GUIDE TO INSPECTIONS OF LOW ACID CANNED FOOD MANUFACTURERS Part 1-ADMINISTRATIVE PROCEDURES/SCHEDULED PROCESSES TABLE OF CONTENTS Introduction Pg 1

Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers

Pg 1

Inspectional Authority

Pg 2

History of Emergency Permit Control and LACF Regulations

Pg 3

Emergency Permit Control

Pg 5

Establishment Registration

Pg 7

Process Filing Requirements

Pg 8

Process Adherence

Pg 9

Processing Authorities

Pg 9

Inspectional Considerations

Pg 11

Process Deviations

Pg 12

Detection and Correction In-Process

Pg 13

Reprocessing

Pg 13

Isolation of Affected Production

Pg 14

Submissions to Process Authorities

Pg 14

Incomplete Records

Pg 14

Issues Pertaining to Evaluation

Pg 15

Reporting Evaluation Results to The Processor

Pg 15

Better Process School

Pg 16

Forms

Pg 16

INTRODUCTION The Guide to Inspection of Low-Acid Canned Foods consists of three separate documents; Part 1 covers Administrative Procedures\Scheduled Processes; Part 2 covers Manufacturing Procedures; and Part 3 covers Container/Closures (Part 2 and 3 of the manual are still in process, and will issue at a later date). In addition to providing guidance for inspections of low acid canned foods (LACF) manufacturers, the guide also contains background and general information on LACF regulations and procedures. In addition to the information and instructions provided in IOM Subchapter 530, 21CFR 108 and 113, and applicable compliance programs, direct attention to areas covered in this Guide when covering LACF manufacturers. Another good reference is the Food Processors Institute 'Canned Foods' manual, which should be available from anyone in your district who has attended a Better Process Control School. At the current time DFI has available, for loan only, the following NFPA manuals: 1. Thermal Processes For Low-Acid Foods in Metal Containers (NFPA Bulletin 26-L)

2.

Thermal Processes For Low-Acid Foods in Glass Containers (Bulletin 30-L)

3.

Flexible Package Integrity Bulletin (Bulletin 41-L)

4.

Guidelines for Thermal Process Development for Foods Packaged in Flexible Containers

5.

Continuous Rotary Sterilizers-Design and Operation (Bulletin 44-L)

6.

Automatic Control Guidelines For Aseptic System Manufacturers and Companies Using Aseptic Processing and Packaging for Preserving Foods (Bulletin 43L)

THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS 21 CFR 113 Low-acid foods are defined as "any foods, other than alcoholic beverages, with a finished equilibrium pH value greater than 4.6 and a water activity greater than 0.85." The following foods are not considered low-acid foods. Therefore, processors of these foods do not have to register and file processing information for these products: 1. 2. 3. Acid foods (natural or normal pH 4.6 or less) Alcoholic beverages Fermented foods with a final equilibrium pH of 4.6 or less as a result of organic acids produced during controlled bacterial fermentation Foods processed under the continuous inspection of the meat and poultry inspection program of the United States Department of Agriculture under the Federal Meat Inspection Act and the Poultry Products Inspection Act Foods with water activity (aw) of 0.85 or below Foods which are not thermally processed Foods which are not packaged in hermetically sealed containers Foods stored, distributed and retailed under refrigeration

4.

5. 6. 7. 8.

9.

Tomatoes and tomato products having a finished equilibrium pH less than 4.7

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 (aw) 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 21 CFR 108.35(h) and 21 CFR 108.25(g) requires LACF and acidified food processors to prepare, review and retain records of critical factor control; including thermal processing, processing deviations, and container closure inspection for three years (at least 1 year at the actual processing facility and 2 additional years at some reasonably accessible facility). The FDA 482a is normally issued to the same person to whom the FDA-482, "Notice of Inspection" is issued. If this is not possible it should be issued to the next most responsible individual. A copy of the FDA 482a is submitted with the EIR. Written Request for Information (FDA 482b) (Attached as Form #2) 21 CFR 108.35(c)(3)(ii) and 108.25(c)(3)(ii) requires that LACF and acidified food manufacturers shall provide FDA with any information concerning processes and procedures which are deemed necessary by FDA to determine the adequacy of the process. These include records on process establishment, such as heat penetration data, and temperature distribution data upon which the scheduled processes and procedures are based. Many processors will not have this data readily available. In fact, 21 CFR 113.83 requires only that the person or organization establishing the process permanently retain all records covering establishment of the process. The processor should, however, have in his files a letter or other written documentation (e.g. NFPA Bulletin 26L) from a processing authority delineating the recommended scheduled process and associated critical factors. Documentation on hand at the processor should include the establishment of venting procedures for steam retorts and the establishment of operational procedures (e.g. come-up times) for other retort systems.

The FDA 482b is issued to request the firms copies of scheduled processes, supporting documentation from a processing authority (e.g. letter or bulletin) and the documentation which delineates the venting or retort operational procedures. The FDA 482b is not routinely issued to request detailed supporting documentation (e.g. heat penetration or temperature distribution test data) from a processing authority. However, when situations are encountered where you believe control of certain factors are critical to the process, and there is no evidence to document that these factors (e.g. a change in formulation that could effect consistency) were considered by the processing authority or listed on the filed scheduled process; after checking with your supervisor or LACF monitor, contact the Center for Food Safety and Applied Nutrition (CFSAN), Regulatory Food Processing and Technology Branch (HFS-617). If requested by the Center, obtain all available information about the situation, including the name or the person or organization who established the process and the specific practices of the firm and forward this information to CFSAN, Division of Enforcement (HFS-605) for review as soon as possible. If additional process establishment information is required CFSAN may request the information directly from the processor, who may have to obtain the data from the "processing authority", or CFSAN may request the district to obtain the information. When retort design, construction or venting procedures do not match those detailed in 21CFR 113, copies of temperature distribution studies or a letter from a processing authority should also be obtained (also see Processing Authorities and Process Adherence section of this guide for additional information). The FDA 482b "Request for Information" should be prepared by listing the specific information required. Specify each product involved by the food product name and form, container size and processing method (e.g. supporting documentation from a processing authority, or other source, for thermally processed french style green beans in 300 x 303 size cans or, e.g. Supporting documentation from a processing authority, or other source, for your firms 3 basket vertical retort vent schedule of 4 minutes to 220 F). The FDA 482b is normally issued to the same person to whom the FDA 482, "Notice of Inspection" is issued. If this is not possible it should be issued to the next most responsible individual. A copy of the FDA 482b is submitted with the EIR. Note the FDA 482, 482a and 482b are not issued during foreign inspections. HISTORY OF EMERGENCY PERMIT CONTROL AND LACF REGULATIONS Two botulinum episodes occurred during the summer of 1971. The first involved vichyssoise soup, and resulted in one death, and the recall of all 90 products manufactured by the firm. The next episode involved two soup products manufactured at another firm. Botulinum toxin was discovered in a few cans of chicken vegetable soup during a routine check for non-toxic spoilage. This led to the recall of