Few events are truly global but the 2020 pandemic has affected every living being on the planet in some way. It is the rare person whose life and/or business has not been turned upside down this year but I am pleased to bring you a tiny bit of normality: FDA Food Facility Registrations must be renewed between now and the end of 2020. For FDA, “Food Facilities” include any domestic or foreign facility that manufactures, processes, packs, or holds food or dietary supplements for human or animal consumption in the United States. Mobile facilities must also register but farms, transport vehicles and fishing vessels are exempt from the registration requirement.
FDA has been swamped this year with duties relating to the agency’s response to the pandemic. Food manufacturing operations have been greatly impacted by changes in facility operations. As a result FDA has allowed flexibility on egg packaging, ingredient labeling, and sale of foods labeled for use in the restaurant industry directly to consumers. In addition, the agency announced that it will exercise enforcement discretion regarding the January 1, 2021 deadline for the smallest food manufacturers to comply with the 2016 Food Labeling Regulations. It could happen that FDA will also defer enforcement of the facility registration renewal requirement and are simply slow to notify industry. However, since the registration is easily accomplished online, it makes sense to comply.
FDA has published a step-by-step user guide to the registration process. In addition to expected queries about the facility’s name, location, and management, two very important bits of information are required for registration:
- A statement in which the owner, operator, or agent in charge provides an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act;
- A statement in which the owner, operator, or agent in charge certifies that the information submitted is true and accurate.
These two requirements ensure that FDA will have cause and authority to cancel a facility’s registration if the agency is denied access to the facility or if there is a finding that the information submitted was incorrect.
This year is the first in which use of a ”Unique Facility Identifier” (UFI) is required. The UFI will have to meet FDA requirements. A Data Universal Numbering System D-U-N-S (DUNS) number is listed as an acceptable UFI. DUNS numbers are assigned and managed by Dun & Bradstreet. Information on obtaining a DUNS number can be found here.
My colleagues and I wish you and yours good health. It has been a true joy to hear from past clients and know they are well. We have also been privileged to work with new clients this year. We are ready to assist you with facility registrations or other aspects of compliance with FDA regulations.