|
CFSAN/Office of Compliance
June 16, 2006
| List of Reasons for Revisions to this Hazard Guide | |
|---|---|
| DATE | REASON |
| 03/21/2006 | Editorial revisions made in page numbering and minor heading numbering corrections. |
| 06/16/2006 | Title changed from "Dairy Foods HACCP Hazards and Controls Guide" to "Hazards and Controls Guide Dairy Foods HACCP" |
This Hazards and Controls Guide represents the National Conference on Interstate Milk Shipments (NCIMS) perspective on identifying and evaluating potential hazards in milk and milk products and their control. It is designed to assist processors in the development of Hazard Analysis Critical Control Point (HACCP) systems to satisfy the requirements of the NCIMS HACCP alternative to the traditional regulatory system for Grade A dairy products that are regulated by the states under the NCIMS milk safety system. The guide should also be useful to State Regulators who are responsible for the evaluating the completeness of a plants hazard analysis.
This Hazards and Controls Guide provides a framework for answering some of the questions to be considered when conducting a hazard analysis for the processing of milk and milk products.
This guide has been separated into two parts. The first part provides background information that can be useful in understanding the basic food safety concerns and goals to be addressed by the hazard analysis. The second part of the hazard guide is an evaluation of specific potential hazards associated with the processing of milk and milk products. It is also divided into two major sections. The first section identifies many potential food safety hazards associated with ingredients and packaging materials. In the second section, a "unit operations" approach has been used to identify food safety potential hazards which may be associated with processing.
HACCP, as it relates to the NCIMS HACCP alternative, is a food safety system whose design is based on practical experience and the scientific understanding of the potential hazards associated with various types of milk and milk products. References to the available scientific literature can be found throughout this document. A list of references can be found at the end of this guide.
The purpose of this guidance is to assist you in the development of a written HACCP program, as defined by the NCIMS Voluntary HACCP System. You will find information in this guidance that will help you identify hazards that may potentially occur in your products and help you identify and use methods of controlling and preventing hazards. This guidance is also intended to serve as a tool for Federal and State regulatory officials in the evaluation of HACCP systems for dairy products.
To help understand some key aspects of the NCIMS Voluntary HACCP System and plan how you will initiate your HACCP activities, we have included information on some other important aspects of the Dairy HACCP System.
The following table is provided to dairy processors as a visual comparison of the FDA Juice HACCP regulations and the NCIMS Voluntary Dairy System.
| Requirements | FDA Juice HACCP | NCIMS HACCP |
|---|---|---|
| Regulation Implementation Dates: |
1/22/02 Large Business (>500 employees) 1/21/03 for Small Business (<500 employees) 1/20/04 for Very Small Businesses (<100 employees) |
January 1, 2004 |
| Prerequisite Program Concept | Yes (GMP & SSOP) |
Yes (PP) |
| Written Sanitation Standard Operating Procedure (SSOP) or Required PP | No | Yes |
| Sanitation Monitoring & Documentation (SSOP) or Required PP |
Yes (8 elements) |
Yes (8 elements) |
| Perform Hazard Analysis | Yes | Yes |
| Written Hazard Analysis | Yes | Yes |
| Written HACCP Plan | Yes | Yes |
| Written Corrective Action Plan Required: | Yes | Yes |
| HACCP Plan shall be signed and dated | Yes, updated annually |
Yes |
| Plan Revalidation Upon plan development |
Yes, at least once within 12 months of implementation | Yes |
| Upon any change that affect ingredients, process, hazard analysis or HACCP Plan | Yes | Yes |
| At least annually | Yes | Yes |
| Regulator Consumer Complaint Record Access | No | No |
| Maintain Customer Complaint Summary | Yes | Yes |
| Monitoring & Corrective Action Records Review | Within 7 days | No minimum specified, appropriate to records being kept |
| Required Info on Records | Yes |
|
| Name & Location Date & Time |
Yes (if more than 1 location) Yes |
Yes |
| Monitor's Initials or Signature | Yes, where appropriate | Yes |
| ID of product & Code | Yes, where appropriate | Yes |
| Record Retention | 1 year after the production of the product | At least 1 year after the date that such products were prepared. |
| Record Retention | 2 years for frozen, preserved or shelf stable, or the shelf life of the product, whichever is greater. | In the case of frozen, preserved or shelf stable products 2 years or the shelf life of the product whichever is greater, after the date that the products were prepared unless longer retention time is required by other regulations. |
| Industry Training (HACCP plan developers, validators and record reviewers) or equivalent experience | Yes (Juice HACCP Core Curriculum) |
YES (NCIMS Dairy HACCP Core Curriculum) |
| Confidentiality | Yes, within the limits of FOIA | Not Addressed |
| Copying Records | Yes | Not Addressed |
| Electronic Records | Yes | Yes |
| 5-Log Pathogen Reduction Performance Standard | Yes | Mandatory CCP for pasteurization |
| LACF or One Step Thermally Processed Shelf-Stable Juice or Juice Concentrates | Exempt from the 5-log performance standard. Other hazards must be controlled. Shelf-stable and concentrate processors must include a copy of their thermal process in their written hazard analysis. Must be packaged in final form under single roof or 5-log needs to be done. | Hazards addressed as critical factors by process authority are not required to be addressed in the HACCP Plan Summary Table |
This guide addresses development of a product flow diagram, description of the product, hazard identification and hazard evaluation. It is not intended to provide examples for development of prerequisite programs, formation of the HACCP team, product distribution, risk analysis, etc.
Prior to conducting the hazard analysis, the HACCP team must complete the following preliminary steps:
The following section is a brief synopsis of Appendix K of the PMO detailing the requirements of the NCIMS alternative HACCP program. For a complete understanding of the NCIMS HACCP Alternative, please refer to the most recent version of the PMO.
The NCIMS HACCP Program alternative to the traditional inspection system is a voluntary system as described in the applicable sections and Appendices of the Pasteurized Milk Ordinance (PMO). No plant, receiving station or transfer station may participate in the voluntary NCIMS HACCP Program unless the Regulatory Agency responsible for the oversight of the facility agrees to participate with the dairy plant(s), receiving station(s) and transfer station(s) in the NCIMS HACCP Program. Both parties must provide written commitment to each other that the necessary resources to support participation in the NCIMS HACCP Program will be made available. Management responsible for both the State and plant, receiving station or transfer station must be willing to provide the resources needed to develop and implement a successful HACCP System.
HACCP training for industry and regulatory personnel will be based on the current "Hazard Analysis and Critical Control Point Principles and Application Guidelines" of NACMCF, the current FDA HACCP recommendations, and the regulatory requirements of Appendix K and related Sections of the PMO.
Regulatory Agency personnel responsible for the evaluation, licensing and regulatory audits of facilities using the NCIMS HACCP Program will have equivalent training to the training required to perform traditional NCIMS functions. They shall also have specialized training in conducting HACCP System audits.
Industry, State and Federal regulatory and listing personnel should be trained together.
Basic HACCP training consists of instruction in the application of the NACMCF Principles of HACCP to Food Safety. This training includes practical exercises in conducting a hazard analysis and evaluating potential hazards; in writing a HACCP Plan, and in the validation of the plan. It should be taught by experienced instructors.
The orientation component ideally is coupled with the basic HACCP training, but can be taught separately. The content of the orientation will be conducted under the guidance of the NCIMS. It is intended to familiarize industry and regulatory personnel with specific dairy HACCP concerns and the regulatory requirements under the NCIMS HACCP Program. It is to be taught by instructors experienced in the application of HACCP under the NCIMS HACCP Program.
The industry individual(s) performing the functions listed in Part 2 of this Section shall have successfully completed appropriate training in the application of HACCP principles to milk and milk product processing at least equivalent to that received under the Dairy HACCP Core Curriculum. Alternatively, job experience may qualify an individual to perform these functions if the experience has provided knowledge at least equivalent to that provided through the standardized curriculum.
The following required Prerequisite Programs shall have a brief written description or checklist that the prerequisite programs can be audited against to ensure compliance. Prerequisite Programs shall include procedures that can be monitored, records that specify what is monitored, and how often it will be monitored.
In addition to the required PP's specified above, any other prerequisite programs that are being relied upon in the Hazard Analysis to reduce the likelihood of occurrence of hazards such that they are not reasonably likely to occur must also be monitored, audited, and documented as required PP's.
Prior to the implementation of a HACCP Plan, there is a requirement for dairy plants, receiving stations and transfer stations to develop, document and implement written PP's. PP's provide the basic environment and operating conditions that are necessary for the production of safe, wholesome food. Many of the conditions and practices are specified in Federal and State regulations and guidelines.
HACCP is not a stand-alone program, but is part of a larger control system. PP's are the universal procedures used to control the conditions of the plant environment that contribute to the overall safety of the product. They represent the sum of programs, practices and procedures that must be applied to produce and distribute safe products in a clean, sanitary environment. They differ from CCP's in that they are basic sanitation programs that reduce the potential occurrence of a milk or milk product safety hazard. Frequently, both HACCP Plan CCP's and PP's control measures are necessary to control a food safety hazard.
HACCP may be implemented only in a facility that is constructed and operated to provide a sanitary environment. Milk plant, receiving station or transfer station premises, building construction, maintenance, and housekeeping shall be maintained in a manner sufficient to provide such an environment. These factors shall be controlled by effective plant, receiving station or transfer station programs or by PP's, as the plant, receiving station or transfer station chooses.
PPs are the universal procedures used to control the condition of the plant environment that contribute to the overall safety of the product. They represent the sum of programs, practices and procedures that must be applied to produce and distribute safe products in a clean, sanitary environment. They differ from CCP's in that they are basic sanitation programs that reduce the potential occurrence of a food safety hazard. Frequently, both HACCP Plan CCP's and PP's control measures are necessary to control a food safety hazard. The exact set of PP's will vary since their application is product and process specific. The existence and effectiveness of PP's should be assessed during the design and implementation of each HACCP Plan. PP's should be documented and regularly audited. An audit review consists of verifying that the company has a program implemented that indicates how the company monitors and controls each of the PP's. PP's are established and managed separately from the HACCP Plan.
Although not required by the NCIMS HACCP alternative, the 5 preliminary steps of HACCP as outlined by the National Advisory Committee of Microbiological Criteria for Foods (NACMCF) will help you in conducting your hazard analysis and developing your HACCP plan, and will prove valuable for other HACCP functions. The steps you should follow are:
The dairy hazard analysis is a process of collecting and evaluating information on hazards associated with dairy products, to determine which hazards are reasonably likely to occur and must be addressed in a HACCP Plan. Under the dairy HACCP alternative, you are required to produce, for each type of Grade A dairy product you process, a written hazard analysis to determine whether there are food hazards that are reasonably likely to occur and to identify measures that you can apply to control those hazards. The dairy alternative requires a written hazard analysis for each type of dairy product unless different types of dairy products have identical hazards and control measures that can be combined into one hazard analysis.
Do not conduct the hazard analysis untilthe prerequisite programs have been developed, implemented and documented. This Hazard and Controls Guide may be used to aid in constructing and evaluating those prerequisite programs to be considered in the hazard analysis. The hazard analysis may point out the need for additional prerequisites.
All processors that decide to participate in the NCIMS HACCP alternative are required to prepare a written hazard analysis. If you determine that any hazard is "reasonably likely to occur" in a particular product, you must control that hazard in the product by applying control measures as part of a properly designed and implemented HACCP plan, except that some hazards can be managed under your PP's. If you determine that no hazards are "reasonably likely to occur," you are not required to develop a HACCP Plan, but you must establish and implement PP's. Your PP monitoring and correction records and your hazard analysis are still subject to the record keeping and official record review requirements. Under the NCIMS HACCP system, pasteurization must always be managed as a CCP. Useful examples of both batch and continuous flow pasteurization can be found in the PMO, Appendix H.
Your hazard analysis must be developed by an appropriately trained individual (or individuals) based on the Core Curriculum or comparable experience, as specified in the NCIMS HACCP Alternative. This person may be your employee or a hired outside expert.
The vegetative pathogens of concern associated with milk and processed milk products are Salmonella spp., L. monocytogenes, enterohemorrhagic E. coli, and Campylobacter jejuni. Spore forming bacteria of concern include C. botulinum, and B. cereus. All these organisms occur in raw milk and most have been associated with illness outbreaks in milk products. These pathogens in milk have the potential for causing severe adverse health effects with the very young, the elderly, and immune-compromised individuals being at the greatest risk. While enteric pathogens have been implicated as the cause of most food-borne illness outbreaks associated with milk products, these are not the only organisms that could occur in milk.
The potential of hazards associated with toxin-producing bacteria and spore-formers should be evaluated in processing circumstances where unusual conditions exist. In the case of toxin-producers such as S. aureus and B. cereus, these organisms must multiply to significant levels to produce sufficient toxin to be a public health risk. This is a concern when levels reach above 106 or greater. However, the rule of thumb for temperature control of a food is that controls should be implemented when conditions indicate that there might be a 3- log increase in S. aureus or B. cereus. 1
Validation of processes requiring measurement of the production of enterotoxin is expensive and difficult. However, during the 2005 NCIMS, the NCIMS Scientific Committee reviewed and accepted some useful guidelines that have been actually incorporated into the PMO.
These guidelines, below, should be construed generally as "safe harbor" when conducting hazard analyses and validating control measures:
Other properly validated times and temperatures that have been recognized by FDA and that are approved by the State Regulatory Agency may also be considered to be safe.
This guidance does not cover the hazards associated with the formation of C. botulinum toxin in milk products that are classified as shelf-stable acidified foods or low acid canned foods.
Bad Bug Book
U.S. Food & Drug Administration
Center for Food Safety & Applied Nutrition
Foodbourne Pathogenic Microorganisms
And Natural Toxins Handbook
| Organism | Growth Temperature (°C) | Growth pH | Growth aw | |
|---|---|---|---|---|
| Salmonella spp. | 6.5 - 47 | 4.5 - ? | > 0.95 (a) | |
| Clostridium botulium | A & B | 10 - 50 | 4.7 - 9 | > 0.93 |
| Nonproteolytic B | 5 - ? | (b) | NR (c) | |
| E | 3.3 - 15 - 30 | (b) | > 0.965 | |
| F | 4 - ? | (b) | NR (c) | |
| Staphylococcus aureus | 7 - 45 | 4.2 - 9.3 | > 0.86 | |
| Campylobacter jejuni | 25 - 42 | 5.5 - 8 | NR | |
| Yersinia enterocolitica | 1 - 44 | 4.4 - 9 | NR | |
| Yersinia pseudotuberculosis | 5 - 43 | (b) | NR | |
| Listeria monocytogenes | 0 - 45 | 4.4 - 9.4 | > 0.92 (d) | |
| Vibrio cholerae O1 | 8 - 42 | 6 - 9.6 | > 0.95 | |
| Vibrio cholerae non-O1 | (b) | (b) | (b) | |
| Vibrio parahaemolyticus | 12.8 - 40 | 5 - 9.6 | > 0.94 | |
| Clostridium perfringens | 10 - 52 | 5.5 - 8 | > 0.93 | |
| Bacillus cereus | 10 - 49 | 4.9 - 9.3 | > 0.95 | |
| Escherichia coli | 2.5 - 45 | 4.6 - 9.5 | > 0.935 | |
| Shigella spp. | > 8 - < 45 | ? - 9 - 11 | NR | |
| Streptococcus pyogenes | >10 - < 45 | 4.8 - < 9.2 | NR | |
(a) For a genus as large as Salmonella, the aw lower limit for species growth may vary, e.g., S. Newport = 0.941, S. typhimurium = 0.945. |
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(b) The value, though unreported, is probably close to other species of the genus. |
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(c) NR denotes that no reported value could be found, but for most vegetative cells, an aw of > 0.95 would be expected. |
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(d) Updated values from the 1996 ICMSF Microorganisms in Foods 5: Characteristics of Microbiological Pathogens. |
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| Most values taken from Microbial Survival in the Environment, E. Mitscherlich and E.H. Marth (eds.), Springer-Verlag, Berlin and Heidelberg, 1984. This is a valuable, recommended reference. [ISBN 3-540-13726-2 Springer-Verlag, Berlin, New York, Tokyo] [ISBN 0-387-13726-2 Springer-Verlag, Heidelberg, Berlin, Tokyo]. |
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Contamination of food by viruses, if it occurs, is most likely to be caused by contaminated water or an ill individual2. Contamination of milk by viruses is not likely to occur in a processing facility that controls employee health and hygiene conditions that could result in the microbiological contamination of food, food packaging materials, and food contact surfaces under its Prerequisite Programs (PP's).
Allergens, or proteins derived from allergenic foods, may be present in foods as the result of cross-contact during processing and handling. The term "cross-contact" describes the inadvertent introduction of an allergen into a product that would not intentionally contain that allergen as an ingredient.
Eight major foods or food groups--milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybeans-- account for 90 percent of food allergies. In addition, some food ingredients can cause food sensitivities in certain individuals. Certain ingredients which cause food sensitivities, such as sulfites, Yellow #5 (21 CFR 74.1705), and aspartame (21 CFR 172.804), require special labeling statements to alert consumers to their presence. Cross-contact is generally the result of environmental exposure during processing or handling, which may occur when multiple foods are produced in the same facility or on the same processing line, through poor re-work management or ineffective cleaning.
Cross-contact of foods with allergens has been shown to lead to allergic reactions in consumers on numerous occasions (Gern et al., 1991; Jones et al., 1992; Yunginger et al., 1983). Most cross-contact can be avoided by controlling the production environment.
Procedures to ensure that these ingredients of concern are properly identified on the label should be a part of the HACCP system. Dairy plants should implement label control as part of their allergen control program. This label control program includes verification that the label reflects the current formulation and the correct ingredient statement. Prerequisite Programs addressing product changeover(s), scheduling, and sanitation practices normally assist in managing products containing allergens or substances that cause food sensitivities.
The following references may prove useful in the area of allergen control.
While not within the scope of the NCIMS Dairy product safety HACCP system, it is necessary for milk plants that manufacture juice or other food products using common equipment for both milk or milk products and these other foods to take precautions to prevent contamination of these foods with milk allergens.
Allergens are not present in all products. Scheduling product changeovers and run matrices, labeling, and sanitation practices are suggested prerequisite programs used to manage products containing allergens. Some products (e.g., flavored bottled waters, cultured products of dairy-based beverages with juice) can contain ingredients such as soy protein or preservatives, such as sulfites, that can cause allergic or food intolerance reactions in sensitive individuals. The presence of any ingredient must be declared on the label in accordance with the food labeling regulations in 21 CFR Part 101. Programs to ensure that the proper labels are used should be part of the PP within the HACCP Program. Ingredient controls should be implemented for the big eight allergens and ingredients which cause food sensitivities.
Cleaning chemical and sanitizers are used widely in dairy plants. The proper use of cleaning and sanitizing compounds renders the risk of contamination a hazard not likely to occur when managed by a properly implemented prerequisite program. Numerous U.S. government regulatory programs address aspects of cleaning and / or sanitizer usage. Cleaning and sanitizing chemicals should be used in accordance with the manufacturer's instructions and recommendations. These chemicals must be used at proper concentrations for effective use and in the case of sanitizers for their no-rinse properties. Proper cautions must be taken to fully drain all processing equipment of cleaners and sanitizers prior to use.
During processing, pipelines and equipment used to contain or conduct milk products shall be effectively separated from tanks or circuits containing cleaning and / or sanitizing solutions. Proper guidelines for proper chemical and product separation can be found in the PMO section 15p (B).
Pesticides are used widely to treat (e.g., for insect control) fruits, vegetables, grains and other foods, and may be present in small amounts as residues on these foods. Numerous U.S. government regulatory programs address aspects of pesticide usage. Experience in the U.S. has demonstrated that domestically grown fruits and vegetables have a high level of compliance with U.S. pesticide tolerance regulations and that the occurrence of unlawful pesticide residues in food is likely to be infrequent and unlikely to have a severe public health impact. Based on current regulatory programs and FDA market basket surveys, pesticide residues do not present food hazard likely to occur in dairy products and do not need to be addressed in the hazard analysis.
Animal drug residues are present at low levels in a very low percentage of raw milk received at milk plants in the U.S. These residues are regulated under PMO Appendix N for both the traditional and the HACCP alternative systems.
Information in recent National Milk Drug Residue Database Reports showed that less than one-tenth of 1 percent of milk samples from bulk milk pick-up tankers (the form in which raw milk is received at milk plants) tested positive for drug residues last year. The report contains data on samples and tests conducted during fiscal year 2003 (October 1, 2002 - September 30, 2003). During this period, 4,382,974 total samples were analyzed for drug resides. Samples included bulk milk pickup tankers (78 percent, or 3,571,834 samples), producer milk (18 percent), pasteurized products (2 percent), and other (2 percent). Fifty-three methods were used to analyze these samples for residues. The most recent National Drug Residue data base should be consulted to obtain the latest information on drug residues in milk.
Jacobus et al3 reported that "Vitamin D has been added to milk in the United States since the 1930's." In an article published in the New England Journal of Medicine, Holick3 discusses vitamin D intoxication caused by drinking milk fortified with excess vitamin D over an extended period of time that led to questions about the level of vitamin D in milk. Jacobus3 also reported an analysis of the amount of vitamin D, in milk from a dairy implicated in an intoxication that revealed concentrations that ranged from undetectable to as high as 232,565 IU per quart. Vitamin A can also be toxic if consumed at extremely high levels (see PMO Appendix O).
In many parts of the country mycotoxins are not normally a potential hazard. However in those milk plants that receive milk from an area that has a history of aflatoxin contaminated feed or if weather conditions are appropriate for mycotoxin growth, it should be considered.
Foreign material includes such things as metal, glass, or plastic fragments or any other material that might cause injury or present a choking hazard. Consideration of potential hazards associated with metal fragments should be a part of the hazard analysis when metal fatigue, wear of metal parts, or metal to metal contact can occur in processing equipment. See FDA compliance policy guide chapter 5 sub 555 section 555.425 (Adulteration involving hard or sharp objects March 1999).
Evaluate each of the potential hazards (from Step 1) by assessing the likelihood of occurrence and the severity of health consequences associated with the potential hazard. For instance:
Although potential hazards that may be introduced into food through pests in your facility may be of low to moderate severity, they are unlikely to occur if your facility carries out an effective pest control program as part of its required PP's.
If a potential hazard has a severe, acute public health impact, that hazard is reasonably likely to occur, even at an extremely low frequency of occurrence, and thus should be identified as a hazard that is reasonably likely to occur (e.g., pathogenic microorganisms or injury caused by ingestion of metal fragments). Milk containing enteric microbial pathogens such as E. coli O157:H7 and various Salmonella species have caused serious food borne illness outbreaks.
Those hazards which are determined to be "reasonably likely to occur" in the hazard analysis must be controlled by a CCP.
The determination that a potential hazard is "not reasonably likely to occur" is made in the hazard analysis and takes into account existing PP's, GMP's, etc. This determination is based on the unique conditions at the plant making the hazard analysis.
If conditions in the plant change, the hazard needs to be reevaluated. If the hazard analysis is performed correctly, based on the individual conditions at the milk plant and if the HACCP system is validated at least once each year as required, these types of determinations will be more likely to be sustained during regulatory and listing audits of the plants HACCP system.
When the hazard analysis identifies hazards classified as hazards "not reasonably likely to occur," they should be managed by the PP's or GMP's.
HACCP may be implemented only in a facility that is constructed and operated to provide a sanitary environment. Milk plant premises, building construction, maintenance and housekeeping shall be maintained in a manner sufficient to provide such an environment. These factors shall be controlled by effective plant, receiving station or transfer station programs or by PP's, as plant, receiving station or transfer station chooses.
Hazards can occur in milk due to unsanitary food contact surfaces that can contaminate milk with pathogens or with residual allergens from product processed on the equipment in prior runs that can cause allergic reactions in sensitive individuals. Hazards that arise from unsanitary food contact surfaces have the potential to affect the safety of a milk product because they arise from points within the process and not from general conditions within the facility. Control of these hazards may be accomplished by the use of Prerequisite Programs. For example, an appropriate PP could be to establish a procedure for cleaning equipment with a cleaning solution, e.g., a pre-rinse followed by a caustic wash followed by a rinse. The procedure could include maintaining a log of which foods, e.g., juice, eggnog, soy drinks, were processed on the equipment, the sequence in which the foods were processed, and how/when the equipment was cleaned. The operator could check that log prior to starting any production run for milk. The procedure could provide that the equipment would not be used for milk until the prescribed cleaning procedure was carried out, recorded in the log, and the equipment was visually checked for cleanliness.
Under the voluntary HACCP alternative, you are required to implement HACCP control measures if you determine in your hazard analysis that a food hazard is reasonably likely to occur in your dairy product. Examples of HACCP control measures used in the processing of dairy products include measures carried out at CCPs specified in a HACCP plan such as pasteurization of dairy products for the elimination or reduce to an acceptable level of micobiological pathogens
The pasteurization of milk is the most effective single control measure for protecting consumers from pathogenic microorganisms. Therefore, the pasteurization process is a required control measure for pathogens.
When a chemical hazard is identified that is reasonably likely to occur in milk, a control measure needs to be established in the HACCP plan for that hazard. Chemical hazards that are most commonly identified in the hazard analysis include equipment cleaning and sanitizing chemicals, animal drug residues and over addition of food grade vitamins. The likelihood of occurrence of each of these hazards will vary according to the plant and its procedures. If control measures are warranted for any of these hazards they are addressed below.
The necessity for control measures for any potential physical hazard is dependent upon a conclusion from the hazard analysis that the specific hazard is reasonably likely to occur in the milk product. FDA has issued a Compliance Policy Guide (CPG Section 555.425) describing when hard or sharp foreign objects in food, such as glass or metal fragments, could pose a health hazard. If it is reasonably likely that the milk product may become contaminated with hard or sharp foreign objects that meet the criteria in this CPG, you should regard the object as a potential hazard in the milk.
The hazard analysis may identify hazards that can be eliminated or reduced to hazards not likely to occur if adequate changes are made in the plant facility or its environment, by equipment replacement or modifications, or adjustments to operating procedures. Engineering the hazard out of the process is usually the best alternative to eliminate or reduce the likelihood of occurrence.
CCP decision trees have been developed to assist HACCP developers in determining CCP's in the facilities process. Three example CCP decision trees are in the following pages of this hazard guide. Two decision trees are prepared by the NACMCF and the third has been developed by IDFA. The HACCP team may use decision trees to evaluate each hazard to determine if each hazard can be prevented, eliminated or reduced to an acceptable level.
A common problem with using existing HACCP decision trees is trying to apply the questions prior to completion of the hazard analysis. Decision trees sometimes also show results which common sense says is incorrect. Thus, decision trees should be used with caution.
Decision trees are only tools that can be used to assist in determining CCP's. Milk plants are not required to use them to determine CCP's. Many HACCP teams determine CCP's based on the knowledge and experience of their process and existing plant control measures.
NACMCF CCP Decision Tree #1
NACMCF CCP Decision Tree #2
NACMCF CCP Decision Tree #3
Under the voluntary HACCP alternative, you are not required to implement control measures if you determine in your hazard analysis that a food hazard is not reasonably likely to occur in your dairy product.
Examples of HACCP control measures used in the processing of dairy products include measures carried out at CCP's specified in a HACCP plan such as pasteurization of dairy products for the elimination or reduction to an acceptable level of microbiological pathogens.
Some activities that firms may undertake in processing milk and milk products and in related functions are not HACCP control measures. These include Good Agricultural Practices (GAPs) and Current Good Manufacturing Practices (cGMP).
GAPs are measures voluntarily undertaken by these parties which are not HACCP controls. However, if a hazard originating from the agricultural environment is determined to be reasonably likely to occur in your incoming dairy products, it must be identified in your hazard analysis and controlled through your HACCP plan. If control of such a hazard involves actions that will be carried out by your supplier, your control measure could be based upon a supplier guarantee to this effect implemented as part of your HACCP plan.
However, we encourage you to work with your suppliers to evaluate and modify agricultural practices in accordance with FDA's GAPs guidance document.
As noted above, dairy processors are still required to comply with the CGMPs requirements of 21 CFR Part 110. One common misconception about HACCP is that some hazards that are reasonably likely to occur can be controlled under a firm's CGMP programs under 21 CFR Part 110. Because programs to comply with 21 CFR Part 110 are general in nature and are not designed to control specific hazards, they are not HACCP control measures. Therefore, you cannot use CGMP programs to control a specific hazard that you have concluded is reasonably likely to occur in your hazard analysis. You must use HACCP controls for any such hazard.
Successful implementation of HACCP requires trained people who cooperate from the preliminary stages to the implementation and ongoing operation of the HACCP system. We strongly recommend that you begin with Step 1 of NACMCF's 5 preliminary steps of HACCP, by assembling a HACCP team that includes plant level and corporate level personnel.
These tables may be used by the milk plant HACCP team as a guide to the identification of potential hazards that may be associated with the incoming raw materials (Table 1) and the processing steps (Table 2) used by a typical dairy processing plant.
This guide may, or may not, be relevant to the conditions found at a specific milk plant.
Each milk plant HACCP team must determine, for itself, the relevance of the potential hazards identified in the tables or other potential hazards, identified independently by the milk plant HACCP Team or by experts the HACCP Team may employ when developing its HACCP system.
The "Ingredient or Process" column presents typical steps used in milk processing. It is not intended to be complete or accurate for any specific milk plant or to serve as a template for describing process steps in specific milk plants.
The "Potential Hazard" column identifies some hazards that might be expected at various processing steps. Additional hazards may exist in individual circumstances and MUST be identified and considered in the hazard analysis.
The "Hazard Rationale" column provides the reasons why each hazard was listed in the Hazard Identity column for a particular processing step.
The "Hazard Management Controls" column provides examples used to illustrate the accepted level of public health protection that is likely to be found acceptable for regulatory licensing and IMS listing. Any measure that can be demonstrated to provide a similar level of public health protection, but is not listed in this Guide, is also acceptable, as long as it meets the requirements of the NCIMS Dairy HACCP Program and is consistent with relevant state and federal laws or regulations.
The "Additional Resources" column provides references to the following sources of information: Key to Abbreviations and References Used in Tables 1 and 2
| INGREDIENT OR PROCESS | TYPE OF HAZARD | POTENTIAL HAZARD | HAZARD RATIONALE | HAZARD MANAGEMENT OR CONTROLS | ADDITIONAL RESOURCES |
|---|---|---|---|---|---|
| Raw Milk | |||||
| Biological | B-1: Presence of vegetative Pathogens |
B-1: Scientific studies have shown that a wide range of pathogens (organisms which can cause illness in humans) can be present in unpasteurized milk. 4, 5 |
B-1: Minimize the incoming bacterial load by purchasing Grade "A" IMS listed raw milk and testing incoming product. Verify that tank trucks were cleaned and sanitized prior to picking up the milk being unloaded (wash tags or in the case of trucks that only deliver to one plant, plant cleaning records) and that milk has been maintained at the proper temperature. |
PMO Sec 4 PMO Item 12p IMS List PMO Item 17p DPC 25 DPC 50 |
|
| Chemical | C-1: Presence of Therapeutic Drugs |
C-1: This hazard must be addressed based on "Other NCIMS Requirements". |
C-1: At a minimum, screen all tankers for animal drug residues as required by Appendix N or other regulatory mandates. In addition, plants are encouraged to screen for other residues as indicated by available information. |
M-a-75 M-a-86 PMO Appendix N DPC 22 |
|
| Chemical | C-2: Presence of Mycotoxins |
C-2: Mold growth in animal feed can contaminate milk with aflatoxin M1. |
C-2: Aflatoxin has been shown to be present in raw milk dependent on geographic locations, growing season conditions and past history. Other management controls may include supplier guarantees and COA's. |
||
| Physical | P-1: Extraneous Material |
P-1: If dairy cattle are not kept clean or if milk is drawn in an unclean environment and is not properly protected, physical objects from the farm environment may become incorporated into the milk. |
P-1: Not to be included in the hazard analysis if purchasing milk from Grade "A" IMS listed sources to minimize the contamination. |
||
| Pasteurized milk, heat treated milk or cream, and condensed skim milk | Biological | B-1: Presence of vegetative Pathogens |
B-1: Heat-treated milk products may not have been heated sufficiently to deactivate these organisms. |
B-1: Heat-treated milk or cream should be treated as raw milk and come from approved sources. |
IMS List PMO Sec 7 |
| Biological | B-2: Contamination by vegetative pathogens | B-2: Bulk shipped pasteurized milk products may have been subject to recontamination during transit. |
B-1: Verify that tank trucks were cleaned and sanitized prior to picking up the milk being unloaded (wash tags or in the case of trucks that only deliver to one plant, plant cleaning records) and that milk has been maintained at the proper temperature. |
PMO Items 12p, 17p, & 21p 3-A SS 605 |
|
| Chemical | None | ||||
| Physical | None | ||||
| Other Ingredients / Packaging Materials | |||||
| Biological | B-1: Presence of vegetative Pathogens |
B-1: Pathogens may be present in ingredients. 6, 7, 8 |
B-1: Supplier certificates of analysis. |
21 CFR 110.80(a) |
|
| Chemical | C-1: Presence of toxic or carcinogenic substances |
C-1: Adulteration with toxic or carcinogenic chemicals has been documented. 9, 10, 11 |
C-1: IMS Listed packaging suppliers. Supplier letter of guarantee. |
21 CFR 110.80(a) 21CFR 176.260 21CFR 178.010 |
|
| Physical | P-1: Extraneous Material |
P-1: Free of foreign materials which constitute food safety hazards. 7, 12 |
P-1: |
21 CFR 110.80(a) CPG 555.425 |
|
| INGREDIENT OR PROCESS | POTENTIAL HAZARD | TYPE OF HAZARD | HAZARD RATIONALE | HAZARD MANAGEMENT OR CONTROLS | ADDITIONAL RESOURCES |
|---|---|---|---|---|---|
| Receiving - Materials shipped by bulk tanker, e.g. fluid milk and milk products | |||||
| Biological | B-1: Contamination with vegetative pathogens. |
B-1: The truck unloading area has the potential to contaminate liquid milk products. These products are normally transmitted through equipment that if unclean, (or uncleanable) can result in bacterial contamination. |
B-1: Truck unloading are should be constructed to protect the milk (at a minimum overhead protection and concrete, or equivalent surface under the truck that is properly drained). Maintain the truck unloading area and equipment clean. Protect the milk that is being unloaded by closing in the unloading area or using filters over the vent /personnel access port area. Using equipment meeting sanitary design guidelines. |
DPC 8 PMO Item 5p(4) & 15p(A)(3) 3-A SS 02-, 11-, 28-,29-,53-, 58-, 59-, 62-, 63-, 74- |
|
| Chemical | C-1: Cleaning & Sanitizing Residues |
C-1: Without proper separation between cleaning & sanitizing solutions and product there could be contamination of the product. 9 |
C-1: Maintain proper separation or a physical break between circuits containing cleaning solutions and vessels and lines used to contain or conduct product |
PMO Item 15p(B)(1) 3-A AP 605 21CFR178.1010(a) |
|
| Physical | P-1: Extraneous Materials |
P-1: Free of foreign material which constitute food safety hazards. 7, 12 |
P-1: Use a filter, screen or other appropriate device at some point in the system. |
3-A SS 10- & 42- PMO Item 11p(8) |
|
| Physical | P-2: Metal shavings, gasket material & other foreign material from receiving equipment |
P-2: Equipment in poor repair or improperly assembled may contaminate product with foreign material. |
P-2: An effective preventive maintenance program and routine (daily) inspection of equipment for wear or missing parts. Use of a filter, screen or other appropriate device at some point in the system. |
PMO Item 11p 3-A SS 10- & 42- |
|
| Receiving - Materials shipped by common carrier, e.g. dry ingredients, flavors and packaging materials. | |||||
| Biological | B-1: Contamination with vegetative pathogens |
B-1: Product may become contaminated if product containers are damaged during shipment. |
B-1: Inspect product during unloading operations for damage. |
DPC 8 21CFR 110.80(a)(2) |
|
| Chemical | C-1: Toxic Chemicals |
C-1: Delivery trucks may have been used to transport toxic chemicals prior to food products or packaging materials. 9 |
C-1: Inspect vehicles prior to unloading for evidence of unsanitary conditions, spilled chemicals, off odors, of evidence that might indicate the delivered product may have been contaminated. |
DPC 8 | |
| Physical | P-1: Extraneous Materials |
P-1: Vehicles may have not been maintained in good repair or have been used to carry metal or wood articles. 12 |
P-1: Inspect vehicles prior to unloading for evidence of foreign materials that may have contaminated the product. |
DPC 8 | |
| Raw Milk Storage | |||||
| Biological | B-1: Contamination with vegetative pathogens |
B-1: These products are normally stored in vessels that, if unclean (or uncleanable), can result in bacterial contamination. 9, 11 |
B-1: Verify that storage vessels and associated lines and valves similar appurtenances are constructed in such a way that they can be cleaned. Maintain records storage vessels are cleaned after each use. Maintain records that the associated lines, valves and similar appurtenances are cleaned as needed but at least each day used. Pipeline openings (e.g., flow control panels) and outlet valves are capped when not in use, other openings are closed with tight fitting covers. Associated pipelines and similar appurtenances are similarly protected. |
PMO Item 12p 3-A SS 22- & 63- 3-A AP 605- 21CFR 110.35(d) PMO Item 15p(A)(3) |
|
| Biological | B-2: Growth of vegetative pathogens |
B-2: Without proper temperature and time controls, vegetative pathogens can multiply to levels that may be capable of overwhelming the pasteurization process with out proper temperature and time controls. 9, 11 |
B-2: Maintain the temperature sufficiently low to minimize the growth of pathogens. Clean the storage vessels and associated lines and valves similar appurtenances at frequencies that do not allow for bacterial growth of pathogens in the product at the product temperature used. Note: If times or temperatures less stringent than specified in the PMO are used, they must be reviewed and found acceptable to the State and FDA. |
PMO Item 17p PMO Item 12p 21CFR 110.35(d) PMO Item 12p |
|
| Chemical | C-1: Cleaning & Sanitizing Solution Residues |
C-1: Without proper separation between cleaning & sanitizing solutions and product there could be product contamination. 9 |
C-1: Maintain proper separation or physical break between circuits containing cleaning solution and vessels and lines used to contain product. |
PMO Item
15p(B) 3-A AP 605 21CFR 178.1010(a) |
|
| Physical | None | ||||
| Storage, Blending & Addition of Ingredients | |||||
| Biological | B-1: Contamination with vegetative pathogens |
B-1: Pathogens can be present in the environment in the dry blending area. Product is usually exposed during blending. Ingredients may become contaminated by equipment that is unclean or uncleanable. 9 |
B-1: Verify that blending equipment and associated lines and valves similar appurtenances are constructed in such a way that they can be cleaned. Maintain records that they are cleaned as needed but at least each day used. Maintain the addition / blending environment clean and relatively free of dust or soil that could contaminate product during addition / blending. Equipment used for addition / blending is constructed to minimize product or ingredient exposure. |
DPC 8 3-A SS 32-, 63-, & 73- 21CFR 110.35(d) 3-A AP 605- PMO Item 9p(3) & 9p(4) |
|
| Chemical | C-1: Cleaning & Sanitizing Solution Residues |
C-1: Without proper separation between cleaning & sanitizing solutions and product there could be product contamination. 9 |
C-1: Maintain proper separation or physical break between circuits containing cleaning solution and vessels and lines used to contain product. |
PMO Item 15p(B) 3-A AP 605 21CFR 178.1010(a) |
|
| Chemical | C-2: Allergens being mixed with products that are not labeled as containing allergens |
C-2: Foods which contain undeclared allergens may cause life threatening reactions in sensitive individuals. |
C-2: Documented PP's or other effective practices and programs must be in place and monitored in such a way that will assure allergen containing ingredients (other than milk and milk products) are used only in Grade A milk and milk products that are properly labeled as containing those allergens in the ingredients. These documented and monitored programs need, at a minimum to include requirements and procedures to assure:
|
FDA CPG 555.250 | |
| Physical | P-1: Extraneous Materials |
P-1: Inadvertent addition of packaging material and other objects which are present in the blending area. |
P-1: Opening of ingredients is conducted in a manner that will minimize the opportunity for bits of packaging, cutting tools, etc. from entering the product. Verification that, at some point in the process ingredient or the milk product to which the ingredient is added, will pass through a filter, screen, small orifice (such as occurs during homogenization or other appropriate device. |
DPC 8 3-A SS 10- & 42- PMO Item 9p(3) & 9p(4) |
|
| Separation | |||||
| Biological | B-1: Contamination with vegetative pathogens |
B-1: If this equipment is unclean or uncleanable, it can contaminate products that pass through it. 12 |
B-1: Verify that the separation equipment and associated lines and valves and similar appurtenances are constructed in such a way that they can be cleaned. Maintain records that the equipment is cleaned after each day used. |
DPC 8 3-A AP 605- 21CFR 178.1010(a) |
|
| Chemical | None | ||||
| Physical | None | ||||
| Skim and / or Cream Cooling and Storage | |||||
| Biological | B-1: Cold separated or heat treated skim or cream can have vegetative pathogens |
B-1: Vegetative pathogens can multiply to levels that may be capable of overwhelming a pasteurization process. 11 |
B-1: Maintain the temperature sufficiently low to minimize the growth of pathogens. Clean the storage vessels and associated lines and valves and similar appurtenances at frequencies that do not allow for bacterial growth of pathogens in the product at the product temperature used. Note: If times or temperatures less stringent than specified in the PMO are to be used, they must be reviewed and found acceptable to the State and FDA. |
3-A AP 605- 3-A SS 22- & 63- |
|
| Chemical | C-1: Cleaning & Sanitizing Solution Residues |
C-1: Without proper separation between cleaning & sanitizing solutions and product there could be product contamination. 9 |
C-1: Maintain proper separation or physical break between circuits containing cleaning solution and vessels and lines used to contain product. |
PMO Item 15p(B) 3-A AP 605 21CFR 178.1010(a) |
|
| Physical | None | ||||
| Pasteurization | |||||
| Biological | B-1: Survival of vegetative pathogens |
B-1: Minimum pasteurization times and temperatures have been well documented and are required for the elimination of pathogens normally present in unpasteurized milk. 9, 11, 13, 14 |
B-1: Under NCIMS Dairy HACCP program, pasteurization and the design, construction and operation and testing of pasteurization equipment must conform to all of the requirements of the Grade A Pasteurized Milk Ordinance. Note: If cleaning frequencies are to be performed at frequencies less than those specified in PMO Item 12p, the cleaning frequencies are to be reviewed and found acceptable to the State and FDA. |
PMO Items 12p, 15p(B), 16p and Appendices H & I 3-A AP 603- 3-A AP 605- |
|
| Biological | B-2: Contamination with vegetative pathogens |
B-2: Pasteurizer regenerator sections have been documented to occasionally leak. Raw and pasteurized milk are on opposite sides of a metal barrier (plate or tubular) in these regenerator sections. 11 |
B-2: Under NCIMS Dairy HACCP program, pasteurization and the design, construction and operation and testing of pasteurization equipment must conform to all of the requirements of the Grade A Pasteurized Milk Ordinance. |
PMO Item 16p 3-A AP 603- 3-A AP 605- |
|
| Chemical | C-1: Cleaning & Sanitizing Solution Residues |
C-1: Without proper separation between cleaning & sanitizing solutions and product there could be product contamination. 9 |
C-1: Maintain proper separation or physical break between circuits containing cleaning solution and vessels and lines used to contain product. Particular attention is needed to assure that the required separation remains in place during partial washes, sometimes called "short washes" or " inter-washes" that may be done during an operating day. |
PMO Item 15p(B) 3-A AP 605 21CFR 178.1010(a) |
|
| Chemical | C-2: Allergens being mixed with products that are not labeled as containing allergens. |
C-2: Foods which contain undeclared allergens may cause life threatening reactions in sensitive individuals. |
C-2: Pasteurization equipment and associated piping and valves that are used for both Grade "A" milk and milk products foods that do not, must be thoroughly cleaned after use for allergen containing foods before it is used for foods that do not declare that allergen. |
3-A 603- 3-A 605- FDA CPG 555.250 |
|
| Chemical | C-3: Boiler Additives |
C-3: Some boiler water compounds used in the production of steam to be used in contact with food or food contact surfaces may contain toxic substances. |
C-3: If indicated by the hazard analysis, boiler water additives may be managed by PP #1 - Safety of Water. Compliance to 21CFR 173.310 may be verified by a letter of guarantee from the chemical supplier. |
21CFR 173.310 | |
| Chemical | C-4: Cooling water / Media Additives. |
C-4: Some cooling water / media additives that may come in contact with food or food contact surfaces may contain toxic substances. |
C-4: Cooling water additives that are non-toxic under the condition of use should be used and their safety verified by a letter of guarantee form the chemical supplier. |
||
| Physical | None | ||||
| Pasteurized Milk & Milk Product Storage (Except dry products) | |||||
| Biological | B-1: |
B-1: Human illness outbreaks have been linked to post-pasteurization contamination of milk and milk products. 11, 15, 16, 17 |
B-1: Openings and outlet valves are capped when not in use, other openings are closed with tight fitting covers. Associated pipelines and similar appurtenances are similarly protected. Verify that storage vessels and associated lines and valves and similar appurtenances are constructed in such a way they can be cleaned. Maintain records storage vessels are cleaned after each use. Maintain records that associated lines and valves and similar appurtenances are cleaned as needed but at least each day used. |
3-A AP 605 3-A SS 22- & 63- |
|
| Biological | B-2: Growth of Vegetative Pathogens |
B-2: Human illness outbreaks have been linked to post-pasteurization contamination of milk and milk products. 11, 15, 16, 17 |
B-2: Maintain the temperature sufficiently low to minimize the growth of pathogens. Clean the storage vessels and associated lines and valves and similar appurtenances at frequencies that do not allow for bacterial growth of pathogens in the product at the product temperature used. Note: If times or temperatures less stringent than specified in the PMO are to be used, they must be reviewed and found acceptable to the State and FDA. |
3-A AP 605 | |
| Chemical | C-1: Cleaning & Sanitizing Solution Residues |
C-1: Without proper separation between cleaning & sanitizing solutions and product there could be product contamination. 9 |
C-1: Maintain proper separation or physical break between circuits containing cleaning solution and vessels and lines used to contain product. |
PMO Item 15p(B) 21CFR 178.1010(a) |
|
| Physical | None | ||||
| Pasteurized Milk and Milk Product - Packaging (Except Dry Products) | |||||
| Biological | B-1: Contamination with vegetative pathogens |
B-1: Human illness outbreaks have been linked to post-pasteurization contamination of milk and milk products. 9 |
B-1: Packaging may come from an IMS listed source with associated letters of guarantee, or the milk plant may perform tests to verify the ongoing safety of the packaging. After receipt, single service containers and other single service items must be protected from recontamination. Filling equipment and appurtenances must be cleanable and inspectable and must be constructed and operated to protect the product being packaged from contamination. Acceptable criteria for such construction can be found from such sources as the PMO and 3A Sanitary Standards and Practices. |
IMS List 3-A SS 17- & 23- 21CFR 178.1010 |
|
| Chemical | C-1: Cleaning & Sanitizing Solution Residues |
C-1: Without proper separation between cleaning & sanitizing solutions and product there could be product contamination. 9 |
C-1: Maintain proper separation or physical break between circuits containing cleaning solution and vessels and lines used to contain product. |
PMO Item 15p(B) 3-A AP 605 21CFR 178.1010(a) |
|
| Chemical | C-2: Toxic or Carcinogenic substances in the packaging |
C-2: Packaging material that does not meet CFR requirements may contain non-food grade substances. 18 |
C-2: Packaging material or components comes from a sourced from suppliers to be free of certain toxic or carcinogenic substances. One way to do this is to use packaging from IMS listed sources |
CFR IMS List | |
| Chemical | C-3: Allergens being mixed with products that are not labeled as containing allergens. |
C-3: Foods that contain undeclared allergens may cause life threatening reactions in sensitive individuals. |
C-3: Packaging machinery and associated piping and valves that are used for both Grade A milk and milk products foods that contain allergens (other than milk) and Grade A milk and milk products that do not, must be thoroughly cleaned after use for allergen containing foods before it is used for foods that do not declare that allergen. |
FDA CPG 555.250 | |
| Physical | P-1: Glass |
P-1: Glass fragments may be present in processors packaging in glass. |
P-1: Maintain a glass free zone. |
||
| Packaged Milk Product Storage (Except Dry Products) | |||||
| Biological | B-1: Contamination with vegetative pathogens |
B-1: Condensate which drips on the pouring lip of the container may contaminate the pouring lip of the container with pathogens. |
B-1: Product needs to be stored away from areas where condensate could drip on the container. |
||
| Biological | B-2: Growth of Pathogens |
B-2: Lack of temperature control in coolers may result in growth of pathogens if present in the product. 19 | B-2: Thermometers need to be located in the warmest sections of product coolers and monitored to be sure that the coolers will hold product below the bacterial growth range. Temperature meets the NCIMS requirements. |
||
| Chemical | None | ||||
| Physical | None | ||||
| Bulk Pasteurized Product - Load Out (Except Dry Products) | |||||
| Biological | B-1: Contamination with vegetative pathogens |
B-1: Pathogens have been found in bulk pasteurized product either from the load out process or from loading into tankers which have not been cleaned and sanitized. 9, 11 | B-1: Load out product "fitting to fitting" with the truck openings closed or otherwise adequately protected. Use and properly maintain a system of lies and valves for load out that is separate from that used to receive products for pasteurization or repasteurization. Tank trucks must not be used to haul contaminating substances such as unpasteurized liquid eggs without a through cleaning and a detailed inspection. Verify that the trucks were clean and sanitized prior to loading (wash tags or in the case of trucks that only deliver to one plant, plant cleaning records). |
3-A AP 605- PMO Section 4 3-A SS 02- & 62- |
|
| Chemical | C-1: Cleaning & Sanitizing Solution Residues |
C-1: Without proper separation between cleaning & sanitizing solutions and product there could be product contamination. 9 | C-1: Maintain proper separation or physical break between circuits containing cleaning solution and vessels and lines used to contain product. |
PMO Item 15p(B) 3-A AP 605 21CFR 178.1010(a) |
|
| Physical | None | ||||
| Starter Media Preparation, Starter Media Culturing and Product Culturing | |||||
| Biological | B-1: Contamination with vegetative pathogens. |
B-1: Starter media and culture is added to product post-pasteurization. |
B-1, B-2: Starter media is pasteurized as required in the PMO prior to culturing and is protected during culturing of the media and during addition to the product to be cultured. Dairy products being cultured will be protected from contamination during set either by enclosing or covering the vats during set or by controlling environmental conditions around the vats during set. Some environmental controls would include, positive air pressure in the set room (the incoming air must be filtered or otherwise treated to prevent it from being a source of bacterial contamination). Pallets of packaging or other potential sources of contamination must not be present during set. Packaging or other operations that could be a source of contamination must be isolated from the vats being set. A separate room for setting open vats is preferred. |
PMO Item 16p 3-A AP 603- 3-A SS 25- 3-A SS 02-, 25-, & 38- 3-A AP 605- 3-A AP 604- |
|
| Biological | B-2: Growth of Pathogens | B-2: Dairy products are cultured under conditions conductive to the growth of pathogens. | |||
| Biological | B-3: Development of Toxins |
B-3: Dairy products are cultured under conditions that may allow toxin-producing bacteria to grow and produce toxins in the case of starter culture failure or partial failure. |
B-3: The plant needs a procedure to handle "Slow" vats that will eliminate the possibility that cultured products containing toxins sold or distributed as food. |
||
| Chemical | C-1: Cleaning & Sanitizing Solution Residues |
C-1: Without proper separation between cleaning & sanitizing solutions and product there could be product contamination. 9 | C-1: Maintain proper separation or physical break between circuits containing cleaning solution and vessels and lines used to contain product. If curd wash water is treated with a disinfectant, the levels shall be controlled to prevent adulteration. |
PMO Item 15p(B) 3-A AP 605 21CFR 178.1010(a) |
|
| Physical | P-1: Extraneous Material |
P-1: Market withdrawals and recalls have occurred for foreign materials in dairy products. 12 | P-1: Openings on the starter media and cultured products vessels and associated equipment are kept closed. All product-handling equipment is properly designed and maintained in good repair. |
3-A SS 24- & 25- | |
| Milk or Milk Product - Direct Set | |||||
| Biological | None | ||||
| Chemical | C-1: Cleaning & Sanitizing Solution Residues |
C-1: Without proper separation between cleaning & sanitizing solutions and product there could be product contamination. 9 | C-1: Maintain proper separation or physical break between circuits containing cleaning solution and vessels and lines used to contain product. |
PMO Item 15p(B) 3-A AP 605 21CFR 178.1010(a) |
|
| Physical | P-1: Extraneous Material |
P-1: Market withdrawals and recalls have occurred for foreign materials in dairy products. 12 | P-1: Openings on the starter media and cultured products vessels and associated equipment are kept closed. All product-handling equipment is properly designed and maintained in good repair. |
3-A SS 24- & 25- | |
| Ingredient / Flavoring other than dry - Added Post Pasteurization | |||||
| Biological | B-1: Contamination with vegetative pathogens |
B-1: Ingredient / flavorings are added post pasteurization. |
B-1: Ingredients to be added after pasteurization are verified / certified to be sterilized and hermetically sealed, incapable of supporting bacterial growth (salt and some alcohol based flavors, etc.) or otherwise rendered incapable of carrying pathogens into the product. Use of fresh fruit having a pH of 4.7 or less, or ingredients having a water activity of 0.85 or less, or a high acid content product or roasted nuts, or flavoring extracts having high alcohol content as part of a plant quality assurance programs to assure that these ingredients do not contaminate the dairy product. |
||
| Chemical | C-1: Contaminates in the Ingredient |
C-1: Ingredients may contain unintended contaminates. |
C-1: Supplier guarantees obtained for all post pasteurization added ingredients. |
||
| Chemical | C-2: Allergens being mixed with products that are not labeled as containing allergens. |
C-2: Foods that contain undeclared allergens may cause life threatening reactions in sensitive individuals. |
C-2: Ingredient addition equipment such as hoppers and feeders and associated piping and valves that are used for milk and milk products that contain allergens (other than milk) and milk and milk products that do not , must be thoroughly cleaned after use for allergens before it is used for foods that do not declare that allergen. |
3-A SS 02-, 32-, 35-, 51-, 52-, 63- , 68-, 73-, 81- FDA CPG 555.250 |
|
| Physical | P-1: Extraneous Material |
P-1: Market withdrawals and recalls have occurred for foreign materials in dairy products. 12 | P-1: Openings on the starter media and cultured products vessels and associated equipment are kept closed. All product-handling equipment is properly designed and maintained in good repair. |
3-A SS 24- & 25- | |
| Whey - Handling and Storage | |||||
| Biological | B-1: Contamination with vegetative pathogens |
B-1: Pathogens may be introduced during whey handling and storage. |
B-1: Verify that storage vessels and associated lines and valves and similar appurtenances are constructed in such a way they can be cleaned. Maintain records storage vessels are cleaned after each use. Maintain records that associated lines and valves and similar appurtenances are cleaned as needed but at least each day used. |
3-A SS 01-, 02-, 22-, 25-, 32-, 57- 3-A AP 605- |
|
| Biological | B-2: Growth of Pathogens |
B-2: Pathogens, if present, may grow during storage. |
B-2: Condensed products (including foam and splash) are not held in bacteria growth range. Maintain the temperature sufficiently low to minimize the growth of pathogens. Clean the storage vessels and associated lines and valves and similar appurtenances at frequencies that do not allow for bacterial growth of pathogens in the product at the product temperature used. Note: If times or temperatures less stringent than specified in the PMO are to be used, they must be reviewed and found acceptable to the State and FDA. |
||
| Chemical | C-1: Cleaning & Sanitizing Solution Residues |
C-1: Without proper separation between cleaning & sanitizing solutions and product there could be product contamination. 9 | C-1: Maintain proper separation or physical break between circuits containing cleaning solution and vessels and lines used to contain product. |
PMO Item 15p(B) 3-A AP 605 21CFR 178.1010(a) |
|
| Physical | None | ||||
| Milk and Whey Product - Membrane Filtration | |||||
| Biological | B-1: Contamination with vegetative pathogens |
B-1: Pathogens may be introduced during membrane filtration. |
B-1: Product balance bowl and other openings into the system must be kept tightly closed during processing. |
3-A AP 610 3-A SS 26- PMO Item 16p 3-A A 603 |
|
| Chemical | C-1: Cleaning & Sanitizing Solution Residues |
C-1: Without proper separation between cleaning & sanitizing solutions and product there could be product contamination. 9 | C-1: Maintain proper separation or physical break between circuits containing cleaning solution and vessels and lines used to contain product. |
PMO Item 15p(B) 3-A AP 605 21CFR 178.1010(a) |
|
| Physical | None | ||||
| Milk and Whey Product - Condensing | |||||
| Biological | B-1: Growth of Pathogens |
B-1: Pathogens, if present, may grow during storage. 10 | B-1: Product to be condensed must be pasteurized prior to entering the condenser. |
3-A AP 607 | |
| Chemical | C-1: Cleaning & Sanitizing Solution Residues |
C-1: Without proper separation between cleaning & sanitizing solutions and product there could be product contamination. 9 | C-1: Maintain proper separation or physical break between circuits containing cleaning solution and vessels and lines used to contain product. |
PMO Item 15p(B) 3-A AP 605 21CFR 178.1010(a) |
|
| Physical | None | ||||
| Whey Product Crystallization | |||||
| Biological | B-1: Contamination with vegetative pathogens |
B-1: Pathogens may be introduced during crystallization. |
B-1: Openings into crystallization vessel are closed with tight fitting covers. |
||
| Biological | B-2: Growth of Vegetative Pathogens |
B-2: Pathogens, if present, may grow during the crystallization process. |
B-2: The control limit is the maximum limit on the crystallization time. |
||
| Chemical | C-1: Cleaning & Sanitizing Solution Residues |
C-1: Without proper separation between cleaning & sanitizing solutions and product there could be product contamination. 9 | C-1: Maintain proper separation or physical break between circuits containing cleaning solution and vessels and lines used to contain product. |
PMO Item 15p(B) 3-A AP 605 21CFR 178.1010(a) |
|
| Physical | None | ||||
| Condensed Milk and Whey Product Storage | |||||
| Biological | B-1: Contamination by Pathogens |
B-1: Pathogens may be introduced during storage. |
B-1: Outlet valves and other openings into tanks are protected with tight fitting covers. |
||
| Biological | B-2: Growth of Pathogens |
B-2: Pathogens, if present, may grow during storage. |
B-2: Condensed product (including foam and splash) are not held in bacterial growth range. |
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| Chemical | C-1: Cleaning & Sanitizing Solution Residues |
C-1: Without proper separation between cleaning & sanitizing solutions and product there could be product contamination. 9 | C-1: Maintain proper separation or physical break between circuits containing cleaning solution and vessels and lines used to contain product. |
PMO Item 15p(B) 3-A AP 605 21CFR 178.1010(a) |
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| Physical | None | ||||
| Milk and Whey Product - Drying | |||||
| Biological | B-1: Contamination by Pathogens |
B-1: Cracks and crevices in dryers have been found to contain Salmonella capable of surviving in dry environment. 12 | B-1: Dryers need to be carefully inspected and any cracks, crevices or similar dead end areas repaired or the dryer removed from service. |
3-A AP 607 & 608 | |
| Chemical | None | ||||
| Physical | P-1: Extraneous Material |
P-1: Market withdrawals and recalls have occurred for foreign materials in dairy products. 12 | P-1: Openings on the dryer and associated equipment are kept closed. All product-handling equipment is properly designed and maintained in good repair. Product should pass through screens to remove extraneous materials. |
3-A SS 24- & 25- | |
| Packaged and Bulk Dry Milk and Whey Products - Storage and Shipment | |||||
| Biological | B-1: Contamination with Pathogens such as Salmonella that can survive in dry environments and products . |
B-1: Salmonella has been found in environmental testing in dry product storage areas. 9, 12 | B-1: Keep dry product storage areas, including overhead ledges and beams as well as electrical boxes and similar areas clean. Do not salvage damaged bags for human food. Bags, bulk containers & totes in storage areas are dust tight. Bulk powder storage must be of sanitary construction and cleanable. |
T14 3-A SS 34- | |
| Chemical | None | ||||
| Physical | None | ||||
| Aseptic Product - Processing | |||||
| Biological | B-1: Contamination by pathogens, such as C. botulinium |
B-1: Botulism toxin is one of the most toxic substances that can be found in food. 15, 20, 21 | B-1: Under the NCIMS Dairy HACCP program, aseptic processing and the design, construction and operation and testing of aseptic processing equipment must conform to all of the requirements of the Grade "A" Pasteurized Milk Ordinance, 21CFR 108 and 113, and the filed process for the products being produced. Note: If cleaning frequencies are to be performed at frequencies less than those specified in the PMO Item 12p, they are to be reviewed and found acceptable to the State and FDA. |
PMO Section 5 21 CFR 108 & 113 PMO Items 12p, 15p(B), 16p & Appendices H & I PMO Item 16p(D) |
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| Biological | B-2: Survival of pathogens such as C. botulinium |
B-2: Botulism toxin is one of the most toxic substances that can be found in food. 15, 20, 21 | B-2: Under the NCIMS Dairy HACCP program, aseptic processing and the design, construction and operation and testing of aseptic processing equipment must conform to all of the requirements of the Grade "A" Pasteurized Milk Ordinance, 21CFR 108 and 113, and the filed process for the products being produced. |
21 CFR 108 & 113 PMO Item 16p(C) | |
| Chemical | C-1: Cleaning & Sanitizing Solution Residues |
C-1: Without proper separation between cleaning & sanitizing solutions and product there could be product contamination. 9 | C-1: Maintain proper separation or physical break between circuits containing cleaning solution and vessels and lines used to contain product. Particular attention is needed to assure that the required separation remains in place during partial washes, sometimes called "short washes" or " inter-washes" that may be done during an operating day. |
PMO Item 15p(B) 3-A AP 605 21CFR 178.1010(a) |
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| Physical | None | ||||
| Aseptically Processed Product (bulk) - Storage | |||||
| Biological | B-1: Survival of pathogens such as C. botulinium |
B-1: Pathogens, if present, can grow during storage. 15, 20, 21 | B-1: Aseptic processing and the design, construction and operation and testing of aseptic processing equipment must conform to all of the requirements of the Grade "A" Pasteurized Milk Ordinance, 21CFR 108 and 113, and the filed process for the products being produced. Note: If cleaning frequencies are to be performed at frequencies less than those specified in the PMO Item 12p, they are to be reviewed and found acceptable to the State and FDA. |
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| Chemical | C-1: Cleaning & Sanitizing Solution Residues |
C-1: Without proper separation between cleaning & sanitizing solutions and product there could be product contamination. 9 | C-1: Maintain proper separation or physical break between circuits containing cleaning solution and vessels and lines used to contain product. |
PMO Item 15p(B) 3-A AP 605 21CFR 178.1010(a) |
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| Chemical | C-2: Toxic or carcinogenic substances in the packaging |
C-2: Packaging material, which does not meet CFR requirements, may contain toxic or carcinogenic substances. 18 | C-2: Packaging material comes from a source that has been verified to be free of toxic or carcinogenic substances. One way to do this is to use packaging from IMS listed sources. |
IMS List 21CFR 110.80 |
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| Physical | None | ||||
| Product lines and Equipment (General Concerns) | |||||
| Biological | B-1: Contamination by Vegetative Pathogens |
B-1: May introduce pathogens if unclean or uncleanable. |
B-1: Verify that product lines and equipment are constructed in such a way that they can be cleaned. Maintain records that storage vessels are cleaned after each use. Maintain records that the product lines and equipment cleaned as needed nut at least each day unless a longer interval has been reviewed and found acceptable to the State and FDA. |
3-A AP 605- PMO Item 10p, 11p, &12p |
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| Chemical | C-1: Allergens being mixed with products that are not labeled as containing allergens |
C-1: Foods may contain undeclared allergens may cause life threatening reactions in sensitive individuals. |
C-1: Ingredient addition equipment such as hoppers and feeders and associated piping and valves that are used for milk and milk products that contain allergens (other than milk) and milk and milk products that do not , must be thoroughly cleaned after use for allergens before it is used for foods that do not declare that allergen. |
3-A SS 02-, 32-, 35-, 51-, 52-, 63- , 68-, 73-, 81- FDA CPG 555.250 |
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| Physical | P-1: Extraneous Materials |
P-1: Maintain equipment in good repair. 12 | P-1: Foreign materials that may have contaminated the product. |
3-A SS 10- & 42- | |
| Use of water reclaimed from condensing or membrane processing of milk or whey Products | |||||
| Biological | B-1: Contamination by & growth of pathogen |
B-1: |
B-1: Properly implemented mandatory PP #1 - Safety of Water may reduce the likelihood of the occurrence of pathogens. |
PMO Appendix D - IV PMO Appendix K |
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| Chemical | None | ||||
| Physical | None | ||||
| Direct Addition of Steam | |||||
| Biological | None | ||||
| Chemical | C-1: Toxic Substances |
C-1: Some boiler water compounds used in the production of steam may contain toxic substances. |
C-1: Supplier guarantees that boiler water additives comply with 21CFR 173.310 and PMO requirements for culinary steam. |
3-A AP 609 PMO Appendix H(III) 21CFR 173.310 |
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| Physical | None | ||||
| Air Under Pressure (Incorporated into product or directed at a food contact surface.) | |||||
| Biological | B-1: Contamination by Pathogens |
B-1: Pathogens may be introduced in the air supply. |
B-1: Air is drawn from a clean area, is filtered at the intake as needed, and is provided to the point of use oil free and with free of excess moisture. A final filter is provided as near as possible to the point of use to verify these aspects. |
PMO Appendix H (II) PMO Item 15p(A)(4) DPC 8 |
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| Chemical | C-1: Toxic Substances |
C-1: Air compressor lubricants may be carried over into air and may be toxic. |
C-1: Air is drawn from a clean area, is filtered at the intake as needed, and is provided to the point of use oil free and with free of excess moisture. A final filter is provided as near as possible to the point of use to verify these aspects. |
3-A AP 604 21CFR 110.40(g) |
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| Physical | None | ||||
| Addition of reworked or reclaimed product | |||||
| Biological | B-1: Contamination by Pathogens |
B-1: Reclaimed or reworked product may have been handled in such a way to subject it to contamination with pathogens. |
B-1: Product, which has not been continuously in control of the plant, to be reclaimed or reworked is assumed to contain pathogens. When product is no longer under the control of the plant, it can not be assumed to have been held to preclude temperature abuse or adulteration. Only product that has not left the control of the plant should be used, kept segregated, handled, protected and cooled as appropriate for the product with the exception of product approved by the regulatory agency. Reworking is done in a clean area and in a manner that will not contaminate the product being salvaged. |
PMO 15p(A)(2), 15p(B)(4), 5p(3) & 18p(3) 21CFR 110.80(a) DPC 8 DPC 63 |
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| Chemical | C-1: Allergens being mixed with products that are not labeled as containing allergens |
C-1: Foods may contain undeclared allergens may cause life threatening reactions in sensitive individuals. |
C-1: Rework foods containing allergens "like into like". |
21CFR 110.80(a)(5) 21CFR 101.100(a)(3) FDA CPG 555.250 |
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| Physical | P-1: Extraneous Materials |
P-1: These can result in choking or other physical harm to consumers. 9, 12 | P-1: Opening of products is conducted in a manner that will minimize the opportunity for bits of packaging, cutting tools, etc. from entering the product. Verification that, at some point in the process ingredient or the milk product to which the ingredient is added, will pass through a filter, screen, small orifice (such as occurs during homogenization or other appropriate device. |
3-A 10 & 42 | |
