Juice HACCP Regulator Training

Table of Contents

Introduction
Review of HACCP Principles
Components of a HACCP Inspection
Conducting the Initial Interview
Performing Your Own Hazard Analysis
Evaluating the Processor's Hazard Analysis
Evaluating the Processor's HACCP Plan
Determining If the HACCP Plan is Properly Implemented
5-Log Reduction Performance Standard
Reviewing Records: HACCP Records
Determining if Sanitation Monitoring is Properly Implemented
Reporting HACCP Violations
Importer Inspections and Imports
Special Considerations

Chapter 1

Introduction

This guidance document for regulator training represents FDA's current thinking on the individual components of a juice HACCP inspection and attempts to provide the tools necessary to conduct inspections of juice processing firms operating under HACCP and to effectively assess their compliance with the Juice HACCP regulation. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such an approach satisfies the requirements of applicable statutes and regulations. In addition, this regulator training manual references the Juice HACCP Hazards and Controls Guide which is a draft guidance document that is subject to change, therefore this manual is also subject to change.

Background

In January 2001, the Food and Drug Administration (FDA) issued juice regulations based on the principles of Hazard Analysis and Critical Control Point (HACCP) 21 CFR Part 120. The FDA issued these regulations to ensure the safe processing and importing of juice. All juice sold as juice, or for use as an ingredient in other beverages except juice produced at retail establishments, is subject to the juice HACCP regulations. This includes juice sold in both intrastate and interstate commerce (21 CFR Part 120.1). Juice processors must implement a HACCP based system to be in compliance with the new regulations. Certain critical jobs must be performed by individuals trained in HACCP. These persons are responsible for developing and modifying the HACCP plan and reviewing records.

This course, the Juice HACCP Regulator Training Course, is a continuation of the training provided by the Juice HACCP Alliance Training or equivalent. This course will provide you with tools to conduct inspections of juice processing firms operating under HACCP and to effectively assess their compliance with the regulation.

Components and Presentation of Training

The training program begins with a quick review of the seven principles of HACCP in the context of the juice HACCP regulation (21 CFR Part 120). It is not our intent to re-teach the HACCP concept. We expect that you already know this from your prior training.

We will then cover the individual components of a HACCP inspection, including special considerations for imported juice products. We will discuss performing the initial interview, performing your own hazard analysis, reviewing a processor's hazard analysis, evaluating the processor's HACCP plan, determining whether the plan is being properly implemented, the 5-log reduction performance standard, reviewing records, and documenting objectionable conditions.

At the conclusion of this course you will complete a course evaluation.

Chapter 2 Review of HACCP Principles

Purpose

The intent of this review is to refresh your memory on how a HACCP plan is developed. Knowing all the stages that a processor goes through in developing a HACCP plan is essential if you are going to audit the processor's HACCP program.

Prerequisite Programs

Before a HACCP plan can be developed, a firm must have their prerequisite programs in place. Of particular importance is a sound sanitation control program. Each processor shall have and implement a sanitation standard operating procedure (SSOP) that addresses sanitation conditions and practices before, during, and after processing (21 CFR Part 120.6). SSOPs outline the firm's controls for ensuring:

The safety of the water that contacts the food or food contact surfaces or that is used in the manufacture of ice;
The condition and cleanliness of food contact surfaces; including utensils, gloves, and outer garments;
The prevention of cross contamination from insanitary objects to food, food packaging material, and other food contact surfaces, including utensils, gloves, and outer garments, and from raw product to processed product;
The maintenance of hand washing, hand sanitizing, and toilet facilities;
The protection of food, food packaging material, and food contact surfaces from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate, and other chemical, physical, and biological contaminants;
The proper labeling, storage, and use of toxic compounds;
The control of employee health conditions that could result in the microbiological contamination of food, food packaging materials, and food contact surfaces; and
The exclusion of pests from the food plant.

Processors must keep records that document their compliance with the requirements of Good Manufacturing Practice regulations (21 CFR Part 110). Records (21 CFR Part 120.12) are required that document monitoring and any corrections that are made as a result of the monitoring.

Preliminary Steps

Once a firm's prerequisite programs are in place, the firm should then address the five preliminary steps of HACCP, although these are not mandated by the regulation. They are:

Obtain Top Management Support
Obtain HACCP Training
Assemble HACCP Team
Identify Product
- product description
- method of distribution and storage
- intended customer
- intended use of the product
Develop Flow Diagram

The processor or individual(s) who will develop the HACCP plan must receive HACCP training (21 CFR Part 120.13), such as training provided by the Juice HACCP Alliance Course.

The firm should assemble a HACCP team to conduct the hazard analysis, and to develop and oversee the HACCP plan. The team may consist of management, maintenance personnel, quality control personnel, line workers, and others, including experts, as necessary, from outside the company.

The processor's first duty should be to describe the product to be covered under the HACCP plan. The description should include the characteristics of the product, the method of distribution and storage, the intended customer, and the intended use of the product. This information is useful in performing a hazard analysis.

The processor's second duty should be to develop a flow diagram for the product, listing each step in the process, although once again, this is not required by the regulation. Once the flow diagram is complete, the team should verify the accuracy of the flow diagram by walking through the process on the processing floor.

HACCP Principles

Principle 1. Conduct Hazard Analysis

Once the processor completes the five preliminary steps, if they chose to do so, remember these five preliminary steps are not mandated by the regulation, and determines that the prerequisite programs are adequate, the processor must then conduct a hazard analysis (21 CFR Part 120.7). The hazard analysis begins with the HACCP team brainstorming the potential ingredient-related and process-related food safety hazards that could affect the product. They then determine the significance of each potential hazard - whether it is reasonably likely to occur. For each reasonably likely to occur hazard the team needs to identify control measures.

The Juice HACCP Hazards and Controls Guide and the Juice HACCP Questions and Answers document are two references that may be used to assist the team in their hazard analysis. The results of the hazard analysis can then be recorded on the Hazard Analysis Worksheet.

Remember that the regulation requires that every processor perform a written hazard analysis to be included in their HACCP plan (21 CFR Part 120.7).

Principle 2. Determine Critical Control Points (CCPs)

After completing the hazard analysis, the processor determines the appropriate critical control points for each of the significant hazards (21 CFR Part 120.8). Remember that a critical control point is a point, step or procedure in a food process at which control can be applied, and a food-safety hazard can be prevented, eliminated, or reduced to an acceptable level. The processor may use the CCP decision tree as a tool in identifying critical control points.

Principle 3. Establish Critical Limits

Once the critical control points are determined for each of the significant hazards, the processor establishes critical limits for each control measure (21 CFR Part 120.8). The definition of a critical limit is the minimum or maximum value to which a physical, biological, or chemical parameter 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 (21 CFR Part 120.3).

Principle 4. Establish Monitoring Procedures

The processor then establishes monitoring procedures (21 CFR Part 120.8), to ensure that the critical limits were consistently met. Each procedure should specify:

what has to be monitored;
how it is to be monitored;
the frequency of monitoring; and
who is to perform the monitoring.

Monitoring is usually performed using physical or chemical measurements or by observation. It must provide real-time data, but may be continuous or intermittent.

Principle 5. Establish Corrective Action Procedures

After monitoring, the processor may establish corrective action procedures to be followed when critical limits are not met (21 CFR Part 120.10). If corrective actions are predetermined, they must be included in the HACCP plan (21 CFR Part 120.10). Corrective action procedures must be sufficient to restore control to the process and to ensure that no unsafe product is distributed (21 CFR Part 120.10). The regulations do not require that processors predetermine their corrective actions; but if they do not, they must follow the standard procedure prescribed by the regulation (21 CFR Part 120.10).

Principle 6. Establish Verification Procedures

The processor then establishes verification procedures (21 CFR Part 120.11). Verification is the use of methods, procedures or tests, in addition to those used in monitoring, to determine if the HACCP system is in compliance with the HACCP plan and whether the plan is adequate to address the significant hazards.

Verification may include calibration, product testing at the option of the processor, record review, and plan reassessment. As with the monitoring principle, verification procedures should state both the method and frequency of the procedure.

Principle 7. Establish Recordkeeping System

Finally, the processor develops a system of recordkeeping to document the accomplishment of the monitoring procedures, corrective action procedures, and verification procedures (21 CFR Part 120.12). The regulations require that monitoring records be listed in the HACCP plan (21 CFR Part 120.12).

With that, the processor has developed a HACCP plan. The information may be recorded on the HACCP Plan form, an example of which is provided in the Juice HACCP Hazards and Controls Guide.

Chapter 3 Components of a HACCP Inspection

General

It is important to remember that HACCP is only one element of a juice inspection, not the entire agenda. You will need to continue to apply your existing skills to look for violations of other regulations and statutes, such as those relating to economic fraud, filth, sanitation, and good manufacturing practice. HACCP is another tool in addition to those which you are already using, one which is designed to address the safety of the product.

Keep in mind that every inspection is unique. Conditions during an inspection may require you to adjust the inspectional approach provided in this course. You will need to use your judgment at these times.

As the course progresses, you will see that your existing inspectional skill of interviewing will be called upon even more than before. Communication between you, plant management, and line employees is important for you to fully understand how the firm's HACCP program works, and to resolve disagreements over whether it is adequate.

To begin, the steps of the HACCP portion of the inspection are:

Conduct the Initial Interview
Perform Your Own Hazard Analysis
Evaluate the Processor's Hazard Analysis
Evaluate the Processor's HACCP Plan and
Determine Whether the HACCP Plan is Properly Implemented
Understanding and Evaluating the Processor's 5-Log Reduction Performance Standard
Review Records
Document Objectionable Conditions

Conducting the Initial Interview

In addition to identifying yourself, displaying your credentials, and issuing a Notice of Inspection, the primary purpose of the initial interview is to determine which product or products you will be covering during the inspection. This portion of the inspection should be as brief as possible, so that you can take full advantage of the nature of the unannounced inspection.

Performing Your Own Hazard Analysis

The second component of the inspection, developing your own hazard analysis, is conducted primarily during your initial "walk-through" of the firm. In this phase of the inspection, you will be gathering as much information about the process flow and the firm's controls as you can, both by observation and by interview. This will help you to deduce the significant hazards. This is also an important phase of the inspection for documenting other types of violations.

Evaluating the Processor's Hazard Analysis

You will then compare your hazard analysis to the firm's written hazard analysis. The firm's opinion of the significant hazards may differ from yours so you will need to be prepared to discuss your judgments and to review the basis of their decisions. Communication is critical at this stage of the inspection.

Evaluating the Processor's HACCP Plan

After you and the processor have reached agreement on the significant hazards of the processor's juice process, you will evaluate the firm's written HACCP plan. During the evaluation, you will make decisions about the adequacy of the critical limits and the monitoring procedures, among other things.

Determining Whether the HACCP Plan is Properly Implemented

Next, you will evaluate the firm's implementation of the HACCP plan. This evaluation is best accomplished by observing what occurs on the production floor. It is a continuation of the initial "walk-through." The goal is to see whether the monitoring procedures contained in the HACCP plan are being accomplished, and that the plan is otherwise being followed.

Understanding and Evaluating the Processor's 5-Log Reduction Performance Standard

You will then evaluate what the processor is using to accomplish the required 5-log reduction performance standard. During this evaluation, you will make decisions about the adequacy of the 5-log reduction and how it is being implemented. Communication and date gathering is critical at this stage of the inspection.

Reviewing Records

An integral part of your evaluation of a firm's HACCP plan implementation is an evaluation of the firm's HACCP records. The records you will be reviewing include implementation of SSOPs, the written hazard analysis, written HACCP plan, monitoring records, corrective action records, verification, and validation documents.

Documenting Objectionable Conditions

You should document any violations of the requirements of the juice HACCP regulations that you encounter during your inspection. FDA inspectors will continue to use the form FDA-483.

Chapter 4 Conducting the Initial Interview

Information You Will Need to Perform a HACCP Inspection

The first part of the inspection is the initial interview. The initial interview is important because it sets the stage for the rest of the inspection. After you present your credentials and the proper paper work to management, take a brief period of time to collect the information that will help you properly focus your inspection.

You will be able to perform the interview more efficiently if you have taken the time before hand to learn what types of juice products the firm processes and how the processing is performed and controlled. This kind of information can generally be acquired from previous inspection reports.

Some relevant questions to ask at the start of the inspection include:

What juice products do you process?
What are you processing today?
How many employees work at the firm?
What production lines will you be producing them on?
What time does processing begin and when will it end today?
How are the products that are being produced today shipped and stored?
What is the intended use of the products that are being produced today?
Do you have HACCP plans for these products?
Do you have sanitation SOPs?

You may notice that some of these questions are asked during the preliminary steps in establishing a HACCP plan. You will need this information in order to develop your own hazard analysis, which will be discussed in the next section.

Choose a Product to Develop Your HACCP Plan

Unless your inspection is specifically directed towards a particular product, you should cover one of the products being produced on the day of the inspection. This is important because the adequacy of the HACCP plan and its implementation cannot be fully judged by an in-office review of the plan and the records.

If a firm is producing more than one product on the day of the inspection, you will need to determine which product(s) to evaluate. Several factors should be considered in making this decision:

The product's potential for a safety hazard
The products covered during the previous inspections
The firm's compliance history

The Juice HACCP Hazards and Controls Guide provides information about the kinds of hazards to expect in the various types of juice.

Where past inspections of a firm detected significant problems with HACCP programs for a particular product, your follow-up inspections should concentrate on those, or similar products before moving on to other products.

Chapter 5 Performing Your Own Hazard Analysis

Reasons for Conducting an Independent Hazard Analysis

Performing a complete hazard analysis is crucial to the successful implementation of a HACCP system. It is usually best to avoid looking at the firm's Hazard Analysis, HACCP plan, or Sanitation Standard Operating Procedures until after you have performed your initial "walk-through" and have completed your own hazard analysis. To establish a plan that effectively prevents food-safety hazards it is important to identify all significant food safety hazards and control measures.

Although the processor is required to perform a hazard analysis (21 CFR Part 120.7), it is equally important that you develop your own hazard analysis independent of the processors. The purpose of this independent assessment is to determine whether or not the processor has addressed all of the relevant hazards. This is done by:

considering the intended use of the product;
determining the method of distribution and storage;
watching the processing operation.

By doing this before you review the firm's hazard analysis, you independently reach tentative conclusions about the food safety hazards that are reasonably likely to occur, without being swayed by the firm's hazard analysis. It's also necessary to develop your own hazard analysis if the firm did not perform a hazard analysis or performed it improperly.

Performing the Hazard Analysis

You will conduct your hazard analysis in much the same way as the processor conducts their hazard analysis. However, where the processor may use a HACCP team, you must make decisions on your own. For this reason, your hazard analysis will involve asking a lot of questions of plant management and line employees to learn about the process and where in the process a loss of control could lead to a food safety hazard. Conducting the hazard analysis also involves using your own experience with the industry and applying the information contained in the Juice HACCP Hazards and Controls Guide.

The hazard analysis process usually starts with a "walk-through" of the processing facility, from receipt of raw materials to finished product shipping including any alternative product paths for byproducts resulting from fruit extraction that may be added back to the juice later. Depending on the firm, you may or may not be accompanied during this walk-through. During this process, you should:

Develop a flow diagram
Write a brief process description at each step in the flow diagram
Observe the processing operation and ask yourself questions such as:
- How long does product remain at a processing step?
- At what temperature is the product held?
- What is the potential for delay beyond the conditions that you noted?
- Is there equipment that could cause metal fragments to become incorporated into the product?
- Are any food additives used?
- How are raw materials delivered and stored?
- What instruments are in place for measuring or controlling the process?
Ask questions of plant management and line employees, e.g.,:
- Where do your raw materials come from?
- What checks do you make on your raw materials?
- What, if any, information does your supplier provide to you about your raw materials?
- What time/temperature combination is used to pasteurize the product? (if applicable)
- How long do you usually hold this product under refrigeration?
- At what temperature do you hold the product?
- What is the maximum amount of time that you will hold the product?
Brainstorm biological, chemical, and physical hazards at each processing step in the flow diagram and judge whether the hazard is "reasonably likely to occur" and needs to be controlled. You may want to use a tool such as a CCP decision tree to help you during this process.
Determine if the processor is applying any control measures at some point in the process to control the significant hazards, such as:
- time/temperature controls
- metal detection
- raw material screening
Document non-HACCP violations as you encounter them, such as insanitation, economic fraud, and filth, etc. Your initial "walk-through" is very often the most likely time to encounter these kinds of violations, so you should pace your HACCP inspection accordingly.

Independent Evaluation

After you perform the "walk-through" portion of the inspection it is important that you independently evaluate the information that you have gathered. You may wish to transfer the information collected onto a Hazard Analysis Worksheet.

If you have any questions concerning the hazards or controls that you identified during the walk-through this is the time to consult other sources of information that are available, including:

Juice HACCP Hazards and Controls Guide;
Juice HACCP Questions and Answers;
National, district, and state experts;
Center for Food Safety and Applied Nutrition experts.

The Juice HACCP Hazards and Controls Guide will ordinarily be the first reference. This is a valuable reference for juice processors. You may also contact national, district and state Experts, including those at the Center for Food Safety and Applied Nutrition.

At this time, you should make your best judgment about the significant hazards, control measures, and critical control points that the processor is utilizing to provide a safe juice product.

Chapter 6 Evaluating the Processor's Hazard Analysis

Comparing Flow Diagrams

After you have performed your own hazard analysis you will review the processor's hazard analysis. The first step in this process is to make sure the firm has included all of the process steps in their hazard analysis; you can do this by comparing your flow diagram to the steps outlined in the processor's hazard analysis. Some firms may not have prepared a flow diagram or may not choose to share it with you. There is no regulatory requirement for either.

If the process steps do not match, you should revalidate your own flow diagram and discuss the differences with the firm's management. It is possible that either you or the firm missed something during the development of the flow diagram. It is important that no process step is missed, including process steps that involve diverted product because it could affect the validity of the hazard analysis and could add or eliminate a hazard or critical control point.

Comparing Hazard Analyses

Under the regulations, juice processors are required to have a written hazard analysis (21 CFR Part 120.7) in addition to or as part of their HACCP plan. You're now ready to look at the firm's hazard analysis. The goal of this step is to compare the processor's list of potential hazards, their decisions about the significance of the potential hazards, their list of control measures, and their CCP determinations, with the information contained in your own notes.

The firm should identify the specific hazards that are present, not just the type. For example, the term "microbiological hazards" may not be descriptive enough. Controlling Salmonella and Escherichia coli, may require distinct control strategies and therefore should be identified.

In your hazards analysis, determine if the same significant hazards that you identified are named as significant in the firm's written hazard analysis. When they are not, interview the processor to determine the reason(s) for the difference(s). Does the firm's reasoning concur or conflict with:

Information contained in the Juice HACCP Hazards and Controls Guide?
Your own experience?
The experience(s) of national, regional, or district experts?

Do your best to resolve differences between your hazard analysis and the processor's. There may be a good reason a processor controlled a hazard in a way that is different than that outlined in the Juice HACCP Hazards and Controls Guide. However, understand that if there is a control measure utilized that is different from that listed in the Guide, it is the burden of the processor to provide an equivalent level of control. Remember the Guide is a guideline and not a regulation.

It is possible, and appropriate, that a processor judged some hazards as insignificant because of the existence of prerequisite programs, such as sanitation. For example a pasteurized juice processor may determine that pathogen recontamination is a significant hazard after the heat process, but because their existing sanitation program controls the hazard, a CCP was not mandated. In this case, the firm's sanitation monitoring program should include checks on their recontamination controls.

Also, hazards should not be ruled as not reasonably likely to occur because of the existence of control measures. For example, it would be inappropriate for an apple juice processor to conclude that the hazard of patulin is not significant because the firm is controlling the hazard by buying apples from reputable growers. In this case, the control measure(s) is purchasing apples from known growers and that should be monitored as part of their HACCP plan.

As was previously referenced, some hazards may be controlled by controlling sanitation, in a program separate from HACCP. You should consider sanitation controls at the very beginning of your inspection. By determining which hazards are controlled by a processor's sanitation monitoring program - "ruling them out," so to speak - you will be left with fewer significant hazards that need to be controlled in the HACCP plan. If the firm's hazard analysis relies upon sanitation controls to control certain hazards, the firm's sanitation records should indicate that the hazard is being controlled. If after reviewing the sanitation records you determine that the controls are ineffective, you should consider whether the hazard analysis was based on inappropriate assumptions. This could result in an inadequate HACCP plan.

After reviewing the firm's Hazard Analysis, compare the firm's number and placement of CCPs and control measures with your own determinations.

Hazard Analyses that Do Not Match

You may find that the firm has additional hazards or CCPs, fewer hazards or CCPs, or CCPs in different locations.

What if the processor does not have a written hazard analysis?

The firm is in violation of 21 CFR Part 120. This condition should be documented as such. Collect as much information as available and submit it with your establishment inspection report. This will help agency experts review the case.

What if the processor identified MORE CCPs than I did in my Hazard Analysis?

If the firm has additional hazards, you will first need to determine if they are all food safety related. You may find that some relate to quality or economic fraud. For these non-food safety hazards, tell the firm that the hazard is not referenced as a food safety hazard in the Juice HACCP Hazards and Controls Guide; and you will concentrate your efforts on food safety related hazards and CCPs. The firm is free, however, to include such hazards in their plan.

You may find the firm has identified some significant food safety hazards that you did not consider, or which you determined to be insignificant. Or, you may agree on the hazards, but the firm may have identified CCPs that you did not identify. In either case, engage the firm's management in a discussion about why they selected the hazards or the CCPs. There may be something about the food or the process you did not know that caused the firm to make the determination they did. The goal is to understand the firm's rationale for the extra controls.

You will have to use judgment about whether to change your initial determination, using any available references. If you remain unconvinced about the significance of the hazard, do not expend any effort to review controls for the hazard or the CCP. If appropriate, you can point out that a HACCP plan may lose focus if points are unnecessarily identified as CCPs, and that too many CCPs may reduce the effectiveness of the HACCP plan.

If you see some validity in the firm's contention that the hazard is significant, and that the CCP is appropriate, you should proceed as if it were a significant hazard or a CCP. Be sure to collect any documentation that supports the firm's contentions. A final agency position on the significance of the hazard or the CCP can be made, if necessary, during the agency's review process.

What if the processor has identified FEWER CCPs than I did in my Hazard Analysis?

If the processor has identified fewer hazards or CCPs then you determined were present, you should ask the processor to justify the difference. If the processor does not convince you that the additional hazard(s) you identified are insignificant, or that the hazard is being properly controlled through other CCPs, you should document the condition. Again, remember to use any available references. It is important to collect documentation supporting the firm's point of view, and submit it with your establishment inspection report. That will help agency experts review the case.

What if the firm has identified CCPs in different locations?

A critical control point can be established at any process step where you can effectively apply control. If the firm has different locations for CCPs than those you determined, again find out why. When you use the Juice HACCP Hazards and Controls Guide as a reference, remember that control strategies other than those specified in the document may also be effective. When a processor is using another control strategy, compare the level of safety assurance that you believe it provides to the level of assurance that the strategies contained in the Hazards and Controls Guide provide. Document the condition if you remain unconvinced that the firm's strategy provides at least the same level of assurance.

Chapter 7 Evaluating the Processor's HACCP Plan

HACCP Plan Overview

After you have settled on the appropriate hazards reasonably likely to occur and critical control points, the next step is to take a look at the firm's HACCP plan to see whether these hazards are properly controlled at the CCPs.

You should look at the in-plant operations for a product even if the firm does not have a HACCP plan. In this case, you must determine whether the necessary controls may be in place, despite the absence of a written plan. Therefore, existence or absence of a HACCP plan should not ordinarily affect your selection of a product for coverage during an inspection.

The HACCP plan itself may consist of a one-page document or a group of related documents. For example, a process authority may have provided a process establishment letter that sets the critical limits for a pasteurization process. This should be listed as part of the firm's verification procedures in the HACCP plan, and may be attached to the plan as a supporting document. Additionally, not every processor will use the standardized HACCP Plan Form that is provided in the Juice HACCP Hazards and Controls Guide.

Reviewing the Firm's HACCP Plan Development

Next, determine who developed the plan. The juice HACCP regulation requires that the person or persons developing, verifying and modifying the plan be trained in the application of HACCP principles to juice processing (21 CFR Part 120.13). This can be accomplished either by completing a standardized course, or through experience. The trained individual does not have to be an employee of the processing firm (21 CFR Part 120.13).

The most straight-forward way for a processor to meet this requirement is to have the person who is going to develop and modify the plan and perform record review attend a training course based on a standardized curriculum recognized as adequate by the FDA or an equivalent (21 CFR Part 120.13).

HACCP training is also available from a variety of other sources. None of these have been specifically recognized as meeting the requirements of the regulation, although many probably do. You should collect relevant information about the course(s) the individual(s) attended - the course date, and provider in order to confirm appropriate HACCP training.

If the individual's training requirement is met by on-the-job experience, you should collect relevant information about that position, responsibilities of the individual, and years of experience.

Unless the firm has clearly not met the training requirement, you should not ordinarily challenge the HACCP-trained person's qualifications. The real test is whether the firm can properly develop and implement a HACCP plan. If your inspection discloses serious violations of the regulation that cast doubt on the processor's understanding of HACCP concepts, you should document those findings, with the information that you collected about training, in your inspection report for review by the agency.

Signature of the HACCP Plan

The signature or initials on the HACCP plan identifies the creator of the record. If the plan is developed by an outside contractor, the signature or initials identify the processors official who accepted the plan (21 CFR Part 120.12). The person signing the plan must be the most responsible individual on site at the processing facility or a higher company official (21 CFR Part 120.12).

The plan must be signed initially, whenever it is modified, and at least annually (21 CFR Part 120.11 and 120.12). Determine if it has been signed within one year of your inspection. Also, if during the inspection you learn about a modification in plant operations within the last year that caused the plan to be modified, look to see that the plan was re-signed at that time, or shortly thereafter.

Firms Without HACCP Plans

The regulation requires juice processors to have and implement a HACCP plan whenever the hazard analysis reveals one or more food safety hazards that are reasonably likely to occur during processing (21 CFR Part 120.8). We don't expect a large percentage of the industry will be able to support a claim that there are no significant hazards in their products, but some probably will.

Therefore, some firms may not have a HACCP plan because they do not need one. Others may not have a plan because they did not know that they needed one or because they chose to ignore the requirement. Not having a HACCP plan when one is required is a serious violation of the regulation (21 CFR Part 120.9).

Technical Requirements of a HACCP Plan

You need to evaluate the technical aspects of the plan. It is here where you will really begin to apply your understanding of HACCP.

You may begin by asking yourself the following questions:

Is the HACCP plan specific to this processing location and this type of juice?
Does the plan include a written hazard analysis that identifies all food safety hazards that are reasonably likely to occur for that product? (Principle 1)
Does the plan list the critical control points for each of the identified food safety hazards that are reasonably likely to occur? (Principle 2)
Does the plan identify critical limits for each CCP? (Principle 3)
Are the critical limits appropriate? (Principle 3)
Does the plan list the procedures that will be used to monitor each of the CCPs to ensure compliance with the critical limits? (Principle 4)
Does the plan list the frequency of the monitoring procedures? (Principle 4)
Is the monitoring and the frequency of that monitoring appropriate for the product? (Principle 4)
Does the plan describe corrective action procedures that are both process and product specific for each critical limit? Keep in mind that processors are not required to predetermine corrective actions. If not, does the processor understand the regulation mandated corrective actions? (Principle 5)
Are any corrective action procedures that are listed appropriate for the product? (Principle 5)
Does the plan provide for a record-keeping system that documents the monitoring of the CCPs, corrective actions, and verification procedures? (Principle 6)
Do these monitoring records contain actual values and observations? (Principle 6)
Are verification and validation procedures, such as product testing and HACCP plan review, included in the plan? (Principle 7)
Is the frequency of verification and validation procedures included in the plan? (Principle 7)

As will be discussed later in this course, the juice HACCP regulation specifies that processors of juice products must include in their HACCP plans control measures that will consistently produce, at a minimum, a 5-log (or 100,000 fold) reduction in the pertinent microorganism for a period at least as long as the shelf life of the product when stored under normal and moderate abuse conditions (21 CFR Part 120.24). If the firm's hazard analysis indicates microbiological hazards, you should see in the firm's HACCP plan, validated treatments intended to achieve a 5-log pathogen reduction.

Review of the HACCP Plan Hazards, CCPs and Critical Limits

The plan may or may not list all of the reasonably likely to occur hazards, critical control points or critical limits that you have identified. Those which are not included but which you have identified as necessary should be cited as objectionable conditions, as we discussed in the previous session.

The initial step in reviewing the firm's control strategy is to compare it to those strategies that are described in the Hazards and Controls Guide.

Remember to use the Hazards and Controls Guide as a guideline and compare controls included in the processor's plan to those in the Hazards and Controls Guide to determine whether they provide an equivalent level of control.

For example, a firm may base its critical limits on information other than the Hazards and Controls Guide. In this instance you'll need to review the information and determine if the critical limit is sufficient to control the identified hazard. You should rely on experience and any available references. You may not be able to make that determination during the inspection if the firm's scientific data needs to be evaluated by other FDA personnel. In this case, you should gather all pertinent information and submit it with your inspection report.

Examples of HACCP control measures used in the processing of juice that you may encounter include: the thermal processing of juice for the elimination of microbial pathogens, culling (or trimming) of apples after storage to eliminate moldy, damaged, or rotten apples to ensure that patulin will not be present at levels of concern in the finished apple juice, or observing processing lines for evidence of glass breakage. Remember that some actions undertaken in processing juice are not HACCP control measures, such as Good Agriculture Practices (GAPs), Current Good Manufacturing Practices (CGMPs), and Sanitation Standard Operating Procedures (SSOPs).

Reviewing Monitoring Procedures

When reviewing the firm's monitoring procedures, check to see that the monitoring frequency is sufficient to detect any deviations from the critical limits. Continuous monitoring is not always required, but, in many cases, it is the only way to assure that the limit is consistently met. If discontinuous monitoring is used, look carefully to see whether the critical limit could be violated between monitoring events, without being detected.

Do not be bound by traditional means of monitoring. Industry implementation of HACCP will undoubtedly require some changes, and one likely area of change is monitoring equipment.

Ask the firm for an example of each monitoring record that is listed in the plan, so that you can determine whether the documentation is sufficient to cover the monitoring being performed at the prescribed frequency, and that the critical limits were met. When you review the firm's completed monitoring records later, you will be able to take a closer look at the firm's ability to monitor the critical limits.

Reviewing Corrective Actions

If the firm includes predetermined corrective actions in its HACCP plan, you should assess the adequacy of those actions. The corrective action must return control to the process by fixing the cause of the deviation, and it must ensure the safety of the product produced under the deviation (21 CFR Part 120.10). Keep any predetermined corrective actions in mind, so that when you review the firm's records you can verify that the prescribed corrective action was taken when needed.

Reviewing Verification Procedures

There are three basic verification procedures. These include records review, calibration of process monitoring instruments (or other instruments), and product testing.

Virtually all process-monitoring instruments need to be calibrated. Look for calibration procedures and frequencies in the plan.

When monitoring procedures are weak, verification procedures should be strong to compensate. For example, if a processor uses a supplier's guarantee as his monitoring procedure, he may need to couple it with periodic product testing as a verification tool, in order to ensure control.

The entire control strategy for a particular food safety hazard is interrelated. You should not look at one component, for example, the monitoring procedure, individually. You should look at the entire strategy and determine whether it is likely to control the hazard. One example is the coupling of monitoring and verification procedures.

Another example is the inter-relationship between the critical limit and the corrective action. The point at which a processor sets his critical limit will, in part, determine what options are available to him when the limit is not met. Remember, in essence, verification is ensuring that the processor is following what they say they will follow.

A mandatory verification procedure for citrus juice processors that use exterior cumulative surface treatments to achieve the 5-log reduction performance standard is conducting finished product analysis. The regulation is very specific regarding the analysis; you must ensure that the firm is following the steps as outlined in the regulation. The regulation is also very specific in regards to corrective actions that must be taken in response to positive identification of E. coli. You need to ensure that the firm is following these corrective action procedures, when necessary, as outlined in the regulation.

Obviously, ensuring that the juice processor is following their HACCP plan and sanitation monitoring through a comprehensive records review is one of the primary functions of verification.

Reviewing Validation Procedures

Validation is a subset of the overall verification system. In validation, the processor is checking to ensure that the system, as set up, will actually control those hazards identified in the HACCP plan. For example, is the process time and temperature (and other related critical factors) in a flash-pasteurizer adequate to ensure a 5-log reduction of the most pertinent microorganism of concern? A prudent processor would have support documentation available to "back-up" their decisions at critical control points. For example, a study to show a certain time/temperature set-up is effective to ensure microbiological inactivation at the 5-log level. Validations of the HACCP plan must occur at least once within 12 months after implementation of the HACCP plan and at least annually after that or whenever any changes in the process could affect the hazard analysis or the HACCP plan. If a processor does not have a HACCP plan because they have determined that no reasonably likely food hazards are likely to occur, the processor must still validate the adequacy of the hazard analysis whenever there are changes in the process (21 CFR Part 120.11).

Chapter 8 Determining if the HACCP Plan is Properly Implemented

Basis for Determining HACCP Plan Implementation

After you conduct your own hazard analysis, compare that analysis to the firm's hazard analysis, and evaluate the firm's HACCP plan, the next step is to determine whether or not the firm has properly implemented their HACCP plan. In other words, is the firm doing what they say they are doing in their HACCP plan? This element of the HACCP inspection may be one of the most important aspects of your inspection.

You start this process by asking, "Does this plan reflect what is happening in the plant?" This is accomplished in two ways: observation and interview.

Observation

A large part of your job is observation. For example, you determine whether or not a plant is clean by observing the clean up operations at the facility first and then observing any evidence of insanitation after the cleanup. In the same way, if a firm's HACCP plan says that they are monitoring product temperatures every four (4) hours, you should observe the firm's employees to see if they in fact take the temperatures at the proper frequency and in an appropriate manner. Time in the plant also helps to verify the integrity of the records. Are they really prepared in the manner that they appear to be?

Remember, during the in-plant portions of your inspections, you should always continue to look for other kinds of violations, such as insanitation, filth, economic fraud, decomposition, etc.

Interview

Interviewing managers and line employees can serve the same purpose. Properly conducted, they are an important tool for sorting through the large number of issues that must be addressed in assessing whether the processor is properly implementing their HACCP plan. These interviews will, in many cases, enable you to identify those areas where you are satisfied that things are under control and those areas where you believe that further investigation is warranted. Wherever possible, negative findings from an interview, especially an interview of a line employee, should be verified by observation, or checked with other evidence.

Interviewing line employees may be necessary to further an investigation. However, it is not appropriate to interview an employee when it is clear that they are busy. Distracting an employee not only disrupts the firm's production but may also create safety hazards.

Purpose of Observation and Interview Information

The purpose of interviews and observations is not only to determine whether or not the firm is following their HACCP plan but also give you valuable information to use during record review. You will do a much better job of reviewing records if you have a good understanding of how the firm and its employees implement the plan. Through observation and interviewing, you can determine how, at what time, and under what conditions the monitoring is being performed. You can determine who performs the monitoring and judge their competency. You can learn about the equipment and instrumentation and its limitations. The answers to these questions and other questions will help make sense of what otherwise might appear to be a stack of sterile paper. The bottom line is you will know what the employee is filling out on the records and why.

Verification of HACCP Plan Components

In order to determine if the firm's HACCP plan is being properly implemented, there are several components of the plan that should be verified in-plant. Some of the more important issues are:

Is monitoring performed as prescribed by the plan?
Is monitoring performed at the prescribed frequency?

e.g., If the plan calls for hourly monitoring, are they actually checking every hour, or is the employee too busy or disinterested to monitor that often?
Is the appropriate monitoring equipment available?

Sometimes the plan will prescribe specific equipment. In other cases, you will have to use your judgement to determine whether a particular piece of equipment is right for the job.
Is the monitoring equipment operated properly, and in good working order?

e.g., If the equipment is provided with a mercury-in-glass thermometer does it have a divided column? Is the recording thermometer accurately keeping time?
Is the monitoring equipment calibrated as prescribed by the plan?

e.g., Is the mercury-in-glass thermometer calibrated yearly as outlined in the plan?
Are the monitoring results accurately and promptly recorded?

Monitoring results must be recorded at the time of the observation, not beforehand, and not significantly after-the-fact. The actual values must be recorded, not judgements, such as "meets," or "exceeds." You should check the readings on monitoring equipment to see if the values correspond with what the firm has recorded. For example, check the temperature of the cooler with your own calibrated thermometer, and check the concentration of a sanitizer solution with your own test strips.
Are corrective actions taken after critical limit deviations?

Corrective actions should correct the cause of the deviation and ensure that no unsafe product is distributed. Remember that the firm does not have to predetermine their corrective action (s). If corrective actions are predetermined, processors must follow their own HACCP plan or the standard procedures outlined in the regulations. If corrective actions are not predetermined, processors must follow the standard procedures (21 CFR Part 120.10).
Are corrective actions properly documented?
Are other verification procedures, such as product testing, performed as prescribed?
Where required, are verification procedures properly documented?

Chapter 9 5-Log Reduction Performance Standard

Background

Processors of juice products must include in their HACCP plans control measures that will consistently produce, at a minimum, a 5 log (or 100,000 fold) reduction in the pertinent microorganism for a period at least as long as the shelf life of the product when stored under normal and moderate abuse conditions (21 CFR Part 120.20).

The 5-log pathogen reduction standard is intended to assure that juice is safe regardless of the method used to process it. The standard is based on the expert advice of a panel of recognized food safety experts, the National Advisory Committee on Microbiological Criteria for Food (NACMCF).

"Pertinent Microorganism"

The likelihood that a pathogen present on fruit will survive in the juice depends on the type of pathogen and its ability to survive in the conditions of the juice. There are many factors that may affect the survival of any microorganism in a juice product such as the pH of the juice or pH of the treatment process, brix, viscosity, total solids, the presence of particulate material, temperatures of treatment(s), and even color. The pertinent microorganism is defined as the most resistant microorganism of public health significance that is likely to occur in the juice (21 CFR Part 120.24). The 5-log reduction performance standard is applied to the population of the most pertinent microorganism.

The pertinent pathogen may not be the same for all juice products or all processes. For example, E. coli O157:H7 and Cryptosporidium parvum are both pathogens likely to occur in apple cider. However, Cryptosporidium parvum is more heat resistant than E. coli O157:H7 is, therefore, if you were pasteurizing apple cider, Cryptosporidium parvum would be the pertinent organism of concern. On the other hand, if the firm is using UV light to treat the juice, the pertinent pathogen may or may not be Cryptosporidium parvum as the relative resistance of a pathogen is not necessarily the same as its resistance to heat treatment.

Exemptions

There are exemptions from the mandatory 5-log reduction that are to be included in a processor's HACCP plan. Firms that may claim exemptions include (21 CFR Part 120.24):

a juice processor that is subject to the requirements of 21 CFR part 113 or part 114 and
a juice processor who uses a single thermal processing step sufficient to achieve shelf-stability of the juice or a thermal concentration process that includes thermal treatment of all ingredients.

However, these processors must include a copy of their thermal process used to achieve shelf-stability or concentration in their written hazard analysis (21 CFR Part 120.24). During the inspection you will have access to the firm's hazard analysis and you should confirm that their process does result in a shelf-stable product, therefore exempting their juice from the 5-log pathogen reduction requirement.

Parameters of the 5-Log Treatment

The 5-log reduction must be applied to the population of the pertinent microorganism that may be in a juice product (21 CFR Part 120.24). For our purposes, each log represents a 10-fold difference in the number of bacterial cells in a juice, for example, 1-log is equal to 10, 2-log is equal to 100, 3-log is equal to 1000, 4-log is equal to 10,000, and 5-log is equal to 100,000 cells. Therefore, if you were going to reduce 100,000 bacterial cells by 5-log, you would need to reduce the population to 1 cell. Alternatively, if you started with 100 bacterial cells, you would need to go down to 0.001, less than one cell. Of course, the 5-log reduction standard doesn't apply to a hypothetical number. So, while you cannot reduce 100 cells to less than 1 cell, you can go from finding 100 bacterial cells in one cup of juice to finding 1 cell in 100 cups of juice.

All juice processors subject to the 5-log pathogen reduction performance standard must achieve the 5-log reduction by treatment of the extracted juice with the exception of citrus juice processors (21 CFR Part 120.24). The 5-log reduction, whether applied as a single treatment or as cumulative treatments, must be accomplished within a single production facility where the juice will be packaged into its final form (21 CFR Part 120.24). The facility must be operating under current GMPs. Note that processors who claim the exemption must also process and perform final product packaging of all juice subject to the exemption within a single production facility that is operating under current GMPs (21 CFR Part 120.24).

[NOTE: A new guidance document from CFSAN regarding bulk concentrate transport and the 5-log reduction is currently under review by the Center and General Counsel].

During your "walk-through," make a note of the 5-log treatment that the firm is employing. You should ask yourself:

Is the facility operating under cGMPs?
Is the 5-log treatment applied in a single production facility where the final product will be packaged?
Is the 5-log treatment applied to the extracted juice for non-citrus juices?

Citrus

Although many citrus juice processors may elect to apply 5-log reduction treatments to the extracted juice, they also have the option to utilize treatments applied to the fruit surfaces provided that the treatment process begins after culling and cleaning of the fruit. Cleaning is defined as washing with water of adequate sanitary quality and culling means the separation of damaged fruit from tree-picked, undamaged fruit. No dropped fruit, damaged fruit or ground harvested may be used for this type of juice product.

Surface treatment processes to accomplish the 5-log standard for citrus juices may involve a series of cleaning, brush washing, and sanitizing steps. The 5-log pathogen reduction standard, whether it is applied as a single surface treatment or as cumulative surface treatments on citrus must be validated (21 CFR Part 120.24). Furthermore, all such cumulative treatments for the 5-log reduction must occur in one facility prior to final consumer product packaging (21 CFR Part 120.24).

For some citrus products, the extraction method may also be part of the cumulative 5-log reduction. Validated extraction methods that may be included consist of a single pinpoint extraction method. For this method, only a single puncture is made and care is taken that the peel of the fruit is not brought into contact with the extracted juice.

Remember that the use of cumulative surface treatments will require a number of validation and monitoring steps that must be detailed in the firm's HACCP plan (21 CFR Part 120.24). You should expect the firm to validate and monitor such things as:

the concentration of the chemical used;
the pH of the treatment;
the duration of exposure to the treatment; and
the temperature of treatment.

Validation of the 5-Log Treatment

Once the pertinent pathogen for the product has been determined, the firm must validate the process they use for the 5-log reduction (21 CFR Part 120.11 and 120.24). Validation needs to be performed with clearly defined physical and chemical parameters. In addition, if the firm is using a model pilot system, whole citrus fruit or other juices that have been artificially inoculated or inoculated at higher then normal pathogen levels, confirm that additional studies have been conducted to ensure that the pilot production method accurately mimics real plant production conditions.

Under the juice HACCP regulation, use of surface treatments on citrus for achieving the 5-log pathogen reduction standard requires that end product microbial testing be implemented as part of the verification process. End product testing for citrus juice is detailed in 21 CFR 120.25. Testing consists of examining a specific amount of juice for the presence of non-pathogenic E. coli.

One 20 mL sample consisting of two 10 mL subsamples for each 1,000 gallons of juice produced must be sampled each production day (21 CFR Part 120.25). If less than 1,000 gallons of juice is produced per day, the sample must be taken for each 1,000 gallons produced but not less than once every 5 working days (21 CFR Part 120.25). Each subsample shall be a randomly selected package of juice ready for consumption by the consumer.

If either 10 mL subsample is positive for E. coli, the 20 mL sample is recorded as positive and the processor must take and document appropriate corrective actions to ensure that the process achieves a 5-log reduction in the pertinent microorganism (21 CFR Part 120.25).
If, in a series of 7 tests, 2 samples are found to be positive for E. coli, then the process to achieve the 5-log reduction standard will be assumed to be inadequate and corrective steps must be taken (21 CFR Part 120.25).

A review of the firm's HACCP plan and records should verify the procedures for end-product testing, implementation and monitoring of the testing, and any deviations and subsequent corrective actions taken in response to positive identification of E. coli.

Corrective actions may include the use of an alternate process to achieve the 5-log reduction on the extracted juice, an extensive review of monitoring records to determine if control measures were properly applied. The corrective action taken must ensure that no product enters commerce that is dangerous to the health of consumers.

Validation of the HACCP system will need to be documented within 12 months of implementation and at least once annually. If, at any time, the firm's process or product changes significantly from the original HACCP plan, the entire process may need to be re-validated (21 CFR Part 120.11).

In addition, once a system is in place, the processor must maintain records to verify that the firm is following the procedure and monitoring as required by the HACCP plan (21 CFR Part 120.12).

5-Log Treatment Methods for Extracted Juices

Pasteurization

Pasteurization is a heating method commonly used to reduce the number of pathogens in fluid products. The purpose of pasteurization is to provide only enough heat to destroy pathogenic microorganisms and possibly to inactivate food enzymes in the juice. Pasteurization will not kill all microorganisms present and will not provide a shelf-stable product. Some processors will use a heat treatment that goes far beyond pasteurization that will result in a shelf-stable product. As discussed previously, shelf-stable products are exempt from the 5-log pathogen reduction requirement provided that the processor includes a copy of their heat treatment with the written hazard analysis (21 CFR Part 120.24).

Pasteurization has historically been used for fluid milk and appropriate heating requirements for dairy products are well established. Unfortunately, appropriate parameters for juice products are not as well established. However, factors that will influence the efficacy of such a heat treatment are well known and characterized, for example, higher solids content in the product will require a more extensive heat treatment.

Given the many factors that may influence the efficacy of thermal treatment, it is important that any pasteurization process be validated for each specific product. The actual validation process requires a high level of expertise in the field of food processing. Processors will most likely consult with process authorities for assistance with validation procedures. The Juice Guide will also provide assistance in this area.

You should be aware of the two types of thermal pasteurization methods used in juice processing.

Batch Method

The first type of thermal pasteurization is known as the batch method. In the batch method, heat is applied to one large lot, or batch, of juice. The temperature is brought up to the point where it will result in the inactivation of pathogenic organisms. The entire batch of juice is held long enough to ensure the pathogens are reduced in population by at least 5-log. Following the holding period, the juice is cooled.

During your walk-though and when you review the firm's records, you should observe that the temperature is monitored to ensure adequate heat treatment. Also, it is important the firm monitors the length of holding time, and the cooling step as detailed in their HACCP plan. If the critical temperatures and times deviate from those specified in the HACCP plan the firm must make and document corrective actions.

Continuous Method

The second type of thermal pasteurization is known as the continuous method. In this process, juice is pumped at a specific rate from a storage vessel to heat exchanger plates and brought to the temperature required for pathogen destruction. From the heat exchanger the juice continues through holding tubes. The holding tubes are insulated pipes that will maintain the juice at the temperature required for pathogen destruction. These holding tubes need to be designed long enough and large enough, with proper slope to ensure the juice maintains the appropriate temperature for an appropriate length of time to achieve the 5-log standard. How long the juice remains in the holding tubes will be determined by the pump rate. Therefore calibration and proper operation of the pump will be important to the success of such a process. Following the holding period, the juice will once again pass through heat exchangers to bring the temperature back to what is required for hot or cold filling and packaging.

Continuous systems have an advantage over batch systems in the speed at which they can heat and cool the product. Consequently, the amount of heat applied can be better controlled. Temperatures used in the continuous method are usually higher than those used in a batch system. This results in faster destruction of the pathogen and a much shorter holding time is required. For this reason, such systems are called "high temperature short time" or HTST pasteurization. Some processors will use very high temperatures in order to further reduce holding times to seconds instead of minutes. Such systems are referred to as "flash pasteurization" or ultra-high temperature, UHT systems.

In addition to heat exchangers and holding tubes, HTST systems frequently contain "flow diversion valves." The purpose of such values is to redirect any juice that does not meet the minimum temperature requirement back to the storage tank for reprocessing. Such flow diversion valves are a very important safety feature of this type of equipment. If the firm's equipment does not have such a feature, and the juice fails to meet minimum temperature requirements specified in the HACCP plan as critical limits, the firm must document that the juice was separated to be reprocessed at a later time (corrective actions as specified in 21 CFR Part 120.10).

For all such systems, the firm is required to monitor temperatures throughout the processing and ensure that appropriate holding times and temperatures for the process are maintained as outlined as critical limits in their HACCP plan (21 CFR Part 120.8), unless the firm qualifies for the shelf stable/concentrate exemption as outlined in the regulation in 21 CFR Part 120.24.

Alternative Treatments

Although pasteurization is currently the most common and well-studied process for achieving the 5-log standard, other methods do exist and are becoming more popular. However, as with pasteurization, the use of any new technology will require proper validation and documentation of the 5-log reduction process. After validation, proper controls and records must be maintained to assure the process is properly implemented (21 CFR Part 120.12).

One of these alternative treatments is the use of UV irradiation, which was approved in 2000 for use on juices. UV radiation works primarily by breaking apart the DNA of organisms. The amount of radiation required to kill microorganisms may vary dramatically since UV radiation is absorbed by many of the components in juice. In general, the more colored a juice is and the more particles there are in a juice, the more difficult it will be to kill any microorganisms present. Consequently, each type of juice will likely require its own processing parameters and UV irradiation may not be applicable to all types of juices.

Current requirements for the use of UV radiation on juice specify the use of low-pressure mercury lamps emitting 90% of the emission at a wavelength of 253.7 nanometers or 2,537 Angstroms. In addition, any juice treated with UV irradiation must undergo turbulent flow through tubes with a minimum Reynolds number of 2,200.

Ozone was also approved for food use in June 2001. Ozone is a strong oxidizing agent that has historically been used to clean and disinfect water. Its mode of action is similar to chlorine. Ozone is a highly unstable chemical and is also toxic to people at very low concentrations. Although it is approved for food use, the firm should take care to prevent excessive exposure of workers. As with UV irradiation, parameters for usage are not well characterized and the use of a process authority is highly recommended.

A number of other processes are used to a more limited extent. Most of these processes, such as pulsed-light, use of high hydrostatic pressure, or the use of CO₂in combination with high pressure are still in the developmental stages and may become more generally available in the future.

Chapter 10 Reviewing Records: HACCP Records

Record Review - General

Records play a vital role in the HACCP inspection process. Records enable you to determine whether the HACCP plan is being properly and consistently implemented.

It is usually best to save your intensive record review until near the end of the inspection, because records are more meaningful when you understand their relationship to the operation of the plant and after you have seen how they are prepared. It is also often advisable to take advantage of the unannounced feature of the inspection by first performing certain in-plant activities, such as a review of the plant's sanitary conditions.

By the time you review the records you will have already reviewed the firm's HACCP plan. As part of that review, you will have determined whether the monitoring procedures specified in the plan are adequate to ensure critical limits are consistently being met. You will also have made a determination about whether the specified monitoring records are adequate to document that the monitoring procedures have been accomplished. These records must be listed in the HACCP plan.

Types of Mandatory Records

Each processor is required to maintain certain records documenting their HACCP system (21 CFR Part 120.12). These include:

Records documenting the implementation (monitoring and corrective actions) of the SSOPs;
The written hazard analysis;
The written HACCP plan;
Records documenting the ongoing application of the HACCP plan that includes CCP monitoring and corrective actions; and
Records documenting verification of the HACCP system and validation of the HACCP plan or hazard analysis, as appropriate.

Importer verification records are required elsewhere in the regulation. These will be covered in Chapter 13. However, the principles included in this chapter should be applied to those records as well.

As a regulator, you have access to all of these records. This includes the right to copy the records.

Record Selection

You should initially select sufficient numbers of each of the monitoring, verification, and corrective action records to evaluate whether:

The records are complete and accurate;
The appropriate critical limits are consistently met;
Appropriate corrective actions are taken when the critical limits were not met;
Calibration and product testing are performed in accordance with the HACCP plan; and
Record review is performed in a timely manner.

Initially, select complete record sets for given production days. This should include the relevant sanitation monitoring records. Looking at all of the records for a particular production day gives you a complete picture of the plant operations on that day, and also provides you with some tools for judging the integrity of the records.

Unless you are directed to cover a particular product during the inspection, select records that relate to the product or products that are being produced on the day of the inspection. This enables you to understand how the records relate to the operation and how they are prepared. If you uncover a problem, during the in-plant portion of the inspection or during record review that you believe may affect other products as well, you should also review records for those products. Your goal should be to determine the extent of the problem over time, and across product lines.

There are a number of ways to select the records that you will review. Many inspectors develop their own system, and some of these methods are quite good. Here is one approach:

First, determine the number of production days, and their dates, since the last inspection or since a HACCP plan was first implemented for the product. Remember that monitoring records must be retained for one year for refrigerated products and two years for frozen, preserved, and shelf-stable products (21 CFR Part 120.12).

Second, take the square root of the number of production days. This is the number of dates that you should select, except that you should always select at least twelve dates.

Third, the dates selected should be distributed over the months of production. Attempt to select dates from a month proportionate to the number of production days in that month - more from months with high production and fewer from low production months.

Finally, within the month, selectively chose the dates, targeting potentially worst-case dates, such as:

After seasonal shut-downs or changes;
After HACCP plan revisions;
After equipment changes;
After personnel changes;
During peak production, especially where production volume exceeds design capacity;
During long shifts or overtime situations;
During holidays or weekends.

If the firm operates properly under these conditions, they are likely to operate well under more ideal conditions.

If you encounter significant problems during the review of this initial selection of records, you should select more records from the time period from which you detected the problem, expanding outward until you have determined the scope of the problem. It is important to know whether the problem is an isolated event, or if it represents a pattern of noncompliance.

Review of Monitoring Records

Of primary importance in the review of monitoring records is to determine:

Has monitoring been performed as specified?
Have the critical limits been met?
Has corrective action been taken when necessary and is it adequate to address the product and the process?
Are actual values and observations recorded, rather than conclusions, such as "OK," "Met," or "Exceeded?"

The records should be designed so that these kinds of determinations can be made.

Of secondary importance is to determine:

Is the date and time of the monitoring activity recorded?
Is the signature or initials of the person performing the monitoring activity recorded?
Is the identity of the product and the production code, if any, recorded?
Is the name and location of the processor recorded?
Is the signature and date of review recorded?
Is the date of review within one week of the date of the record?

During record review, you should pay particular attention to those areas in which problems or indications of problems were detected during the in-plant portion of the inspection.

Review of Corrective Action Records

Corrective action records should be reviewed to ensure that any critical limit deviations that you noted during your monitoring record review or in-plant inspection have been properly addressed, and that the corrective action was documented. If a processor maintains a separate file of critical limit deviations you should review the entire contents of the file for products produced since the last inspection of the firm, or since a HACCP plan was first implemented for the product.

Corrective actions must either conform to the standard procedures described in the regulations, or must be detailed in the processor's HACCP plan (21 CFR Part 120.10). The regulations do not give you access to consumer complaints - only to the records of corrective actions that are taken in response to consumer complaints.

Of primary importance when reviewing corrective action records is to determine:

Is the nature of the corrective action described?
Is the date of the corrective action recorded?
Is the signature or initials of the person taking the corrective action recorded?
Is the identity of the product and the production code, if any, recorded?
Is the name and location of the processor recorded?
Is the signature of the person performing the record review and the date of the review recorded?
Is the date of the review within one week of the date of the record.

Review of Verification Records

Your selection of verification records for review will depend primarily upon the frequency of the verification activity. If, for example, a thermometer used at a critical control point is calibrated semi-annually it would be reasonable for you to request all of the calibration records since the date of the last inspection. If, however, a pH meter used at a critical control point is calibrated daily, it may only be necessary for you to request calibration records for the same dates as the monitoring records that you requested for review.

Of primary importance when reviewing verification records is to determine:

Is instrument calibration and product testing conducted in the manner and at the frequency specified in the HACCP plan?
Is appropriate corrective action taken when the verification procedures reveal a need?

For example, if, during calibration the processor determined that a pasteurizer thermometer was registering too high the following corrective actions might have been taken: the thermometer should be adjusted, if possible; and the pastuerizer temperature monitoring records generated since the last calibration should have been reviewed again by the firm and adjusted for the instrument error. You should also review the same records, looking for any deviations from the critical limits after adjustment for the instrument error.
Are the actual values and observations recorded?

Of secondary importance when reviewing verification records is to determine:

Is the date of the calibration or testing recorded?
Is the signature or initials of the person performing the calibration or testing recorded?
Is the identity of the product and the production code, if any, recorded?
Is the name and location of the processor recorded?
Is the signature of the person performing the record review and the date of the review recorded?

Records Falsification

A lot hinges on the legitimacy of HACCP records. For this reason, looking for signs of records falsification is an important part of the HACCP inspection. There are some "tricks-of-the-trade," but most inspectors find that they develop their own as they get used to the kinds of records that processors use and how they look under ordinary circumstances.

Records falsification can sometimes be detected during the in-plant portion of the inspection. In fact, that is the best time to detect one type of falsification - the pre-recording of data.

For example, you may discover when you arrive at the start of a day's operations, that the results of the visual check of the pasteurizer temperature for a pasteurized product, which were to have been performed every 1/2 hour over the course of the day, are already recorded for the entire day. This information should be documented as evidence of falsification. The documentation should include information about: whether the visual checks were ever really performed; if they were, whether the results differed from the pre-recorded data; and, if they did, whether the data was corrected. This kind of information helps establish the employee's motive for falsification. The motive might be a scheme to disguise a problem, such as expected poor results or a lack of intent to perform the check, or it might be that the employee simply found it easier to pre-record the data, which might have historically been very consistent.

Interviewing employees who are responsible for performing monitoring functions is another good way to expose records falsification. If you suspect falsification, discretely watch the monitoring operation. At some point later in the inspection ask the employee responsible for monitoring to describe how and at what frequency he performs the monitoring function. Look for inconsistencies. Sometimes employees falsify monitoring records because they do not know how to perform the operation, because they are too busy to accomplish it at the required frequency, or because they are afraid of management's reaction to adverse monitoring results.

Other evidence of falsification can be detected during record review. Some of the most obvious signs are:

Monitoring frequencies that are uncharacteristically regular.

It is not often possible for processing employees to perform monitoring functions at precise intervals - for example, 7:00, 7:30, 8:00, etc. - because they must also accomplish their production function. When you see this kind of record-keeping you should become suspicious about the possibility of data pre-recording.
Monitoring data that is unusually constant.

For example, it is unusual for the temperature of a cooler to hold consistently at 40°F for extended periods of time. Likewise, it is unusual for product weights or counts to remain constant for extended periods of time. There is a natural variation in most attributes that are measured in a HACCP program. Become suspicious when you don't see it in records, especially if your in-plant experience tells you that it should be there.
Unusually neat monitoring records.

Some monitoring records and many corrective action and verification records are generated in an office or laboratory setting. In these cases, they are often very neat in appearance. Of course, some production employees will also maintain their records in an orderly manner. However, if, based on your in-plant experience, you know that a record is generated in a processing area where it is exposed to wet conditions, lubricants, or food, become suspicious if some records are immaculate.
The absence of handwriting or ink changes when a record covers more than one personnel shift.

If you suspect falsification, you should also compare handwriting styles on dissimilar records that were reportedly prepared by the same or different employees.
The absence of characteristic instrument markings on mechanically generated records.

For example, most temperature recorders leave four pinholes in the chart, the result of contact with the drive mechanism. Other instruments may leave different types of impressions or markings on the record, the absence of which is an indication of possible falsification.
Improbable events.

Again, your in-plant experience will help you identify improbable events that may be chronicled in records. For example, if you see that it takes about one hour for a processor to refill a pasteurizing vat under ordinary circumstances, you should become suspicious when a record shows a series of turn-around times of only twenty minutes. You should also become suspicious when the heating curves on a temperature-recording chart are different for a single record or group of records than for other records for the same product and pasteurizer. To recognize these improbable events, you will have to become familiar with the plant's normal operations.

Perhaps one of the best ways to uncover falsification during your record review is to look at the "overlap" between records. Processors will often use separate records to document the monitoring of separate critical control points. However, you can often link the records by considering the relationship of the product covered by one record with product covered by another record. Is it the same product? If so, do the records cover the same processing step or sequential steps? By comparing the times that monitoring operations are recorded and keeping in mind the answers to the previous questions and your in-plant experience, you may be able to detect irregularities.

When you discover records that you suspect have been falsified, it is usually important to investigate the magnitude of such falsification before discussing the situation with management of the firm. You should copy the records as soon as possible. This may be your only opportunity to obtain them. They may subsequently be removed or altered by the firm.

It is usually best to discuss your findings with management and provide them with an opportunity to explain the events represented by the records. However, in some circumstances, especially where you suspect that there was intent to conceal a problem, it may be necessary to discuss the situation with your supervisor before you disclose the information to the firm's management. Remember that falsification with the intent to defraud may be a felony violation of Title 18 of the Code of Federal Regulations.

Copying Records

There are four reasons to copy records:

To document records falsification;
To document deficiencies;
To provide information for agency review;
To facilitate the next inspection

Records are often needed to document deviations from the regulations, such as: inadequate corrective actions; inadequate monitoring or inadequate monitoring frequency; inadequate verification activities as specified in the HACCP plan; and, incomplete records. In some cases, it may be necessary for you to collect the complete set of records for that day's production, to facilitate a full review of the significance of the deficiency.

Records may be needed to enable an agency review of the adequacy of a processor's HACCP plan, critical control parameters, certain control measures, or corrective actions. For example, if you are not sure about the suitability of a critical limit that a processor has selected, you should collect any data that the processor has to support his selection. If you are not sure of the appropriateness of a corrective action that a processor has taken, you should collect records that document the monitoring activities and the corrective action, as well as any data that the processor may have to support the adequacy of the corrective action that was taken. These records should be submitted by the district office to the Center for Food Safety and Applied Nutrition for review.

Finally, records may be collected to facilitate the performance of the next inspection. If you believe that having a copy of the HACCP plan, blank copies of records, or other documents to which the regulations grant access, will assist in the efficient enforcement of the regulations by helping prepare the next inspector, you may copy the documents and include them in the district's files.

Chapter 11 Determining if Sanitation Monitoring is Properly Implemented

You should view compliance with the sanitation monitoring requirements of the Juice HACCP regulation in the larger context of the existing requirements of the Part 110 GMP's. Although sanitation-monitoring requirements are new, sanitation standards for all foods have been in place for many years as part of FDA's Good Manufacturing Practice Regulation - 21 CFR Part 110 or GMP's - which still apply to juice processors.

With the advent of HACCP, many have recognized that sanitation is a prerequisite to HACCP and provides a foundation for safe food production. In writing the Juice HACCP regulation, FDA recognized that monitoring sanitation conditions would be necessary to achieve and maintain improvements in sanitation in juice processing operations (21 CFR Part 120.6). When looking for compliance with the regulation the investigator will need to:

Determine what key areas of sanitation need to be monitored
Determine if the processor has implemented sanitation monitoring in those areas
Determine if monitoring is at a sufficient frequency to ensure conformance with the GMP's
Determine if the processor makes corrections to sanitation deficiencies detected during monitoring
Determine if the processor maintains sanitation monitoring records and sanitation correction records.

Determining what key areas of sanitation need to be monitored.

The regulation requires monitoring in eight key areas of sanitation (21 CFR Part 120.6). Not all of these areas are relevant to all processing facilities. For example, many are not relevant to warehouses that store finished packaged juice. The key areas are somewhat arbitrary and overlapping, but were designed to include those aspects of GMP's that are most likely to have an impact on the safety of the product. The eight key areas cited in the regulation are:

1. Safety of Water

This area relates to the sourcesave treatment of water that comes in contact with food or food contact surfaces, or is used in the manufacture of ice. It also relates to cross connections between potable and non-potable water systems. In juice processing plants cross connections can be found in: hard plumbing between potable and non-potable water lines; unprotected hose bibs (i.e. those with no backflow prevention devices) lying in pooled water or submerged in a wash tanks; or metering pumps used for cleaning chemicals without a backflow prevention device.

2. Conditions and Cleanliness of Food Contact Surfaces

This area relates to the design, workmanship, materials, and maintenance of food contact surfaces and the cleaning and sanitizing of those surfaces. It includes gloves and outer garments that may contact the food. Processing equipment must be designed to be easily cleaned and maintained in a sanitary condition and, it must withstand the environment of its intended use and the action of cleaners and sanitizers. This includes equipment for ice production and storage. At a minimum, cleaning and sanitizing of all equipment that contacts food must be done daily. All equipment should be cleaned at the end of each day's operation, and sanitized either after cleaning or before the day's operations begin.

3. Prevention of Cross Contamination

This area relates to:

employee practices to prevent product contamination;
physical separation of raw and cooked product; and
plant design to prevent contamination

Hands, gloves, outer garments, utensils, food contact surfaces of equipment that come in contact with waste, the floor, or other unsanitary objects can contribute to product contamination. Employees should be trained on how and when to properly wash and sanitize their hands, gloves and outer wear, as well as equipment such as shovels, or buckets that come in contact with the floor or waste. It is important to stress that in order to effectively clean equipment, all residual product should be removed, equipment cleaned with hot water and detergent, and then sanitized.

Also be aware of cross contamination between raw and cooked products. If a facility does not dedicate employees to work in either the raw or cooked side, when these employees move from the raw to the cooked side, their hands, gloves and outer wear should be washed and sanitized.

Un-packaged finished product should also be separate from raw products during storage and processing.

4. Maintenance of hand washing, hand sanitizing and toilet facilities

This area relates to the location and maintenance of hand washing, sanitizing and toilet facilities, as well as the adequacy of sewage disposal. Hand washing and hand sanitizing facilities should be located in all processing areas where good sanitary practices require employees to wash and sanitize their hands. Hand washing should always precede hand sanitizing so hand sanitizing stations must have hand washing stations located adjacent to them. It is important that there is a supply of hot water, soap and sanitizer at each station. Toilet facilities must have adequate sanitary supplies and be in good repair.

5. Protection from adulterants

This area covers protection of food, food-packaging material and food contact surfaces from various microbiological, chemical and physical contaminants, such as lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate and floor splash.

6. Proper labeling, storage and use of toxic compounds

This area is covers labeling, storage and use of toxic compounds. Improper use of toxic compounds is a frequent cause of product adulteration.

7. Control of Employee Health Conditions

This area relates to the exclusion of persons who appear to have an illness, wound or other affliction that could be a source of microbial contamination to the food. It is imperative that owners encourage employees not to work when they are ill or have an infectious wound that might contaminate the product.

8. Exclusion of Pests

This area relates to the presence of pests, such as rodents, birds, and insects. These pests carry a variety of human disease agents, which can be introduced into the processing environment. The presence of rodents, insects, birds or other pests in the processing plant is unacceptable. Even if pest control is contracted to an outside company, it is still the responsibility of the plant owner to make sure that there are no pests in the facility.

The table that follows takes each of the eight key areas of sanitation and relates them to specific parts of the GMP. You can use the table to help evaluate the adequacy of the processor's sanitation self-monitoring efforts.

SANITATION PROVISIONS OF THE JUICE HACCP REGULATION
AND RELEVANT REQUIREMENTS OF THE FOOD GMPs
PART 120.6(a)REQUIREMENT	CORRESPONDING PART 110 REQUIREMENT(S)
(1): Safety of water that comes into contact with food or food-contact surfaces or that is used in the manufacture of ice	110.37(a): The water supply shall be sufficient for the operations intended and shall be derived from an adequate source. Any water that contacts food or food-contact surfaces shall be safe and of adequate sanitary quality. 110.80(b)(16): When ice is used in contact with food, it shall be made from water that is safe and of adequate sanitary quality, and shall be used only if it has been manufactured in accordance with current good manufacturing practice as outlined in part 110.
(2): Condition and cleanliness of food contact surfaces, including utensils, gloves, and outer garments	110.10(b)(5): Maintaining gloves, if they are used in food handling, in an intact, clean, and sanitary condition. The gloves should be of an impermeable material. 110.35(d): All food-contact surfaces, including utensils and food-contact surfaces of equipment, shall be cleaned as frequently as necessary to protect against contamination of food. 110.40(a): All plant equipment and utensils shall be so designed and of such material and workmanship as to be adequately cleanable, and shall be properly maintained. The design, construction, and use of equipment and utensils shall preclude the adulteration of food with lubricants, fuel, metal fragments, contaminated water, or any other contaminants. All equipment should be so installed and maintained as to facilitate the cleaning of the equipment and of all adjacent spaces. Food-contact surfaces shall be corrosion-resistant when in contact with food. They shall be made of nontoxic materials and designed to withstand the environment of their intended use and the action of food, and, if applicable, cleaning compounds and sanitizing agents. Food-contact surfaces shall be maintained to protect food from being contaminated by any source, including unlawful indirect food additives.
(3): Prevention of cross contamination from insanitary objects to food, food packaging material, and other food contact surfaces, including utensils, gloves, and outer garments, and from raw product to processed product	110.10(b)(5): Maintaining gloves, if they are used in food handling, in an intact, clean, and sanitary condition. The gloves should be of an impermeable material. 110.35(d): All food-contact surfaces, including utensils and food-contact surfaces of equipment, shall be cleaned as frequently as necessary to protect against contamination of food. 110.40(a): All plant equipment and utensils shall be so designed and of such material and workmanship as to be adequately cleanable, and shall be properly maintained. The design, construction, and use of equipment and utensils shall preclude the adulteration of food with lubricants, fuel, metal fragments, contaminated water, or any other contaminants. All equipment should be so installed and maintained as to facilitate the cleaning of the equipment and of all adjacent spaces. Food-contact surfaces shall be corrosion-resistant when in contact with food. They shall be made of nontoxic materials and designed to withstand the environment of their intended use and the action of food, and, if applicable, cleaning compounds and sanitizing agents. Food-contact surfaces shall be maintained to protect food from being contaminated by any source, including unlawful indirect food additives.
(4): Maintenance of hand washing, hand sanitizing, and toilet facilities	110.37(d): Each plant shall provide its employees with adequate, readily accessible toilet facilities. 110.37(e): Hand-washing facilities shall be adequate and convenient and be furnished with running water at a suitable temperature. Compliance with this requirement may be accomplished by providing: (1) Hand washing and, where appropriate, hand-sanitizing facilities at each location in the plant where good sanitary practices require employees to wash and/or sanitize their hands. (2) Effective hand-cleaning and sanitizing preparations. (3) Sanitary towel service or suitable drying devices. (4) Devices or fixtures, such as water control valves, so designed and constructed to protect against recontamination of clean, sanitized hands.
(5): Protection of food, food packaging material, and food contact surfaces from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate, and other chemical, physical, and biological contaminants	110.20(b)(4): Plant construction and design-constructed in such a manner that floors, walls, and ceilings may be adequately cleaned and kept clean and kept in good repair; that drip or condensate from fixtures, ducts and pipes does not contaminate food, food-contact surfaces, or food-packaging materials; and that aisles or working spaces are provided between equipment and walls and are adequately unobstructed and of adequate width to permit employees to perform their duties and to protect against contaminating food or food-contact surfaces with clothing or personal contact. 110.40(a): All plant equipment and utensils shall be so designed and of such material and workmanship as to be adequately cleanable, and shall be properly maintained. The design, construction, and use of equipment and utensils shall preclude the adulteration of food with lubricants, fuel, metal fragments, contaminated water, or any other contaminants. All equipment should be so installed and maintained as to facilitate the cleaning of the equipment and of all adjacent spaces. Food-contact surfaces shall be corrosion-resistant when in contact with food. They shall be made of nontoxic materials and designed to withstand the environment of their intended use and the action of food, and, if applicable, cleaning compounds and sanitizing agents. Food-contact surfaces shall be maintained to protect food from being contaminated by any source, including unlawful indirect food additives. 110.80(b)(12)(iv): Providing adequate physical protection of components from contaminants that may drip, drain, or be drawn into them.
(6): Proper labeling, storage, and use of toxic compounds	110.35(b)(2): Toxic cleaning compounds, sanitizing agents, and pesticide chemicals shall be identified, held, and stored in a manner that protects against contamination of food, food-contact surfaces, or food-packaging materials. All relevant regulations promulgated by other Federal, State, and local government agencies for the application, use, or holding of these products should be followed. 110.35(c): Pest control - The use of insecticides or rodenticides is permitted only under precautions and restrictions that will protect against the contamination of food, food-contact surfaces, and food-packaging materials.
(7): Control of employee health conditions	110.10(a): Any person who, by medical examination or supervisory observation, is shown to have, or appears to have, and illness, open lesion, including boils, sores, or infected wounds, or any other abnormal source of microbial contamination by which there is reasonable possibility of food, food-contact surfaces, or food-packaging materials becoming contaminated, shall be excluded from any operations which may be expected to result in such contamination until the condition is corrected. Personnel shall be instructed to report such health conditions to their supervisors.
(8): Exclusion of pests	110.35(c): No pests shall be allowed in any area of a food plant.

During an inspection, consider whether each standard in the table is relevant to the firm's operations. If it is, the processor should be monitoring its own operations to ensure compliance with the standard.

Remember, the insanitary condition need not have a direct impact on product safety in order to judge it relevant. The insanitary condition need only have an impact on product adulteration. Poor employee hygienic practices or vermin activity in a juice processing plant are not reasonably likely to affect the safety of the product, but either of these insanitary conditions certainly could cause the product to be deemed adulterated, and are, therefore, relevant. Because of this, most of the standards listed in the table are relevant to most processors, but there are some exceptions. For example, it would not be relevant to monitor employee hand washing in a facility such as a warehouse where there is no employee contact with exposed product.

During your "walk-through," in addition to looking at the process flow and controls, you should be making judgments about the relevance of the listed sanitation standards. You will also need to determine where in the plant the relevant standards should be monitored. For example, hand washing may need to be monitored in certain processing areas, but not in the packaged finished product storage areas, or on the loading docks.

Basis for Determining Sanitation Monitoring Implementation

Once you have determined the relevant areas of sanitation that the plant must monitor, you should evaluate the firm's monitoring efforts to determine whether they are adequate. Remember that sanitation monitoring can be performed either as part of the HACCP program or as part of a separate sanitation program. If a processor elects to perform some or all of the sanitation monitoring as part of their HACCP program, you should evaluate those sanitation components as you would any other part of the HACCP program. This discussion covers how to evaluate the adequacy of sanitation monitoring that is part of a separate sanitation program, the option that most processors will likely select.

The scope and effectiveness of a processor's sanitation monitoring program is determined in the same way the HACCP Plan is:

Reviewing the firm's sanitation monitoring records;
Observing sanitation monitoring operations; and
Interviewing the person responsible for sanitation monitoring.

After reviewing the firm's records and while you accompany the person performing the monitoring you should determine:

The key areas of sanitation their monitoring covers
What areas of the plant are monitored; and
How often the monitoring is performed.

Sanitation Standard Operating Procedures (SSOP's)

Processors are required to have SSOPs, but the regulation does not specify that they must be written (21 CFR Part 120.6). The standard that you are bound to apply toward sanitation is the standard that is contained in 21 CFR Part 110. If you judge that the standard the firm has set is inadequate because it does not meet the standard contained in 21 CFR Part 110, you will need to document the firm is not meeting the proper standard. If through observation you determine that the equipment is unclean or a cleaning procedure is inadequate, you should link the deficient item to the corresponding weakness in the SSOP in order to strengthen the observation.

Determining if Monitoring Is At A Sufficient Frequency and Corrections to Deficiencies Are Adequate

Compliance with the sanitation monitoring requirements require:

observing and recording on the conditions in the plant; and
making and recording corrections for any deficiencies noted.

There are also two factors to consider in sanitation monitoring. First is the frequency sufficient to meet the requirements in 21 CFR Part 110, and is that frequency reasonable. For example, if the equipment were cleaned daily, it would meet the standards set forth in 21 CFR Part 110 if the processor checks the condition of the equipment each time the equipment is cleaned (e.g. daily). On the other hand, to meet the requirements of 21 CFR Part 110 employees wash their hands every time they use the restroom, or handle unsanitary objects either at or away from their workstation, it isn't reasonable that the processor would have to check hand washing each time. It is reasonable to check periodically over the course of the day, particularly at times when large numbers of employees would be required to wash their hands such as after breaks or returning from lunch.

Secondly, you need to consider if there are any special circumstances that might affect your judgment about a reasonable frequency. For example, did you note any sanitation deficiencies during your walk through, or did the firm's monitoring records note problems in a particular area; or is there something about the operation that would affect the firm's ability to meet the sanitation standard such as equipment that is difficult to clean.

There are many ways the processor can set up a sanitation-monitoring program to comply with the regulation. One way is to place the sanitation elements into groups based on the frequency of monitoring. For example, monthly or daily, etc. with monitoring records prepared accordingly. This can be done as follows (Note: recommended frequencies in these examples below are based on 21 CFR Part 110 and used for illustrative purposes; other frequencies may be adequate to comply with the regulation):

Monthly monitoring

Areas that can be covered in a monthly monitoring report are:

Safety of water; and
Condition and cleanliness of food contact surfaces; and
Prevention of cross contamination.

Common terms for reporting conditions are "satisfactory" or "unsatisfactory, or "pass"/"fail".

1. Safety of water

How a firm monitors their water supply is dependent on the source of their water.

Municipal source:

Frequency: For a municipal source it is usually sufficient that a firm attaches a copy of the water bill to their monthly SSOP monitoring report or they can also request verification of the water quality from the city and maintain that record on file.

Private source:

Frequency: The firm could have the water tested for total coliform on a semi-annual basis. The results of analysis could be maintained with the monthly report.

Cross Connections: Monitoring of hard plumbing between potable and non-potable water:

Frequency: Once a month and more often if there are any changes to the plumbing.

2. Conditions and Cleanliness of Food Contact Surfaces:

Monitoring the condition of processing equipment and utensils to assure it's properly designed, constructed and maintained and determine if it is necessary to replace inadequate equipment.

Frequency: Once a month and more often if equipment is replaced to make sure that it meets the construction standards.

3. Prevention of Cross Contamination:

The monitoring requirement for proper plant design can be as simple as a monthly walk-through to assure that the plant layout and structure does not contribute to contamination of the product.

Frequency: Monthly, or more if modifications are made to the facility to verify the change did not contribute to the possibility of cross-contamination.

Daily monitoring

Areas that could be covered in a daily monitoring report are:

Safety of water; and
Condition and cleanliness of food contact surfaces; and
Prevention of cross contamination.

And all of:

Maintenance of hand-washing, hand-sanitizing, and toilet facilities; and
Protection from adulterants;
Proper labeling, storage and use of toxic compounds;
Employee health conditions;
Exclusion of pests

Note: just like the monthly monitoring records, daily monitoring records need to reflect the actual observations made in the plant, as well as any corrections taken as a result of an observed deficiency.

1. Safety of water:

In addition to concerns about cross connections between hard plumbed water and sewage lines covered in monthly monitoring, there could be daily monitoring of cross connections in the plant environment such as unprotected hose bibs with the hose submerged in the wash tank, or metering of cleaning chemicals.

Frequency: Before operations begin (pre-op) and every 4 hours of operation.

2. Condition and cleanliness of food contact surfaces:

Daily monitoring of the: cleaning and sanitizing of all equipment, utensils, gloves and outer garments that come in contact with food; and the condition of gloves and outer garments.

Frequency: Cleaning and sanitizing of all equipment could be monitored every time the equipment is cleaned and sanitized. That should include monitoring and recording of sanitizer strength.

Frequency: Cleaning and sanitizing of gloves and outer garments could be done at the start of operations and every 4 hours after.

3. Prevention of cross contamination:

Includes daily monitoring of: employee practices and physical separation of raw and cooked products.

Employee practices

Frequency: In general, employee practices could be monitored at the beginning of the day's operation and at least every four hours of production, and more often if necessary - concentrating on employee breaks. Monitoring employees that move from working in the raw side of the operation to the cooked side of the operation could be done at 4 hour intervals or when necessary.

Separation of raw and cooked product

Frequency: Coolers and processing areas could be monitored during the pre-op and post operative inspections and every four hours in between.

4. Hand-washing, hand-sanitizing, and toilet facilities:

Hand-washing, hand-sanitizing facilities

Frequency: Monitoring of hand-washing and sanitizing stations could be done during the pre-op inspection. Also, the concentration of hand sanitizing solutions could be monitored every four hours during operation.

Toilet facilities

Frequency: Monitoring is to assure that toilet facilities are adequate and in good repair. Seals around the bottom of each toilet, the functioning of the toilet, and toilet supplies could be monitored at least before the start of the day.

5 & 6. Protection from adulterants/Labeling, storage and use of toxic compounds:

Protection from adulterants, labeling, storage, and use of toxic compounds can be combined in monitoring and reporting.

Protection from adulterants

Frequency: Monitoring must be done to ensure that the food is protected from all contaminants including such things as condensate, floor splash, glass breakage, use of toxic chemical and other sources of contamination. Frequency of monitoring these conditions could be at start-up and every four hours after.

Labeling, storage and use of toxic compounds

Frequency: Once per day during the pre-op inspection could be an established frequency.

7. Employee health conditions:

Employee health conditions must be monitored.

Frequency: Daily, before the start of production.

8. Pest control:

Frequency: Monitoring for pest could be done daily, during the pre-op inspection.

Sanitation Corrections

It is important to remember that the sanitation correction requirements of the regulations are different than the corrective action requirements for critical limit deviations in the HACCP plan. In many cases corrections will not involve corrective action to the product itself, but more often will involve such actions as repairing or re-cleaning the equipment, providing training to employees, improving ventilation, or moving cleaning supplies out of the processing area. These corrections must be timely, but don't always need to be immediate. For example, if an employee returns from the restroom without washing their hands and then handles the product, it would not be reasonable to expect the processor to hold and evaluate the product or destroy the product. A more reasonable correction would be to re-train the employee. Under other circumstances, action against the product might be warranted, for example, an overhead sewage pipe found leaking on exposed product.

Critical to the success of both the monthly and daily monitoring record is the correction column where corrections that have been taken as a result of an observed deficiency are recorded. Examples could include:

If the monthly monitoring of a well water supply showed high total coliform counts, correction may be for the firm to stop processing and to resample immediately. If the resample is satisfactory, processing can begin. Another acceptable corrective action would be to find an alternative water source until the problem is corrected. All of this information is to be recorded in the correction column.

If the daily check of the storage warehouse found rodent excreta pellets, correction made might be to remove the pellets, assure no raw material has been contaminated, and clean the area before start-up, and call the pest control company. This correction would be recorded in the correction column of the daily report.

Sanitation Records

The regulations require that sanitation monitoring and corrections be documented in records. All sanitation records must have (21 CFR Part 120.12):

Firm name;
Firm location;
Date of record;
Signature or initials of the person performing the monitoring; and
The actual time the observation was made.

All of the principles discussed in the HACCP records chapter of this course apply to sanitation records.

You should select sanitation records for the same product days for which you select HACCP records. This ensures a complete package of records for those days and affords a greater opportunity to look at the overlap between records.

Monthly and Daily Sanitation Monitoring Records Examples

Following are example sanitation monitoring forms based on frequency of monitoring the 8 key areas of sanitation. These example forms can be used during the inspection to help determine if the processor is covering all of the sanitation monitoring requirements. However, these example forms are only one way to record sanitation monitoring and may not apply to every situation.

"FOR EXAMPLE ONLY"
DAILY SANITATION REPORT
Report Date:____________________ Line 1: Apple juice Line 2: Grape Juice	Firm Name:________________________________ Firm Address:______________________________ _________________________________________
Sanitation Area and Goal	Pre-Op Time:	Start Time:	4 Hour Time:	8 Hour Time:	Post-Op Time:	Comments / Corrections
1)Safety of Water (See Monthly Sanitation Report)
Back Siphonage - Hoses	(circle one) S/U
2) Condition and cleanliness of food contact surfaces (See Monthly Sanitation Report)
Equipment cleaned and sanitized	Line 1:	(circle one) S / U
Equipment cleaned and sanitized	Line 2:	(circle one) S / U
Sanitizer Strength Sanitizer Type:_______________ Minimum Strength: ___ ppm	Line 1:	___ ppm
	Line 2:	___ ppm
Gloves and aprons clean and in good repair	Line 1:	(circle one) S / U
Gloves and aprons clean and in good repair	Line 2:	(circle one) S / U
3) Prevention of cross-contamination (See Monthly Sanitation Report)
Hands, gloves, equipment, and utensils washed / sanitized after contact with unsanitary objects		(circle one) S / U	(circle one) S / U	(circle one) S / U
Employees working on raw products, wash and sanitize hands / gloves / outerwear before working with cooked products			(circle one) S / U	(circle one) S / U
Unpackaged cooked products separated from raw products			(circle one) S / U	(circle one) S / U	(circle one) S / U
4) Maintenance of hand-washing, hand-sanitizing, and toilet facilities
Hand-wash and hand-sanitizing stations adequate
Hand-wash station	Line 1:	(circle one) S / U
Hand-wash station	Line 2:	(circle one) S / U
Hand-sanitizing station Sanitizer Type:_______________ Minimum Strength: ___ ppm	Line 1:	___ ppm		___ ppm	___ ppm
	Line 2:	___ ppm		___ ppm	___ ppm
Toilets clean, properly functioning, and adequately supplied	(circle one) S / U
5) Protection from adulterants and 6) Labeling, storage, and use of toxic compounds
Product protected from contamination		(circle one) S / U	(circle one) S / U	(circle one) S / U
Cleaning compounds, lubricants, and pesticides labeled and stored properly	(circle one) S / U
7) Employee health conditions
Employees do not show signs of medical problems	(circle one) S / U
8) Exclusion of Pests
Pests excluded from processing area	(circle one) S / U
Other area(s)
Additional Comments: S = Satisfactory U = Unsatisfactory Signature (or Initials): ________________________________________________

"FOR EXAMPLE ONLY"
MONTHLY SANITATION REPORT
Sanitation Area and Goal	Decision	Comments / Corrections
Report Date:____________________ Line 1: Apple juice Line 2: Grape Juice	Firm Name:________________________________ Firm Address:______________________________ _________________________________________
1) Safety of Water
Safe and sanitary source (semi-annual)	(circle one) S / U
No cross-contamination - Hard Plumbing	(circle one) S / U
2) Condition and cleanliness of food contact surfaces
Processing equipment and utensils in suitable condition	(circle one) S / U
3) Prevention of cross-contamination
Physical conditions of plant and layout of equipment	(circle one) S / U
Additional Comments: S = Satisfactory U = Unsatisfactory Signature (or Initials): ________________________________________________

Chapter 12 Reporting HACCP Violations

Background

It is important to recognize that approaches for reporting objectionable conditions may vary from district to district. It is not the intention here to change or debate the various philosophies for reporting inspectional findings. Rather, it is to provide the basics so that you can apply them in a manner consistent with the agency's policies.

The Federal Food, Drug and Cosmetic Act (FD&C Act) requires that FDA Investigators leave processors with a written list of any conditions or practices they observe during the inspection. These written observations typically indicate that the food processed in the establishment may consist in whole or in part of any filthy, putrid, or decomposed substance, or may have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. The HACCP deficiencies that you will report will most likely fall under the portion of the FD&C Act that talks about foods that are prepared, packed, or held under insanitary conditions.

Preparing a list of the objectionable conditions and practices observed during an inspection and presenting that list to management can be done in many different ways. Some state agencies present their findings verbally unless they are issuing some type of warning or order. FDA investigators also handle some of their objections verbally, when there are only a few minor problems.

Written lists of objectionable conditions may take the form of a checklist, an abbreviated outline, or a detailed narrative. FDA Investigators report their findings in writing to management on a FDA-483 form. Some state agencies use similar forms. This chapter will address the FDA-483 format.

Basics of Writing FDA-483 Items

Listing objectionable conditions for HACCP deficiencies should follow the same rules and guidelines as for GMP problems and other deficiencies. The following information about 483s is a summary of information contained in FDA's Investigations Operations Manual.

Your written objections should be:

Factual, what you actually observed.
Written in a succinct and direct manner. The facts should be written in such a way that the person receiving the list can easily understand them. You should get a feel for the background and expertise of the people you are dealing with and adjust your vocabulary and writing style accordingly.
Significant and related to observed or potential problems. Potential problems should have a reasonable likelihood of occurrence.
Concise, with similar observations grouped to avoid redundancy. The significance of the items, not the number of items, is important.
Free of opinions or assumptions. Factual conclusions may be reported, but you should not draw unqualified conclusions that are not strongly supported by what you observed. For example, if you observe a person entering the wrong temperatures on a HACCP document, you should state that the entry or entries are not the correct temperatures. You should not conclude in writing that the employee was falsifying the document or the entries.
Free of any reference to the juice HACCP Regulations or the Juice Hazards & Controls Guide.

Additional Suggestions for Writing FDA-483 Items

The following are some additional tips and suggestions for 483 writing that are not contained in the IOM.

One of the easiest traps to fall into is the need or desire to be original. This almost always gets you into trouble. If a particular word, phrase, or format describes an objectionable condition directly and succinctly, then use it when appropriate. If you see the same or similar problem in different areas, the same wording can be used to emphasize the similarity of the problem. Eliminating redundancy does not mean that you need to vary how you describe the objectionable conditions or how you refer to a particular observation. Redundancy in the context of FDA-483s refers to repeated items that are similar and should be grouped together.

The phrase, "During an inspection of your firm (I) (We) Observed:" precedes the block on the FDA-483 where individual items are to be written. This lets you write items as incomplete sentences without a verb. For example, you might write:

No HACCP plan for the processing of apple juice outlining the controls measures for the hazard of Cryptosporidium parvum.

In this case "we observed" is understood to be the verb for each item. This can be confusing to the reader.

Consider, instead using full sentences. This allows the verb to be varied and better fit the situation. The previous examples could be written in full sentences as follows:

There is no written HACCP plan for the processing of apple juice outlining the controls measures for the hazard of Cryptosporidium parvum.

You should lead with the deficiency or problem in the first part of the written observation. This identifies the problem right up front instead of burying the problem in a lot of verbiage. This is particularly important when the written observations get quite lengthy.

You should use words that indicate frequency, like repeatedly or routinely, carefully and very deliberately. When an item can be counted, such as the number of deficient documents or the number of times an objectionable practice occurred, you should include that number in the written observation. For example: "On three occasions corrective actions were not taken for....;" or, "On five occasions employees did not...."

You should fully describe the magnitude of the problem. For example, if your HACCP record review revealed eight pasteurization records that did not have the required temperature entries, you might simply write: "Record review revealed eight pasteurization records that did not have the required recording chart temperature entries." But this does not make it clear whether the observation was the result of reviewing an entire year's worth of monitoring records or just a limited number of monitoring records during a period when the employee monitoring the cook step was out sick. A more appropriate way to write this item would be: "Eight out of the 20 pasteurization records reviewed for the week of 6/12/02 did not list the required recording chart temperatures."

When the deficiency recurs on an irregular basis but the number of documented occurrences is limited only by the number of documents you choose to review or the length of time you choose to watch the operations, then you should cite this as a repeated occurrence. For example, "The employee operating and monitoring the pasteurizer repeatedly failed to list the recording chart temperatures on the Pasteurization Log, as observed during the inspection and after review of 25 production records." In other words the more records you would have looked at or the longer you would have watched the operations, the more instances of this intermittent deficiency you would likely have found.

When the deficiency occurs all the time, or almost all the time and it is a regular practice of the firm, then this would be reported as a routine occurrence. For example, "The temperature recording charts for the pasteurizer are routinely not signed or dated by the operator or reviewed by a reviewing official."

Violations Other Than HACCP Violations

You should continue to object to GMP violations and other violations on your FDA-483s, just as you have in the past.

Examples of HACCP Regulation Deficiencies

Following is a list of some of the types of violations of the HACCP regulation that you should expect to encounter during juice HACCP inspections. This is not a definitive, all-inclusive list, and the relative significance of items may vary depending upon the circumstances.

Falsification of records.
No corrective action or inadequate corrective action when deviations from the critical limits occur.
No monitoring or inadequate monitoring at CCPs.
No HACCP plan when required.
Inadequate HACCP plan with some or all of the significant hazards not addressed or inadequately addressed.
No or inadequate monitoring records or inadequate records
No correction or recording of correction for sanitation deficiencies.
No monitoring of sanitation.
No record review.
No trained individual available for HACCP reviews.
No signature/date on HACCP plan.
No signature/dates on required records.
No annual review of HACCP plan.

Examples of FDA-483 Items for Specific Situations

Following are some examples of HACCP regulation violations that might be encountered during an inspection of a juice processor that primarily produces pasteurized, refrigerated apple juice in glass bottles and one way that the condition(s) can be reported.

HACCP Records

Problem: When the investigator arrived at the firm he checked the locations where data was being entered on HACCP records. When he checked the Pasteurization Temperature Record at 8:20 AM, the blanks for the rest of the day were prematurely filled in with false numbers. This is a falsified document and a very serious violation, because the validity of all Pasteurization Temperature Records from this firm was immediately questionable.

FDA-483 Item: At 8:20 AM on 6/12/02 the times and temperatures on the Pasteurization Temperature Record were filled out in advance for the entire day in half hour intervals from 8:30 AM through 1:30 PM.

HACCP Plan
Problem: This firm processes apple juice and orange juice. The firm has made no attempt to prepare a HACCP plan for either of the products

FDA-483 Item: There are no written HACCP plans outlining controls for Cryptosporidium parvum or Salmonella during processing of apple juice and orange juice processed at your facility.

Hazards
Problem: This firm also processes fresh apple juice, but did not identify patulin formation as one of the hazards in their HACCP plan. However, the firm does control the condition of the incoming apple, as part of their operating procedures.

FDA-483 Item: The written HACCP plan for fresh apple juice does not address the hazard of patulin formation.

Hazards and Controls
Problem: The firm's processing includes grinding apples into juice with a hammer mill grinder. There is a significant potential for metal fragments to be incorporated into the finished product. The firm's HACCP plan does not cover the possibility of metal fragments and they have no system or procedures to detect metal in their finished product.

FDA-483 Item: The written HACCP plan for pasteurized apple juice does not address the hazard of metal fragments and there is no control measure in place.

Critical Limit Deviations
Problem: This firm has identified the pasteurization step as a Critical Control Point and set critical limits for time and temperature of pasteurization for their apple juice. Review of the pasteurization records found that the Pasteurization Temperature Record for 6/12/02 documented two occasions where the temperature was at least 5°F below the critical limit set by the firm. There were no notations or comments on the record and a review of the Corrective Action Reports for that date also found no mention of critical limits not being met or correction of the deficiency.

FDA-483 Item: A review of the Pasteurization Temperature Record dated 6/12/02 found that on two occasions the pasteurization temperature was below the critical limit by 5°F and no correction to the deficiency was noted on the record or on file.

Verification
Problem: The juice firm changed the way they monitor for glass fragments. Previously, the firm used visual monitoring to prevent the incorporation of glass fragments into the finished apple juice. Now the firm is using x-ray equipment to continuously monitor for glass. The HACCP plan states that a quality assurance technician will challenge the x-ray equipment at the start of the day's production and at four-hour intervals after that. The investigator observed that a quality assurance technician did not challenge the x-ray equipment either after start-up or any other time during the processing day.

FDA-483 Item: The verification procedures at the x-ray machine are not being implemented as outlined in the HACCP plan in that the x-ray equipment was not challenged at the start of processing or at 4 hour intervals after that.

Verification
Problem: The plant manager, who is the reviewing official has not signed and dated any monitoring records showing they were reviewed. Observation revealed that the monitoring records are placed on his desk but are routinely filed without being reviewed.

FDA-483 Item: Review of the Pasteurization Temperature Log and the Metal Detection Log monitoring records for all dates reviewed found they are not signed and dated as being reviewed as outlined in the HACCP Plan.

Chapter 13 Importer Inspections and Imports

General

Reviewing an importer for compliance is different than inspecting a domestic processor in that, in most cases, the importer was not directly involved in the processing of the product that they are importing. The importer must rely on the foreign processing firm to produce the product according to the HACCP regulation. The importer's role is to verify that the foreign processor is complying with the HACCP regulation (21 CFR Part 120.14).

In the control of imports, you may or may not see the foreign processor's HACCP plan. Even, if you do, you will not have the luxury to compare that HACCP plan to the processing plant. In addition, the process to conduct an inspection of an importer or review documents at entry is more involved.

Memorandum of Understanding (MOU)

Let us begin by reviewing the import requirements as stated in the juice HACCP regulation (21 CFR Part 120.14). All juice products offered for entry into the United States must be processed under conditions that comply with the HACCP regulations. It is the responsibility of the importer to verify that this is occurring. The easiest way for the importer to do this is to obtain juice from a country that has an active Memorandum of Understanding (MOU) with FDA. If an importer obtains product from an MOU country, the importer has no further obligations as a result of the juice HACCP regulation, relative to that importation.

A juice HACCP MOU acknowledges that a foreign country's juice inspection system is equivalent to the U.S. FDA inspection system. With an MOU in place, it becomes the responsibility of the participating country government, not the importer, to verify compliance with the HACCP regulations. An MOU may deal with all juice products that a particular country exports to the United States or may just deal with a particular juice product. In addition, an MOU may cover all juice processors in the country, or only selected processors.

Written Verification Procedures

When importing juice from countries without a juice HACCP MOU, the importer must have and must implement written verification procedures to ensure that the juice is being processed in accordance with the juice HACCP regulation (21 CFR Part 120.14). The written verification must provide (21 CFR Part 120.14): 1) product specifications, and 2) affirmative steps, as discussed below.

Product Specifications

The importer must develop product specifications that are designed to ensure that each imported product is not adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act. These product specifications must list limits for relevant safety issues (21 CFR Part 120.14). For example, a specification for Salmonella could be listed as "no Salmonella present."

Affirmative Steps

In addition to the written specifications, the importer must have and follow written procedures that describe the affirmative steps that the importer will take to ensure that the juice product is being produced in accordance with the regulations (21 CFR Part 120.14).

The juice HACCP regulation lists five affirmative steps. The importer may use one or more of these steps. The importer may:

Obtain from the foreign processor the HACCP and sanitation monitoring records that relate to the specific lot offered for import;
Obtain a continuing or lot-by-lot certificate from an appropriate foreign government inspection authority or competent third party certifying that the imported juice was processed in accordance with the HACCP regulation;
Inspect the foreign processor's facilities to ensure that the product is produced in accordance with the HACCP regulation;
Maintain a copy, in English, of the foreign processor's hazard analysis and HACCP plan along with along with a written guarantee from the processor that the juice was processed according to the HACCP regulation; or
Periodically test the imported juice and maintain a written guarantee from the processor that the juice was processed according to the juice HACCP regulation.

The regulation also allows importers to develop their own affirmation procedures as long as they provide an equivalent level of assurance of compliance with the HACCP regulation. The importer must also maintain records that document the performance and results of their affirmative steps. These records are subject to the record retention, access, and other record provisions of the regulation.

Components of an Importer HACCP Inspection

The components of a HACCP inspection of an importer are:

Conduct the initial interview
Select product(s) to review
Determine the foreign sources of the selected imported juice product(s)
Review importer's product safety specifications
Review importer's verification plans
Review importer's verification records
Document objectionable conditions

Conduct Initial Interview

The initial interview is the same as the initial interview for a domestic processor. During this time, you will be identifying yourself, displaying your credentials, issuing a Notice of Inspection and learning what juice products the importer imports.

Select Product

Importers may only deal with one or two products but, most likely, they will handle numerous juice products and you will need to determine which product or products to evaluate. You should consider the same factors that you use in inspecting domestic processors when you make this determination. Examples are:

the product's potential to contain a safety hazard,
products covered during previous inspections, and
the product's compliance history.

Where past inspections of an importer detected significant problems with a particular product, your follow-up inspections should, as usual, concentrate on those or similar products. However, in the absence of past compliance problems, you should ordinarily review products which have not yet been inspected.

Determine Foreign Sources

Next you need to determine the countries from which the importer receives their juice products. If the specific juice products are obtained from countries with active juice HACCP MOUs with FDA, you should use your judgement to determine whether it is necessary to look at some of the importer's invoices to verify that the juice the importer imports is indeed from such countries.

Review Product Safety Specifications

When importers import juice from countries that do not have active juice HACCP MOUs with the United States, you should review their written verification procedures. One component of verification procedures must be product specifications (21 CFR Part 120.14). These specifications must address the safety attributes of the product. In most cases, the specifications will be derived from existing Federal food safety standards, including tolerances and guidelines. In other cases the specifications may need to be tailored to the circumstances. Importers may seek the advice of qualified experts, as needed, in setting safety specifications.

Review Written Verification Plans

The second part of the importer's written verification procedures must be affirmative steps to verify that their foreign suppliers are in fact operating in a manner that is consistent with the juice HACCP regulation (21 CFR Part 120.14). The regulations allow the importers to select affirmative steps that are workable for their circumstances. The importer can use any one or more of the five affirmative steps, as long as the steps provide assurance that the foreign processor is in compliance with the regulation.

At this point in your inspection, review the affirmative step(s) the importer is using for the products that you have selected for coverage. If the affirmative step is not one of the five affirmative steps as stated in the regulation, then you must determine whether it provides an equivalent assurance of foreign processor compliance.

Review Verification Records

Once you have established which affirmative step is being used, you should review the importer's verification records. Importer records must meet the same requirements as domestic processing records (21 CFR Part 120.12 and 120.14). These include their name and address on the records, signature or initials, proper record retention time, etc. During this review, you will be determining whether the verification procedures have been carried out.

The regulation does allow the importer to use the services of a competent third party to perform the affirmative steps (21 CFR Part 120.14). However, the importer is still the responsible party and must have the verification documents at their disposal.

The most difficult element of reviewing verification records is evaluating foreign processor HACCP plans when the importer has elected to use them as an affirmative step. If an importer has HACCP plans on hand for products that you have chosen for coverage, you should choose several and review them using the procedures that were taught in earlier chapters. The difficulty is that you will not be able to compare the HACCP plan with the actual processing plant nor will you have the opportunity to ask questions of the processor. You will have to rely solely on the Hazards and Controls Guide, other references, and your experience to evaluate the adequacy of the hazards and controls contained in the plan. If the HACCP plan is inadequate, then the imported product is deemed to be adulterated.

Inspection Frequency

Inspections of importers will be conducted at a frequency and under conditions specified by the agency, independent of the entry process. Districts will be assigned a number of such inspections to be performed. The compliance program will also provide a prioritization system to assist the districts in selecting importers for inspection.

Chapter 14 Special Considerations

Overview

There are three special considerations relating to HACCP inspections, which will be discussed in this chapter. They are:

Collecting physical samples
Federal - state contracts
Preliminary HACCP inspections

Collecting Physical Samples

Sampling has always been an important component of inspections (Section 702(b) of the FD&C Act). Therefore, inspectors frequently ask what to do about sampling under the new juice HACCP regulation. Inspectors want to know if they are to collect a physical sample to help verify that a HACCP plan is controlling the significant hazard or collect the sample only when a firm is having problems with their HACCP program.

Some states only collect physical or environmental samples when they are likely to support observations of significant objectionable conditions made during an inspection. They do not have the resources to routinely collect and analyze samples without cause. Even if every regulatory agency had the resources, sampling is not a very effective way of identifying certain kinds of problems, such as low-level microbiological or physical contamination. Large sample sizes of perhaps 10% or more of the total lot, may be needed to determine if the product is contaminated. The time and cost of analyzing samples that large is, in most cases, prohibitive.

When performing a HACCP inspection, the general rule is not to obtain a physical sample of the product for compliance purposes. The HACCP regulation is based on various sections of the Federal Food, Drug, and Cosmetic Act, but most notably section 402(a)(4). Documentation of a deficient HACCP program, in most cases, will demonstrate that the product had been prepared, packed, or held under insanitary conditions and is therefore adulterated under section 402(a)(4) of the Act. A physical sample is not needed to support a 402(a)(4) charge.

There are, however, situations when collecting a physical sample may be appropriate. Generally speaking, physical samples may be collected when, in your judgement, they are likely to disclose the presence of a defect and would be useful to support a 402(a)(1) charge in that the product "bears or contains any poisonous or deleterious substance which may render it injurious to health." For example, you may want to collect an apple juice sample to show patulin formation when you have documented visually moldy apples being processed into juice.

During any inspection you also may need to obtain a physical sample to fulfill the requirement of a compliance program or special assignment, such as the collection of survey samples. For example, it is anticipated that a number of surveillance samples will be collected to assess the overall effectiveness of the national HACCP program.

Physical samples may be collected to document that a product is violative because of a non-safety defect. An example would be the need to collect a physical sample to document filth. While filth is not a health hazard, and therefore is not covered by the juice HACCP regulation, it is an adulterant. In this case, the physical sample would be used to document a violation of 402(a)(3) of the Act.

Federal - State Contracts

Another special consideration are the contracts between the FDA and state agencies in enforcing the juice HACCP regulation. The main objective of a contract is to harmonize and eliminate duplication in juice processing inspections. Doing so should more effectively utilize the expenditure of resources by the agencies. Another benefit will be information sharing including current, pertinent enforcement data.

Preliminary Inspections

FDA recommends that all firms implement HACCP as quickly as possible in the interest of public health safety. However, under the regulation, the effective dates vary depending on the size of the business. The effective dates for compliance with the juice HACCP regulation are January 22, 2002 for all businesses not defined as "small businesses" or "very small businesses," January 21, 2003 for small businesses, and January 20, 2004 for very small businesses.

Initial inspections are planned as educational, i.e., to assist the processor in determining deficiencies in their plan. It will also provide you, the inspectors, with hands-on experience in HACCP-based juice inspections. These evaluations should serve to aid the development of both the industry's HACCP programs and the inspector's HACCP inspection skills. However, violations unrelated to the implementation of the HACCP system, or, if no attempt has been made to implement HACCP, FDA will take regulatory action.