Introduction

On July 25, 1996, the Food Safety and Inspection Service (FSIS) of the United States Department of Agriculture (USDA) published a final rule on Pathogen Reduction; Hazard Analysis and Critical Control Point (HACCP) Systems (PR/HACCP). The PR/HACCP rule requires meat and poultry plants under Federal inspection to take responsibility for, among other things, reducing the contamination of meat and poultry products with disease-causing (pathogenic) bacteria. Reducing contamination with pathogenic bacteria is a key factor in reducing the number of deaths and illnesses linked to meat and poultry products. The Preamble to the final rule describes an overall system in which preventive and corrective measures are instituted at each stage of the food production process where food safety hazards could occur.

The HACCP requirements that plants must meet are set out in 9 CFR Part 417. HACCP is a scientific system for process control that has long been used in food production to prevent problems by applying controls at points in a food production process where hazards could be controlled, reduced or eliminated. A plant must have an effective HACCP system to comply with regulatory requirements and prevent adulteration of product.

The HACCP regulatory requirements become effective on different dates for plants of differing sizes:

Large plants – those with 500 or more employees – on January 26, 1998;
Smaller plants – those with fewer than 500 but at least 10 employees on January 25, 1999; and
Very small plants – those with fewer than 10 employees or annual sales less than $2.5 million – on January 25, 2000.

Note: This Guidebook and other FSIS technical assistance materials are designed to assist establishments subject to the regulatory requirements of 9 CFR Part 417 in complying with those requirements. Part 417 is reproduced in Appendix A. These regulatory requirements are slightly different from the various explanations of HACCP developed by the National Advisory Committee on Microbiological Criteria for Foods (NACMCF), the most recent version of which was published in 1997.

Developing a HACCP Plan

FSIS is providing this Guidebook for the Preparation of HACCP Plans to help plants develop and set up their HACCP systems. There are other FSIS publications which may be helpful. This Guidebook is the most basic of the FSIS materials. FSIS has also developed thirteen generic models that plants can use to see if their specific plans are generally on target or help them get started. The generic models are more specific than this Guidebook and each one has at least one fully developed product example which establishment HACCP teams can study. However, even though the generic models have more detailed information, they are not designed to be used “as is.” A company will still need to tailor the plan to suit the specific circumstances of its own production process.

Policy Notices

In order to clarify issues, which were raised in conjunction with the first implementation date, FSIS published a series of Policy Notices in the Federal Register. Copies are included as Appendix C. The issues addressed include:

Livestock Carcasses and Poultry Carcasses Contaminated with Visible Fecal Material (November 28, 1997)

Contents of HACCP Plans; Critical Control Points (January 30, 1998)

Contents of HACCP Plans (January 30, 1998)

Establishment Review of Product Production Records (March 6, 1998)

HACCP Plan Requirements and Meat and Poultry Product Processing Categories; Policy Clarification (April 1, 1998)

Listeria Monocytogenes Contamination of Ready-to-Eat Products (May 26, 1999)

Establishments may wish to refer to these Policy Notices if they need further clarification about the aspects of the regulations that are addressed.

In addition to written materials, FSIS has held a number of events to assist establishments in meeting regulatory requirements in a timely manner; these include both implementation conferences and technical assistance workshops.

Finally, FSIS has developed and put in place resources which are available to answer specific questions; the FSIS Technical Service Center operates a HACCP Helpline (1-800-233-3935 ext.2) which provides answers to technical questions from inspection personnel and establishments. Also FSIS has organized HACCP contacts in each of the states, to which establishments can turn for help with their specific problems. The District Office can provide information on the State HACCP Network.

Advice and assistance on developing HACCP systems can be obtained from many sources other than FSIS (use the Internet web site: www.nal.usda.gov/fnic/foodborne/haccp/index.shtml). FSIS encourages establishment officials to consult and use a variety of resources as they go about planning, documenting, and validating their HACCP systems. Also included in this Guidebook is a list of references that can be used by all HACCP teams that have been included as Appendix B. However, when HACCP regulations become effective in an establishment, it is the requirements of Part 417 that must be met. Establishment employees with a thorough understanding of HACCP concepts should still review the regulatory requirements of this part to make sure they achieve compliance. This Guidebook has been revised to make it easier for users to relate its practical advice with the need to be in compliance with regulatory requirements.

Preliminary Steps

FSIS and most HACCP experts believe that a company will do a better job of HACCP plan development if it takes some preliminary steps before it attempts to apply the seven principles and write a plan. FSIS believes that a company should take the following steps to get started:

1. Assemble the HACCP team, including one person (consultant, employee, or other resource) who is HACCP-trained.

2. Describe the food and its method of production and distribution; identify the intended use and consumers of the products.

3. Develop and verify process flow diagram(s).

4. Decide whether products can be grouped using the process categories in 417.2(b)(1).

The first part of this Guidebook discusses how companies, especially small or very small companies, can go about taking these preliminary steps. Numbers 2-4 are parts of the regulatory requirements in §417.2(a).

1. Assemble the HACCP team, including one person who is HACCP-trained.

Assembling a HACCP team may seem like a daunting task, especially for the owner of a very small or family-centered company. However, FSIS strongly encourages companies to have more than one person working on the development of HACCP system(s). This is because HACCP system development is one of those tasks that are probably better done by more than one person, even in a very small company. HACCP is an overall process control system and we believe it takes a variety of different kinds of knowledge and experience to develop a good system. If your company has only a few people in it, they may all need to be on the HACCP team, because they all probably have multiple roles and responsibilities in the company’s operations.

You should consider including on your HACCP team, some resources which may be outside your company. You may be able to get help from a trade association or from a local college, university or extension office which has people in it who know about HACCP process control systems. It is possible that companies which supply or receive your products and have already implemented HACCP may be interested in and willing to provide assistance. FSIS has offered technical assistance workshops to groups of plants that came together to a central location and worked through the process of system development in small steps.

One resource you must include is an individual who has been trained in HACCP in accordance with the requirements of Sec. 417.7. These requirements are that the individual has successfully completed a course in applying the seven principles of HACCP to meat or poultry product processing; the course needs to have included a segment on HACCP plan development for a specific product and a segment on record review. This HACCP-trained individual does not need to be a company employee, but does need to be available to you for plan development and for certain other functions, like reassessing your HACCP plan(s).

2. Describe the food and its method of production and distribution; identify the intended use and consumers of the products.

The next preliminary step to take is to have the HACCP team describe the product(s) and their methods of production and distribution. If your team includes the people who know how things work in your operations, they should be able to do this quite easily. The important thing for them to keep in mind is that they need to include every step in the process. In order to help you make sure you include all the key information, we have prepared a form which could be used to accomplish this task. Attachment 1 is this form and like all the forms in this Guidebook, its use is optional.

Whether you use the form or not, the following questions should be answered when you describe the product:

1. What is the common name of the product?
2. How is the product to be used?
3. What type of packaging encloses the product?
4. What is the length of shelf life of the product, at what temperature?
5. Where will the product be sold? *Who is the intended consumer and what is the intended use?
6. What labeling instructions are needed?
7. Is special distribution control needed?

* Regulatory requirement

After your team has described the products in words, they can move on to the next preliminary step.

3. Develop and verify process flow diagram(s).

A flow diagram is a simple schematic picture of the process you use in your plant to produce the product. You do not need any fancy equipment, such as a computer, to produce a flow diagram. However, it does need to be an accurate, clear sketch of the process used in your plant to make the product. Attachment 2 is an example of a simple flow diagram for a relatively simple process; Attachment 3 is a more complex flow diagram for a more complicated process. Either one would be an adequate flow diagram if it accurately pictured what was actually happening in the plant.

The best means to make sure your flow diagram is accurate is to have the HACCP team verify it by walking through the plant and making sure all the steps in the process you carry out are included in the flow diagram. Verifying the flow diagram is a step your team should be sure to do carefully. It is also a common means by which auditors or inspectors verify that a particular flow diagram is correct and complete.

When you are certain that you have an accurate flow diagram and your team has verified it, it is time to move to the final preliminary step.

4. Decide whether products can be grouped using the process categories in 417.2(b)(1).

This part of the regulations lists nine process categories into which meat and poultry production can be grouped; they and some examples are:

(i) Slaughter--all species: beef, swine, and poultry

(ii) Raw product—ground: ground beef, ground pork, ground turkey

(iii) Raw product--not ground: boneless cuts, steaks

(iv) Thermally processed--commercially sterile: canned beef stew, Pasta with meat

(v) Not heat treated--shelf stable: summer sausage, dry salami

(vi) Heat treated--shelf stable: meat and poultry jerky, snack sticks

(vii) Fully cooked--not shelf stable: hot dogs, wieners, roast beef, ham

(viii) Heat treated but not fully cooked--not shelf stable: partially cooked patties, bacon

(ix) Product with secondary inhibitors--not shelf stable: corned beef, cured beef tongue

One way to cut down on the paperwork that is a part of HACCP system is to control all products in the same process category using a single HACCP plan. This is especially advantageous for very small establishments which may produce many different products. If those products differ only in characteristics that would not affect safety, e.g. the amount or kind of seasoning used (hot vs. mild), they are clearly in the same process category and may be covered by the same HACCP plan.

FSIS has developed eleven generic HACCP models for the processes listed above and two more specific processes, Mechanically Separated (Species)/ Mechanically Deboned Poultry and Irradiation (including all forms of approved irradiation procedures).

Now you have completed the preliminary steps that will prepare you for HACCP system development. It is time for your team to apply the seven principles of HACCP and develop your HACCP plan. The next seven sections (principles) of this Guidebook will take you through this process.

PRINCIPLE I: CONDUCT A HAZARD ANALYSIS

The first principle of HACCP is to conduct a hazard analysis. Part 417 contains definitions as well as specific provisions which affect how your HACCP team must go about conducting its hazard analysis. Before beginning the process, your team should review the definitions of food safety hazard and preventive measure, and look specifically at the requirements of 417.2(a).

A. Conducting a hazard analysis is generally considered to be a two-step process. The first step is to identify the threats to human health which might be introduced into meat and poultry products as those products are produced. These hazards are usually grouped into three categories: Biological (including microbiological),Chemical, and Physical.

1 Biological Hazards

Biological hazards are living organisms that can make food unsafe to eat. Biological hazards may be bacterial, parasitical, or viral. Biological hazards are frequently associated with the raw materials from which meat and poultry products are made, including the animals and birds which are primary components. However, biological hazards may be introduced during the processing of meat and poultry products: from the people who are involved in the processing; from the environment in which the foods are processed; from other ingredients in the products; or from the processes themselves.

Identifying the biological hazards to which your production processes might be subjected is clearly a difficult and important task—one that requires all the expertise that your HACCP team can bring to it. Currently, there is a great deal of emphasis on microbial hazards associated with meat and poultry products. Some of the major pathogens that may be associated with meat and poultry products are: Salmonella, Campylobacter jejuni, Escherichia coli 0157:H7, Listeria monocytogenes, Clostridium botulinum, Staphylococcus aureus, and Yersinia enterocolitica. For details, refer to NACMCF document reference 14 listed in Appendix B.

2. Chemical Hazards

Chemical hazards may be the result of something naturally occurring in foods or added during the processing of foods. Harmful chemicals have been associated with both acute cases of foodborne illness and chronic illness.

Naturally occurring chemical hazards are those that are natural constituents of foods and not the result of environmental, industrial, or other contamination. They include aflatoxins, mycotoxins and shellfish toxins.

Added chemical hazards are those which are intentionally or sometimes unintentionally added to food during the growing, harvesting, storage, processing, packaging, or distribution phases of production. This group of chemical hazards is very broad and might include components of animal feed or drinking water, animal drugs, pesticides, food ingredients themselves, or chemicals used in the processing establishment such as lubricants, cleaners, paints, and coatings.

3. Physical Hazards

A physical hazard is a physical component of a food that is unexpected and may cause illness or injury to the person consuming the food. Foreign materials such as glass, metal, or plastic are familiar physical hazards in meat and poultry products, usually found because a process or a piece of equipment has not been properly controlled while the food was being produced.

There are a number of situations that can contribute to physical hazards in foods; they include:

--Contaminated raw materials;
--Poorly designed or poorly maintained facilities and equipment;
--Contaminated packaging materials; and,
--Inattention to details by employees with key responsibilities.

B. This first step in identifying hazards which might be associated with your production process might be considered like a “brainstorming” session. Your HACCP team should use the flow diagram and product description, which you created in your preliminary steps, and systematically think about what could occur at each step in the process. Attachment 4 is a checklist of questions which might help your team to be as thorough as possible in considering the hazards which might be associated with your process.

C. The second step in performing a hazard analysis is to identify preventive measures that could be used to control each hazard. Preventive measures are the physical, chemical, or other means that can be used to control a food safety hazard. Attachment 5 is a form which you can use to go through your process systematically, identify the hazards which might occur at each step in the process and the preventive measures which might be used to prevent, eliminate, or reduce each hazard to an acceptable level which you can use in conjunction with the checklist. More than one preventive measure may be needed to control a food safety hazard and more than one food safety hazard may be controlled by a specific preventive measure.

D. Attachment 6 is a hazard analysis which has been completed for a simple raw, ground process. When developing your hazard analysis, be sure to remember that supporting documentation for the decisions reached by the team is very important and a regulatory requirement [§ 417.5(a)(1)]. The supporting documentation can consist of the regulatory citation if the critical limit is based on a regulation, a scientific paper, study, or in-plant study. Historical information about the process can also be used. This information should be summarized as part of the supporting documentation for the team’s decisions. When making determinations about whether a hazard is reasonably likely to occur, it is helpful to list the actual hazard or organism of concern. For example, metal contamination from equipment, Salmonella, Escherichia coli O157:H7, Campylobacter jejuni, Listeria monocytogenes or other specific pathogenic hazards, or a specific residue that is known to occur in a like product. You will find this information very helpful when yearly reassessment, a deviation, or an unforeseen hazard occurs.

We cannot overemphasize how important it is to do a good job on your hazard analysis. This is often a difficult and time-consuming step, and one that requires all the various technical and scientific resources you can obtain. You can refer to the NACMCF DRAFT document - “FSIS Microbiological Hazard Identification Guide for Meat and Poultry Components of Products Produced by Very Small Plants”, August 1999 (Appendix B, Reference 14)” We know that doing a good job and taking your time here is worth the effort. You cannot expect to develop a good HACCP system if you have not been careful and thorough in your hazard analysis.

PRINCIPLE II: IDENTIFY THE CRITICAL CONTROL POINTS

The second HACCP principle is to identify the critical control points (CCPs) in the process. A CCP is a point, step, or procedure in a food process at which control can be applied and, as a result, a food safety hazard can be prevented, eliminated, or reduced to acceptable levels.

So far, in developing the HACCP plan, your HACCP team has identified biological, chemical, and physical hazards in the raw materials and the ingredients you use as well as in the steps of your process. For each food safety hazard reasonably likely to occur, you have identified a preventive measure. Your next step is to find the point or points in the process where these preventive measures should be applied.

Fortunately, a great deal of work has already been done in identifying points where control can be applied in a process . Many points are commonly recognized in various food processing and production systems. Some common points where control can be applied in your process include:

--Chilling to temperatures that minimize microbial growth;
--Cooking to specific temperatures for exact times in order to destroy microbial pathogens;
--Product formulations, such as the addition of cultures or adjustment of pH or water activity;
--Processing procedures such as filling and sealing cans; and,
--Slaughter procedures such as evisceration or antimicrobial interventions.

These are just a few examples of measures that may be CCPs. There are many more possibilities. Different facilities preparing the same food can differ in the number and types of CCPs they choose to use. This is to be expected.

The FSIS generic models, as well as other generic models, give you some ideas about what CCPs might work in the various process categories which are discussed. Your team needs to remember that these are just ideas designed to help get your team thinking creatively and carefully about your own processes and how you want to control them with your HACCP system.

Note: Identifying CCPs is one area in which there are differences between the regulatory requirements of Part 417 and the NACMCF guidance materials (reference 13). The latter include the use of a Decision Tree; the Decision Tree approach is not necessary for you to meet regulatory requirements; however, the thought process may be helpful. You must make sure that your HACCP system meets regulatory requirements.

PRINCIPLE III: ESTABLISH CRITICAL LIMITS FOR EACH CRITICAL CONTROL POINT

HACCP principle three instructs your team to establish critical limits for each preventive measure you will carry out at each CCP. This step involves establishing a criterion that must be met for each preventive measure associated with a CCP. Part 417 defines a critical limit as: the maximum or minimum value to which a physical, biological, or chemical hazard must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard.

Critical limits are the boundaries of safety for preventive measures put in place at CCPs. A critical limit will usually be a reading or observation such as a temperature, a time, a product property such as water activity, or a chemical property such as available chlorine, salt concentration, or pH. Critical limits need to be exact and specific; HACCP plans should not include ranges as critical limits.

Many critical limits for identified CCPs have been established, either through regulatory requirements or through the technical and scientific literature, which are the bases of production processes. Your HACCP team will probably be familiar with many of these established critical limits such as: the minimum internal temperature to which products must be cooked; the time which may elapse while product is being cooled to a specific temperature; the maximum dimensions of any metal fragments which could be found in products. These critical limits must be met if product safety is to be maintained.

When deciding what your critical limits should be, there are several sources to consider. First and foremost are the regulatory requirements which apply to your processes. These must be met. For example, if you produce cooked beef products, you must have critical limits that meet the current FSIS regulatory requirements for those products. There may be other sources of critical limits, such as the times and temperatures that you use in making the products you produce. These may be based on scientific and technical information from studies or food processing textbooks or they may be based on family recipes that have been passed down from one generation to the next and have scientifically been shown to produce safe product. Critical limits may be drawn from specific challenge studies or from recognized experts. In any case, you need to establish a critical limit for each preventive measure you intend to apply at your CCPs.

There are two types of critical limits. A critical limit can be an upper limit where a set amount or level cannot be exceeded. A critical limit can also be a lower limit where a minimum amount is required to produce the safe effect. To address the hazard in ground product of metal fragments from the grinding equipment, the upper critical limit for the preventive measure could be no sharp metal fragments more than 1/32 inch. A grinding room temperature of 50° F to help control pathogen growth is another kind of upper critical limit. An example of a lower critical limit would be the addition of an acidifier to inhibit bacterial growth.

PRINCIPLE IV: ESTABLISH MONITORING PROCEDURES

To carry out HACCP principle four, your team needs to establish monitoring procedures. Monitoring procedures are those things which are done routinely, either by employee or by mechanical means, which measure the process at a given CCP, and create a record for future use. Some monitoring procedures are employee observations or checks, such as checking the documentation accompanying incoming materials. Some monitoring procedures are records from instruments, such as recording thermometers.

Continuous monitoring is always preferred when it is feasible. When it is not possible, then your HACCP team will need to decide what will be their non-continuous monitoring procedures and how frequently they will be performed. There are several issues to consider when deciding the frequency of non-continuous monitoring checks; the most important is that the procedures must be performed sufficiently often to accurately reflect that the process is under control. Expert advice from people with knowledge of practical statistics and statistical process control will be important in making your decisions about frequency.

Another factor that HACCP teams must consider is the capacity of the plant to take corrective actions when monitoring procedures reveal that there have been deviations from critical limits. When monitoring procedures show that there has been a deviation from a critical limit, corrective actions need to be applied to all the potentially noncomplying product. This usually includes all the product produced since the time of the last successful monitoring procedure result. So, if your monitoring procedure was to perform a physical check on arriving product, and your team decided to do this only once per shift, a deviation from the critical limit would mean that you needed to apply corrective actions to all the product which had arrived during the shift.

Another matter for your HACCP team to consider when they are deciding on what should be the monitoring procedures and how frequently they should be performed is the need for rapid, real time feedback. Generally, physical and chemical procedures are preferred over microbial approaches for monitoring because they provide more rapid feedback.

Monitoring procedures need to be well planned and effective because of the potentially serious consequences of loss of control. Employees monitoring CCPs should be trained in the technique to be used to monitor each preventive measure or control. They should fully understand the purpose and importance of monitoring and accurately report monitoring activities and results. They must have complete access to the CCP being monitored and to the process-monitoring instruments being used.

The persons performing monitoring must record exact values where exact values are indicated, not “yes/no” or “OK” observations. This means that if the critical limit is a minimum internal temperature of 160° F, the observations on the monitoring record would be recorded as “162 ?F,” “163?F” rather than “yes” or “OK.”

Attachment 7 is a simple form which your team might use to help them decide on monitoring procedures and their frequency.

PRINCIPLE V: ESTABLISH CORRECTIVE ACTIONS

HACCP principle five says: Establish corrective actions to be taken when monitoring shows that there is a deviation from a critical limit. In addition, § 417.3 identifies the four features of corrective actions that FSIS regulators will be checking; they are:

1. Has the cause of the deviation been identified and eliminated?;
2. Will the CCP be under control after the corrective action has been taken?;
3. Have measures to prevent recurrence of the deviation been established?; and,
4. Do the corrective action procedures make sure that no product, which is injurious to
health or otherwise adulterated because of the deviation enters commerce?

HACCP is a preventive system to correct problems before they affect the safety of the food products people actually consume. Deviations from critical limits will occur; therefore, you need to have a plan to make sure those deviations do not lead to unsafe products. Planned corrective actions are the way you do this. Your HACCP team needs to understand how important it is to carefully carry out this principle.

For each CCP, your team needs to devise a standardized set of actions that company employees will follow when there is a deviation from a critical limit. These are some questions they might ask in developing corrective actions:

How will people be informed when the deviation occurs? If a person is performing the monitoring procedure, who will that person contact?

Who will be responsible for controlling the product that may have been affected by the deviation? How should that person decide how much product needs to be controlled?

Who will be involved in deciding what to do about the product which might have been affected by the deviation?

How will we decide what was the cause of the deviation? If we need technical experts outside the company, how do we get them?

Once we have figured out what was the cause of the deviation, who will be involved in deciding how to get the process back in control and prevent recurrence of the deviation?

If our HACCP trained individual is not available in the plant immediately, how can we get HACCP expertise to help decide if our plan needs to be modified?

Who in the company needs to sign off on any modifications to our plan?

Who will be responsible for keeping the records of everything we do in response to a deviation from a critical limit at this CCP?

If any person who has a responsibility in our corrective action plan is not available, who will be the back-up?

Is this set of corrective actions feasible at all times?

Attachment 8 is a simple form to help your HACCP team make sure they have developed appropriate corrective actions for each CCP. Part 417 includes regulatory requirements which must be followed when a deviation not covered by a specific corrective action occurs or if an unforeseen hazard occurs. Your team should study § 417.3(b) so that you know what to do when this happens. In many ways, the actions to be taken will be generally similar to what you plan to do at any specific CCP—get control of the product, figure out what was the cause and how to keep it from happening again, decide whether to modify your HACCP plan, etc. Your team should at least think about how you want to handle these situations.

PRINCIPLE VI: ESTABLISH RECORDKEEPING PROCEDURES

HACCP principle number 6 is to establish effective recordkeeping procedures that document the HACCP system. The regulatory recordkeeping requirements for meat and poultry establishments are found in § 417.5 and are quite comprehensive. Your team should review them carefully.

Even though people often complain about it, recordkeeping is an essential feature of a HACCP system and must be planned and carried out as carefully as any other element. This principle requires the development and maintenance of records about both plan development and the operation of the system. In a study on HACCP prepared by the Department of Commerce it was clear that, without recordkeeping, problems were more likely to recur.

Even though people may grumble about keeping records, the practice can be made sensible and suitable for the operation in question. Clearly more sophisticated records will be required for more complex operations. One way to approach development of the recordkeeping requirements of your HACCP system is to review the records you already keep and see if they are suitable, in their present form or with minor modifications, to serve the purposes of your HACCP system. The best recordkeeping system is usually the simplest one that can be easily integrated into the existing operation.

When you are setting up your recordkeeping system, think about who will be in the best position to make the record entry, who will need to review the record prior to shipping, plus, when and where will be the best place to keep the records. Think about making simple understandable forms that will work well in your situation. Make sure your employees know exactly what is expected if they are responsible for making a record entry. It is extremely important that they sign and date the records at the time the specific event occurs.

Records do not need to be in any particular format. Often HACCP plans are presented in a tabular form. Attachment 9 is an example of a blank HACCP Plan form in a typical format. Attachment 10 is a list of some typical records of a HACCP system in operation. The PR/HACCP regulation also includes a requirement for preshipment review in § 417.5(c). This step can provide you added assurance that you have done everything in your HACCP plan before you ship the product. There are examples in each of the generic models on how this can be accomplished.

PRINCIPLE VII: ESTABLISH VERIFICATION PROCEDURES

HACCP principle seven is to establish verification procedures to make sure the plan is working correctly.

Your team needs to decide on what procedures the plant will perform to verify that the HACCP system is working effectively and how often these actions will be performed. Verification uses methods, procedures, or tests in addition to those used in monitoring to see whether the HACCP system is in compliance with the HACCP plan or whether the HACCP plan needs modification. There are three types of verification.

Validation is the initial phase in which the plan is tested and reviewed. The choices made while working through the preliminary steps and HACCP principles must be repeatedly tested and shown to prevent or control identified hazards in the “real world”. In this phase, microbial or residue testing can be used effectively to verify that the process is in control and is producing acceptable product. Such testing provides clear evidence that the techniques and methods adopted by the plant to control hazards are not just effective in theory but will work in this specific plant.

Ongoing verification ensures that the HACCP plan is working effectively on a day-to-day basis. This type of verification includes such tasks as calibrating monitoring instruments, observing monitoring activities and corrective actions, and reviewing HACCP records to see that they are being made and kept according to the plan.

Reassessment is an overall review of the plan that must be performed at least annually, or whenever any changes occur that could affect the hazard analysis or alter the HACCP plan. Reassessment is similar to validation in that it considers whether the plan is adequate in general rather than focusing on the plan's daily operations. It is also similar to validation in that it must be done by a HACCP-trained person.

ATTACHMENTS

Attachment 1 - PRODUCT DESCRIPTION

Attachment 2 - PROCESS FLOW DIAGRAM

Attachment 3 - PROCESS FLOW DIAGRAM

Attachment 4 - Checklist of Questions (Hazard Analysis Process)

This point in hazard analysis consists of asking a series of questions that are appropriate to each step in the flow diagram. The hazard analysis should question the effect of a variety of factors on the safety of the food.

1. Ingredients
Does the food contain any sensitive ingredients that are likely to present microbiological hazards (e.g. Salmonella. Staphylococcus aureus), chemical hazards (e.g., aflatoxin, antibiotic, or pesticide residues) or physical hazards (stones, glass, bone, metal)?

2. Intrinsic factors of food
Physical characteristics and composition (e.g., pH, type of acids, fermentable carbohydrates, water activity, preservatives) of the food during and after preparation which can cause or prevent a hazard.

Which intrinsic factors of the food must be controlled in order to ensure food safety?

Does the food permit survival or multiplication of pathogens and/or toxin formation before or during preparation?

Will the food permit survival or multiplication of pathogens and/or toxin formation during subsequent steps of preparation, storage, or consumer possession?

Are there other similar products in the market place? What has been the safety record for these products?

3. Procedures used for preparation/processing
Does the preparation procedure or process include a controllable step that destroys pathogens or their toxins? Consider both vegetative cells and spores.

Is the product subject to recontamination between the preparation step (e.g., cooking) and packaging?

4. Microbial content of the food
Is the food commercially sterile (i.e., low acid canned food)?

Is it likely that the food will contain viable sporeforming or nonsporeforming pathogens?

What is the normal microbial content of the food stored under proper conditions?

Does the microbial population change during the time the food is stored before consumption?

Does that change in microbial population alter the safety of the food?

5. Facility design
Does the layout of the facility provide an adequate separation of raw materials from ready-to-eat foods?

Is positive air pressure maintained in product packaging areas? Is this essential for product safety?

Is the traffic pattern for people and moving equipment a potential source of contamination?

6. Equipment design
Will the equipment provide the time/temperature control that is necessary to meet critical limits?

Is the equipment properly sized for the volume of food that will be prepared?

Can the equipment be controlled so that the variation in performance will be within the tolerances required to produce a safe food?

Is the equipment reliable or is it prone to frequent breakdowns?

Is the equipment designed so that it can be cleaned and sanitized?

Is product contamination with hazardous substances, e.g., glass, likely to occur?

What product safety devices such as time/temperature integrators are used to enhance consumer safety?

7. Packaging
Does the method of packaging affect the multiplication of microbial pathogens and/or the formation of toxins?

Is the packaging material resistant to damage, thereby preventing the entrance of microbial contamination?

Is the package clearly labeled “Keep Refrigerated” if this is required for safety?

Does the package include instructions for the safe handling and preparation of the food by the consumer?

Are tamper-evident packaging features used?

Is each package legibly and accurately coded to indicate production lot?

Does each package contain the proper label?

8. Sanitation
Can the sanitation practices that are employed impact upon the safety of the food that is being prepared?

Can the facility be cleaned and sanitized to permit the safe handling of foods?

Is it possible to provide sanitary conditions consistently and adequately to ensure safe foods?

9. Employee health, hygiene, and education
Can employee health or personal hygiene practices impact the safety of the food being prepared?

Do the employees understand the food preparation process and the factors they must control to ensure safe foods?

Will the employees inform management of a problem which could impact food safety?

10. Conditions of storage between packaging and the consumer
What is the likelihood that the food will be improperly stored at the wrong temperature?

Would storage at improper temperature lead to a microbiologically unsafe food?

11. Intended use
Will the food be heated by the consumer?

Will there likely be leftovers?

12. Intended consumer
Is the food intended for the general public, i.e., a population that does not have an increased risk of becoming ill?

Is the food intended for consumption by a population with increased susceptibility to illness (e.g., infants, the elderly, the infirm, and immunocompromised individuals)?

Attachment 5 - HAZARD IDENTIFICATION/PREVENTIVE MEASURES

APPROVED BY:_________________________________________ Date:____________

Attachment 6 - HAZARD ANALYSIS – RAW PRODUCT, GROUND – Fresh Pork Sausage

Attachment 7 - HACCP PLAN DEVELOPMENT FORM: MONITORING PROCEDURES AND FREQUENCY

* 417.5(b), 417.2(6), 417.2(4)- Who refers to the requirement that records must be initialed; When – to the time the specific event occurs; What – the measurement to determine compliance at the CCP; and How - the method used to monitor the CCP.

Attachment 8 - HACCP PLAN DEVELOPMENT FORM: CORRECTIVE ACTIONS

*Be sure to include your planned actions to address all parts of § 417.3.

Attachment 9 - HACCP PLAN

Signature: __________________________________

Date: ______________________________________

Attachment 10 - List of Some Typical Records of a HACCP System in Operation

1. Ingredients

• Records from all monitored CCPs

• Supplier certification documenting compliance with establishment’s specifications.

• Establishment’s audit records verifying supplier compliance.

• Storage temperature record for temperature-sensitive ingredients.

• Storage time records of limited shelf-life ingredients.

2. Preparation

• Records from all monitored CCPs.

• Records verifying the continued adequacy of the food preparation procedures.

3. Packaging

• Records indicating compliance with specifications for packaging materials.

• Records indicating compliance with sealing specifications.

4. Finished product

• Sufficient data and records to establish the efficacy of barriers in maintaining product safety.

• Sufficient data and records to establish the safe shelf-life of the product if age of product can affect safety.

• Documentation of the adequacy of the HACCP procedures from an authority knowledgeable of the hazards involved and necessary controls.

5. Storage and distribution

• Temperature records.

• Records showing no product shipped after shelf-life date on temperature-sensitive products.

6. Deviation and corrective action

• Records of all actions taken following deviations at a CCP.

• Reassessment records and modifications to the HACCP plan indicating approved revisions and changes in ingredients, formulations, preparation, packaging, and distribution control, as needed.

7. Employee training

• Records indicating that employees responsible for implementation of the HACCP plan understand the hazards, controls, and procedures.

APPENDIX A

PART 417--HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS

§ 417.1 Definitions.

For purposes of this part, the following definitions shall apply:

Corrective action. Procedures to be followed when a deviation occurs.

Critical control point. A point, step, or procedure in a food process at which control can be applied and, as a result, a food safety hazard can be prevented, eliminated, or reduced to acceptable levels.

Critical limit. The maximum or minimum value to which a physical, biological, or chemical hazard must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard.

Food safety hazard. Any biological, chemical, or physical property that may cause a food to be unsafe for human consumption.

HACCP System. The HACCP plan in operation, including the HACCP plan itself.

Hazard. SEE Food Safety Hazard.

Preventive measure. Physical, chemical, or other means that can be used to control an identified food safety hazard.

Process-monitoring instrument. An instrument or device used to indicate conditions during processing at a critical control point.

Responsible establishment official. The individual with overall authority on-site or a higher level official of the establishment.

§ 417.2 Hazard Analysis and HACCP Plan.

(a) Hazard analysis. (1) Every official establishment shall conduct, or have conducted for it, a hazard analysis to determine the food safety hazards reasonably likely to occur in the production process and identify the preventive measures the establishment can apply to control those hazards. The hazard analysis shall include food safety hazards that can occur before, during, and after entry into the establishment. A food safety hazard that is reasonably likely to occur is one for which a prudent establishment would establish controls because it historically has occurred, or because there is a reasonable possibility that it will occur in the particular type of product being processed, in the absence of those controls.

(2) A flow chart describing the steps of each process and product flow in the establishment shall be prepared, and the intended use or consumers of the finished product shall be identified.

(3) Food safety hazards might be expected to arise from the following:

(i) Natural toxins;

(ii) Microbiological contamination;

(iii) Chemical contamination;

(iv) Pesticides;

(v) Drug residues;

(vi) Zoonotic diseases;

(vii) Decomposition;

(viii) Parasites;

(ix) Unapproved use of direct or indirect food or color additives; and

(x) Physical hazards.

(b) The HACCP plan. (1) Every establishment shall develop and implement a written HACCP plan covering each product produced by that establishment whenever a hazard analysis reveals one or more food safety hazards that are reasonably likely to occur, based on the hazard analysis conducted in accordance with paragraph (a) of this section, including products in the following processing categories:

(i) Slaughter--all species.

(ii) Raw product--ground.

(iii) Raw product--not ground.

(iv) Thermally processed--commercially sterile.

(v) Not heat treated--shelf stable.

(vi) Heat treated--shelf stable.

(vii) Fully cooked--not shelf stable.

(viii) Heat treated but not fully cooked--not shelf stable.

(ix) Product with secondary inhibitors--not shelf stable.

(2) A single HACCP plan may encompass multiple products within a single processing category identified in this paragraph, if the food safety hazards, critical control points, critical limits, and procedures required to be identified and performed in paragraph (c) of this section are essentially the same, provided that any required features of the plan that are unique to a specific product are clearly delineated in the plan and are observed in practice.

(3) HACCP plans for thermally processed/commercially sterile products do not have to address the food safety hazards associated with microbiological contamination if the product is produced in accordance with the requirements of part 318, subpart G, or part 381, subpart X, of this chapter.

(c) The contents of the HACCP plan. The HACCP plan shall, at a minimum:

(1) List the food safety hazards identified in accordance with paragraph (a) of this section, which must be controlled for each process.

(2) List the critical control points for each of the identified food safety hazards, including, as appropriate:

(i) Critical control points designed to control food safety hazards that could be introduced in the establishment, and

(ii) Critical control points designed to control food safety hazards introduced outside the establishment, including food safety hazards that occur before, during, and after entry into the establishment;

(3) List the critical limits that must be met at each of the critical control points. Critical limits shall, at a minimum, be designed to ensure that applicable targets or performance standards established by FSIS, and any other requirement set forth in this chapter pertaining to the specific process or product, are met;

(4) List the procedures, and the frequency with which those procedures will be performed, that will be used to monitor each of the critical control points to ensure compliance with the critical limits;

(5) Include all corrective actions that have been developed in accordance with § 417.3(a) of this part, to be followed in response to any deviation from a critical limit at a critical control point; and

(6) Provide for a recordkeeping system that documents the monitoring of the critical control points. The records shall contain the actual values and observations obtained during monitoring.

(7) List the verification procedures, and the frequency with which those procedures will be performed, that the establishment will use in accordance with § 417.4 of this part.

(d) Signing and dating the HACCP plan. (1) The HACCP plan shall be signed and dated by the responsible establishment individual. This signature shall signify that the establishment accepts and will implement the HACCP plan.

(2) The HACCP plan shall be dated and signed:

(i) Upon initial acceptance;

(ii) Upon any modification; and

(iii) At least annually, upon reassessment, as required under § 417.4(a)(3) of this part.

(e) Pursuant to 21 U.S.C. 456, 463, 608, and 621, the failure of an establishment to develop and implement a HACCP plan that complies with this section, or to operate in accordance with the requirements of this part, may render the products produced under those conditions adulterated.

§ 417.3 Corrective actions.

(a) The written HACCP plan shall identify the corrective action to be followed in response to a deviation from a critical limit. The HACCP plan shall describe the corrective action to be taken, and assign responsibility for taking corrective action, to ensure:

(1) The cause of the deviation is identified and eliminated;

(2) The CCP will be under control after the corrective action is taken;

(3) Measures to prevent recurrence are established; and

(4) No product that is injurious to health or otherwise adulterated as a result of the deviation enters commerce.

(b) If a deviation not covered by a specified corrective action occurs, or if another unforeseen hazard arises, the establishment shall:

(1) Segregate and hold the affected product, at least until the requirements of paragraphs (b)(2) and (b)(3) of this section are met;

(2) Perform a review to determine the acceptability of the affected product for distribution;

(3) Take action, when necessary, with respect to the affected product to ensure that no product that is injurious to health or otherwise adulterated, as a result of the deviation, enters commerce;

(4) Perform or obtain reassessment by an individual trained in accordance with § 417.7 of this part, to determine whether the newly identified deviation or other unforeseen hazard should be incorporated into the HACCP plan.

(c) All corrective actions taken in accordance with this section shall be documented in records that are subject to verification in accordance with § 417.4(a)(2)(iii) and the recordkeeping requirements of § 417.5 of this part.

§ 417.4 Validation, Verification, Reassessment.

(a) Every establishment shall validate the HACCP plan's adequacy in controlling the food safety hazards identified during the hazard analysis, and shall verify that the plan is being effectively implemented.

(1) Initial validation. Upon completion of the hazard analysis and development of the HACCP plan, the establishment shall conduct activities designed to determine that the HACCP plan is functioning as intended. During this HACCP plan validation period, the establishment shall repeatedly test the adequacy of the CCP's, critical limits, monitoring and recordkeeping procedures, and corrective actions set forth in the HACCP plan. Validation also encompasses reviews of the records themselves, routinely generated by the HACCP system, in the context of other validation activities.

(2) Ongoing verification activities. Ongoing verification activities include, but are not limited to:

(i) The calibration of process-monitoring instruments;

(ii) Direct observations of monitoring activities and corrective actions; and

(iii) The review of records generated and maintained in accordance with § 417.5(a)(3) of this part.

(3) Reassessment of the HACCP plan. Every establishment shall reassess the adequacy of the HACCP plan at least annually and whenever any changes occur that could affect the hazard analysis or alter the HACCP plan. Such changes may include, but are not limited to, changes in: raw materials or source of raw materials; product formulation; slaughter or processing methods or systems; production volume; personnel; packaging; finished product distribution systems; or, the intended use or consumers of the finished product. The reassessment shall be performed by an individual trained in accordance with § 417.7 of this part. The HACCP plan shall be modified immediately whenever a reassessment reveals that the plan no longer meets the requirements of § 417.2(c) of this part.

(b) Reassessment of the hazard analysis. Any establishment that does not have a HACCP plan because a hazard analysis has revealed no food safety hazards that are reasonably likely to occur shall reassess the adequacy of the hazard analysis whenever a change occurs that could reasonably affect whether a food safety hazard exists. Such changes may include, but are not limited to, changes in: raw materials or source of raw materials; product formulation; slaughter or processing methods or systems; production volume; packaging; finished product distribution systems; or, the intended use or consumers of the finished product.

§ 417.5 Records.

(a) The establishment shall maintain the following records documenting the establishment's HACCP plan:

(1) The written hazard analysis prescribed in § 417.2(a) of this part, including all supporting documentation;

(2) The written HACCP plan, including decisionmaking documents associated with the selection and development of CCP's and critical limits, and documents supporting both the monitoring and verification procedures selected and the frequency of those procedures.

(3) Records documenting the monitoring of CCP's and their critical limits, including the recording of actual times, temperatures, or other quantifiable values, as prescribed in the establishment's HACCP plan; the calibration of process-monitoring instruments; corrective actions, including all actions taken in response to a deviation; verification procedures and results; product code(s), product name or identity, or slaughter production lot. Each of these records shall include the date the record was made.

(b) Each entry on a record maintained under the HACCP plan shall be made at the time the specific event occurs and include the date and time recorded, and shall be signed or initialed by the establishment employee making the entry.

(c) Prior to shipping product, the establishment shall review the records associated with the production of that product, documented in accordance with this section, to ensure completeness, including the determination that all critical limits were met and, if appropriate, corrective actions were taken, including the proper disposition of product. Where practicable, this review shall be conducted, dated, and signed by an individual who did not produce the record(s), preferably by someone trained in accordance with § 417.7 of this part, or the responsible establishment official.

(d) Records maintained on computers. The use of records maintained on computers is acceptable, provided that appropriate controls are implemented to ensure the integrity of the electronic data and signatures.

(e) Record retention. (1) Establishments shall retain all records required by paragraph (a)(3) of this section as follows: for slaughter activities for at least one year; for refrigerated product, for at least one year; for frozen, preserved, or shelf-stable products, for at least two years.

(2) Off-site storage of records required by paragraph (a)(3) of this section is permitted after six months, if such records can be retrieved and provided, on-site, within 24 hours of an FSIS employee's request.

(f) Official review. All records required by this part and all plans and procedures required by this part shall be available for official review and copying.

§ 417.6 Inadequate HACCP Systems.

A HACCP system may be found to be inadequate if:

(a) The HACCP plan in operation does not meet the requirements set forth in this part;

(b) Establishment personnel are not performing tasks specified in the HACCP plan;

(c) The establishment fails to take corrective actions, as required by § 417.3 of this part;

(d) HACCP records are not being maintained as required in § 417.5 of this part; or

(e) Adulterated product is produced or shipped.

§ 417.7 Training.

(a) Only an individual who has met the requirements of paragraph (b) of this section, but who need not be an employee of the establishment, shall be permitted to perform the following functions:

(1) Development of the HACCP plan, in accordance with § 417.2(b) of this part, which could include adapting a generic model that is appropriate for the specific product; and

(2) Reassessment and modification of the HACCP plan, in accordance with § 417.3 of this part.

(b) The individual performing the functions listed in paragraph (a) of this section shall have successfully completed a course of instruction in the application of the seven HACCP principles to meat or poultry product processing, including a segment on the development of a HACCP plan for a specific product and on record review.

§ 417.8 Agency verification.

FSIS will verify the adequacy of the HACCP plan(s) by determining that each HACCP plan meets the requirements of this part and all other applicable regulations. Such verification may include:

(a) Reviewing the HACCP plan;

(b) Reviewing the CCP records;

(c) Reviewing and determining the adequacy of corrective actions taken when a deviation occurs;

(d) Reviewing the critical limits;

(e) Reviewing other records pertaining to the HACCP plan or system;

(f) Direct observation or measurement at a CCP;

(g) Sample collection and analysis to determine the product meets all safety standards;

and

(h) On-site observations and record review.

APPENDIX B

References for HACCP Teams

1. Agriculture Canada. Food Safety Enhancement Program – HACCP Implementation Manual. Camelot Drive, Nepean, Ontario, Canada, 1996.

2. American Meat Institute Foundation. HACCP: The Hazard Analysis and Critical Control Point System in the Meat and Poultry Industry. Washington, D.C., 1994.

Useful sections in particular are:
Chapter 3 – microbiological hazards, pp. 15-26
Chapter 4 – chemical hazards, pp. 27-32
Chapter 5 – physical hazards, pp. 33-35
Appendix A – NACMCF HACCP
Appendix C – Model HACCP plans

3. Baker, D.A. Application of Modeling in HACCP Plan Development. Int. J. Food Microbiol. 25:251-261, 1995.

4. Corlett, D.A., Jr. and Stier, R.F. Risk Assessment within the HACCP System. Food Control 2:71-72, 1991.

5. Council for Agriculture Science and Technology. Risks Associated with Foodborne Pathogens. February 1993.

6. Easter, M.C., et al. The Role of HACCP in the Management of Food Safety and Quality. J. Soc. Dairy Technol. 47:42-43, 1994.

7. Environmental Protection Agency. Tolerances for Pesticides in Foods. Title 40, Code of Federal Regulations, Part 185. U.S. Government Printing Office, Washington, D.C., 1998.

8. Food and Drug Administration. The Food Defect Action Levels. FDA/CFSAN. Washington, D.C., 1998.

9. Food and Drug Administration. Fish and Fishery Products Hazards and Control Guide --Get Hooked on Seafood Safety. Office of Seafood. Washington, D.C., 1994.

10. International Commission on Microbiological Specification for Foods. HACCP in Microbiological Safety and Quality. Blackwell Scientific Publications, Oxford, 1988.

Useful sections in particular are:
Chapter 10 – raw meat and poultry, pp. 176-193
Chapter 11 – roast beef, pp. 234-238
Chapter 11 – canned ham, pp. 238-242

11. International Commission on Microbiological Specification for Foods. Microorganisms in Foods 4. Application of Hazard Analysis and Critical Control Point (HACCP) Systems to Ensure Microbiological Safety and Quality. Blackwell Scientific Publications, Boston, 1989.

12. National Advisory Committee on Microbiological Criteria for Foods. March 20, 1992 -- Hazard Analysis and Critical Control Point System. Int. J. Food Microbiol. 16: 1-23, 1993.

13. National Advisory Committee on Microbiological Criteria for Foods. Adopted August 14, 1997-- Hazard Analysis and Critical Control Point Principles and Application Guidelines. J. Food Protect. 61(9): 1246-1259, 1998.

14. National Advisory Committee on Microbiological Criteria for Foods. DRAFT document - FSIS Microbiological Hazard Identification Guide for Meat and Poultry Components of Products Produced by Very Small Plants. 1-22, August 1999.

15. National Advisory Committee on Microbiological Criteria for Foods. June 1993 -- Report on Generic HACCP for Raw Beef. Food Microbiol. 10: 449-488, 1994.

16. National Research Council. An Evaluation of the Role of Microbiological Criteria for Foods and Food Ingredients. National Academy Press, Washington, D.C., 1985.

Useful sections in particular are:
Chapter 4 – microbiological hazards, pp. 72-103
Chapter 9 – raw meat, pp. 193-199
Chapter 9 – processed meats, pp. 199-216

17. Notermans, S., et al. The HACCP Concept: Identification of Potentially Hazardous Microorganisms. Food Microbiol. 11:203-214, 1994.

18. Pierson M.D. and Dutson, T. Editors. HACCP in Meat, Poultry, and Fish Processing. Blackie Academic & Professional. Glasgow, 1995.

Useful sections in particular are:
Chapter 4 – meat and poultry slaughter, pp. 58-71
Chapter 5 – processed meats, pp. 72-107
Chapter 7 – risk analysis, pp. 134-154
Chapter 13 – predictive modeling, pp. 330-354

19. Pierson, M.D. and Corlett, D.A., Jr. Editors. HACCP Principles and Applications. Van Nostrand Reinhold, New York, 1992.

20. Stevenson, K.E. and Bernard, D.T. Editors. HACCP: Establishing Hazard Analysis Critical Control Point Programs., A Workshop Manual. The Food Processors Institute, Washington, D.C., 1995.

Useful sections in particular are:
Chapter 11 – forms for hazard analysis, CCPs, critical limits, HACCP master sheet, example HACCP for breaded chicken

21. Stevenson, K.E. and Bernard, D.T. Editors. HACCP: A Systematic Approach to Food Safety. 3rd Edition. The Food Processors Institute, Washington, D.C., 1999.

22. Tompkin, R.B. The Use of HACCP in the Production of Meat and Poultry Products. J. Food Protect. 53(9): 795-803, 1990.

23. Tompkin, R.B. The Use of HACCP for Producing and Distributing Processed Meat and Poultry Products. In Advances in Meat Research. Volume 10. Hazard Analysis Critical Control Point in Meat, Poultry and Seafoods. Chapman & Hall, 1995.

APPENDIX C

Livestock Carcasses and Poultry Carcasses Contaminated With Visible Fecal Material

[Federal Register: November 28, 1997 (Volume 62, Number 229)]
[Rules and Regulations]
[Page 63254-63255]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28no97-2]

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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 301, 307, 308, 310, 318, 381, 416, and 417

[Docket No. 97-067N]

Livestock Carcasses and Poultry Carcasses Contaminated With
Visible Fecal Material

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Notice on complying with food safety standards under the HACCP
system regulations.

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SUMMARY: The Food Safety and Inspection Service is publishing this notice to assure that the owners and operators of federally inspected slaughter establishments are aware that the Agency views its “zero tolerance” for visible fecal material as a food safety standard. Fecal material is a vehicle for microbial pathogens, and microbiological contamination is a food safety hazard that is reasonably likely to occur in the slaughter production process. In controlling microbiological contamination, a hazard analysis and critical control point plan for slaughter must be designed, among other things, to ensure that, by the point of post-mortem inspection of livestock carcasses or when poultry carcasses enter the chilling tank, no visible fecal material is present.

FOR FURTHER INFORMATION CONTACT: Patricia F. Stolfa, Assistant Deputy Administrator, Regulations and Inspection Methods, Food Safety and Inspection Service, Washington, DC 20250-3700; (202) 205-0699.

SUPPLEMENTARY INFORMATION: The Food Safety and Inspection Service (FSIS) administers a regulatory program under the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 et seq.) and the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451 et seq.) to protect the health and welfare of consumers by preventing the distribution of livestock products and poultry products that are unwholesome, adulterated, or misbranded. A livestock product or poultry product is adulterated under any of a number of circumstances, including the following: if it bears or contains any poisonous or deleterious substance which may render it injurious to health, unless when the substance is not an added substance, the quantity in or on the article does not ordinarily render it injurious to health; if it consists in whole or in part of any filthy, putrid, or decomposed substance or is for any other reason unsound, unhealthful, unwholesome, or otherwise

[[Page 63255]]

unfit for human food; or if it has been prepared, packed, or held under unsanitary conditions whereby it may have become contaminated with filth or whereby it may have been rendered injurious to health (21 U.S.C. 453(g)(1), (g)(3), and (g)(4) and 601(m)(1), (m)(3), and (m)(4)). Both the FMIA and the PPIA include requirements for government inspection and prohibit transactions in products required to be inspected unless they have been ``inspected and passed'' or if they are adulterated (21 U.S.C. 458(a)(2) and 610(c)). FSIS enforces a ``zero tolerance'' standard for visible fecal material on carcasses and carcass parts at inspected establishments that slaughter livestock or poultry. This standard is reflected in the Agency's regulations under the FMIA and the PPIA (9 CFR chapter III, subchapter A and subchapter C, respectively), which require (among other things) that establishments handle livestock carcasses and carcass parts to prevent contamination with fecal material and promptly remove contamination if it occurs (Sec. 310.18) and that establishments prevent poultry carcasses contaminated with visible fecal material from entering the chilling tank (Sec. 381.65(e)). When inspection program personnel observe fecal material at post-mortem livestock inspection or thereafter (i.e., at or after the final rail) under the FMIA or when poultry carcasses are about to enter the chilling tank or thereafter (i.e., at any point after the final pre-chiller wash) under the PPIA, they condemn affected carcasses and carcass parts unless the contamination is removed in accordance with regulatory requirements. The Agency is publishing this notice to assure that the owners and operators of federally inspected slaughter establishments are aware that FSIS regards its zero tolerance for visible fecal material as a food safety standard under both the FMIA and the PPIA. Reiterating the Agency's position is particularly appropriate now, as federally inspected establishments prepare to comply with the hazard analysis and critical control point (HACCP) system regulations (part 417).

\1\ Part 417 requirements, as well as pathogen reduction performance standards for Salmonella in establishments that slaughter cattle, swine, chickens, or turkeys, prepare ground beef or fresh pork sausage, or process ground chicken or turkey (Secs. 310.25(b) and 381.94(b)) will apply as of January 26, 1998, in establishments with 500 or more employees; January 25, 1999, in establishments with 10 or more but fewer than 500 employees (unless the establishment has annual sales of less than $2.5 million); and January 25, 2000, in establishments with fewer than 10 employees or annual sales of less than $2.5 million.

The essence of FSIS's position is that fecal material is a vehicle for microbial pathogens, and microbiological contamination is a food safety hazard that is reasonably likely to occur in the slaughter production process (Sec. 417.2(a) and (b)). Consequently, HACCP plans must control for microbiological contamination at slaughter, and to meet the zero tolerance standard, an establishment's controls must (among other things) include limits that ensure that no visible fecal material is present by the point of post-mortem inspection of livestock carcasses or before poultry carcasses enter the chilling tank (Sec. 417.2(c)).

In the Pathogen Reduction-HACCP Systems final rule (61 FR 38806, July 25, 1996), FSIS explained the reasoning underlying its position on fecal contamination, and at the beginning of this year, FSIS addressed the role of its zero tolerance for visible fecal material on poultry carcasses in the final rule that codified the standard under the PPIA (62 FR 5139, February 4, 1997). Preparation for implementation of the HACCP system regulations has not changed the Agency's conclusions about the appropriateness of this standard, under the FMIA as well as the PPIA.

As the Agency stated in the Pathogen Reduction-HACCP Systems final rule (61 FR 38837):

In slaughter establishments, fecal contamination of carcasses is the primary avenue for contamination by pathogens. Pathogens may reside in fecal material and ingesta, both within the gastrointestinal tract and on the exterior surfaces of animals going to slaughter. Therefore, without care being taken in handling and dressing procedures during slaughter and processing, the edible portions of the carcass can become contaminated with bacteria capable of causing illness in humans. Additionally, once introduced into the establishment environment, the organisms may be spread from carcass to carcass.

Because the microbial pathogens associated with fecal contamination are the single most likely source of potential food safety hazard in slaughter establishments, preventing and removing fecal contamination and associated bacteria are vital responsibilities of slaughter establishments. Further, because such contamination is largely preventable, controls to address it will be a critical part of any slaughter establishment's HACCP plan. Most slaughter establishments already have in place procedures designed to prevent and remove visible fecal contamination.

As noted in the zero tolerance final rule and confirmed today with respect to livestock as well as poultry, establishments that process animals must adopt controls that they can demonstrate are effective in reducing the occurrence of microbial pathogens, including controls that prevent the fecal contamination of carcasses (62 FR 5140). Under the HACCP system regulations, critical control points to eliminate contamination with visible fecal material are predictable and essential components of all slaughter establishments' HACCP plans. Initial validation of a HACCP plan for slaughter and monitoring thereunder, as verified and documented in establishment records, must demonstrate the effective operation of the plan's controls on a continuing basis (Secs. 417.3(a), 417.4, and 417.5).

FSIS personnel will continue to verify compliance with the zero tolerance standard in slaughter establishments that are subject to part 417 requirements. The Agency will use visual observations and other findings by FSIS personnel in evaluating the effectiveness of an establishment's preventive controls and corrective actions for fecal contamination (Secs. 417.6 and 417.8). The presence of visible fecal contamination on livestock carcasses presented for post-mortem inspection or poultry carcasses entering the chilling tank will mean that establishment controls have failed; repeated failures will evidence that establishment corrective actions have failed to prevent recurrence and, thus, possible system inadequacy.

In addition to enforcing the zero tolerance for visible fecal material, FSIS will use the results of establishment testing for generic E. coli (Escherichia coli Biotype I, as already required by Sec. 310.25(a) or Sec. 381.94(a)) in assessing how well an establishment is controlling its slaughter and dressing processes to prevent fecal contamination. The pathogen reduction performance standards for Salmonella (Secs. 310.25(b) and 381.94(b)), which FSIS will enforce through its own testing program, will complement the zero tolerance standard and E. coli testing.

Done at Washington, D.C., on November 18, 1997.
Thomas J. Billy,
Administrator.
[FR Doc. 97-31176 Filed 11-26-97; 8:45 am]
BILLING CODE 3410-DM-P

Contents of HACCP Plans: Critical Control Points

[Federal Register: January 30, 1998 (Volume 63, Number 20)]
[Rules and Regulations]
[Page 4560-4562]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30ja98-2]

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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Part 417

[Docket No. 97-082N]

Contents of HACCP Plans; Critical Control Points

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Compliance with the HACCP system regulations.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is publishing this document to ensure that the owners and operators of federally inspected establishments are aware that the identification of appropriate critical

[[Page 4561]]

control points is crucial to complying with the Agency's regulations on hazard analysis and critical control point (HACCP) systems. The HACCP system regulations require that a HACCP plan list critical control points for each food safety hazard identified as reasonably likely to occur in the production process. The number of critical control points will depend upon the production process and the hazard, but a HACCP plan must specify as critic