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Safer Consumer Products Program – Six Year Prioritization Retrospective Introduction The Safer Consumer Products Program was created in the spring of 2013, five years after California’s green chemistry law was signed. Its 27 staff and managers were charged with implementing the four-step process laid out in the Department of Toxic Substance Control’s (DTSC) not-yet-finalized framework regulations. Even before the regulations took effect on October 1 of that year, SCP’s newly-formed Chemical and Product Evaluation Team (CPET) was already at work, evaluating several dozen product-chemical combinations suggested to us by other departments and non-governmental organizations (see supporting doc 1.1.2). CPET needed to work fast to meet a deadline DTSC had imposed on itself in the framework regulations: to make its “initial proposed Priority Products list available for public review and comment … no later than 180 days after …” the regulations took effect. SCP released Priority Product Profiles for three product-chemical combinations in March of 2014 when it announced its proposed Initial Priority Product List. Each profile defined the product being proposed for listing, discussed the chemical’s properties, and laid out DTSC’s rationale for designating the combination as a Priority Product. The program held a series of public workshops in May and June of that year to discuss its findings and unanswered questions. The First Priority Product Work Plan In April of 2015, after a public comment period, DTSC finalized and published its first Priority Product Work Plan. The work plan identified seven product categories the program intended to evaluate in the 2015 – 2017 period. Its introduction predicted that the SCP Program would announce “as many as three” Priority Products in 2015 and “… in 2016 and 2017, … more than five Prioritization Retrospective - 1

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Page 1: Introduction - Department of Toxic Substances …€¦ · Web viewLean Six Sigma In 2017 – 2018, Safer Consumer Products Program Senior ES Simona Bălan led a Lean Six Sigma green

Safer Consumer Products Program – Six Year Prioritization Retrospective

IntroductionThe Safer Consumer Products Program was created in the spring of 2013, five years after California’s green chemistry law was signed. Its 27 staff and managers were charged with implementing the four-step process laid out in the Department of Toxic Substance Control’s (DTSC) not-yet-finalized framework regulations. Even before the regulations took effect on October 1 of that year, SCP’s newly-formed Chemical and Product Evaluation Team (CPET) was already at work, evaluating several dozen product-chemical combinations suggested to us by other departments and non-governmental organizations (see supporting doc 1.1.2). CPET needed to work fast to meet a deadline DTSC had imposed on itself in the framework regulations: to make its “initial proposed Priority Products list available for public review and comment … no later than 180 days after …” the regulations took effect. SCP released Priority Product Profiles for three product-chemical combinations in March of 2014 when it announced its proposed Initial Priority Product List. Each profile defined the product being proposed for listing, discussed the chemical’s properties, and laid out DTSC’s rationale for designating the combination as a Priority Product. The program held a series of public workshops in May and June of that year to discuss its findings and unanswered questions.

The First Priority Product Work PlanIn April of 2015, after a public comment period, DTSC finalized and published its first Priority Product Work Plan. The work plan identified seven product categories the program intended to evaluate in the 2015 – 2017 period. Its introduction predicted that the SCP Program would announce “as many as three” Priority Products in 2015 and “… in 2016 and 2017, … more than five products each year.” While SCP did hold a webinar in November of 2016 and series of public workshops in 2017 on the findings of its product scoping research, the program did not propose any new Priority Products until 2018.

DTSC’s failure to meet the ambitious goals set in its first work plan has led to a view among some stakeholders that the program has not made fast enough progress. This view is reflected in the 2018 report California’s Green Chemistry Initiative at Age 10: an Evaluation of its Progress and Promise by the Public Health Institute (PHI).1 In it, PHI recommends that DTSC “… perform an assessment of the scientific and procedural foundation of its prioritization process to date to ensure that: (1) It is as efficient and transparent as feasible given the language of the statute and the regulations; and (2) The strategy for product selection is resulting in appropriate product choices that meet the goals of the program” and that the department

1https://www.phi.org/uploads/files/CA%20Green%20Chemistry%20Initiative%20at %20Age%2010-final.pdf

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should involve the GRSP in this review. The review might, PHI speculated, “… result in the need to change the regulations, eliminate some pre-regulatory steps, or articulate a more focused strategy.”

While DTSC fell well short of its goal to announce 13 or more Priority Products during the first 3-year work plan cycle, the program laid the groundwork for future success. Staff conducted scoping research on dozens of chemicals and products, many of which, for a variety of reasons, did not result in selection of a Priority Product. The program also invested significant resources in program development and process improvement efforts.

As it enters its seventh year, product prioritization is beginning to move faster. The program has implemented systematic scoping and research process, has identified gaps in its expertise and recruited new staff who can fill them; and has identified, and gained access to, data sources and software tools to significantly improve the efficiency and effectiveness of its work. Today, the SCP team, which has grown from 27 to 41 staff, has several dozen active projects and plans to announce three or more new Priority Products over the next year, with more in the queue for 2021 and beyond. In fact, the earlier concern that CPET was too slow to identify new product-chemical combinations has been replaced by a new issue: the cascade of rulemaking, Alternatives Analysis, and Regulatory Response projects resulting from each Priority Product CPET identifies will soon be unsustainable with the program’s current available resources.

BackgroundWhile the Safer Consumer Products framework regulations require a scientific basis for choosing a Priority Product, they make clear that DTSC’s selection of Priority Products is, fundamentally, a policy decision.2 The central role of policy in the program’s work is manifested in the triennial Priority Product Work Plan, which lists the policy considerations that informed our selection product categories. These considerations are also the lenses through which we evaluate products in our scoping and research phases. This document will briefly discuss approaches the SCP program has taken to exercise this policy discretion in researching products and chemical and selecting Priority Products.

Initial Priority Product List During the first round of SCP’s Priority Product research, which began in 2013, DTSC had no work plan and had not yet developed formalized processes or tools for research and decision-making. The program solicited suggestions of product-chemical combinations from several sister agencies and NGOs and assigned each to a staff member to research and present to CPET. The team members’ initial findings were tabulated, prioritized and presented to executive management. Of five product-chemical combinations proposed for the Initial Priority Product

2“The Department may identify and list as a Priority Product one or more product-chemical combinations that it determines to be of high priority…,” California Code of Regulations, title 22, section 69503.2, subsection (a).

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List, three were greenlit – children’s sleep products with TDCPP (and later, TCEP); paint strippers with methylene chloride; and spray polyurethane foam systems with diisocyanates (later limited to methylene diphenyl diisocyanate – MDI).

Priority Product Work PlanThe framework regulations’ sole requirement for content of the Priority Product Work Plan is that it identify and describe “… the product categories that [DTSC] will evaluate to identify product-chemical combinations to be added to the Priority Products List during the three ... years following [its] issuance….” Given the breadth of products included in the statutory definition of “consumer product,” the broad discretion given to the department by the regulations, and the iterative (and therefore unpredictable) nature of our scoping process, DTSC opted not to use the Work Plan to lay out a schedule for evaluating products and chemicals. Instead, the plan specifies the program’s policy priorities for the Work Plan cycle, identifies and describes the product categories, and summarizes the rationale for selecting them.

Omitting a year-by-year schedule from the Work Plan provides us with flexibility and supports several of the SCP program’s objectives. Staff received executive direction to try multiple methods for researching and prioritizing products and chemicals rather than defining an overly prescriptive research approach early on. Additionally, the GRSP admonished SCP not to “look for the keys under the lamppost” (i.e., not to focus solely on chemicals and products with well-characterized hazard traits and adverse impacts). The program has embraced this advice, however the time and effort required to research an emerging chemical or large class of chemicals (e.g., PFASs) can be difficult to predict from the outset, making it difficult to adhere to a rigid schedule.

SCP also wanted to ensure we demonstrated the scope of the program’s authority by addressing a fairly broad range of products with a wide range of impacts – some whose adverse impacts affect the public at large, some that are primarily environmental concerns, and some that appear to have readily-available substitutes for the Chemicals of Concern. The program also wanted to test the class approach, by naming PFASs, as a group, as a Chemical of Concern, thereby encouraging manufacturers to identify and evaluate non-PFAS alternatives. The breadth of the program’s goals in naming products and the newness of the program, and the lack of well-established workload standards, and unpredictable nature of our research all contribute to the challenge of setting a firm schedule and sticking to it. Instead, we opted to use the work plan as a place to articulate our policy goals, considerations, and priorities and to describe the categories and our concerns with each.

Our accomplishments since 2013Since the its inception, SCP has finalized three Priority Product listings and two Priority Product Work Plans; held a series of scoping workshops on PFASs, consumer products with aquatic impacts, nail products, and paint strippers; issued drafts of 4 other Product-Chemical Profiles; and held pre-regulatory workshops on four product-chemical combinations. Less visibly, SCP

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has conducted scoping research on approximately 70 chemicals, many of which were dropped or put on hold and never publicly announced or specifically discussed (SCP has announced that it is investigating a list of chemicals in nail products, for example but has not, as of yet, discussed its findings). Examples of some products and chemicals for which CPET has conducted scoping research that has not yet led to a Priority Product proposal is provided in Appendix A. (See also Timelines for Priority Products, supporting document 1.1.3.)

Safer Consumer Products Program’s decision-making frameworkThe Safer Consumer Products Program’s selection of a Priority Product relies on a variety of data and information about both chemicals and products. Some is scientific data and market information necessary to make the determinations required by the framework regulations. But the program also needs other information for decision-making, such as:

Would prioritization be meaningful? What is the magnitude of potential adverse impacts from a product-chemical

combination relative to other sources of exposure to the chemical? How would designating this as a Priority Product align with our stated policy priorities?

Obtaining some of this information has proved relatively straightforward, but some has been challenging. Also, the amount of data on individual products and formulations is sometimes voluminous, and DTSC has not had the tools to thoroughly and systematically analyze it.

Data and informationTo support a decision to name a Priority Product and to demonstrate that a product-chemical combination under consideration meets the framework regulations’ criteria, DTSC needs both scientific and market data. SCP’s scientific data needs include physicochemical and toxicological data on chemicals; exposure data for products; and adverse impact data. Market data (including supply chains, identity of manufacturers, etc.) is also essential to understanding which products are sold in California, who manufactures them, and how (and by whom) they are already regulated. When more direct exposure data is not available, market data can help us understand how widespread a product is in the market and give us a rough idea of the magnitude of potential exposure to a chemical it contains. Combining market and demographic data using, data science tools can help us discern whether a product may disproportionately expose sensitive subpopulations to a chemical.

One of the most important, and elusive, types of data for selecting Priority Products is formulation data. Early on, we used sources like the National Library of Medicine's Household Products Database and Walmart’s MSDS data to identify Candidate Chemicals in products. These databases have significant shortcomings for our purposes, however. They often include outdated information; may omit certain ingredients; generally, do not specify weight

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percentages for ingredients; and tell us nothing about the size of the market for the products they contain. While SDS databases continue to be inadequate for SCP’s needs, the program has begun to address these challenges by subscribing to market data services, investing in data science tools (e.g., Tableau), recruiting new staff with data science knowledge and expertise, and pursuing training and partnerships to develop our skills and tools for manipulating and analyzing large datasets.

Appendix D summarizes some of the key types of data information that SCP needs, what we use it for, whether it is readily available, and steps we have taken to address gaps.

Non-Regulatory Consideration for choosing meaningful product-chemical combinations SCP has consistently stated that its regulatory framework is not based on quantitative risk assessment and that selection of Priority Products is largely a matter of policy. This approach is necessitated by the broad range of endpoints we may consider in deciding to list a Priority Product. Given the number of tradeoffs that may need to be considered, there is no meaningful way to objectively determine that one product-chemical combination is “worse” than another.

Many products from each category in the work plan meet the framework regulations’ Key Prioritization Principles (i.e., there is 1) potential for exposure to a Chemical of Concern from the product; 2) potential for this exposure to contribute to or cause harm). Several policy considerations inform a decision by the program to list one of them as a Priority Product. They include:

The strength of the “Story”o Definitiveness of the scienceo How well characterized the chemical’s hazard traits areo Severity of adverse impactso How widespread the adverse impacts are

Other regulatory actions. SCP needs to ensure that naming a Priority Product would “… meaningfully enhance protection of public health and/or the environment with respect to the potential adverse impacts, exposure pathways, and/or adverse waste and end-of-life effects that are the basis for the listing”

Whether or not alternatives to the Chemical of Concern are already available The magnitude of the impact listing as a Priority Product may have

Strategic ConsiderationsGiven that Safer Consumer Products is a new program, our selection of Priority Products had been informed by strategic considerations in addition to their scientific and regulatory bases. As a proof-of-concept for its untested regulatory framework, the program wanted is first Priority Products to demonstrate the breadth of products that fall within its purview and to select products that would follow a different path through the regulatory process. Children’s foam-

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padded sleep products contained unneeded flame retardants that were readily removable without affecting the product’s essential functions. Several alternatives to methylene chloride paint strippers were already on the market. On the other hand, spray polyurethane foam systems, which have a unique combination of performance requirements with no readily available alternative, provided an opportunity to see if California can indeed spur green chemistry innovation.

Due to the SCP program’s small size and limited resources, we have endeavored to select Priority Products that allow us to maximize our impacts, in some cases by leveraging the work of others (e.g., paint strippers), in others by leading the way (e.g., the entire PFAS class in carpets and rugs). We have also made an effort to select a range of product-chemical combinations from multiple sectors, with varying adverse impacts. For example, because all of the first three initial Priority Products were chosen based on adverse impacts to humans, in our second round of scoping research we made a deliberate decision to focus on products with environmental impacts.

SCP has attempted to balance the need to show steady progress and the GRSP’s advice not to look for “the keys under the lamppost.” The seven Priority Products announced to date have included both well-characterized Chemicals of Concern and emerging chemicals. Given program size, SCP technical staff must split time between product and chemical research, rulemaking, and Alternatives Analysis. The program also considers the number of potential responsible entities who might submit AAs and the program’s capacity to review their submittals within the mandated timeframes.

External considerationsIn addition to priorities set within the SCP program, external factors can affect our priorities and focus. For example, SCP has made decisions to stop work on a promising product-chemical combination—hair straighteners with formaldehyde—due to pending litigation (see Appendix A). The program has also received two petitions to add products to the Priority Products List: one for food can linings with bisphenol A, the other for tires with zinc. Both required a significant amount of effort to evaluate, which required the program to re-prioritize other work.

We have also been directed to focus on a product-chemical combination that was not part of the current work plan; in 2016, then-Governor Brown issued an executive order directing DTSC to evaluate lead-acid batteries for potential listing as a Priority Product. The legislature subsequently added the mandate to statute. This mandate required significant effort by SCP staff (justifying an augmentation through a successful Budget Change Proposal, which offset the additional work).

On occasion, a sister agency’s priorities may align with those of SCP and we may undertake a scoping project at the other agency’s suggestion. Most recently, DTSC launched a scoping project on 1,4-dioxane, which is a particular issue in Los Angeles and Orange Counties, where direct potable use of treated wastewater is being contemplated. The 1,4-dioxane project aligns

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with the policy priorities laid out in SCP’s current Priority Products Work Plan and supports the priorities of the Los Angeles and Orange County Sanitation Districts and several Regional Water Quality Control Boards.

ChallengesLooking back over its six-year history, the Safer Consumer Products Program has faced a number of challenges in prioritizing product-chemical combinations; some have been relatively straightforward to address, others more persistent.

Obtaining product ingredient and market data. Obtaining market and formulation data for products under evaluation has been especially challenging. SDS found in databases can be out of date and both market and formulation data can be confidential. The SCP program has made a significant effort to compile and curate a list of useful data sources for various topics (Supporting document 1.1.6). We have also purchased useful datasets like Hoovers, Mintel, Verisk 3E, etc.

Managing data. Reviewing large amounts of data can be cumbersome without the proper expertise and tools. We have addressed this by targeting data science skills in our hiring, training staff in data science techniques, and procuring useful software (e.g., Tableau, AirTable).

Subject matter expertise. Given the vast array of chemicals and products in the SCP program’s purview and our limited staff, the program lacks (or lacked) subject matter expertise in certain critical areas. We have used several approaches to address our expertise gaps.

o Targeted recruitment: we identified exposure science, economics, and data science as three areas where the program’s expertise was weak. To address our need for an economics expertise, we recruited and hired a PhD-level economist. To address our expertise gap in data science, the program recruited applicants and screened applications for Environmental Scientist vacancies with data science experience; we recruited and filled a vacant staff toxicologist position specifically looking for someone with exposure science expertise.

o Collaboration with experts within and outside of DTSC. Since the program’s inception, SCP technical staff have worked closely with toxicologists in DTSC’s Human and Ecological Risk Office. In addition, staff have developed fruitful collaborations with scientists in the Office of Environmental Health Hazard Assessment (OEHHA), the State Water Resources Control Board (SWRCB), US EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP), the San Francisco Estuary Institute (SEFI), Biomonitoring California, and US EPA’s Office of Research and Development (ORD).

o Training. Two of SCP’s technical program staff have enrolled in a data science certificate program.

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Lessons learnedEach iteration of the SCP Program’s scoping, research, and regulatory processes over the past six years has brought lessons about how we can work more efficiently and effectively. Early on, we recognized the benefits of defining our work processes, identifying decision points, and understanding our resource constraints. We have also learned that, despite our best efforts, our internal workflow, external communication, and stakeholder engagement processes can always be improved, and we have embraced the spirit of continuous improvement. We have also come to realize the importance of balancing our need for internal deliberation with our stakeholders’ need to be kept apprised of our progress implementing the program. And we have seen, repeatedly, the benefits of early and frequent communication with a wide range of stakeholders to both the quality of our work and the efficiency with which we complete it.

Workload Management and Process EfficiencyAs noted earlier, the program’s first three product-chemical profiles were developed relatively quickly. This was possible because we started from a list of suggested product-chemical combinations (vs. broad Work Plan categories), had virtually no public engagement prior to announcing the initial Priority Products, and faced a 180-day deadline to announce them.

Almost immediately after announcing the first three Priority Products, SCP began to realize the benefits of early public engagement. At three public workshops in the Spring of 2014, we heard from manufacturers of SPF Systems and contractors who use them that our proposed product definition encompassed what they saw as five separate products and that only methylene diphenyl isocyanate (MDI) is used in these products (we had named the entire class of diisocyanates). We also heard from paint stripper manufacturers and users that these products are used in a wide range of applications and that safer alternatives may be available for certain coatings and substrates, but less feasible for others. Some stakeholders reacted quite strongly to SCP’s initial proposals. When SCP released the first three product-chemical profiles, we told stakeholders that they were discussion documents and, therefore, that we didn’t intend to revise or update them. Nevertheless, after a series of stakeholder meetings and internal discussions, we prepared updated technical documents for each proposed Priority Product that, among other changes, refined our product and chemical descriptions.

In subsequent iterations of product scoping and research, the program has opted to engage with stakeholders prior to proposing specific Priority Products. We have held public workshops, issued background documents describing interim findings and questions, and solicited and considered public comment. While this public engagement process has been invaluable to our deliberation and decision process, we have learned that it adds many months to the product selection process. SCP lacked this insight when we prepared the first Priority Product Work Plan and, thus, significantly underestimated the time required to go from the product categories in our Work Plan to a specific Priority Product proposal.

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Another focus of SCP’s attention has been internal process improvement. Early in its first round of product research, SCP contracted with the Berkeley Center for Green Chemistry to provide a training session titled Building the Case for a Priority Product: Methods, Tools, and Resources, which provided systematic methods, resources, and tools for researching chemicals and products within the SCP regulatory framework. Later, after the initial three product-chemical profiles were released, the program standardized the templates it used for these documents. We also developed standardized instructions for staff working on product and chemical scoping teams, a QA checklist, and a process flow chart, which identified five steps from Work Plan to rulemaking that identified the decision points and deliverables for each step.

External Communication and TransparencySCP has learned the importance of effective external communication over the past six years. Stakeholders want to understand SCP’s scientific, regulatory, and policy rationales when the program publishes a work plan, background document, or product chemical profile. In some respects, the program’s external communications have been very effective; for example, the findings and questions framed in our recent public background documents have led to productive and informative dialogue with our stakeholders at public workshops and meetings. Nevertheless, some SCP stakeholders have felt that the program has not been sufficiently public/transparent about our work that doesn’t result in a Priority Product proposal. One goal of this GRSP topic is to explain our rationale for some of our decisions not to pursue a product or chemical after conducting scoping research.

Another external communication challenge SCP has encountered is misrepresentation of the findings of product-chemical profiles for marketing purposes. Profiles, which are intended to articulate our concerns and rationale for proposing the product, have been portrayed, inaccurately, as a determination that the product is “unsafe,” to market competing products to customers, despite the fact that DTSC has made no determination about the relative safety of the competing product. To address this issue, SCP has added a disclaimer to the profile template.

In the second Priority Products Work Plan, which covers 2018 – 2020, SCP made a deliberate choice to omit mention of specific Candidate Chemicals as examples in the discussion of the plan’s seven product categories. (The only exception was lead in lead-acid batteries.) Naming Candidate Chemicals in the work plan can create the perception that we have already decided to pursue them or that they are the only CCs we’re concerned about.

Stakeholder EngagementEarly and ongoing engagement with a wide range of stakeholders has proven vital to SCP’s product and chemical research, and to identifying and refining proposals to list Priority Products with Chemicals of Concern. On multiple occasions (e.g., scoping of clothing, detergents, nail products, paint strippers, and spray polyurethane foam systems), manufacturers and other industry stakeholders have provided very helpful data and information. In some cases, their

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information has affirmed our course of action; in others, it has helped SCP focus its research, refine its focus, and, in some cases, delay or not pursue regulation of a product or product category. For example, SCP had investigated clothing with nonylphenol ethoxylates as a potential Priority Product with a Chemical of Concern but, after meetings with industry stakeholders gave us a better appreciation of the complexity of the supply chains that led to the presence of the chemicals in clothing, we opted not to pursue NPEs in clothing (see Appendix A).

SCP has found public workshops and webinars particularly helpful venues for sharing its interim findings on a topic and soliciting information and comments from interested stakeholders. The model for this approach was the multi-topic webinar SCP held in November of 2017 to share the initial findings of its scoping research for the first Priority Product Work Plan. The webinar was followed by a series of public workshops on topics introduced at the webinar. Prior to each workshop, SCP issued a public background document describing the topics, the program’s initial findings, and the questions we were seeking to answer. This type of engagement has had multiple benefits. Comments and information that stakeholders submit are sometimes quite helpful in answering our questions and refining our thinking. Equally as important, public workshops have allowed SCP to develop a list of stakeholders with highly relevant subject matter expertise.

SCPs continues to work to make its public workshops more useful and productive. At our August 2019 workshop on 1,4-dioxane, we experimented with a small-group discussion format, which allowed all attendees to share their knowledge and perspectives. Attendees were assigned to sit at tables with representatives of stakeholder other groups with a variety of perspectives (e.g., a table might include an academic researcher, an NGO scientist, and an industry advocate). At each table, an SCP moderator asked prepared, open-ended questions and ensured that everyone had a chance to speak and be heard. The result was noticeably greater participation by attendees than we have seen with a traditional public workshop format, and greater openness in communicating ideas that directly addressed SCP’s discussion questions. Many in attendance shared positive feedback and we plan to continue using this format in the future, when appropriate.

While (as noted above) SCP opted not to list example chemicals in its current work plan, we have found that merely mentioning a product or chemical (e.g., it in a work plan or scoping workshop) can influence manufacturers to change the chemicals they use in their products. For example, at a 2017 meeting, the Resilient Floor Covering Institute (RFCI) informed SCP staff that all its members had voluntarily phased out the use of ortho-phthalates in their vinyl flooring products as a direct result of our mentioning this chemical group in the 2015 – 2017 Priority Product Work Plan.

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Evolving processOrganizational development

Strategic Plan. In addition to its core program work, the SCP program has invested significant resources in program development and process improvement. The “scientific and procedural foundation of [the program’s] prioritization process” have been continuously evolving. In 2017 and 2018, SCP involved its entire staff in developing the program’s Strategic Plan. Each element of the plan—stakeholder engagement, workload coordination, project management, team development, and fiscal stewardship—has directly impacted the program’s processes.

Lean Six Sigma. In 2017 – 2018, Safer Consumer Products Program Senior ES Simona Bălan led a Lean Six Sigma green belt project to analyze and recommend improvements in the scoping and research process for the Chemical and Product Evaluation Team (CPET). Based on limited data, Simona and her team determined that the time elapsed from initial scoping of products, product categories, and/or chemicals to finalizing a Product Chemical Profile (“Profile”) was on the order of 3.5 years. After analyzing the “critical Xs" (activities or inputs that have a lot of influence on the quality of deliverables), the team recommended a list of “solutions” to improve quality and decrease the time required to produce a profile to approximately 18 months. [See Appendix B]

Project Management. SCP has devoted significant resources to training its staff, as a group, in the principles of project management. The program adapted project management tools and templates provided by the instructor for various types of SCP projects. The program’s commitment to project management has enabled SCP to better plan and coordinate its workload and maximize the efficient utilization of its limited staff and has greatly enhanced SCP’s ability to plan and execute projects, balance resources, and achieve its goals. In 2018, SCP did a refresher training in project management and revised and updated its PM toolkit to make it simpler, more useful, and more flexible. Project teams have begun holding regular after-activity reports during their projects to identify and address lessons learned in real time.

New employee buddy system. SCP recently initiated a buddy system, paring newer scientists and engineers with more experienced colleagues to accelerate their integration into the program, thereby enabling to contribute more quickly.

Improving templates. With every cycle of product scoping research, SCP revisits the templates for its internal and public documents (see Supporting doc 1.1.5). Based on our recent experience using it for several product-chemical combinations, the product-chemical profile template was recently revised to simplify it and improve its flow. The new version will better communicate the scientific and regulatory basis for proposals to list Priority Products to all SCP stakeholders. (PP Profile Template will be sent as a separate email.)

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Moving forwardThe SCP Program continues to explore opportunities to enhance its expertise and augment its toolkit. Below is a summary of a few of these efforts.

Systematic Review Case Studies. SCP is in discussion with Patrice Sutton of the University of California, San Francisco’s Program on Reproductive Health and the Environment and Kris Thayer, IRIS Division Director, US EPA, to run a series of case studies, on a range of SCP topics, to gain familiarity with the software and methods of systematic review, under the guidance of these two subject matter experts.

ORD Exposure Tools. SCP recently met with EPA’s Office of Research and Development (ORD) to learn about its new scientific workflow approach to support exposure analysis and how this approach could be applied to exposure analysis-related questions that could help us set program priorities, communicate exposure-related decisions to stakeholders, and evaluate AA submissions.

Coordinating with other states: SCP staff regularly coordinates with several other states that are implementing consumer product-related laws. DTSC has a memorandum of understanding (MOU) with the Oregon Department of Environmental Quality and the Washington Department of Ecology to share data related to the three state’s respective consumer products and children’s product laws. Staff have recently had a series of meetings with their counterparts at the Washington Department of Ecology. SCP staff also participate in a variety of workgroups with other state and local governments, e.g. the Interstate Chemicals Clearinghouse (IC2) Alternatives Assessment and PFAS Workgroups. These interactions are a valuable path to share information and to harmonize responses. However valuable, these meetings also require considerable investment of time.

New software tools and expertise. Reviewing large amounts of data can be cumbersome without the proper expertise and tools. We have addressed this by targeting data science skills in our hiring, training staff in data science techniques, and procuring useful software (e.g., Tableau, Air Table, R).

Better market analysis. SCP is purchasing Nielsen’s Scantrack dataset, which will dramatically improve the amount and quality of market data available to the program. Scantrack will provide SCP with UPC-level sales data for 34 broad categories of consumer product, including units sold in California as a whole and in sub-markets within the state.

California state agency coordination. SCP regularly coordinates with other state agencies to exchange information and expertise. In the past year, we have finalized an MOU with the California Air Resources Board (ARB) to share information from ARB’s consumer products survey, which contains full formulation data for a wide range of volatile organic compound (VOC)-containing consumer products. We have also consulted with:

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o OEHHA for review of toxicology- and exposure-related content in virtually all product-chemical profiles we have issued;

o SWRCB on consumer products with aquatic impacts (notably, products that contain 1,4-dioxane and zinc);

o The California Department of Resources Recycling and Recovery (CalRecycle) on chemicals that impact the recyclability and compostability of food packaging;

o The California Department of Public Health (CDPH) on chemical ingredients in cosmetic products; and

o The Board of Barbering and Cosmetology (BBC) on restrictions of chemical ingredients in nail salon products.

Ingredient disclosure and “right to know” trends. With the passage of California’s Cleaning Products Right to Know Act, SCP will have access to useful ingredient data on many cleaning products sold in the state. After the law’s enactment, SCP staff and managers coordinated their counterparts at the New York department of Environmental Conservation (NYSDEC) (which was launching a similar ingredient disclosure effort) to share information on lists of chemicals that could require disclosure under our respective laws.

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Questions for the GRSP1. Does GRSP have recommendations to speed up or improve the transparency of our

process beyond the process improvement that the DTSC has already undertaken?

2. While the prioritization process has evolved over the course of the Program, the fundamental, non-formulaic approach remains the same. What are the advantages of this approach in fulfilling SCP’s mission? What are the disadvantages and what approaches could be used to mitigate these disadvantages?

3. From PHI, “DTSC should evaluate the scientific and procedural foundation of its prioritization process to ensure that it is as efficient as possible and that the prioritization strategy is clearly articulated and appropriately transparent.” Has this retrospective presentation and background paper satisfied this recommendation from PHI? Is there further information needed to help stakeholders understand our process and pace?

4. To date, SCP’s stakeholder engagement efforts have centered around public workshops and comment periods, which are time consuming to implement and have been variably effective. While targeted stakeholder outreach may, in some cases, be more effective, it lacks the transparency of the public workshops. Are there other ways that SCP could solicit information while still retaining transparency in our prioritization process? SCP recently facilitated small-table discussions at a workshop; the approach elicited more comments and received positive feedback. Are there additional approaches that would make public workshops and comment periods more effective?

5. There are aspects of the prioritization process that could be achieved by leveraging external resources, including environment-specific chemical prioritization (i.e., aquatic), freeing up DTSC resources and potentially expediting the process. What aspects of the process could be achieved outside of DTSC and how can SCP best leverage these external resources?

6. Should SCP publicize our projects earlier in the scoping phase even though we may not have sufficient information to understand whether it will be a good candidate for a Priority Product? How do we strike the right balance between early stakeholder involvement and the known consequences of daylighting our work, including uninformed substitution or market repercussions?

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Appendix A: products scoped but not pursued

Fishing weights with lead. DTSC seriously considered proposing this product-chemical combination as a Priority Product in 2014 but, ultimately, decided against it. At the time, SB 711 of 2013 had just taken effect and the Department of Fish and Wildlife was developing controversial regulations to implement the bill’s ban on the use of lead ammunition for hunting, a product used by many of the same stakeholders as fishing weights. Given the attention and controversy, DTSC was concerned that the potential opposition to a proposed listing of lead fishing weights as a Priority Product could overwhelm the nascent SCP program. While the SCP process would not necessarily have led to a product ban, that nuance may have been missed by already angry stakeholders. SCP opted to delay action on fishing weights until the Department of Fish and Wildlife completed their efforts on lead ammunition. Ultimately, DTSC decided to drop this potential Priority Product because lead-free alternatives were already readily available in the California market, obviating the benefits of requiring manufacturers to conduct Alternatives Analyses.

Hair straighteners with formaldehyde. This product was a strong candidate for inclusion on the Initial Priority Product List in 2014. The product exposes hair salon workers to a formaldehyde-containing product and the exposure potential is exacerbated using heat during application of the product. However, California’s Attorney General was in the midst of litigation against a major manufacturer of formaldehyde-containing hair straighteners at the time, for failing to inform consumers that the product exposed them to a carcinogen, as required by Proposition 65. Because the outcome of the litigation was uncertain (and could have led to the removal of the product from the market or its reformulation), DTSC again determined that the time was not right for regulating the product as a Priority Product.

Pavement sealers with coal tar were also a serious candidate for listing as a Priority Product. Coal tar is identified as a carcinogen on several of the constituent lists of the Candidate Chemicals List and is used in large volumes for pavement sealing. However, after extensive investigation, staff determined that coal tar sealants were not available for sale in California and, therefore, the product was a poor candidate for listing, since doing so would require resources that could otherwise be dedicated to product-chemical combinations that may actually result in adverse impacts in our state.

Clothing with NPEs. SCP discussed this product-chemical combination as part of its 2017 workshops on products with aquatic impacts. During and after our public workshops, we engaged with various brand owners and industry associations like Zero Discharge of Hazardous Chemicals (ZDHC) and learned that the supply chains for clothing were complicated and include:

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o “Cut and sew factories,” which obtain fabrics from are separate from Tier 2 mills;o Tier 2 mills, which are mostly outside of US in Asia and South America;o Tier 1 facilities, which do screen printing and are mostly outside of the U.S., ando Tier 3 facilities, which apply inks and dyes

Given that brand owners and “cut and sew” factories are not the ones adding NPEs to clothing, and that most of the releases and consequent adverse impacts happen before clothing is sewn, it was not obvious who the manufacturer would be and what would be the magnitude of NPE exposure coming from clothing relative to other sources. Given the complexity of the supply chains and uncertainty about the magnitude of NPE exposures from clothing, SCP opted not to pursue Priority Product listing. It became clear that it would be challenging for SCP to impact the industry at the right point in the supply chain.

Ultimately, the clothing category was dropped in its entirety from the 2018-2020 Work Plan – despite well-known global environmental impacts. This example illustrates a key challenge of SCP’s regulatory framework. Many manufacturers have told us they have long, complex, and global supply chains, which they find challenging to control. In many cases, DTSC lacks jurisdiction over the companies formulating raw materials used to make products that are ultimately placed into the California market. It’s not always clear to what extent SCP should take this challenge into account when deciding what products to designate as Priority Products.

For additional examples, see Table 1, below.

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Table 1. Priority Products not pursued.

PP Chemical Reason for selection Policy Priority Challenges

Fishing weights

Lead Carcinogen, reproductive, neuro, and developmental toxicant in all animals. It is persistent and bioaccumulative, and dangerous to children.

Environmental impacts,

Threatened & Endangered Species

Sister agency had competing priorities

Hair Straighteners

Formaldehyde Carcinogen Workers CA lawsuit against major straightener manufacturer for failure to disclose formaldehyde

Nail Polish Solvents There are 121,000 full-time and 284,000 part-time cosmetologists in CA. 59-80% are of Vietnamese descent with limited ability to read health risks and SDS hazard info.

Workers Started with toluene, a reproductive & developmental toxicant. Team is evaluating other CCs in nail products. Many REs; difficult to determine ingredients in products.

Sunscreen Benzophenone-3

Dermal, endocrine toxicant Environmental impacts

No new, UV filters have been approved by FDA in 20 years. Product is important for health and alternatives will not be readily available

Sunscreen Titanium Dioxide

Respirable particles are carcinogenic Children No new, UV filters have been approved by FDA in 20 years. Product is important for health and alternatives will not be readily available

Thermal Paper

BPA Developmental, reproductive, & endocrine toxicant

Workers Controversy over low dose endpoints and CLARITY studies underway to

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PP Chemical Reason for selection Policy Priority Challenges

address data gaps.

Can linings BPA Developmental, reproductive, & endocrine toxicant

Children Controversy over low dose endpoints and CLARITY studies underway to address data gaps.

Personal care & cleaning products

Triclosan Dermal, endocrine, immunological toxicant

Environmental impacts

Triclosan was in the process of being formulated out of many PCP.

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Appendix B: Lean Six Sigma “Critical Xs” and SolutionsSCP’s 2017 – 2018 Lean Six Sigma green belt project team identified the following activities and inputs that have significant impact on the quality and timeliness of SCP’s deliverables:

Internal communication and decision-making (unclear directions, lengthy decision-making process)

External communication (too late and challenging) Research approach (variable, unclear criteria and boundaries) Toolkit (confusing and/or underutilized templates, instructions, external databases)

Based on the above “Critical Xs,” the LSS project team developed a list of recommended solutions to improve quality and decrease the time required to produce a profile to approximately 18 months. The program has implemented five of these:

Combining the first two phases in the CPET scoping and research process Developing a CPET quick-start guide, which was subsequently expanded to cover other

elements of the SCP Program (e.g., the rulemaking and AA processes). (see 1.1.7) Developing a decision log template, which has been incorporated into the SCP’s revised

project roadmap template (see 1.1.8)o All projects will track decisions, decision-makers, requested dates, elapsed time,

etc.o As data is compiled from more and more projects, it will allow us to identify and

address common bottlenecks Developing a new, streamlined product and chemical scoping template (supporting

document 1.1.4 & 1.1.5)

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Appendix C: Data Needs and Solutions

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