On September 8, 2009, the US Food and Drug Administration (FDA) officially launched the Reportable Food Registry (RFR), which is an electronic portal through which food facilities must file a report when there is a reasonable probability that use of, or exposure to, a food will cause serious adverse health consequences or death to humans or animals (“reportable food”).  An FDA guidance document, entitled “Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007”, explains the reporting requirements and the electronic portal in detail.

What Is a “Reportable Food”?

A “reportable food” is any food product – other than a dietary supplement or an infant formula – for which there is a reasonable probability that use of, or exposure to, such food will cause serious adverse health consequences or death to humans or other animals. A “reportable food” includes any animal feed and pet food.

Who Must Report?

The “responsible party” must submit a report to FDA regarding instances of “reportable food.”  The “responsible party” is the person who (i) submitted to FDA the food facility registration currently required under section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for the facility where the food is manufactured, processed, packed, or held, and (ii) has determined that the food is a “reportable food.”  However, a responsible party is not required to submit a report if (i) the reportable food condition originated with the responsible party, (ii) the responsible party detected the condition prior to transferring the food to another person, and (iii) it corrected the condition or destroyed the food. 

What Constitutes “Serious Adverse Health Consequences or Death”?

Surprisingly, FDA did not offer a definition of “serious adverse health consequences or death”, but examples of foods that FDA previously concluded as presenting a reasonable probability of “serious adverse health consequences or death” include (i) peanut butter contaminated with Salmonella; (ii) under-processed canned chili that contained Clostridium botulinum toxin; (iii) smoked salmon contaminated with Listeria monocytogenes (Lm); (iv) ice cream that did not declare peanut-derived ingredients but contained peanut butter as an ingredient; (v) baby food that posed a choking hazard; (vi) horse feed contaminated with elevated levels of monensin; (vii) pet food contaminated with elevated levels of melamine and cyanuric acid; (viii) sheep feed containing elevated levels of copper; and (ix) swine feed containing elevated levels of selenium.

When Must the Report be Submitted?

The responsible party must submit a report to FDA through the Reportable Food electronic portal as soon as practicable, but in no case later than 24 hours after determining that a food is a reportable food.   

While the reporting requirements became effective on September 8, 2009, FDA intends to exercise its “enforcement discretion” for 90 days, until December 9, 2009, after which time the requirements will be strictly enforced.

Where Should the Report be Submitted?
 
The responsible party must report through the Reportable Food electronic portal, which is part of the agency’s MedWatch^Plus Portal, a new electronic system for collecting, submitting, and processing adverse event reports and other safety information for all FDA-regulated products.  The Reportable Food Registry electronic portal is now accessible through a link on FDA’s Web site home page, http://www.fda.gov, and through the URL, http://rfr.fda.gov.  

What Must be Reported?

The responsible party’s initial report to FDA (and subsequent follow-up reports, if necessary), must include as many of the following data elements as are available at the time of the report:  (i) the facility registration numbers of the responsible party; (ii) the date on which the food was determined to be a reportable food; (iii) a description of the food, including the quantity or amount; (iv) the extent and nature of the reportable condition; (v) if it may have originated with the responsible party, the results of any investigation of the cause of the reportable condition; (vi) the disposition of the article of food; and (vii) the product information typically found on packaging, including product codes, use-by dates, and the names of manufacturers, packers, or distributors sufficient to identify the affected food.  Follow-up reports must be submitted when the initial report does not cover all of the data elements or further information becomes available.

What Happens After a Report is Submitted?

After consultation with the responsible party, FDA may require that the company notify the immediate previous source(s) and/or immediate subsequent recipient(s) of the reportable food.  Immediate subsequent recipients include restaurants, delicatessens, supermarkets, and retail outlets.  With the exception of the facility registration numbers, the notification to an immediate previous source and/or subsequent recipient should include the same information listed above, as well as (i) the contact information for parties directly linked in the supply chain and notified by the responsible party; (ii) the unique report number issued through the Reportable Food electronic portal to the person submitting the report; (iii) the actions that the recipient of the notification shall perform (i.e., investigate the cause of the reportable condition); and (iv) any other information FDA may require.

If a party that receives a notification itself qualifies as a “responsible party”, then it also must submit a report to FDA within 24 hours after receiving the notification.

If you have any questions regarding FDA’s “Reportable Food Registry”, please do not hesitate to contact Amy Colvin or Brian Waldman.

Or any of the other attorneys of the Arent Fox Food and Drug Practice, including, Stanley Abramson, Joanne Hawana, Rachel Lattimore, Wayne Matelski, Georgia Ravitz, and James Ravitz.