Food Canning Establishment Registration
REQUIREMENTS OF THE REGULATIONS
THIS PUBLICATION CONTAINS ONLY A SUMMARY OF THE PRINCIPAL REQUIREMENTS OF THESE REGULATIONS. LOW-ACID CANNED FOOD AND ACIDIFIED FOOD PROCESSORS AND SHIPPERS/IMPORTERS OF REGULATED IMPORTED PRODUCTS MUST TAKE STEPS TO FULLY INFORM THEMSELVES CONCERNING THE APPLICABLE REQUIREMENTS OF THESE REGULATIONS BEFORE OFFERING LOW ACID CANNED FOOD OR ACIDIFIED FOODS FOR DISTRIBUTION WITHIN OR IMPORTATION INTO THE U.S.
Food processing establishments in the United States and those which export foods to the United States are subject to regulations which require registration of the establishments and filing of scheduled processes. The registration and process filing regulation for thermally processed low-acid foods packaged in hermetically sealed containers is 21 CFR 108.35. The applicable registration and process filing regulation for acidified foods is 21 CFR 108.25, which became effective in July, 1979. Failure to comply with these requirements can result in detention of specific shipments or may result in a decision to refuse admission of all products produced by a processor.
REASONS FOR REGISTRATION AND PROCESS FILING REQUIREMENTS
Improperly processed low-acid canned foods or acidified foods present life-threatening hazards; therefore registration of those establishments which manufacture, process, or pack low-acid canned foods or acidified foods and filing of the processes they use are necessary to identify processors and to monitor compliance with the regulations, to provide for immediate application of emergency permit control should a potential public health hazard be identified.
Food Facility Registration
The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) directs the Food and Drug Administration (FDA), as the food regulatory agency of the Department of Health and Human Services, to take steps to protect the public from a threatened or actual terrorist attack on the U.S. food supply and other food-related emergencies.
To carry out certain provisions of the Bioterrorism Act, FDA established regulations requiring that:
- Food facilities register with FDA, and
- FDA be given advance notice on shipments of imported food.
These regulations became effective on December 12, 2003.
The FDA Food Safety Modernization Act (FSMA), enacted on January 4, 2011, amended section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), in relevant part, to require that facilities engaged in manufacturing, processing, packing, or holding food for consumption in the United States submit additional registration information to FDA, including an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act. Section 415 of the FD&C Act, as amended by FSMA, also requires food facilities required to register with FDA to renew such registrations every other year, and provides FDA with authority to suspend the registration of a food facility in certain circumstances. Specifically, if FDA determines that food manufactured, processed, packed, received, or held by a registered food facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals, FDA may by order suspend the registration of a facility that:
- Created, caused, or was otherwise responsible for such reasonable probability; or
- Knew of, or had reason to know of, such reasonable probability; and packed, received, or held such food.