29 July 2016
FDA Amends Food Facility Registration Requirements
The Food and Drug Administration has made a number of changes to the system through which foreign and domestic food facilities that manufacture, process, pack or hold food for consumption in the United States register with the FDA. These changes include a number of new requirements as well as codification of some requirements already in effect under the Food Safety Modernization Act. The rule is effective 12 September although some of these changes will not enter into force until 2020.
All food facility registrations and registration renewals will have to be submitted electronically beginning on 4 January 2020, although this requirement could be waived in certain circumstances. A waiver request would need to explain why it is not reasonable to submit the registration, registration renewal, update or cancellation to the FDA electronically.
Additional Data Elements
Registrations must include a unique facility identifier (UFI) recognised as acceptable to the FDA, although this requirement will not enter into force until the registration renewal period beginning 1 October 2020. The final rule also requires information on the type of activity conducted at the facility for each food product category identified; a preferred mailing address (if different from the facility’s mailing address); the email address of the owner, operator or agent in charge of the facility (unless a waiver is granted); and the email address of the emergency contact for domestic facilities. However, the FDA has decided not to require the DUNS number of the facility.
In response to public input, the FDA has decided not to shorten from 60 to 30 calendar days the timeframe for submitting updates and cancellations. Accordingly, the final rule provides that updates to registration information or cancellation of registration must be submitted within 60 days of any change to any of the required information or the reason for the cancellation.
The circumstances under which the FDA would cancel a registration have been expanded to include the following.
- the FDA independently verifies that a facility is no longer in business or has changed owners and the owner, operator or agent in charge of the facility fails to cancel the registration
- the FDA determines that the registration is for a facility that does not exist
- the FDA verifies that a facility is not required to register
- information about the facility’s address was not updated in a timely manner
- the registration was submitted by an unauthorised person
- the registration has expired because the facility failed to renew it
After a foreign facility completes its registration or updates its U.S. agent information as part of its registration renewal, the FDA will verify that the person identified as the U.S. agent for the facility has agreed to serve as such. The FDA will not confirm the registration or renewal or provide a registration number until such confirmation has been obtained. In addition, the U.S. agent of a foreign facility may view the information submitted in that facility’s registration.
The FDA received numerous comments in favour of the creation of a U.S. Agent Voluntary Identification System, which would aim to ensure the accuracy of U.S. agent information and enable U.S. agents to independently identify the facilities for which they have agreed to serve. The FDA therefore plans to implement such a system at some point in the future.
Failure to renew a food facility registration may be subject to civil injunction proceedings, criminal penalties, and debarment of a person who has been convicted of a felony related to the importation of food into the United States. In addition, the FDA will consider a registration to be expired if it is not renewed, and a food facility with an expired registration will be considered to have failed to register.
The final rule codifies in the regulations the following FSMA provisions that were self-implementing and effective upon enactment of that law: registrations for domestic facilities must contain the email address of the contact person of the facility and registrations for foreign facilities must contain the email address of the U.S. agent for the facility; food facilities must renew their registrations between 1 October and 31 December of each even-numbered year; and all food facility registrations must contain an assurance that the FDA will be permitted to inspect the facility at the times and in the manner permitted by the Federal Food, Drug and Cosmetic Act. The rule also expands the number of establishments that are considered retail food establishments, which are exempt from the requirement to register.
Facilities in Hong Kong and mainland China that manufacture, pack or store food, food ingredients, pet foods or dietary supplements and are currently registered to export any such products to the United States must renew their registration by the end of this year if they wish to continue exporting to the United States beginning on 1 January 2017. The failure of a food facility to register with the FDA constitutes a prohibited act under Section 301(dd) of the Federal Food, Drug, and Cosmetic Act.
The FDA may consider a facility not to be registered if it has not submitted a registration to the agency or if its registration is incomplete or has expired. Food imported or offered for import into the United States by an unregistered foreign facility is subject to being held at the port of entry unless U.S. Customs and Border Protection concurrence is obtained for the export of the food and that food is immediately exported from the port of arrival. The FDA may allow the food held at the port to be moved to a secure facility, whenever appropriate, but will not ordinarily allow the food to be transferred by any person from the port of entry into the United States or from the secure facility.