This webinar has been rescheduled from December 7, 2022. The new and correct date and time is December 14, 2022, 12:00 p.m. – 1:00 p.m. (EST).

Registration is open for the "Articles under TSCA" webinar on December 14, 2022, 12:00 p.m. - 1:00 p.m. (EST).

When the Toxic Substances Control Act (TSCA) was enacted in 1976, the U.S. Environmental Protection Agency (EPA) focused its attention on chemical substances and chemical mixtures, while largely exempting the regulation of chemicals in “articles,” generally meaning finished products or manufactured goods. EPA’s more recent announcement of its intent to regulate chemicals in articles to a much greater extent has caught many in the regulated industries off guard and reflects a significant shift in U.S. chemical regulation policy. This change in policy affects all commercial entities that deal with a physical product, as they must now become familiar with the law, its requirements, and the chemical makeup of their finished goods. This webinar will cover the policy changes that led to the regulation of articles, EPA’s authority to regulate these articles, and what companies need to know to stay in compliance.
 
Register now to join Richard E. Engler, Ph.D., Eve Gartner, and Lynn L. Bergeson for the Bergeson & Campbell, P.C. (B&C^®) webinar “Articles under TSCA.”

Topics Covered:  

• What products in commerce qualify as articles;
   
• What EPA’s change in approach means as a practical matter for the supply chain; and
   
• The importance and challenges of transparency in product sourcing.

Speakers Include:

Richard E. Engler, Ph.D. is Director of Chemistry with B&C. Dr. Engler is a 17-year veteran of EPA and is one of the most widely recognized experts in the field of green chemistry, having served as senior staff scientist in EPA’s Office of Pollution Prevention and Toxics (OPPT) and leader of EPA’s Green Chemistry Program. He has participated in thousands of TSCA substance reviews at EPA, as well as pre-notice and post-review meetings with submitters to resolve complex or difficult cases, and he draws upon this invaluable experience to assist B&C clients as they develop and commercialize novel chemistries.
 
Eve Gartner is the Managing Attorney for the Toxic Exposure and Health Program at Earthjustice, where she leads a team of professionals charged with protecting human health from toxic chemicals. Ms. Gartner works with groups around the country to develop state policies that will reduce exposures to chemicals and pesticides. She also serves as part of Project TENDR, a collaboration of scientists, health professionals, and children’s health advocates working to develop policy approaches to address the link between environmental exposure and neurodevelopmental disorders.
 
Lynn L. Bergeson, Managing Partner, B&C, has earned an international reputation for her deep and expansive understanding of how regulatory programs pertain to nanotechnology, industrial biotechnology, synthetic biology, and other emerging transformative technologies. Ms. Bergeson counsels corporations, trade associations, and business consortia on a wide range of issues pertaining to chemical hazard, exposure and risk assessment, risk communication, minimizing legal liability, and evolving regulatory and policy matters.

 By Lynn L. Bergeson and Carla N. Hutton
 
On November 15, 2022, a coalition petitioned the U.S. Environmental Protection Agency (EPA) under Section 21 of the Toxic Substances Control Act (TSCA) to require human and environmental health and safety testing for polyvinyl alcohol (PVA/PVOH) as it is used in consumer-packaged goods, “with particular attention to the use of PVA in laundry and dishwasher detergent pods and sheets.” The petitioners request that until such testing is completed, EPA remove PVA/PVOH from its Safer Choice Program “to curb plastic pollution.”
 
The coalition was filed on behalf of Blueland and Plastic Pollution Coalition, as well as the following “leading nonprofit organizations fighting plastic pollution and climate change”: Beyond Plastics; Plastic Oceans International; The Shaw Institute; Lonely Whale; 5 Gyres; GAIA (Global Alliance for Incinerator Alternatives); Oceanic Global Foundation; The Last Beach Cleanup; Rio Grande International Study Center; Inland Ocean Coalition; Occidental Arts and Ecology Center; Turtle Island Restoration Network; Friends of the Earth; Surfrider; and Made Safe.
 
The American Cleaning Institute (ACI) released a statement on November 15, 2022, regarding the “misinformation that is being spread about PVA/PVOH.” ACI states that it “believe[s] this recent effort by NGOs to petition the EPA is part of an ongoing marketing campaign funded by a company with an interest in preventing other companies from using this technology.” According to ACI, the marketing campaign “ignores decades of science and research demonstrating the biodegradability of this chemistry.”
 
EPA is required to grant or deny TSCA Section 21 petitions within 90 days from the day the petition is filed with EPA. If EPA grants the petition, EPA must promptly commence an appropriate proceeding. If EPA denies the petition, EPA must publish the reasons for its denial in the Federal Register.

By Lynn L. Bergeson and Carla N. Hutton
 
On November 10, 2022, California filed suit in California Superior Court against the manufacturers of per- and polyfluoroalkyl substances (PFAS) “for endangering public health, causing irreparable harm to the state’s natural resources, and engaging in a widespread campaign to deceive the public.” According to California Attorney General Rob Bonta’s November 10, 2022, press release, California “alleges that these manufacturers, including 3M and DuPont, knew or should have known that PFAS are toxic and harmful to human health and the environment, yet continued to produce them for mass use and concealed their harms from the public.” California claims that as a result, “these toxic ‘forever chemicals’ are pervasive across California’s bays, lakes, streams, and rivers; in its fish, wildlife, and soil; and in the bloodstream of 98% of Californians.” The complaint claims that the manufacturers “created and/or contributed to a public nuisance, harmed and destroyed natural resources, marketed defective products, failed to provide adequate warnings concerning the use of their products, and engaged in unlawful business practices.”
 
The press release states that the lawsuit concerns seven common PFAS that have been detected in drinking water supplies, surface waters, and groundwater in California: perfluorooctanoic acid (PFOA); perfluorooctanesulfonic acid (PFOS); perfluorobutanesulfonic acid (PFBS); perfluorohexanesulfonic acid (PFHxS); perfluorohexanoic acid (PFHxA); perfluoroheptanoic acid (PFHpA); and perfluorononanoic acid (PFNA). California requests statewide treatment and destruction of PFAS, including, but not limited to, the treatment of drinking water by regulated water systems; water drawn from private wells and unregulated systems used for drinking water and irrigation; and water from other wastewater treatment plants and systems. California also seeks payment of funds necessary to mitigate the impacts to human health and the environment through environmental testing, medical monitoring, public noticing, replacement water (for period between testing and installation of treatment), and safe disposal and destruction.

By Lynn L. Bergeson and Carla N. Hutton

Research in the U.S. Environmental Protection Agency’s (EPA) Office of Research and Development (ORD) is organized around six highly integrated and transdisciplinary national research programs that are closely aligned with EPA’s strategic goals and cross-EPA strategies. Each program is guided by a Strategic Research Action Plan (StRAP) developed by EPA with input from its many internal and external partners and stakeholders. In October 2022, EPA published six StRAPs for fiscal years (FY) 2023-2026. EPA states that the StRAP for Chemical Safety for Sustainability (CSS) “is focused on addressing the pressing environmental and health challenge of a lack of sufficient information on chemicals needed to make informed, risk-based decisions.” The StRAP for CSS states that CSS will continue to:

• Develop the science needed to reduce, refine, and replace vertebrate animal testing consistent with EPA policies;
• Accelerate the pace of chemical assessment to enable our partners to make informed and timely decisions concerning the potential impacts of environmental chemicals on human health and the environment; and
• Provide leadership to transform chemical testing, screening, prioritization, and risk assessment practices.

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on November 10, 2022, that it is requesting nominations of prospective candidates for membership on the Science Advisory Committee on Chemicals (SACC) established under the Toxic Substances Control Act (TSCA). 87 Fed. Reg. 67898. Any interested person or organization may nominate qualified persons to be considered for appointment to the SACC. Individuals may also self-nominate. Nominations are due December 12, 2022.
 
SACC serves as a scientific peer review mechanism of EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP). According to EPA, SACC provides independent scientific advice and recommendations to EPA on the scientific basis for risk assessments, methodologies, and pollution prevention measures and approaches for chemicals regulated under TSCA. Currently, there are 17 SACC members, with eight membership terms that will expire over the next year.
 
EPA states that its “rigorous scientific peer review processes ensure all Agency decisions are founded on credible science and data. Science provides the foundation for EPA policies, actions and decisions made on behalf of the American people.”
 
To be considered, all nominations should include the following information:

• Current contact information for the nominee (including the nominee’s name, organization, current business address, e-mail address, and daytime telephone number);
   
• The nominee’s disciplinary and specific areas of expertise;
   
• Research activities;
   
• Recent service on other federal advisory committees and national or international professional organizations; and
   
• When available, a biographical sketch of the nominee, indicating current position and educational background.

EPA states that it is seeking nominations from individuals who have demonstrated high levels of competence, knowledge, and expertise in scientific and other technical fields relevant to chemical safety and risk assessment. EPA seeks nominees with expertise in a variety of disciplines and focus areas, including human health and ecological risk assessment, biostatistics, epidemiology, pediatrics, physiologically based pharmacokinetics (PBPK), toxicology and pathology (including neurotoxicology, developmental/reproductive toxicology, and carcinogenesis), and chemical exposure pathways to susceptible life stages and subpopulations (women, children, and other potentially exposed subpopulations).
 
EPA states that nominees should have backgrounds and experiences that would contribute to the diversity of scientific viewpoints on the committee -- including professional experiences in government, labor, public health, public interest, animal protection, industry, and other groups -- and as the EPA Administrator determines to be advisable (e.g., geographical location; social and cultural backgrounds; and professional affiliations).

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on November 9, 2022, that it awarded $7,770,044 in research grant funding to 11 institutions to develop and evaluate innovative methods and approaches to inform its understanding of the human health risks that may result from exposure to chemical mixtures in the environment. EPA states that toxicology studies have traditionally focused on the effects of single chemicals on human health. Chemicals in the environment are often present as mixtures in the air, water, soil, food, and products in commerce, however, and these chemical mixtures include per- and polyfluoroalkyl substances (PFAS), phthalates, polycyclic aromatic hydrocarbons (PAH), disinfection byproducts (DBP), and other well-characterized mixtures. According to EPA, there is a need to assess the toxicity of chemical mixtures to understand how their combined effects on human health and the environment differ from what is known about individual chemicals. Due to their lower cost and higher throughput, new approach methods (NAM) and use of alternative animal models have emerged as potential approaches to advance the risk assessment of mixtures.
 
To help address this research need, the institutions receiving these grants will conduct research focused on the development, improvement, evaluation, and integration of predictive toxicology methods to evaluate environmental chemical mixtures. The grantees and their project titles include:

• Georgia Institute of Technology, Atlanta, Georgia -- High-Throughput Lung Damage and Inflammation Assessment of Polyaromatic Hydrocarbon Mixtures;
   
• Medical University of South Carolina, Charleston, South Carolina -- Developing an Integrated Framework for Evaluating Toxicity of Real-life Chemical Mixtures;
   
• Purdue University, West Lafayette, Indiana -- Protein Binding Affinity as the Driver for Studying PFAS Mixture Toxicity;
   
• The Research Foundation of CUNY, New York, New York -- Innovative Approach to Assess the Effect of Metal Mixtures from Infant Meconium Associated with Adverse Infant Outcomes by Identifying Methylation Loci in Mothers and Infants;
   
• Texas A&M University, College Station, Texas -- A Tiered Hybrid Experimental-Computational Strategy for Rapid Risk Assessment of Complex Environmental Mixtures Using Novel Analytical and Toxicological Methods;
   
• University at Buffalo, Buffalo, New York -- Assessment of Neurotoxicity of Mixtures of PFAS and Other Neuroactive Organic Pollutants through Integrated in Silico, in Vitro Cellular, and in Vivo Models;
   
• University of Georgia Research Foundation, Inc., Athens, Georgia -- Development of a Quantitative Adverse Outcome Pathway Network to Assess Neurodevelopmental Toxicity of PFAS Mixture in C. Elegans;
   
• University of Houston, Houston, Texas -- Oral Toxicity Assessment of PAH Mixtures Using an in Vitro 3D Cell Culture Bioreactor Mimicking the in Vivo Intestinal Tract Environment;
   
• University of Massachusetts Boston, Boston, Massachusetts -- Whole Animal New Approach Methodologies for Predicting Developmental Effects of Air Pollutant Mixtures;
   
• University of North Carolina at Chapel Hill, Chapel Hill, North Carolina -- Wildfire Smoke Mixtures Toxicity Testing; and
   
• Wayne State University, Detroit, Michigan -- Assessment of Underlying Molecular Mechanisms Promoting Adipogenic Outcomes in Complex Mixtures.

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.

By Lynn L. Bergeson and Carla N. Hutton
 
On November 1, 2022, the U.S. Environmental Protection Agency (EPA) announced 26 Safer Choice Partner of the Year award winners, recognizing their achievements in the design, manufacture, selection, and use of products with safer chemicals. The awardees represent a wide variety of organizations, including small- and medium-sized businesses, women-owned companies, state and local governments, non-governmental organizations, and trade associations.
 
EPA encouraged applicants for the 2022 awards to show how their work advances environmental justice, bolsters resilience to the impacts of climate change, results in cleaner air or water, or improves drinking water quality. According to EPA, many of the organizations being recognized are working to reduce greenhouse gas (GHG) emissions and combat the climate crisis. For example, several winners offer products with concentrated formulas that reduce water consumption and plastic use. This practice also lowers GHG emissions by reducing the amount of product that must be transported.
 
EPA states that additionally, many awardees increased access to products with safer chemical ingredients in underserved and overburdened communities. For example, one nonprofit winner conducted targeted outreach in both English and Spanish to promote safer cleaning techniques and products, including Safer Choice-certified products, in food trucks. Many of these businesses are owned and operated by immigrant entrepreneurs. Another winner made its Safer Choice-certified product line more accessible to lower income shoppers by offering affordable prices and making these products available at retailers that often serve low-income communities.
 
In early 2023, EPA intends to build on this work by announcing a grant opportunity for projects that can increase supply and demand for safer, environmentally preferable products such as those certified by the Safer Choice program or identified by EPA’s Environmentally Preferable Purchasing program.
 
The 2022 winners include:

• American Cleaning Institute, District of Columbia;
• The Ashkin Group, LLC, Channel Islands Harbor, California;
• Bona US, Englewood, Colorado;
• Case Medical, Bloomfield, New Jersey;
• Church & Dwight Co., Inc., Ewing, New Jersey;
• Clean Safety & Health in Food Trucks (CleanSHiFT) Team, Seattle, Washington;
• The Clorox Company, Oakland, California;
• Colgate-Palmolive, New York, New York;
• Design for the Environment Logo Redesign Coalition: Environmental Defense Fund, The Natural Resources Defense Council, The Clorox Company, The Procter & Gamble Company, and Reckitt;
• Dirty Labs Inc., Portland, Oregon;
• ECOS, Cypress, California;
• Grove Collaborative, San Francisco, California;
• The Hazardous Waste Management Program, Seattle, Washington;
• Holloway House, Inc., Fortville, Indiana;
• The Home Depot, Atlanta, Georgia;
• Household & Commercial Products Association, District of Columbia;
• Jelmar, LLC, Skokie, Illinois;
• Lemi Shine, Austin, Texas;
• LightHouse for the Blind and Visually Impaired, San Francisco, California;
• Mother Africa, Kent, Washington;
• Novozymes North America, Raleigh, North Carolina;
• The ODP Corporation, Boca Raton, Florida;
• The Procter & Gamble Company, Cincinnati, Ohio;
• PurposeBuilt Brands, Gurnee, Illinois;
• Sensitive Home, Greenbrae, California; and
• Solutex, Sterling, Virginia.

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) has provided a report to Congress on its capacity to implement certain provisions of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act). The report provides point-in-time estimates of EPA’s current estimated capacity and resources needed to implement the 2016 Lautenberg Act amendments to the Toxic Substances Control Act (TSCA). EPA states that it recognizes its responsibility to identify and implement opportunities to reduce costs as it incorporates lessons learned since the Lautenberg Act was enacted and builds the scientific, regulatory, and other infrastructure needed to implement the program effectively. For example:

• The resources included in President Biden’s fiscal year (FY) 2023 budget request would allow EPA to modernize its information technology (IT) systems, which at times hinder and significantly slow chemical review work. These improvements will ultimately reduce TSCA implementation costs;
• The resources included in the FY 2023 budget request would allow EPA to increase and further diversify the expertise of the TSCA program’s scientific workforce, which will reduce re-work and enable more timely and robust chemical reviews, and thus ultimately reduce TSCA implementation costs;
• As EPA further develops its scientific and regulatory tools (including but not limited to systematic review, techniques to assess chemical risks to potentially exposed and susceptible subpopulations, and potential measures to address occupational safety), EPA expects costs of developing these tools to decrease;
• EPA has made significant efforts to enhance its intra- and inter-agency coordination to improve the efficiency of the prioritization, risk evaluation, and regulatory processes by identifying and resolving concerns earlier, thus increasing EPA’s capacity to implement the Lautenberg Act in accordance with statutory deadlines; and
• Many of the first 30 chemicals subject to the amended TSCA risk evaluation and regulatory process are high production volume substances used by many sectors for many purposes, and about which health and environmental concerns are known to exist. As EPA continues to meet the TSCA mandate continuously to select and evaluate chemical substances from among the thousands of chemical substances in commerce, it is reasonable to expect that a reduction in the scope and complexity of each risk evaluation, as well as the associated risk management actions, would reduce implementation costs.

According to the report, the combination of the resources included in Biden’s FY 2023 budget request, an amended fees rule, and EPA’s ongoing efforts to build and improve the scientific, regulatory, and other infrastructure needed to implement TSCA more efficiently should, over time, reduce the levels of resources needed in the future. Our forthcoming memorandum will include a detailed summary of the proposed rule and an insightful commentary.

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.

By Lynn L. Bergeson and Carla N. Hutton
 
On October 26, 2022, the Biden Administration announced that it is expanding the Industrial Control Systems (ICS) Cybersecurity Initiative to the chemical sector. The White House’s fact sheet states that the majority of chemical companies are privately owned, so a collaborative approach is needed between the private sector and government. According to the fact sheet, “[t]he nation’s leading chemical companies and the government’s lead agency for the chemical sector -- the Cybersecurity and Infrastructure Agency (CISA) -- have agreed on a plan to promote a higher standard of cybersecurity across the sector, including capabilities that enable visibility and threat detection for industrial control systems.”
 
The fact sheet states that the Chemical Action Plan will serve as a roadmap to guide the sector’s assessment of their current cybersecurity practices over the next 100 days, building on the lessons learned and best practices of the previously launched action plans for the electric, pipeline, and water sectors to meet the needs for this sector. The Chemical Action Plan will:

• Focus on high-risk chemical facilities that present significant chemical release hazards with the ultimate goal of supporting enhanced ICS cybersecurity across the entire chemical sector;
• Drive information sharing and analytical coordination between the federal government and the chemical sector;
• Foster collaboration with the sector owners and operators to facilitate and encourage the deployment of appropriate technologies based on each chemical facility’s own risk assessment and cybersecurity posture. The federal government will not select, endorse, or recommend any specific technology or provider; and
• Support the continuity of chemical production critical to the national and economic security of the United States. The chemical sector produces and manufactures chemicals that are used directly or as building blocks in the everyday lives of Americans, from fertilizers and disinfectants to personal care products and energy sources, among others.

The ICS Cybersecurity Initiative emphasizes that cybersecurity continues to be a top priority for the Administration.

By Lynn L. Bergeson and Carla N. Hutton
 
The California Department of Toxic Substances Control (CDTSC) invites stakeholders to two external engagement sessions, on November 1 and November 3, 2022, to share their perspectives on an actionable definition of sustainable chemistry. CDTSC states that stakeholders’ participation and expertise can help refine a draft, consensus definition and set of criteria for sustainable chemistry. According to CDTSC, the draft definition and criteria were developed over the past six months by a 20-person Expert Committee on Sustainable Chemistry (ECOSChem) that includes representatives from industry, academia, and governmental and non-governmental organizations, including a representative from the Safer Consumer Products Program (SCP). The charge of ECOSChem is to establish “an ambitious, actionable definition and criteria for sustainable chemistry that can enable effective government policy, inform business and investor decision making, enhance chemistry education, and spur the adoption across all supply chains of chemicals that are safer and more sustainable.” More  information about the project is available in a background document.
 
The ECOSChem process is facilitated and supported by Beyond Benign and the Lowell Center for Sustainable Production (LCSP), who will host two external engagement meetings. CDTSC asks participants to register in advance for the November 1, 2022, meeting or the November 3, 2022, meeting. During the meetings, the Project Team will introduce the project and the draft definition and criteria (15 minutes). Participants will then move into small groups organized by sector that will be moderated by ECOSChem members (45 minutes), followed by a wrap-up session where key input will be shared with the large group with time for discussion (30 minutes). Discussion materials for these meetings will be sent out on October 31, 2022.

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) will hold a webinar on October 27, 2022, in its Computational Toxicology and Exposure Communities of Practice (CompTox Communities of Practice) series on “Analysis of High-Throughput Profiling Assays in Chemical Safety Screening.” The abstract for the webinar states that recent technological advancements have led to the development of new high-throughput profiling methods, such as transcriptomics, that can be used to screen rapidly chemicals for potential hazards. Decreasing costs have made it feasible to profile all protein-coding genes across thousands of samples, allowing for broad evaluation of many target pathways and modes of action in a single screening assay. Similarly, it is now possible to apply high-content imaging across many different chemical exposures to capture a variety of changes in cell morphology. According to the abstract, such methods have been applied to in vitro chemical screening studies, including screening studies at EPA that were recently released on the CompTox Chemicals Dashboard. These types of data can be used for both hazard prediction and potency estimation, thereby informing risk assessments and prioritizing chemicals for further testing.
 
The abstract notes that assessing the reliability and reproducibility of these screening platforms is critical to their utility in regulatory applications. While these platforms often have lower signal-to-noise ratios compared to individual targeted assays, the resulting data are also high-dimensional, allowing for the analysis of consistent trends across many molecular endpoints. The webinar will provide an overview of computational methods and best practices for reliable analysis of high-throughput profiling data in a variety of use cases and will highlight the recent data release on the CompTox Chemicals Dashboard. Registration is open.

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Government Accountability Office (GAO) released a report on October 19, 2022, entitled “Persistent Chemicals: EPA Should Use New Data to Analyze the Demographics of Communities with PFAS in Their Drinking Water.” The Congressional requesters asked GAO to examine per- and polyfluoroalkyl substances (PFAS) contamination in drinking water and related state actions. GAO’s report examines what recent data from selected states show about the occurrence of PFAS in drinking water; the demographic characteristics of communities in selected states with and without PFAS in their drinking water; and factors that influenced states’ decisions to test and develop standards or guidance for PFAS in drinking water. GAO states that recent drinking water data from six selected states show that at least 18 percent of the states’ 5,300 total water systems had at least two PFAS -- perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS) --above the U.S. Environmental Protection Agency’s (EPA) 2022 interim revised health advisory levels. GAO found that 978 water systems had the two PFAS at or above EPA’s minimum reporting level of 4 parts per trillion (ppt), the lowest level reliably quantified by most laboratories, and above EPA’s health advisory levels. The demographic characteristics of communities with PFAS in their drinking water varied in the states GAO examined. GAO states that according to EPA officials, EPA does not currently have information to determine the extent to which disadvantaged communities are exposed to PFAS in drinking water nationally; EPA plans to collect comprehensive nationwide data, however.
 
GAO states that according to state officials, public health and PFAS contamination concerns influenced some states’ decisions to test and develop enforceable standards or nonenforceable guidance for PFAS in drinking water. As of July 2022, six states set standards and were influenced to do so by public health concerns. When the states set standards, the levels they set were more stringent than EPA’s 2016 lifetime health advisory levels. Fourteen additional states developed guidance or began developing standards because of PFAS contamination.
 
GAO recommends that EPA conduct a nationwide analysis using comprehensive data to determine the demographic characteristics of communities with PFAS in their drinking water. EPA agreed with the recommendation.

By Lynn L. Bergeson and Carla N. Hutton
 
On October 13, 2022, Earthjustice, on behalf of a coalition of environmental organizations and community advocates, petitioned the U.S. Environmental Protection Agency (EPA) to revoke the approval of approximately 600 per- and polyfluoroalkyl substances (PFAS) that were granted through low volume exemptions (LVE) or low release and low exposure exemptions (LoREX) to the premanufacture notice (PMN) requirements of the Toxic Substances Control Act (TSCA). In its October 13, 2022, press release, Earthjustice states that these exemptions “allow EPA to approve chemicals through lax safety reviews only if it ‘will not present an unreasonable risk’ to humans or the environment.” According to Earthjustice, PFAS do not meet that standard, and EPA must revoke previously granted LVEs and LoREXs for PFAS. The petition follows an April 27, 2021, petition filed by Earthjustice on behalf of many of the same petitioners, and it incorporates the 2021 petition by reference.
 
The petition requests the following actions:

• For all outstanding LVEs and LoREXs granted for PFAS, EPA must make a preliminary determination that these LVEs and LoREXs do not meet the terms of TSCA Section 5(h)(4) or 40 C.F.R. Section 723.50(d);
• For all outstanding LVEs and LoREXs granted for PFAS, EPA must notify their manufacturers that it believes their substance does not meet the requirements for a PMN exemption and then proceed to make a final determination based on the current science that no PFAS meets the TSCA Section 5(h)(4) standard for a PMN exemption, taking into account potentially exposed or susceptible subpopulations, in accordance with the protocols set forth in 40 C.F.R. Section 723.50(h);
• In the alternative, EPA must individually re-assess all PFAS for which there is an outstanding LVE and/or LoREX to determine whether the substance meets the standard set forth in 40 C.F.R. Section 723.50(d) and in TSCA Section 5(h)(4); and
• Petitioners incorporate by reference all of the requests set forth in the 2021 petition and reiterate the same requests here:
• EPA must initiate a rulemaking to prohibit: (a) future use of the byproducts exemption for new PFAS; and (b) continued manufacture of any PFAS byproduct under the auspices of the byproducts exemption unless and until such PFAS has undergone a full PMN review and been approved by EPA, with a two-year window for manufacturers to receive such approval; and
• EPA should immediately stop permitting the use of the LVE, LoREX, and polymer exemption for any new PFAS.