Verdant Law Presents on Chemical Regulatory Framework and Implications for Product Design

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This month Verdant Law founder Phil Moffat traveled to Orlando, Florida, to present at the International Consumer Product Health and Safety Organization (ICPHSO) 2023 Annual Meeting and Training Symposium. Mr. Moffat’s presentation discussed the implications of chemical regulation for product design.

The presentation outlined recent trends in the chemical regulatory landscape, including EPA’s PFAS reporting rule, state regulations banning PFAS in children’s toys, flame retardants, and other products, and state PFAS labeling and reporting rules. The presentation discussed the risk of regrettable substitutions from both human health and environmental perspectives, as well as from a product efficiency perspective. (An example of decreased product efficiency could be removing PFAS used to waterproof a product may decrease the product’s efficiency if the replacement doesn’t repel water as well.) It also addressed risks associated with introducing multiple versions of the same product into commerce. In addition, Mr. Moffat covered risks of regulatory noncompliance, including penalties, seizures, recall, and market backlash, as well as risks of legal liability. The presentation recognized that the regulatory framework could be incredibly difficult for companies to navigate.

If you would like to view the presentation, it can be found here. For questions or assistance with regulatory compliance for consumer and industrial products, please contact Verdant Law.

California releases draft Alternatives Analysis guidance under Safer Consumer Products program.

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Today, California’s Department of Toxic Substances Control (DTSC) released the first part of draft guidance on conducting Alternatives Analysis (AA) under the state’s Safer Consumer Products (SCP) program.

The Draft Stage 1 Alternatives Analysis Guide (AA Guide) covers the first of the two stages of the AA process, which entails an initial screening of alternatives and preliminary analysis. During Stage 1, “the responsible entity identifies the goal, scope, legal, functional, and performance requirements of the Priority Product and the Chemical of Concern, and uses this information to identify an array of alternatives to consider.” At the end of Stage 1, the analysis findings, work plan, and implementation schedule are documented in a Preliminary AA Report which is submitted to DTSC.

DTSC reports that a draft guide for Stage 2 will be released in the first quarter of 2016. In Stage 2, the responsible entity follows the Work Plan approved in Stage 1 and conducts an in-depth analysis considering impacts such as life cycle and cost. This process culminates in selecting an alternative and making a regulatory response recommendation.

The Draft Stage 1 AA Guide also notes that companies have alternative compliance options to the AA process if an AA or similar comparative analysis has already been completed, or if the company prefers a different AA approach. After demonstrating to DTSC that the alternate approach is “adequate for evaluating the Priority Product and the alternatives” and “sufficiently equivalent to the AA process described in the regulations,” responsible entities may choose instead to conduct an Abridged AA or Alternate Process AA, or use a previously completed AA.

The draft AA Guide discusses in detail the following topics:

  • Product Requirements and Alternatives – including product function and performance, legal requirements, and the role of the Chemical of Concern.
  • Relevant Factors – how to use an iterative process to identify “relevant factors” used throughout the AA process to characterize, evaluate, and compare impacts of the Priority Product and its alternatives.
  • Impact Assessments – approaches, tools, and information sources a responsible entity may use to conduct analyses throughout the AA process.
  • Screening Alternatives – considerations for and approach to screening, assessing tradeoffs, and conducting limited screens.

DTSC will hold two webinars to discuss the Draft Stage 1 Alternatives Analysis Guide, on October 7 and October 21. The comment period on the Guide runs through October 23, 2015.

Alternatives Assessments for flame retardants in flexible polyurethane foam and printed circuit boards finalized.

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Yesterday, EPA released two final Alternatives Assessment reports, for flame retardants used in flexible polyurethane foam and printed circuit boards, as well as a technical correction to an alternatives assessment report on bisphenol A (BPA) in thermal paper. These reports were developed under the agency’s Design for Environment (DfE) program to characterize chemical hazards and identify safer chemicals, and continue EPA’s scrutiny of flame retardant chemicals.

The final Alternatives Assessment for flame retardants used in flexible polyurethane foam finalizes the draft update, released in June 2014, to a 2005 report on the flame retardant pentabromodiphenyl ether (pentaBDE). PentaBDE was voluntarily phased out by industry in the U.S. in 2004, and is subject to a proposed Significant New Use Rule and section 4 test rule under the Toxic Substances Control Act (TSCA) as part of the EPA’s Polybrominated Diphenyl Ethers (PBDEs) Action Plan. The final report evaluates 19 alternatives, including one non-proprietary mixture and two proprietary mixtures, and covers all upholstered consumer products containing flexible polyurethane foam, including car seats and nursing pillows. In addition, EPA released a document responding to public comments to the draft report [PDF].

EPA also finalized its Alternatives Assessment report for flame retardants in printed circuit boards used in electronic products, like computers and cell phones, and released a response to comments on the 2014 draft report [PDF]. The Alternatives Assessment was published in draft form in December 2014 as an update to a draft first released in 2008. As in the 2014 draft, the final Alternatives Assessment focuses on alternatives to tetrabromobisphenol-A (TBBPA), a commonly used halogenated flame retardant which is also the subject of a recently released TSCA Work Plan Problem Formulation and Initial Assessment. Based on a confidential study and comment submitted following the release of the 2014 draft report, the final Alternatives Assessment changed the skin sensitization designation for magnesium hydroxide from Moderate to Low. Responding to another comment, EPA elaborated on performance testing of halogen-free flame-retardant printed circuit boards, which reportedly “found that the eight halogen-free flame retardant laminates tested generally outperformed the traditional… laminate control.”

The technical correction revises a final Alternatives Assessment report for BPA in thermal paper originally released in January 2014. BPA, a high production volume (HPV) chemical, is commonly used as a developer in thermal paper, like cash register receipts. The correction changes the developmental toxicity designation of one alternative, Pergafast 201, from High to Moderate. The change is based on further analysis of new data submitted in response to the draft report.

EPA updates Alternatives Assessment for flame retardants in printed circuit boards.

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Today, EPA’s Design for the Environment (DfE) program released an updated draft Alternatives Assessment of flame retardants in printed circuit boards (PCBs) in electronics. The report [PDF] revises a draft released in 2008; according to the agency, the new report “is being released for a second public comment period because of the large amount of information added describing the combustion testing conducted between 2008 and 2012,” and to update hazard profiles to align with the 2011 DfE Hazard Assessment Criteria [PDF]. In addition, the new draft addresses comments made on the 2008 draft.

This report is the result of a partnership convened in 2006 by EPA and members of the electronics industry and other sectors to develop information to better understand materials used to provide fire safety for PCBs in electronic equipment like computers and cell phones. The report’s purpose is to provide objective information to help electronics-makers “more efficiently factor human health and environmental considerations into decision-making when selecting flame retardants for PCB applications.”

The new draft assessment provides health and environmental information on flame retardant alternatives to tetrabromobisphenol-A (TBBPA), one of the most commonly used flame retardants for printed circuit boards. Hazard profiles vary across the three categories studied: reactive flame retardant alternatives (TBBPA, DOPO, and Fyrol PMP), reactive flame retardant resins (TBBPA-based resin and DOPO-based resin), and additive flame retardant alternatives (aluminum diethylphosphinate, aluminum hydroxide, magnesium hydroxide, melamine polyphosphate, and silicon dioxide). Human health effects for all of the assessed substances varied, with a range of toxicity endpoints. In terms of environmental fate, the reactive flame retardant alternatives and reactive flame retardant resins were all rated High or Very High for persistence, although TBBPA and DOPO were rated Moderate and Low for bioaccumulation, respectively. All five of the additive flame retardant alternatives are expected to have High persistence and Low bioaccumulation potential.

The report applies “life-cycle thinking” to explore factors affecting exposure, including occupational best practices, raw material extraction, and manufacturing. Results of combustion testing experiments simulating end-of-life disposal processes are also described.

Comments will be accepted on the draft report through February 15, 2015, under docket number EPA-HQ-OPPT-2014-0893.

National Academy of Sciences propose framework on chemical alternatives assessments.

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A committee of the National Academy of Sciences’ National Research Council has released a proposal on decision-making in conducting alternatives assessments. The report, titled A Framework to Guide Selection of Chemical Alternatives and authored by the Committee on the Design and Evaluation of Safer Chemical Substitutions, also presents evaluations of existing frameworks and recommendations for implementation and future research. Suggested audiences and users of the report include regulatory agencies at every level, industry, organizations working for the adoption of safer chemicals, and developers of chemicals and chemical processes.

The recommended framework is 13 steps, with some steps and sub-steps treated as optional, and is designed for flexibility such that “certain steps are completed sequentially, in parallel, or iteratively, providing an opportunity for fit-for-purpose decision making.” The framework is summarized as follows (asterisks indicate optional activities):

  • Step 1: Identify Chemical of Concern
  • Step 2: Scoping and Problem Formulation
  • Step 3: Identify Potential Alternatives
  • Step 4: Initial Screening of Identified Alternatives
  • Step 5: Assess Physicochemical Properties
  • Step 6-1:Assess Human Health Hazards
  • Step 6-2: Assess Ecotoxicity
  • Step 6-3: Conduct Comparative Exposure Assessment
  • Step 7: Integration of Information to Identify Safer Alternatives
  • Step 8: Life Cycle Thinking
  • Step 9-1: Additional Life Cycle Assessment*
  • Step 9-2: Performance assessment*
  • Step 9-3: Economic assessment*
  • Step 10: Integrate Data and Identify Acceptable Alternatives
  • Step 11: Compare Alternatives*
  • Step 12: Implement Alternatives
  • Step 13: Research and Innovation*

The committee highlighted the following as the framework’s most important and unique elements:

  • a focus on scoping and problem formulation;
  • an increased emphasis on comparative exposure assessment;
  • increased use of physicochemical properties to assess human health and ecotoxicity hazards;
  • a two-tiered approach to evaluating chemical alternatives that includes health and ecotoxicity, followed by a consideration of broader impacts; and
  • recognition of the need for research and innovation.

EPA identifies safer alternatives for flame retardants.

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Yesterday, EPA’s Design for Environment (DfE) program released two reports on flame retardants and their safer alternatives. One report is a draft update of a 2005 Alternatives Assessment on the flame retardant pentabromodiphenyl ether (pentaBDE) in flexible polyurethane foam; the other is a final Alternatives Assessment on Hexabromocyclododecane (HBCD), a brominated flame retardant used in polystyrene building insulation. Both chemicals pose risks to human health and the environment, including “potential reproductive, developmental, and neurological effects and can be persistent, bioaccumulative, and toxic to aquatic organisms.”

PentaBDE has already been phased out of use in the U.S.; in 2004, industry voluntarily agreed to cease production and EPA issued a Significant New Use Rule (SNUR) aimed at ending the chemical’s domestic manufacture. EPA proposed another SNUR in 2012 to address imports of pentaBDE-containing furniture or other articles. EPA identified oligomeric phosphonate polyol as a safer alternative to pentaBDE. PentaBDE has also been subject to flammability standards recently proposed and finalized by the Consumer Product Safety Commission and the state of California, respectively. EPA’s updated alternatives assessment is “[complementary to] the CPSC and California actions by providing important information for informed selection of flame retardants in the manufacture of home and office furniture, as well as the many home products not covered by these standards.” The draft update provides a hazard assessment for flame retardant chemicals used in upholstered consumer products containing polyurethane foam, including updated health and environmental profiles previously profiled in 2005 and new products in the category.

EPA issued this report on HBCD as part of the agency’s action plan for HBCD under the Existing Chemicals Management Plan. Although HBCD is also used as a flame retardant in textile back coatings and high-impact polystyrene in electronics housings, the Alternatives Assessment only addresses its use in expanded polystyrene (EPS) and extruded polystyrene (XPS) foam insulation produced for the building and construction industry for fire safety. Butadiene styrene brominated copolymer was identified as a safer alternative to HBCD based on hazard considerations, with lower human health, ecotoxicity, and exposure potentials, although it is also inherently persistent due to its molecule size. Butadiene styrene brominated copolymer is regulated by its own SNUR and is commercially available from chemical suppliers, according to EPA.

EPA publishes Alternatives Assessments for DecaBDE and BPA in thermal paper.

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EPA has released final Alternatives Assessment Reports for DecaBDE and bisphenol A (BPA) in thermal paper. The assessments were developed under the agency’s Design for Environment (DfE) program to characterize the environmental and human health hazards for the substances and their alternatives, and are intended to inform substitution decisions.

DecaBDE is a flame retardant belonging to the class of polybrominated diphenyl ethers (PBDEs), and has been used in a wide range of products from textiles to building materials. EPA has been concerned that DecaBDE and related chemicals may be persistent, bioaccumulative, and toxic to humans and the environment. The Alternatives Assessment released yesterday is part of the agency’s action plan for PBDEs, which encourages industry to voluntarily phase out the manufacture and import of these chemicals. The Alternatives Assessment Report [PDF] profiles 29 alternative flame retardants with varying hazard profiles, including substances that have been use for decades as well as others that are relatively new to the market.

BPA is widely used as a developer in thermal paper, as in the case of cash register receipts. The chemical is common in manufacturing polycarbonate plastics and epoxy resins; thermal paper represents a smaller percentage of overall BPA use, but EPA is concerned that “use of BPA in thermal paper could increase cumulative human exposures and direct and indirect environmental releases of BPA.” The Alternatives Assessment Report, also part of an EPA action plan, profiles 19 potential chemical alternatives evaluated for human health effects, ecotoxicity, and environmental fate. The report did not identify a clearly safer alternative to BPA, as “most alternatives have Moderate or High hazard designations for human health or aquatic toxicity endpoints.”

BPA in thermal paper has recently come under increased scrutiny in Europe as well. Last week, France submitted a dossier to the European Chemicals Agency (ECHA) proposing to restrict the use of the substance; in August, France proposed reclassifying BPA from a category 2 reprotoxicant to category 1B.

California’s New Revisions to Proposed Safer Consumer Products Regulations Released.

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Last week, California’s Department of Toxic Substances Control (“DTSC”) released the revised proposed regulations implementing the Safer Consumer Products law. The 15-day public comment period for the revised proposed regulations is open through April 25, 2013. The revised text, as well as an underline/strike-out version showing changes from the January 2013 version, is available online.

Notably, the revisions contain several changes affecting Alternatives Analysis. The definition of “Alternatives Analysis Threshold” now means the Practical Quantitation Limit or another applicable concentration limit which DTSC may specify. Under the new provision at §69503.5(c), DTSC may set a threshold concentration in a proposed or final Priority Products list for any Chemical of Concern that is an “intentionally added ingredient.” Under this provision, DTSC may also specify a threshold concentration higher than the Practical Quantitation Limit for any Chemical of Concern that is a contaminant. In addition, the revised regulations move the requirement for identifying factors relevant to comparing a Priority Product and alternatives (such as adverse public health impacts or physical chemical hazards) from the second to the first step of the Alternatives Analysis process. The new § 69505.8 provides that Final Alternatives Analysis Reports will now be subject to a public comment period, instead of the Preliminary Alternatives Analysis Report. The responsible entity will not be required to respond to all public comments, but instead will only have to address issues identified by DTSC upon review of the comments in an “AA Report Addendum.”

The revised proposed regulations change the definitions of several other key terms. The definition of “assemble” was revised to clearly specify repair and maintenance activities, and “manufacturer” now means anyone who “specifies the use of chemicals to be included in the product,” rather than anyone who has the capacity to do so. “Reliable information” has been re-defined to include only information that could be considered “scientific.” The definition also now specifies that the information must meet certain criteria – such as publication in a scientifically peer reviewed report or by a government agency “that implements laws governing chemicals” – which under the previous version were only considered as indicators of a study’s trustworthiness.

In addition, the revisions removed the provision requiring manufacturers to compensate retailers participating in any end-of-life collection program. In its summary of changes [PDF], DTSC states that these costs will instead be addressed by agreements between manufacturers and retailers.

For more information about California’s Safer Consumer Products Regulations, contact Verdant Law.

IC2 Releases Draft Risk Reduction/Safer Alternatives Guidance

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The Interstate Chemicals Clearinghouse (IC2) has released a draft guidance document for alternatives assessment and risk reduction.  The public comment period continues through Friday, May 3, 2013.

The IC2 is an association of state and local governments working together to coordinate inter-agency efforts promoting the use of safer chemicals and products.  Of the member states, only California currently has a robust green chemistry program. The draft Guidance for Alternatives Assessment and Risk Reduction was developed with technical support from EPA’s Design for the Environment and Clean Production Action.

The Guidance is designed to meet the needs of a wide range of users.  Principles instrumental to developing the Guidance include:

  • reducing risk by reducing hazards,
  • transparency, and
  • life cycle thinking.

The IC2 emphasizes that through life cycle thinking, users can avoid merely shifting impacts from one aspect of the product life cycle to another.  The Guidance observes that only in rare instances will no safer alternatives be available.

The Guidance includes four scoping modules to help users set parameters for the scope of the alternatives assessment process and seven decision modules to evaluate criteria, ranging from performance to hazard and materials management to cost and availability.  Within each module, users can select the level of complexity and corresponding data requirements appropriate to their needs and capabilities.  For example, criteria in the performance module include measures that test whether potential alternatives are technically feasible.  The Guidance also provides mechanisms to identify uncertainties and consider them in the decision-making process.

EU Commission Releases Roadmap on Substances of Very High Concern

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EU REACH Substances of Very High Concern:

Last week, the EU Commission released its Roadmap on Substances of Very High Concern (SVHC). The Roadmap outlines a process for identifying and assessing potential SVHCs within the following categories: substances that are carcinogenic, mutagenic or toxic for reproduction (CMRs); substances that are persistent, bioaccumulative or toxic for the environment (PBTs); substances that are very persistent and very bioaccumulative (vPvBs); and substances of equivalent concern, such as endocrine disruptors. The Roadmap estimates that the process will evaluate up to 440 substances, a far lower number than the 1,900 substances originally anticipated, with an initial goal of completing 80 assessments by the end of 2014.

The Roadmap follows the Commission’s commitment to compile a comprehensive REACH candidate list of SVHCs and is designed to help meet the Commission’s plan to include all currently known SVHCs on the candidate list by 2020.

The SVHC Roadmap proposes first screening substances with REACH registration dossiers by applying a minimum quantity threshold and generally exempting substances registered only for intermediate uses. The second step entails conducting a “Risk Management Options” (RMO) analysis. Under this approach, the best regulatory option to manage a particular risk is chosen after considering actions available within REACH (like imposing authorization, restriction or substance evaluation requirements) or under other legislative schemes, such as RoHS. For example, the Roadmap suggests that substances with demonstrated risk should be restricted under REACH.

The roadmap is downloadable as a PDF from the EU website.