CFSAN Constituent Update
March 23, 2010
On Friday, March 19, 2010, the U.S. Food and Drug Administration (FDA) published additional guidance entitled “Guidance for Industry: Submitting a Report for Multiple Facilities to the Reportable Food Electronic Portal as Established by the Food and Drug Administration Amendments Act of 2007” to make the submission of reportable food reports more efficient and less burdensome for companies with multiple facilities. A reportable food is an article of food (other than infant formula and dietary supplements) for which there is a reasonable probability that the use of, or exposure to, will cause serious adverse health consequences or death to humans or animals. The new guidance permits companies in which a specific reportable food is located in multiple facilities, e.g., the recently recalled hydrolyzed vegetable protein, to submit one combined report. Clarifying the RFR requirements will facilitate compliance and implementation, and will lessen the burden on industry and FDA caused by unnecessary submission of multiple reports when one reportable food situation affects more than one of a company’s facilities.
Under the new guidance, a company may submit a combined report for a specific reportable food situation that involves more than one of its facilities, such as manufacturing and processing facilities, storage facilities, and/or distribution facilities. The owner, operator, or agent in charge of each facility may authorize an individual to submit a combined report on their behalf through the Reportable Food electronic portal, in lieu of each responsible party for each facility submitting a separate reportable food report for the specific reportable food. The combined report must include all of the required data elements.
To complete the screens in the Reportable Food electronic portal, the authorized individual may provide the required information for only one of the facilities. The required information relating to all of the facilities, which may also include the facility for which the screens were completed, may be provided in a separate attachment in tabular or spreadsheet format, but should be provided in a manner that clearly associates each facility with the required information that is specific for that facility.
The following file types are supported as attachments:
- .pdf – Portable document format
- .jpg, .jpeg – Image file format
- .tiff - Tagged image file format
- .rtf – Rich text format
- .txt – Text format.
- .xls – Spreadsheet file format
- .doc, docx – Word processing document formats
- .wpd – Word processing document format
If using a tabular or spreadsheet format, FDA recommends that responsible parties use the following column headings, in the order listed, for the required (*) and optional information for each facility:
Name of facility*
Food facility registration number*
Contact phone number