Genetic Toxicology Technical Committee (GTTC)

Mission Statement

The mission of this committee is to improve the scientific basis of the interpretation of results from genetic toxicology tests for purposes of more accurate hazard identification and assessment of human risk; to develop follow-up strategies for determining the relevance of test results to human health; to provide a framework for integration of testing results into a risk-based assessment of the effects of chemical exposures on human health; to promote the integration and use of new techniques and scientific knowledge in the evaluation of genetic toxicology; and to monitor and promote the development of innovative tests and testing strategies.

Announcing the HESI GTTC 2024 Professional Development Awardees!

The HESI GTTC Education and Science Outreach Committee is excited to announce the recipients of the 2024 Professional Development Travel Award and the inaugural Training Award.

The Professional Development Travel Award offers individuals with the opportunity to attend scientific conferences or workshops, while the Training Award supports travel for specific training programs (e.g., training courses, cross-lab training) to enhance core competencies and transferable skills. As part of this recognition, the awardees will be invited to GTTC’s 2025 Annual Meeting, where they will have the chance to engage with emerging projects and scientific advancements at HESI and to connect with industry, academic, and government experts in the genetic toxicology field.

Congratulations to all the well-deserving recipients! We wish them continued success in their scientific endeavors.
  • Past Award Winners

    2023 Spring Awardees: Tony Okeke (Drexel University), Ammer Khawam (McGill University), Natalia Bertolez (University of Coruna), Sarah Park (Oak Ridge, US EPA), Victoria Bastos (Maastricht University), Alper Alcarez (NIEHS), Idoia Meaza Izusi (University of Louisville)

    2022 Spring: Jonathan Axellson (UOttawa), Julie Sanders (Sciensano), Anouk Thienpont (VUB), Sam Vielee (U Louisville), David Schuster (UOttawa), Danila Cuomo (Texas A&M).

    2022 Fall: Zhenming Yang (Rutgers), Lee Pribyl (MIT), Natalie Laspata (Pittsburg), Daniela Muoio (Pittsburg), Elizabeth Irvin (NC State), Rebekah Petroff (Michigan).

Working Groups

  • Education and Science Outreach Committee

    Established in 2022, the committee aims to increase awareness of genetic toxicology careers and provide training for the next generation of scientists through various networking activities and awards. The committee launched a new professional development award, aimed at providing opportunities to attend scientific conferences, workshop or trainings to build core competencies and transferable skills and/or to share their research. Awardees are invited to the GTTC’s annual meeting to learn more about HESI emerging projects and science and to network with experts in the genetic toxicology field. A new early career seminar series award will also be launched in 2023, among other to-be-determined activities.

    Leadership Team:
    Joel Bercu (Gilead)
    Erica Briggs (Litron Laboratories)

    HESI Staff:
    Raechel Puglisi, MPH

  • Error-Corrected Sequencing

    This group is evaluating error-corrected next-generation sequencing (NGS) as an alternative methodology for evaluating in vivo mutagenesis. Over the past year, the group worked to qualify this platform in a second species and other mouse strains and began to work out the details on a technology transfer. Currently, the group is discussing the different workstreams/subgroups that would need to be established to move this project to the next phase, along with collaborations with both the eSTAR and CT-TRACs committees.

    Leadership Team:
    Shaofei Zhang (Pfizer)
    Barbara Parsons (US FDA/NCTR)

    HESI Staff:
    Connie Chen, PhD, MPH

  • Germ Cells

    Work for this group is centered around establishing/enhancing protocols for conducting genotoxicity assessment of effects to germ cells. After a series of publications in 2019, the group is finalizing a review on the impact of analyzing mutations in fast proliferating tissues at 28+28. This group is also considering future projects and the course of action for 2020–2021.

    The United Nations subcommittee on the Globally Harmonized System of Classification and Labelling of Chemicals is examining whether or not to revise it’s definition of a germ cell mutation. Changes to the definition could impact the classification and labeling for many chemicals. HESI’s Genetic Toxicology Technical Committee Germ Cell Working Group is working to support their evaluation by re-visiting existing data regarding a substance’s molecular interaction with germ cell DNA. The working group will provide their opinion on what positive endpoints in somatic tissues and/or level of exposure in gonads would allow classification and labelling as a germ cell mutagen. The terms of reference and work program information can be found here: UN-SCEGHS-ToR GCM IGW

     

    Leadership Team:
    Jan van Benthem, PhD (National Institute for Public Health and the Environment, RIVM, The Netherlands)
    Francesco Marchetti, PhD (Health Canada)

    HESI Staff:
    Connie Chen, PhD, MPH
    Raechel Puglisi, MPH

  • Historical Control Distribution (HCD)

    The GTTC HCD Working Group is querying laboratories about their experiences with compiling, maintaining and using historical control data and distributions for genetic toxicology assay acceptance and evaluation. The compiled data will be used to determine where consensus approaches exist and, where possible, make recommendations on compiling, maintaining and monitoring historical control data and distributions.

    Historical Control Distribution Working Group Survey
    The GTTC HCD Working Group is querying laboratories about their experiences with compiling, maintaining and using historical control data and distributions for genetic toxicology assay acceptance and evaluation. The compiled data will be used to determine where consensus approaches exist and, where possible, make recommendations on compiling, maintaining and monitoring historical control data and distributions.

    Completed surveys should be sent to Connie Chen (cchen@hesiglobal.org) by April 15, 2022.

    Please download both the survey (excel-based survey) and the PDF instructions that you can use as a reference.

    NOTE: If you have trouble editing the xls file survey please try two things: 1) Enable editing 2) Enable macros

     

    Leadership Team:
    Robert Smith (Labcorp)
    Robert Heflich (US Food and Drug Administration)

    HESI Staff:
    Connie Chen, PhD, MPH

  • In Vitro

    This newly established work group started this year with the following goals: (1) critically evaluate NAMs for in vitro genotoxicity testing, (2) envision how NAMs could expand current in vitro genetic toxicology testing strategies (e.g., developing a weight-of-evidence approach), and (3) make recommendations for creating an “in vitro only” approach for genetic toxicology testing that would meet the needs of various regulatory decision-makers.

    Leadership Team:
    Giel Hendriks, PhD (Toxys B.V.)
    Marc Beal (Health Canada)

    HESI Staff:
    Connie Chen, PhD, MPH

  • In Vivo Follow-Up

    This work group was formed in 2016. This working group focused on providing more detailed advice about which in vivo tests to choose to follow-up on in vitro positive results and how to conduct the tests. As a first step, the group compared data for 90 chemicals for the transgenic rodent assay, the in vivo comet assay, and cancer data. This work was published in Mutation Research/Genetic Toxicology and Environmental Mutagenesis in January 2019 in an article titled “A Comparison of Transgenic Rodent Mutation and In Vivo Comet Assay Responses for 91 Chemicals.” Two follow-up areas include (1) providing best practices on the in vivo comet assay and collecting data on substances that are positive (i.e., induce micronuclei [MN]) in vivo and (2) comparing the plasma concentrations at the lowest effective dose (LOED) with the lowest effective concentration (LOEC) for MN induction in vitro, which could shed some light as to whether there is any relationship between LOEC and LOED for MN-inducing compounds.

    Leadership Team:
    Carol Beevers (Corteva)
    David Lovell, PhD (St. George’s University of London)
    Matt LeBaron, PhD (Dow Chemical Company)

  • Mechanism-based Genotoxicity Risk Assessment

    The MGRA Working Group will develop a new mechanism-based risk assessment paradigm for genotoxicity, based on the Clean Sheet approach and using genotoxicity AOP’s including the ones developed by GTTC. Case studies will be used to demonstrate the usefulness of innovative, mechanism-based, testing approaches to the scientific and regulatory community in a real risk assessment context. A series of workshops will also be established to identify challenges and hurdles for acceptance of innovative methods, where successful examples will be discussed with relevant stakeholders.

    Leadership Team:
    Maik Schuler, PhD (Pfizer)
    Stefan Pfuhler, PhD (Procter & Gamble Company)

    HESI Staff:
    Raechel Puglisi, MPH

    Titanium Dioxide (TiO2) Subteam
    This work group is undertaking a literature review to understand ability for TiO2 to generate oxidative species and assess TiO2 oxidative stress potential towards filling in the experimental evidence related to the molecular initiating event of the Adverse Outcome Pathway 296 “Oxidative DNA damage leading to chromosomal aberrations and mutations” (increase in oxidative DNA damage).

    Leadership Team:
    Paul Fowler (FS Tox Consulting)
    Stefan Pfuhler (P&G)

    HESI Staff:
    Connie Chen (HESI)

    Nitrosamines Subteam
    This subteam has three goals: (1) to develop a protocol for an optimized Ames assay to predict the carcinogenicity of nitrosamines; (2) identify and verify in vitro assays with metabolically competent cells to support nitrosamines risk identification, and (3) develop a possible in vivo follow-up strategy to verify Ames data within the frame of ICH M7.

    Leadership Team:
    Tetyana Cheairs (NY Medical College), Andreas Czich (Sanofi)

    GTTC – Nitrosamines

  • Mode of Action

    The MOA Work Group established four subteams to develop tubulin binding, topoisomerase II inhibition, aurora kinase inhibition, and reactive oxygen species activation adverse outcome pathways (AOPs). These AOPs will be submitted to the OECD AOPWiki site, a public repository for approved AOPs. Once these four subteams complete their work, the goal will be to merge them with the Clean Sheet Work Group.

    Leadership Team:
    Mirjam Luitjen, PhD (National Institute for Public Health and the Environment, RIVM, The Netherlands)
    Jan van Benthem, PhD (National Institute for Public Health and the Environment, RIVM, The Netherlands)
    Stefan Pfuhler, PhD (Procter & Gamble Company)

    HESI Staff:
    Connie Chen, PhD, MPH

  • Quantitative Analysis

    The work group is evaluating chemical data and enhancing tools for genetic toxicology dose-response modeling. The group has a planned 2020 virtual EMGS workshop scheduled for December 2020. Additionally, the group is planning to present at the International Workshops on Genotoxicity Testing (IWGT) 2021 meeting and is working on publishing guidance for the standard use and regulatory acceptance of using the benchmark dose (BMD) approach with genetic toxicology data.

    Leadership Team:
    George Johnson, PhD (Swansea University)
    Andreas Zeller, PhD (Roche)

    HESI Staff:
    Raechel Puglisi, MPH

HESI Staff

Leadership Team

  • Stephen Dertinger, PhD

    Litron Laboratories

  • George Johnson, PhD

    Swansea University

Committee Events

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FDA-CDER and HESI | Nitrosamine Ames Data Review and Method Development Workshop

October 15, 2024 – October 16, 2024

FDA White Oak Campus, Silver Spring

The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) and Health & Environmental Sciences Institute (HESI) Global agree to co-sponsor the Nitrosamine Ames Data Review and Method Development Workshop that convenes subject matter experts to review data and discuss recommended test ...

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EUROTOX 2024

September 8, 2024 – September 11, 2024

Copenhagen, Denmark

Members of the HESI DART, eSTAR and GTTC Committees will be in attendance at EUROTOX 2024 taking place September 8-11 in Copenhagen.

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Committee Publications

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Permitted Daily Exposure Limits for Noteworthy N-Nitrosamines

Environmental and Molecular Mutagenesis, 2021

Johnson GE, Dobo K, Gollapudi B, Harvey J, Kenny J, Kenyon M, ...

A genotoxic carcinogen, N-nitrosodimethylamine (NDMA), was detected as a synthesis impurity in some valsartan drugs in 2018, and other N-nitrosamines, such as N-nitrosodiethylamine (NDEA), were later detected in other sartan products. N-nitrosamines are pro-mutagens that can react with DNA following metabolism to produce ...

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Recommendations for Conducting the Rodent Erythrocyte Pig‐a Assay: A Report from the HESI GTTC Pig‐a Workgroup

Environmental and Molecular Mutagenesis, 2021

Dertinger SD, Bhalli JA, Roberts DJ, Stankowski LF, Gollapudi BB, ...

The rodent Pig‐a assay is a flow cytometric, phenotype‐based method used to measure in vivo somatic cell mutation. An Organization for Economic Co‐operation and Development (OECD) test guideline is currently being developed to support routine use of the assay for regulatory purposes (OECD project number ...

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Relationships Between p53 Status, Apoptosis and Induction of Micronuclei in Different Human and Mouse Cell Lines In Vitro: Implications for Improving Existing Assays

Mutation Research/Genetic Toxicology and Environmental Mutagenesis, 2015

Whitwell J, Smith R, Jenner K, Lyon H, Wood D, Clements J, ...
  • HESI - Health and Environmental Sciences Institute

Accumulated evidence has shown that in vitro mammalian cell genotoxicity assays produce high frequencies of "misleading" positive results, i.e. predicted hazard is not confirmed in in vivo and/or carcinogenicity studies [1], raising the question of relevance to human risk assessment.

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