By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) has posted the justification for its fiscal year (FY) 2024 appropriation estimates for the Committee on Appropriations (Congressional Justification (CJ)). According to the CJ, EPA’s FY 2024 budget includes $470.7 million and 1,677 full-time equivalents (FTE) for Objective 7.1, “Ensure Chemical and Pesticide Safety.” The CJ includes the following target dates for actions under the Toxic Substances Control Act (TSCA):

• By September 30, 2026, complete at least eight high-priority substance TSCA risk evaluations annually within statutory timelines compared to the FY 2020 baseline of one;
• By September 30, 2026, initiate all TSCA risk management actions within 45 days of the completion of a final existing chemical risk evaluation; and
• By September 30, 2026, review 90 percent of risk management actions for past TSCA new chemical substances reported to the 2020 Chemical Data Reporting Rule (CDR) compared to the FY 2021 baseline of none.

The CJ provides a summary of activities for the Chemical Risk Review and Reduction (CRRR) Program. According to the CJ, in FY 2024, EPA will emphasize the integrity of scientific products, adherence to statutory intent and requirements, and timelines applicable to pre-market review of new chemicals, chemical risk evaluation and management, data development and information collection, the review of confidential business information (CBI) claims, and other statutory requirements. The CJ states that the resources requested are essential for EPA to address its workload, including:

• Maintaining at least 20 EPA-initiated existing chemical risk evaluations in development at all times and completing EPA-initiated existing chemical risk evaluations within the statutory timeframe;
• Having up to five existing chemical risk evaluations requested by manufacturers in development;
• Issuing protective regulations in accordance with statutory timelines addressing all unreasonable risks identified in each risk evaluation;
• Establishing a pipeline of chemicals to be prioritized for future risk evaluation;
• Using test orders and a new strategy for tiered data collection, requiring development of data critical to existing chemical risk evaluation and risk management activities, and systematically collecting, reviewing, and synthesizing data for risk assessments in a transparent manner as mandated by the 2016 TSCA amendments;
• Conducting risk assessments for approximately 550 new chemical notices and exemption submissions and managing the identified risks associated with the chemicals;
• Continuing to implement a collaborative research program focused on developing new scientific approaches for performing risk assessments on new chemical substances;
• Reviewing and making determinations on CBI claims contained in TSCA submissions; making certain non-CBI available to stakeholders; and publishing identifiers for each chemical substance for which a confidentiality claim for specific chemical identity is approved; and
• Carrying out other required TSCA CRRR activities.

The Senate Committee on Environment and Public Works held a hearing on March 22, 2023, on EPA’s proposed FY 2024 budget. A summary of the hearing will be available in our forthcoming memorandum.

• Email This
• Print

By Lynn L. Bergeson and Carla N. Hutton
 
The Senate Committee on Environment and Public Works will hold a hearing on March 22, 2023, on the proposed fiscal year (FY) 2024 budget for the U.S. Environmental Protection Agency (EPA). The only listed witness is EPA Administrator Michael Regan. As reported in our March 14, 2023, blog item, the budget requests over $12 billion in discretionary budget authority for EPA, a $1.9 billion or 19 percent increase from the FY 2023 enacted level. Highlights of the FY 2024 budget include:

• Ensuring Safety of Chemicals for People and the Environment: The budget provides an investment of $130 million, $49 million more than the 2023 enacted level, to build core capacity to implement the Toxic Substances Control Act (TSCA). Under TSCA, EPA has a responsibility to ensure the safety of chemicals in or entering commerce. According to EPA, in FY 2024, it “will focus on evaluating, assessing, and managing risks from exposure to new and existing industrial chemicals to advance human health protection in our communities.” EPA states that “[a]nother priority is to implement [the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)] to ensure pesticides pose no unreasonable risks to human health and the environment.”
   
• Tackling Per- and Polyfluoroalkyl Substances (PFAS) Pollution: The budget provides approximately $170 million to combat PFAS pollution. This request allows EPA to continue working toward commitments made under EPA’s 2021 PFAS Strategic Roadmap, including: increasing its knowledge of PFAS impacts on human health and ecological effects; restricting use to prevent PFAS from entering the air, land, and water; and remediating PFAS that have been released into the environment.

• Email This
• Print

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) has opened registration for the second of its two-part webinar series 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). The webinar, which will be held March 30, 2023, will give an in-depth look into the standardized risk assessment approach and present various case scenarios and a decision tree for identifying potential hazards and risks. The kickoff webinar, held in November 2022, provided a broad overview of the approach and answered stakeholder questions. A summary of the first webinar is available in our November 23, 2022, memorandum.
 
Under the Toxic Substances Control Act (TSCA), EPA reviews all new chemical substances before they enter the marketplace to ensure they do not present unreasonable risk to human health or the environment. As reported in our October 11, 2022, memorandum, EPA announced an innovative effort to help make its review of new MMOs, including new and modified CAMs, more efficient. According to EPA, MMOs have many electrical applications in batteries and uses as catalysts, adsorbents, and in ceramics. Notably, MMOs, including CAMs, are a key component in lithium-ion batteries used in electric vehicles, making them a vital part of clean energy sectors.

• Email This
• Print

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on February 13, 2023, that it will accept public comments on candidates under consideration for selection as ad hoc reviewers to assist the Science Advisory Committee on Chemicals (SACC) with peer review of two draft documents related to cumulative risk assessment under the Toxic Substances Control Act (TSCA). Biographies of these candidates are available on regulations.gov. If selected, candidates will serve as peer reviewers for two documents, which will be reviewed by the SACC at a public virtual meeting May 8-11, 2023. Comments on the candidates are due February 25, 2023.
 
EPA states that it plans to release the following documents for public comment in late February 2023:

• Draft Proposed Principles of Cumulative Risk Assessment under the Toxic Substances Control Act: According to EPA, this document will describe the fundamental principles of cumulative risk assessment of chemicals and how they may be applied within the regulatory requirements of TSCA to ensure TSCA risk evaluations are based on the best available science and are protective of human health; and
   
• Draft Proposed Approach for Cumulative Risk Assessment of High-Priority Phthalates and a Manufacturer Requested Phthalate under the Toxic Substances Control Act: EPA states that this document will describe its proposed approach for evaluating a subset of high-priority and manufacturer-requested phthalates for cumulative risk to human health under TSCA based on the principles of cumulative risk assessment described in EPA’s draft principles document referenced above.

The SACC serves as a scientific peer review mechanism of EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP). It provides independent scientific advice and recommendations to EPA on the scientific basis for risk assessments, methodologies, pollution prevention measures, and approaches for chemicals regulated under TSCA.

• Email This
• Print

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on February 23, 2023, that the New Chemicals Program will hold a webinar on February 28, 2023, on EPA’s process for assessing the potential risks of new chemicals under Section 5 of the Toxic Substances Control Act (TSCA) and the types of data EPA considers in this assessment. EPA states that specifically, the upcoming webinar will cover commonly missed information in Section 5 submissions and how EPA evaluates environmental release information for operations that occur at non-submitter sites. Registration is now open.
 
As reported in our June 27, 2022, memorandum, in June 2022, EPA announced outreach to describe how it evaluates engineering (i.e., environmental release and worker exposure) data for new chemical submissions and common causes of EPA having to reconduct risk assessments (i.e., “rework”). The goal of this effort is to prevent delays of EPA’s new chemical reviews caused by rework.
 
The February 28, 2023, webinar is the third and final webinar in a series to increase the efficiency and transparency of EPA’s new chemical determinations. The first two webinars, held in July and October 2022, focused on common issues that cause EPA to rework risk assessments, clarifications of common misconceptions in EPA’s new chemical assessments, and other information related to TSCA Section 5 submissions. More information on these webinars is available on EPA’s website and in our July 28, 2022, and October 25, 2022, memoranda.

• Email This
• Print

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on December 21, 2022, that it seeks public nominations of scientific and technical experts whom EPA can consider for service as ad hoc reviewers assisting the Science Advisory Committee on Chemicals (SACC) with the peer review of two draft documents entitled “Draft Proposed Principles of Cumulative Risk Assessment Under the Toxic Substances Control Act” and “Draft Proposed Approach for Cumulative Risk Assessment of High-Priority Phthalates and a Manufacturer Requested Phthalate Under the Toxic Substance Control Act.” 87 Fed. Reg. 78103. EPA states that it will submit the two draft documents to SACC and release them for public review and comment in late February 2023. EPA will solicit comments from SACC on issues related to chemical grouping for purposes of cumulative risk assessment (CRA), health outcomes related to phthalate syndrome, and possible approaches to developing the cumulative hazard and exposure assessment for high-priority phthalates and a manufacturer-requested phthalate. EPA also announced the scheduling of a four-day virtual public meeting for SACC to consider and review the two draft documents. EPA provides the following chronological listing of the dates for the specific activities:

• January 20, 2023 -- Deadline for submitting all nominations to EPA;
   
• April 24, 2023 -- Deadline for submitting a request for special accommodations to allow EPA time to process the request before the meeting; and
   
• May 8 to 11, 2023, from 10:00 a.m. to approximately 5:30 p.m. (EDT) -- The public virtual meeting will be held via a webcast platform such as “Zoom.gov” and audio teleconference, and you must register to receive the links.

• Email This
• Print

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.”

• Email This
• Print

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.

• Email This
• Print

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.

• Email This
• Print

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency’s (EPA) New Chemicals Program will host a webinar on October 18, 2022, on EPA’s process for assessing the potential risks of new chemicals under Section 5 of the Toxic Substances Control Act (TSCA) and the types of data EPA considers in this assessment. The webinar will cover examples of quantitative and qualitative data unlikely to be accepted for engineering assessment, considerations EPA makes when evaluating data, and clarifications of common misconceptions in EPA’s new chemical assessments.
 
As reported in our June 27, 2022, memorandum, in June 2022, EPA announced a broad outreach effort to describe to stakeholders how EPA evaluates engineering data (i.e., data related to environmental release and worker exposure) provided for new chemical submissions and common issues that cause EPA to have to reconduct risk assessments (“rework”). The goal of this effort is to prevent delays of EPA’s new chemical reviews caused by rework.
 
This will be the second in a series of webinars intended to increase the efficiency and transparency of EPA’s new chemical determinations. As reported in our July 28, 2022, memorandum, in July 2022, EPA hosted the first webinar, analyzing common issues that cause EPA to have to rework risk assessments. Meeting materials are available for those who missed the first webinar.

• Email This
• Print