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.

Laboratory Scientist at Work

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.

2015 Research Accomplishments

  • Conducted research to develop a model for exposing suspension cultures of mammalian cells to whole smoke generated by a cigarette smoking machine.
  • Participated in OECD Working Groups for updating existing genetic toxicology Test Guidelines, and for developing guidance for the evaluation of nanomaterials.
  • Published “New Approaches to Advance the Use of Genetic Toxicology Analyses for Human Health Risk Assessment and Regulatory Decision Making” as a result of an ILSI/HESI collaboration.
  • Published manuscripts on the in vivo alkaline Comet assay and enzyme-modified Comet assay for measuring DNA strand breaks and oxidative DNA damage induced by FDA-relevant food contaminants and pharmaceuticals.
  • Published a manuscript on the utility of a transgenic hairless albino mouse mutational model for use in photogenotoxicity and photocarcinogenicity studies, and for assessing the safety of nanoparticles in cosmetics.

Research Plans for 2016

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

  • Develop and maintain a database for the Pig-a gene mutation assay.
  • Start a project involving an immunotoxicity assessment of nanomaterials using human immune cell-based biomarkers of innate immunity.
  • Conduct an Office of Women’s Health (OWH) project comparing oncomutation profiles of breast cancers in African American and Caucasian women.
  • Develop microRNA biomarkers for mutagens and carcinogens.
  • Develop methods for evaluating Pig-a mutations in rat erythroid precursor cells.
  • As part of a Memorandum of Understanding between the State of Arkansas and FDA, perform research on the genotoxicity of the nanomaterial, graphene.

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: 04/27/2016
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