On Track: The FDA-TRACK Monthly Newsletter

Learn More: GenomeTrakr Program

The GenomeTrakr Program was created by FDA’s Center for Food Safety and Applied Nutrition (CFSAN) in 2012 to establish and deploy the whole genome sequencing of bacteria across the FDA Foods program. Whole genome sequencing (WGS) is used to reveal the complete DNA make-up of a bacterial pathogen, enabling us to better understand variations within species. This in turn allows us to differentiate between organisms with a precision that other technologies do not allow. FDA is using this technology to perform detailed foodborne pathogen characterization and traceback during foodborne illness outbreaks. WGS methods are also being applied in novel ways that have the potential to help reduce foodborne illnesses and deaths over the long term both in the U.S and abroad. The most basic application of this technology to food safety is using it to identify pathogens isolated from food or environmental samples. These can then be compared to clinical isolates from patients. If the pathogens found in the food or food production environment match the pathogens from the sick patients, a more precise link between the two can be made, which helps define the scope of a foodborne illness outbreak and provides the opportunity to stop outbreaks sooner, avoiding additional illnesses. There are many additional applications for this technology currently in use by FDA and in development for future use. FDA-TRACK now has five new program measures related to the current use of the GenomeTrakr Program and one new key project to track development for new technologies. The program measures include information on:

You can learn more about the GenomeTrakr Program and its impact on food safety at fda.gov.

What’s New in March 2016

New performance data are available for the dashboards below.

Center for Biologics Evaluation and Research (CBER)

CBER Dashboard: The number of actions taken on efficacy supplements during the quarter and the number of actions taken on efficacy supplements in the quarter that were within goal dates both reached an all-time high of 17 in FY16 Q1. Check out CBER’s review measures on the CBER Dashboard under Strategic Goal 3: Enhance the ability of advances in science and technology to facilitate development of safe and effective biological products.

Center for Food Safety and Applied Nutrition (CFSAN)

CFSAN Dashboard: As of FY16 Q1, there have been 44,158 pathogen isolates sequenced by the GenomeTrackr Network; 32,258 of them were Salmonella isolates, 6,281 were Listeria, 670 were Campylobacter, 58 were Cronobacter, and 4,891 were E. coli/Shigella.

Center for Veterinary Medicine (CVM)

CVM Dashboard: During FY16 Q1, 100% of export certificates for animal food related productsand 94% of those for drug products were issued within 20 days.

Office of the Commissioner (OC)

OC Administrative Offices Dashboard: The Freedom of Information Act (FOIA) program achieved a 7% backlog reduction in FY 2015 and closed the ten oldest requests. Check out the FOIA measures in FDA-TRACK.