FDA Updates Compliance Information, Fax Numbers for Food Facility Registration Under Bioterrorism Act
The Food and Drug Administration has issued (1) an updated document that provides a country-by-country list of the number of food facilities registered with the FDA as of January 29, 2008, and (2) a final rule that updates the fax numbers for food facility registration.
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(FDA states that as required by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act or BTA), domestic and foreign facilities are required to register with the FDA if they manufacture, process, pack, or hold food for human or animal consumption in the U.S.
For foreign facilities, FDA generally intends to enforce the registration requirement for prior notices (PNs), by requiring, with certain exceptions, the registration numbers assigned to the foreign manufacturer's and shipper's facilities that are associated with the article of food.)
FDA Has Received 340,430 Food Facility Registrations as of January 29, 2008
FDA estimates that the total number of food facilities that must register is approximately 420,000, approximately half of which are domestic. As of January 29, 2008, FDA had received 340,430 registrations, of which 198,271 are foreign facilities and 142,159 are domestic facilities.
The following table is a sampling of the listed countries and the number of food facility registrations for each, as tallied by FDA and current as of January 29, 2008:
| Canada | 13,540 | Mexico | 14,728 |
| China | 18,701 | Taiwan | 2,707 |
| India | 4,577 | Thailand | 2,751 |
| Japan | 22,043 | Vietnam | 5,152 |
(Also provided in this document is a state-by-state list for U.S. domestic registrations, which includes Washington, D.C., Puerto Rico, and certain insular possessions.)
FDA Updates Fax Numbers for Registration, Updating and Canceling Registration
The FDA's final rule amends 21 CFR 1.231, 1.234, and 1.235 in order to include the following fax numbers for registration, updating registration, and canceling registration: 301-436-2804 or 1-800-573-0846.
(See ITT's Online Archives or 08/06/07 news, 07080625, for BP summary of FDA's earlier compliance information on food facility registration, including the listing of registration numbers for the same countries as list above as of July 3, 2007.
See ITT's Online Archives or 11/30/05 news, 05113025, for Part II of BP's summary of FDA's November 2005 revised compliance policy guide, which describes changes made to the guide on PN of imported food.)
FDA contact - Catherine Copp (301) 436-2379
FDA compliance document (updated 01/29/08) available at http://www.cfsan.fda.gov/furls/ffregsum.html
FDA final rule updating fax numbers (FDA-2008-N-0160 (formerly 2002N-0276), FR Pub 03/26/08) available at http://edocket.access.gpo.gov/2008/pdf/E8-6052.pdf