Guide to Inspections of Low Acid Canned Food Manufacturers - 1

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have to register and file processing information for these products:

Figs, pears, and pineapples, or their juices, and any products with a finished equilibrium pH above 4.6 and a water activity greater than 0.85 are considered low-acid foods. If they are thermally processed and packaged in hermetically sealed containers, they are subject to the LACF regulations. If figs, pears, or pineapples have a normal pH greater than 4.6 prior to processing, and are acidified to a equilibrium pH of 4.6 or below, they are regulated under the Acidified Foods regulations (21CFR 114).

The regulations also pertain to "any normally low-acid fruits, vegetables, or vegetable products in which, for the purpose of thermal processing, the pH value is reduced by acidification. For example, acid may be added to reduce the product pH from 5.8 to 4.9 to take advantage of the fact that microorganisms are more easily destroyed in an acidic environment. In this case, acidification to pH 4.9 is a critical factor and control must be documented. The food is not an acidified food because the product is not acidified to a final equilibrium pH of 4.6 or less.

Although this guide is primarily limited to low-acid foods in hermetically sealed containers, some information is provided on administrative procedures for acidified foods, as they are similar to those for LACF. The Process Authority, Process Deviation and Better Process Control School sections apply only to LACF, as the regulations for acidified food are substantially different. A separate 'Guide to Inspection of' is planned for acidified foods.

For purposes of identification the following information on acidified products is provided:

Acidified foods are defined as "low-acid foods to which acid(s) or acid food(s) are added; these foods include, but are not limited to, beans, cucumbers, cabbage, artichokes, cauliflower, puddings, peppers, tropical fruits, and fish, singly or in any combination. they have a water activity (a_w) greater than 0.85 and have a finished equilibrium of pH of 4.6 or below. These foods may be called, or may purport to be "pickles" or "pickled". Carbonated beverages, jams, jellies, preserves, acid foods (including such foods as standardized and nonstandardized food dressings and condiment sauces) that contain small amounts of low-acid food(s) and have a resultant finished equilibrium pH that does not significantly differ from that of the predominant acid or acid food, and foods that are stored, distributed, and retailed under refrigeration are excluded".

INSPECTIONAL AUTHORITY

FDA's authority to inspect thermally processed and acidified low-acid canned foods is obtained from section 704 of the Food Drug and Cosmetic Act. This section of the Act requires that credentials and a written Notice of Inspection (FDA 482) be presented to the owner, operator or agent in charge of the firm before the inspection begins.

Additional authority to obtain records and information in thermally processed and acidified food plants is as follows:

Written Demand for Records (FDA 482a) (Attached as Form #1)

21 CFR 113 and 21 CFR 114 requires commercial processors of LACF and acidified foods to maintain complete records of processing, production and initial distribution of these food products. 21 CFR 108.35(h) and 21 CFR 108.25(g) provide that a commercial processor shall permit the inspection and copying of these records by duly authorized employees of the FDA. The Demand for Records must identify the specific records requested and must be signed by you.

To obtain the processing records that are to be reviewed and/or copied, list the records on the FDA 482a as accurately as you can, e.g. "All thermal process and production records mandated by 21 CFR 113 (or 114) for the foods (state name of food) processed at this plant on (specific date or period of time)". If only a specific record, or records are desired they should be requested specifically, e.g. Retort operators thermal processing log for retort #2 for the period of June 22 through June 28, 1992, or e.g. Fill weight records for green beans, 16 oz size can, filling machine #3 for the period of June 22