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

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

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By Lynn L. Bergeson and Carla N. Hutton
 
The National Academies of Sciences, Engineering, and Medicine (NASEM) announced on July 21, 2022, publication of a new report entitled The Importance of Chemical Research to the U.S. Economy. The National Science Foundation (NSF), the Department of Energy (DOE), the National Institute of Standards and Technology (NIST), and the American Chemical Society (ACS) asked NASEM to convene a committee to consider strategies to sustain and enhance the economic activity driven by fundamental research investments in the chemical sciences. According to NASEM, “a new and evolving chemistry landscape requires changes with regard to funding, training, and a focus on integrating sustainability into manufacturing, product usage, and product disposal.” NASEM states that the report identifies strategies and options for research investments intended to support U.S. leadership “while considering environmental sustainability and developing a diverse chemical economy workforce with equitable opportunities for all chemistry talent.” The report recommends that funding agencies and philanthropic organizations that support the chemical sciences “fund as large a breadth of fundamental research projects as possible.” The chemical industry and their partners at universities, scientific research institutions, and national laboratories “should align the objectives of fundamental research” to assist directly with new practices toward environmental stewardship, sustainability, and clean energy. Additionally, the report recommends that funding agencies “make substantial investment toward education research to enable innovative ways of teaching about emerging concepts, tools and technologies.”

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By Lynn L. Bergeson and Carla N. Hutton
 
On May 27, 2022, the U.S. Environmental Protection Agency (EPA) requested nominations for technical experts to serve as special government employees (SGE) to participate in the review of the New Chemicals Collaborative Research Program with the Board of Scientific Counselors (BOSC), a federal advisory committee to EPA’s Office of Research and Development (ORD). 87 Fed. Reg. 32161. BOSC will be evaluating ORD’s draft Strategic Research Action Plans Fiscal Years 2023-2026 in fall 2022. According to EPA, the fall 2022 meeting will provide a more in-depth evaluation of the Toxic Substances Control Act (TSCA) New Chemicals Collaborative Research Program and associated research plan. EPA states that it will provide an additional draft document that summarizes technical details of the research plan. ORD, in partnership with 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 will consider nominees from industry, business, public and private research institutes or organizations, academia, government (federal, state, local, and Tribal), non-governmental organizations, and other relevant interest areas. EPA notes that it values and welcomes diversity. EPA encourages all qualified candidates to apply regardless of gender, race, disability, or ethnicity.

EPA invites nominations of individuals to serve as SGEs with expertise or extensive experience in the following scientific disciplines and topic areas as they relate to human health and the environment:

• Using data to develop predictive models and use of predictive models in data-poor environments:
  • Read across and analogue selection;
  • Chemical structures and cheminformatics; and
  • Quantitative structure-activity relationships (QSAR);
• Development, implementation, and validation of new approach methods (NAM). Relevant expertise may include:
  • Veterinary pathology or comparative physiology for perspective on relevance of laboratory animals for predicting human outcomes; and
  • Reference data curation to support validation;
• Computational modeling, bioinformatics, and/or statistics;
• Toxicokinetics, physiologically based pharmacokinetic models (PBPK), and in vitro to in vivo extrapolation (IVIVE);
• Systems biology;
• Human health and ecological risk assessment;
• Exposure modeling and/or assessment, including near-field and far-field sources;
• Knowledge of TSCA; and
• Environmental fate of chemicals.

Nominations are due June 30, 2022. More information on EPA’s Draft Document on “Modernizing the Process and Bringing Innovative Science to Evaluate New Chemicals Under TSCA” is available in our March 14, 2022, memorandum.

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) has placed a March 29, 2022, memorandum correcting the deadline for public comment on the Toxic Substances Control Act (TSCA) Collaborative Research Program to Support New Chemicals. The memorandum states that EPA is clarifying the deadline because the February 25, 2022, Federal Register notice erroneously referenced two different dates. The 60-day comment period on the supporting technical document began when EPA added the document to the docket on March 10, 2022. Comments are due May 10, 2022. More information on EPA’s supporting technical document, “Modernizing the Process and Bringing Innovative Science to Evaluate New Chemicals Under TSCA,” is available in our March 14, 2022, memorandum.
 

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By Lynn L. Bergeson and Carla N. Hutton
 
On January 11, 2022, the White House Office of Science and Technology Policy (OSTP) released the report of its Scientific Integrity Task Force on protecting the integrity of government science. According to OSTP, the scientific integrity principles and best practices identified in the report “aim to ensure that science is conducted, managed, communicated, and used in ways that preserve its accuracy and objectivity and protect it from suppression, manipulation, and inappropriate influence -- including political interference.” The report finds that:

• While violations of scientific integrity are small in number compared to the magnitude of the federal government’s scientific enterprise, they can significantly undermine federal decision-making and public trust in science;
• Existing federal scientific integrity policies are responsive to previous Executive actions but need to be strengthened to deter better inappropriate influence in the conduct, management, communication, and use of science; and
• Supporting scientific integrity requires attention to other policy areas, including greater transparency into research processes and outputs; clear guidelines for data and information that agencies release; and policies that promote safe, equitable workplaces free from harassment and discrimination.

OSTP notes that the Obama Administration identified six principles of scientific integrity in 2009. To not only restore, but to strengthen the integrity of federal science beyond the efforts of any previous Administration, the Task Force makes the following additional recommendations to guide policymaking and foster a culture of scientific integrity in federal agencies:

• All federal agencies -- not just those that fund and conduct scientific research -- should develop, implement, and periodically update scientific integrity policies. Protecting scientific integrity is essential for any federal agency or entity that communicates or makes use of scientific and technical information in decision-making;
• Scientific integrity policies should apply to all those in federal agencies who manage, communicate, or use science, not just to scientists and engineers who conduct research, and not just to career employees, but contractors and political appointees as well. All must be trained in scientific integrity and their roles in upholding it;
• Scientific integrity policies should be modernized to address important, emergent issues. They must advance diversity, equity, inclusion, and accessibility; address new concerns arising from the use of emerging technologies such as artificial intelligence and machine learning; and apply to emerging modes of science, such as citizen science and community-engaged research with federal involvement;
• There should be broader dissemination and adoption of good scientific integrity practices across the federal government, a task that could be facilitated by more formalized interagency collaboration; and
• There should be widespread training for agency scientists so they can communicate scientific findings effectively to nonscientists in their agencies and to lay audiences, with the idea of helping to ensure that policies and actions are based on an accurate understanding of the science.

OSTP states that in the coming months, it will draw upon the findings of the Task Force to develop a plan for the regular assessment and iterative improvement of scientific integrity policies and practices. In addition, agency leadership, working closely with OSTP, will deploy this framework to ensure that their scientific integrity policies are informed by the Task Force report and adhere to scientific integrity principles.

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on March 23, 2021, that it is now accepting nominations for the 2021 Safer Choice Partner of the Year Awards.  According to a Federal Register notice scheduled for publication on March 24, 2021, the awards will recognize the leadership contributions of Safer Choice partners and stakeholders who, over the past year, have shown achievement in the design, manufacture, selection, and use of products with safer chemicals that further outstanding or innovative source reduction.  EPA “especially encourages” award applications that show how the applicant’s work in the design, manufacture, selection, and use of those products promotes environmental justice, bolsters resilience to the impacts of climate change, results in cleaner air or water, or improves drinking water quality.  All Safer Choice stakeholders and program participants in good standing are eligible for recognition.  Interested parties should submit to EPA information about their accomplishments and contributions during 2020.  Submissions are due May 31, 2021.  EPA will recognize award winners at a ceremony in fall 2021.
 
Safer Choice is an EPA Pollution Prevention (P2) program, which includes practices that reduce, eliminate, or prevent pollution at its source, such as using safer ingredients in products.  The Safer Choice program certifies products containing ingredients that have met its “specific and rigorous” human health and environmental toxicological criteria.  EPA notes that the Safer Choice program allows companies to use its label “on certified products that contain safer ingredients and perform, as determined by expert evaluation.”  EPA states that the Safer Choice program certification “represents a high level of achievement in formulating products that are safer for people and the environment.”

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) issued a press release on September 10, 2019, announcing that EPA Administrator Andrew Wheeler signed a directive to prioritize efforts to reduce animal testing.  Administrator Wheeler also announced $4.25 million in funding to five universities to research the development and use of alternative test methods and strategies that reduce, refine, and/or replace vertebrate animal testing.  Administrative Wheeler directs the Office of Chemical Safety and Pollution Prevention (OCSPP) and the Office of Research and Development (ORD) “to prioritize ongoing efforts and to direct existing resources toward additional activities that will demonstrate measurable impacts in the reduction of animal testing while ensuring protection of human health and the environment.”  The directive states that EPA “will reduce its requests for, and [its] funding of, mammal studies by 30 percent by 2025 and eliminate all mammal study requests and funding by 2035.  Any mammal studies requested or funded by the EPA after 2035 will require Administrator approval on a case-by-case basis.”  Administrative Wheeler requests that OCSPP and ORD hold a joint animal conference on new approach methods (NAM), with the first conference to be held in 2019. 
 
Five universities were awarded grants through EPA’s Science to Achieve Results Program.  According to EPA, the research focuses on advancing the development and use of alternative test methods and strategies to reduce, refine, and/or replace vertebrate animal testing.  The grantees are advancing the science of non-vertebrate alternative test methods and strategies in chemical hazard assessment.  The grantees include:

• Johns Hopkins University to develop a human-derived brain model to assess the mechanism by which environmental chemicals might cause developmental neurotoxicity;
   
• Vanderbilt University to test their organ-on-a-chip to study the blood brain barrier and potential brain injury after organophosphate exposure;
   
• Vanderbilt University Medical Center to use their Endo Chip technology to research how preexisting diseases affect cellular responses to environmental toxicants with a focus on reproductive disorders in women;
   
• Oregon State University to develop in vitro test methods for fish species to screen chemicals in complex environmental mixtures; and
   
• University of California Riverside to use human cells to develop a cost-effective end point to characterize potential skeletal embryotoxicants.

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By Lynn L. Bergeson and Carla N. Hutton
 
The House Science, Space, and Technology Subcommittee on Research and Technology will hold a hearing on “Benign by Design:  Innovations in Sustainable Chemistry” on July 25, 2019.  Witnesses will include:

• Dr. Tim Persons, Chief Scientist and Managing Director, Science, Technology Assessment, and Analytics, U.S. Government Accountability Office (GAO);
   
• Dr. John Warner, President and Chief Technology Officer, Warner Babcock Institute for Green Chemistry;
   
• Dr. Julie Zimmerman, Professor and Senior Associate Dean, School of Forestry and Environmental Studiesa and Deputy Director, Center for Green Chemistry and Green Engineering, Yale University;
   
• Ms. Anne Kolton, Executive Vice President, Communications, Sustainability, and Market Outreach, American Chemistry Council; and
   
• Mr. Mitchell Toomey, Director of Sustainability, BASF in North America.

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