Regulatory Developments

DTSC Issues Guidance to Companies on How to Prepare Alternative Analysis under the Safer Consumer Products Regulations

October 1, 2015 PRINT

California's Department of Toxic Substances Control (DTSC) released for comment its Draft Stage 1 Alternatives Analysis Guide (Draft AA Guide). Under the Safer Consumer Products Regulations (SCPR), responsible entities (generally, manufacturers) must perform an AA for the listed Chemical of Concern (COC) and Priority Product (PP) combination 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 SCPR, before the Initial PP List is issued in final, DTSC must make available on its website guidance materials to assist persons performing AAs.

DTSC is accepting comments on the Draft AA Guide until October 23, 2015. DTSC also is holding two webinars on October 7, 2015, and October 21, 2015, to learn about and discuss the Draft AA Guide.

Guidance

Under the Regulations, AAs must be conducted in two stages. The Draft AA Guide relates only to the first stage of the AA process. Below we describe the major steps in Stage 1 and what the Draft AA Guide provides to assist responsible entities in completing each step.

  • Identify the PP's Requirements: Under the Regulations, the first step is for the responsible entity to: (1) identify the PP's functional, performance, and legal requirements that must be met for any potential alternative; (2) identify the role of the COC in meeting the PP's function, performance, and legal requirements; (3) determine if the COC or any alternative replacement chemical is "necessary" to meet the PP's identified requirements; and (4) if the COC or any alternative replacement chemical is not "necessary," evaluate removal of the COC from the PP.
     
    The Draft AA Guide provides the following guidance related to this part of the AA:
     
    • Identify Functional Requirements: DTSC describes a product's "function" as the service or utility the product provides. When defining function, DTSC asks responsible entities to consider the following:
       
      1. The purpose or utility of the product itself or the service provided by the product; the task that the product performs. Be as specific as possible.
         
      2. The conditions, such as temperatures or light exposure, under which the task, or function, must be performed. These conditions may restrict the alternatives that perform effectively under the particular conditions.
         
      3. The extent or duration of the function or service, expressed in use frequency or time frame, such as service life.
         
    • Identify Performance Requirements: DTSC describes performance as one of the measures of how well a product carries out its functions. DTSC states: "Performance requirements typically include criteria for the minimum acceptable performance of a product, and specify methods to assess these criteria, either qualitatively or quantitatively." When defining performance, DTSC asks responsible entities to consider the following:
       
      1. The desired result expected from the product. For example, a surface disinfectant must prevent bacteria from growing when left on a surface for the specified time.
         
      2. The efficacy of the product. In the disinfectant example, efficacy may refer to preventing test bacteria from growing in 59 out of 60 samples.
         
      3. The compatibility of the product with different substrates.
         
      With regard to performance measurements, consumer requirements and market expectations, DTSC states the following:
      During the AA, when evaluating potential alternatives, a responsible entity may consider if the product would remain marketable if its array of attributes or standards changes. Some responsible entities may elect to educate consumers about the benefits of any changes and as a result, consumers may accept such changes if they are aware of the value of a safer product. Although the Department acknowledges the importance of consumer acceptance, the Department will consider how a responsible entity justifies that a viable alternative was not selected because of consumer resistance by describing how it measured consumer acceptance. For example, the Department will be interested in the relevant questions that responsible entities ask consumers to determine acceptance.
    • Identify Legal Requirements: DTSC describes a product's legal requirements as "the specific requirements, performance standards, or labeling requirements that a chemical, product, or product packaging must meet under federal or California law." DTSC clarifies that legal requirements can include technical standards specified in laws or regulations (e.g., restrictions on the concentration of lead and cadmium in children's products in California requirements).
       
    • Identify the Role of the COC and Its Necessity in the PP: Determining the role the COC plays in the PP and its necessity in such product are important determinations in the Stage 1 AA process, as a decision that a COC is necessary must be documented in the AA report, while a decision that a COC is not necessary requires further analysis whether the COC can be eliminated or removed from the PP. DTSC poses the following questions for consideration on the role and necessity of a COC in a PP:
       
      1. Why is the Chemical of Concern used in this specific application?
         
      2. Is the Chemical of Concern necessary for the Priority Product's function?
         
      3. Does the Chemical of Concern contribute specific product characteristics needed to meet performance requirements?
         
      4. Will the quality or necessary features of the product be affected if the Chemical of Concern is reduced or eliminated?
         
      5. Are there characteristics imparted by the Chemical of Concern to the Priority Product that are required to meet legal requirements?
         
      If the COC appears unintentionally in a product (e.g., trace byproduct, contaminant), DTSC states that the responsible entity "should always search for ways to eliminate or reduce the contaminant chemical, such as seeking different chemical sources or specifying higher purity ingredients."
       
  • Identify Alternatives: Under the Regulations, the responsible entity must identify alternative(s), defined to include: (1) removal of a COC from a PP with or without use of one or more replacement chemicals; (2) reformulation or redesign of a PP and/or manufacturing process to eliminate or reduce the concentration of a COC in a PP; (3) redesign of a PP and/or manufacturing process to reduce or restrict potential exposures to COC(s) in a PP; or (4) "[a]ny other change" to a PP or manufacturing process that reduces the potential adverse impacts and/or potential exposures associated with a COC in the PP.
     
    In the Draft AA Guide, DTSC provides the following list of questions to assist responsible entities identify alternatives:
     
    1. Are there similar products offered for sale that use a safer alternative?
       
    2. Do other manufacturers advertise their product as free of the Chemical of Concern? What alternative was used?
       
    3. Do chemical manufacturer(s) offer alternatives to the Chemical of Concern? Is an alternative listed on a manufacturer's website?
       
    4. Are there publications from trade journals or input from trade associations, technical articles, or other sources of information that identify potential alternatives?
       
    5. Does the chemical supplier offer an alternative?
       
    6. Does the chemical supplier's competition offer an alternative?
       
    7. Are there safer alternatives identified in online, internet sources?
       
    8. Have other AAs identified possible alternatives associated with similar use functions?
       
    9. Have state, local, federal or international organizations identified alternatives?
       
    10. Are there technical resources that identify chemicals or materials or design changes with similar or equivalent functionality?
       
    11. Can changes potentially be made to the manufacturing process or product design to allow the use of the alternative?
       
    Appendix 2 of the Draft AA Guide also provides a useful list of sources that may be used to help identify alternatives.
     
  • Identify Factors Relevant for Comparison of Alternatives: Under the Regulations, the responsible entity must identify "relevant" factors and use available quantitative information and analytical tools, supplemented by available qualitative information and analytical tools, to identify certain factors that are relevant for the comparison of the PP and the alternatives under consideration.
     
    In its Draft AA Guide, DTSC states that a potential factor becomes relevant if it fulfills both of two requisite criteria:
     
    • The factor makes a material contribution to adverse public health impacts, adverse environmental impacts, adverse waste and end-of-life impacts, or materials and resource consumption. This relates to a factor that is both meaningful and consequential to an observed outcome or impact.
       
    • There is a material difference in the factor's contribution to the impacts between the Priority Product and one or more of the alternatives under consideration. This relates to a factor's contribution to an observed impact that is both meaningful and consequential to the comparison of alternatives.
       
    The Draft AA Guide provides the following list of potential regulatory factors requiring consideration in the first AA stage, with particular focus on identifying and incorporating associated exposure pathways and life cycle segments:
     
    • Adverse environmental impacts
    • Adverse public health impacts
    • Adverse waste and end-of-life effects
    • Environmental fate
    • Materials and resource consumption
    impacts
    • Physical chemical hazards
    • Physicochemical properties
    • Associated exposure pathways and life cycle segments

     
    Appendix 3-1 provides a list of factors for consideration in the AA while Appendix 3-2 provides some potential useful checklists with questions for responsible entities to consider when identifying relevant factors, and asking entities to determine if any factor may be relevant and thus requiring further analysis, or the reason why a factor is not believed to be relevant. DTSC states: "With the large number of hazard traits specified in the SCP regulations and a number of potentially relevant factors to consider, the impact assessments can quickly become complex depending upon the number of alternatives and factors identified." [Citation omitted.] In such cases, DTSC states that an iterative approach can help make the analysis more manageable.
     
    With regard to data gathering, DTSC provides lists of sources and guidance on obtaining information from specific sources, including reference volumes (e.g., The Merck Index (Merck, 1989)), compiled data summaries (e.g., National Institute for Occupational Safety and Health (NIOSH) Pocket Guide to Chemical Hazards), authoritative lists providing a summary of traits or additional detail about a chemical or its listing (e.g., Prop 65), available electronic databases and portals (e.g., ToxRefDB), literature searches, propriety data, and modeling tools (e.g., ToxCast).
     
  • Evaluate and Screen Alternative Replacement Chemicals: Under the Regulations, the responsible entity must use "available quantitative information and analytical tools, supplemented by available qualitative information and analytical tools, to evaluate and compare each of the alternative replacement chemicals under consideration with the Chemical(s) of Concern in the Priority Product."
     
    In the Draft AA Guide, DTSC states: "A screening approach may take a number of different forms, from a sequential comparison of select factors to a complex simultaneous analysis of multiple factors, with many interim grading schemes in between."
     
    DTSC states a determination that an alternative is inferior to a PP can be made where the responsible entity finds that the alternative:
     
    • Exhibits a greater adverse impact to air quality, ecological, soil quality, or water quality.
       
    • Exhibits a greater impact from toxicological hazard traits such as carcinogenicity, developmental toxicity, reproductive toxicity, cardiovascular toxicity, dermatotoxicity, endocrine toxicity, epigenetic toxicity, genotoxicity, hematotoxicity, hepatotoxicity, immunotoxicity, musculoskeletal toxicity, nephrotoxicity, ocular toxicity, ototoxicity, reactivity in biological systems, or respiratory toxicity.
       
    • Generates more material waste or byproducts during its life cycle.
       
    • Is more persistent in the environment, as determined by its environmental fate characteristics.
       
    • Creates a greater consumption burden on society by using a larger volume or amount of renewable and nonrenewable resources throughout its life cycle.
       
    • Poses a greater handling danger, as indicated by its physical chemical hazards.
       
    • Poses a greater reactive or flammability hazard, as indicated by its physicochemical properties.
       
    While acknowledging that the process of making trade-offs and the choice among alternatives is one of the "most difficult aspects" and "likely subjective," DTSC does not provide significant guidance, instead stating only that the responsible entity "must describe in the AA Report all of the assumptions and rationale for the decisions and trade-offs so the Department understands these choices."
     
  • Consider Additional Information: The responsible entity may consider other relevant information and data not specifically identified above. A responsible entity "may eliminate an alternative from further consideration based on the additional factors and information as long as the reason for its elimination is explained in the Preliminary AA Report and there are alternatives remaining to be evaluated in the second AA stage." The Draft AA Guide notes that responsible entities may consider other factors such as economic impacts and performance, but does not discuss these issues in any detail. It appears instead that these issues will be discussed in future chapters related to Stage 2 of the AA process.
     
  • Prepare Preliminary AA Report: Under the Regulations, the responsible entity must prepare the Preliminary AA Report and develop a work plan and implementation schedule for completion of the second AA stage and preparation and submission of the Final AA Report.
     
    The Draft AA Guide at Appendix 1 provides a summary of all the elements required in the Preliminary AA Report.

Commentary

Although DTSC states repeatedly that the Draft AA Guide is an "advisory" resource and not a regulatory document or legal standard, it is nevertheless an important blueprint for how responsible entities are to conduct Stage 1 of the AA. From the discussion above, it should be clear that DTSC has provided many open-ended questions and points for consideration in lieu of more constructive templates or guidance on what DTSC will be looking for and evaluating when it reviews the first Preliminary AA Reports. To some extent, DTSC had little choice in how it presents its guidance considering the sweeping factors to be evaluated and the broad array of products that can be identified as PPs. The Appendices arguably provide more useful information with resources and checklists to ensure responsible entities consider the array of factors necessary to produce an acceptable AA report.

Companies should review the Draft AA Guide carefully and consider submitting comments to ensure the final AA Guide provides accurate and useful information when conducting AAs and preparing AA reports. Even companies that may not consider themselves to be "responsible entities" under the Regulations may still be impacted by the Draft AA Guide. DTSC, for example, discusses the possibility of responsible entities using the results of proprietary research that are summarized in public sources but does not discuss the possibility that reliance on such data summaries can create data compensation obligations.

DTSC is accepting comments on the Draft AA Guide until October 23, 2015. DTSC also is holding two webinars on October 7, 2015, and October 21, 2015, to learn about and discuss the Draft AA Guide.


 
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