About FDA

Genetic and Molecular Toxicology

Director: Robert Heflich, Ph.D.

The Division of Genetic and Molecular Toxicology (DGMT) conducts basic and applied research to address specific high-priority issues related to the induction of genetic damage. Division research is directed toward developing and validating new methods or improving existing methods for the identification of potentially hazardous food additives, human and animal drugs, biological therapies, and medical devices. In collaboration with other FDA scientists, DGMT utilizes the methodologies it develops to understand the potential toxicity of specific high-priority drugs, dietary supplements, and other agents. 

As experts in the field of genetic toxicology, scientists in DGMT are actively involved in national and international efforts to harmonize the conduct of genetic-toxicology tests and to improve their interpretation and use for regulatory decision making. DGMT scientists frequently provide expert advice to the FDA Centers, other government agencies, academia, and industry. They also are active participants in the FDA Genetic Toxicology Network, Interagency Coordinating Committee on the Validation of Alternate Methods (ICCVAM), and other interagency workgroups. 

The Division’s research is divided into the three research areas listed below and is being used to improve the ability of FDA to incorporate new and powerful technologies into regulatory decision making. 

  1. genetic-toxicology research addresses the development of methods to assess the potential for chemicals to negatively impact human-genetic material or the function of the genetic material
  2. dietary research primarily focuses on the potential hazards of dietary supplements
  3. omics research, coupled with more traditional approaches 

DGMT activities provide both direct support for, and the generation of, new approaches used by FDA Centers and, in particular, provide research and expertise directly related to the FDA Critical Path Initiative.

Ongoing Research Projects
  • Cancer Mutations as Biomarkers of Cancer Risk: Human Studies with Implications for Personalized Medicine (E0726501)
  • Determining Oncomutation Profile of Triple Negative Breast Cancer: Information to Direct Developement of Personalized Therapies (E0743801)
  • Development and evaluation of exposure dosimetry methods to optimize the standard in vitro mammalian genotoxicity assays for assessing engineered nanomaterials (E0745701)
  • Development of 3D human skin model for in vitro genotoxicity testing of chemical and physical agents (E0740001)
  • Development of a high-throughput assay for measuring in vivo mutation in an autosomal gene (E0741301)
  • 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) - CRADA with TERA (E0722911)
  • Development of Cancer-Relevant Biomarkers for Identification of Potential Carcinogens: Research to Understand the Normal Background Frequencies in Rats (E0733601)
  • Development of Methods for Evaluating DNA Damage using Single Cell Gel Electrophoresis (Comet Assay) in Rodents (E0729001)
  • Development of methods to expose cells in culture to volatile chemicals (E0754301)
  • Differential Transcriptomic Characterization of TK6 and WTK1 Human Lymphoblast Cells by Next Generation RNA Sequencing (E0744001)
  • Do engineered silver nanomaterials (Ag-ENMs) varying by size and coatings behave differently than bulk silver in their ability to induce genetic damage' (E0750101)
  • Dose-Response Genotoxicity of Ethylmethane Sulfonate (EMS) in Mice using the Pig-a and Transgenic gpt Delta Assays (E0739011)
  • Evaluating the toxicity and inflammation produced by cigarette smoke using human in vitro airway models (E0754901)
  • Evaluating the toxicity of tobacco products using in vitro 3D tissue models (E0746801)
  • Evaluation of microRNAs in blood and urine for detection of chemical-induced carcinogenicity (E0753001)
  • Evaluation of the ability of standard genetic toxicology assays to assess the relative genotoxic potential of cigarette smoke condensates (E0745901)
  • Evaluation of the Applicability of In Vivo Micronucleus Assays for Assessing Genotoxicity of Engineered Nanomaterials (E0731001)
  • Improving the Efficacy and Development of Targeted Cancer Therapeutics by Establishing a Model to Identify Molecularly-Targeted Therapies that Prevent Acquired Resistance (E0755101)"
  • In vitro genotoxicity of graphene-family nanomaterials using FDA recommended short-term genetic toxicity test battery. (E0753301)
  • Phosphatidylinositol glycan complementation group A (Pig-a) mutagenesis; an international validation study comparing Pig-a mutation in rats with other biomarkers of genetic toxicity (E0741201)
  • Procurement of Equipment to Expose Cell, Tissue, and Bacterial Cultures to Tobacco Smoke for Protocols E07459.01 and E07468.01 (E0751301)
  • Using standard genetic toxicology assays to assess the genotoxic potential of smokeless tobacco products (E0752101)
  • Validation of a newly developed transgenic, hairless and albino mice (E0727701)
  • 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 (E0750401)

NCTR's Annual Report contains information on the latest accomplishments and plans for the Division of Genetic and Molecular Toxicology (formerly the Division of Genetic and Reproductive 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: 07/01/2014
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