US Regulations For Canned Foods

Neither the FDA nor the USDA/FSIS have jurisdiction over foods that are canned at home. This creates big safety problems for low acid-products such as meat, poultry, fish and vegetables that are produced at home. Too often, home owners who have produced jams in the past incorrectly assume that all foods can be processed with the same procedure. This may in part be attributed to the insufficient information on the subject of canning low-acid foods that has been written for a home owner, but ultimately, the responsibility rests with the person who makes the product. He cannot blame his ignorance on the canning techniques of his mother or grandmother, as they did not have access to the information that abounds today. It is his duty to learn the basic rules of canning before he attempts to make a product. Almost all cases of food poisoning can be traced to canned food produced at home. It is very rare that a commercial plant will employ incorrect procedures or use a faulty recipe. The commercial packers work under such tight regulations and inspection programs, that any violation of the process is usually the product of a human error. Commercial canning is controlled in the United States by the Food and Drug Administration and the United States Department of Agriculture Food Safety Inspection Service. We enclose below the list of canning regulations that must be followed by commercial packing plants. Although home canning is not subject to government control, we feel that anybody who is seriously interested in proper canning procedures will greatly benefit from this information. Government regulations are the result of 100 years if intensive studies and research. The FDA and the USDA are concerned with the safety of consumers and not the taste or flavor of the canned product. However, each formulation must be designed by a competent processing authority and approved by the FDA. The regulations listed in the Code of Federal Regulations will help anybody who is thinking of starting his own commercial packing venture.

Code of Federal Regulations may be accessed for free online at:

• ELECTRONIC CODE OF FEDERAL REGULATIONS
• http://www.ecfr.gov/cgi-bin/ECFR?page=browse

Food and Drug Administration (FDA)

• Title 21, Code of Federal Regulations (21 CFR)
• Part 108 - Emergency Permit Control.
• Forms required for food canning establishment registration and process filing with FDA:
• FD-2541 Registration for Canning Establishment.
• FD-2541a Process filing for all processing methods, except aseptic processing of low-acid foods.
• FD-2541c Process filing for aseptic processing of low-acid foods.

• Forms can be downloaded from:
• http://www.fda.gov/AboutFDA/ReportsManualsForms/Forms/default.htm
• Part 113 - Thermally Processes Low-Acid Foods Packed in Hermetically Sealed Containers.
• Part 114 - Acidified Foods.
• Fish products fall under FDA jurisdiction.

United States Department of Agriculture (USDA) - Food Safety Inspection Service

NOTE that meat and poultry products fall under the jurisdiction of the USDA/FSIS. This, however, does not create problems or confusion as both FDA and USDA/FSIS regulations are almost identical.

• Title 9, Code of Federal Regulations (9 CFR)
• Subpart G - CANNING AND CANNED PRODUCTS
• Part 318.300 - .311 Meat Production.
• Part 381.300 - .311 Poultry Production.
• Part 416 - Sanitation Procedures, Meat and Poultry.

Useful General Information

• Part 110 - Good Manufacturing Practices in the manufacture, packing and holding of human food.
• Part 120 - Sanitation Procedures, Juice and Juice Products.
• Part 123 - Sanitation Procedures, Fish and Fishery Products.

According to the FDA regulation 21 CFR Part 113, a canned food with a water activity greater than 0.85, and a pH greater than 4.6 is considered a low-acid food, and its heat process will have to be filed by the individual packer with the FDA. If reduced water activity is used as an adjunct to the process, the maximum water activity must also be specified.

If the pH of the product has been adjusted to 4.6 or less and the water activity is greater than 0.85, the product is covered by the acidified food regulation, 21 CFR, Part 114, and requires only enough heat to destroy vegetative bacterial cells.

All low-acid and acidified low acid meat or poultry products are subject to the USDA canning regulations if the water activity is greater than 0.85. Any non-meat food product, regardless of the pH, with a water activity of 0.85 or less is not covered by the regulations for either the low-acid food (21 CFR, Part 113) or the acidified food (21 CFR. Part 114). However, these products are covered by the FDAís Current Good manufacturing Practices (CGMPs) regulation 21 CFR, Part 110. Meat or poultry products with a water activity of 0.85 or less are not covered by the USDA/FSIS canning regulations but are covered by other regulations, such as the USDA/FSIS meat and poultry HACCP regulation (9 CFR, Part 117) and Sanitation SOP regulation (9 CFR, Part 416).

Better Process Control Schools

In 1963, 1971, 1978 and 1982, there were botulism incidents in commercially produced cans in the USA. The 1971 incident led the National Canners Association (NCA), now Grocery Manufacturers Association/Food Processors Association (GMA/FPA), to revaluate the commercial sterilization processes for low-acid foods. The result was a recommendation to the U.S. Food and Drug Administration (FDA) for a program known as NCA-FDA Better Process Control Plan. The plan became effective in 1973 and is known today as 21 CFR Part 113 - Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers. The Better Process Control Plan (BPC Plan) places responsibility for the production of safe food products on individual food industry employees. The program stresses the point that ì in the processing of food, no amount of mechanical devices, regulations, inspections or physical measurements can prevent or offset human error and the resultant potential for tragic consequences to consumers, processors or the industry in general. The BPC Plan requires that operators of thermal processing and packaging systems work under the supervision of a person who attended, completed and passed the exam of a prescribed course of instruction at a school approved by the FDA Commissioner. The 4-day course is a cooperative venture of universities, FDA and industry personnel.