FDA is responsible for regulating products Americans use every day. Decisions on the safety, efficacy, quality, and performance of FDA-regulated products are based on sound regulatory science. 

The National Center for Toxicological Research (NCTR), within FDA’s Office of the Chief Scientist, is recognized and sought after as a leader, collaborator, and advisor across scientific disciplines throughout the international research community. Its dedicated researchers work to promote the health of humans, animals, and the environment using science, technology, and innovation. The research topics discussed below, are examples of how NCTR research uses a One Health approach to regulatory science.  

Another One Health-related collaboration between FDA's NCTR and the Center for Veterinary Medicine (CVM) has focused on exploring alternative approaches to combat infectious diseases. Antimicrobial resistance (AMR) is defined as the ability of microorganisms—bacteria, viruses, fungi, or parasites—to resist the effects of a drug. AMR in pathogens spread between animals and humans has limited the effectiveness of several existing therapeutic options. This has led to an increased need for alternatives to combat bacterial infectious diseases. One alternative being explored is the use of compounds with antivirulence (AV) activities. These AV activities limit the disease-causing mechanisms that contribute to the morbidity and mortality associated with disease progression. NCTR and CVM scientists gave scientific presentations at the Twelfth International Conference on Antimicrobial Agents in Veterinary Medicine in Athens, Greece. The presentations highlighted ongoing research efforts to identify and verify the potential AV therapeutic targets, as well of the potential application of effective AV compounds to prevent illnesses and minimize the development of AMR. The spread of AMR is a key concern of traditional antimicrobial usage as it relates to One Health.

NCTR collaborated with the Center for Food Safety and Applied Nutrition (CFSAN) and Center for Veterinary Medicine (CVM) to augment traditional developmental toxicity testing with emerging research models. They assessed the risk of human developmental problems from exposure to inorganic arsenic. Inorganic arsenic is a contaminant frequently found in rice and rice-based products, including foods commonly eaten by infants and children, as well as canine feed. It can also be found in groundwater, soils, and sediments. Read the NCTR Research Highlight to find out more about the study and the publications that describe the research.