise be the basis for the product being listed as a PP; 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 was listed as a PP.
       
    The regulations establish a process by which DTSC can identify and "periodically update" additional chemicals as COCs after considering the potential chemical adverse impacts, potential exposures, availability of reliable information, and availability of safer alternatives. Section 69502.2(b). The proposed revisions to the COC list will be available for a 45-day public comment period and DTSC will hold one or more public workshops to provide an opportunity for oral comments. Section 69502.3(c)-(d). There also is a procedure for any person to petition DTSC to evaluate a claim that a chemical or product should be listed as a COC or PP. Under this procedure, DTSC would review and determine if the petition is complete within 60 days of receipt. No deadline is set on or before which DTSC must conduct a technical review of the petition and prepare a notice of decision. Sections 69504, 69504.1.
     
  • DTSC to Develop a "Priority Products" List: DTSC will evaluate and prioritize products that contain COCs to develop a list of PPs for which AAs must be conducted. To determine those 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 regulations (Sections 69503.2, 69503.2(c)(4)): (1) the potential adverse impacts from the COCs (e.g., hazard traits, environmental fate properties) and potential exposures (e.g., market presence, types of uses, frequency and duration of exposure); (2) the "availability of reliable information to substantiate the potential adverse impacts and exposures"; (3) the extent to which other regulatory programs regulate the products; and (4) the existence, if any, of a known "readily available safer alternative, that is functionally acceptable and technologically and economically viable." The regulations also provide criteria by which DTSC is to prioritize among these products. For example, the proposal contemplates prioritizing formulated products that are applied directly to the body, dispersed as an aerosol or vapor, or applied to hard surfaces with the likelihood of runoff or volatilization. Section 69503.2(b)(5).
     
    In any proposed or final PP list, DTSC must list for each product the COCs that are the basis for the product being listed as a PP; the de minimis level for the COCs; for each assembled product, the components that are the basis for the product being listed as a PP ("[t]his/these component(s) is/are the component(s) to which the de minimis level applies, and which is/are the required minimum focus of the AA"); and the date when the entity must submit to DTSC a Preliminary AA Report. Section 69503.3. The list will be available for a 45-day public comment period and DTSC will hold one or more public workshops to provide for oral comments. The first proposed PP list will be made available for public comment no later than 180 days after the effective date of the regulations. DTSC states that it expects its initial list of PPs will include only two to five products. DTSC also must review the PP list at least once every three years.
     
  • Companies Must Identify Their Priority Products and Conduct AAs If Not Exempt: 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 or satisfies an exemption. The responsibilities for these entities are tiered, such that primary responsibility will lie with the manufacturer (the person that makes the product or the person who controls the specifications and design of, or use of materials in, the products), 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 and such information is posted on a "Failure to Comply" list on DTSC's website. Section 69501.3(a)(1).
     
    AA Exemptions: Persons (generally, manufacturers) 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. Importantly, AAs need not be performed if a product "is no longer placed into the stream of commerce in California by any person on and after the date that the product is listed as a [PP]" or if the product is a "bulk chemical that is placed into the stream of commerce in California and that meets the definition of 'consumer product' . . . but that is not packaged for sale to, or end use by, a retail consumer." Section 69505.1(b). Manufacturers, importers, and retailers can "opt out" of these requirements by providing DTSC with a notice containing information "demonstrating to the Department's satisfaction that the product is no longer placed into the stream of commerce in California." Section 69501.3(b) and (c). In addition, entities that can satisfy the de minimis exemption can submit to DTSC a De Minimis Exemption Notification that will exempt them from the requirement to perform an AA. DTSC provides the following de minimis criteria:
    • For a formulated product, the cumulative concentration in the product of all COCs that are the basis for the PP listing and that exhibit the same hazard trait, or environmental or toxicological endpoint, and mode of action shall not exceed the de minimis level.
       
    • For an assembled product, the cumulative concentration in each component that is a basis for the PP listing, of all COCs that are a basis for the PP listing, and that exhibit the same hazard trait, or environmental or toxicological endpoint, and mode of action, shall not exceed the de minimis level.
       
    The de minimis level is defined as 0.01% by weight for chemicals exhibiting one of nine specific hazard traits (carcinogenicity, developmental toxicity, reproductive toxicity, endocrine toxicity, genotoxicity, immunotoxicity, neurotoxicity, bioaccumulation, or environmental persistence); 0.1% by weight for chemicals that do not exhibit any of the nine specific hazard traits; or a lower or higher level if specified by DTSC. Section 69501.2(a)(25), 69503.4.
     
    If the manufacturer cannot satisfy the criteria to submit a De Minimis Exemption Notification, it must submit a Priority Product Notification and conduct an AA. DTSC's regulations include general provisions for conducting AAs, but also commit to issue guidance materials to assist persons conducting AAs. Section 69505. Under the regulations, AAs must be conducted in two stages:
     
    • In the first stage, the responsible entity must: (1) identify the PP criteria (function, performance, technical feasibility and legal requirements that must be met for any potential alternative; the function of the COC in meeting the PP's function, performance, technical feasibility, and legal requirements; if the COC or any substitute chemical is "necessary" to meet these functions); (2) identify alternative(s) that eliminate or reduce the concentration of the COC in the PP; (3) screen and compare alternative chemical(s) from "available" information; and (4) develop a work plan and implementation schedule. Section 69505.3.
       
    • In the second stage, the responsible entity must identify those factors, in conjunction with an associated exposure pathway and life cycle segment, that are relevant for comparing alternatives -- meaning those factors that make a "demonstrable contribution to the adverse impacts of the PP and/or one or more alternatives under consideration" and make a "demonstrable difference between two or more alternatives being considered, including the [PP]" -- and evaluate and compare the PP and each alternative with respect to each factor and associated exposure pathway and life cycle segment. Section 69505.4. These factors include:
      • Multimedia Life Cycle Impacts and Chemical Hazards: These include physical chemical hazards, adverse public health impacts, adverse environmental impacts, physicochemical properties, environmental fate properties, materials and resource consumption impacts, and adverse waste and end-of-life impacts.
         
      • Product Function and Performance: These include useful life (expressed in single use or number of applications, days, months, or years of the PP and the potential alternatives), functional and performance comparisons, and technological and economic feasibility of alternatives (considering the extent to which a functionally acceptable alternative is currently available in the marketplace, the affordability of any currently available functionally acceptable alternative, and the purchase price differential between the PP and alternatives).
         
      • Economic Impacts: These include internalized and externalized costs during the life cycle of the PP and alternatives, including costs to government agencies, the public, businesses, and consumers.
         
      • Exposure Pathways: These include chemical quantity information (quantities of COCs necessary to manufacture the PP or alternative and estimated volume and/or mass of the COC or substitute chemical that would be placed in the stream of commerce in California) and exposure potential (i.e., those exposure potential factors considered when prioritizing PPs).
         
    The responsible entity "shall select the alternative that will replace or modify the Priority Product, unless the decision is to retain the existing Priority Product." Section 69505.4(c). DTSC will have an opportunity effectively to override a responsible entity's decision to retain an existing PP, or to select an alternative that is still a COC based on a determination that a safer alternative exists that does not contain a COC and is both functionally acceptable and technologically and economically feasible. A Preliminary AA Report will be due no longer than 180 days after the date the product is listed on the final PP list unless DTSC specifies a different date.
     
    After January 1, 2015, AAs must be performed, and reports must be completed by, or under the responsible charge of, an assessor certified by an accreditation body designated by DTSC. Sections 69505.1(d), 69508-69508.4. This is a significant difference from the initial regulations, which had required third-party verifications of the AAs.
     
    The Report must include an executive summary, information about the preparer, supply chain information, facility description and location, product information, methodology used to conduct the AA, supporting information (this can be cited in the reports and made available to DTSC upon request) and information gaps, scope of alternatives, scope of comparison factors, comparison of alternatives, the selected alternative, the work plan and implementation schedule, and "any regulatory response(s) that the responsible entity wishes to propose that would best limit the exposure to, or reduce the level of adverse public health and environmental impacts posed by, any [COC] that will be in the selected alternative or that is in the Priority Product if the decision resulting from the AA is to retain the Priority Product." Section 69505.5. A Final AA Report is due no later than 12 months after the date DTSC issues a notice of compliance for the Preliminary AA Report unless DTSC approves an extension request that cannot exceed 24 months. Section 69505.6(a)(3).
     
    With respect to any documents or information submitted to DTSC, a person may assert a claim of trade secret protection. Section 69510. These claims will need to be substantiated by providing certain information to DTSC specified in the regulations and by providing a redacted copy of the documentation being submitted with the trade secret information removed. DTSC states that trade secret protection "may not be claimed for information identifying or describing a hazard trait exhibited by a chemical or chemical ingredient."
     
  • DTSC Will Identify and Impose Regulatory Responses on Priority Products/Chemicals of Concern: Once a Final AA Report is submitted and DTSC determines it is compliant (i.e., not deficient), DTSC will specify a proposed due date for implementation of the regulatory response after considering the complexity of implementing the regulatory response. Section 69505.6(c)(2). No regulatory response is required if DTSC determines, after review of the Final AA Report, that the selected alternative does not contain a COC in a concentration exceeding the de minimis level and does not pose significant potential adverse public health or environmental impacts. Other regulatory responses discussed in the regulations include the following:
    • Product Information for Consumers: For PPs that the responsible entity selected to maintain or alternative products that contain a COC in exceedance of the de minimis level, information must be made available to the consumer, prior to any exposure to the COC, within 12 months. This information includes the manufacturer's name, the brand name/product name, the COCs in the product, end-of-life management programs or requirements, safe handling procedures, and a website address to obtain additional information about the product, the potential adverse public health and/or environmental impacts posed by the product, and proper end-of-life disposal or management of the product. Section 69506.3.
       
    • End-of-Life Management Requirements: Finished products required to be managed as hazardous waste in California must provide the information required to be provided to consumers noted above plus state that the product must be disposed or otherwise managed as a hazardous waste at the end of its useful life. In addition, within two years of the DTSC's notice of compliance with the Final AA Report, the responsible entity must fund, establish, and maintain an end-of-life management program for the product that meets criteria specified in the regulations. Section 69506.4.
       
    • Additional Information: DTSC can require a responsible entity to provide any information supplementary to the Final AA Report if DTSC determines it is necessary to determine and ensure implementation of regulatory responses. DTSC can also require responsible entities to obtain or develop and provide to DTSC information to fill one or more information gaps identified in the Final AA Report, if DTSC determines such information is needed to evaluate the initial regulatory responses imposed for the product. Section 69506.1.
       
    • 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, 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 and is both functionally acceptable and technologically and economically feasible. Sections 69506.5, 69506.8. If DTSC issues such a notification, the responsible entity for the product at issue will have no more than one year to cease to place that product into the stream of commerce. In those circumstances, the responsible entity will also have an opportunity to revise its Final AA Report to select an alternative that does not contain a COC.
       
    • Other Regulatory Responses: Other responses that DTSC may impose include requiring engineered safety measures to control access to or limit exposure to the COC; restricting the use of the COC in the PP; requiring the responsible entity to initiate a research and development project pertinent to the PP; and requiring the development of a new AA. Section 69506.6.

Analysis

The good news is the availability of the regulations now provides a useful snapshot of where the Green Ribbon Science Panel's thinking is at following months of deliberations. The bad news is this is a cumbersome "informal draft" regulation with many definitions, criteria, and procedures. Companies with consumer products in the stream of commerce in California will need to notify DTSC that its product is a PP (or cease to enter the product in the stream of commerce in California or satisfy a de minimis exemption); perform an AA and prepare a Preliminary AA Report and Final AA Report; and comply with any regulatory responses applicable to its product or that DTSC determines are necessary. 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. DTSC provides that these responsibilities may be fulfilled by a consortium, trade association, etc., but does not provide in the regulations any conditions or criteria for how issues (e.g., formation, compensation) will be resolved.

While the potential impact of this regulation is expansive, and the initial list of COCs and initial list of PPs will be issued within 30 and 180 days of the effective date of the regulations, respectively, DTSC has noted that it anticipates the initial list of PPs will include only two to five products. In addition to opportunities now for companies to review and comment on these informal draft regulations and eventual draft regulations, the small number of products that will be subject to regulations initially may provide some opportunity for interested parties to understand how these regulations will be implemented and what changes or refinements may be needed.


 
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