October 4, 2010
In September 2010 the U.S. Food and Drug Administration (FDA) published "Draft Guidance for Industry: Acidified Foods", which provides recommendations on manufacturing, storage, packaging, distribution processes, and appropriate quality control procedures for acid foods, acidified foods, and fermented foods. This guidance complements the current good manufacturing practice requirements in 21 CFR part 114 and emergency permit control requirements for acidified foods (21 CFR 108.25) that require commercial processors of acidified foods to register and file with FDA certain information about their establishments.
FDA’s regulations regarding acidified foods are necessary to control the microorganism Clostridium botulinum (C. botulinum), which can cause botulism, a rare but serious paralytic illness that can be fatal and is considered a medical emergency. C. botulinum will not germinate and grow when the pH of a food is 4.6 or below. An acidified food can pose a risk of botulism if pH and other critical factors are not carefully controlled during processing to prevent the germination and growth of viable spores of C. botulinum.
Acid foods are foods that have a natural pH of 4.6 or below. Examples of acid foods include most fruits. Fermented foods are low-acid foods subjected to the action of acid-producing microorganisms to reduce the pH of the food to 4.6 or below. Examples of fermented foods include some kinds of sauerkraut, pickles and green olives. Acidified foods are low-acid foods to which acid(s) or acid food(s) are added to reduce the pH of the food to 4.6 or below. Examples of acidified foods include many salsas, pickled beets, and cold-pack pickles.
The draft guidance, when finalized, will assist commercial food processors in determining whether their food products are subject to FDA’s regulations for acidified foods, and will provide recommendations on quality control procedures to ensure that finished foods do not present a health hazard. The draft guidance clarifies that a process used to produce an acidified food should be sufficient to destroy spores of those microorganisms of non health significance capable of reproducing and increasing the pH of acidified foods above 4.6 and to destroy or prevent the presence of vegetative cells of pathogenic microorganisms (such as E. coli O157:H7, Listeria monocytogenes and Salmonella species) that are acid-tolerant but do not produce spores.
Many establishments that evaluate whether their products are subject to the acidified foods regulations have contacted FDA with information about products that are not subject to the acidified foods regulations. The draft guidance also describes a voluntary registration program for processors of foods that may not be subject to the regulations for acidified foods. Under the draft guidance, processors of non-acidified foods who are not subject to the acidified food regulations may choose to voluntarily register their establishments and file processing procedures with FDA. FDA will make the results of its evaluation of the information available to its investigators for use during inspections of food facilities and during evaluations of foods offered for import. From past experience, FDA believes that many processors of foods that are not subject to the regulations for acidified foods would choose to submit information to the agency, because doing so would facilitate decisions by FDA investigators about the regulatory status of specific food products.