FDA Product Tracing System (PTS) Owner’s Manual

June 16, 2024
FDA

FDA Product Tracing System (PTS)

Product Tracing System (PTS)

Specifications

  • Application Hosting : Amazon Web Services (AWS)
  • Front End Development : Django
  • Data Analytics & AI/ML: Domino Data Labs & Amazon Sagemaker
  • Data Visualization : Qlik

Advancing Food Traceability through Innovation
The Product Tracing System (PTS) is designed to advance food traceability and help protect consumers from contaminated products. It is a central repository for food safety data, offering workflow automation, data analytics, reporting, and intelligent processing.

Why Food Traceability?
Tracking and mitigating foodborne outbreaks has been a challenge for the FDA. The FDA is advancing traceability to perform rapid trace-forward and traceback analyses, identify specific product sources, and remove products from the marketplace quickly.

Protecting public health through innovation and automation
The PTS is part of the FDA’s efforts to protect public health through innovation and automation. It supports the FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods.

Product Tracing System Workflow

  1. Enhancing Collaboration
  2. Strengthening Infrastructure
  3. Modernizing Services
  4. Sharing Data
  5. Adopting AI and Innovations
  6. Cultivating Talent and Leadership

Data Sources

  • Industry Submitters
  • Outbreak Investigations Center for Disease Control
  • State Partners
  • Social Media
  • External Data Services
  • GS1 Data Hub Global Dialogue on Seafood Traceability(GDST)

Data Processing and Storage
The PTS utilizes data intake through a submission portal and submission API. It performs data acquisition, transformation, cleansing, and storage using the EPCIS-X repository, Graph DB, and Data Warehouse.

Data Reporting & Analytics
The system provides data reporting and visualization capabilities. It offers trending analysis and predictive analysis for better decision-making. It integrates with FDA Enterprise Platforms such as FDA GeoWeb, MLaaS, RPAaaS, Tableau/PowerBI, and Conversational AI.

Product Tracing in Action
Data submitted by industry and imported displays logically in a tracing diagram. Color coding highlights tracing paths to help investigators understand possible common sources of illness. Setting the trace allows outbreak investigators to more easily identify possible sources of foodborne illness.

Technology Summary – WILEE

  • Application Hosting : Amazon Web Services (AWS)
  • Front End Development : Django
  • Data Analytics & AI/ML: Domino Data Labs & Amazon Sagemaker
  • Data Visualization : Qlik

Technology Summary – CAPS

  • Application Hosting : Amazon Web Services (AWS)
  • Front End Development : Vue.js JavaScript Framework
  • Data Retrieval : AWS Lambda
  • Data Visualization : Amazon Quicksight
  • Food Label Text Extraction : Amazon Textract

FAQ

  • Q: What is the purpose of the Product Tracing System?
    A: The purpose of the Product Tracing System is to advance food traceability, protect consumers from contaminated products, and help identify and remove products from the marketplace quickly in case of outbreaks or contamination.

  • Q: What data sources does the Product Tracing System utilize?
    A: The Product Tracing System utilizes data from industry submitters, the Outbreak Investigations Center for Disease Control, state partners, social media, external data services, and the GS1 Data Hub Global Dialogue on Seafood Traceability (GDST).

  • Q: How does the Product Tracing System help investigators in outbreak investigations?
    A: The system displays data in a tracing diagram, with color coding highlighting possible common sources of illness. Investigators can easily set the trace to identify possible sources of foodborne illness.

Product Tracing System (PTS)

Advancing Food Traceability through Innovation
Bhabani Das – Office of Management (OM), Division of Information Technology Management (DITM)

Why Food Traceability?
Tracking and mitigating foodborne outbreaks has been a challenge for the FDA – FDA is advancing traceability to help protect consumers from contaminated products with the goal to perform rapid trace-forward and traceback analyses, identify specific product sources, and help to remove products from the marketplace as quickly as possible.

FDA-Product-Tracing-System -PTS\)-image-01

  • Protecting public health through innovation and automation.
  • FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods | FDA
  • New Era for Smarter Food Safety
    Core Element 1 – Tech-enabled Traceability

Food Product Tracing as a Platform

Central repository for food safety data

  • Master data management (firm, location, product)
  • FSMA rule requirements
  • Web form for traceability data submissions.
  • Integration with CDC, State Partners for end-to-end data

Product Tracing

  • Product tracing in alignment with data standard (EPCIS)
  • End-to-end network tracing and link event relationships
  • Map/GIS tracing views
  • Outbreak investigation – traceback / trace-forward

Workflow, Automation

  • Advanced search and filter capability
  • Automation to improve efficiency and data accuracy
  • Output to existing FDA systems to support other food safety goals

Data Analytics, Reporting

  • Advanced reporting
  • Trending and predictive analytics through use of AI/ML
  • Network similarity
  • Risk assessment data

Intelligent Processing

  • Perform subcluster linking and analysis
  • Using CDC data and ML, early detection/prevention
  • ChatBot features to support rule review
  • Data generation for testing/ML model refinement

FY24–27 ODT Strategic Plan Goals

  1. . Enhancing Collaboration
  2. Strengthening Infrastructure
  3. Modernizing Services
  4. Sharing Data
  5. Adopting AI and Innovations
  6. Cultivating Talent and Leadership

Product Tracing System

FDA-Product-Tracing-System -PTS\)-image-02 Product Tracing in Action

FDA-Product-Tracing-System -PTS\)-image-03

Product Tracing in Map View

FDA-Product-Tracing-System -PTS\)-image-04

Technology Summary

Technology Summary – WILEE

Application Hosting Amazon Web Services (AWS)

  • CFSAN AWS East Applications Environment
  • Key Services : AWS RDS.S3, OpenSearch, EKS

Front End Development Django

  • Free and open-source
  • Python-based web framework
  • Embedded BI interfaces

Data Analytics & AI/ML Domino Data Labs & Amazon Sagemaker

  • Machine learning and predictive analytics
  • Sentiment Analysis
  • Anomaly Detection

Data Visualization Qlik

  • Development Collaboration
  • Data Integration and Preparation
  • Data Discovery & Robust Scalability

Technology Summary – CAPS

****Application Hosting Modern cloud native server less stack in Amazon Web Services (AWS)

  • Minimal operational costs, fraction of penny per web request
  • AWS RDS, S3, API Gateway, Lambda, DynamoDB

Front End Development Vue.js JavaScript Framework

  • Will run on any modern web browser (cross platform / device)
  • Enables reusable components throughout the application
  • Leverages Google material design specifications

Retrieve data from RDS and DynamoDB AWS Lambda
AWS Lambda functions for Data Handler, Metadata Handler, Dashboard Handler, and Survey Handler

Data Visualization Amazon Quicksight

  • Server less architecture that automatically scales
  • Directly connect to and import data
    SPICE (super-fast, parallel, in-memory calculation engine)

Food Label Text Extraction Amazon Textract

  • Reducing the manual burden of processing product label images
  • Accessible from CAPS user interface
  • Integration with standardized data processing engines

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