The purpose of 21 CFR 108, 113, and 114 is to ensure safety from harmful bacteria or their toxins, especially the deadly Clostridium botulinum (C botulinum). This can only be accomplished by adequate processing, controls, and appropriate processing methods, such as cooking the food at the proper temperature for sufficient times, adequately acidifying the food, or controlling water activity.
C. Botulinum is a living organism which is almost universally present. Under certain conditions, C. botulinum can grow in foods and produce a powerful toxin which affects the nervous system. C. botulinum will only grow in foods which: are packaged in the absence of oxygen; have a "favorable" pH and temperature; and contain water and nutrients necessary for its growth. Low-acid canned foods provide this favorable environment. When a product is acidified to a pH of 4.6 or less, according to FDA's Good Manufacturing Practices, inhibition of the growth of C. botulinum is assured.
FDA does not approve, license, or issue permits for finished food products shipped in interstate commerce. However, all commercial processors of LACF and AF, are required to register their establishments and file processing information for all products with the FDA using appropriate forms. Forms are available on the web. You can also request forms by writing to:
Labeling and other requirements that apply generally to all foods are also contained in Title 21, Code of Federal Regulations (CFR). For ordering information please refer to the inside backcover of this booklet.
A subscription to the Federal Register (FR), will keep you up to date with FDA's requirements. While the CFR is published once a year, the Federal Register is published daily, except for weekends and federal holidays. It is the responsibility of the user of this booklet to stay current with FDA's requirements.
Text and PDF versions of the Code of Federal Regulations:
*PDF Readers are available for free from the Adobe Acrobat web site.
Hypertext updated by ear/cjm 2001-JUN-13