eLEXNET will be decommissioned on 9/30/2020. As of 6/1/2020, FDA ORA has stopped collecting eLEXNET Data (DX Client and eLEXNET.fda.gov). Click on the "Retirement FAQ" tab for more information.

eLEXNET Retirement Frequently Asked Questions

Download the eLEXNET Retirement Frequently Asked Questions (PDF | 92 KB)

Q: What is eLEXNET?

A: Released in September 2000, eLEXNET (Electronic Laboratory Exchange Network) was created to share a core set of food sample and E. coli O157:H7 test result data through a secure, internet-based information network. In April 2001, eLEXNET expanded to include data on additional pathogens and new laboratory partners. Currently, labs partners voluntarily provide surveillance information through eLEXNET, and FDA also contributes lab outcomes data into the eLEXNET system

Q: Why is eLEXNET being retired?

A: There are several reasons that factored into the decision to retire eLEXNET. FDA has automated and streamlined data exchanges and has increased its analytical capacity and expertise in the event of food outbreaks or large scale-food emergencies.

Food safety testing efforts have also been streamlined and improved through targeted data collection that support compliance decisions and risk analysis. Other mechanisms are currently being used for the exchange and mining of surveillance data.

The Food Safety Modernization Act (FSMA) builds a formal system of collaboration with other government agencies. This results in better information sharing and coordination, increased capacity and capability at the state, local, tribal and territorial level. eLEXNET doesn't contain all the critical information for FDA to take enforcement action, thus it no longer meets the increased regulatory requirements.

FDA is consolidating the mechanisms by which food safety agencies and partners share information so that FDA can more easily perform risk assessments analysis and locate problem products. FDA is transitioning to a more streamlined data exchange solution via the Office of Regulatory Affairs (ORA) Partners Portal (ORAPP).

ORAPP is web-based platform that provides role-based access for regulatory partners to exchange information with FDA. ORAPP is envisioned to be a secured comprehensive portal for any electronic data sharing between FDA and regulatory partners. ORAPP will enable regulatory partners to search and view historical FDA firm related information, provide updates to FDA on contracted and non-contracted inspection results, review inspection assignments, upload samples analysis outcomes data for regulatory samples, resource libraries for regulatory partner, and other capabilities etc. ORAPP integrates seamlessly with FDA systems of record to enable regulatory partners access to all relevant information.

Q: When is ORA retiring eLEXNET?

A: FDA has stopped collecting all surveillance, voluntary, or required data via eLEXNET as of June 1, 2020 and eLEXNET will be completely retired on September 30, 2020.

Q: Will legacy surveillance data be archived?

A: Surveillance data will be archived after eLEXNET has been retired.

Q: Will archived surveillance data be accessible to previous users?

A: FDA is working with users to determine the business value and priority of providing mechanisms for users to obtain the archived data.

Q: Will data be collected by ORA?

A: ORA will continue to collect regulatory data, including sample analysis outcomes data under the Food Emergency Response Network (FERN) Cooperative Agreement Program (CAP) for FDA collected samples. The sample analysis outcomes data will be collected using Excel uploads submitted via the ORAPP website, as well as related FDA system-to-system integrations such as the National Food Safety Data Exchange (NFSDX). For additional information about options for submitting regulatory data, contact the ORA Data Exchange team.

FDA will continue to involve federal, state and local food safety partners in developing standards for food safety data elements, data sharing and electronic data submission capabilities.

Q: How will the states submit regulatory data?

A: States participating in regulatory sample data exchange initiative have been provided detailed instructions, including account requests and process information. For additional information, contact the ORA Data Exchange team.

Q: Will existing eLEXNET users be transitioned to the ORAPP?

A: Existing users will not be transitioned to ORAPP.

Q: How do I get assistance when using the ORAPP

A: General information, demo requests, or information about participating in the ORAPP is available on the ORAPP website. You can also email the support team for assistance. Existing users can email the ORA Application Help Desk for assistance.

Q: Will the data submitted to FDA be available to state laboratories?

A: For ORAPP users, sample analysis files (Excel files) submitted to FDA will be retained within the portal. Any sample analysis files (which are in Excel format) submitted to the FDA through ORAPP will be available for download by the users who submitted it.

For users of system-to-system integrations such as NFSDX, sample analysis data can't be downloaded from FDA IT systems but should continue to be available to the state laboratory as part of their internal IT system. For additional information, contact the ORA Data Exchange team.

Q: Will these changes affect state accreditation?

A: The retirement of eLEXNET will not affect the accreditation status of state laboratories.

Q: How does eLEXNET's retirement affect the Laboratory Flexible Funding Model and Cooperative Agreement Program?

A: The retirement of eLEXNET will not affect the Laboratory Flexible Funding Model (LFFM) or other Cooperative Agreements. Alternative FDA IT systems will be used to collect laboratory data.

Q: Will eLEXNET communities be available after the system is retired?

A: No, once eLEXNET is retired, the eLEXNET communities will no longer be available.

Q: Will the information and data housed in the communities be archived and available?

A: FDA is currently working with community owners to provide a mechanism to extract and save data currently housed in eLEXNET related communities.

Q: Will training be available to ORAPP users?

A: Yes, training and detailed documentation will be provided to states participating in regulatory sample analysis data exchange implementation.

Q: Can states expect any other changes in the exchange of data?

A: FDA is moving toward the concept of Mutual Reliance with state labs. Mutual reliance is a partnership that enables FDA and the states to rely on, leverage, and coordinate with one another's work, data, and actions to achieve a safer national food supply. The concept dates back decades and was initially advanced as an "integrated food safety system," under several initiatives including the Partnership for Food Protection.

This will enable regulatory partners to electronically submit sample analysis results data to FDA. FDA is also evaluating enabling the Food Emergency Response Network (FERN) Cooperative Agreement Program (CAP) analysis for FDA collected samples for elements, pesticides, mycotoxins, and microbiology.

This initial implementation lays the foundation for future Samples/Lab capabilities.