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.

Working Groups

  • Education and Science Outreach Committee

    Launched in 2022, the Education and Science Outreach Working Group aims to promote genetic toxicology as a career path and equip the next generation of scientists with foundational skills and experiences. By creating opportunities for networking, skill-building, and mentorship, the group supports early-career researchers in advancing their expertise and connecting with leaders in the field.

    Since 2024, the GTTC has offered two professional development awards that help trainees share their research and grow professionally.

    • Professional Development Travel Award – This award supports attendance at scientific conferences and workshops, allowing trainees to engage with current research, expand their networks, and gain insights into cutting-edge topics in genetic toxicology.
    • Professional Development Training Award – This award supports travel for specialized training courses, cross-laboratory exchanges, and skill-building activities, this award is designed to strengthen core competencies and enhance the practical skills needed in research.

    All awardees are invited to the GTTC Annual Meeting to learn about emerging projects and science at HESI and to network with experts in the gene toxicology field.

    Leadership Team:
    Joel Bercu (Gilead)

    HESI Staff:
    Raechel Puglisi, MPH

  • Error-Corrected Sequencing

    This working group is focused on evaluating error corrected next generation sequencing (ECS) as an alternative method for assessing in vivo mutagenesis. It’s current focus is on investigating the suitability of ECS for regulatory mutagenicity testing. The working group is currently focused on:

    • Supporting efforts to develop a publicly available database to be housed at the Division of Translational Toxicology/ National Institute of Environmental Health Sciences (DTT/NIEHS);
    • Supporting and advancing the use of  ECS for in vivo mutagenicity testing to enable broader genomic model applications and improved quantitative risk assessment;
    • Advancing in vitro applications of ECS

    Leadership Team:
    Shaofei Zhang (Pfizer), Javier Revollo (US FDA/NCTR)

    HESI Staff:
    Connie Chen, PhD, MPH

  • Germ Cells

    This working group focuses on developing and refining protocols for assessing genotoxic effects on germ cells. Current efforts include:

    • Quantitative analyses of germ cell data
    • Genotoxic effects in oocytes
    • In vitro approaches for germ cell mutagenicity

    Leadership Team:
    Roger Godschalk (Maastricht University), Jan van Benthem, PhD (RIVM, Retired)

    HESI Staff:
    Connie Chen, PhD, MPH

  • In Vitro

    This working group aims to critically evaluate new approach methodologies (NAMs) for in vitro genotoxicity testing, aiming to expand current testing strategies and ultimately make recommendations for creating an “in vitro only” approach for genetox testing that meets the needs of various regulatory decision-makers. The group is currently focused on the first of its committee-defined goals, which involves a comprehensive critical evaluation of NAMS through four focus areas:

    • Identification of aneugens;
    • Metabolism;
    • Indirect genotoxicity;
    • IVIVE

    Leadership Team:
    Marc Beal (Merck & Co.), Giel Hendriks, PhD (Toxys B.V.)

    Subteam Leadership: IVIVE – Alexandra Long (Health Canada); Metabolism – Nikolai Chepelev (Health Canada), Xiaoqing Guo (US FDA/NCTR); Indirect GTX – Ashley Allemang (P&G), Inger Brandsma (Toxys); Aneugens – Xiaowen Sun (Pfizer)

    HESI Staff:
    Alexandra Taraboletti, PhD

  • In Vivo Follow-Up

    This working group is dedicated to offering detailed guidance and best practices for selecting and conducting in vivo tests following a positive genotoxicity result. A key focus is ensuring that follow-up testing aligns with regulatory requirements and scientific best practices. The current  focus is on cytotoxicity of in vivo comet assays (data collection for retrospective analysis and development of a novel in vivo study). The recent pilot study data are under analysis, and on the following:

    • Evaluating the sensitivity of in vivo methods to detect weak effects of known mutagens.
    • Investigating how tail intensity influences the ability to detect subtle genotoxic effects.
    • These efforts aim to refine in vivo follow-up testing strategies, enhancing their precision and reliability in genotoxicity assessments.

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

    HESI Staff:
    Connie Chen, PhD, MPH

  • Mechanism-based Genotoxicity Risk Assessment (MGRA)

    The MRGA working group integrates the efforts of the former MOA and Clean Sheet working groups to establish a new mechanism-based paradigm for genotoxicity risk assessment. The group is composed of two subgroups focusing on Nitrosamines, and Titanium Dioxide (TiO2).

    Nitrosamines Working Group
    The primary objective of this subteam is to advance the scientific understanding and risk assessment of nitrosamines’ genotoxic potential through innovative mechanism-based testing approaches. (Leadership Team: Tetyana Cheairs (NY Medical College), Joel Bercu (Gilead))

    This subteam has four working groups:

    1. Ames Optimization – Goal: Develop an optimized Ames protocol that is predictive of the carcinogenic potential of nitrosamines (Leadership Team: Anthony Lynch (GSK), Joel Bercu (Gilead); HESI Staff: Raechel Puglisi, MPH)
    2. In Vitro Approaches – Goal: Identification and verification of in vitro assays to assist in nitrosamine risk identification (Leadership Team: Xiaowen Sun (Pfizer) and Xiaoqing (Carol) Guo (US FDA/NCTR); HESI Staff: Raechel Puglisi, MPH)
    3. In Vivo Folow-up – Goal: Develop an in vivo strategy to verify Ames data within the frame of ICH M7 (Leadership: Joel Bercu (Gilead), Robert Jolly (Eli Lilly), Sheroy Minocherhomji (Eli Lilly), Timothy McGovern (US FDA); HESI Staff: Raechel Puglisi, MPH)
    4. (Q)SAR/QM – Goal: Refine and extend the CPCA using (Q)SAR and QM for improved predictive performance. (Leadership: David Ponting (Lhasa), Jakub Kostal (George Washington University), Clarence Wybon (Independent); HESI Staff: Alex Taraboletti, PhD

    For more information about this subgroup – https://hesiglobal.org/gttc-nitrosamines/

    o-NNO Working Group
    This working group is focused on developing a science-based framework for evaluating the genotoxic and carcinogenic potential of n-nitroso compounds that are not nitrosamines (o-NNOs). The group will assess the current scientific data regarding genotoxicity and carcinogenicity of o-NNOs, identify data gaps, and generate experimental evidence and develop predictive models to inform quantitative risk assessment and safety limit setting

    Leadership Team:
    Michelle Kenyon (Pfizer)

    HESI Staff:
    Connie Chen, PhD, MPH

  • Mode of Action (MOA)

    This working group is completing several OECD AOP wikis. The first AOP “Oxidative DNA damage leading to mutations and chromosomal damage” was published on the AOPWiki in April 2023. The tubulin binding and topoisomerase II inhibition AOPs will be completed in early 2024, after which this work group will merge into the new MGRA work group.

    Leadership for Tubulin binding AOP:
    Yasmin Dietz (Sanofi)

    Leadership for Topoisomerase II AOP:
    Xiaowen Sun (Pfizer), Ryan Wheeldon (J&J)

    HESI Staff:
    Connie Chen, PhD, MPH

  • Quantitative Analysis (QA)

    This working group is driving advancements in genetic toxicology by evaluating chemical data and enhancing dose-response modeling tools. Key projects include:

    • Conducting a comprehensive genotoxicity dose-response study involving 48 mutagenic carcinogens.
    • Establishing critical effect size parameters to guide risk assessments.
      Providing data-driven insights to inform exposure limits for nitrosamines.
    • Collaborating with industry partners to expand the functionality of the GeneToxPi visualization tool.

    Research highlights involve optimizing in vivo study designs for precise Benchmark Dose (BMD) calculations and assessing inter-individual DNA repair variability. These efforts aim to promote broader adoption of dose-response modeling in regulatory decision-making.

    Leadership Team:
    George Johnson (GTox Ltd.), Andreas Zeller (Roche), Paul White (Health Canada)

    HESI Staff:
    Alexandra Taraboletti, PhD

HESI GTTC Professional Development Awardees 2026

The HESI Global Genetic Toxicology Technical Committee (GTTC) Education and Science Outreach Committee is pleased to announce the recipients of the 2026 Professional Development Travel Awards.

These awards will provide opportunities for new investigators to attend scientific conferences, workshops, or courses, etc., to build core competencies and transferable skills, and/or share their research.

Two award categories:

• Professional Development Travel Award: Provides $1,500 USD for travel to attend scientific conferences or workshops.
• Professional Development Training Award: Provides $4,000 USD for travel specific to training courses, cross-lab trainings, etc., to build core competencies and transferrable skills.

  • Past Award Winners

    2025 Travel Awardees: Alina Göpfert (BASF SE, Ludwigshafen / Free University Berlin), Caitlin Maggs (Swansea University), Deniz Akin (Swansea University), Gloria Melzi (University of Milan), Josie Jabbour (University of Ottawa), Sofija Stojanovic (University of Groningen, The Netherlands), Vanitha Thurairsu (National University of Malaysia)

    2025 Training Awardees: Alina Göpfert (BASF SE, Ludwigshafen / Free University Berlin), Alper James Alcaraz (University of Ottawa)

    2024 Travel Awardees: Elena Esina (University of Ottawa), Rim Nassar (University of Montpellier – France and Lebanese University), Madeleine Oman (University of Toronto), Lily Thompson (Thomas Jefferson University), Xinwen Zhang (NIEHS)

    2024 Training Awardee: Caitlin Maggs (Swansea University)

    2023 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 Awardees: Jonathan Axellson (UOttawa), Julie Sanders (Sciensano), Anouk Thienpont (VUB), Sam Vielee (U Louisville), David Schuster (UOttawa), Danila Cuomo (Texas A&M).

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

HESI Staff

Leadership Team

  • Carol Beevers, PhD

    Corteva Agriscience

  • Francesco Marchetti, PhD

    Health Canada

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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Standardized Cell sources and Recommendations for Good Cell Culture Practices in Genotoxicity Testing

Mutation Research/Genetic Toxicology and Environmental Mutagenesis. (2016) 809: 1–15., 2016

E. Lorge, M.M. Moore, J. Clements, M. O’Donovan, M.D. Fellows, ...
  • HESI - Health and Environmental Sciences Institute

Good cell culture practice and characterization of the cell lines used are of critical importance in in vitro genotoxicity testing. The objective of this initiative was to make continuously available stocks of the characterized isolates of the most frequently used mammalian cell lines in genotoxicity testing anywhere in the ...

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Next-generation testing strategy for assessment of genomic damage: a conceptual framework and considerations.

Environmental and Molecular Mutagenesis, 2016

Dearfield KL, Gollapudi BB, Bemis JC, Benz RD, Douglas GR, ...
  • HESI - Health and Environmental Sciences Institute

 

To enable the broader context for examining genetic damage, a next generation testing strategy needs to take into account a broader, more flexible approach to testing, and ultimately modeling, of genomic damage as it relates to human exposure. The outline of a flexible ...

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Mutagenesis Special Issue: Quantitative Genetic Toxicology (2016) This special issue was inspired by the HESI Genetic Toxicology Technical Committee’s Workshop: Genetic Toxicology at the Crossroads – From Qualitative Hazard Evaluation to Quantitative Risk Assessment

Mutagenesis, 2016

Multiple Contributors
  • HESI - Health and Environmental Sciences Institute

Applied genetic toxicology is undergoing a transition from qualitative hazard identification to quantitative dose–response analysis and risk assessment. To facilitate this change, the Health and Environmental Sciences Institute (HESI) Genetic Toxicology Technical Committee (GTTC) sponsored a workshop held in ...

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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.

Read more

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Center for Translational Sciences

The Genetic Toxicology Technical Committee (GTTC) is part of the Center for Translational Sciences. This HESI Center serves as a focal point for staff to share strategic approaches, scientific developments, management best practices and innovations with other related HESI committees.

Other Committees in the Center for Translational Sciences are:

For questions about the Center contact:

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