Background

The Food and Drug Administration is accepting through July 5 comments on the proposed extension of information collections associated with the registration of food facilities.

Domestic and foreign facilities that manufacture, process, pack or hold food for human or animal consumption in the U.S. must register with the FDA. Facilities are also required to submit updates within 60 days of a change to any required information on their registration forms and to cancel their registrations when they cease to operate, are sold to new owners, or cease to manufacture, process, pack or hold food for consumption in the U.S.

Domestic facilities are required to register whether or not food from the facility enters interstate commerce. Foreign facilities that manufacture, process, pack or hold food are also required to register unless food from that facility undergoes further processing (including packaging) by another foreign facility before it is exported to the U.S. However, if the further processing consists of adding labeling or any similar activity of a de minimis nature, both facilities are required to register.

Registration is accomplished using form FDA 3537, which refers to both the paper form and the electronic system known as the Food Facility Registration Module. Information required on this form includes the name and full address of the facility, emergency contact information, all trade names the facility uses, applicable food product categories, and a certification statement that includes the name of the individual authorized to submit the form. Facilities are also encouraged to submit their preferred mailing address; type of activity conducted at the facility; type of storage, if the facility is primarily a holding facility; and approximate dates of operation if the facility’s business is seasonal.

The Food Safety Modernization Act requires registrants for food facilities to submit additional information and renew their registrations biennially. When determined necessary by the FDA through guidance, a food facility is also required to submit information about the general food category of a food manufactured, processed, packed or held at such facility.

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