Overview
The Food and Drug Administration (FDA) Human Foods Program (HFP), which oversees all FDA activities related to food safety and nutrition, works to advance the goals within the New Era of Smarter Food Safety to enhance traceability, improve predictive analytics, respond more rapidly to outbreaks, address new business models, reduce contamination of food, and foster the development of stronger food safety cultures. The New Era aims for end-to-end traceability across the food system.
Challenge
Both the FDA Food Safety Modernization Act (FSMA) and the New Era of Smarter Food Safety prioritize protecting consumers from contaminated products by being able to rapidly identify their source and remove them from the marketplace as quickly as possible. Many food outbreaks occur among people who live far apart and eat food that was contaminated where it was grown or prepared before it was distributed in stores or restaurants across different states.
Efficient product tracing helps government agencies and those who produce and sell food to rapidly find the source of the product and where contamination may have occurred. Food traceability enables organizations to follow the movement of a food product and its ingredients through all steps in the supply chain, both backward and forward.
Data fragmentation across multiple FDA systems limited the agency’s ability to rapidly detect, analyze, and respond to foodborne illness outbreaks and forced FDA to rely on manual traceback processes. In addition, the Food Traceability Final Rule established enhanced traceability recordkeeping requirements for manufacturers, processors, packers, and holders of foods listed on the Food Traceability List (FTL), leading to additional data collection and analysis requirements.
Solution
Precise modernized FDA’s food safety technological infrastructure by applying Artificial Intelligence (AI) / Machine Learning (ML) to enable automated traceback and real-time outbreak response capabilities. Our team designed and developed the FDA’s internal Product Tracing System (PTS), an advanced food traceability analytics system that supports the ability of the FDA to trace products across their supply chain.
The system receives and analyzes industry’s traceability data and more effectively and rapidly trace food within the United States. PTS will also enhance existing foodborne outbreak response processes. This is consistent with requirements in Section 204(c) of FDA FSMA.
PTS enables FDA to more quickly address contaminated products through:
- Advanced data visualization, generating interactive tracing diagrams for rapid outbreak analysis. By incorporating Geographic Information Systems (GIS) technologies and Geocoding, we enhanced mapping features and event data accuracy by displaying the supply chain network with diagram, map, and satellite views.
- Seamless ingestion of supply chain data, converting complex supply chain records into structured tracing diagrams for rapid data analysis.
- Accurate and timely reporting and communication of outbreak-related information.
- A single, reliable master repository of food facility and traceability data, enabling cross-system integration and consistency across FDA’s regulatory platforms.
Impact
PTS is FDA’s core IT component for food traceability and has enhanced and accelerated FDA’s response to foodborne outbreaks by:
- Reducing response times by applying AI/ML driven predictive analytics to facilitate early outbreak detection and prevention and to minimize the risks of outbreak spread.
- Increasing automation and image-based data ingestion, expediting data entry and improving data accuracy and analysis, and supporting data-driven insights for more effective outbreak response.
- Strengthening interoperability, allowing seamless integration of epidemiology and other data from other FDA systems and data repositories, enhancing risk assessments and response coordination.
- Data and network security, PTS will have very strict security protocols with only permissioned government users to access the data and FDA will protect confidential information from disclosure.
