New Rule on Administrative Detention

• Press Release: FDA Finalizes Rule on Administrative Detention of Suspect Food; Final Rule Increases Security and Safety of U.S. Food Supply May 27, 2004
• Final Rule: Administrative Detention of Food for Human or Animal Consumption Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 June 4, 2004
• Fact Sheet: FDA's New Food Bioterrorism Regulation Final Rule: Administrative Detention May 27, 2004
• "Dear Colleague" Letter on Administrative Detention Final Rule May 27, 2004

New Rules on Registration and Prior Notice

• HHS Issues New Rules to Enhance Security of the U.S. Food Supply October 9, 2003

  Some of the documents below are also available in Arabic, Chinese, French, Hindi, Japanese, Korean, Malay, Polish, Portuguese, Russian, Spanish, and Thai as noted.

  • Registration of Food Facilities
    • Compliance Policy Guide: Guidance for FDA Staff December 2003
      (Federal Register Notice of Availability December 19, 2003)
    • Compliance Information: Registration September 22, 2004
    • Fact Sheet: FDA's New Food Bioterrorism Regulation: Interim Final Rule -- Registration of Food Facilities October 2003
      (also available in French, Malay, Polish, Portuguese, Spanish, Arabic (PDF*), Chinese (PDF*), Hindi (PDF*), and Japanese (PDF*))
    • Booklet (SECG): What You Need to Know About Registration of Food Facilities November 2003 (also available in French and Spanish)
      (Federal Register Notice of Availability December 12, 2003)
    • Interim Final Rule: Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 October 10, 2003
      • Technical Amendment May 24, 2004
      • Reopening of Comment Period April 14, 2004
    • Slide Presentation: Overview of Registration Interim Final Rule Implementing the Bioterrorism Act October 15, 2003
      (also available in Arabic, French, Malay, and Spanish)
    • Guidance for Industry: Necessity of the Use of Food Product Categories in Registration of Food Facilities July 2003
    • Guidance for Industry: Questions and Answers Regarding Registration of Food Facilities (Edition 4) August 6, 2004
      (Federal Register Notice of Availability August 6, 2004)
    • Press Release: FDA Introduces New Technology to Improve Food Security: Electronic Food Facility Registration Goes "Live" October 16, 2003
    • How To Register
      • Electronic Registration via the Internet October 16, 2003
        • Electronic Registration Index of Help Files and Tutorials
      • New Features in the Food Facility Registration Module (FFRM) March 27, 2004
      • Mail or Fax: Registering by Paper or CD-ROM (and download forms) October 16, 2003
        (also available in Spanish)
      • Verification: Registration of Food Facility Database Information Verification February 2, 2004
  • Prior Notice of Imported Food Shipments
    • Guidance for Industry: Prior Notice of Imported Food Contingency Plan for System Outages August 12, 2004
      (Federal Register Notice of Availability August 16, 2004)
    • Press Release: FDA and CBP Define Their Transitional Compliance Policy on Food Imports Under the Bioterrorism Act December 11, 2003
      • Compliance Policy Guide: Guidance for FDA and CBP Staff August 2004
        (Federal Register Notice of Availability August 16, 2004)
      • Compliance Summary: Prior Notice Compliance Summary Information August 12, 2004
    • Press Release: FDA and CBP Bolster Safeguards on Imported Food December 3, 2003
    • Joint FDA-CBP Plan for Increasing Integration and Assessing the Coordination of Prior Notice Timeframes August 2004
    • Fact Sheet: FDA's New Food Bioterrorism Regulation: Interim Final Rule - Prior Notice of Imported Food Shipments October 2003
      (also available in French, Malay, Polish, Portuguese, Spanish, Arabic (PDF*), Chinese (PDF*), Hindi (PDF*), and Japanese (PDF*))
    • Flyer - Notice to Truckers: New FDA Regulations Will Affect Imported Food Shipments November 2003
      (also available in Spanish)
    • Flyer - Notice to Importers and Filers: New FDA Regulations Will Affect Imported Food Shipments November 2003
    • Booklet (SECG): What You Need to Know About Prior Notice of Imported Food Shipments November 2003 (also available in French and Spanish)
      (Federal Register Notice of Availability December 12, 2003)
    • Interim Final Rule: Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 October 10, 2003
      • Corrections to Interim Final Rule February 2, 2004 (also available in PDF*)
      • Reopening of Comment Period April 14, 2004
      • Extension of Comment Period to July 13, 2004 May 18, 2004
    • Slide Presentation: Overview of Prior Notice Interim Final Rule Implementing the Bioterrorism Act October 15, 2003
      (also available in Arabic, French, Malay, and Spanish)
    • Guidance for Industry: Prior Notice of Imported Food: Questions and Answers (Edition 2) May 3, 2004
      ( Federal Register Notice of Availability May 3, 2004 (available in PDF))
    • Guidance for Industry: Prior Notice of Imported Food: Harmonized Tariff Schedule Codes Flagged with Prior Notice Indicators August 26, 2004
      • HTS Codes August 26, 2004
      • HTS Codes Revision History August 26, 2004
    • International Mail: Sending Food Through International Mail October 2004
      Selected Excerpts from the Prior Notice Interim Final Rule, Guidance Documents, and Fact Sheets
    • How to Submit Prior Notice
      • Submit Prior Notice through PNSI, Overview & Background
        • PNSI: Tutorials and Index of Help Files
        • Step-by-Step Web System Instructions for Food Articles sent by International Mail

• Slide Presentation: New FDA Rules Implementing the Bioterrorism Act of 2002 - Overview of Registration and Prior Notice Interim Final Rules April 2004
  (also available in Korean)

• Videos: FDA's Implementation of the Bioterrorism Act: An update with Leslye Fraser March 2004 (27:22 min) (Requires Real Player or Windows Media Player)
  (also in captioned English, Chinese, French, Japanese, Korean, Spanish, and Thai)
  
  
• October 28, 2003 Satellite Broadcast on Registration and Prior Notice
  (Discussion of interim final rules)
  • Regulations Implementing Title III of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Notice of Public Meeting via SATELLITE downlink October 28, 2003 (also available in PDF) October 1, 2003
  • Videos of Satellite Broadcast (1:43 hrs.) (Requires Real Player or Windows Media Player)
    (also in captioned English, French, and Spanish)
  • Transcript: Text of Closed Captioning of Satellite Broadcast (also available in French and Spanish)
    
    
• Bioterrorism Outreach Meetings For Asia (April 2004): "What You Need to Know to Ensure Compliance With the New FDA Bioterrorism Act Registration and Prior Notice Final Rules" April 2004
• Domestic Outreach Meetings (March & April 2004): FDA Updates - "What You Need to Know to Ensure Compliance With the New FDA Bioterrorism Act Registration and Prior Notice Final Rules" February 2004
• Risk Assessment for Food Terrorism and Other Food Safety Concerns October 7, 2003

May 2003

May 2004: See New Rule on Administrative Detention

• FDA Issues Final Two Proposed Food Safety Regulations Press Release, May 6, 2003 (also available in Spanish and French)
  • Proposed Regulations: Establishment and Maintenance of Records (also available in Spanish and French) May 2003
    • Notice of Proposed Rulemaking: Establisment and Maintenance of Records Under the Public Health and Bioterrorism Preparedness and Response Act of 2002 (also available in PDF*)

• May 7, 2003 Satellite Broadcast on Recordkeeping and Administrative Detention
  (Discussion of proposed regulations)
  • Proposed Regulations Implementing Title III of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Notice of Public Meeting via SATELLITE downlink May 7, 2003 April 8, 2003
  • Video of Satellite Broadcast (1:57 hrs.) (Requires Real Player or Windows Media Player)
    (also in captioned English, French, and Spanish)
  • Transcript of Satellite Broadcast (also available in Spanish)
  • Errata Sheet For the Official Transcript of the Satellite Broadcast

• Overview of Records and Administrative Detention Proposed Regulations Implementing the Bioterrorism Act (Slide Presentation) May 7, 2003 (also available in Spanish)

See also Background Information on Protecting the Food Supply

*PDF Readers are available for free from the Adobe Acrobat web site.