About FDA

Biochemical Toxicology

Director: Frederick A. Beland, Ph.D.

The Division of Biochemical Toxicology conducts fundamental and applied research specifically designed to define the biological mechanisms of action underlying the toxicity of products regulated by, or of interest to, the Centers of the Food and Drug Administration (FDA). This research is focused on measuring the toxicities and risk of cancer related to specific chemicals and the introduction of new techniques to enable regulatory agencies to evaluate better the risks associated with exposure to chemicals. The risk-assessment research is firmly rooted in mechanistic and exposure studies focused on the understanding of toxicological endpoints. This approach allows greater confidence in the subsequent risk assessments. 

Research within the Division capitalizes on scientific knowledge in the areas of:

FDA Employee working in Lab
  • Biochemistry
  • Organic and analytical chemistry
  • Cellular and molecular biology
  • Nutritional biochemistry
  • Toxicology
  • Phototoxicology
  • Computational risk-assessment methods
  • Pharmacology 


A major theme within the Division continues to be toxicological assessments on on compounds nominated by FDA for evaluation by the National Institute of Environmental Health Sciences/National Toxicology Program (NIEHS/NTP). This focus reflects NCTR’s superb animal facilities supported by a multidisciplinary staff of scientists with strong research experience, which allows toxicological assessments to be conducted in a rigorous manner to address FDA’s needs. These studies currently serve as the benchmark by which toxicological assessments are made by FDA,other federal agencies, and international regulatory bodies. In addition to providing basic information on toxicological endpoints, such as cancer, these experiments form the basis for studies to determine if the response detected in the experimental model is applicable to humans


Examples of Ongoing Research Projects

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

  • Prepare a NTP report on a chronic bioassay of the food contaminant furan.
  • Prepare a draft report on the toxicities associated with a sub-chronic exposure to silver nanoparticles.
  • Prepare draft reports on 13-week and 1-year photo-co-carcinogenicity studies on retinyl palmitate.
  • Prepare a draft report on the sub-chronic study to evaluate the toxicities of melamine in combination with cyanuric acid in adult rats.
  • Complete the in-life phase of a 2-year chronic study to investigate the toxicities of topically applied triclosan.
  • Continue to develop methods for the rapid detection of potential bioterrorism agents in foods..
  • Predict effective thermal inactivation conditions for food-borne novel Staphylococcal enterotoxins using advanced computational methods and perform thermodynamic studies to test predictions made in silico.
  • Continue to investigate the role of epigenetic and microRNA alterations as potential biomarkers for noninvasive evaluation of exposure to genotoxic and non-genotoxic compounds of interest to the FDA.
  • Continue investigations on the pharmacokinetics of vaccine adjuvants containing squalene and α-tocopherol.
  • Continue studies to investigate the induction of arrhythmia in induced pluripotent stem cell-derived human cardiomyocytes.
  • Using computational approaches, continue to investigate the effects of thyroid active chemical mixtures on thyroid hormone homeostasis in pregnant women and their fetuses.
  • Continue to conduct sub-chronic studies with Aloe vera whole leaf preparation components, specifically aloin.
  • Using computational approaches, investigate the utility of in vitro models in predicting the in vivo toxicity.

NCTR's Annual Report contains information on the latest accomplishments and plans for the Division of Biochemical 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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