The Food and Drug Administration is accepting comments through June 8 on a proposed rule that would make 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 U.S. 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.
Electronic Submission. All food facility registrations would have to be submitted electronically, although this requirement would not take effect before Jan. 4, 2016, and could be waived in certain circumstances; e.g., the registrant has conflicting religious beliefs or lacks reasonable access to the Internet.
Additional Data Elements. Registrations would have to include the type of activity conducted at the facility for each food product category, the DUNS number of the facility, 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, and the email address of the emergency contact for domestic facilities.
Updates. Food facilities would have to immediately update any previously submitted registration information that was incorrect at the time of submission of an electronic registration or registration renewal. In addition, the period for a food facility to update or cancel its registration would be shortened from 60 calendar days to 30.
Cancellations. The circumstances under which the FDA would cancel a registration would be 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 independently 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 unauthorized person
- the registration has expired because the facility failed to renew it
U.S. Agents. After a foreign facility completes its registration or updates its U.S. agent information as part of registration renewal, the FDA would email the person identified as the U.S. agent to verify that the person has agreed to serve as such. In addition, the U.S. agent of a foreign facility could view the information submitted in that facility’s registration.
The FDA is also seeking comments on whether it should issue a future guidance document to provide for the creation of a U.S. Agent Voluntary Identification System or otherwise create such a 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 believes such a system is likely to increase the accuracy of U.S. agent contact information and reduce the number of unauthorized and/or fraudulent U.S. agent listings.
Penalties. Failure to renew a food facility registration would 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 U.S. In addition, the FDA would consider a registration to be expired if it is not renewed, and a food facility with an expired registration would be considered to have failed to register.
Other. The proposed rule would codify 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 Oct. 1 and Dec. 31 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.
Finally, this proposal would expand the number of establishments that would be considered retail food establishments, which are exempt from the requirement to register as well as certain requirements in the FSMA preventive controls rulemakings that apply to establishments required to register.
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