To help smaller food processing, storage and distribution facilities better understand and meet new registration requirements under the Federal Food Drug & Cosmetic (FD&C) Act, the U.S. FDA has issued a Small Entity Compliance Guide (SECG).
The guide includes in-depth explanations, as well as an ‘At-a-Glance’ summary of important information, on key mandates of the provision including:
• Which types of facilities are required to register, and when and how to do that.
• The consequences for facilities that fail to register or to renew their registration as required.
• When the FDA can suspend a facility’s registration and the effect of a suspension order.
The FD&C Act requires domestic and foreign food manufacturing/processing, packing, or storage facilities for human or animal food in the United States to register with the FDA. The new registration provisions, which include giving the FDA the authority to suspend a facility’s registration, require companies to do the following:
- Provide FDA with assurance that they will be permitted to inspect their facility (in accordance with the FD&C Act).
- Renew their registration every other year.
Why must food facilities register under this program? With the FDA’s inspection resources already stretched thin, having this information will allow the agency to better determine the location and source of a food- borne illness outbreak or a potential bioterrorism incident. It will also speed up the notification process to affected facilities and not let critical time pass in the event of an outbreak.
Types of food included under the facility registration regulation
If your facility handles any of the food products listed here, it must be registered:
- Dietary supplements and dietary ingredients
- Infant formula
- Beverages (including alcoholic beverages and bottled water)
- Fruits and vegetables
- Fish and seafood
- Dairy products and shell eggs
- Raw agricultural commodities for use as food or components of food
- Canned and frozen foods
- Bakery goods, snack food, and candy (including chewing gum)
- Live food animals
- Food for animals (e.g., pet food, pet treats and chews, animal feed)
Facilities that manufacture, process, pack, or store only a food contact substance or pesticides are NOT required to register.
Need help interpreting the new compliance guide and how it impacts your facility? Call our food safety experts
at Sprague and we can walk you and your staff through it.