Bergeson & Campbell, P.C. (B&C®) is a Washington, D.C. law firm providing chemical and chemical product stakeholders unparalleled experience, judgment, and excellence in matters relating to TSCA, and other global chemical management programs.
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on December 7, 2022, that the final video recording, slide deck, and case study worksheets from the CompTox Chemicals Dashboard virtual training are now available. EPA also announced that the Dashboard recently released a new version (v2.1.1). New features include:

  • A new link to an updated set of Help Pages containing new information;
  • Ability to visualize structures in Batch Search;
  • Ability to filter out chemicals that are structures;
  • Moving the chemistry-related data tabs under a single tab;
  • reCAPTCHA implementation to ensure continued functionality;
  • Updating the Production Volume data;
  • Updating the ADME > IVIVE table using the latest HTTK R-package v2.2.1 algorithm; and
  • Several bug fixes.

EPA suggests that if users do not see these updates to try clearing the cache.

The recordings and slides from the October 12-13, 2022, EPA New Approach Methods (NAM) Conference are available on the conference web page. Conference topics included:

  • Variability and Relevance of Traditional Toxicity Tests;
  • Evolution of Validation and Scientific Confidence Frameworks to Incorporate 21st Century Science; and
  • Breakout groups discussing Variability of Traditional Toxicity Tests, Relevance of Traditional Toxicity Tests, and Feedback on EPA Scientific Confidence Framework.

 
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By Lynn L. Bergeson and Carla N. Hutton
 
Under the Reports Consolidation Act of 2000, each agency’s inspector general must prepare an annual statement summarizing what the inspector general considers to be “the most serious management and performance challenges facing the agency” and to assess briefly the agency’s progress in addressing those challenges. On November 29, 2022, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) released its report regarding EPA’s fiscal year (FY) 2023 top management challenges. According to the report, the eight top management challenges for EPA in FY 2023 include:

  • Providing for the Safe Use of Chemicals: The public must be able to depend on the EPA’s ability to conduct credible and timely assessments of the risks posed by pesticides, toxic chemicals, and other environmental chemicals.

OIG states in its full report that it conducted an evaluation in 2020 of EPA’s progress toward meeting deadlines established by the Toxic Substances Control Act (TSCA) as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act), focusing primarily on TSCA’s existing chemicals program. OIG recommended that the Office of Chemical Safety and Pollution Prevention (OCSPP) assistant administrator publish the annual existing chemicals plan, including the anticipated implementation efforts and required resources; conduct a workforce analysis to assess the Office of Pollution Prevention and Toxics’ (OPPT) capability to implement TSCA; and specify what skill gaps had to be filled in FY 2021 to meet the TSCA requirements. According to OIG, on February 7, 2022, OCSPP certified that it had completed all corrective actions for the recommendations in its report. More information on OIG’s 2020 report is available in our August 18, 2020, blog item.
 
OIG notes that an audit of TSCA’s New Chemicals Review Process is currently ongoing as part of its FY 2022 Oversight Plan. According to OIG, the objective of that review is to determine the extent to which EPA is using and complying with applicable records-management and quality-assurance requirements and employee performance standards to review and approve new chemicals under TSCA to manage human health and environmental risks.
 
According to OIG, per EPA, “an increased workload and the need for resources -- especially staff trained in specific science skills -- are major factors in not being on track to meet many of the EPA’s statutory deadlines.” Citing a trade press article, OIG states that “[s]pecifically, the OCSPP stated that it does not have the resources to address statutory requirements. The OCSPP also stated that it has not received the necessary funding to complete its mission.” For example, OCSPP reports that it has approximately 310 full-time equivalent staff but estimates that it needs about 500 full-time equivalents for its mission. EPA also cited a lack of resources for its failure to post publicly the risk reports for 1,240 new chemicals.
 
In FY 2022, EPA requested an additional $15 million and 87.6 full-time equivalents -- a 35 percent increase from the FY 2021 enacted full-time equivalent level -- to meet the increased responsibilities from the Lautenberg Act. The FY 2022 enacted budget provided for 25.6 full-time equivalents for TSCA programs, however. Furthermore, according to OIG, OCSPP conducted a recent assessment that recommended that the office hire more staff, mitigate the workload to manage the workforce’s daily stress, modernize information technology (IT) systems, and eliminate the use of multiple tracking systems.
 
OIG concludes that many of the Biden Administration’s top priorities rely on the work of the OCSPP. Both EPA OIG and EPA have noted that key OCSPP programs face a steep staffing shortage and a lack of planning that could negatively impact critical chemical work, however. Absent the resources OCSPP needs for its TSCA programs, EPA “will remain challenged with meeting its statutory deadlines.” OIG states that if OCSPP is unable to balance the workload with its resource needs, EPA “will continue to face the key challenge of ensuring the safety of chemicals.”


 
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By Lynn L. Bergeson and Carla N. Hutton
 
On November 21, 2022, the U.S. Environmental Protection Agency (EPA) announced that it has improved public access to certain reports submitted by chemical companies in ChemView, EPA’s web application for public access to non-confidential business information (non-CBI) on chemicals regulated under the Toxic Substances Control Act (TSCA), including new chemical notices and notices of substantial risk. EPA has published previously unpublished new chemical notices received under TSCA Section 5 and notices of substantial risk provided by companies under TSCA Section 8(e). EPA states that going forward, it will continue to identify older, previously submitted unpublished information to make available in ChemView and will publish newly received TSCA Section 5 notices and TSCA Section 8(e) reports on a “near real-time basis.” EPA has also published in ChemView chemical health and safety studies received under TSCA Section 8(d).
 
New Chemical Submissions
 
TSCA Section 5 requires EPA to publish a list of new chemical submissions it has received, including premanufacture notices (PMN), significant new use notices (SNUN), microbial commercial activity notices (MCAN), test market exemption (TME) applications, notices of commencement of manufacture or import (NOC), and test information submitted under Section 5. According to EPA, in 2022 it made available in ChemView more than 25,000 new chemical notice records received under TSCA Section 5, including notices received between 2014 and 2019 that had not been published previously. In 2019, EPA began publishing non-CBI notices on an ongoing basis, and “new records are now generally published within five days of receipt.” EPA states that it will also continue to identify and make public older, previously unpublished new chemicals notices.
 
Notices of Substantial Risk
 
TSCA Section 8(e) requires chemical companies to inform EPA of information that reasonably supports the conclusion that a chemical may present a substantial risk of injury to health or the environment. EPA uses these notices to inform new and existing chemical risk assessment activities. According to EPA, in 2022 it has published 3,900 notices of substantial risk records received under TSCA Section 8(e) in ChemView, including more than 3,300 non-CBI notices submitted between January 1, 2019, and December 20, 2021, that were not previously published due to resource limitations. EPA states that over the next several months, it will publish all non-CBI versions of Section 8(e) notices received from December 20, 2021, to the present. Going forward, “EPA will strive to publish 8(e) notices deemed complete within a week of receiving them from companies.” Additionally, EPA will work to identify and publish Section 8(e) notices received before 2019 as resources allow.
 
Health and Safety Data Reporting
 
Regulations promulgated under TSCA Section 8(d) require chemical companies to submit lists and copies of health and safety studies relating to the health and/or environmental effects of specified chemical substances and mixtures. According to EPA, in 2022 it published more than 1,700 health and safety study records received since September 2021 under TSCA Section 8(d) in ChemView. EPA notes that many of these records were in response to EPA’s 2021 Section 8(d) rulemaking, Health and Safety Data Reporting; Addition of 20 High-Priority Substances and 30 Organohalogen Flame Retardants. EPA states that it expects to publish additional Section 8(d) records “in the future.”


 
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) will hold a webinar on December 6, 2022, to provide an overview to stakeholders about its November 16, 2022, supplemental proposed rule modifying and adjusting certain aspects of the fees rule established under the Toxic Substances Control Act (TSCA). EPA states that it is publishing these changes to ensure that collected fees provide it with 25 percent of authorized TSCA costs consistent with direction in the fiscal year 2022 appropriations bill to consider the “full” implementation costs of the law. According to EPA, updating TSCA fees will strengthen its ability to implement successfully TSCA in a way that is both protective and sustainable and significantly improve on-time performance and quality. The webinar will provide stakeholders an opportunity to provide comment to EPA on the supplemental proposed rule. Registration for the webinar is open. Stakeholders who wish to provide oral comments during the webinar are asked to register by December 1, 2022. Comments on the supplemental proposed rule are due January 17, 2023. More information on the supplemental proposed rule will be available in our forthcoming memorandum.


 
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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.


 
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 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.


 
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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.


 
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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.
Tags: CSS, ORD, StRAP

 
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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).

Tags: SACC, OCSPP, Review

 
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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.

 
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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
 
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.

 
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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.


 
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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
 
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.


 
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