December Deadline: Biennial Food Facility Registration and Qualified Facility Attestation
The biennial food facility registration and qualified facility attestation period is open. The December 31, 2020, deadline is coming soon.
Qualified facility attestations help the FDA determine which facilities will be inspected for the full requirements or modified requirements of the Preventive Controls for Animal Food (PCAF) rule.
The U.S. Food and Drug Administration (FDA) recently published a reminder with Animal Food Facility Registration and Qualified Facility Attestation Frequently Asked Questions. The FAQs cover
- who must register as a food facility with the FDA,
- who must renew their food facility registration,
- registration fees (there are no registration or renewal fees),
- how to create or renew registration,
- determination of status as a qualified facility,
- resubmission of a qualified facility attestation, and
- who to contact if you have questions about the registration process.
We’ve highlighted some of the FAQs below, to help you meet the registration and attestation deadline.
FAQ 1. Who Must Register as a Food Facility With the FDA?
Food facility registration is required for domestic and foreign facilities that manufacture/process, pack or hold food for human or animal consumption in the United States, unless the facility meets the exemptions listed in 21 CFR 1.226. The FDA has a guidance document with Questions and Answers Regarding Food Facility Registration (Seventh Edition) including a list of food facility exemptions.
FAQ 2. Who Must Renew Their Food Facility Registration?
There are several things to keep in mind for food facility registration:
- If your facility was registered before October 1, 2020, you must renew your facility registration before December 31, 2020 and provide any applicable updated information;
- If your facility registration was updated before October 1, 2020, you must complete the renewal process before December 31, 2020 and provide any applicable updated information;
- If a new owner has acquired a registered facility, the previous owner must cancel the facility’s registration within 60 calendar days of the change of ownership and the new owner must re-register the facility;
- If you are registering a food facility for the first time, create a Food Unified Registration Listing System (FURLS) account to access the module and submit your food facility registration renewal. You will also need a unique facility identifier (UFI) to include with your registration information. You can use the FDA’s DUNS Portal to obtain or verify your UFI.
FAQ 5. How do I Determine if My Facility is a Qualified Facility?
NC State Extension has a new FSMA Preventive Controls for Animal Food (PCAF) Exemption Decision Tree Tool (and factsheet, below) to help industry determine whether or not their facility meets the requirements of a qualified facility exemption. Note: This tool is for informational purposes only; it does not take the place of independent legal advice, and it is not intended to be used as legal advice.
Under the Food Safety Modernization Act (FSMA), a qualified facility is a facility that is exempt from the hazard analysis and risk-based preventive controls requirements in 21 CFR 507, subparts C and E, and is subject to modified requirements.
If a facility meets the requirements of the qualified facility definition, the facility must submit a qualified facility attestation to the FDA to claim the exemption. Facilities that do not submit a qualified facility attestation are subject to the full requirements of the rule, regardless of status.
Instructions for Submitting Qualified Facility Attestation can be found on the FDA website, along with the attestation form (Form FDA 3942b for animal food).
For more detailed instructions for how to calculate your facility’s status as a qualified facility, read the FDA Guidance for Industry Determination of Status as a Qualified Facility Under Part 507: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals.
FAQ 6. When do I Need to Resubmit My Qualified Facility Attestation?
The initial implementation and submission of qualified facility attestations occurred in Fall 2019. This was in the middle of the biennial registration renewal process, so a new attestation must be submitted with the updated 2020 food facility registration renewal.
If your facility submitted a qualified facility attestation before October 1, 2020, you’re required to resubmit the attestation with your facility renewal before December 31, 2020. After this cycle, the registration renewal process and qualified facility attestations will happen at the same time.
Qualified facility attestations should be submitted to the FDA every two (2) years during the biennial registration period, beginning in 2020. Keep a record of your submitted attestation(s), as well as any applicable calculations used to determine your status as a qualified facility. These calculations should be done each year and the related records should be maintained.
If your facility’s status changes from a qualified facility to a not qualified facility, you must submit FDA form 3942b to notify the FDA of the change in status no later than July 31 during the calendar year of the status change.
FAQ 7. Get Help
If you have questions about facility registration or qualified facility attestations, contact the FDA Industry Systems Help Desk at email@example.com, toll-free in the USA 1.800.216.7331, or 240.247.8804. You can also submit questions to the FDA FSMA Technical Assistance Network. Expect extended wait times for answers, as the anticipated volume of requests is high.
NC State Extension is here to help answer questions regarding facility registration and qualified facility attestations. Contact Marissa Herchler for help with these processes or animal food safety.