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INTRO. & HISTORY Pg 1

DEFINITIONS Pg 2

IS IT AN ACIDIFIED FOOD? Pg 3

ACIDIFIED FOODS - CGMP Pg 5

Personnel , Schooling Pg 5

Processes and Controls Pg 5

Oper. of Thermal Process. Equip. Pg 6

Process Control Pg 7

Acidification Procedures Pg 8

Container Closures Pg 9

Coding Pg 10

Establish. Scheduled Processes Pg 10

Deviations from Sched. Process. Pg 11

Methodology Pg 11

Sample Prep. Pg 12

Measurement of pH Pg 12

Standardization of pH Meters Pg 13

Records Pg 14

EMERGENCY PERMIT CONTROL Pg 15

Introduction Pg 15

[see IOM LACF Guide, Part 1]

Reporting to FDA Pg 15

Recall Procedures Pg 15

Schools for Supervisors Pg 15

Records Retention, Inspect., Copying Pg 16

USDA Products Pg 16

State Regulations Pg 16

Imports Pg 16

Confidential Information Pg 16

SPOILAGE OF ACIDIFIED FOODS Pg 16

EX. INSPECTIONAL APPROACH Pg 17

Acidified foods were covered in the GMP regulations published on January 24, 1973 (FR Vol. 38, No. 16) for thermally processed low-acid foods packaged in hermetically sealed containers, but only in a short paragraph. This short paragraph only covered acidified foods, which were thermally processed.

In 1973, there were seven cases of botulism food poisoning in West Virginia after consumption of peppers that had been improperly acidified. There was also one case in Canada after consumption of marinated mushrooms packed in the United States, which were improperly acidified. In 1973 and 1974, FDA found inadequately acidified pimentos and hearts of palm processed by 29 firms in other countries. No illnesses were ever documented.

In 1976, eight persons were diagnosed as having botulism food poisoning. Sweet cherry peppers were implicated epidemiologically. This evidence demonstrated that certain manufacturers of acidified foods did not realize the importance of adequate pH control and that a separate, more detailed GMP regulation was needed. Proposed regulations covering pickled, fermented, and acidified food were published in the Federal Register on July 23, 1976 in response to a petition filed by the Pickled Packers International. After review of comments received and available data, fermented and refrigerated foods were excluded from the regulations. The final regulations (GMP and emergency permit control) covering acidified foods (the term pickled was dropped because it can refer to acidified or fermented products) were published on March 16,1979 (FR, Vol. 44, No. 53).

The GMP regulations are referred to as 21 CFR 114 and the emergency permit control regulations, in Subpart B of 21 CFR 108, are referred to as 21 CFR 108.25 . Subpart A, 21 CFR 108.3 to 21 CFR 108.19 contains the procedural administrative sections of the emergency permit control regulations and are discussed in the Guide to Inspection of Low-Acid Canned Food Manufacturers, Part 1.

Acidified foods rely almost entirely on reduced pH for preservation. The heat treatment given to acidified foods is primarily for the purpose of destroying the vegetative cells of microorganisms of public health significance and those of non-health significance capable of reproducing in the food under the conditions in which the food is stored, distributed, retailed or held by the user. Usually these treatments are applied at temperatures of 212 ^oF [100 ^oC] or less. These heat treatments are not sufficient to destroy heat resistant spore forming microorganisms, which are prevented from germinating and growing by the reduced pH.

This document is intended to serve as a resource for FDA Investigators. It was written by the Office of Regulatory Affairs (ORA) and the Center for Food Safety and Applied Nutrition (CFSAN). If you discover errors in printing or have any comments relative to this guide, please contact Jody Robinson, Division of Emergency and Investigational Operations (DEIO), at (301) 827-5653.

Or send via e-mail to jrobinson@ora.fda.gov.

Acid Foods - are foods that have a natural pH of

4.6 or below.

"Natural pH" means the pH prior to processing. However, if a processor receives an acid food (including fermented foods with a pH of 4.6 or below) and during processing allows the pH to rise above 4.6 (through washing, lye peeling, etc.) and then adds an acid or acid food to reduce the pH to 4.6 or below, that product would be considered an acidified food.

Acidified foods - are low-acid foods to which acid(s)or acid food(s) are added and which have a water activity (aw) greater than 0.85 and a finished equilibrium 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 non-standardized food dressings and condiment sauces) that contain small amounts of low-acid food(s) and have a resultant finished quilibrium 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 from the coverage of this regulation.

Lot- means the product produced during a period indicated by a specific code.

Low-acid foods - means any foods, other than alcoholic beverages, with a finished equilibrium pH greater than 4.6 and a water activity (aw) greater than 0.85.

Tomatoes and tomato products having a finished equilibrium pH less than 4.7 are not classed as low-acid foods.

Scheduled process - means the process selected by a processor as adequate for use under the conditions of manufacture for a food in achieving and maintaining a food that will not permit the growth of microorganisms having public health significance. It includes control of pH and other critical factors equivalent to the process established by a competent processing authority. The process, which is filed on Form FDA 2541a, is considered to be the scheduled process. Only those critical factors, as established by a qualified person, which are necessary to achieve and maintain a safe product, including maximum equilibrium pH, are required to be filed with FDA. All critical factors listed on the process filing form shall be controlled and records of the results of tests or determinations shall be kept.

Water activity (aw) - is a measure of the free moisture in a product and is the quotient of the water vapor pressure of the substance divided by the vapor pressure of pure water at the same temperature. In simpler terms, it is a measure of relative humidity.

Where acid is added to large particles (e.g., whole peppers), equilibrium might not be reached for several hours or several days. If this is the case, the product may need to be refrigerated until a pH of 4.6 is reached. The anticipated equilibrium pH can be determined immediately after processing by blending the entire contents of the finished product container and taking the pH or blending the solid particles and acid brine in the proportion present in the finished product and taking the pH.

Fermented foods - are low-acid foods subjected to the action of certain microorganisms, which produce acid during their growth and reduce the pH of the food to 4.6 or below. In the 1976 proposed regulation, fermented foods were defined as foods that have been prepared from low-acid ingredients and fermented to an equilibrium pH value of 4.6 or lower. They may be partially desalted, processed, or preserved in the original salt brine or in a new salt brine or in a vinegar solution with other ingredients. Foods partially fermented requiring addition of acid to reduce the pH to 4.6 or less are considered acidified foods.

It is often useful to state what is not an acidified food when defining acidified foods. The regulation does this, in part, in §114.3(b).

Acid foods - Those foods such as most tomatoes and many fruits, which have a natural pH of 4.6 or less even if acid, is added during processing.

Repacked Acidified or Fermented Foods -

Previously acidified or fermented foods, which are usually received in bulk, and which are then repacked into retail size containers, generally with the addition of a fresh acid brine, are not acidified foods as long as the repacker does nothing, such as washing, to raise the pH above 4.6 prior to packing. If there is a washing step to remove the old brine, or any other similar processing step, determine the pH of the product prior to the addition of the fresh acid brine.

Fermented foods - Foods such as some kinds of cucumber pickles, most green olives and sauerkraut are not acidified foods because pH reduction is not accomplished by the addition of acids or acid foods.

Carbonated beverages - The products excluded from these regulations are those beverages which until 1989 were covered by a standard of identity (21 CFR 165) for Soda Water. They were excluded because of their low pH and the fact that CO2 is somewhat bacteriostatic.

Jams, Jellies, Preserves - The products excluded from these regulations are only those covered by the standard of identity (21 CFR 150). This is because the water activity is low (because of the minimum brix) and the pH is low since they are all made from acid fruits. Any non-standardized products labeled using these terms must conform to certain product attributes set forth in the standard such as, but not limited to, brix, consistency, acidity and fruit/sugar ratio in order to be exempt (refer to CPG 550.475).

Refrigerated foods - Products which rely, in part, on refrigeration for preservation and are stored, distributed and retailed under refrigeration are not covered by these regulations even if they are low- acid foods which are acidified.

In order to qualify for this exclusion, the product must be refrigerated after processing and the label must prominently bear the statement "Must Be Kept Refrigerated To Maintain Safety" (refer to FR Vol. 62, No. 36, February 24, 1997 Guidance on Labeling of Foods That Need Refrigeration by Consumers.

Water Activity 0.85 or less - Any food, which always has a water activity of 0.85, or less is excluded from coverage under these regulations.

This exclusion applies to acid foods (finished equilibrium pH of 4.6 or below) where the addition of small amounts of low-acid food(s) results in a finished equilibrium pH that does not significantly differ from that of the predominant acid or acid food. These products are referred to as "formulated acid foods."

This category of foods covers a multitude of products including sauces, dressings, fillings, toppings, etc. [Note: that in the definition of acidified foods, this category of excluded foods contains the terms "small amount", "significantly differ" and "predominant acid or acid food."] These terms are not definitive and are therefore subject to interpretation. It is therefore difficult to address this issue in a manner, which applies to all products because of the diversity of products. Basically, it must be determined whether the acid(s) or acid food(s) are acidifying the low-acid ingredients(s) or whether the addition of the low- acid ingredients(s) significantly raises the pH of the acid(s) or acid food(s). When does the finished equilibrium pH significantly differ from the pH of the acid or acid food? This will depend on the closeness of the finished equilibrium pH to 4.6 and possibly other factors. For example:

This might be a significant difference:

Finished product pH = 4.5

Acid ingredients pH = 4.4

This might not be a significant difference:

Finished product pH = 3.8

Acid ingredients pH = 3.4

Predominant acid or acid food- may be an ingredient, which either by quantity, amount of acidity contributed or its characterizing attributes is providing certain characteristics to the product. For example, in a product like salsa, tomatoes characterize the food by odor, and taste, and may be predominant by weight. Jalapeno Peppers (which are received acidified) characterize the product by taste even though the quantity may be small. The vinegar or other acids will be predominant by the amount of acidity provided. As noted below, all acid ingredients are considered to be predominate for the purpose of determining if a product is an acidified food.

It is the processor's responsibility to determine the status of his or her products under these regulations. A processor should first request the assistance of an expert on acidified foods. Such assistance may be available at a university that has a food science extension service. In some cases, the processor may desire an opinion in writing from the FDA as to the status of their products.

The following list delineates the information

needed about each product to determine whether

they are acidified or acid foods:

1. Quantitative formula.

t Express ingredients in same units of measure (e.g. oz., lbs., fluid oz., liter, kilograms, ect.) or use percent of total formula.

2. Designate which ingredients are acid and low acid.

t By pH preferably or describe, e.g., fresh, dried, previously frozen or canned.

t pH of each ingredient will be most helpful - range of pH values where appropriate

t Describe ingredients - particle size, dry

3. Describe processing steps including times (e.g., how long in the acid brine) and temperatures (i.e., time of heat treatment, hot-fill temperature and hold time), acidification method (i.e., batch, direct) and type of finished product container.

4. pH of the acid ingredients combined in the proportion in which they appear in the formula.

5. pH of the finished product (after addition of the low-acid ingredients to the acid ingredients and all processing and packing has been completed).

t At least 6 units of a code lot or batch and relate to ingredient pH values.

t Should have several batches or days production to get a feel for normal variation.

If a processor or his adviser/consultant determines that a product is not covered by the regulations as an acidified food, he should have this kind of information available as evidence to document that the product is not an acidified food.

If a processor states that a product(s) is not acidified, but the investigator believes it is, ask them to provide the information as stated above to document their conclusion. If they do not provide this information, the investigator must obtain as much of this information as possible and submit it to CFSAN (HFS-607) for review and evaluation. Only after a determination has been made that a product is an acidified food should the firm be cited for violations of the Acidified Food regulations.

Any questions about the status of a food under the regulations should be directed to the Center for Food Safety and Applied Nutrition, Division of

Enforcement, HFS-607, 200 C Street, S.W., Washington, DC 20204.

Processors of formulated acid foods (those multi-ingredient products determined to have been excluded from Part 114, i.e., not acidified foods) are responsible for assuring that the food products that they manufacture are safe. This means that they should employ manufacturing procedures, which will insure that their products are at a pH of 4.6 or lower.

The criteria in §114.10, §114.80, §114.83, §114.89, and §114.100, as well as the criteria in Part 110, apply in determining whether an article of acidified food is adulterated.

All operators of processing and packaging systems must be under the operating supervision of a person who has attended a specialized school. Supervisors who have satisfactorily completed the required portions of the courses presented under §108.35 and Part 113 before March 16, 1979, will be considered to be in compliance.

The required training may be obtained from either an approved Better Process Control School or an approved Acidified Food GMP School.

Investigators inspecting foreign plants should recognize that there is only a small probability a foreign firm s supervisors of processing and packaging operations will have attended and completed an approved school. Therefore, you should attempt to ascertain and document the extent and nature of training, the supervisors have received in acidified food preservation and processing operations. The most important aspect, however, is how they do their job and their knowledge of processing requirements.

An operating supervisor is one who is routinely on duty during processing and packing. The person should be present or reasonably accessible on premises during processing, packing operations and container closing.

Many of the requirements in this section are very general in nature and speak to the desired result of the requirement and not how it should be achieved. It is therefore necessary to obtain appropriate evidence to document that the requirements are not being met. When an investigator believes that a deviation of a requirement exists, they should delineate on the FDA 483, and fully explain in the Establishment Inspection Report, exactly what the firm was or was not doing to make the item a legitimate FDA 483 observation.

114.80 (a) A manufacturer must employ appropriate quality control procedures to ensure a safe finished product. An example of a situation where this would be a legitimate observation is where evidence from a firm s records or FDA analyses shows a wide range of pH values in the finished product with the highest value close to 4.6. This situation should of course be investigated further to determine the cause of the wide range of pH values. For example, the firm may not be controlling solid to liquid (brine) ratio; the firm may have variation in the pH of the brine; there may be a wide range of pH values of the raw low acid ingredients or the acid ingredients.

114.80 (a)(1) A manufacturer must manufacture, process and pack acidified foods so that a finished equilibrium pH value of 4.6 or below is achieved and maintained in all finished foods.

The achievement of a pH of 4.6 or below may be dependent on the control of numerous factors as will be discussed later. The maintenance of a pH of 4.6 or below is equally important. Maintaining a pH of 4.6 or below means that the pH will never rise above 4.6 prior to consumption. Several factors may affect the maintenance of an adequate pH.

For example: insufficient heat treatment which does not destroy all vegetative cells of microorganisms and eventually manifest itself in spoiled product or swollen cans (or lids on jars). Yeast and mold, which can grow in an acid environment, could be evidence of inadequate heat treatment and some bacteria will also grow in an acid environment and often raise the pH because the acid is a nutrient they utilize during growth. Another example is improper container closure resulting in contamination with microorganisms. However, the lack of control of container integrity by itself is not always sufficient evidence to document that pH will not be maintained.

Manufacturing must be in accordance with the scheduled process. As stated in the definition, the scheduled process includes pH control as well as control of other critical factors which will achieve and maintain a food that will not permit the growth of microorganisms having public health significance. A processor is required to file their scheduled process (21 CFR108.25(c)(2)). Therefore any critical factors filed with FDA must be controlled.

A manufacturer must thermally process acidified foods to an extent necessary to destroy vegetative cells of microorganisms of public health significance and those of non-health significance capable of reproducing in the food under the conditions in which the food is stored, distributed, retailed and held by the user. Permitted preservatives may be used to inhibit the reproduction of microorganisms of non-health significance (in lieu of thermal processing).

It is important to keep in mind that a thermal process may be necessary to destroy vegetative cells of microorganisms of non-health significance, which could grow and raise the pH to a level where microorganisms of public health significance would grow. In this case, the thermal process could be considered a critical factor. However, without knowing that those microorganisms are present, we cannot at this time insist that a thermal process is always a critical factor. As stated above, preservatives may be used in lieu of a thermal process, but they can only be used to inhibit the growth of microorganisms of non-health significance (i.e., molds and yeast).

The failure to destroy microorganisms of non-health significance (spoilage microorganisms) with a heat treatment can also lead to product spoilage and subsequently product adulteration. There is also a concern that pathogens such as E. coli 0157:H7 and yersinia may be able to survive in acid mediums with pH values below 4.6 for extended periods of time. This fact should be considered by the processor when choosing a scheduled process.

If the thermal process, as established by a qualified person, is not required to ensure public health protection, it need not be filed with FDA (see scheduled process definition).

Although not specifically required by these regulations (it is a requirement of the low-acid canned food regulations), if a thermal process is necessary for public health protection a mercury- in-glass thermometer (or equally accurate and reliable temperature measuring device) should be used as the reference instrument for indicating the processing temperature.

There may be situations where a mercury-in-glass thermometer is not practical or is unsafe to use, such as measuring the temperature of a solid particle or temperature measurements in a kettle. In these cases, a calibrated, accurate dial or digital thermometer, thermocouple, RTD or other equally accurate and reliable temperature measuring device may be used.

Appropriate temperature recording devices should also be used to document thermal process delivery and should be calibrated or compared to the temperature indicating device.

The specific thermal processing procedure for each food product in each size and type of container should be carefully detailed, and made readily available to the supervisor in charge of the operation of the thermal processing equipment, provided the thermal process is indicated as a critical factor. It should be the supervisor s responsibility to insure that each item receives the appropriate heat treatment and this should be completely documented in the records. The thermal process equipment should be in good operating condition, the food should be properly packed, sealed, and at the correct temperature upon entering the equipment, and the correct temperatures should be achieved during the thermal process.

Check thermal processing equipment for:

1. Incoming steam line controls.

(a) Are pressure gauges functional?

2. Conveying belt speed.

3. Steam line controls for individual zones.

4. Cooling sections.

5. Curtains between zones.

6. Jars should be evenly distributed across full width of pasteurizer belt to insure best quality as related to cook time.

7.Determine how often the temperature distribution is checked.

114.80 (a)(2) A manufacturer must control the processing of acidified foods by frequent testing to ensure that the finished equilibrium pH of each container is no higher than 4.6.

In most cases, the control of acidification should be monitored by measurements on both in-process samples and finished product. Proper control of such things as formulation, fill-in weight, solid to liquid ratio, etc., may be considered adequate to control acidification, in lieu of in-process pH control, if sufficient written documentation is available to warrant such consideration.

Formulation control would have to include consideration of such things as raw material pH variability, buffering capacity of raw materials and other variables, which could affect the pH of the finished product. In-process controls may also be considered adequate in lieu of extensive finished product testing if there is adequate written documentation that such control will ensure control of the finished equilibrium pH of all containers of product. In most cases, some finished product testing must be conducted since finished equilibrium pH is always a critical factor. One exception might be where a product is being packed in oil and the acidification takes place (as it should) prior to adding the oil. The pH of the food prior to adding the oil is the important factor since the oil will not affect the pH.

In situations where products such as garlic, spices, herbs or other naturally low-acid foods are packed in oil or the finished product is an oil emulsion, such as some sauces and dressings, assurance of proper pH control should be determined prior to adding the oil. In some cases, pH testing at this point might be considered as equivalent to finished product testing as long as subsequent operations will not affect the pH. This is because of the difficulty of separating the oil phase from the water phase of the finished product to get the pH of the water phase of the product. These procedures could result in erroneous pH values, which do not accurately reflect the actual pH of the water phase of the product.

A determination as to whether this is appropriate will be made on a case-by-case basis by the Center. When this situation occurs, obtain all the pertinent information about the processing procedures, sequence of processing steps, controls utilized at each step, and pH data and submit to the CFSAN (HFS-607) for review.

The frequency of testing needed to ensure adequate pH control will depend on such things as the method of acidification, product characteristics (such as raw product pH variability), and control of other factors during processing. Processing procedures may dictate the frequency of in process or finished product testing. For example, subjecting ingredients to high pH materials such as lye during lye peeling may affect the pH of an acid ingredient, which if not monitored could result in inadequate acidification.

Measurements of acidity may be made by potentiometric methods (pH meter), titratable acidity or colorimetric methods (litmus or pH paper) depending on the finished equilibrium pH. If the finished equilibrium pH of a food is above 4.0, the measurement of the finished equilibrium pH must be made by a potentiometric method and the in-process measurements by titration or colorimetry must be related to the finished equilibrium pH. If the finished equilibrium pH is 4.0 or below, any suitable method of measuring acidity may be used for determining both finished product and in-process pH levels.

114.80 (a)(3) Procedures for acidification.

Heating products before they are put into containers is often useful. Heating and acidification can be combined by blanching in a hot acid solution. If the blanch solution is the only source of acid in the final product, blanching times and temperatures must be established so the intended maximum equilibrium pH is not exceeded. If this technique is used for acidification, and the target equilibrium pH is close to 4.6, the product should be held until the equilibrium pH is at least below 4.6 before being placed into individual containers.

This is a variation of blanching of a low-acid food in an acidified solution. Blanching can make it easier for the acid to penetrate tissues, but it is sometimes more convenient to blanch in steam or water than in an acid bath. In that situation, the blanching can be done first and then the product immediately transferred to the acid solution. Again, if this technique is used for acidification and the target equilibrium pH is close to 4.6, the product should be held until the equilibrium pH is at least below 4.6 before being placed into individual containers. Although immersion of food in an acid solution is a satisfactory method for acidification, care must be taken to ensure that the acid concentration is properly maintained because over time as the food absorbs the acid the low-acid product will dilute the acid in the solution.

This can be achieved by adding a known amount of an acid solution to specified amount of food during acidification. If an acidified food with a finished equilibrium pH of 4.0 or above is to be packed, all ingredients should be at or below 4.6 prior to packing into containers and the equilibrium pH of the product checked prior to packing.

This is probably the most common method used for acidified vegetables. Jars are filled with product and a liquid packing media from a brining machine. The packing media contains all the acid required to lower the finished equilibrium pH of the product, including all ingredients, to 4.6 or below. Sometimes individual containers are acidified with a pellet or tablet containing citric acid. When this is done, it is essential that the acid be completely dissolved in the container. In addition, proper storage of the pellets is important to ensure that the acid strength is not depleted. Pellets should be tested to be sure they are of the proper acid strength. Liquid acids are generally more effective than solid or pelleted acids because the acid is already in solution.

There is one important caution concerning acidification in individual containers. Care should be taken to ensure that the proper amount of acid is added to each container. In addition to the variability that will occur in raw products and other ingredients in a formulation, additional container-to-container variation will occur due to variations in the proportion of solids to liquid in individual containers, or due to variations in the amount of solid product added to each container, as well as small variations in the volume of individual containers (especially jars). The equipment used to dispense tablets or liquid acids must be well maintained and must function in a manner that insures that each container will receive the acid tablet or liquid acid component.

During inspections of manufacturers using this type of equipment, the operation of the equipment should be observed to determine that it is functioning as designed. With all of these unavoidable sources of variation, it is possible that an occasional container could have a finished equilibrium pH greater than 4.6 in those cases where the target maximum pH is between 4.0 and 4.6. Therefore, control of such things as solid-to- liquid ratio, raw product pH, brine pH, acidity of pellets, etc. becomes very important and may in some cases be considered to be critical factors.

This method of acidification is used when acid foods, such as tomato products, with pH values less than 4.6 are added to low-acid foods. The product formulation should be developed to assure that the finished equilibrium pH is 4.6 or below.

When using this method of acidification, it is important to maintain control of the proportion of high-acid and low-acid ingredients in each container so that the finished equilibrium pH is 4.6 or below. Alternatively, the ingredients can be mixed in batches and allowed to equilibrate prior to filling the containers. The firm should have a written quantitative formula, which relates to the process establishment document so that any changes to the formula are well documented and can be related to a process source document. In addition, raw product specifications may be of importance.

For example, if the firm uses as an ingredient, an acidified food from another packer, they should have some means to ensure that the pH of that raw material is within the range upon which the process is based. There may also be occasions where a firm uses an acidified ingredient sometimes and a fresh un-acidified ingredient at other times. In this case, there should be appropriate allowances in the formulation as well in the process source document to take into consideration the pH differences between the fresh and previously acidified product. In most cases, the firm would be wise to file two process- filing forms since the critical control factors and the amount of acid added will probably be different.

114.80 (a)(4) Container closures must be examined and tested often enough to ensure container integrity.

The tests and examinations considered by FDA to be adequate will vary with container type but will be similar to those procedures delineated in 21 CFR 113 for low-acid canned foods. For example, 21 CFR 113 requires visual and can seam teardown examinations for metal containers, and measurement of cold water vacuum for glass containers with vacuum closures. For other containers, appropriate, detailed inspections and tests should be conducted. The container supplier should be contacted by the firm to obtain information on the appropriate inspection and testing procedures needed to ensure container integrity.

For glass containers, lids should be designed to make adequate closure with the particular finish of the glass jar being used (the finish is the very top of the jar). The lid should be adequately applied (by screwing, torquing, etc.) to the jar finish as recommended by the closure manufacturer. An applied lid should be seated well down on the finish and parallel to the transfer bead at the bottom of the finish. Removal of the lid should show an even furrow or impression in the gasket sealing compound around the periphery of the lid created by intimate contact between the lid and the finish.

Jars of finished product should have adequate vacuum to prevent entry of microorganisms, help to hold the lid on the container and maintain a tight seal. Presence of a vacuum will usually be noticeable by the concave appearance of the lid. If a steam flow capper is used, a cold water vacuum test should be performed to test the ability of the capper to form a vacuum. The cold water vacuum test is not required by these regulations but is required for LACF. Visual exams should note any container defects such as chips or cracks in the jars, especially in the finish area where the lid contacts the jar. Over or under application of the lid, tilted caps and any sign of leakage would be evidence that container integrity has been compromised.

Records of all testing should be maintained [Note: the regulations do not require the maintenance of records of container closure tests, however, without them it is not possible to determine whether a firm is in fact making the appropriate examinations]. If the firm is not keeping records of closure exams, report if they have the equipment to do so and whether they conducted the tests during the inspection. Explain to the firm that without records it is not possible to determine compliance with this requirement.

The tests necessary and the frequency for containers not covered in Part 113 should be those recommended by the container supplier. A copy of these recommendations should be obtained if available. This requirement will be considered to be in compliance as long as a processor is conducting appropriate tests for the container. Evidence of leakage contamination related to seam/container defects or inadequate closures will have to be obtained before this requirement will be considered to be out of compliance.

114.80 (b) Coding

A manufacturer must mark each container with a permanently visible code delineating the processing establishment, the product, year, day and packing period. The codes should be embossed or inked whenever possible; otherwise the labels may be legibly perforated or otherwise marked as long as the label is securely fixed to the container. The packing period code must be changed often enough to enable ready identification of lots during their sale and distribution. Changes may be made at intervals of 4-5 hours, personnel shift changes or batches as long as the containers constituting a batch do not represent those processed during more than one personnel shift.

Scheduled processes must be established by a qualified person having expert knowledge acquired through appropriate training and experience in the acidification and processing of acidified foods.

The "qualified person" referred to is not necessarily limited to so-called processing authorities such as some container and equipment suppliers or some industry associations. A published paper or written document prepared by experts in acidified food processing may be a sufficient basis for a scheduled process. However, these documents may speak to the control of processing parameters which may not necessarily be essential to ensuring public health safety but which would have to be filed with FDA since they are listed in the document.

The investigator should check the process source carefully and be sure all processing parameters discussed are filed with FDA and controlled. If it appears that the process source delineates factors, which may not be critical, suggest that they have the scheduled process reviewed by a qualified person and obtain a process which delineates only those critical factors necessary to ensure public health safety. If it appears that there may be critical factors, which are not delineated by the process source and are not filed, request review by the Center before informing the firm. If the firm has listed themselves as the process source, determine the basis on which the process was developed, such as a published document, training, experience or education.

If published or written documents were used as the basis for developing the process, such documents should be listed as the process source and copies of the documents must be kept at the firm. Any modifications to a process listed in a document or publication should be substantiated by a qualified person and that person should be listed as the process source. The letter or document from the process source should list the critical factors and limits. If the thermal process is not listed as a critical factor and it has not been filed and the investigator has reason to believe that it is critical, attempt to determine the basis for that determination.

Any product involved in a deviation from the scheduled process, including equilibrium pH values of the finished product above 4.6 must be set aside and evaluated by a competent processing authority, fully reprocessed by a process established by a competent processing authority as adequate to ensure a safe product, thermally processed as a low-acid food under 21 CFR 113 [or destroyed]. The "destroy" option does not appear in this part of this section of the regulations- it appears in the part describing the firm's options after evaluation.

However, the firm can decide to destroy the lot rather than choosing the above three options.

A deviation below the filed thermal process may not represent a potential danger to public health if the finished equilibrium pH is 4.6 or below. However, if the thermal process is filed as a critical factor, a deviation below that process must still be evaluated. This is why it is important for the processor to check the process source to be sure that the critical factors delineated are only those which are necessary to inhibit the growth of microorganisms of public health significance. If the process deviation is set aside for evaluation by a competent processing authority and the evaluation demonstrates that the food has not undergone a process, which would make it safe, it must either be reprocessed or destroyed. A record must be made of the evaluation procedures and the results.

If the processor decides to reprocess a lot where pH has been improperly controlled, the reprocessing (re-acidifying) should be done immediately or the product should have been refrigerated until reprocessing occurred. The same applies if there is any other deviation from the filed process. If the product is set aside for evaluation by a competent processing authority, precautions, such as refrigeration, should have been taken to prevent microbial growth.

A pH of greater than 4.6 even in only a single container constitutes a process deviation. If a processor has selected a maximum pH below 4.6 for process control purposes (target pH) even though they have filed a maximum pH of 4.6, and that target pH is exceeded and is close to but not greater than 4.6, it would be prudent for them to conduct additional testing to be sure that no container has a pH greater than 4.6 and investigate the cause of the high pH values. This situation is not a process deviation but if it occurs, additional records should be reviewed to determine if other similar situations occurred. This kind of situation would be a good reason to collect samples of the suspect lot for pH determination. In some cases the manufacturer may file a scheduled process with a pH below 4.6 (e.g. a filed scheduled process of 4.4). If the pH of the product exceeds the pH of the filed process but not pH 4.6, this would be a process deviation. This process deviation must be handled in the manner explained above. In some cases the process authority or process documentation may state a pH lower than 4.6 as a critical factor.

This section deals with the methods, equipment and procedures that may be used to measure pH or acidity. These are not the only methods, which may be used. The AOAC official method is found in the 16th Edition, Chapter 42, section 1.04. [Note that there is considerable emphasis placed on the proper maintenance of the equipment and sample preparation.] Erroneous results due to faulty equipment are essentially the same as no control of acidification. In order to determine if pH is controlled to meet the scheduled process, pH meters should be standardized often against known buffer solutions with sufficient frequency to ensure proper control.

[Note: Standardization is not required by the regulations but if the pH meter is not standardized properly and frequently, the firm cannot determine if pH is properly controlled.]

The frequency of standardization that is necessary will depend on such things as the frequency and number of samples tested, and the type of product. For example, if they are conducting tests at specific times throughout the day with a space of time between testing, the pH meter should be standardized prior to each testing period. If they are conducting tests every few minutes, it may be appropriate to standardize on a half-hour basis or less. The type of product will also dictate the frequency of standardization. A product containing oil or other substances can foul electrodes, and standardization should be conducted on a more frequent basis, possibly every third or fourth sample. (See section on standardization of pH meters).

The pH is defined as the negative logarithm of the hydrogen ion concentration. The lower the pH the higher the hydrogen ion concentration. pH is a measure of the free hydrogen ions in solution.

There are a variety of pH meters, from small hand held units to complex bench-top units. pH meters have either an analog (dial with points) or digital readout. pH meters all function in a similar manner and require special care and attention to assure proper functioning. In general, the manufacturer s instructions should be followed for maintenance, storage and use.

The reference electrode contains a specially prepared metal wire immersed in a concentrated solution of potassium chloride. There is a porous ceramic or fiber junction which looks like a rough spot on the side of the combination electrode.

This junction must be immersed in the sample and not clogged so a very slow flow of potassium chloride solution goes into the sample. This establishes an electrical contact between the reference electrode and the sample.

The sensing electrode is completely sealed. At its tip there is a glass bulb with a thin membrane. When it is put in a water solution, it builds up an electrical potential on its surface that is proportional to the concentration of hydrogen ions in solutions. If the glass membrane is scratched or damaged, the electrode is ruined and must be replaced.

pH paper may however be used as a tool during inspections to make quick checks on acid ingredients, blended ingredients, and finished products. The results of these test may need to be confirmed by sample collection and laboratory testing of samples with a pH meter. A narrow range pH paper (e.g. pH 2.8 - 4.6) should be used to provide the best results.

It is necessary to standardize a pH meter to get an accurate pH measurement. The directions for standardization and storage supplied by the manufacturer of the equipment should be followed.

A pH meter should be standardized at least once a day. The pH of pH 4.0 standard buffer can be checked as often as necessary to ensure accurate readings. If the pH measurement on the standard buffer deviates significantly from pH 4.0, the meter should be re-standardized. When samples contain oil or grease, which can coat the electrodes, standardization should be done every two or three samples. In a situation where the objective is to have a target equilibrated pH near the critical pH of 4.6 the pH meter should be standardized after each sample.

Standardization is normally done for acidified foods with pH 7.0 and pH 4.0 buffers. This gives an accurate reading within the pH region of interest, pH 4.6. If desired, the pH of a 9.18 standard buffer may then be measured. If the electrodes and pH meter are working properly, the pH reading on the pH 9.18 buffer should be between pH 8.88 and pH 9.48. The electrodes and meter should be checked out according to the manufacturer s instructions if the pH reading is outside this range.

Due to the effect of temperature on pH the temperature of the standard buffer solutions should be the same as the temperature of the samples that are to be measured. If a magnetic stirrer or other type of stirring device is used to mix samples while pH measurements are done, the standard buffers should be stirred in the same way during standardization. A backup electrode and sufficient standard buffers should always be available. The EIR should report the model of the pH meter (include a copy of the manual if possible) and the method of calibration, the frequency of calibration relative to time intervals, number of samples tested and production quantities between samples.

Records are a necessary ingredient in any good quality control program.

Written Request for Records: Processors must furnish information concerning the adequacy of the Scheduled Process when requested in writing. Use the FDA 482b, Request for Information. Do not routinely request this information. See IOM 530.2 for guidance. In addition, the firm must permit the inspection and copying of processing, acidification and other records, including records of initial distibution required under 21 CFR 114 upon Written Demand. Use the FDA 482a, Demand for Records.

EMERGENCY PERMIT CONTROL

Introduction

These regulations were promulgated under authority of sections 402, 404 and 701 of the Federal, Food, Drug, and Cosmetic Act. Section 404 of the Act states in part:

"Whenever the Secretary finds after investigation that the distribution in interstate commerce of any class of food may, by reason of contamination with microorganisms during manufacture... be injurious to health, and that such injurious nature cannot be adequately determined after such articles have entered interstate commerce he... shall promulgate regulations [21 CFR 108] providing for the issuance... of permits to which shall be attached conditions governing manufacture [21 CFR 113 and 114]...for such temporary period of time, as may be necessary to protect public health..."

The above statement refers only to situations where ... articles have entered interstate commerce... . This means that any firm whose products do not cross state lines does not have to comply with Part 108. There are some states, which require that the intrastate firms producing acidified foods or LACF register and file processes with us. We will accept these forms if submitted but our jurisdiction under Part 108 is limited to those situations where the firm s products move in interstate commerce.

Reporting to FDA

Any instance of spoilage, process deviation, or contamination with microorganisms having potential health-endangering significance must be promptly reported to FDA when any or all of a lot has entered distribution channels.

Recall Procedures

A recall procedure must be prepared and on file at the process establishment. Procedures must include plans for recalling products which may be injurious to health; for identifying, collecting, warehousing, and controlling products; for determining the effectiveness of recalls; for notifying the FDA of any recalls; and for implementing recall programs.

Schools for Supervisors

All plant personnel involved in acidification, pH control, heat treatment, or other critical factors of the operation must be under the operating supervision of a person who has attended and satisfactorily completed the prescribed course of instruction at an approved school. Persons may attend the approved schools, which offer the Better Process Control School curriculum or an approved Acidified Food GMP School.

An operating supervisor is one who is routinely on duty during processing and packing. The person should be present or reasonably accessible on premises during processing, packing operations and container closing.

Records Retention, Inspection, Copying

All records of processing, deviations in processing, pH and other records specified in Part 114 must be kept for 3 years and must be made available for inspection and copying by a duly authorized employee of FDA upon written demand* during the course of an inspection to verify the pH and the adequacy of processing.

* refer to Part 1, LACF Guide, page 2.

USDA Products

This regulation does not apply to foods processed under the continuous inspection of USDA under the Federal Meat Inspection Act and the Poultry Products Inspection Act. Generally these are products with 3 percent or more raw meat or 2 percent or more cooked meat or poultry in the formulation. If the investigator encounters products, which contain meat or poultry and the firm, is not under USDA inspection, report this to the appropriate USDA office. If USDA decides that the product is not under their jurisdiction, then it is FDA s responsibility.

State Regulations

If a State regulates processors of acidified foods under effective regulations specifying at least the requirements of 21 CFR 114, compliance with such regulations will constitute compliance with 21 CFR 108.25, as long as the State or each processor registers and files processing information with FDA for each processing establishment. This does not exempt firms from complying with this regulation nor exempt them from inspection by FDA.

Imports

This section applies to any foreign processor offering acidified foods into the U.S. except that, in lieu of providing for the issuance of an emergency permit, the agency will request the Secretary of the Treasury (U.S. Customs) to refuse admission of such foods into the United States. Any foods refused admission will not be admitted into the U.S. until the agency determines that the processor has complied with the requirements of 21 CFR 108.25 and 114 and that the food is not injurious to health. An inspection of the facility may be necessary before allowing entry of these foods.

Confidential Information

The following information submitted to FDA is not available for public disclosure (with some exceptions - 21 CFR Part 20):

(1) Manufacturing methods or processes, including quality control information.

(2) Production, sales distribution, and similar information.

(3) Quantitative or semiquantitative formula.

SPOILAGE OF ACIDIFIED FOODS

Fresh food should be handled quickly, carefully and kept at low temperatures to prevent the build-up of microorganisms which can spoil the product or affect the efficiency of subsequent processing procedures.

For example, damaged products allow for the entry of microorganisms past their natural barrier (surfaces of fruits and vegetables). High numbers of Microorganisms may affect the adequacy of the thermal process. Plant sanitation is also important. Mold can grow quickly on food contact surfaces if not kept clean. Molds and some bacteria can grow in an acid environment and actually utilize acid as one of their nutrients thus raising the pH to a level above 4.6 where C. Botulinum or other toxin production microorganisms could grow. Microbial spoilage can be detected by observing swollen lids on jars or swollen can ends. The liquid may be turbid and a whitish deposit may be visible on product or in the bottom of the jar. If a product has received a heat treatment, spoilage is often caused by lactic acid bacteria since yeasts are more sensitive to heat. When preservation is dependent on sugar and acid concentrations, yeasts are more commonly the cause of spoilage. Leakage after processing will usually be manifested with mold or filamentous yeasts, which grow on the surface. Exclusion of air in the headspace is therefore very important.

SUMMARY GUIDE TO INSPECTIONS OF ACIDIFIED FOOD MANUFACTURERS

The following information has been complied in an effort to obtain the minimum information necessary to make a valid assessment of a processors operations. EIRs should include but not be limited to all applicable items.

1. Establishment registration and process filing.

a. Determine if the firm has registered with FDA and obtain the firms FCE number.

b. Determine if the firm has filed scheduled processes for each of their acidified foods in each container size produced.

i. If there are questions as to whether a food is an acidified food, an acid food or a formulated acid food. Obtain the information needed, (quantitative formula, pH of ingredients, processing steps etc.) which is needed by CFSAN to determine the status of the food product.

ii. Processors must furnish information concerning the adequacy of the Scheduled Process when requested in Writing. Use form FD-482 b-REQUEST FOR INFORMATION.

2. Recall Procedures

a. Determine if the firm has written recall procedures

b Describe the firms recall procedures

3. Schooling for Supervisors

a. Determine which supervisors have been to a Better Process Control School, or other school approved by FDA for Acidified Foods.

b. Determine the duties of each supervisor who has attended an approved school.

c. In the case of foreign processors where the supervisors have not attended an approved school, determine the type and extent of training provided to the supervisor.

4. Acidification Procedures

a. Describe the method (s) used to acidify the food products.

b. Describe the critical control points in the firm's process

c. Make a flow diagram to explain the firm's process

d. Describe how the firm controls equilibrium pH in the final product container.

e. Describe the firm's method for checking the pH of in- process and final product.

f. If a pH meter is used

i. Is it standardized correctly (as per manufacturer or regulations)?

ii. Is it used correctly to determine the pH of in-process and finished product?

g. Describe the records used to document pH control

5. Thermal Process

a. Determine if the thermal process is a critical part of the established process to destroy microorganisms of public health significance.

b. Describe the thermal process

c. Describe the records used document the thermal process.

d. Determine if the instruments used to measure and control the thermal process are accurate and are routinely checked for accuracy.

e. Determine that pasteurization equipment is operating correctly.

6. Process deviations

a. Determine if the firm has had any process deviations.

b. Describe how process deviations are handled by the firm

7. Containers

a. Are container examinations made as per the container manufacturer specifications and or FDA's regulations part 114.60?

b. Describe the firm's container coding system. Are all the required elements present ?

8. Processing records.

Acidified food manufacturers must permit the inspection and copying of processing, acidification and other records required under 21 CFR 114 upon written demand. This includes records of initial distribution. The FDA 482a DEMAND FOR RECORDS, is used to request the records that are to be reviewed during an inspection.

a. Remember that processing records are not required to be signed or initialed by the operator or reviewed by management.

b. Describe firm's records covering examination of raw materials, containers, processing and finished products.

c. Determine if the firm can identify the initial distribution of the finished food product?

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