On June 19 to June 20, 2025, the European Union (EU) Horizon Europe projects ACCORDs, iCare, MACRAMÉ, and nanoPASS are hosting a joint summit to address the needs of industry and regulators in assessing the safety and sustainability of advanced materials. The summit will feature discussions, latest method developments, and direct engagement with regulators, scientists, and industry professionals. Key sessions will focus on regulatory challenges, scientific developments, and pathways towards...
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On April 28, 2025, the U.S. Environmental Protection Agency (EPA) outlined upcoming Agency action to address per- and polyfluoroalkyl substances (PFAS). According to EPA’s announcement, “[i]n line with Administrator Zeldin’s Powering the Great American Comeback initiative, EPA’s work in this space will advance Pillar 1: Clean Air, Land, and Water for Every American, and Pillar 3: Permitting Reform, Cooperative Federalism, and Cross-Agency Partnership.” EPA states that these actions...
April 15, 2025
EUON Publishes Nanopinion on Enhancing the Regulatory Application of NAMs to Assess Nanomaterial Risks in the Food and Feed Sector
On April 8, 2025, the European Union (EU) Observatory for Nanomaterials (EUON) published a Nanopinion entitled “A Qualification System to Accelerate Development and Regulatory Implementation of New Approach Methodologies (NAMs)” by Andrea Haase, Ph.D., German Federal Institute for Risk Assessment (BfR), Shirin M. Usmani, Ph.D., BfR, Irene Cattaneo, European Food Safety Authority (EFSA), Maria Chiara Astuto, EFSA, and Francesco Cubadda, Ph.D., National Institute of Health (ISS). The authors...
January 17, 2025
EPA Releases Final Risk Evaluation for DINP, Finding Unreasonable Risk of Injury to Human Health When Workers Are Exposed under Four COUs
On January 14, 2025, the U.S. Environmental Protection Agency (EPA) released the final risk evaluation for diisononyl phthalate (DINP) conducted under the Toxic Substances Control Act (TSCA). EPA states that it has determined that DINP presents an unreasonable risk of injury to human health because workers could be exposed to high concentrations of DINP in mist when spraying adhesive, sealant, paint, and coating products that contain DINP. According to EPA, DINP can cause developmental toxicity...
October 11, 2023
EC Recommends Carrying Out Risk Assessment on Biotechnologies
The European Commission (EC) announced on October 3, 2023, that it adopted a Recommendation on critical technology areas for the European Union’s (EU) economic security, for further risk assessment with EU member states. According to the EC, the Recommendation relates to the assessment of technology risk and technology leakage. The EC states that the risk assessment “will be objective in character, and neither its results nor any follow-up measures can be anticipated at this stage.” In the...
The U.S. Environmental Protection Agency (EPA) is launching a webinar series in collaboration with the PETA Science Consortium International (PSCI), Institute for In Vitro Sciences (IIVS), and the California Department of Pesticide Regulation (CDPR). According to EPA, the quarterly series will focus on the use of new approach methodologies (NAM), or alternative methods to reduce vertebrate animal testing, for risk assessment within EPA and CDPR. The first webinar in the series will take place...
The U.S. Environmental Protection Agency (EPA) is launching a webinar series in collaboration with the PETA Science Consortium International (PSCI), Institute for In Vitro Sciences (IIVS), and the California Department of Pesticide Regulation (CDPR). According to EPA, the quarterly series will focus on the use of new approach methodologies (NAM), or alternative methods to reduce vertebrate animal testing, for risk assessment within EPA and CDPR. The first webinar in the series will take place...
On May 18, 2023, Senator Alex Padilla (D-CA) and Representative Zoe Lofgren (D-CA) introduced the Supercomputing for Safer Chemicals (SUPERSAFE) Act (S. 1685, H.R. 3457). According to Padilla’s May 18, 2023, press release, the legislation would establish a SUPERSAFE Consortium led by the U.S. Environmental Protection Agency (EPA) “to identify chemicals that are safe to use in commerce through science-backed decision making.” The press release states that the bill would direct the use...
June 6, 2023
GAO’s Priority Open Recommendations for EPA Include Recommendations Regarding the IRIS Program
On May 16, 2023, the U.S. Government Accountability Office (GAO) released publicly a report on its priority open recommendations for the U.S. Environmental Protection Agency (EPA). GAO’s priority recommendations include three in the area of “assessing and controlling toxic chemicals.” According to GAO, EPA’s ability to protect effectively public health and the environment depends on credible and timely assessments of the risks posed by toxic chemicals, including per- and...
April 3, 2023
EPA Seeks Nominations for Ad Hoc Expert Reviewers for Review of Draft Supplement to the 1,4-Dioxane Risk Evaluation
The U.S. Environmental Protection Agency (EPA) announced on March 23, 2023, that it is seeking public nominations of scientific and technical experts that EPA can consider for service as ad hoc reviewers assisting the Science Advisory Committee on Chemicals (SACC) with the peer review of the “2023 Draft Supplement to the 1,4-Dioxane Risk Evaluation.” 88 Fed. Reg. 17566. EPA states that it will release the draft supplement for public review and comment in June 2023. EPA also plans to...
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...
February 14, 2023
EPA Accepting Public Comments on Candidates to Be Ad Hoc Reviewers for Draft Documents Related to Cumulative Risk Assessment under TSCA
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...
December 21, 2022
EPA Requests Nominations for Ad Hoc Reviewers to Assist SACC in Reviewing Phthalate Documents, Will Hold Meeting in May 2023
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...
December 1, 2022
ORD Publishes Six Strategic Research Action Plans for FYs 2023-2026, Including for Chemical Safety f
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...
November 29, 2022
EPA Requests Nominations for Science Advisory Committee on Chemicals
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...
November 10, 2022
EPA Awards $7.7 Million for Research Grants to Improve Risk Assessment of Chemical Mixtures in the Environment
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...
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...
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...
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...
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...
August 23, 2022
EPA New Chemicals Program Will Discontinue Use of Exposure Modeling Thresholds When Assessing Health and Environmental Risks
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...
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...
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...
March 25, 2022
EPA Holds Webinar on Biofuel PMNs: New Chemical Risk Assessment and Applications of the Tools and Mo
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...
March 24, 2022
EPA Holds Webinar on Biofuel PMNs: New Chemical Risk Assessment and Applications of the Tools and Models
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...
February 8, 2022
OECD Publishes Report on Important Issues on Risk Assessment of Manufactured Nanomaterials
The Organization for Economic Cooperation and Development (OECD) published a February 2022 report entitled Important Issues on Risk Assessment of Manufactured Nanomaterials. The report provides the current practices, challenges, and strategies for assessing the risk of manufactured nanomaterials in circumstances where data are limited, and the report states that there is a necessity for more research on specific risk assessment issues. As such, the report presents an overview of the...
February 2, 2022
EPA’s Biofuels Webinar Series Will Include Webinar on TSCA Requirements and the PMN Process on February 23, 2022
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,...
December 15, 2021
EPA OIG FY 2022 Oversight Plan Includes Oversight Projects Intended to Ensure the Safe Use of Chemicals
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...
The U.S. Environmental Protection Agency (EPA) announced on November 30, 2021, the release of the National Academies of Sciences, Engineering, and Medicine’s (NASEM) external peer review report of the Office of Research and Development (ORD) Staff Handbook for Developing Integrated Risk Information System (IRIS) Assessments (IRIS Handbook). EPA states that the IRIS Handbook provides standard operating procedures for staffers developing IRIS assessments and includes systematic review...
November 17, 2021
OIG Report Includes Ensuring the Safe Use of Chemicals among EPA’s FY 2022 Top Management Challenges
On November 15, 2021, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) announced the availability of its annual report summarizing what OIG considers the “most serious management and performance challenges facing the agency.” According to OIG, EPA’s top management challenges in fiscal year (FY) 2022 include: Mitigating the Causes and Adapting to the Impacts of Climate Change: EPA must take a leadership role in limiting climate change and mitigating...
November 4, 2021
EPA Announces BOSC CSS HERA Subcommittee Meeting
By Lynn L. Bergeson On October 1, 2021, EPA announced a series of virtual meetings of the Board of Scientific Counselors (BOSC) Chemical Safety for Sustainability and Health and Environmental Risk Assessment (CSS HERA) Subcommittee to review recent progress and activities of the Chemical Safety Analytics (CSA) and Emerging Materials and Technologies (EMT) research areas. Meetings are open to the public, and EPA accepted comments until November 3, 2021. The initial meeting will be held over...
On October 27, 2021, the U.S. Environmental Protection Agency (EPA) requested public nominations of scientific experts to consider for service as ad hoc reviewers assisting the Science Advisory Committee on Chemicals (SACC) with two peer review topics anticipated for early 2022: the draft EPA Toxic Substances Control Act (TSCA) Systematic Review Protocol and the draft EPA TSCA Screening Level Approach for Assessing Ambient Air and Water Exposures to Fenceline Communities. 86...
August 6, 2021
EFSA Updates Guidance on Nanomaterials Risk Assessment to Be Applied in Food and Feed Chain: Human and Animal Health
The European Food Safety Authority (EFSA) has updated its “Guidance on risk assessment of nanomaterials to be applied in the food and feed chain: human and animal health.” The updated guidance, published on August 3, 2021, covers the application areas within EFSA’s remit, including novel foods, food contact materials, food and feed additives, and pesticides. The guidance takes into account relevant scientific studies on physico‐chemical properties, exposure assessment and hazard...
On June 15, 2021, the U.S. Environmental Protection Agency (EPA) appointed nine new members to serve on the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC). Additionally, EPA appointed a new Chair and reappointed seven existing members. In EPA’s July 13, 2021, announcement, EPA notes that members of the TSCA SACC serve staggered terms of appointment, generally of three years. They possess expertise in scientific and technical fields relevant to chemical risk...
The U.S. Environmental Protection Agency (EPA) announced on April 8, 2021, that it is releasing an updated toxicity assessment for perfluorobutane sulfonic acid (PFBS), which is a member of the group of per- and polyfluoroalkyl substances (PFAS). EPA states that this PFBS assessment is part of its commitment to restore scientific integrity to all of the Agency’s actions and increase the amount of research and information available to the public on PFAS. According to EPA’s...
The European Food Safety Authority (EFSA) announced on March 15, 2021, that it has begun a public consultation on a draft updated Guidance on the assessment of exposure of operators, workers, residents, and bystanders in risk assessment for plant protection products (PPP). According to EFSA, the Guidance is designed to assist risk assessors and applicants when quantifying potential non-dietary, systemic exposures as part of the regulatory risk assessment for PPPs. The Guidance is based on...
By Lynn L. Bergeson On April 29, 2020, the U.S. Environmental Protection Agency’s (EPA) Office of Research and Development (ORD) announced a virtual meeting of the Board of Scientific Counselors (BOSC) Chemical Safety for Sustainability and Health and Environmental Risk Assessment (CSS-HERA) Subcommittee. The purpose of the meeting will be to review the draft 2019-2022 Strategic Research Action Plan (StRAP) of the HERA research program. The videoconference meeting will be held over a...
February 11, 2020
EPA OIG Prepares to Audit EPA’s Adherence to Pesticide Registration Risk Assessment Regulations, Policies, and Procedures
On January 27, 2020, the U.S. Environmental Protection Agency’s (EPA) Office of Inspector General (OIG) issued a notification for Project Number OA&E-FY20-0095, announcing that it will begin fieldwork to audit EPA’s adherence to pesticide registration risk assessment regulations, policies, and procedures. In a memorandum addressed to EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP), OIG stated that its objective is to evaluate EPA’s ability...
December 24, 2019
EPA Issues Proposed Interim Registration Review Decisions To Require New Risk Mitigation Measures for Three Triazine Herbicides
On December 18, 2019, the Office of Pesticide Programs (OPP) of the U.S. Environmental Protection Agency (EPA) issued for comment a Proposed Interim Decision (PID) in the ongoing registration review process for each of the three registered triazine herbicides: atrazine, propazine, and simazine. EPA will allow 60 days for comment on each of these triazine PIDs, but the specific comment deadline will only be established after EPA has published notice concerning the...
December 24, 2019
EPA Issues Proposed Interim Registration Review Decisions To Require New Risk Mitigation Measures for Three Triazine Herbicides
On December 18, 2019, the Office of Pesticide Programs (OPP) of the U.S. Environmental Protection Agency (EPA) issued for comment a Proposed Interim Decision (PID) in the ongoing registration review process for each of the three registered triazine herbicides: atrazine, propazine, and simazine. EPA will allow 60 days for comment on each of these triazine PIDs, but the specific comment deadline will only be established after EPA has published notice concerning the...
December 11, 2019
EPA Will Host First Annual Conference on New Approach Methods for Reducing Animal Testing for Chemical Safety on December 17
The U.S. Environmental Protection Agency (EPA) will host its first annual conference to discuss alternative test methods and strategies to reduce animal testing on December 17, 2019, in Washington, D.C. According to EPA, the conference will bring together some of the leading voices in environmental and health research to discuss efforts to reduce testing on mammals. The conference will focus on the New Approach Methods (NAM) and will feature presentations by U.S. and...
On October 15, 2019, EPA posted a total of 11 documents to the registration review docket for paraquat dichloride (EPA-HQ-OPP-2011-0855). Of primary interest in the registration review process under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) are the draft human health and ecological risk assessments. Additional supporting documents posted to the docket include dietary, residential, and occupational exposure assessments; a review of analytical...
October 8, 2019
EFSA Opens Consultation Period on Two Pilot Assessments on the Risks Caused by Multiple Pesticide Residues in Foods
On September 17, 2019, the European Food Safety Authority (EFSA) opened a consultation period on two pilot assessments of the risks posed to humans by residues of multiple pesticides in food. EFSA is seeking comments from interested parties on the assessments. The first assessment considers the chronic effects of multiple pesticides on the thyroid system. The second looks at acute effects on the nervous system. EFSA produced the assessments in collaboration with the...
By Lynn L. Bergeson On September 3, 2019, the Chinese Ministry of Ecology and Environment (MEE) and National Health Commission (NHC) jointly issued a final Technical Framework Guideline for Environmental Risk Assessment of Chemical Substances (Trial). This Trial Guideline provides a basic framework, including evaluation steps, technical requirements, and report preparation, for the environmental risk assessment of a single chemical substance under standard production and uses. The Trial...
September 6, 2019
Environmental Modeling Public Meeting Announced by EPA Environmental Fate and Effects Division
On September 4, 2019, the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs’ Environmental Fate and Effects Division (EFED) announced that the next Environmental Modeling Public Meeting (EMPM) will be held on October 16, 2019. The EMPM is a semi-annual public forum for EPA, pesticide registrants, and other stakeholders to discuss current issues related to modeling pesticide fate, transport, and exposure for risk assessments in a regulatory...
On August 2, 2019, the U.S. Environmental Protection Agency (EPA) Office of Pesticide Programs (OPP) announced that it has decided to reduce the Food Quality Protection Act (FQPA) safety factor for infants and children for pyrethroids from its current value of 3X to a new value of 1X. This decision is based on a July 1, 2019, OPP report entitled “USEPA Office of Pesticide Programs’ Re-evaluation of the FQPA Safety Factor for Pyrethroids: Updated Literature and CAPHRA Program Data...
On May 31, 2019, Health Canada’s Pest Management Regulatory Agency (PMRA) issued its Proposed Re-evaluation Decision PRVD2019-05, Chlorpyrifos and Its Associated End-use Products: Updated Environmental Risk Assessment (Updated Environmental Risk Assessment). PMRA states that this re-evaluation “considers data and information from pesticide manufacturers, published scientific reports, and other regulatory agencies” and that “Health Canada applies internationally accepted...
On May 9, 2019, the U.S. Environmental Protection Agency (EPA) announced it will hold the first meeting of the Science Advisory Committee on Chemicals (SACC) under the Toxic Substances Control Act (TSCA), for Pigment Violet 29 (PV29), the first chemical of the initial ten chemicals undergoing review, on June 18-21, 2019, from 9:00 a.m. to 5:30 p.m. (EDT) at the Holiday Inn Rosslyn at Key Bridge, Rosslyn Ballroom, 1900 North Fort Myer Drive, Arlington, Virginia. 84 Fed....
Beginning on January 23, 2018, the European Commission (EC) opened a consultation period on the European Food Safety Authority (EFSA) risk assessment process (scientific advice). The EC states it is seeking feedback on its process both as a “follow-up to the commitments made by the Commission in reply to the European Citizens’ Initiative on glyphosate,” and in response to “citizens [that] have put into question the risk assessment based on studies provided by the...
December 19, 2017
EPA Releases Draft Human Health and Ecological Risk Assessments for Glyphosate for Public Comment
On December 18, 2017, the U.S. Environmental Protection Agency (EPA) announced it is releasing for public comment the draft human health and ecological risk assessments for glyphosate. EPA’s Draft Human Health and Ecological Risk Assessments for Glyphosate website states that the “draft risk assessments and supporting documents will be available in glyphosate’s registration review docket EPA-HQ-OPP-2009-0361 on www.regulations.gov in early 2018,”...