The ORA Data Exchange (DX) enables FDA and regulatory partners to securely share food safety Sample Collections, Receipt, and Analysis data via ORA Partners Portal (ORAPP), System-to-System Services, and Enhanced DX Client using FDA approved standardized template for selected microbiological, chemical, and radiological analytes that could endanger the food supply and environment such as elements, pesticides, mycotoxins, microbiological, nutritional analysis, nutritional infant formula, viruses, radionuclides, parasites, and decomposition in seafood.
This data sharing capability allows FDA to rapidly review analysis data to improve food safety testing efforts, assist in risk assessment analysis, increase efficiencies, and aid in timely and accurate regulatory decision making.
Sample data sharing activities include:
- Submission of Sample Collections data for state collected samples
- Submission of Sample Receipt and Analysis data for FDA or state collected samples
The ORA DX currently supports Sample Receipt and Analysis data under the following program:
- Food Emergency Response Network (FERN) Cooperative Agreement Program (CAP) (i.e., FDA Collected Samples)
The ORA DX currently supports Sample Collections, Receipt, and Analysis data under the following programs:
- Food and Feed Contracts (State Collected Samples)
- Lab Flexible Funding Model (LFFM) Cooperative Agreements (State Collected Samples)
Sample Workgroup (WG)
The Sample Workgroup (WG) provides a structured and collaborative platform to support participating regulatory partners for Sample Data Sharing via ORA DX systems.
The Sample WG meets monthly, on the 1st Tuesday of the month. For more information on how to participate, contact us via the Contact Us page.
