New Rule on Establishment and Maintenance of Records

• Press Release: FDA Issues Final Rule on the Establishment and Maintenance of Records to Enhance the Security of the U.S. Food Supply Under the Bioterrorism Act December 6, 2004
  FDA also issues draft guidance regarding records access
• Final Rule: Establishment and Maintenance of Records Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 December 9, 2004
  • Correction to the Final Rule February 23, 2005
• Booklet (SECG): What You Need to Know About Establishment and Maintenance of Records December 2004 (also available in French and Spanish)
• Fact Sheet: FDA's New Food Bioterrorism Regulation: Establishment and Maintenance of Records Revised November 2005
• Guidance for Industry: Questions and Answers Regarding Establishment and Maintenance of Records (Edition 4) September 21, 2006
  (Federal Register Notice of Availability September 26, 2006)
• Guidance for Industry and FDA Staff: Guidance for Records Access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 November 2005
• Domestic Outreach Grassroot Meetings (June 2005) FDA Updates: "Ensuring Compliance With the New Rule for Establishment and Maintenance of Records Implementing Section 306 of the Bioterrorism Act" May 2005
  • Public Meetings: Federal Register notice May 13, 2005
  • Meeting Agenda
  • Slide Presentation: Overview of Bioterrorism Act's Establishment and Maintenance of Records Final Rule June 2005
  • Transcript of June 9, 2005 meeting in College Park
• Domestic Outreach Grassroot Meetings (January & February 2005) Proposed Schedule for BT Final Rules: "What You Need to Know to Assure Compliance with the New FDA BT Final Regulation for Establishment and Maintenance of Records Final Rule that Implements Section - 306 of the Bioterrorism Act" December 6, 2004
  • Public Meetings: Federal Register notice December 9, 2004
  • Meeting Agenda
    • Video of January 13, 2005 meeting in College Park (requires Quicktime)
    • Transcript of Meeting (also available in French and Spanish)
    • Slide Presentation: Overview of Bioterrorism Act Establishment and Maintenance of Records Final Rule January 13, 2005 (also available in French and Spanish)

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
• Booklet: What You Need to Know About Administrative Detention of Foods November 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 August 2006
    • Compliance Information: Registration January 16, 2009
    • Fact Sheet: FDA's New Food Bioterrorism Regulation: 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)
    • Final Rule: Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 October 3, 2005
    • 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
      • FDA Notice Regarding Firms Offering Registration Services June 30, 2003
  • Prior Notice of Imported Food Shipments
    • Final Rule
      • Final Rule: Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 Federal Register, November 7, 2008
      • Compliance Policy Guide: Guidance for FDA and CBP Staff May 2009
    • Fact Sheet: FDA'S Food Bioterrorism Regulation: Final Rule - Prior Notice of Imported Food Shipments March 2009
    • Slide Presentation: Overview of Prior Notice Final Rule and Draft CPG Implementing the Bioterrorism Act March 2009
    • 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 November 2005
      • Summary Information: Prior Notice Summary Information April 2005
    • 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 September 2, 2005
      • HTS Codes Revision History September 2, 2005
    • Guidance for Industry: Entry Types and Entry Identifiers - Prior Notice of Imported Food April 7, 2005
    • International Mail: Sending Food Through International Mail October 2004
      Selected Excerpts from the Prior Notice Interim Final Rule, Guidance Documents, and Fact Sheets
    • Gift Packs: Importing Gift Packs and Prior Notice November 2004
    • Sending Gifts to Your Friends and Family: Prior Notice Policy December 2004
    • Information Sheets- Shipments of Food that Appear to be for Commercial Purposes December 2004
    • How to Submit Prior Notice
      • Submit Prior Notice through PNSI, Overview & Background
        • New Features in Version 1.6.01 of the Prior Notice System Interface (PNSI) October 29, 2005
        • 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

See also Background Information on Protecting the Food Supply

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