Market Information
United States

New Regulations Under the
FDA Bioterrorism Act

Table of Contents

New
General
Contacts

US Customs and Border Protection Liaison Officers
Provincial Contacts

FDA

Overview
Prior Notice
Registration
Administrative Detention
Record Keeping

United States Customs

New

• DHHS and DHS Issue Bioterrorism Act Food Facilities Registration Final Rule (September 2005)
• Fact Sheet on FDA rule on Establishment and Maintenance of Records
• FDA Issues Final Rule on the Establishment and Maintenance of Records (December 2004)
• Compliance Policy Guide - Prior Notice of Imported Food (November 2004)

General

• CFIA Information Bulletin
• Health and Human Services Issues New Rules to Enhance Security of the US Food Supply
• Food Safety and Inspection Service (FSIS) - Imported Meat, Poultry and Egg Products Remain Under USDA Jurisdiction

Contacts

Department of Homeland Security Contacts
Jim Swanson
Tel: (202) 927-0966
Email: james.d.swanson@dhs.gov
Tom Heffernan
Tel: (202) 927-1185
Email: thomas.p.heffernan@dhs.gov

US Food and Drug Administration
Helpline: 301-575-0156

Canadian Border Services Agency
List of Customs Offices

Canadian Food Inspection Agency Import Service Centres (ISC)

Eastern ISC
(Quebec & Atlantic)
7:00 a.m. to 11:00 p.m.(local time)
Telephone and EDI: 1-877-493-0468 (inside Canada or U.S.)
1-514-493-0468 (all other countries)
Fax: 1-514-493-4103

Central ISC
(Ontario)
7:00 a.m. to 12:00 a.m.(local time)
Telephone and EDI: 1-800-835-4486 (inside Canada or U.S.)
1-416-661-3039 (all other countries)
Fax: 1-416-661-5767

Western ISC
(Manitoba, Alberta, Saskatchewan & British Columbia)
7:00 a.m. to 12:00 a.m.(local time)
Telephone: 1-888-732-6222 (inside Canada or U.S.)
1-604-666-9240 (all other countries)
EDI: 1-604-666-9240
Fax: 1-604-270-9247

US Customs and Border Protection Liaison Officers

Provincial Contacts

FDA

Overview

• Index of FDA Help Pages
• Joint FDA-CBP Plan for Increasing Integration and Assessing the Coordination of Prior Notice Timeframes, April 14, 2004
• FDA Introduces New Technology to Improve Food Security: Electronic Food Facility Registration Goes "Live," Allowing More Than 400,000 Facilities to Register in Minutes; FDA Reports on Progress in Developing Rapid Tests of Food Contamination October 16, 2003
• FDA and CBP Bolster Safeguards on Imported Food
• FDA/CBP Transitional Compliance Policy on Food Imports Under the Bioterrorism Act
• Press Release - Food Gifts Can Be Mailed To The United States (December 19, 2003)

Prior Notice

• Fact Sheet on FDA'S New Food Bioterrorism Regulation
• Interim Final Rule -- Prior Notice of Imported Food Shipments
• FDA - Other language documents
• FDA and CBP Announce Revised Compliance Schedule for Enforcement of The Prior Notice Interim Final Rule and Contingency Plan for Prior Notice System Outages
• Compliance Policy Guide - Prior Notice of Imported Food (November 2004)
• Prior notice of Imported Food: Harmonized Tariff Schedule Codes Flagged with Prior Notice Indicators (August 26, 2004)
• Comments of the Government of Canada on the Interim Final Rule concerning Prior Notice (July 13, 2004)
• *Comments of the Government of Canada on the Interim Final Rule concerning Prior Notice (December 19, 2003)
• *Implementation of the United States Food and Drug Administration Bioterrorism Rules for Prior Notice and Registration
  Questions and Answers (June 2004)
• Comments of the Government of Canada on the Joint Food and Drug Administration - Customs and Border Protection Plan for Increasing Integration and Assessing the Coordination of Prior Notice Timeframes
• How do I provide comments to FDA on Prior Notice?
• Information Document
• Guidance for Industry Prior Notice of Imported Food: Harmonized Tariff Schedule Codes Flagged with Prior Notice Indicators
• Prior Notice Questions and Answers
• Prior Notice Overview and Background
• Prior Notice Tutorials
• Prior Notice Help Index
• Prior Notice: Questions and Answers - Final Gudance
• Prior Notice - Sending Gifts of Food Articles by International Mail
  - Step-by-Step Web System Instructions
• Prior Notice - Sending Gifts of Food Articles by International Mail - Guidance Documents and Fact Sheets
• Compliance Summary Information re: Prior Notice of Imported Food Shipments, April 2, 2004
• Compliance Summary Information: Prior Notice, April 2, 2004
• *What You Need to Know About Prior Notice of Imported Food Shipments
• *Federal Register: Final Interim Rule for Prior Notice of Imported Food, October 10, 2003
• *US Import Operations
• Overview of Prior Notice Interim Final Rule Implementing the Bioterrorism Act (Slide Presentation) October 10, 2003
• *Prior Notice of Imported Food
• Corrections to Prior Notice of Imported Food
• *Reopening of Comment Period on Prior Notice of Imported Food, April 14, 2004
• *Federal Register Notice- Reopening of Comment Period on Prior Notice of Imported Food, April 14, 2004
• *Operational Components of Prior Notice

Registration

• DHHS and DHS Issue Bioterrorism Act Food Facilities Registration Final Rule (September 2005)
• Compliance Policy Guide - Registration of Food Facilities (November 2004)
• *Implementation of the United States Food and Drug Administration Bioterrorism Rules for Prior Notice and Registration
  Questions and Answers
• Comments of the Government of Canada on the Interim Final Rule concerning Registration of Food Facilities
• Facility Registration Electronically via the Internet
• Facility Registration by Paper (Mail or Fax) or CD-ROM
• Electronic Registration Tutorial
• Food Facility Registration: Questions and Answers     
• Food Facility Registration: Table of Contents     
• How do I provide comments to FDA on Facility Registration?
• Food Facility Registration: Questions and Answers - Final Guidance
• Prior Notice of Imported Food Shipments
• *What You Need to Know About Registration of Food Facilities
• *Federal Register: Final Interim Rule for Registration of Food Facilities, October 10, 2003
• *Overview of Registration Interim Final Rule Implementing the Bioterrorism Act (Slide Presentation) October 10, 2003
• *Registration of Food Facilities
• Questions and Answers Regarding Registration of Food Facilities (Edition 3), Final Guidance
• Registration of Food Facility Database Information Verification

Administrative Detention

• Fact Sheet on FDA's New Food Bioterrorism Regulation:
  Interim Final Rule - Registration of Food Facilities
• Administrative Detention
• *Federal Register: Proposed Rule for Administrative Detention, May 9, 2003

Record Keeping

• Fact Sheet on FDA rule on Establishment and Maintenance of Records
• FDA Issues Final Rule on the Establishment and Maintenance of Records (December 2004)
• Draft Guidance for Records Access Authority (December 2004)
• Establishment and Maintenance of Records
• *Federal Register: Proposed Rule for Establishment and Maintenance of Records, May 9, 2003

United States Customs

• *U.S Customs and Border Protection Moves to Implement the Bioterrorism Act (June 02, 2004)
• Questions & Answers Regarding US Customs and Border Protection Procedures under the FDA Bioterrorism Act of 2002
• *Interim Bioterrorism Act Procedures for Trade Partners
• Joint FDA-CBP Plan for Increasing Integration and Assessing the Coordination of Prior Notice Timeframes, April 14, 2004
• FDA and CBP Bolster Safeguards on Imported Food
• *US Customs and Border Protection and FDA Regulations
• *Operational Components of Prior Notice
• C-TPAT (Customs and Trade Partnership Against Terrorism
• FAST (Free and Secure Trade)
• One Face at the Border
• *Federal Register, Trade Act of 2002 - Advanced Electronic Filing Rule
• *Summary of Final Trade Act Regulations Sent to Congress for Review
• *Matrix of Rules by Mode of Transportation
• *Regulatory Impact Analysis - Advanced Electronic Filing Rule
• *US Customs and Border Protection and FDA Regulations