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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.

 

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.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on October 11, 2022, that the Office of Research and Development’s (ORD) Board of Scientific Counselors (BOSC) will review the Toxic Substances Control Act (TSCA) New Chemicals Collaborative Research Program. 87 Fed. Reg. 61313. The meeting will be held October 24-25, 2022, via videoconference. Attendees must register by October 23, 2022. Comments must be received by October 23, 2022, to be considered by BOSC. EPA states that requests for the draft agenda or to make a presentation at the meeting will be accepted until October 23, 2022.
 
BOSC is a federal advisory committee that provides advice and recommendations to ORD on technical and management issues of its research programs. The meeting agenda and materials will be posted on BOSC’s website. According to the Federal Register notice, proposed agenda items for the meeting include, but are not limited to, review of the New Chemicals Collaborative Research Program.
 
As reported in our March 14, 2022, memorandum on the draft document entitled “Modernizing the Process and Bringing Innovative Science to Evaluate New Chemicals Under TSCA,” the Office of Chemical Safety and Pollution Prevention (OCSPP) proposes to develop and implement a multi-year collaborative research program focused on approaches for performing risk assessments on new chemical substances under TSCA. On April 20-21, 2022, EPA held a virtual public meeting to provide an overview of the program and give stakeholders an opportunity to provide input. EPA has posted the meeting materials in the online docket. A summary of the meeting is available in our April 22, 2022, memorandum.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) will hold a webinar on October 13, 2022, on its web-based Interspecies Correlation Estimation (Web-ICE) tool. According to EPA, protecting the diversity of species from the adverse effects of chemicals is a significant environmental challenge. EPA acknowledges that information on the effects of chemicals on species is either very limited or lacking entirely, making management and mitigation of environmental contaminants difficult. EPA developed the Web-ICE tool to allow toxicity extrapolation from standard test organisms to diverse taxa, including endangered species. The publicly-accessible application allows risk assessors and environmental managers from all sectors to estimate chemical toxicity to a diversity of fresh and saltwater invertebrates and fish, birds and mammals, and aquatic plants (algae) that may have limited toxicity data. The training webinar will provide an overview of Web-ICE, including a brief overview of ICE models, demonstration of its application with example case studies, and a tutorial on using the Internet application. Registration is open.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on August 22, 2022, that as part of its commitment to re-evaluate policies and practices under the Toxic Substances Control Act (TSCA) New Chemicals Program to ensure they adhere to statutory requirements and the Biden Administration’s executive orders and directives, it has updated its policy to discontinue the use of exposure modeling thresholds when assessing the health and environmental risks of new chemicals under TSCA. According to EPA, due in part to the automation of modeling, it has become less burdensome to complete these calculations. Furthermore, according to EPA, removing the thresholds supports President Biden’s Executive Order 13985, “Advancing Racial Equity and Support for Underserved Communities Through the Federal Government,” which calls on federal agencies to advance equity, including by reviewing and revising as needed government policies and programs impacting underserved communities.
 
The New Chemicals Program will implement this change by making minimal changes to the coding in the New Chemical Review application to remove the thresholds and will update standard operating procedures and training materials for exposure and human health risk assessors. EPA states that it will implement this policy change “as soon as feasible.” According to EPA, despite the resource challenges it is currently facing in the TSCA program, it anticipates that the change “will have minimal impact on the amount of time it takes to complete new chemical reviews and that the benefits gained from a more comprehensive accounting of all potential air and water releases will help ensure any needed protections are in place before a new chemical can come to market.”
 
More information and a detailed commentary that discusses thresholds of toxicological concern (TTC) are available in our August 22, 2022, memorandum.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Government Accountability Office (GAO) published a report on July 28, 2022, entitled Persistent Chemicals: Technologies for PFAS Assessment, Detection, and Treatment. GAO was asked to conduct a technology assessment on per- and polyfluoroalkyl substances (PFAS) assessment, detection, and treatment. The report examines the technologies for more efficient assessments of the adverse health effects of PFAS and alternative substances; the benefits and challenges of current and emerging technologies for PFAS detection and treatment; and policy options that could help enhance benefits and mitigate challenges associated with these technologies. GAO assessed relevant technologies; surveyed PFAS subject matter experts; interviewed stakeholder groups, including government, non-governmental organizations (NGO), industry, and academia; and reviewed key reports. GAO identified three challenges associated with PFAS assessment, detection, and treatment technologies:

  • PFAS chemical structures are diverse and difficult to analyze for health risks, and machine learning requires extensive training data that may not be available;
     
  • Researchers lack analytical standards for many PFAS, limiting the development of effective detection methods; and
     
  • The effectiveness and availability of disposal and destruction options for PFAS are uncertain because of a lack of data, monitoring, and guidance.

GAO developed the following three policy options that could help mitigate these challenges:

  • Promote research: Policymakers could support development of technologies and methods to more efficiently research PFAS health risks. This policy option could help address the challenge of limited information on the large number and diversity of PFAS, as well as a lack of standardized data sets for machine learning;
     
  • Expand method development: Policymakers could collaborate to improve access to standard reference samples of PFAS and increase the pace of method and reference sample development for PFAS detection. This policy option could help address the challenges of a lack of validated methods in media other than water, lack of analytical standards, and cost, which all affect researchers’ ability to develop new detection technologies; and
     
  • Support full-scale treatment: Policymakers could encourage the development and evaluation of full-scale technologies and methods to dispose of or destroy PFAS. This policy option could help address the challenges of cost and efficiency of disposal and destruction technologies and a lack of guidance from regulators.

GAO notes that these policy options involve possible actions by policymakers, which may include Congress, federal agencies, state and local governments, academia, and industry.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) held a virtual public meeting on April 20-21, 2022, to provide an overview of the Toxic Substances Control Act (TSCA) New Chemicals Collaborative Research Program and give stakeholders an opportunity to provide input. As described in EPA’s draft document entitled “Modernizing the Process and Bringing Innovative Science to Evaluate New Chemicals Under TSCA,” the Office of Chemical Safety and Pollution Prevention (OCSPP) proposes to develop and implement a multi-year collaborative research program focused on approaches for performing risk assessments on new chemical substances under TSCA. EPA has posted the following presentations from the April 20-21, 2022, meeting:

More information on the meeting is available in our April 22, 2022, memorandum, and more information on EPA’s draft document is available in our March 14, 2022, memorandum. Written comments on the draft document are due May 10, 2022.


 

By Lynn L. Bergeson and Carla N. Hutton

On March 23, 2022, the U.S. Environmental Protection Agency (EPA) held a webinar on “Biofuel Premanufacture Notices: New Chemical Risk Assessment and Applications of Tools and Models.” As reported in our January 24, 2022, blog item, in January 2022, EPA announced an effort to streamline the review of new biobased or waste-derived chemicals that could displace current, higher greenhouse gas (GHG)-emitting transportation fuels. EPA states that to support this effort, it is offering outreach and training to stakeholders interested in biofuels. According to EPA, the bi-weekly webinar series includes reviewing requirements under the Toxic Substances Control Act (TSCA), outlining the streamlined approaches for risk assessments and risk management actions, and providing information on how to navigate the new chemicals premanufacture notice (PMN) process. EPA provided background and outlined the following challenges for each risk assessment conducted:

  • Chemistry Assessment:
    • Fuel stream and related substances are broad in number and scope, especially with the addition of current biobased and waste feedstock blends; they can be class 1, class 2, or chemical substances of unknown or variable composition, complex reaction products, and biological materials (UVCB) substances;
    • Many petroleum-derived fuel streams are on the original TSCA Inventory and there are very little data associated with them; and
    • Complete characterization of the new chemical substance is often unavailable;
  • Environmental Fate and Transport Assessment:
    • Analysis of constituents may not represent the properties of the new chemical substance;
  • Engineering Assessment: Environmental Releases:
    • EPA’s release assessment analyzes each manufacturing, processing, and use operation and determines the sources/activities that can result in releases to the environment. These release estimates are used to estimate exposure estimates for ecological and human receptors;
    • Examples of release data: (1) Measured release data; (2) Measured release data for a “surrogate” chemical; (3) Modeled release estimates; and
    • Release estimates have limitations -- examples:
      • Lack of appropriate model/method to estimate releases from specific industrial activities (e.g., storage tank emissions); and
      • Limitation in certain release models (e.g., limited to a vapor pressure threshold of 35 torr);
  • Engineering Assessment: Occupational Exposures:
    • The occupational exposure assessment estimates the magnitude, frequency, and duration of exposures to the new chemical substance at the workplace;
    • Worker inhalation and dermal exposures are expected throughout the lifecycle of the new chemical substance (e.g., manufacturing, processing, use); and
    • Exposure models do not account for some engineering controls (vapor capture/reduction);
  • Exposure Assessment: General Population and Consumer Exposures:
    • The occupational exposure assessment estimates the magnitude, frequency, and duration of exposures to the new chemical substance for the general population and consumers via inhalation and drinking water pathways; and
    • The confidence of the exposure estimates are affected by:
      • Assumptions, limitations, and areas of uncertainty in the fate and engineering analyses; and
      • Inherent uncertainties of the exposure parameters and assumptions for the estimation of the general population and consumer exposures;
  • Hazard Assessment:
    • Data on the new chemical substance or an analogous biofuel are preferred, but few submissions include toxicological or composition data;
    • EPA often lacks acute/chronic environmental test data on the new chemical substance and the analogous substances; and
    • There are challenges in performing read-across approaches and route-to-route extrapolations with analogous substances of variable composition.

For biofuel PMNs, EPA has started generating one report that combines the results of each of the above assessments. The final webinar in the series will be held April 6, 2022, on new chemicals risk management actions, including TSCA Section 5 orders and significant new use rules (SNUR).


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency’s (EPA) New Chemicals Program will hold a webinar on Wednesday, February 23, 2022, from 2:00 to 3:00 p.m. (EST) to learn about requirements under the Toxic Substances Control Act (TSCA) and the premanufacture notice (PMN) process for biofuels. As reported in our January 24, 2022, blog item, in January 2022, EPA announced an effort to streamline the review of new biobased or waste-derived chemicals that could displace current, higher greenhouse gas (GHG)-emitting transportation fuels. EPA states that to support this effort, it is offering outreach and training to stakeholders interested in biofuels. According to EPA, the bi-weekly webinar series includes reviewing TSCA requirements, outlining the streamlined approaches for risk assessments and risk management actions, and providing information on how to navigate the new chemicals PMN process. Future webinars will include:

Registration is required for the February 23, 2022, webinar.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) announced the availability of its fiscal year (FY) 2022 oversight plan on December 14, 2021. According to OIG, the plan reflects the priority work that the OIG believes is necessary to keep EPA, the U.S. Chemical Safety and Hazard Investigation Board (CSB), and Congress fully informed about issues relating to the administration of EPA programs and operations. The planned oversight projects concerning Ensuring the Safe Use of Chemicals include:

  • Audit of EPA’s Management of New Chemical Risk Assessments Conducted under the Toxic Substances Control Act (TSCA): 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;
     
  • Evaluation of EPA Regions’ Oversight Responsibilities for State and Tribal Drinking Water Certification Programs: Determine whether select EPA regions are fulfilling oversight responsibilities for drinking water certification programs in states and tribal nations;
     
  • Evaluation of EPA’s Use of Pesticide Incident-Reporting Data: Determine whether EPA uses pesticide incident-reporting data to prevent unreasonable adverse effects on human health and the environment;
     
  • Evaluation of Implementation of EPA’s Federal Certification for Applicators and Dealers of Restricted-Use Pesticides within Indian Country: Determine how EPA monitors and enforces the requirements for restricted-use pesticide applicators (private and commercial) and restricted-use pesticide dealers in Indian Country;
     
  • Evaluation of EPA’s Progress toward Providing States with Clear Benchmarks to Address Per- and Polyfluoroalkyl Substances (PFAS) in Drinking Water: Determine why EPA has not established a mandatory limit for PFAS in drinking water; what challenges may prevent EPA from setting such a limit; and what EPA’s plan -- if one exists -- is for implementing such a limit; and
     
  • Evaluation of EPA’s Progress to Identify Key Regulatory Stakeholders for TSCA Existing Chemical Risk Management: Determine whether EPA identified and partnered with key regulatory stakeholders and developed a process to coordinate the regulation of occupational exposures from existing chemicals under TSCA.

Ongoing projects concerning Ensuring the Safe Use of Chemicals include:

  • Evaluation of EPA’s Cancer Assessment Review for Pesticide 1,3-Dichloropropene: Evaluate the extent to which EPA followed policies and procedures in developing the cancer assessment for the 1,3-dichloropropene pesticide registration review decision to prevent unreasonable adverse effects on human health; and
     
  • Evaluation of EPA’s Overdue Residual Risk and Technology Reviews: Evaluate whether EPA has conducted residual risk and technology reviews in a timely manner, as required for EPA to revise standards, as needed, to protect the public from air toxics emitted by stationary sources.

Planned and ongoing projects concerning Safeguarding Scientific Integrity Principles include:

  • Congressional Request: Evaluation of EPA’s Changes to Final Perfluoroalkyl Carboxylate and Perfluoroalkyl Sulfonate Significant New Use Rule (SNUR): Determine the extent to which EPA followed applicable policies, procedures, and guidance for the changes made to the Long-Chain Perfluoroalkyl Carboxylate and Perfluoroalkyl Sulfonate Chemical Substances SNUR between the EPA Administrator’s signing of the final SNUR on June 22, 2020, and the publication of the final SNUR in the Federal Register on July 27, 2020; and
     
  • Evaluation of EPA’s January 2021 Perfluorobutane Sulfonic Acid (PFBS) Toxicity Assessment: Determine whether EPA’s Office of Research and Development (ORD) and Office of Chemical Safety and Pollution Prevention (OCSPP) followed applicable policies and procedures in the development and publication of the January 19, 2021, PFBS toxicity assessment.

OIG states that it is important to note that its planning efforts “are not static and that the projects included herein may be modified throughout the year as challenges and risks for the EPA and the CSB evolve and emerge.”


 
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