About FDA

Genetic and Molecular Toxicology

Director: Robert Heflich, Ph.D.


Internationally recognized expertise in developing, validating, and interpreting genetic toxicology research for regulatory decisions that improve public health.

Division Research Themes

  1. Development, validation, and maintenance of regulatory genetic-toxicology assays
  2. Chemical-specific research
  3. Development of new paradigms for regulatory decision-making that Integrate measures of genetic risk with biomarkers of toxicity by conducting research Involving:

• More relevant biological models

• More comprehensive approaches to monitoring genetic variation

• Better ways of evaluating data to determine human risk

Division scientists actively participate in FDA committees and international working groups that form consensus on how to conduct regulatory genetic toxicology testing. The international working groups that Division scientists participate in include the International  Workshop for Genotoxicity Testing (IWGT), the Organisation for Economic Co-Operation and Development (OECD), and the International Life Sciences Institute/Health and Environmental Sciences Institute (ILSI/HESI). Division scientists will continue to be involved in discussions concerning the appropriate strategies for conducting risk assessments of regulated products.

Recent Division Accomplishments

  • Served as a member of the FDA Taskforce on nanomaterials.
  • Participated in OECD Working Groups for updating existing genetic toxicology test guidelines, and for developing guidance for the evaluation of nanomaterials.
  • Contributed to a new OECD test guideline on the in vivo Comet assay by conducting research to evaluate important parameters of this technique.
  • Led an IWGT Workgroup that produced a consensus document on using the Pig-a assay for regulatory safety assessments.
  • Conducted RNA-seq and data analysis to identify transcriptomic variations in human B-lymphoblastoid lines used in genetic toxicology testing.

2015 Research Projects

The following list is just a sample of research projects being conducted at NCTR in the Division of Genetic and Molecular Toxicology.

  • Cancer Mutations as Biomarkers of Cancer Risk: Human Studies with Implications for Personalized Medicine
  • Continue an OWH-funded project Determining the Oncomutation Profile of Triple-Negative Breast Cancers
  • Development and Evaluation of Exposure Dosimetry Methods to Optimize the Standard in vitro Mammalian Genotoxicity Assays for Assessing Engineered Nanomaterials
  • Development of 3D Human-Skin Model for in vitro Genotoxicity Testing of Chemical and Physical Agents
  • Development of a High-Throughput Assay for Measuring In Vivo Mutation in an Autosomal Gene
  • Development of a Method to Use In Vivo Mutagenicity Data to Address the Question as to Whether a Specific Chemical Induces Cancer via a Mutagenic or a Non-mutagenic Mode-of-Action (MOA) -
  • Development of Cancer-Relevant Biomarkers for Identification of Potential Carcinogens: Research to Understand the Normal Background Frequencies in Rats
  • Development of Methods for Evaluating DNA Damage using Single Cell Gel Electrophoresis (Comet Assay) in Rodents
  • Development of Methods to Expose Cells in Culture to Volatile Chemicals
  • Differential Transcriptomic Characterization of TK6 and WTK1 Human Lymphoblast Cells by Next Generation RNA Sequencing
  • Do Engineered Silver Nanomaterials (Ag-ENMs) Varying by Size and Coatings Behave Differently than Bulk Silver in their Ability to Induce Genetic Damage
  • Dose-Response Genotoxicity of Ethylmethane Sulfonate (EMS) in Mice using the Pig-a and Transgenic gpt Delta Assays
  • Evaluating the Toxicity and Inflammation Produced by Cigarette Smoke Using Human In Vitro Airway Models
  • Evaluating the Toxicity of Tobacco Products Using In Vitro 3D Tissue Models
  • Evaluation of MicroRNAs in Blood and Urine for Detection of Chemical-induced Carcinogenicity
  • Evaluation of the Ability of Standard Genetic Toxicology Assays to Assess the Relative Genotoxic Potential of Cigarette Smoke Condensates
  • Evaluation of the Applicability of In Vivo Micronucleus Assays for Assessing Genotoxicity of Engineered Nanomaterials
  • Improving the Efficacy and Development of Targeted Cancer Therapeutics by Establishing a Model to Identify Molecularly-Targeted Therapies that Prevent Acquired Resistance
  • In Vitro Genotoxicity of Graphene-family Nanomaterials Using FDA-recommended Short-term Genetic Toxicity Test Battery
  • Phosphatidylinositol Glycan Complementation Group A (Pig-a) Mutagenesis; an International Validation Study Comparing Pig-a Mutation in Rats with other Biomarkers of Genetic Toxicity
  • Using Standard Genetic Toxicology Assays to Assess the Genotoxic Potential of Smokeless Tobacco Products
  • Validation of a Newly Developed Transgenic, Hairless, and Albino Mice
  • Validation of the In Vivo Comet Assay for Pre-market Submissions and Preparation of Detailed Review Paper to Assist in the Development of a New OECD Guideline

NCTR's Annual Report contains information on the latest accomplishments and plans for the Division of Genetic and Molecular Toxicology as well as project and publication listings.

Contact FDA

National Center for Toxicological Research

Food and Drug Administration

3900 NCTR Road

Jefferson, AR 72079

Page Last Updated: 05/19/2015
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