Who must register under the food facility registration requirements?
If you are the owner, operator, or agent in charge of either a domestic or foreign facility that is engaged in manufacturing/processing, packing, or holding of food for human or animal consumption in the United States, you must register with FDA, unless you are exempt under 21 CFR 1.226 from the requirement to register. If you are an owner, operator, or agent in charge of a domestic facility, you must register your facility whether or not the food from the facility enters interstate commerce (21 CFR 1.225(b)). If you are the owner, operator, or agent in charge of a facility, you may authorize an individual to register your facility on your behalf (see 21 CFR 1.225(c) and 1.230(a)). A foreign facility’s U.S. agent may, but is not required to, register the facility (21 CFR 1.230).
If you have questions concerning whether you are required to register, visit Questions and Answers Regarding Food Facility Registration (Seventh Edition): Guidance for Industry.
What is the biennial food facility registration renewal period?
Every facility that is required to register with FDA as a food facility must renew their registration every 2 years. This is commonly referred to as the “biennial food facility registration renewal period.” The Federal Food, Drug, and Cosmetic Act (FD&C Act) sets the biennial food facility registration renewal period as beginning on October 1 and ending on December 31 of each even-numbered year. That means 2020 is a registration year.
A few things to keep in mind if you have registered, or updated your registration since the last biennial food facility registration renewal period:
- If you registered your food facility before October 1, 2020, you must renew your registration before December 31, 2020 and provide us with any updated information, if applicable.
- If you updated your food facility registration before October 1, 2020, you must renew your registration before December 31, 2020 and provide us with any updated information, if applicable.
- As a reminder, if you are the new owner of a registered food facility, the previous owner is required to cancel the food facility’s registration within 60 calendar days of the change of ownership and you must re-register the facility reflecting the new ownership (see 21 CFR 1.234 and 1.235).
Is there a fee associated with registering or renewing the registration for my animal food facility?
No. There is no fee associated with registration or renewal.
When is the biennial food facility registration renewal period?
The 2020 Biennial Registration Renewal Period begins October 1, 2020 and concludes on December 31, 2020.
I’m registering for the first time. What do I need before I register?
First, you need to create or have an existing Food Unified Registration Listing System (FURLS) account to access the module and submit your renewal. You must also have a unique facility identifier to include with your registration information.
What is a unique facility identifier and how do I get one?
A unique facility identifier is a way to assure that information associated with your facility, such as your address is accurate and to enhance the accuracy of FDA’s food facility registration database.
In accordance with 21 CFR 1.232(a)(2), effective October 1, 2020, all facilities must include a unique facility identifier (UFI) recognized as acceptable by FDA with their registration information. To date, FDA recognizes the Data Universal Numbering System D-U-N-S (DUNS) number as an acceptable UFI.
DUNS numbers are assigned and managed by Dun & Bradstreet (D&B). Obtaining a DUNS number is available free of charge. DUNS numbers can be obtained or verified by visiting D&B’s website or by phone at 866-705-5711. The UFI field has been added to Section 2-Facility Name/Address Information of Form FDA 3537. You will be required to provide your UFI in “Section 2- Facility Name/Address Information” of your food facility registration.
If you have not yet obtained or verified a DUNS number for your facility, FDA has provided guidance and additional information for how to complete your food facility registration while your DUNS number is pending. Please see FDA’s Constituent Update for more information.
How do I create or renew my registration?
The owner, operator, or agent in charge of the facility, or a person authorized by one of them, can submit a facility's registration renewal electronically through the Registration of Food Facilities and Other Submissions page.
My password to the food facility renewal system has expired. How do I reset my password?
For security purposes, password resets are required every 90 days and an automated email message to reset your password is sent from FDA’s FURLS database to your user account when a password reset is required. FDA does not recommend sharing accounts with multiple individuals; each user should have their own account to access the system.
You can reset your password when you click Login / Create Account on the Registration of Food Facilities and Other Submissions page. If you require additional assistance, please contact the FDA Industry Systems Help Desk at firstname.lastname@example.org, toll-free in the USA 1-800-216-7331 or 240-247-8804.
If I am a qualified facility, do I fill out a qualified facility attestation during my food facility registration renewal?
Yes. If you are a qualified facility, you also fill out and submit your qualified facility attestation during the food facility registration renewal period.
I just submitted my qualified facility attestation; do I have to submit it again?
Yes. The initial submission of the animal food qualified facility attestation occurred in the fall of 2019. This was in the middle of a food facility registration renewal biennial period, so many animal food facilities submitted their qualified facility attestations in the last year. Your facility does need to resubmit a new attestation with your 2020 food facility registration renewal so that your attestation submission will happen at the same time as subsequent biennial food facility registrations.
So, if you have submitted a qualified facility attestation before October 1, 2020, you must re-submit your attestation before December 31, 2020 (21 CFR 507.7(c)(2)(ii)).
Once logged into FURLS, please re-submit your attestation electronically via the Qualified Facility Attestation Module. Please ensure renewal of your food facility registration before re-submitting your qualified facility attestation.
How do I determine if I’m a qualified facility?
A qualified facility is determined by your business size. A "qualified facility" is (when including the sales by any subsidiary; affiliate; or subsidiaries or affiliates, collectively, of any entity of which the facility is a subsidiary or affiliate) either:
- A "very small business," a business (including any subsidiaries and affiliates) averaging less than $2,500,000, adjusted for inflation, per year, during the 3-year period preceding the applicable calendar year in sales of animal food plus the market value of animal food manufactured, processed, packed, or held without sale (e.g., held for a fee), or
- A facility to which both of the following conditions apply: During the 3-year period preceding the applicable calendar year,
- (1) the average annual monetary value of the food manufactured, processed, packed or held at such facility that is sold directly to qualified end-users exceeded the average annual monetary value of the food sold by such facility to all other purchasers; and
- (2) the average annual monetary value of all food sold during the 3-year period preceding the applicable calendar year was less than $500,000, adjusted for inflation.
Additional information to assist you in determining if you are a qualified facility, including the inflation adjusted cut offs for all of the FSMA rules can be found on the Qualified Facility Attestation page.
What does it mean for me if I attest that I am a qualified facility?
Qualified facilities are exempt from implementing a food safety plan (i.e., the hazard analysis and risk-based preventive controls requirements in 21 CFR part 507, subpart C and E), and instead follow the modified requirements in 21 CFR 507.7.
Facilities that do not attest that they are a qualified facility, must have a food safety plan and meet the requirements in 21 CFR part 507, subpart C and E. If you do not submit a qualified facility attestation, then you do not meet the requirements for an exemption from having a food safety plan.
Attesting that you are a qualified facility allows FDA and our state partners to plan and coordinate what type of inspection may be appropriate for your facility, such as either a preventive controls inspection or one evaluating compliance with the modified requirements in 21 CFR 507.7. Attesting that you are a qualified facility during the food facility renewal period allows us to coordinate between FDA and our state partners to provide you with the most accurate and efficient inspectional experience.
Where do I go to find more information?
Please visit Registration of Food Facilities and Other Submissions for more information about food facility registration and the 2020 biennial renewal period including guidance documents and user guides for our Food Facility Registration Module (FFRM).
Please visit Qualified Facility Attestation for more information about qualified facility attestations, including the FSMA Inflation Adjusted Cut Offs to help you determine that your facility meets the definition of a qualified facility.
Who can I contact if I have questions?
Please contact the FDA Industry Systems Help Desk at email@example.com, toll-free in the USA 1-800-216-7331, or 240-247-8804 if you require additional assistance. When contacting the FDA by phone, please anticipate long hold times during the renewal period. Likewise, please anticipate a delay in the time it takes FDA to respond to e-mails due to the significant increase in call and email volume that FDA receives during the registration renewal period.