FSMA Update: Food Facility Registration and FAQ Guidance for Industry Updates

Deadline to Register Facilities Extended to January 31

The Food Safety Modernization Act requires the Bioterrorism Act registration to be renewed between the months of October and December of even-numbered years for owners, operators or agents in charge of "domestic and foreign facilities that manufacture/process, pack or hold food for human or animal consumption" in the U.S., as defined in 21 C.F.R. 1.227.

The food facility registration system became operational and started accepting applications on Oct. 22, 2012, three weeks after the original Oct. 1 deadline; therefore, the Food and Drug Administration decided to exercise its enforcement discretion and extend the registration deadline from Dec. 31, 2012, until Jan. 31, 2013, as indicated in question 3.1 of the questions and answers document (see “Updated FAQ” section below for more information).

Access the FDA Food Facilities Registration System.

FDA has released an updated industry guidance document that was updated to reflect the FSMA amendments to the FD&C Act and contains other critical information. The guidance was created to inform domestic and foreign food facilities about the food facility registration requirements. The document includes information on who is required to register and who may be exempt, how often facilities must register and renew registrations, when FDA may suspend a registration, and how facilities may submit their registrations and registration renewals to FDA. Some additional registration information that must be provided in a facility’s registration, as provided by FSMA, include the email address of the U.S. agent for the foreign facility, and an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act.

Updated FAQ

FDA has also released the fifth edition of the questions frequently asked regarding facility registration. The guidance contains helpful questions and answers regarding food facility registration and is based on the FSMA amendments and is available here: Guidance for Industry: Questions and Answers Regarding Food Facility Registration.

The updated document provides the following information:

• Amendments to Section 415 of the FD&C Act Made by Section 102 of FSMA
• Who Must Register
• Who is Exempt from Registration
• Definitions
• What Information is Required in the Registration
• What Optional Items are Included in the Registration
• How and When You Update Your Facility's Registration Information
• How and When You Cancel Your Facility's Registration Information
• Other Registration Requirements That Apply
• The Consequences of Failing to Register, Renew, Update or Cancel Your Registration
• What The Assignment of a Registration Number Means
• Whether or Not Food Registration Information Is Available to the Public
• General Registration Questions

For more information on FDA's Food Safety Modernization Act, visit www.fda.gov/fsma.