FDA Publishes Interim Final Rules on Registration of Food Facilities and Prior Notice of Imported Food Shipments

Registration System Goes Live on October 16, 2003

On October 10, 2003, FDA published the interim final rules for "Registration of Food Facilities" and "Prior Notice of Imported Food Shipments." The two new interim final rules are part of the requirements of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. They were published as part of FDA's efforts to protect the nation's food supply against terrorism and other food-related emergencies.

They require:

• Registration with FDA of all domestic and foreign food facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States

  • Beginning October 16, 2003, FDA will accept food facilities registration electronically through the Internet or by CD-ROM through surface mail. Paper submissions may be sent by surface mail or by fax. Internet registration will be available at https://www.access.fda.gov starting at 6 p.m. EDT on October 16th.

  • Affected food facilities must register with FDA by December 12, 2003.

• Prior notice to FDA of any shipment of human or animal food imported or offered for import begins later this year on December 12, 2003.

For additional information, see the following press release, fact sheets, and published interim final rules:

• Press Release (October 9, 2003): HHS Issues New Rules to Enhance Security of the U.S. Food Supply http://www.hhs.gov/news/press/2003pres/20031009.html

Fact Sheets

• Interim Final Rule -- Registration of Food Facilities http://www.cfsan.fda.gov/~dms/fsbtac12.html
• Interim Final Rule -- Prior Notice of Imported Food Shipments http://www.cfsan.fda.gov/~dms/fsbtac13.html

Federal Register notices (the complete interim final rules)

• Registration of Food Facilities (http://www.cfsan.fda.gov/~lrd/fr03o10a.html)
• Prior Notice of Imported Food Shipments (http://www.cfsan.fda.gov/~lrd/fr03o10b.html)

FDA has also scheduled a public meeting by satellite downlink on October 28, 2003, to describe these two interim final rules and provide the public an opportunity to ask questions. More information about the satellite downlink is available at http://www.fda.gov/cdrh/ohip/dcm/html/cfsan_event_page.html.

Food Safety and Security Staff E-mail: CFSAN-FSS@cfsan.fda.gov

Office Number: (301) 436-2277· FAX (301) 436-2605 CFSAN Web site: http://www.cfsan.fda.gov/