FDA Requests Comments on Draft 2nd Edition of Reportable Food Registry Guide
The Food and Drug Administration requests comments on the draft second edition of its guidance, “Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007 (Edition 2),” which provides further information to the industry in complying with RFR requirements and on the new Safety Reporting Portal.
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Comments are due by July 26, 2010.
(Registered food facilities must report via the RFR electronic portal within 24 hours when there is reasonable probability that an article of food (other than dietary supplements or infant formula) or feed will cause serious adverse health consequences.
FDA issued Edition 1 of this guidance with the launch of the RFR in September 2009. See ITT’s Online Archives or 09/09/09 news, 09090920, for BP summary.)
New Safety Reporting Portal Available May 24
Among other things, FDA has issued draft amendments to various questions and answers in order to provide information on the new Safety Reporting Portal.
The draft document states that as of May 24, 2010, the Reportable Food electronic portal will be a part of the FDA-National Institutes of Health Safety Reporting Portal, which facilitates the process of reporting several categories of safety information to the FDA and the NIH, including safety information related to reportable foods, pet foods, animal drugs, and NIH gene replacement therapy centers.
Safety Reporting Portal account holders are able to save a report, finish it at a later time, and see a list of all of submitted reports.
New Draft Questions and Answers on Foreign Facility Info
The draft second edition of the guidance document also includes a new questions and answers section regarding foreign facility information, which includes the following answers (partial list):
Required foreign facility registration. Any foreign food facility that manufactures, processes, packs, or holds food for human or animal consumption in the U.S. is required to register unless food from the facility undergoes further manufacturing/processing (including packing) by another facility outside the U.S., unless such subsequent activity is of a de minimis nature.
A foreign facility that is required to register can be a responsible party who is required to report via the Reportable Food electronic portal within 24 hours of determining that there is a reasonable probability that the use of, or exposure to, an article of food that the facility manufactured, packed, processed, or held will cause serious adverse health consequences or death to humans or animals.
Reporting by foreign facility agent. An owner, operator, or agent in charge of a foreign facility may authorize an individual to report an instance of reportable food on their behalf through the Reportable Food electronic portal. An individual who is authorized by the responsible party to submit a reportable food report need not be the same individual who is authorized to register a facility. FDA also encourages the individual submitting the reportable food report to provide his or her contact information in the reportable food report, especially if the registration information does not include the individual reporter’s contact information.
Reporting not required for non-U.S. recipients. If a foreign facility that is required to register and that exported human food/animal food to the U.S. subsequently determines that the food it exported is a reportable food, the facility is not required to submit information about non-U.S. recipients of the food. However, FDA encourages the submitter to notify other recipients of the food and take appropriate action.
(See draft guidance for complete questions and answers, including added and amended Q&As on infant formula and dietary supplement exclusions, requirements for undeclared allergens, etc.)
FDA contact -- Faye Feldstein(301) 436-2428