Updated FDA Food Facility Registration Overview August 3 2016

Food Facility Registration FDA issued the Final Rule for Food Facility Registration Regulations Amendments on July 14, 2016, that updates the registration requirements many of the revised requirements were already implemented in 2012, as provisions were mandated by FSMA Updated Section 102 of FSMA - amends section 415 of the fd&c act 21 cfr part 1 Federal register 81 45911 effective September 12, 2016 – and is required for this years renewal period! FDA will Publish a guidance document in the near future, and will be asking for comments.

Purpose of the registration creates an up to date database Fsma Now Links food facility registration to food safety requirements FINAL RULE WILL further enhance fda’s capabilities with respect to responding to food safety issues: Helps fda better respond in the event of actual or potential bioterrorist incidents Helps fda Respond quicker to other food related emergencies Helps fda focus and use its inspectional resources more efficiently

Who Must Register All Domestic and foreign facilities That manufacture/Process Pack Or Hold Food for human or animal consumption and registration does not hinge on whether the facility owns the food! Facilities regulated exclusively and throughout the entire facility by the U.S. Department of Agriculture that is, facilities handling only meat, poultry, or egg products. are exempt! nfi will seek Clarification for Siluriformes (including Catfish) Registration is Required to be Done by the owner, operator or agent in charge and will certify the information is true and accurate. He/she can authorize an individual to renew on their behalf. An individual that registers on the owner’s behalf also certifies the information is true and accurate and is authorized to submit the registration.

Facility Registration requirements include: Listing the type of activity conducted at the facility for each food product category Optional fields are now mandatory Email address for facility contact person and U.S. Agent (if applicable ) Renewal of registration every two years (even Year) New abbreviated process created if no changes are needed A new company that registers prior to October of an even year still needs to renew between Oct 1 and Dec 31st An assurance that the FDA will be permitted to inspect the facility at the times and in the manner permitted by the fd&c Act

Facility Registration includes several other new requirements All food facility registrations are required to be submitted to the FDA electronically effective January 4, 2020.   Provide a unique facility identifier (UFI) as part of the registration process starting October 1, 2020  (more information is forthcoming from FDA on this requirement)   Verifications will be obtained by FDA for registrations not submitted by the owner, operator, or agent in charge Affirmation from the US Agent agreeing to serve as the US agent will be obtained prior to the Registration confirmation from FDA

Retail food establishment Revised definition included in this rule Expanded the definition of a retail food establishment to include: Sales of food products directly to consumers from food stands if not where manufactured or processed Community supported agriculture program Any other direct sale s platform although they are not required to register - this is for consistency with section 102 (c ) of FSMA However fda Notes that all food establishments including retail continue to have a responsibility to ensure their food is safe

Unique facility identifier (ufi) requirement Why require: Since FDA implemented the registration requirement one of the issues has been incorrect facility address information Part of mandate to compile and maintain an up to date list Will make it more difficult for an unauthorized person to submit registrations Registration lists and documents are not subject to disclosure under the Freedom of information act (Foia), so the UFI # will be kept confidential

Unique facility identifier (ufi) requirement The registration will require a unique facility identifier number Recognized as acceptable to fda - to Provide assurance that the address associated with the food facility is accurate (validation step) Guidance to be provided on acceptable UFI options D-u-n-s # (data universal number system,) one example of acceptable UFI The D&B D-U-N-S® Number provided by Dun & Bradstreet (D&B) is a unique nine-digit identifier for each physical location businesses. It is used to establish a business credit file Is FREE for all businesses required to register with the US Federal government for contracts or grants Unique food facility identifier becomes effective October 1, 2020

Foreign facility registration foreign facilities definition only if food from such facility is exported to the united states for consumption In this country, without further processing or packaging outside the united states Registration now includes Email address of facility and US agent Us agent acts as the communication link and will be contacted in case of an emergency unless the registration specifies another emergency contact FDA will treat representations by the US Agent as those of the foreign facility and documents provided to the US agent by FDA as equivalent of providing information or documents to the foreign facility.

US agents Us agents are required for foreign facilities and must agree to serve as their agent An affirmative step will be done by FDA prior to the registration being confirmed You must respond to the FDA’s email/communication for the registration to be completed for the designated foreign facility! Us agent may view the information submitted in the foreign facility registration through FDA Unified Registration and listing Systems (FURLS) US Agent requirements have not changed and are liable for re-inspection fees

Verification Fda will verify that the individual is in fact has authorization to submit on behalf of the owner/operator or agent in charge Fda will verify that the person agreed to serve as the us agent Registration is not completed until fda has done the verification steps and sends you the confirmation! this should eliminate double registrations submission s and you being designated a US agent without your knowledge Don’t wait till the last minute to renew and don’t ignore emails or other communication from the fda!

Food facility registration reminder to actively manage Final rule Includes Ensuring the database stays up to date Companies are required to submit updates and cancellations within 60 days Fda Will send a confirmation using the contact information submitted by the facility in the registration database Fda Can now bring civil action in federal court if you fail to register, update, renew or cancel

Registration Cancellations Fda now has the authorization to suspend the registration of a food facility under certain circumstances: if there is a reasonable probability of causing serious adverse health consequences or death to humans or animals Fda Will also cancel the registration if the facility registration has expired and company has failed to renew If suspended you can not import or export food or offer to import or export from your facility In the united States or otherwise introduce food from the facility into interstate commerce in the united states If suspended An article of food being imported will be Held at port and may not be delivered to the importer, owner or consignee. This will be further addressed in a separate rulemaking.

Where do I register Electronic registration and renewal – FDA Website http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/ucm2006831.htm http://www.fda.gov/furls Open 7 days/week and 24 hours A Log In account is required (with Password) Reminder - the login information should be kept with other important company documents or known by more than one individual as it is needed for renewals and updating your registration a Group email address is also acceptable

About seafood members portal A Final Rule Summary Sheet is also posted on the Members Portal of the About Seafood website ( http://www.aboutseafood.com/ ) under the Regulatory Information tab. summary Sheets for other current Regulatory Activity and the Regulatory Overview Presentation from the June Webinar is posted there, as well. ”.