To improve the efficiency and efficacy of FDA inspections, as well as meet the federally-mandated requirements of the Food Safety Modernization Act (FSMA), FDA seeks to develop an Integrated Food Safety System (IFSS) solution with which food safety data can be exchanged, analyzed, and acted upon, across all levels of the regulatory spectrum. Additionally, FDA requires a system that is functional beyond the existing capabilities of the Electronic State Access to FACTS (eSAF) and Electronic Laboratory Exchange Network (eLEXNET) systems. To meet these desired objectives, FDA is establishing the National Food Safety Data Exchange (NFSDX) to provide regulatory partners involved in ensuring the safety of the nation’s food supply an investigative tool that will allow sharing and exchange of food safety information, such as inspection findings and Firm information, on a national basis.
The NFSDX will provide secure and immediate access to relevant information, enhancing the ability of the food safety community to share that information in a timely manner, and will provide analysis and other collaboration tools to assist investigators and regulatory partners working cases cooperatively with other agencies. The ultimate goal of the exchange will support an IFSS in achieving mutual reliance amongst partner agencies, assuring high rates of compliance with food safety laws and regulations. In addition, the NFSDX may serve as a model or starting point for a future effort to share information on other types of regulatory inspections of interest to FDA.
Ensuring project success has required collaboration among many individuals and groups, with a significant focus on engaging the seven pilot States that have agreed to support the NFSDX development effort. The pilot has garnered a substantial amount of support from associates within the Partnership for Food Protection (PFP) IT Workgroup (WG), which has been instrumental in launching the pilot. Since its formation, the PFP has utilized a workgroup structure to develop and implement procedures, best practices, and other work products to advance food safety data integration. Many of the PFP IT WG State Representatives participated in a 2015 survey that assisted in identifying numerous data elements that would later become a part of the pilot system schema. It was working with the PFP IT WG that enabled FDA’s NFSDX team to recruit the first pilot States. The NFSDX team attends the PFP IT WG’s biweekly meetings where they provide updates on the pilot, and team feedback is both provided and received.
NFSDX Release 1.0 is the result of the Initial Operating Capability (IOC) phase effort to provide State and FDA users with a means to automate data transfers from State to FDA. NFSDX Release 1.0 comprises the business scenario wherein the State submits Contracted Inspection data to FDA/eSAF through a system-to-system integration mechanism. Release 1.0 was deployed into production on May 10, 2017; however, it will not be used by the States immediately, as pilot States are undergoing the process of integrating their individual systems with NFSDX.
Besides the business capability to receive Contracted Inspection results, NFSDX Release 1.0 implements reusable components for authentication, validation, and audit trail logging. In addition, it provisions the infrastructure for future NFSDX releases. The image below depicts the current and possible future capabilities of the NFSDX system.
From the technical interface perspective, NFSDX Release 1.0 offers synchronous and asynchronous integration mechanisms for pilot States to submit their Contracted Inspection data. The State client invokes the NFSDX web service endpoint to submit data using the HTTPS protocol.
Release 2.0 of the NFSDX project IOC is currently under development, with plans to integrate with the pilot States in September 2017.