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

On 30 June 22, the Organisation for Economic Cooperation and Development (OECD) published Test #470: Mammalian Erythrocyte Pig-a Gene Mutation Assay, a Test Guideline (TG) that describes an in vivo gene mutation assay that can be combined with other genetic and general toxicology tests to promote the efficient use of animal resources. This TG is the culmination of fruitful discussions over more than a decade among the GTTC Pig‐a Workgroup members who contributed directly to the Pig-a Assay Detailed Review Paper, the Pig-a Assay Retrospective Validation Report, the draft OECD TG, the OECD Expert Working Group, as wells as the recent GTTC best practices Review Paper.

“Starting in the late 2000s, the HESI GTTC Pig-a Workgroup was instrumental in acting as a clearing house for discussing protocol changes that greatly improved the precision of the assay, discussing results from several international interlaboratory validation studies, and later in organizing an International Workshops on Genotoxicity Testing meeting on the assay in Foz do Iguacu, Brasil. The Workgroup also had a major role in developing the OECD Standard Project Submission Form (SPSF), that initialed the OECD TG project in 2015.” – Robert Heflich (US FDA), GTTC Pig-A working group co-chair

“HESI staff provided key logistical support that kept the OECD Test Guideline endeavor organized and focused. Also, the importance of HESI-GTTC members’ recommendations regarding study designs and scoring approaches cannot be overstated—they laid the foundation for this OECD approval.” – Stephen Dertinger (Litron Laboratories), GTTC Pig-A working group co-chair

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

    On 30 June 22, the Organisation for Economic Cooperation and Development (OECD) published Test #470: Mammalian Erythrocyte Pig-a Gene Mutation Assay, a Test Guideline (TG) that describes an in vivo gene mutation assay that can be combined with other genetic and general toxicology tests to promote the efficient use of animal resources. This TG is the culmination of fruitful discussions over more than a decade among the Pig‐a Workgroup members who contributed directly to the Pig-a Assay Detailed Review Paper, the Pig-a Assay Retrospective Validation Report, the draft OECD TG, the OECD Expert Working Group, as wells as the recent GTTC best practices Review Paper.

    “Starting in the late 2000s, the HESI GTTC Pig-a Workgroup was instrumental in acting as a clearing house for discussing protocol changes that greatly improved the precision of the assay, discussing results from several international interlaboratory validation studies, and later in organizing an International Workshops on Genotoxicity Testing meeting on the assay in Foz do Iguacu, Brasil. The Workgroup also had a major role in developing the OECD Standard Project Submission Form (SPSF), that initialed the OECD TG project in 2015.” – Robert Heflich (US FDA), GTTC Pig-A working group co-chair

    “HESI staff provided key logistical support that kept the OECD Test Guideline endeavor organized and focused. Also, the importance of HESI-GTTC members’ recommendations regarding study designs and scoring approaches cannot be overstated—they laid the foundation for this OECD approval.” – Stephen Dertinger (Litron Laboratories), GTTC Pig-A working group co-chair

    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 Luijten, PhD

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

  • Stephen Dertinger, PhD

    Litron Laboratories

Committee Events

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Committee Publications

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A comparison of the lowest effective concentration in culture media for detection of chromosomal damage in vitro and in blood or plasma for detection of micronuclei in vivo

Mutation Research/Genetic Toxicology and Environmental Mutagenesis, 2022

David Kirkland, James Whitwell, Robert Smith, ...

It is often assumed that genotoxic substances will be detected more easily by using in vitro rather than in vivo genotoxicity tests since higher concentrations, more cytotoxicity and static exposures can be achieved. However, there is a paucity of data demonstrating whether genotoxic substances are detected at lower ...

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In vivo Mammalian Alkaline Comet Assay: Method Adapted for Genotoxicity Assessment of Nanomaterials

Frontiers in Toxicology, Nanotoxicology, 2022

Cardoso R, Dusinska M, Collins A, Manjanatha M, Pfuhler S, ...

The in vivo Comet assay measures the generation of DNA strand breaks under conditions in which the DNA will unwind and migrate to the anode in an electrophoresis assay, producing comet-like figures. Measurements are on single cells, which allows the sampling of a diversity of cells and tissues for DNA damaging effects. The Comet ...

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Common Considerations for Genotoxicity Assessment of Nanomaterials

Frontiers in Toxicology, Nanotoxicology, 2022

Elespuru RK, Doak SH, Collins AR, Dusinska M, Pfuhler S, ...

Abstract: Genotoxicity testing is performed to determine potential hazard of a chemical or agent for direct or indirect DNA interaction. Testing may be a surrogate for assessment of heritable genetic risk or carcinogenic risk. Testing of nanomaterials (NM) for hazard identification is generally understood to require a ...

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AOP report: Development of an adverse outcome pathway for oxidative DNA damage leading to mutations and chromosomal aberrations

Environmental and Molecular Mutagenesis, 2022

Eunnara Cho, Ashley Allemang, Marc Audebert, Vinita Chauhan, ...

HESI Genetic Toxicology Technical Committee's first adverse outcome pathway (AOP) describing modes of actions leading to potentially heritable genomic damage is now online! This AOP focused on oxidative DNA damage and resulting mutations and chromosomal aberrations.  It is currently included in the OECD workplan and is ...

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Utility of a next-generation framework for assessment of genomic damage: A case study using the pharmaceutical drug candidate etoposide

Environmental and Molecular Mutagenesis, 2021

Nicolette J, Luijten M, Sasaki JC, Custer L, Embry M, Froetschl R, ...

The HESI Genetic Toxicology Technical Committee (GTTC) applies their systematic and flexible approach for assessing the risk of genetic damage due to exposure to chemical substances to etoposide, a drug used in certain types of cancer treatments, as a representative pharmaceutical case study.

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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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