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  1. FDA-TRACK: Agency-wide Program Performance

FDA-TRACK: Center for Food Safety and Applied Nutrition - Regulatory Science

FDA's Center for Food Safety and Applied Nutrition (CFSAN) administers the Foods Program. CFSAN ensures the safety of the human food supply, dietary supplements, and cosmetics as well as the proper labeling of foods and cosmetics. The Foods Program is responsible for a safe food supply and ensuring FDA regulations and guidance provide clear and reliable direction and assistance to industry, both inside and outside the United States, with a goal to obtain high rates of compliance with standards necessary to protect public health and meet consumer and stakeholder expectations.

The FDA conducts research that advances regulatory science, the science of developing tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products. Regulatory science facilitates evaluation or development of FDA-regulated products and supports regulatory decision-making and policy development. It also enables the FDA to understand and assess risk, prepare for, and respond to, public health emergencies, and help ensure the safety or reduce the harm of products used or consumed by patients and consumers.

Explore the progress CFSAN is making towards its Regulatory Science efforts below:

GenomeTrakr Laboratory Network

GenomeTrakr Network Contributing Laboratories

The GenomeTrakr Program is creating a sustainable network of public health laboratories using whole genome sequencing (WGS) to investigate foodborne illness outbreaks and attribute illnesses to specific food products, processing or farming practices, or geographic regions. The program is changing the way that foodborne illnesses are investigated, allowing authorities to investigate small illness clusters before there is a chance to sicken large numbers of people. The network is linked by a common, publicly-accessible database that uses a common sequencing platform, with common laboratory and quality control procedures, common on-board training, and a common metadata (sample information) standard.

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Whole Genome Sequencing (WGS)

The GenomeTrakr network has built a database of Salmonella, Listeria monocytogenes, Campylobacter, Cronobacter, and E. coli/Shigella genomes from real time surveillance and historical collections. This database has supported multiple foodborne illness outbreak investigations and is fundamentally changing the way that outbreak investigations are conducted.

Cumulative Number of Isolates Sequenced by the GenomeTrakr Network

Whole Genome Sequencing Database

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Institute for Food Safety and Health

Institute of Food Safety and Health Workgroup Members

The Institute of Food Safety and Health (IFSH), which is a collaboration between the FDA, the Illinois Institute of Technology, and a consortium of food industry members, has constituted a workgroup to collaborate on whole genome sequencing of bacterial isolates submitted by industry partners. The IFSH workgroup facilitates the participation of industry partners in the selection of bacterial isolates, obtains limited metadata about the isolates, arranges sequencing in the IFSH facilities, after which data is uploaded to the GenomeTrakr database. To date there are four industry partners participating in submission of isolates, although IFSH itself has nearly 100 private sector partners.

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Key Projects

Key Project: Environmental Microbiology and Foodborne Outbreaks

This program conducts microbiological work to enhance Good Agricultural Practices (GAPs) and other novel preventive controls for reducing pathogen contamination of high risk produce commodities such as tomatoes, cantaloupes, and leafy greens. The program also helps to pinpoint important reservoirs of environmental contamination, thereby enhancing preventive controls and reducing time needed to conduct field investigations to identify sources of human illness. This program component is critical to FSMA mandates on the establishment of science-based rules and guidelines for the produce industry. The program provides the laboratory science necessary for the Centers regulatory, policy, and compliance and enforcement programs for fresh-cut produce microbiology. This program specifically identifies environmental and farm management risks and practices leading to the internal contamination of produce cultivated for the US food supply. Collectively this work will lead to better and more specific enhanced regional produce safety guidance and safer, ready-to-eat vegetables and fruits.

Key Project: Evaluation of Cannabinoid Toxicity Using Alternative Models

Despite the increased use of cannabidiol (CBDs) and other cannabinoids such as cannabichromene (CBC), cannabigerol (CBG), and cannabinol (CBN), little research addressing the safety of use of these products exists, particularly the non-CBD cannabinoids (NCC). The goal of the proposed study is to screen NCC for any toxicity effects on different organs (e.g., hepatotoxicity, renal, reproductive and developmental toxicities), and evaluate our tools, which include in silico, in vitro (2D cell cultures, organ chips, and stem cell-derived hepatocytes), and non-vertebrate in vivo methods (C. elegans) to predict their potential organ toxicities; and compare to in vivo studies. This tiered strategy will rapidly screen these compounds for toxicity and select compounds for further testing. These studies will address some of the toxicology data gaps that exist in understanding the safety of CBDs and other cannabinoids such as CBC, CBG, CBN and non-CBD cannabinoids.

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Key Project: Produce Safety Research - Simulating Field Conditions

OARSA scientists are establishing and providing an optimal applied produce in-laboratory research facility using growth chambers and/or rooms to respond to emerging hypotheses, programmatic needs, and/or outbreak investigations. We are generating data that represent real-life growing conditions of produce and their interaction with human pathogens of concern (bacteria, virus, and parasites). Those interactions represent an on-going threat to the health and well-being of the US consumers that look into improving their nutrition intake by consuming fresh fruits and vegetables. The goal of the proposed studies is to fill data gaps to evaluate FSMA-related guidance and implementation by simulating the environmental conditions in the growing fields (e.g., agricultural water, soil amendment, produce rule). Additionally, the possibility of unidentified sources of transfer is concerning since unknown sources cannot be managed to mitigate risk. A better understanding of how pathogens survive and circulate in the environment is needed to develop better approaches to prevent contamination of fresh produce.

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Download FDA-TRACK CFSAN Regulatory Science Dataset

Note:  The data provided on this website are produced on an ongoing basis for performance management purposes and are subject to change due to updates of preliminary estimates, corrections, or other reasons.



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