Registration of Food Facilities

 

NOTE: FDA issued a guidance document stating that because there was a delay in FDA’s implementation of biennial registration renewal for the 2012 cycle, and registration renewal did not become available until October 22, 2012, FDA intends to exercise enforcement discretion with respect to registration renewals submitted to FDA after December 31, 2012 for a period of 31 days, until January 31, 2013. See Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Fifth Edition).

 

 

FDA Actions on the Bioterrorism Act of 2002 Legislation   

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) directs the Food and Drug Administration (FDA), as the food regulatory agency of the Department of Health and Human Services, to take steps to protect the public from a threatened or actual terrorist attack on the U.S. food supply and other food-related emergencies.

To carry out certain provisions of the Bioterrorism Act, FDA established regulations requiring that:

• Food facilities register with FDA, and

• FDA be given advance notice on shipments of imported food.

These regulations became effective on December 12, 2003. Below are links to important information about the Bioterrorism Act.

• Final Rule: Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (70 FR 57505)
  October 3, 2005
• Fact Sheet: Fact Sheet on FDA's New Food Bioterrorism Regulation:  Final Rule - Registration of Food Facilities
  October 2003 
• Booklet (SECG): What You Need to Know About Registration of Food Facilities
  November 2003
• Compliance Policy Guide Guidance for FDA Staff: Registration of Food Facilities
  August 2006
• Slide Presentation: Overview of Registration Interim Final Rule Implementing the Bioterrorism Act
  October 15, 2003
• Important FDA Notice Regarding Firms Offering Registration Services
  March 2008

 

FDA Actions under the FDA Food Safety Modernization Act (FSMA) 

The FDA Food Safety Modernization Act (FSMA), enacted on January 4, 2011, amended section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), in relevant part, to require that facilities engaged in manufacturing, processing, packing, or holding food for consumption in the United States submit additional registration information to FDA, including an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act. Section 415 of the FD&C Act, as amended by FSMA, also requires food facilities required to register with FDA to renew such registrations every other year, and provides FDA with authority to suspend the registration of a food facility in certain circumstances. Specifically, if FDA determines that food manufactured, processed, packed, received, or held by a registered food facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals, FDA may by order suspend the registration of a facility that:

• Created, caused, or was otherwise responsible for such reasonable probability; or
• Knew of, or had reason to know of, such reasonable probability; and packed, received, or held such food.

For more information on Food Facility Registration under the FDA Food Safety Modernization Act (FSMA), visit the FSMA Inspection & Compliance page or the links below.

• Guidance for Industry: What You Need To Know About Registration of Food Facilities; Small Entity Compliance Guide (December 2012) 

• Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Fifth Edition) (December 2012)