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U.S. Department of Health and Human Services

About FDA

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Genetic and Molecular Toxicology

Director: Martha Moore, 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, the CDER Genetic Toxicology Network, 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
  • Analysis of p53 Codon 270 CGT to TGT Mutation in Simulated Solar Light-Induced Skin Tumors and Exposed Mouse Skin (E0715201)
  • Animal models of pregnancy to address medical countermeasures for influenza and chemical, biological, radiological and nuclear threats in the "at risk " population of pregnant women.  Phase I. (E0746201)
  • Cancer Mutations as Biomarkers of Cancer Risk: Human Studies with Implications for Personalized Medicine (E0726501)
  • 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 (E0722901)
  • Development of a Molecular Cytogenetics Laboratory in the Division of Genetic and Reproductive Toxicology (E0734201)
  • Development of a New Safety Evaluation Method Using MicroRNA (miRNA) Expression Analysis as a Biomarker for Detecting Carcinogens (E0728101)
  • Development of a New T-cell Receptor (TCR) Gene Rat Model for Safety Screening of Pharmaceuticals and Other Chemicals for Potential Mutagenicity (E0719601)
  • 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)
  • Dose-Response Genotoxicity of Ethylmethane Sulfonate (EMS) in Mice using the Pig-a and Transgenic gpt Delta Assays (E0739001)
  • Effect of p53 Genotype on Gene-Expression Profiles in Mice Exposed to the Model Mutagen, N-ethyl-N'-nitrosourea (ENU) (E0712901)
  • Evaluating the toxicity of tobacco products using in vitro 3D tissue models (E0746801)
  • Evaluating the Utility of ACB-PCR in Dose-Response Assessment and Mode-of-Action Evaluation (E0726901)
  • Evaluation of the Ability of Both the Agar and Microwell Versions of the Mouse Lymphoma Assay (MLA) to Optimally Detect the Mutagenic Potential and Potency of Complex Chemical Mixtures (E0728401)
  • 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)
  • Further Evaluation of the Types of Genetic Events Detected by the Mouse Lymphoma Assay (MLA) and the Role of the Assay in Mechanistically Based Risk Assessment (E0711701)
  • Phosphatidylinositol Glycan - Complementation Group A (PIG-A) Mutagenesis: Development of Methods for the Identification and Molecular Characterization of Mutations in the PIG-A Gene in Human Lymphoblastoid Cells and C57Bl/6 Mice (E0720901)
  • 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)

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

870-543-7000
National Center for Toxicological Research

Food and Drug Administration

3900 NCTR Road

Jefferson, AR 72079