There are still a number of questions about the requirement to report. We have been concerned if, for instance, a load of corn that tests over 20 ppb aflatoxin is a “reportable food” incident. First, it is up to each facility to decide whether or not it believes the incident is reportable. In Texas, corn is marketable up to 500 ppb. With that fact in mind, we believe that an aflatoxin contamination problem would not be reportable unless it exceeded 500 ppb. We have visited with both the National Grain & Feed Association (who will be on a conference call with FDA later today) and Dr. Tim Herrman with the Office of the Texas State Chemist. Both will hopefully get better clarification on this issue. One important issue that NGFA reminded us on was that FDA states in the guidance that it will exercise enforcement discretion for 90 days – until Dec. 8 – for companies that make “reasonable” efforts to comply with the requirement to report products that meet this danger threshold, and take other appropriate actions to protect public health. If you have further questions, please contact us and we will do our best to get them answered.
A “reportable food” is defined by FDA as one having the reasonable probability that the use of or exposure to would cause serious adverse health consequences or death in humans or animals. This includes any food, feed, ingredient or pet food products. There are some exemptions described in the Q&A updated guide issued today. It can be found here: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodSafety/ucm180761.htm
FDA is required to contact the facility making the report and gather additional information to determine if the report is, in fact, about a reportable food. If the FDA determines the product is a reportable food, the agency will enter the product into the Reportable Food Registry, contact the facility for other information, set deadlines for the facility and may issue public notices about the reportable food to alert the public and protect the public health. Local, state and other federal health officials may also report reportable foods to the electronic portal.
Failure to report reportable foods is a prohibited act under the federal Food, Drug and Cosmetic Act.
In this updated guide, FDA says:
12.You must comply with the requirements of the Reportable Food Registry (Section 417 of the FD&C Act) on September 8, 2009, and the prohibited act provisions of the FD&C Act related to the Registry will apply on that date. However, FDA intends to consider exercising enforcement discretion for a period of 90 days, until December 8, 2009, in circumstances where FDA determines that a responsible party has made a reasonable effort to comply with the requirements of section 417 of the FD&C Act and has otherwise acted to protect public health. FDA is allowing 90 days of enforcement discretion if you attempt to comply but the portal doesn’t work.
Please read the guide carefully and evaluate the need to file a reportable food. Also, at the end of the guide, there is a link to the appendix on the operation of the electronic portal for filing.
