By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on November 4, 2022, that it will hold the first of a two-part webinar series on November 17, 2022, on EPA’s new standardized process to assess risk and apply mitigation measures, as appropriate, for mixed metal oxides (MMO), including new and modified cathode active materials (CAM). As reported in our October 11, 2022, memorandum, in October 2022, EPA announced an innovative effort intended to help make its review of new MMOs, including new and modified CAMs, more efficient. According to EPA, MMOs are used in batteries, electric vehicles, semiconductors, and renewable energy generation, making them a vital part of clean energy sectors.
 
EPA states that the kickoff webinar will provide statutory and regulatory background, including the related compliance advisory, a broad overview of the approach for risk assessment and risk management, and information on the Toxic Substances Control Act (TSCA) Inventory, nomenclature, and the bona fide process for those seeking to find out if their MMOs are already on the Inventory.
 
According to EPA, the second webinar, currently targeted for early 2023, will go into greater detail on the standardized risk assessment approach, present various case scenarios and a decision tree for identifying potential hazards and risks, and provide tips on risk calculators, tools, and models that are used for the risk assessment.
 
EPA encourages stakeholders to provide feedback, ideas, and questions at the kickoff webinar. This will help EPA supplement the information that will be shared at the second webinar and any follow-up communication on the new approach.

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on August 18, 2022, that it is accepting nominations for the 2023 Green Chemistry Challenge Awards from companies or institutions that have developed a new green chemistry process or product that helps protect human health and the environment. The awards again include a category to recognize technology that reduces or eliminates greenhouse gas (GHG) emissions. EPA will hold a webinar on September 28, 2022, from 2:00 to 3:30 p.m. (EDT) to educate stakeholders on the Green Chemistry Challenge Awards and the nomination process. Registration for the webinar is open. Nominations are due to EPA by December 9, 2022.
 
EPA states that green chemistry is the design of chemical products and processes that reduce or eliminate the generation and use of chemicals that are hazardous to the environment and people’s health. According to EPA, its efforts to “speed the adoption of this revolutionary and diverse discipline” have led to significant environmental benefits, innovation, and a strengthened economy. Green chemistry aims to prevent pollution before it is created, making it the preferred approach for providing solutions to some of the most significant environmental challenges.
 
An independent panel of technical experts convened by the American Chemical Society Green Chemistry Institute will formally judge the 2023 nominations and make recommendations to EPA for the 2023 winners. EPA anticipates giving awards to outstanding green chemistry technologies in six categories in fall 2023.

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By Lynn L. Bergeson and Carla N. Hutton
 
On September 22, 2021, the U.S. Environmental Protection Agency (EPA) recognized 33 Safer Choice Partner of the Year award winners across 16 states and the District of Columbia for achievement in the design, manufacture, selection, and use of products with safer chemicals. The Safer Choice program helps consumers and purchasers for facilities, such as schools and office buildings, find products that perform and are safer for human health and the environment. According to EPA, the work of many of the organizations being recognized addressed climate change, including by reducing greenhouse gas emissions. Additionally, several awardees have worked to increase access to products with safer chemical ingredients in underserved communities. EPA states that in the coming year, it hopes to build on this work by expanding the Safer Choice program to make products containing safer chemicals increasingly available to underserved communities, including communities of color and low-income communities. The 2021 Partner of the Year award winners include:

• Albertsons Companies, Safer Choice Retailer: Albertsons expanded their line of Safer Choice-certified products by adding six laundry detergent products that have SmartLabels that allow customers to scan a product quick response (QR) code and learn more about the Safer Choice certification. Albertsons also worked with cities and counties to identify opportunities to educate underserved households about safer cleaning and disinfecting products.
   
• American Cleaning Institute (ACI), Safer Choice Supporter: ACI contributed toxicological reviews that resulted in eight chemicals being added to EPA’s Safer Chemical Ingredients List (SCIL) and was the first non-manufacturer to do so. ACI’s news media coverage featuring the Safer Choice program generated a total potential reach of 11.2 million in 2020 and highlighted that “Adding chemicals to SCIL encourages innovation and growth in safer products, increases markets for manufacturers and helps protect people and the environment.”
   
• Apple, Safer Choice Supporter: Apple uses internal Apple Safer Cleaner Criteria based on Safer Choice criteria, among other assessment tools, to determine the safer chemical status of chemicals used in its manufacturing processes. Apple assessed 54 new cleaners, bringing the total to more than 80 safer cleaner and degreaser alternatives approved for use by more than 80,000 employees in their supply chain.
   
• The Ashkin Group, Safer Choice Supporter: The Ashkin Group included Safer Choice in training programs for frontline cleaning workers, training more than 30,000 workers to date, the majority of whom are from underserved communities.
   
• BASF Home Care and I&I Cleaning Solutions (BASF), Safer Choice Innovator: BASF added 13 and renewed 25 safer ingredients on CleanGredients, a database of chemical ingredients pre-approved for use in Safer Choice-certified products. This brought their total to 74 ingredients across seven functional class categories.
   
• Bona, Safer Choice Formulator-Product Manufacturer: Achieving Safer Choice-certification is a companywide objective for Bona. Since becoming a Safer Choice partner in 2020, Bona has certified 13 products. Bona has reformulated more than 90 percent of their current cleaner line for Safer Choice certification.
   
• Case Medical, Safer Choice Formulator-Product Manufacturer: Case Medical broadened the availability of their line of Safer Choice-certified products to additional markets. They built these formulations with ingredients from the SCIL and from CleanGredients.
   
• Church & Dwight Co., Inc. (CHD), Safer Choice Formulator-Product Manufacturer: CHD had a new product certified by Safer Choice. CHD’s advertising of this new Safer Choice-certified product included national television, digital, and print ads, and social media, with a potential reach of 169 million. CHD partnered with Safer Choice to develop and implement an in vitro testing strategy to meet Safer Choice pH criteria for laundry detergents.
   
• The Clorox Company, Safer Choice Formulator-Product Manufacturer: Clorox updated ten formulations and added a new product to their offering of Safer Choice- and Design for the Environment (DfE)-certified products, bringing the total to 37 Stock Keeping Units (SKU) spanning 19 retail and 18 industrial and institutional products. They also increased the percentage of Safer Choice-certified products displaying the Safer Choice label prominently on the front product label from 57 percent of products in 2019 to 70 percent of products in 2020.
   
• Defunkify, Safer Choice Formulator-Product Manufacturer: Defunkify has 15 Safer Choice-certified products, a 67 percent increase over 2019. Defunkify centers their communications strategy on emphasizing product performance and Safer Choice certification.
   
• Dirty Labs Inc., Safer Choice Formulator-Product Manufacturer: Dirty Labs’ first two commercial products are Safer Choice-certified, and every ingredient in these products is listed on CleanGredients. The lifecycles and sources for these ingredients are mapped on Dirty Labs’ website.
   
• ECOS, Safer Choice Formulator-Product Manufacturer: ECOS added four new products, renewed four products, and updated 11 product formulations. In total, ECOS offers more than 150 products that are Safer Choice-certified, which represents 79 percent of all ECOS product offerings.
   
• Grove Collaborative, Safer Choice Formulator-Product Manufacturer: Grove Collaborative expanded beyond the hand soap category to certify their entire liquid laundry and dishwasher detergent collections. Grove Collaborative made it easier for customers to learn about the Safer Choice program and find certified products on their website by creating an EPA Safer Choice Spotlight store.
   
• Hazardous Waste Management Program, King County, Washington, Safer Choice Supporter: The program featured Safer Choice in presentations at virtual webinars, as well as in publications and educational materials available in more than a dozen languages. The program also piloted a Safer Choice retail product mapping database that lists Safer Choice-certified products and information on the store where each product is sold, with the goal of increasing access to Safer Choice-certified products.
   
• The Home Depot, Safer Choice Retailer: In 2020, Home Depot carried 173 Safer Choice-certified products. These products are featured in a callout on Home Depot’s Eco Options website, which had more than 410,000 views in 2020.
   
• Household & Commercial Products Association (HCPA), Safer Choice Supporter. HCPA continued its support of the Safer Choice program by bringing stakeholders together from across HCPA’s membership virtually to strengthen Safer Choice, encourage more HCPA members to get their products certified by Safer Choice, and engage in discussions with Safer Choice staff about improvements to the program.
   
• Jelmar, LLC, Safer Choice Formulator-Product Manufacturer: Jelmar added three new products to its Safer Choice partnership. Jelmar displays the Safer Choice label to consumers on 100 percent of its Safer Choice-certified products. In addition to its product labels, Jelmar features the Safer Choice label in advertisements for television, social media, online video, podcasts, and at trade shows.
   
• Lake Monroe Sailing Association (LMSA), Safer Choice Supporter: The City of Bloomington, Indiana, relies on the Lake Monroe watershed for drinking water, recreation, and supporting the local economy. LMSA uses Safer Choice-certified products on facility-owned boats and makes these products easily accessible at no cost to their 200 members by placing them at boat cleaning stations.
   
• Lemi Shine, Safer Choice Formulator-Product Manufacturer: Lemi Shine added three products and updated five Safer Choice-certified formulations in 2020. Currently, 18 of their 21 products are Safer Choice-certified, and Lemi Shine prioritizes formulating with chemicals from the SCIL in over 99 percent of their materials.
   
• LightHouse for the Blind and Visually Impaired, Safer Choice Formulator-Product Manufacturer: LightHouse is a non-profit that has programs to help blind and visually impaired employees get experience in many areas, including chemical manufacturing, chemical blending, and quality assurance and control. LightHouse had record sales for their Safer Choice-certified products in 2020, with all proceeds going directly to the blind and visually impaired community.
   
• LSI, Innovator: LSI developed a formula for a DfE-certified, fast-acting hydrogen peroxide-based disinfectant that combats SARS-CoV-2, the virus that causes COVID-19. This base formulation is registered under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and certified under the DfE program.
   
• Novozymes North America, Safer Choice Innovator: In 2020, Novozymes added six enzyme ingredients to CleanGredients. Novozymes also supported 25 requests made by formulators and brand owners for certification of formulations by the Safer Choice program.
   
• Oregon Department of Environmental Quality (DEQ)-Toxics Use Reduction Program, Safer Choice Supporter: Oregon DEQ developed innovative projects with goals of building a community that purchases safer products and of directly supporting businesses in obtaining Safer Choice certification. In partnership with the Pollution Prevention Resource Center, Oregon DEQ’s team developed and implemented a Safer Chemical Alternatives Training Program that focused on increasing knowledge about Safer Choice-certified products.
   
• The Procter & Gamble Company (P&G), Safer Choice Formulator-Product Manufacturer: P&G added 12 products to their Safer Choice-certified line and updated two formulations. P&G designed, formulated, and manufactured their first complete Safer Choice-certified brand portfolio that is a collection of fabric and home care products.
   
• PurposeBuilt Brands, Safer Choice Formulator-Product Manufacturer: PurposeBuilt Brands added 12 products (with 27 SKUs) to their line of Safer Choice-certified products.
   
• Roger McFadden and Associates, LLC, Safer Choice Supporter: McFadden and Associates designed 21 products to meet Safer Choice criteria. Based on their pro bono technical recommendations, three health care facilities replaced eight cleaning products, amounting to 84,500 pounds, with Safer Choice-certified products.
   
• Rust-Oleum Corporation, Safer Choice Formulator-Product Manufacturer: Rust-Oleum increased their offering of Safer Choice-certified products by 19 percent to 16 products (with 42 SKUs). They also began focusing on using concentrates and refillable bottles to reduce plastic use and emissions, contributing to EPA’s goal of addressing climate change.
   
• Sea Mar Community Health Centers, Safer Choice Supporter: Sea Mar continued to act on the top two concerns for the Hispanic/Latino community identified during an earlier stakeholder meeting: the overuse of disinfectants and the common and dangerous practice of mixing cleaning products. Sea Mar conducted 100 trainings with Spanish-speaking households on safer cleaning practices, reaching 369 people with their training.
   
• Sensitive Home, Safer Choice Formulator-Product Manufacturer: All of Sensitive Home’s 14 dish, laundry, and surface cleaners became Safer Choice-certified in 2020. Sensitive Home designed their products for sensitive people, including those with skin sensitivities, compromised immune systems, and respiratory issues.
   
• Seventh Generation, Safer Choice Formulator-Product Manufacturer: Seventh Generation added 16 products, bringing their total to 66 Safer Choice-certified products. Seventh Generation also promoted their Safer Choice-certified products through digital and print marketing materials, including Safer Choice promotions through major e-commerce retail partners.
   
• University of Washington Department of Environmental and Occupational Health Sciences (UW DEOHS) Continuing Education Programs, Safer Choice Supporter: In response to a surge in calls to the Poison Control Center because of increased misuse of cleaning and disinfecting products in 2020, a team at the UW DEOHS collaborated with the Occupational Health and Safety Section of the American Public Health Association to publish a fact sheet on best practices for safer cleaning and disinfecting to prevent the spread of COVID-19. In both English and Spanish, the fact sheet highlights certified safer cleaning products, including those with the Safer Choice label and DfE-certified disinfectants and products with DfE-approved active ingredients.
   
• Wegmans Food Markets, Safer Choice Retailer: Wegmans added nine products (with 16 different SKUs) to their line of Safer Choice-certified products. Wegmans offers more than 70 SKUs of national brand Safer Choice-certified products.
   
• Wexford Labs, Inc., Formulator-Product Manufacturer: Wexford Labs has three DfE-certified products, after bringing on a new brand of disinfecting wipes in 2020. They also assisted their partners in obtaining DfE certifications for seven new private-label products.

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By Lynn L. Bergeson, Carla N. Hutton, and Richard E. Engler, Ph.D.
 
The U.S. Environmental Protection Agency (EPA) has posted a Compliance Advisory entitled “Applicability of the Toxic Substances Control Act to Chemicals made from Petroleum and Renewable Sources Used as Fuels and Fuel Additives and Distillates.”  The Compliance Advisory states that EPA is reaffirming that chemical substances used as fuels, fuel additives, and distillates made from either petroleum or renewable sources are subject to the Toxic Substances Control Act (TSCA).  Anyone who plans to manufacture (including import) a chemical made from petroleum or renewable sources must comply with the statutory and regulatory new chemical requirements under TSCA Section 5.  According to the Compliance Advisory, EPA has received stakeholder inquiries “as to whether fuel and fuel additives made from renewable sources (such as renewable naphtha) are subject to the TSCA new chemicals requirements under section 5.”  EPA states that it is issuing the Compliance Advisory “to affirm that fuel and fuel additives either made from petroleum or renewable sources are subject to TSCA and have been subject to its requirements since 1976.”
 
According to the Compliance Advisory, there are about 142 “naphthas” and 178 “distillates” (that compositionally can qualify as naphthas) currently on the TSCA Inventory, and they are considered Unknown, Variable composition, Complex, or Biological (UVCB) substances.  Any substance that is not on the TSCA Inventory is a new chemical under TSCA Section 5(a)(1)(A).  Prior to manufacture (including import) of a new chemical for commercial use, a premanufacture notice (PMN) must be filed with EPA under TSCA Section 5.  The Compliance Advisory includes several questions and answers (Q&A), including:
 
Can you manufacture or import a chemical substance made from a renewable source if it is not listed on the TSCA Inventory?
 
No.  Anyone who intends to manufacture (including import) a new chemical substance that is subject to TSCA for a non-exempt commercial purpose is required to submit a PMN at least 90 days prior to the manufacture of the chemical.  Manufacturers (importers) are in violation of TSCA if they fail to comply or are late in complying with TSCA notice requirements.  If you are required to submit a PMN, failure to do so is a violation of TSCA Section 15 and you may be subject to penalties.  PMN submissions must include all available data, pursuant to 40 CFR 720.45 and 720.50.  TSCA requires EPA to review the notice and make a determination; and, if appropriate, regulate the proposed activity.
 
EPA’s “compliance advisory” is disappointing.  It signals this EPA is disinclined to promote renewable petroleum cuts and essentially (and emphatically) reaffirms what we believe to be EPA’s inflexible and unimaginative stance on “source” being determinative in petroleum cut UVCBs.  This position, as we have noted in a variety of regulatory contexts, is a substantial disincentive to commercializing renewable petroleum cuts.  EPA’s view is especially problematic when a refinery might wish to use a combination of petroleum and renewable feedstocks to make a single naphtha (or other distillate) cut.
 
For example, to avail itself of the equivalence determination, a company would have to submit a PMN for the renewable equivalent of a petroleum cut, sign the almost certain resultant consent order (EPA will undoubtedly identify aquatic toxicity concerns and may also identify health concerns), commence manufacture, file a Notice of Commencement of Manufacture or Import (NOC), and then request an equivalency determination.  If EPA denies the equivalency determination, any downstream processor or user will have to either segregate the renewable products from the petroleum products so that the downstream entity can maintain records of compliance with the consent order or treat both the renewable and petroleum products as being subject to the order.  Neither option is commercially feasible or sustainable.
 
This sequence of events illustrates why commercial entities are disinclined to avail themselves of renewable sources in the distillate space.  EPA’s “compliance advisory” is an unexpected and, to many, unwanted parting gift from the Trump Administration.  The Biden Administration may wish to revisit the wisdom and prudence of this inflexible, antiquated, and inequitable view.

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By Lynn L. Bergeson and Carla N. Hutton
 
On June 30, 2020, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) released a report on its audit to determine whether the Safer Choice program effectively meets its goals and whether the program achieves quality standards through its product qualification, renewal, and required audit processes.  OIG states that EPA’s Safer Choice program does not have formal goals included in the fiscal year (FY) 2018-2022 EPA Strategic Plan, and the program has not reported results for FYs 2018-2019.  The program does have internal, non-outcome-oriented goals, however, which it is generally achieving.  The Safer Choice program’s goal is to add 200 Safer Choice products to the program and 25 chemicals to the Safer Chemical Ingredients List each year.  According to OIG, in FY 2019, EPA added 265 products and 24 chemicals.  OIG states that by not including formal goals for the Safer Choice program in EPA reports while continuing to receive Congressional funding and support, EPA limits not only accountability to Congress and the public, but also the extent that the program can use performance management information to make policy, budget, and management decisions.  OIG notes that the Safer Choice program has general controls in place for the required Safer Choice audit process, and EPA reviews audit summaries and corrective actions provided by third-party profilers (TPP).  EPA does not routinely review all supporting documentation, however, relying on TPPs to review and retain these documents.  Additionally, the Safer Choice program does not have procedures in place to conduct any formal performance reviews of TPPs or oversight reviews of TPP partner audits.  According to OIG, without periodic audit oversight, including full reviews of supporting documents and formal performance reviews of TPPs, EPA risks approving products that do not comply with the Safer Choice Standard.  OIG recommends that the Assistant Administrator for Chemical Safety and Pollution Prevention develop and publish adequate Safer Choice program goals and performance measures, establish and implement procedures for formal audit oversight of TPPs, amend its memorandums of understanding with TPPs to require performance reviews conducted by EPA, and collect and document TPP audit supporting information.

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