By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on October 28, 2022, that it awarded $748,180 in research grant funding to three institutions for research to improve understanding of how people are exposed to per- and poly-fluoroalkyl substances (PFAS) in several communities throughout the country. EPA states that there is evidence that continued exposure above specific levels to certain PFAS may lead to adverse health effects. According to EPA, more data are needed to measure the nature and levels of PFAS in homes and food to understand pathways for human exposure and risk mitigation.
 
The following institutions are receiving awards:

• Silent Spring Institute, Newton, Massachusetts, to measure PFAS in air and dust in homes and to evaluate associations between potential residential sources and PFAS occurrence at home. According to EPA, this research will enhance understanding of the contribution of residential pathways to PFAS exposures and improve the interpretation of PFAS biomonitoring data;
   
• Duke University, Durham, North Carolina, to determine how different sources of PFAS exposure, including PFAS in drinking water and in homes, contribute to levels measured in blood. EPA states that this study will address key questions on the most relevant PFAS exposure pathways for the general U.S. population; and
   
• Emory University, Atlanta, Georgia, to develop a standardized, validated, scientific protocol to measure levels of a targeted set of PFAS in the home. According to EPA, data collected from home samples will be compared to data collected from PFAS in blood to help identify residential sources of PFAS measured in people’s blood.

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Department of State (State Department) will hold a joint meeting from 2:00 p.m. to 3:30 p.m. (EDT) on September 22, 2022, to discuss United Nations Environment Assembly (UNEA) Resolution 5/8 and the related upcoming first session of the ad hoc open-ended working group (OEWG) on a science-policy panel (SPP) to contribute further to the sound management of chemicals and waste. In Resolution 5/8, UNEA states that an SPP should be established to contribute further to the sound management of chemicals and waste and to prevent pollution. UNEA further decided to convene, subject to the availability of resources, an OEWG to prepare proposals for the SPP, to begin work in 2022 with the ambition of completing it by the end of 2024. According to the resolution, the principal functions of the SPP should include:

• Undertaking “horizon scanning” to identify issues of relevance to policymakers and, where possible, proposing evidence-based options to address them;
• Conducting assessments of current issues and identifying potential evidence-based options to address, where possible, those issues, in particular those relevant to developing countries;
• Providing up-to-date and relevant information, identifying key gaps in scientific research, encouraging and supporting communication between scientists and policymakers, explaining and disseminating findings for different audiences, and raising public awareness; and
• Facilitating information sharing with countries, in particular developing countries seeking relevant scientific information.

The first session of the OEWG will be held in two parts, with the first part taking place on October 6, 2022, in a hybrid format, while the second part will be held in person in Bangkok early in the first quarter of 2023.
 
Industry and environmental non-governmental organization (NGO) stakeholders who would like to participate in the joint meeting on September 22, 2022, should .(JavaScript must be enabled to view this email address) by 10:00 a.m. (EDT) on September 22, 2022. This meeting is for U.S. stakeholders only and is not open to non-U.S. organizations, companies, or individuals.

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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 

Since the U.S. Supreme Court issued its blockbuster ruling in West Virginia v. EPA, 597 US _ 2022 WL 2347278 (June 30, 2022), many are asking whether the Court’s amplification of the “major questions doctrine” (MQD) might be used to seek to limit the U.S. Environmental Protection Agency’s (EPA) authority in implementing Congress’s 2016 amendments to the Toxic Substances Control Act (TSCA), the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act).
 
The answer is yes. West Virginia will henceforth be cited with predictable regularity in claiming that EPA, or any federal agency for that matter, has taken final agency action in what detractors will claim is an “extraordinary case” with outsized “economic and political significance” that, as Chief Justice John Roberts somewhat glibly noted, “raise[s] an eyebrow.” The full text of this article, written by Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C. (B&C^®) for Chemical Watch, is available here.

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency’s (EPA) New Chemicals Program will hold a webinar on Wednesday, July 27, 2022, from 1:00 - 2:00 p.m. (EDT). During the webinar, EPA will provide an in-depth look at its analysis of common issues that cause EPA to have to reconduct risk assessments (“rework”) before taking questions from the audience. As reported in our June 27, 2022, memorandum, in June 2022, EPA announced a broad outreach effort to describe and to discuss with stakeholders how EPA evaluates engineering data (i.e., data related to environmental release and worker exposure) provided for new chemicals submissions under the Toxic Substances Control Act (TSCA) and common issues that cause EPA to have to rework risk assessments for these submissions.
 
Registration for the July 27, 2022, webinar is open. According to EPA, subsequent webinars over the coming months will communicate its considerations in evaluating qualitative claims or quantitative data, especially when they deviate from model defaults such as those used in the Chemical Screening Tool for Exposures and Environmental Releases (ChemSTEER) and its considerations for evaluating information about sites not controlled by the submitter. EPA will release information about these webinars, including dates and instructions on how to register, as it becomes available.

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Bergeson & Campbell, P.C. (B&C^®) is pleased to provide our Forecast 2022 to TSCAblog^® readers, offering our best informed judgment as to the trends and key developments we expect to see in the new year. In 2022, the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT) will continue to focus on implementing the 2016 Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg) amendments to the Toxic Substances Control Act (TSCA), including the development of required risk evaluations and risk management actions on certain existing chemicals, review of and determinations on new chemical premanufacture notices (PMN), and issuance of a final rule requiring the reporting of hazard and exposure information on per- and polyfluoroalkyl substances (PFAS). In 2022, OPPT is also expected to initiate the prioritization for risk evaluation of certain chemicals to replace in the TSCA risk evaluation pipeline those “high-priority” chemicals for which risk evaluations may be completed in late 2022 or 2023. More details on this, and expected regulatory changes of all varieties, are available in our Forecast for U.S. Federal and International Chemical Regulatory Policy 2022.

WEBINAR
“What to Expect in Chemicals in 2022”
January 26, 2022, 12:00 p.m. EST
Register Now

B&C will be presenting a complimentary webinar, “What to Expect in Chemicals in 2022,” focusing on themes outlined in the forecast. Join Lynn L. Bergeson, Managing Partner; Richard E. Engler, Ph.D., Director of Chemistry; and James V. Aidala, Senior Government Affairs Consultant, for this informative and forward-looking webinar.

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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 and Carla N. Hutton
 
On August 19, 2021, the U.S. Environmental Protection Agency (EPA) announced a collaborative agreement with Unilever to explore better ways to assess chemical risks associated with consumer products. According to EPA, this agreement builds on prior cooperation between EPA and Unilever regarding New Approach Methods (NAM), “which are a promising alternative to conventional toxicity testing that are intended to reduce reliance on the use of animals.” EPA states that the collaboration aims to establish a framework for the Next Generation of Risk Assessments based on NAMs. The collaboration will bring together more than $2 million in both monetary and in-kind contributions, including scientific expertise and equipment, to develop a comprehensive NAMs dataset for a minimum of 40 chemicals. According to EPA, the chemicals will be selected and grouped such that half will be benign and the other half will have known adverse implications for human health. These chemicals will be tested using a wide variety of NAMs, and the results will be compared between the two groups to determine how well particular NAMs can infer differences in risk. EPA states that these data will be used in case studies to evaluate the potential to use NAMs in regulatory decisions. All data generated through the collaboration will be in the public domain, allowing academic, corporate, government, and nonprofit scientists to use the project results in their own research.
 
EPA states that in addition to the data generated through the collaboration, EPA and Unilever will use chemical data from EPA’s high-throughput screening efforts and the federal government’s Tox21 consortium, which is a collaboration among EPA, the National Institutes of Health (NIH), and the U.S. Food and Drug Administration (FDA). According to EPA, “[t]hese automated chemical screening technologies rapidly test thousands of chemicals for their effects on human cells or cellular components that are critical to normal function.” EPA notes that data from these technologies are then incorporated into computational models to predict potential adverse health effects and estimate the amount of chemical that may cause these effects.

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By Lynn L. Bergeson and Carla N. Hutton
 
Effective May 21, 2021, Yvette T. Collazo has resigned as the Director of the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT). Collazo began as OPPT Director in March 2020. During her tenure, OPPT’s accomplishments include:

• Publishing final risk evaluations for the first ten chemicals reviewed under the amended Toxic Substances Control Act (TSCA) and initiating the risk evaluation process for the next 20 high-priority chemicals;
• Beginning risk management activities for the first ten chemicals, including public engagement and consultations with tribal and environmental justice communities;
• Issuing final rules to reduce exposures to five persistent, bioaccumulative, and toxic (PBT) chemicals;
• Proposing revisions to the TSCA fees rule;
• Increasing transparency by conducting and updating data on TSCA Confidential Business Information reviews, publishing updated 2016 Chemical Data Reporting (CDR) information, updating the TSCA Inventory, and making additional information on new chemical submissions available in ChemView;
• Recognizing significant stakeholder achievements through the 2020 Safer Choice and Green Chemistry Awards;
• Re-organizing OPPT to align new chemicals, existing chemicals, confidential information/transparency, and “forward-looking” data collection functions structurally; and
• Establishing an Office for Project Management and Operations that is intended to manage effectively and efficiently the TSCA Program.

More information on these developments is available on our website in our TSCA memoranda.

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on May 11, 2021, that it has launched a new application in the Central Data Exchange (CDX), EPA’s electronic reporting site, that will allow users to submit electronically certain communications under the Toxic Substances Control Act (TSCA).  According to EPA, the new application provides users with a faster, secure, and more convenient way to comply with TSCA reporting requirements and is “expected to be used for hundreds of individual communications every year.”
 
EPA states that the application is located within the Chemical Safety and Pesticide Programs (CSPP) data flow and supports numerous types of communications, including General Confidential Correspondence, Requests for Chemical Information, Pre-manufacture Notice (PMN) Corrections for Submissions made Prior to 2016, and Copy of Record Requests.  Previously, these types of communications were required to be sent to EPA in hard copy.  EPA will continue to accept paper documents, but recommends submitting TSCA communications electronically when possible “since paper communications could take longer to process.”

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