FDA Revises its Reportable Food Registry Guidance

By Ricardo Carvajal –

FDA has revised its draft guidance on the Reportable Food Registry (“RFR”)  to address the new electronic portal for submission of reports, and in response to recent questions that the agency received from industry.  Among the more significant changes and additions:

• A human food that contains an undeclared allergen “may be a reportable food. . . regardless of how the major food allergen was incorporated into the human food.”

• If a facility receives a bulk trailer shipment (meaning that the trailer is dropped off at the facility and the driver leaves) and the shipment is determined to contain a reportable food, the facility must submit a report even if the shipment is not off-loaded and is rejected.

• A report pertaining to a food later determined by FDA not to be a reportable food will not be entered into the RFR, but does remain in FDA’s records.

• Consumers should not use the RFR.

• The reporting obligation extends to a reportable food even if that food is manufactured solely for export.

• The reporting obligation does not extend to a reportable food in a foreign facility that exports to the U.S. and elsewhere if the reportable food is not shipped to the U.S.

In the Federal Register notice announcing the availability of the guidance, FDA asks for comments on  the meaning of “transfer” as that term is used in section 417(d)(2) of the FDC Act.  As explained by FDA:

Section 417(d)(2) of the act provides an exemption from the requirement that a responsible party submit a reportable food report. In order for the exemption to apply, the adulteration must have originated with the responsible party, the responsible party must have detected the adulteration prior to any transfer to another person of the article of food, and the responsible party must have corrected the adulteration or destroyed the food. However, Congress did not provide a definition for the term “transfer” as it is used in section 417(d)(2)(B) of the act. In Edition 1 of the guidance at Question and Answer numbers 27 and 28, and in the draft Edition 2 guidance at Question and Answer numbers E.4 and E.5, FDA said that a transfer to another person occurs when the responsible person releases the food to another person. In this document, FDA is asking for comment on whether this interpretation of the term “transfer” is appropriate, and if not, what other interpretations of the term “transfer” as it is used in section 417(d)(B)(2) of the act would be more appropriate. Specifically, we are requesting comment on whether the interpretation of the term “transfer” should be dependent upon possession of the food, whether the interpretation should be dependent on ownership of the food, or whether there are other interpretations we should consider, such as a combination of possession and/or ownership.

There have been numerous expressions of concern about FDA’s current broad interpretation of “transfer,” which severely limits the applicability of the statutory exception to the reporting requirement.  Interested parties should submit comments on this and other issues of concern by July 26, 2010 to ensure that they receive full consideration by the agency.