DTSC Approves Preliminary Report on 6PPD Alternatives

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This August, the California Department of Toxic Substances Control (DTSC) approved a revised stage 1 alternatives analysis report for 6PPD (CASRN 793-24-8) from the U.S. Tire Manufacturers Association (USTMA).  The preliminary report identified seven potential 6PPD alternatives for use in tires, which will be further assessed in the stage 2 alternatives analysis report due in August 2026.

6PPD, or N-(1,3-Dimethylbutyl)-N’-phenyl-p-phenylenediamine, has been used as an anti-degradant in tires since about the 1950s.  In 2020, it was discovered that 6PPD has a transformation product, 6PPD-quinone, that is extremely toxic to salmon and other aquatic species.  According to USTMA’s website, the organization “is not aware of any new motor vehicle tires available today that do not contain 6PPD.”

The seven potential 6PPD alternatives identified by the preliminary report are 7PPD, IPPD, 77PD, CCPD, specialized graphene, octyl gallate, and Irganox 1520, selected based on available information on potential hazards, performance, and chemical and physical properties indicative of exposure potential.  7PPD, IPPD, 77PD, and CCPD come from the same chemical family as 6PPD.  Eliminating the use of 6PPD without replacement is not an option, according to the preliminary report.

The stage 2 alternatives analysis will include a “more in-depth evaluation of hazard and exposure potential,” including additional evaluation of potential transformation products.  “At the end of [stage 2], we are optimistic that we will have identified one or more possible alternatives that hold promise to replace or materially reduce 6PPD in motor vehicle tires,” the preliminary report states.

The initial report was revised due to a notice of deficiency issued by DTSC, which was described by USTMA as “a standard step in the alternatives analysis process” that allows “regulators to provide suggestions and seek clarification about certain parts of a preliminary submission.”  Octyl gallate and Irganox 1520 were added to the list of potential alternatives in the revised report.

DTSC added 6PPD to the list of Priority Products under California’s Safer Consumer Products Program effective October 2023, prompting the alternatives analysis.  The following month, EPA granted a Toxic Substances Control Act citizen petition requesting that EPA take action to prohibit its use in tires.  EPA has since proposed a data call for substances including 6PPD-quinone, discussed in a previous blog post.

Microplastics and PPD Derivatives Proposed for Regulation in California

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California state regulators recently announced plans to potentially regulate two additional groups of chemicals under the state’s Safer Consumer Products Program (“SCP”). The California Department of Toxic Substances Control (“DTSC”) has proposed adding microplastics and para-Phenylenediamine (“PPD”) derivatives to its Candidate Chemicals List (“CCL”) due to their reported impacts on human health and the environment. Regulators are beginning a public comment process in the hopes of gathering valuable input and feedback from stakeholders to help inform a potential regulatory proposal.

Scientific evidence has been growing regarding the harmful effects of microplastics on both human health and the environment. These minuscule plastic particles, released directly or through the breakdown of larger plastic items, persist and spread throughout the ecosystem. DTSC detailed this issue and identified products that release microplastics into the environment as one of their top five policy priorities in the 2021-2023 Priority Product Work Plan.

PPD derivatives, a family of chemicals widely used in various industrial applications, have also come under scrutiny. Specifically, 6PPD, a member of the PPD derivative family, is extensively used in motor vehicle tires to prevent degradation over time. DTSC is finalizing regulations to include motor vehicle tires containing 6PPD on its Priority Product List. This regulation will require tire manufacturers to identify and assess potential alternatives to 6PPD that ensure tire safety and performance. By adding the entire PPD derivative class to the CCL, manufacturers will be prompted to thoroughly evaluate the tradeoffs involved before switching from 6PPD to another PPD derivative.

Adding chemicals to the CCL does not automatically impose new requirements. Instead, it enables the SCP Program to select consumer products containing these chemicals for evaluation and potential regulation as Chemicals of Concern in Priority Products.

Public workshops are scheduled for June and July, providing an opportunity for interested parties to contribute to the discussion and share their expertise. Information on the upcoming workshops can be found here.

California Department of Toxic Substances Hosted Engagement Sessions on Sustainable Chemistry Definition

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The California Department of Toxic Substances Control (CDTSC) hosted two engagement sessions encouraging stakeholders to share their perspectives on an actionable definition of sustainable chemistry that was provided by the Expert Committee on Sustainable Chemistry (ECOSChem). ECOSChem is a 20-person group including representatives from academia, government, industry, and non-governmental organizations.  The group has been tasked with establishing “an ambitious, actionable definition and criteria for sustainable chemistry that can enable effective government policy, inform business and investor decision making, enhance chemistry education, and spur the adoption across all supply chains of chemicals that are safer and more sustainable.”

In its draft, ECOSChem defined sustainable chemistry as “the practice and application of chemistry that eliminates negative impacts to humans and ecosystems, as well as benefits current and future generations.” The definition was drafted with five criteria in mind (1) health and safety through hazard elimination, (2) climate and ecosystem impacts, (3) circularity, (4) equity and justice, and (5) transparency. In addition to the definition, , ECOSChem provided the following indicators of what sustainable chemistry will look like:

A sustainable chemical, material, process, or product will…

  • Eliminate all associated hazards and hazardous emissions to all people and ecosystems across its existence.
  • Not result in releases, including releases of byproducts or breakdown products, that negatively persist or bioaccumulate.
  • Eliminate impacts on climate and biodiversity by utilizing earth-abundant, non-toxic chemical building blocks that minimize habitat and resource degradation, greenhouse gas emissions, carbon footprints, and energy consumption, including for transportation and distribution.
  • Be designed to have [a] lifetime appropriate for its use and enable safe reuse and non-toxic recycling.
  • Prioritize resource and energy conservation and reclamation, reduce consumption of finite resources, and waste prevention, minimization, and elimination.
  • Be designed such that all associated negative social impacts are eliminated.
  • Be made or implemented to prioritize the remediation of harms for communities and societies that have been disproportionately impacted by traditional chemistries, chemicals, and chemical processes, and/or support the needs of workers, marginalized groups (e.g., immigrant communities, and communities of color), and vulnerable groups (e.g., pregnant women and children).
  • Be made or implemented in a way that does not create new problems or shift harm to other communities or societies.
  • Have had its health, safety, and environmental data disclosed in an accessible format to individuals, workers, communities, policymakers, and the public.
  • Use independent, third-party systems to verify sustainability, health, safety, and other claims. The sources for verification should be openly accessible.

ECOSChem members will use the feedback received at the meeting to revise the definition to ensure that the language is clear and actionable.

 

 

 

 

California Issues Expanded Draft Priority Product Workplan

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The California Department of Toxic Substances Control (DTSC) recently issued a Draft Three-Year Priority Product Work Plan (2018-2020) under the state Safer Consumer Products program (also known as the “green chemistry” program). The draft Work Plan would supersede the current plan adopted in 2015, and lists the categories of products that DTSC intends to investigate under the program for the next three years. Public comments on the draft Work Plan will be accepted until March 9.

The new draft Work Plan includes seven product categories. Five were carried over from the prior Work Plan: (1) beauty, personal care and hygiene products; (2) cleaning products; (3) household, school and workplace furnishings; (4) building products and materials used in construction and renovation; (5) consumable office, school, and business supplies. The two new categories proposed are food packaging and lead acid batteries.

The Work Plan does not specifically identify any product as a regulatory priority, but identifies categories from which DTSC will propose future priority products. DTSC is limited to regulation of products within these categories, except for other products identified by legislation, Executive Order or a petition to DTSC that has been granted.

In investigating potential priority products, DTSC intends to solicit information from manufacturers and their supply chain partners as well as trade associations and others with relevant expertise. They also may make targeted information requests to specific industry sectors; gather information through public workshops and comment periods; and issue “information call ins” as described in the state regulations. This information would be available to the public except for trade secrets protected by the regulations. DTSC expects to engage in discussion with industry experts about product formulations, supply chain considerations, and industrial toxicology studies among other topics that can expand and refine their knowledge for the purposes of selecting priority products.

Draft Alternatives Analysis Guide released for California’s Safer Consumer Products program.

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On Monday, the California Department of Toxic Substances Control (DTSC) released a draft version of its Alternatives Analysis Guide, a document that will be critical to the implementation of the state’s Safer Consumer Products (SCP) program. Once finalized, the Guide will provide a framework and steps to help responsible entities (the manufacturers, importers, assemblers, and retailers of designated “Priority Products”) conduct an “Alternatives Analysis,” as required by the SCP regulations.

Under the SCP program, each Alternatives Analysis will look at how to best limit or prevent potential harm from the potentially hazardous “Candidate Chemical” in Priority Products. Every Alternatives Analysis must consider important impacts of the product throughout its life cycle and provide for specific actions to make the product safer.

After receiving and approving a final Alternatives Analysis report, DTSC will implement Regulatory Responses which favor the safest feasible alternatives. These actions may take the form of enforceable orders or agreements requiring further manufacturer research, additional information to DTSC or consumers, product redesign, end-of-life product stewardship, or sales restrictions or prohibition.

The draft Alternatives Analysis Guide provides information about the general process of conducting an Alternatives Analysis and is meant to be a “resource book” for people preparing Alternatives Analyses. The Guide provides methods, tools, information sources, and “best practice approaches” for conducting an Alternatives Analysis, and is expected to be updated periodically. The Guide is not a “regulatory document” or standard, nor is it meant to be used as a checklist.

In September 2015, DTSC released a Draft Stage 1 Alternatives Analysis Guide and scheduled the release of Stage 2 guidance for 2016. Stage 1 of the Alternatives Analysis process will begin with identifying product requirements and chemicals of concern, alternatives, and factors for comparing alternatives. Then, responsible entities will conduct an initial evaluation and screening of alternative replacement chemicals. Stage 1 culminates in the submission to DTSC of the Preliminary Alternatives Analysis Report, including a Work Plan.

After the preliminary report is approved, Stage 2 begins with executing the Work Plan and conducting an in-depth analysis that includes life cycle and economic effects. After an iterative evaluation and comparison process, the responsible entity will select an alternative, based on the information and conclusions generated through the comparative analysis, and recommends a regulatory response. Finally, the responsible entity must submit a Final Alternatives Analysis Report, including an implementation plan and timeline, if applicable. This final report will be available for public review and comment before DTSC makes any determination about regulatory responses.

The draft Guide released this week covers both stages of the Alternatives Analysis process. New chapters of the draft Alternative Analysis Guide, addressing the steps in Stage 2, are as follows:

  • Exposure
  • Life Cycle Impacts
  • Economic Impacts
  • Informational Needs
  • Selection of Alternatives
  • Self-Evaluation

DTSC is accepting public comments on the draft Alternatives Analysis Guide through January 20, 2017. The agency has also scheduled a public webinar to present and discuss the draft on January 10, 2017.

California’s Department of Toxic Substances Control is Seeking Collaboration on the Next Round of Products

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The Safer Consumer Products (SCP) program, under CA’s Department of Toxic Substances Control (DTSC), is using a four-step process to reduce toxic chemicals in products that consumers buy and use. One of these steps includes developing Priority Products, which are products that contain one or more Candidate Chemicals. The DTSC is now seeking stakeholder engagement for implementing its Priority Product Work Plan (PPWP) in a webinar, scheduled for November 15. 2016 from 10:30am- 12:00pm PST.

The webinar will provide an overview of DTSC’s progress towards Priority Product selection. The webinar will also focus on three topics, which the DTSC would like stakeholder engagement in:

  • Potential aquatic impacts and continued uses of nonylphenol ethoxylates (NPEs) and triclosan,
  • Nail products, and
  • Perfluoroalkyl and polyfluoroalkyl substances (PFASS) in carpets, rugs, upholstered furniture, and their care and treatment products.

Potential Aquatic Impacts and Continued Uses of Nonylphenol Ethoxylates and Triclosan:

This category contains chemicals that may adversely impact aquatic resources, or that have been observed through water quality monitoring. SCP identified NPEs, triclosan, and some of their transformation products as Candidate Chemicals that may warrant further research. A Candidate Chemical as a chemical that exhibits a “hazard trait and/or an environmental or toxicological endpoint” and is either: 1) found on one or more of the authoritative lists specified in Section 69502.2(a) of the regulations; or 2) listed by DTSC using the criteria specified in Section 69502.2(b). SCP would like to better understand the presence of these Candidate Chemicals in the aquatic environment, and would like current product use information for these Candidate Chemicals in cleaning, personal care, and clothing products.

Nail Products:

Nail salon workers have daily exposure to a variety of hazardous chemicals in nail products. Additionally, nail products in salons and at home are used by potentially sensitive subpopulations such as pregnant women and children. Three key questions being explored for this topic are:

  • What are the potentially hazardous chemicals present in nail products?
  • Why are these potentially hazardous chemicals being used in nail products?
  • What alternative chemicals are being used including products marketed as green, safer, or free of specific chemicals?

PFASS in Carpets, Rugs, Upholstered Furniture, and Their Care and Treatment Products:

DTSC is concerned about the hazard traits of PFASs and their widespread presence in the environment, humans, and other living organisms. Carpets, rugs, and upholstered furniture treated with PFASs for stain-, soil-, oil-, or water-resistance, as well as their PFASs-based care and treatment products, are potential long-term sources of widespread human and ecological exposures to this class of chemicals. DTSC is requesting public input to better understand:

  • The exposure potential from the use of PFASs in these consumer products, and
  • The hazard traits of short-chain PFASs, fluorinated ethers, and other “novel” PFASs.

First Priority Products listing proposed under CA’s Safer Consumer Products program.

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Today, California’s Department of Toxic Substances Control (DTSC) announced that the comment period is now open for the first Priority Product listing regulation under the state’s Safer Consumer Products (SCP) program. The proposed regulation would establish a Priority Products list containing one item: children’s foam-padded sleeping products containing tris(1,3-dichloro-2-propyl) phosphate (TDCPP) or tris(2-chloroethyl) phosphate (TCEP). Both substances, which are used as flame retardants, are known to the state of California as carcinogenic and are associated with various other hazard traits, including genotoxicity, neurotoxicity, and reproductive toxicity. TDCPP and TCEP are described in the proposal’s accompanying Technical Report [PDF] as “easily released to indoor and outdoor environments” and “ubiquitous,” having been detected worldwide in homes, offices, and daycare centers, as well as in waterways, wildlife, and human breast milk.

The proposed listing encompasses products designed for children, toddlers, babies, or infants to nap or sleep on that incorporate polyurethane foam mats, pads, or pillows that contain TDCPP or TCEP. This includes, among other products: nap mats, soft-sided portable cribs, play pens, bassinets, co-sleepers, and baby or toddler foam pillows. The listing specifically excludes:

  • mattresses “as defined and covered by the requirements of CPSC 1632/1633”;
  • furniture regulated under California Technical Bulletin 117-2013; and
  • “[a]dd-on child restraint systems for use in motor vehicles and aircraft that are required to meet federal flammability standards.”

This is the first of three Priority Products that DTSC originally proposed, in draft form, more than two years ago. DTSC will list the other two Priority Products – spray polyurethane foam (SPF) systems containing unreacted diisocyanates and paint/varnish strippers and surface cleaners containing methylene chloride – through separate rulemaking proposals. Based on the Priority Products Work Plan released last year, the agency will identify as many as five additional Priority Products, drawn from the seven product categories ranging from Cleaning Products to Clothing, in 2016 and 2017.

The comment period runs through August 29, 2016. Once finalized, the Priority Products listing triggers the requirement that manufacturers submit a Preliminary Alternatives Analysis Report within 180 days after the effective date of the regulation.

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.

California’s Safer Consumer Products program finalizes Priority Products Work Plan.

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Last week, California’s Department of Toxic Substances Control (DTSC) released its final 2015-17 Priority Product Work Plan outlining the agency’s policy priorities and product categories to be evaluated over the next three years. The Work Plan implements the Safer Consumer Products program, the part of California’s Green Chemistry Initiative that serves to “accelerate the quest for safer products.” In its final form, the Work Plan retains the same seven product categories as were included in the draft Work Plan released in September, although DTSC made changes like adding example products and clarifying or modifying the scope of certain categories.

Selected changes from the draft to final versions of the Work Plan include:

  • Beauty, Personal Care, and Hygiene Products – Sunscreen added as an example in this category.
  • Building Products – Carpet padding added as an example in this category, and nomenclature-related changes (“engineered wood,” “plywood subfloors,” and “compressed wood flooring products,” are now “Engineered Wood and Laminate Flooring” and “Plywood and OSB Subflooring.” The Work Plan’s list of changes from the Draft Work Plan also includes “insulation” and “wall coverings with flame retardants” as examples included in this category, although they are not actually discussed in the category’s narrative description or table of example products.
  • Household, Office Furniture and Furnishings – Curtains added as an example in this category. DTSC also adds that this category constitutes a subset of the Global Product Classification (GPC) standard segment “Household/Office Furniture/Furnishings,” which is divided into three families: “Fabric/Textile Furnishings,” “Household/Office Furniture,” and “Ornamental Furnishings.”
  • Cleaning Products – Surface cleaners and wax removers added as examples in this category.
  • Clothing – DTSC now states that it “will exclude consideration of protective wear intended exclusively for occupational safety.” In addition, chlorinated paraffins, halogenated compounds, and organophosphates – all flame retardants – were removed from the table of potential candidate chemicals in clothing products.
  • Fishing and Angling Equipment – DTSC has clarified the scope of this category, specifying that the agency is “most concerned about fishing weights and gear that might be consumed by water fowl due to characteristics of size, shape and density,” and thus will not consider large weights used in off-shore salmon fishing.
  • Office Machinery (Consumable Products) – The product example “Specialty paper” is narrowed down to thermal paper, while “Printer inks” is now ink cartridges.

DTSC stresses that the Work Plan is only “the first step in identifying the next set of Priority Products.” The Work Plan does not identify specific Priority Products or Chemicals of Concern, nor does it establish any new compliance requirements. Rather, the Work Plan is intended to help DTSC “move from these broad [product] categories to specific product-chemical combinations that warrant consideration as potential Priority Products.” Moreover, the Plan is meant to provide “a level of predictability to potential manufacturers, importers, retailers, and other stakeholders.”

According to the Work Plan, the number of Priority Products to be identified in 2015 “will likely be as many as three,” the same number as was announced in 2014. DTSC anticipates ramping up to more than five products in 2016 and 2017.

The Work Plan covers January 2015 through December 2017, and will be updated in 2017 with the next Work Plan, covering 2018 through 2010. However, DTSC could be required to revise this Work Plan before its expiration in the case of two scenarios: if instructed to take action on a particular chemical, product, or product-chemical combination by legislative mandate or executive order; or if the agency grants a petition to add a product-chemical combination to the Priority Products list.

DTSC encourages stakeholders to stay engaged with the Safer Consumer Products program through its “newly enhanced information management system,” CalSAFER. The system facilitates reading or writing comments on proposed regulations, filing petitions, and submitting other documents to DTSC.

California extends comments period on Safer Consumer Products draft Work Plan.

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Yesterday, the California Department of Toxic Substances Control (DTSC) made a series of announcements related to the Safer Consumer Products program. DTSC is extending the comments period for the Safer Consumer Products draft Priority Products Work Plan, and will now accept comments on the draft Plan until October 21.

DTSC also announced that its Candidate Chemicals database and downloadable list have been updated. The update reflects changes made in authoritative lists, such as the IARC (International Agency for Research on Cancer) carcinogens monographs.

In addition, DTSC invites the public to attend the next meeting of the Green Ribbon Science Panel. The Panel will convene on October 20-21 in Sacramento to “discuss and advise DTSC on evaluating Product Categories identified” in the draft Work Plan as well as alternative analysis topics. DTSC has posted the meeting’s agenda [PDF] and supporting documents including discussion topics for the draft Plan [PDF] and an Alternatives Analysis Guidance Document Synopsis [PDF].