documentation on hand at the firm to determine that all critical factors identified by the processing authority have been listed on the filed scheduled process. If the firm is controlling factors other than those listed on the filed scheduled process as critical to the thermal process, or if the investigator finds factors which they believe may be critical to the process, but which are not being controlled as such by the firm, document as completely as possible the actions of the firm for submission to CFSAN for process review.
The regulations state critical factors specified in the scheduled process (factors deemed critical by the processing authority) must be measured and recorded on the processing record at intervals of sufficient frequency to ensure that the factors are within the limits specified in the scheduled process. The regulations suggest critical factors should be measured and recorded at intervals not to exceed 15 minutes [113.40(a)(13), (b)(14), (c)(10), (d)(8), (e)(7), (f)(9), and (g)(4)]. Per 113.100, all 'critical factor' operations must be recorded on processing records.
The control of raw materials used in the production of lacf is essential not only because of quality considerations but also due to the effect that variations in raw materials may have on the safety of the thermal process. Increased microbiological loads, product maturity, product size and other product characteristics can alter the lethality of the thermal process received by the product. In some cases this could lead to a health hazard.
The manufacturer of the lacf should be aware of the characteristics of the raw materials used which may affect the thermal process. Raw material factors which are critical to the thermal process, must be identified by the processing authority and filed as part of the scheduled process with the FDA. Maturity of mushrooms as indicated by the veil condition; shrimp size; and adequate rehydration of dry beans and peas are examples of raw material qualities which can effect the thermal process. Raw materials should be purchased using specifications that will assure the manufacturer that the raw materials are suitable for use in producing lacf's.
A wide variety of thermophilic bacteria, mesophilic bacteria, yeast and molds may be encountered in/on lacf raw materials. The raw materials for lacf must be handled in manner which does not allow these organisms to increase to levels which will challenge the thermal process or cause the food product to spoil under normal conditions of canning and storage. In general there are no microbiological standards by which the suitability of ingredients for use in lacf can be measured, except for the standards set by the NFPA for sugars and syrups. The significance of spoilage agents in sugars and starches has been recognized by the lacf industry for several years. Standards have been developed by the NFPA for total thermophilic spore counts, flat sour spores, thermophilic anaerobic spores and sulfide spoilage spores in sugar. The same criteria can be used for starches. Thermophilic organisms may not be destroyed by the thermal process. These organisms may however be of concern only if the product is subjected to and held at temperatures in the thermophilic growth range (100 -170° F). Thermophilic organisms do not produce toxins during growth and do not affect the safety of the food.
Raw agricultural products should be handled and cleaned to remove excess soil from the surface of the product. All raw materials should be held under conditions which prevent contamination of raw materials, prevent increases in microbiological loads, and which maintain the quality of raw material.
It is the responsibility of the food manufacturer to insure that acceptable lacf raw materials are received and maintained. Upon receipt raw materials should be examined to insure that they meet the specifications and requirements of the filed scheduled process, and other specifications set by the manufacturer. Examination of raw material factors which are critical to the process must be recorded and made part of the daily process records. Water is one of the major raw materials used in the production of lacfs, as well as being used to wash, transport, process and cool lacfs. The water supply should meet the acceptable qualities of potable water and/or be treated to meet those qualities. This may require chlorination of water supplies from sources other than municipal water supplies. Its composition with respect to organic and inorganic impurities affects it use in cleaning, and may also affect the physical characteristics of the food being processed. If the water is too alkaline the product may disintegrate or become mushy. If the water is too hard (contains calcium in excess of 200 ppm) it can harden vegetables such as peas and beans making them difficult to process. The manufacturer is responsible for testing the water supply and assuring that the water supply does not affect the thermal processes used for lacfs.
The investigator should determine the controls that the manufacturer exercises over raw materials including control of the growing practices to prevent undesirable quality and microbiological concerns.