Differences Between EMR Vs. RFR

There are several differences between EMR and RFR, two regulatory mechanisms of the U.S. Food and Drug Administration.

The U.S. Food and Drug Administration (FDA) goes to great lengths to ensure consumer safety, but the differences between the many regulatory mechanisms can sometimes be vexing for manufacturers. There are several key differences between the reportable food registry (RFR) and the guidelines for electronic management of records (EMR).

History

The EMR guidelines were established under the federal Public Health Security and Bioterrorism Preparedness and Response Act of 2002 . The RFR was established by the Food and Drug Administration Amendments Act of 2007; the RFR's electronic registry was opened in September 2009.

Purpose

The EMR guidelines were instituted to enable the federal government to track the production and shipment of food and monitor any credible public health threats that might occur from tampering or other illegal activity. The RFR, on the other hand, is a mechanism for the federal government to track patterns in food adulteration and contamination.

Applicability

EMR guidelines require data on ingredients and transportation routes are maintained for all items defined as food under federal statutes. Conversely, RFR guidelines require food manufacturers to maintain data on the preparation and packing of food items that could potentially cause an illness and immediately report any detected adulteration or contamination that occurs.

References

• FDA--Reportable Food Registry: At a Glance
• FDA--What You Need to Know About Establishment and Maintnenance of Records
• Food Safety Magazine--Simplifying compliance with the FDA Reportable Food Registry