Director: Martha Moore, Ph.D.

Documents

The Division of Genetic and Reproductive Toxicology (DGRT), one of NCTR’s research divisions, has its roots with the founding of the NCTR in 1971. DGRT conducts translational and applied research to address specific high-priority issues regarding genetic and reproductive/developmental toxicology. Division research develops and validates new methods or improves existing methods for the identification of potentially hazardous food additives, human and animal drugs, biological therapies, and medical devices. In collaboration with other NCTR scientists, DGRT uses the methodologies that it develops to conduct research to understand the potential toxicity of specific high-priority drugs, dietary supplements, or other agents. For example, acrylamide, bitter orange, and the AIDS therapeutic drugs (including zidovudine, lamivudine, nelfinavir and nevirapine), are undergoing extensive evaluations in cross-division collaborative research efforts.

As experts in the field of genetic toxicology, scientists in DGRT 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. DGRT scientists frequently provide expert advice to other FDA Centers, other government organizations, and various other public and private organizations. They are active participants in the FDA Genetic Toxicology Network and the FDA's Center for Drug Evaluation and Research (CDER) Genetic Toxicology Network.

Currently there are four focus areas in the Division research program - genetic toxicology, reproductive/developmental toxicology, dietary research, and omics research. 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. Reproductive/developmental toxicology focuses on methods to understand normal human development and how chemicals might alter normal development. Dietary research primarily focuses on understanding the physiological and genetic consequences of dietary modulation and on the potential hazards of dietary supplements. Emphasis on omics research is rapidly increasing in the Division and is coupled with more traditional approaches to improve the ability of FDA to incorporate these new and powerful technologies into regulatory decision making.

DGRT activities provide both direct support to, and the generation of, new approaches that are used by the other FDA Centers.

• Facilities/expertise for the development of transgenic models
• Facilities/expertise for the culture and genetic manipulation of mouse embryonic stem cells
• Leader in the development of methods to detect mutations on the basis of their change in sequence (genotypic selection)
• Experts in the use of animal models to detect in vivo mutation
• Extensive experience with rodent caloric restriction models
• Flow cytometry laboratory dedicated to toxicology research
• Expertise/facilities to conduct in vivo and in vitro rodent developmental toxicity studies
• Expertise in conducting rodent physiology studies using implanted monitors

The NCTR Research Plans and Accomplishments Document contains information on the latest accomplishments and plans for the Division of Genetic and Reproductive Toxicology as well as project and publication listings.