Facility Registration Under Bio-terrorism Act

Action Required – FDA Biennial Registration due October 1, – December 31, 2016

The Bioterrorism Act of 2002 requires all Food (Human and Animal) facilities to register with the FDA. In 2011 FSMA changed the registration requirements from one-time registration to every two years in even years between Oct 1 and Dec 31. Failure to register is a federally prohibited act.

It has been CFD’s position that most members (and many customers) must register! Each facility under company ownership that has a different address requires registration. There are exceptions to the registration requirements. In the future the FDA will allow for cancelling registrations (#6 below) based on its verification that a facility is not required to register. If a member has any questions regarding the requirement to register, it may be safer to register and let the FDA exempt one or more of your facilities than to not register.

Between October 1, 2016 and December 31, 2016 go to: http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/ucm2006831.htm

During registration some of the information you will be required to provide includes the following:

  • The e-mail address for the contact person of the domestic facility
  • Assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act
  • Updated food product category information, as determined appropriate by FDA in already-published guidance

Changes to the rule will be implemented in the coming years (there are many but these apply to our members):

  1. Unique Facility Identifier (UFI) – Will be assigned by the FDA and assist the FDA in verifying accuracy of site specific address, the FDA will verify the UFI prior to issuance of registration number or confirmation of registration. This will be implemented October 1, 2020.
  2. If you use a 3rd party to do your registration, the email of owner, operator, or agent in charge who authorized a third party to act on behalf of the facility will be required.
  3. Some previously optional fields are now mandatory. Such as preferred mailing address, emergency contact email address, type of activity.
  4. Electronic registration will be required as of January 4, 2020 (Changes to the waiver of electronic registration will also being made).
  5. Abbreviated Registration Renewal Process
  6. The FDA will have authority to cancel registrations in additional circumstances (such as: FDA independent verification that a facility is not required to register, facility address not updated in a timely manner, unauthorized registration submissions, registration expiration due to failure to renew.
  7. Requirement for immediate update to incorrect registration information
  8. Changes to activity types (such as Farm Mixed-Type Facility, Animal food warehouse/holding facility).

The FDA is preparing guidance on some of these changes and as more information is available we will provide updates!