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.

Recent News

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.

Terms of Reference and Work Program

Working Groups

  • 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

  • Evaluation of New Compounds: Nanomaterials

    The work group has evaluated the current testing paradigm for genotoxicity assessment of nanomaterials and is publishing the findings and recommendations for modifying the tests as needed. They are currently considering publishing a series of protocols for genetic toxicity testing of products containing nanomaterials.

    Leadership Team:
    Rosalie Elespuru, PhD (US Food and Drug Administration)
    Shareen Doak, PhD (Swansea University)

    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:
    Dan Roberts, PhD (Charles River Laboratories)
    David Lovell, PhD (St. George’s University of London)
    Matt LeBaron, PhD (Dow Chemical Company)

    HESI Staff:
    E’Lissa Flores, PhD

  • 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

  • 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

  • Pig-a Assay

    This work group had their Detailed Review Paper (DRP) and a Validation/Retrospective Performance Analysis document accepted by OECD. It is currently drafting a Test Guideline to be reviewed and accepted by OECD in the future.

    Leadership Team:
    Steven Dertinger, PhD (Litron Laboratories)
    Bob Heflich, PhD (US Food and Drug Administration)

    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:
    E’Lissa Flores, PhD

  • 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:
    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:
    E’Lissa Flores, PhD

  • 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:
    Bob Young, MS (MilliporeSigma)
    Francesco Marchetti, PhD (Health Canada)
    Sheroy Minocherhomji, PhD (Amgen)

    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.)
    Stepahnie Smith-Roe, PhD (National Institute of Environmental Health Sciences, National Toxicology Program)

    HESI Staff:
    Connie Chen, PhD, MPH

HESI Staff

Leadership Team

  • Mirjam Luitjen, PhD

    National Institute for Public Health and the Environment, RIVM, The Netherlands

  • Leon Stankowski, PhD

    Charles River Laboratories

Committee Events

Filter

HESI Sessions at EMGS 2021 Virtual Annual Meeting

September 15, 2021 – September 25, 2021

Virtual annual meeting, hosted by the Environmental Mutagenesis and Genomics Society (EMGS)

The Botanical Safety Consortium (BSC), Genetic Toxicology Technical Committee (GTTC), and Emerging Systems Toxicology for the Assessment of Risk (eSTAR) Committee will present their work at the Environmental Mutagenesis and Genomics Society (EMGS) 2021 Virtual Annual Meeting on September 15-25, 2021.

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HESI GTTC Committee 2021 Annual Meeting

June 1, 2021 – June 3, 2021

Virtual meeting, hosted by the HESI GTTC Committee

The HESI GTTC Committee 2021 Annual Meeting will take place on June 1-3, 2021 from 9am-1pm EST. The virtual meeting is open to GTTC Committee participants only.

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GTTC Quantitative Analysis Working Group Workshop

May 25, 2021

Virtual workshop, hosted by the HESI GTTC Committee

This workshop is a pre-GTTC Annual Meeting workshop to provide extra time to discuss 2020-21 Quantitative Analysis Working Group activities, as well as emerging challenges and upcoming milestones. The presentations will collectively cover a variety of topics and issues pertaining to the refinement of quantitative methods for ...

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Quantitative Interpretation of Genetic Toxicity Dose Response Data for Risk Assessment and Regulatory Decision-Making: Current Status, Persistent Challenges, and Emerging Priorities

December 3, 2020

Virtual workshop, hosted by HESI and the Environmental Mutagenesis and Genomics Society (EMGS)

The workshop will (1) provide a brief overview of the state of the science regarding quantitative interpretation of genetic toxicity dose-response data, including a brief overview of the BMD combined covariate approach for potency ranking and MOA investigation, (2) a summary of recent genotoxicity risk assessment case ...

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Validation of New Approaches in Genetic Toxicology

May 8, 2019

Newark, Delaware, USA

Novel in vitro and in vivo assays have been developed to improve the reliability of tools employed for identification of genotoxic hazard. Several of the new assays can provide insight into mode-of-action (MoA). As emerging technologies generally used for evaluating human hazard and/or risk, these novel ...

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Committee Publications

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New and Emerging Technologies for Genetic Toxicity Testing

Environmental and Molecular Mutagenesis, 2011

Lynch AM, Sasaki JC, Elespuru R, Jacobson‐Kram D, Thybaud V, ...

The International Life Sciences Institute (ILSI) Health and Environmental Sciences Institute (HESI) Project Committee on the Relevance and Follow-up of Positive Results in In Vitro Genetic Toxicity (IVGT) Testing established an Emerging Technologies and New Strategies Workgroup to review the current State of the Art in ...

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Need and Potential Value of the Pig‐a In Vivo Mutation Assay—A HESI Perspective

Environmental and Molecular Mutagenesis, 2011

Schuler M, Gollapudi BB, Thybaud V, Kim JH

The Health and Environmental Sciences Institute (HESI), a global branch of the International Life Sciences Institute (ILSI), initiated a project committee entitled “Relevance and Follow-up of Positive Results from In Vitro Genetic Toxicity Testing (IVGT)” with the overall objective of improving the scientific basis for ...

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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

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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Identifying Germ Cell Mutagens Using OECD Test Guideline 488 (Transgenic Rodent Somatic and Germ Cell Gene Mutation Assays) and Integration with Somatic Cell Testing

Mutation Research / Genetic Toxicology and Environmental Mutagenesis, 2018

Marchetti F, Aardema MJ, Beevers C, van Benthem J, Godschalk R, ...

The Organisation for Economic Co-operation and Development Test Guideline 488 (TG 488) provides recommendations for assessing germ cell and somatic cell mutagenicity using transgenic rodent (TGR) models. However, important data gaps exist for selecting an optimal approach for simultaneously evaluating mutagenicity in ...

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