Booklets Available on Bioterrorism Act of 2002 Legislation (SECG)

FDA Actions on Bioterroism Act of 2002 Legislation
Small Entity Compliance Guides

Guidance documents contain nonbinding recommendations.

Registration and Prior Notice
Administrative Detention
Establishment and Maintenance of Records

Registration and Prior Notice Small Entity Compliance Guides

FDA has published the two Small Entity Compliance Guides as booklets, What You Need to Know About Registration of Food Facilities and What You Need to Know About Prior Notice of Imported Food Shipments, which cover the key points of the two new interim final regulations for manufacturing/processing, packing and holding facilities, and for importers, filers, and brokers of imported food.

• Registration:
  • What You Need to Know About Registration of Food Facilities (available in English PDF, French PDF, and Spanish PDF) November 2003
• Prior Notice:
  • What You Need to Know About Prior Notice of Imported Food Shipments (available in English PDF, French PDF, and Spanish PDF) November 2003; Revised April 2009

Additional copies may be requested by calling 1-800-216-7331 or 301-575-0156 or by faxing a request to 301-436-2804 or 1-866-573-0846**.

Administrative Detention

FDA has published the booklet What You Need to Know About Administrative Detention of Foods to inform food manufacturers, processors, packers, transporters, importers, and exporters about a new FDA bioterrorism regulation that is in effect.

• Administrative Detention: What You Need to Know About Administrative Detention of Foods (available in English PDF) November 2004

Additional copies of the English booklet may be requested by calling 1-800-216-7331 or 301-575-0156 or by faxing a request to 301-436-2804 or 1-866-573-0846**.

Establishment and Maintenance of Records Small Entity Compliance Guide

FDA has published the Small Entity Compliance Guide as a booklet, What You Need to Know About Establishment and Maintenance of Records to inform domestic persons in the U.S. that manufacture, process, pack, transport, distribute, receive, hold or import food; foreign persons that transport food; and persons who place food directly in contact with its finished container about a new FDA bioterrorism regulation that is in effect.

• Establishment and Maintenance of Records: What You Need to Know About Establishment and Maintenance of Records (available in  English PDF, French PDF, Spanish PDF) December 2004

Additional copies of the English booklet may be requested by calling 1-800-216-7331 or 301-575-0156 or by faxing a request to 301-436-2804 or 1-866-573-0846**.

See more Information on Protecting the Food Supply

Notice of Availability: Small Entity Compliance Guides on Registration of Food Facilities and Prior Notice of Imported Food (Federal Register, December 12, 2003)
Correction: Small Entity Compliance Guides on Registration of Food Facilities and Prior Notice of Imported Food (Federal Register, January 7, 2004)

**Phone numbers were updated June 2008.