Food Defense Guidance Documents & Regulatory Information

Guidance documents contain nonbinding recommendations.

• Registration of Food Facilities
• Establishment and Maintenance of Records
• Administrative Detention
• Fees
• Food and Cosmetic Security Preventive Measures Guidance
• ALERT

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• Dear Colleague Letter: Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (PL107-188) July 17, 2002
• Small Entity Compliance Guides Related to FDA Actions on Bioterroism Act of 2002 Legislation and The Food Safety Modernization Act of 2011

 

Registration of Food Facilities

• What You Need To Know About Registration of Food Facilities; Small Entity Compliance Guide (December 2012) 
• Questions and Answers Regarding Food Facility Registration (Fifth Edition) (December 2012) 
• Necessity of the Use of Food Product Categories in Food Facility Registrations and Updates to Food Product Categories (October 2012)
• Compliance Policy Guide - Guidance for FDA Staff: Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (December 2003; Revised November 2004 and August 2006)

 

Establishment and Maintenance of Records

• Draft Guidance for Industry: FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug, & Cosmetic Act (February 2012)
• Questions and Answers Regarding Establishment and Maintenance of Records By Persons Who Manufacture, Process, Pack, Transport, Distribute, Receive, Hold, or Import Food (Edition 5) (February 2012)
• Questions and Answers Regarding Establishment and Maintenance of Records (Edition 4) (September 21, 2006)
• 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)
• What You Need to Know About Establishment and Maintenance of Records (includes French and Spanish) (December 2004)

 

Administrative Detention

• What You Need to Know About Administrative Detention of Foods; Small Entity Compliance Guide (November 2004; Revised October 2011 and March 2013)

 

Fees

• Implementation of the Fee Provisions of Section 107 of the FDA Food Safety Modernization Act (September 2011)

  

Food and Cosmetic Security Preventive Measures Guidance

• Cosmetics Processors and Transporters: Cosmetics Security Preventive Measures Guidance (October 2007)
       This document also available in:
       Dutch
       German
       French
       Arabic (PDF - 274 KB)
       Korean (PDF - 213KB)
       Simplified Chinese (PDF - 240KB)
       Traditional Chinese (PDF - 255KB)
       Thai (PDF - 303KB)

• Retail Food Stores and Food Service Establishments: Food Security Preventive Measures Guidance (October 2007)

• Dairy Farms, Bulk Milk Transporters, Bulk Milk Transfer Stations and Fluid Milk Processors Food Security Preventive Measures Guidance (October 2007)
       This document also available in:
       Dutch
       German
       French
       Arabic (PDF - 181KB)
       Korean (PDF - 179KB)
       Simplified Chinese (PDF - 240KB)
       Traditional Chinese (PDF - 151KB)
       Thai (PDF - 187KB)

• Importers and Filers: Food Security Preventive Measures Guidance (October 2007)
       This document also available in:
       Dutch
       German
       French
       Arabic (PDF - 55KB)
       Korean (PDF - 381KB)
       Simplified Chinese (PDF - 264KB)
       Traditional Chinese (PDF - 234KB)
       Thai (PDF - 293KB)

• Food Producers, Processors, and Transporters: Food Security Preventive Measures Guidance (October 2007)
       This document also available in:
       Dutch 
       German
       French
       Arabic (PDF - 280KB)
       Korean (PDF - 267KB)
       Simplified Chinese (PDF - 271KB)
       Traditional Chinese (PDF - 244KB)
       Thai (PDF - 300KB)

  

ALERT

• Letter to Industry, State and Local Food Regulators and Inspectors Regarding Web-based ALERT Training (February 22, 2007)