NEED FOR THE REGULATION

In the early 1970's, several life-threatening botulism outbreaks occurred as a result of inadequate thermal processing of commercially prepared low-acid foods packaged in hermetically sealed containers and improper acidification of commercially prepared acidified foods. Consequently, the following regulations were published by the FDA:

The current Good Manufacturing Practice Regulations (GMP's) for low-acid canned foods (21 CFR 113) became effective in March 1973 (revision became effective May 15, 1979). The GMP's for acidified foods (21 CFR 114) became effective in May 1979. These GMP's outline the equipment, controls, manufacturing, processing, and packing procedures which are required to ensure the production of a safe product.

The purpose of the above regulations is to protect consumers from microorganisms of public health significance (i.e., harmful bacteria or their toxins), especially Clostridium botulinum. The spores of Clostridium botulinum must be destroyed or effectively inhibited to avoid germination and subsequent production of the deadly toxin which causes botulism. This is accomplished with good manufacturing practices which must include:

• The use of thermal processes and/or other means of preservation that are properly designed by a competent processing authority to destroy or inhibit Clostridium botulinum spores;

   

   

• Proper delivery of these thermal processes and/or adequate control of other methods of preservation being used.

   

   

• Sufficient documentation that the scheduled processes are delivered through the keeping of appropriate records.