Guidance for Industry

Juice HACCP

Hazards and Controls Guidance

First Edition

DRAFT GUIDANCE

This guidance document is being distributed for comment purposes only.

**Draft released for comment on: September 12, 2002**

**Comments and suggestions regarding this draft document should be
submitted by November 12, 2002, to Dockets Management Branch (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD
20852. For questions regarding this draft document, contact Michael
Kashtock at (301) 436-2022.**

**U.S. Department of Health and Human Services**

**Food and Drug Administration**

**Center for Food Safety and Applied Nutrition**

**September 2002**

Guidance for Industry

Juice HACCP

Hazards and Controls Guidance

First Edition

Draft Guidance

**This draft guidance represents FDA's current views on potential
hazards in juice products and how to control them, and it is designed to
assist juice processors in the development of HACCP plans to satisfy the
requirements of the Hazard Analysis Critical Control Points (HACCP)
regulation for juice in 21 CFR Part 120. 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.**

###  {#section .unnumbered}

# Highlights of the Juice HACCP Regulation

-   Both interstate and intrastate juice processors must evaluate their
    processing operations using HACCP principles.

-   Effective dates for the regulation are January 20, 2002, January 21,
    2003, or January 22, 2004, depending upon the size of your business.

-   The regulation does not pre-empt the existing requirements to follow
    the current Good Manufacturing Practice (CGMP) regulations for your
    juice processing operations.

-   The HACCP Plan and other records of your sanitation standard
    operating procedures (SSOPs) and HACCP operations must be available
    for official inspection and copying.

-   Employees involved in developing, or in certain aspects of
    implementing, a HACCP plan, must be trained in HACCP principles.

-   The 5-log pathogen reduction must

> \- be accomplished for the microbe you identify as the "pertinent
> microorganism," which is the most resistant microorganism of public
> health significance that is likely to occur in the juice, e.g., *E.
> coli* O157:H7,

\- take place in one facility just prior to or after packaging,[^1] and

\- be applied directly to the juice, except for citrus juices.

-   Fruit surface treatments may be used to accomplish the 5-log
    reduction for citrus fruits, but cleaned and undamaged tree-picked
    fruit must be used and the effectiveness of the treatment must be
    verified by regularly testing your product for generic *E. coli.*

-   Shelf stable juices made using a single thermal processing step and
    juice concentrates made using a thermal concentration process that
    includes all of the ingredients, are exempt from the requirement to
    include control measures in your HACCP plan to achieve the 5-log
    pathogen reduction, but a copy of the thermal process must be
    included in your hazard analysis.

-   Low-acid canned juice is exempt from the requirement to include
    control measures in your HACCP plan to achieve the 5-log pathogen
    reduction, but the juice is still subject to the low-acid canned
    food regulation and all of the other requirements of the juice HACCP
    regulation.

-   Retail establishments or businesses that make and sell juice
    directly to consumers and do not sell or distribute juice to other
    businesses are exempt from the juice HACCP regulation, but must
    comply with any applicable state regulations.

### Juice HACCP Hazards and Controls Guidance {#juice-haccp-hazards-and-controls-guidance .unnumbered}

Guidance for Industry

# Table of Contents

##### I. Introduction  {#i.-introduction .unnumbered}

::: Definition-Term
A. Status
:::

B. Purpose

C. Scope and Limitations

II\. Terms and Definitions

## III. Overview of the Juice HACCP Regulation {#iii.-overview-of-the-juice-haccp-regulation .unnumbered}

## A. Compliance Required for All Juice Processors  {#a.-compliance-required-for-all-juice-processors .unnumbered}

1.0 Intrastate and Interstate Firms

::: Definition-Term
2.0 Effective Dates---Very Small Businesses, Small Businesses, All
Others
:::

3.  Juice Importers

4.  If You Process a Non-Juice Beverages with a Juice Ingredient

B. Some Key Requirements of the Juice HACCP Regulation

1.  Warning Label Statement Versus HACCP System

2.  Specialized Training in HACCP Principals Required

3.  Trained Employee or Consultant Acceptable

4.  Record Keeping and Electronic Records

4.1 Official Review of Records

## C. Part 110 (CGMPs) Applicable to Firms Subject to Juice HACCP Regulation {#c.-part-110-cgmps-applicable-to-firms-subject-to-juice-haccp-regulation .unnumbered}

## D. Exemptions and Items Not Subject to the Regulation {#d.-exemptions-and-items-not-subject-to-the-regulation .unnumbered}

1.  Retail Businesses

2.  Non-Beverage Foods with Juice Ingredient (a fruit-flavored candy)

3.  Processors of Ingredients From Fruit Other Than Juice

IV\. Juice Hazard Analysis

## A. Overview of the Hazard Analysis {#a.-overview-of-the-hazard-analysis .unnumbered}

1.  Description

2.  Relevance to HACCP Plan and SSOPs

3.  Developed by HACCP-trained Employee or Consultant

### B. Preparing for a Hazard Analysis\--Five Preliminary Steps  {#b.-preparing-for-a-hazard-analysis--five-preliminary-steps .unnumbered}

### C. Basic Steps of the Hazard Analysis  {#c.-basic-steps-of-the-hazard-analysis .unnumbered}

1.  Identify All Potential Hazards

    1.  Biological Hazards

> 1.11 Enteric Microbial Pathogens

12. Other Potential Bacterial Hazards

13. Viruses

> 1.2 Chemical Hazards
>
> 1.21 Patulin

22. Undeclared Food Allergens in Juice Due to Cross-Contact from Shared
    Processing Equipment

23. Allergens and Food Intolerance Substances Added to Juice as
    Ingredients

> 1.24 Pesticide Residues
>
> 1.25 Lead
>
> 1.26 Tin

::: Definition-Term
> 1.3 Physical Hazards
:::

31. ::: Definition-Term
    Glass Fragments
    :::

> 1.32 Metal Fragments

2.  Evaluate All Potential Hazards

3.  Determine If Potential Hazards Will Require Controls in Your HACCP
    Plan

    1.  Potential Hazards "Reasonably Likely to Occur"

    2.  Potential Hazards Not "Reasonably Likely to Occur"

    3.  Hazards Related to Facility Sanitation

    4.  Controls for Pathogens and Allergens Arising from Food Contact
        Surfaces

4.  Identify Control Measures and CCPs

4.1 NACMCF CCP Decision Tree

2.  Location of CCPs

V. Control Measures

A. HACCP Control Measures

B. Activities [Not]{.underline} Considered to be HACCP Control Measures

> 1.0 GAPs
>
> 2.0 CGMPs

#### C. Control Measures for Biological Hazards

#### Minimum Requirement of 5-Log Pathogen Reduction

#### 1.1 What Does "Pertinent Microorganism" Mean?

#### 1.2 Shelf Life and Moderate Temperature Abuse Conditions

#### 1.3 5-Log Treatment Performed on Juice After Extraction with One Exception

### 2.0 Location of Juice Extraction, Processing and Packaging  {#location-of-juice-extraction-processing-and-packaging .unnumbered}

## 3.0 Requirements for Certain Citrus Juices {#requirements-for-certain-citrus-juices .unnumbered}

> 3.1 Compliance with Requirement to Use Tree-Picked, Culled Fruit
>
> 3.2 Positive *E. coli* Test Results for Citrus Juices Made Using
> Surface Treatment of Fruit to Achieve 5-Log Reduction

4.0 Heat Treated Shelf Stable Juices and Concentrates, and Other
Non-Heat Treated Juices

4.1 Heat Treated Shelf Stable Juices and Concentrates

> 4.2 Example of a Process for a Shelf Stable Juice
>
> 4.3 Juices Subject to the Low-Acid Canned Foods and Acidified Foods
> Regulations
>
> 4.4 Other Non-Thermal Treatments for Juice

5.  Process Validation

    1.  Role of a "Process Authority"

    2.  Validated Pasteurization Treatments for Juice

> 5.3 Equipment and System Considerations
>
> 5.31 Pasteurization Equipment
>
> 5.32 UV Processing Systems
>
> 5.33 High Pressure Processing Systems
>
> 5.34 Extraction Equipment for Certain Citrus Juice Processes

D. Control Measures for Chemical Hazards

1.  Control Strategies for Patulin for Apple Juice Processors

    1.  Hazard Analysis

    2.  Control Measures

    3.  If You Make Apple Juice from Purchased Concentrate

> 2.0 Control Measures for Food Allergens That Can Contaminate Juice
> from Improperly Cleaned Shared Processing Equipment

## E. Control Measures for Physical Hazards {#e.-control-measures-for-physical-hazards .unnumbered}

1.0 Physical Hazards

1.  ::: Definition-Term
    Glass Fragments
    :::

> 1.2. Metal Fragments

F. Table of Most Likely Hazards/Control Measures for Juice

VI\. Preparing for HACCP

## A. Getting People Ready {#a.-getting-people-ready .unnumbered}

B. HACCP Training and HACCP Resource Materials

1.0 Juice HACCP Alliance Training Curriculum

2.0 USDA/FDA HACCP Training Programs and Resources Database

## VII. Example Documents {#vii.-example-documents .unnumbered}

A. Hazard Analysis Examples

> 1.0 Example Hazard Analysis for Pasteurized Refrigerated Apple Juice
>
> 2.0 Hazard Identification and Evaluation Exercise for Apple Juice
>
> 2.1 Step 1 -- Hazard Identification
>
> 2.2 Step 2 -- Hazard Evaluation
>
> 3.0 Example Hazard Analysis for Fresh Orange Juice
>
> 4.0 Example Hazard Analysis for Not-from-concentrate Pasteurized
> Orange Juice

B. HACCP Plan Examples

1.  Example HACCP Plan for Pasteurized Refrigerated Apple Juice

2.  Example HACCP Plan for Fresh Orange Juice

3.  Example HACCP Plan for Not-from-Concentrate Pasteurized Orange Juice

C. Example CCP and SSOP for prevention of occurrence of undeclared milk
residues in juice

**I. Introduction**

A. Status

This is a draft of the first edition of the Food and Drug
Administration's (FDA) \"Juice HACCP Hazards and Controls Guidance.\"
This guidance may be used in conjunction with FDA\'s final regulation
(21 CFR Part 120) that requires a processor of juice to evaluate its
operations using Hazard Analysis Critical Control Point (HACCP)
principles and, if necessary, to develop and implement HACCP systems
(i.e., a system of preventive control measures based upon HACCP
principles) for their operations. The final regulations were published
in the Federal Register on January 19, 2001 and become effective one,
two, or three years from that date, depending upon the size of your
business. We may revise and reissue this guidance from time to time as
the state of knowledge advances relative to juice hazards and controls.
We will accept public comment on this edition of the guidance at any
time for consideration in drafting a future edition. Comments should be
submitted to:

U.S. Food and Drug Administration\
Dockets Management Branch\
Room 1-23\
12420 Parklawn Drive\
Rockville, MD 20857

Comments should be identified with Docket Number 02D-0333.

B. Purpose

The purpose of this guidance is to assist you in the development of a
HACCP plan, should your hazard analysis show that such a plan is
necessary under 120.8(a). You will find information in this guidance
that will help you identify hazards that may potentially occur in your
products, and help you identify and use methods of controlling and
preventing hazards. This guidance is also intended to serve as a tool
for federal and state regulatory officials in the evaluation of HACCP
plans for juice products.

To help you understand some key aspects of the juice HACCP regulation
and plan how you will initiate your HACCP activities, we have included
information on some other important aspects of the juice HACCP
regulation such as effective dates, use of the label warning statement,
and training. Additional information on juice HACCP is available at
[www.cfsan.fda.gov](http://www.cfsan.fda.gov/) under "Program Areas" and
"HACCP." The information available at this website includes the HACCP
regulation, the publication, "The Juice HACCP Regulation Questions and
Answers," and additional guidance FDA has issued related to the juice
HACCP regulation. By periodically checking this website you will have
access to the most up- to- date FDA information on juice HACCP. The
documents at this website also are available by mail from the address
given in section I. C below. In addition, all FDA Compliance Policy
Guide (CPG) documents referred to in this guidance are available at
<http://www.fda.gov/ora/compliance_ref/cpg/default.htm>.

**C. Scope and Limitations**

The controls and practices provided in this guidance are recommendations
and guidance from FDA to the juice industry. This guidance is not a set
of binding requirements. Importantly, this guidance may not identify all
hazards that need to be controlled, and it is the ultimate
responsibility of the juice processor to identify all hazards that are
reasonably likely to occur and all appropriate controls for such
hazards. You may choose to use other control measures, as long as they
meet the requirements of the juice HACCP regulation and are consistent
with relevant state and federal laws or regulations.

The information contained in section IV provides guidance for
determining which hazards are \"reasonably likely to occur\" in specific
types of juice products under ordinary circumstances. This section lists
potential hazards for specific types of juice products. This information
should be combined with other relevant information available to you and
used in conducting the hazard analysis to determine the likelihood of
occurrence of a hazard.

This guidance is not a substitute for a processor's performance of its
own hazard analysis as required by FDA\'s regulations. Hazards not
covered by this guidance may be relevant to certain products under
certain circumstances. In particular, you should be alert to new or
emerging problems.

This guidance does not cover the hazard associated with the formation of
*Clostridium botulinum* toxin in juices that are low acid canned foods
(LACF) or shelf stable acidified foods. Mandatory controls for this
hazard are contained in the LACF regulation (21 CFR Part 113) and the
acidified foods regulation (21 CFR Part 114). As explained in section
VI, such controls need not be included in HACCP plans for these juice
products.

Additional copies

You may obtain single copies of this guidance as long as supplies last
from:

U.S. Food and Drug Administration\
Office of Plant and Dairy Foods and Beverages\
5100 Paint Branch Parkway\
College Park, MD 20740\
301-436-1400

This guidance also is available electronically at the web address in
section I. B above.

**II. Terms and Definitions**

This section lists definitions of several terms as they appear in FDA's
juice HACCP regulation. Following many of the definitions below, you
will find *Additional helpful information* about the defined term.
Although not formally defined in the juice HACCP regulation, this
section also describes the terms "fallen fruit," "hazard analysis,"
"HACCP," "HACCP plan," HACCP team," "juice concentrate,"
"pasteurization," "process authority," and "retail establishment."

**[Cleaned]{.underline}** means washed with water of adequate sanitary
quality.

**[Control]{.underline}** means to prevent, eliminate, or reduce.

**[Control measure]{.underline}** means any action or activity that is
used to prevent, reduce to acceptable levels, or eliminate a hazard.

*Additional helpful information:* You are required to identify control
measures in your hazard analysis for all hazards that were determined to
be "reasonably likely to occur" in your hazard analysis. This is
illustrated in Column 5 of the Hazard Analysis examples in section VII.
A.

## [Critical control point (CCP)]{.underline} means a point, step, or procedure in a food process at which a control measure can be applied and at which control is essential to reduce an identified food hazard to an acceptable level. {#critical-control-point-ccp-means-a-point-step-or-procedure-in-a-food-process-at-which-a-control-measure-can-be-applied-and-at-which-control-is-essential-to-reduce-an-identified-food-hazard-to-an-acceptable-level. .unnumbered}

*Additional helpful information:* You are required to identify CCPs in
your hazard analysis for all hazards that were determined to be
"reasonably likely to occur" in your hazard analysis. This is
illustrated in Column 6 of the Hazard Analysis examples in section VII.
A.

## [Critical limit]{.underline} means the maximum or minimum 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 hazard. {#critical-limit-means-the-maximum-or-minimum-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-hazard. .unnumbered}

*Additional helpful information:* You are required to specify critical
limits in your HACCP plan for each hazard to be controlled at a critical
control point. This is illustrated in Column 3 of the HACCP plan
examples in section VII. B.

**[Culled]{.underline}** means separation of damaged fruit from
undamaged fruit. For processors of citrus juices using treatments to
fruit surfaces to comply with 21 CFR 120.24, [culled]{.underline} means
undamaged, tree-picked fruit that is U.S. Department of Agriculture
(USDA) choice or higher quality. (*Note: There is no current USDA
standard for choice or higher quality. FDA will consider tree-picked,
and undamaged citrus fruit to meet this definition of "culled" for
purposes of compliance with the juice HACCP regulation).*

**[Fallen fruit]{.underline}** means fruit that has fallen naturally
from the tree to the ground in an orchard. It does not include
mechanically harvested fruit, which is obtained by shaking the tree and
collecting the fruit from the ground with appropriate mechanical
machinery; also called *grounders, windfall fruit, drops.*

## [Food hazard]{.underline} means any biological, chemical, or physical agent that is reasonably likely to cause illness or injury in the absence of its control. {#food-hazard-means-any-biological-chemical-or-physical-agent-that-is-reasonably-likely-to-cause-illness-or-injury-in-the-absence-of-its-control. .unnumbered}

**[HACCP]{.underline}** means a systematic approach to the
identification, evaluation, and control of food safety hazards.

**[HACCP Plan]{.underline}** means the written document that is based
upon the principles of HACCP and delineates the procedures to be
followed.

## [HACCP Team]{.underline} means the group of people who are responsible for developing, implementing, and maintaining the HACCP system. {#haccp-team-means-the-group-of-people-who-are-responsible-for-developing-implementing-and-maintaining-the-haccp-system. .unnumbered}

## [Hazard Analysis]{.underline} means the process of collecting and evaluating information on hazards associated with the food under consideration to decide which are significant and must be addressed in the HACCP plan. All juice processors subject to the juice HACCP regulation are required to prepare a written hazard analysis. {#hazard-analysis-means-the-process-of-collecting-and-evaluating-information-on-hazards-associated-with-the-food-under-consideration-to-decide-which-are-significant-and-must-be-addressed-in-the-haccp-plan.-all-juice-processors-subject-to-the-juice-haccp-regulation-are-required-to-prepare-a-written-hazard-analysis. .unnumbered}

##  {#section-1 .unnumbered}

## *Additional helpful information*: The hazard analysis process for juice products is covered in section IV. Example Hazard Analyses for refrigerated pasteurized apple juice, fresh orange juice and not-from-concentrate pasteurized orange juice are covered in section VII. A.  {#additional-helpful-information-the-hazard-analysis-process-for-juice-products-is-covered-in-section-iv.-example-hazard-analyses-for-refrigerated-pasteurized-apple-juice-fresh-orange-juice-and-not-from-concentrate-pasteurized-orange-juice-are-covered-in-section-vii.-a. .unnumbered}

**[Juice concentrate]{.underline}** means the aqueous liquid expressed
or extracted from one or more fruits or vegetables and reduced in weight
and volume through the removal of water from the juice.

## [Monitor]{.underline} means to conduct a planned sequence of observations or measurements to assess whether a process, point, or procedure is under control and to produce an accurate record for future use in verification. {#monitor-means-to-conduct-a-planned-sequence-of-observations-or-measurements-to-assess-whether-a-process-point-or-procedure-is-under-control-and-to-produce-an-accurate-record-for-future-use-in-verification. .unnumbered}

*Additional helpful information*: You are required to specify monitoring
procedures including what, how, how often and who is performing the
monitoring, in your HACCP plan for each hazard to be controlled at a
critical control point. This is illustrated in the HACCP Plan examples
in section VII. B.

**[Pasteurization]{.underline}** means a heat treatment sufficient to
destroy pathogens.

**[Process Authority]{.underline}** means an expert in the processes for
controlling pathogenic microorganisms in food, and as such, is qualified
by training and experience to evaluate all of the aspects of your
pathogen control measures, e.g., process time, temperature, type of
equipment, etc., and determine that your control measures, if properly
implemented, will control pathogens effectively.

**[Retail Establishment]{.underline}** means an operation that provides
juice directly to consumers and does not sell or distribute juice to
other businesses. The term "provides" includes storing, preparing,
packaging, serving, and selling juice.

## [Shelf stable product]{.underline} means a product that is hermetically sealed and, when stored at room temperature, should not demonstrate any microbial growth. {#shelf-stable-product-means-a-product-that-is-hermetically-sealed-and-when-stored-at-room-temperature-should-not-demonstrate-any-microbial-growth. .unnumbered}

*Additional helpful information:* If you process certain types of shelf
stable juice products, you are exempt from the requirements in 21 CFR
120.24 to include control measures in your HACCP plans for those
products for achieving a 5-log reduction in the pertinent microorganism.
This exemption applies to the following types of products:

-   products subject to the requirements of the Low Acid Canned Foods
    and Acidified Foods regulations in 21 CFR Parts 113 and 114,
    respectively

```{=html}
<!-- -->
```
-   acidic shelf stable juices like canned orange juice, which are made
    using a single thermal processing step

```{=html}
<!-- -->
```
-   juice concentrates like orange juice concentrate in which all
    ingredients of the concentrate receive a thermal concentration
    process

## [Validation]{.underline} means that element of verification focused on collecting and evaluating scientific and technical information to determine whether the HACCP system, when properly implemented, will control effectively the identified food hazards. {#validation-means-that-element-of-verification-focused-on-collecting-and-evaluating-scientific-and-technical-information-to-determine-whether-the-haccp-system-when-properly-implemented-will-control-effectively-the-identified-food-hazards. .unnumbered}

*Additional helpful information:* A person trained in accordance with
the requirements of 21 CFR 120.13 must validate your HACCP plan
initially and at least annually thereafter, or whenever changes in the
process occur that could affect the hazard analysis or alter the HACCP
plan in any way.

Even if your hazard analysis shows that there are no food hazards that
are reasonably likely to occur during the processing of your juice, a
person with appropriate training must validate your hazard analysis. In
addition, your hazard analysis must be reassessed (e.g., revalidated) by
a person with appropriate training whenever there are any changes in the
process that could reasonably affect whether a food hazard exists.

Section 120.25 of the juice HACCP regulation also describes
circumstances in which it may be necessary to revalidate your HACCP plan
due to process deviations, problems noted in the weekly review of
monitoring records, or positive generic *E. coli* test results for
certain citrus juices.

**[Verification]{.underline}** means those activities, other than
monitoring, that establish the validity of the HACCP plan and that the
system is operating according to the plan. It includes validation
procedures.

*Additional helpful information:* Section 120.11 specifies certain
actions, e.g., a review of consumer complaints, and a review of records
of the monitoring of CCPs, that you must carry out as part of your
verification activities. You should review this section and take note
that review of records for verification purposes must be carried out by
an appropriately trained individual within a specified period of time.

######  {#section-2 .unnumbered}

###### III. Overview of the Juice HACCP Regulation {#iii.-overview-of-the-juice-haccp-regulation-1 .unnumbered}

Section III provides a brief discussion of the juice HACCP regulation.
The section includes details on who must comply, the deadlines for
compliance, the key requirements, the CGMPs requirements, and the
exemptions to the regulation.

####### A. Compliance Required for [All]{.underline} Juice Processors

All juice (as defined in 21 CFR 120.1(a)) sold as juice or for use as an
ingredient in other beverages, with the exception of juice produced at a
retail establishment (i.e., for sale directly to consumers only; see
definition of "Retail Establishment"), is subject to the requirements of
the juice HACCP regulation.

1.  **Intrastate and Interstate Firms**

The regulation's requirements apply equally to juices produced and sold
within the same state as well as juices sold in interstate commerce.

2.  **Effective Dates---Very Small Businesses, Small Businesses, All
    Others**

The requirements take effect on the following dates. However, FDA
recommends that all firms implement HACCP as quickly as possible.

-   January 20, 2004 for very small businesses - as defined in 21 CFR
    120.1(b)(2), those operations that have either total annual sales of
    less than \$500,000, or have total annual sales greater than
    \$500,000 but their total food sales are less than \$50,000, or are
    operations that employ fewer than an average of 100 full-time
    equivalent employees and sell fewer than 100,000 units of juice in
    the United States.

-   January 21, 2003 for small businesses - as defined in 21 CFR
    120.1(b)(1), those operations employing fewer than 500 persons.

-   January 22, 2002 for all businesses not defined as "small
    businesses" or "very small businesses."

3.  **Juice Importers**

Section 120.14 of the juice HACCP regulation specifically describes
requirements for imported juice. In brief, if you are an importer of
juice you must either:

-   ensure that all juice offered for import into the U.S. has been
    processed in compliance with the juice HACCP regulation, or

-   import juice from a country that has an appropriate memorandum of
    understanding (MOU) with the U.S. that covers juice and documents
    the equivalency or compliance of the inspection system of the
    foreign country with the U.S. system, accurately reflects the
    relationship between the signing parties, and is functioning and
    enforceable in its entirety.

In addition, if you import juice, you are required to maintain records
that document the performance and the results of your affirmative steps
as specified in 21 CFR 120.14 (a)(2)(ii).

4.  **If You Process a Non-Juice Beverage with a Juice Ingredient**

The juice HACCP regulation applies to the processing of juice that is
sold either as juice or for use as an ingredient in beverages. Non-juice
beverages that contain juice as an ingredient, e.g., carbonated
beverages that contain juice, or fruit flavored drinks that contain
juice, are not required to be produced under a HACCP system. However,
juice that is used as an ingredient in the non-juice beverage is
required to be produced under a HACCP system.

**B. Some Key Requirements of the Juice HACCP Regulation**

1.  **Warning Label Statement Versus HACCP System**

Since September 8, 1998, for apple juice (including apple cider) and
November 5, 1998, for all other juices, 21 CFR 101.17(g) has required
any container of juice that has not been treated to achieve a 5-log
reduction in the most resistant pathogen to bear a warning label
informing consumers of the risk associated with consuming untreated
juice. Upon your applicable date of coverage under the HACCP regulation,
you may no longer sell juice that has not been treated to achieve the
5-log pathogen reduction, even if you use the label warning statement.
You may continue to use the label warning statement until your
applicable effective date. For example, after January 22, 2002, small
businesses and very small businesses may still use label warning
statements for an additional one and two years respectively. After the
respective effective date, the label warning statement is no longer an
alternative to compliance with the HACCP regulation.

2.  **Specialized Training in HACCP Principles Required**

Individuals who perform certain functions, such as developing the hazard
analysis and HACCP plan and reviewing the HACCP records, must have
successfully completed training in the application of HACCP principles
to juice processing. The training must be at least equivalent to that
received under the standardized curriculum described in section VI. B.

Alternatively, job experience may qualify an individual to perform these
functions if the experience has provided knowledge at least equivalent
to that provided through the standardized curriculum.

The training requirements are in 21 CFR 120.13. In section VI.B we have
listed several sources of information about HACCP resource materials and
HACCP training.

**3.0 Trained Employee or Consultant Acceptable**

The trained individual who performs functions under the juice HACCP
regulation, such as development of your HACCP plan, may be an employee
of the processing firm, an outside consultant, or both. For example, you
may retain a qualified consultant to carry out the hazard analysis and
use a trained plant employee to carry out the periodic review of HACCP
records.

> **4.0 Record Keeping and Electronic Records**

You must maintain several types of records to document each HACCP
system. These records include records pertaining to sanitation standard
operating procedures (SSOPs), the hazard analysis, the HACCP plan, and
operational records such as records of monitoring, corrective actions,
and verification and validation activities. These requirements are
listed in 21 CFR 120.12 .

When the records required by the HACCP regulation are to be collected
electronically, the systems used to generate the electronic records
should comply with the electronic records and electronic signature
provisions of the regulations in 21 CFR Part 11. These regulations
address procedures for system validation, system access, audit trails,
authority and data checks, user education, documentation control, and if
used in conjunction with electronic signatures, electronic signature
control. Most of the processing systems of today have incorporated an
electronic record keeping system for all of the process control
variables. For example, if pasteurization, which is a heat treatment
sufficient to destroy pathogens, is used as a control step, and the
system incorporates an electronic control/recording system, the
electronic record data generated for temperature and time would be an
electronic record and the data collection system should be in compliance
with 21 CFR Part 11.

**4.1 Official Review of Records**

You must make certain records available for review and copying by the
regulatory agency at reasonable times. 21 CFR 120.12 lists these
records.

**C. Part 110 (CGMPs) Applicable to Firms Subject to Juice HACCP
Regulation**

When your firm becomes subject to the juice HACCP regulation, you must
still comply with the CGMPs requirements in 21 CFR Part 110. Compliance
with the juice HACCP regulation does not substitute for compliance with
21 CFR Part 110. In fact, compliance with 21 CFR Part 110, e.g.,
maintaining appropriate sanitation, employee hygiene, and pest control
practices in a facility is an essential foundation for a successful
HACCP system.

**D. Exemptions and Items Not Subject to the Regulation**

1.  **Retail Businesses**

If you qualify as a retail establishment, you are not required to
process juice under a HACCP system.

A retail establishment is an operation that provides juice directly to
consumers and does not sell or distribute juice to other businesses. The
term "provides" includes storing, preparing, packaging, serving, and
selling juice.

If you hire someone to make juice from your fruit and sell the juice at
your roadside stand, you, the retailer, are exempt from the juice HACCP
regulation, but the processor who makes your juice is subject to the
regulation. That processor is not a retail establishment because the
processor is not vending the juice directly to consumers.

If you produce your own juice and sell it at your roadside stand, and
also sell or distribute some of your juice to other businesses to sell
or resell, your juice must be processed under a HACCP system because not
all of the juice is being provided directly to consumers.

For more information on what types of businesses qualify as retail
establishments, see the publication, "Juice HACCP Regulation Questions
and Answers (see section I. C for availability information).

2.  **Non-Beverage Foods with Juice Ingredient (e.g., fruit flavored
    candy)**

The juice HACCP regulation only applies to the processing of juice that
is sold either as juice or for use as an ingredient in beverages. Thus,
in the case of a non-beverage food such as a fruit flavored candy that
contains juice as an ingredient, neither the candy nor the juice
ingredient is subject to the requirements of the juice HACCP regulation.
Processors may find it beneficial to use HACCP systems voluntarily to
produce such foods.

3.  **Processors of Ingredients from Fruit Other than Juice**

Food ingredients other than juice that are derived from fruits and
vegetables, e.g., citrus oil, are not subject to the juice HACCP
regulation. The juice HACCP regulation applies only to juice that is
sold either as juice or for use as an ingredient in beverages and not to
any other fruit or vegetable product.

**IV. Juice Hazard Analysis**

Section IV begins with a definition of hazard analysis and outlines a
process that will prepare you to conduct the analysis, covers the basic
steps of a hazard analysis, and identifies potential hazards for juice
and juice products.

**A. Overview of the Hazard Analysis**

> **1.0. Description**

## The juice hazard analysis is a process of collecting and evaluating information on hazards associated with juice, to determine which hazards are reasonably likely to occur and, thus, pursuant to 21 CFR 120.8(a) must be addressed in a HACCP plan.  {#the-juice-hazard-analysis-is-a-process-of-collecting-and-evaluating-information-on-hazards-associated-with-juice-to-determine-which-hazards-are-reasonably-likely-to-occur-and-thus-pursuant-to-21-cfr-120.8a-must-be-addressed-in-a-haccp-plan. .unnumbered}

##  {#section-3 .unnumbered}

## Under 21 CFR 120.7(a), you are required to produce, for each type of juice you process, a written hazard analysis to determine whether there are food hazards that are reasonably likely to occur and to identify measures that you can apply to control those hazards. This is illustrated in the Hazard Analysis examples in section VII.A. The regulation requires a written hazard analysis for each type of juice unless different types of juice have identical hazards and control measures and then they can be grouped in one hazard analysis. {#under-21-cfr-120.7a-you-are-required-to-produce-for-each-type-of-juice-you-process-a-written-hazard-analysis-to-determine-whether-there-are-food-hazards-that-are-reasonably-likely-to-occur-and-to-identify-measures-that-you-can-apply-to-control-those-hazards.-this-is-illustrated-in-the-hazard-analysis-examples-in-section-vii.a.-the-regulation-requires-a-written-hazard-analysis-for-each-type-of-juice-unless-different-types-of-juice-have-identical-hazards-and-control-measures-and-then-they-can-be-grouped-in-one-hazard-analysis. .unnumbered}

**2.0 Relevance to HACCP Plan and SSOPs**

All juice processors subject to the juice HACCP regulation are required
to prepare a written hazard analysis.

If you determine that any hazard is "reasonably likely to occur" in a
particular juice product, pursuant to 21 CFR 120.8(a), you must control
that hazard in the product by applying control measures as part of a
properly designed and implemented HACCP plan, except that some hazards
can be controlled under your SSOPs as discussed in section IV. C. 3.2.
If you determine that no hazards are "reasonably likely to occur," you
are not required to develop a HACCP plan, but you must establish and
implement SSOPs as required under 21 CFR 120.6. Your SSOP monitoring and
corrective action records and your hazard analysis are still subject to
the record keeping and official record review requirements in 21 CFR
120.12.

**3.0 Developed by HACCP-trained Employee or Consultant**

Your hazard analysis must be developed by an appropriately trained
individual (or individuals), as specified in 21 CFR 120.13. This person
may be your employee or a hired outside expert.

**B. Preparing for a Hazard Analysis - Five Preliminary Steps**

Although not required by FDA, the 5 preliminary steps of HACCP as
outlined by the National Advisory Committee on Microbiological Criteria
for Foods (NACMCF) will help you in conducting your hazard analysis and
developing your HACCP plan, and will prove valuable for other HACCP
functions. The steps you should follow are:

> **Step 1** Assemble a HACCP team.
>
> **Step 2** Describe the food and its distribution.
>
> **Step 3** Identify the intended use and consumers of the food.
>
> **Step 4** Develop a flow diagram that describes the process.
>
> **Step 5** Verify the flow diagram, i.e., ensure that it is accurate.

For more information, see the NACMCF publication "Hazard Analysis and
Critical Control Point Principles and Application Guidelines," Journal
of Food Protection, Vol. 61, No. 9, pp. 1246-1259 (1998) (the "HACCP
Principles and Guidelines" publication).

::: Definition-Term
**C. Basic Steps of the Hazard Analysis**
:::

In order to prepare the written hazard analysis, your HACCP team should
carry out the basic steps of a hazard analysis as described in the
following sections 1.0-4.0 of this guidance. In carrying out these
steps, we recommend that your team refer to Appendix C, "Examples of
Questions to be Considered When Conducting a Hazard Analysis" and
Appendix D, "Examples of How the Stages of Hazard Analysis Are Used to
Identify and Evaluate Hazards" in the HACCP Principles and Guidelines
publication.

1.  **Identify All Potential Hazards**

**Step 1---** You should identify all potential physical, chemical, and
biological hazards associated with the juice. Section 120.7 (c) lists
specific types of hazards, e.g., natural toxins, microbial contaminants,
undeclared allergenic ingredients, that should, at a minimum, be
considered in your hazard analysis.

In this section*,* we have included some specific biological, chemical,
and physical hazards that you should consider in your hazard analysis.
However, depending on your product, process, equipment, and facility,
you may need to consider additional hazards in your hazard analysis.

**1.1 Biological Hazards**

## 1.11 Enteric Microbial Pathogens {#enteric-microbial-pathogens .unnumbered}

Juices containing enteric microbial pathogens such as *E. coli* O157:H7,
various Salmonella species, and the protozoan parasite *Cryptosporidium
parvum* have caused serious foodborne illness outbreaks. Because these
microorganisms inhabit the intestinal tracts of animals, they may
contaminate produce in environments where animals and manure may be
present. The use of contaminated produce to produce the juice, and the
ability of some of these pathogens to survive in acidic foods like
juices, along with use of inadequate controls for these pathogens during
juice processing, are believed to be among the causative factors for
these outbreaks. Unless your juice is a thermally processed shelf stable
juice, a thermal concentrate, or is subject to either the low acid
canned foods or acidified foods regulations, one of the microorganisms
listed in IV. C. 1.11 or 1.12 likely will be the pertinent microorganism
for purposes of meeting the 5-log pathogen reduction requirement.

######### **1.12 Other Potential Bacterial Hazards** 

While enteric pathogens have been the cause of most food-borne illness
outbreaks associated with juice, these are not the only types of
microorganisms that could occur in juice. Illness-causing organisms that
are ubiquitous in nature, such as *Listeria monocytogenes*, could become
contaminants in juice. Unless your juice is a thermally processed shelf
stable juice, a thermal concentrate, or is subject to either the low
acid canned foods or acidified foods regulations, one of the
microorganisms listed in IV. C. 1.11 or 1.12 likely will be the
pertinent microorganism for purposes of you meeting the 5-log pathogen
reduction requirement.

# 1.13 Viruses

Juices contaminated with viruses have been implicated in foodborne
illness outbreaks.

Contamination of food by viruses is most likely to be caused by an ill
individual, such as a farm worker or food handler. Thus, contamination
of juice by viruses is not likely to occur in a processing facility that
controls employee health and hygiene conditions that could result in the
microbiological contamination of food, food packaging materials, and
food contact surfaces under its SSOPs.

We also encourage you to work with your suppliers to promote their use
of FDA's "Guide to Minimize Microbial Food Safety Hazards for Fresh
Fruits and Vegetables," (FDA's GAPs guidance document). This guidance
document includes provisions that address worker health and hygiene for
individuals that handle the fruits and vegetables you use to produce
juice.

**1.2 Chemical Hazards**

######## **1.21 Patulin**

Patulin is a mycotoxin that is produced by fungi commonly found on
apples. High levels of patulin can be produced in rotting or moldy
apples. Fallen fruit, apples that have been damaged, e.g., by insects or
birds, or bruised, e.g., during handling, are more susceptible to the
growth of patulin producing molds. Storage of apples under conditions
that are not inhibitory to the growth of molds also can lead to high
levels of patulin in the apples. If fallen fruit, moldy, rotten, bruised
or damaged apples, or improperly stored apples are used to make juice,
high levels of patulin may occur in the juice, including pasteurized
juice, because thermal processing does not destroy patulin.

Exposure over time to high levels of patulin may pose a health hazard.
FDA has established an action level[^2] for patulin in apple juice of 50
micrograms per kilogram (50 parts per billion) as determined on single
strength apple juice or reconstituted single strength apple juice (see
FDA's Compliance Policy Guide (CPG Section 510.150) concerning patulin)
(see section I. C for availability information). In fact, if one rotten
apple (containing \>10,000 parts per billion (ppb) patulin) is used
along with 200 sound apples to make juice, the resulting patulin level
in the juice could exceed FDA's action level for patulin.

# 1.22 Undeclared Food Allergens[^3] in Juice due to Cross-Contact from Shared Processing Equipment

If you are a juice processor and handle other foods containing
allergenic food ingredients in the same facility, you should consider
the potential for hazards from cross-contact of your juice by other food
substances that can cause allergic reactions.

A chemical hazard, specifically, an undeclared food allergen, can occur
when juice is processed on equipment that has been used to process a
potentially allergenic food without adequate cleaning prior to the juice
run. FDA believes that there is scientific consensus that the following
foods can cause serious allergic reactions in some individuals and
account for more than 90% of all food allergies:

1.  Peanuts

2.  Soybeans

3.  Milk

4.  Eggs

5.  Fish

6.  Crustacea

7.  Tree nuts

8.  Wheat

For instance, inadvertent introduction of milk protein to juice can
occur if juice is processed using inadequately cleaned equipment
previously used to produce milk or a dairy-based beverage. An individual
who is allergic to milk could face a potentially serious unexpected
health risk upon consuming the juice containing the milk protein.

Under 21 CFR 120.6 of the juice HACCP regulation, you could address
these types of potential hazards by establishing effective equipment
cleaning procedures at a CCP in your process, or as part of your SSOPs
(See discussion about when FDA recommends use of a CCP vs. an SSOP for
contaminants from food contact surfaces in section IV. C. 3.2).

FDA has issued a Compliance Policy Guide (CPG Section 555.250) entitled
"Statement of Policy for Labeling and Preventing Cross-contact of Common
Food Allergens" (see Section I. C for availability) and an Inspection
Guide entitled "Guide to Inspections of Firms Producing Products
Susceptible to Contamination with Allergenic Ingredients" (available at
<http://www.fda.gov/ora/inspect_ref/igs/Allergy_Inspection_Guide.htm)>.
We encourage you to read these documents and consider the information in
them as you establish your HACCP system).

23. **Allergens and Food Intolerance Substances Added to Juice as
    Ingredients**

Some products that contain 100 percent juice also can contain added
ingredients such as soy protein or preservatives, e.g., sulfites, that
can cause allergic or food intolerance reactions in sensitive
individuals. Because these types of products are juice with added
ingredients, and not beverages that contain juice as an ingredient
(e.g., a flavored bottled water or a dairy-based beverage with juice),
these products are subject to the HACCP regulation. Should any
ingredient of a 100 percent juice product have the potential to cause
allergic or food intolerance reactions in sensitive individuals, the
presence of the ingredient must be declared on the label in accord with
the food labeling regulations in 21 CFR Part 101. Controls to ensure
that the proper labels are used should be part of your HACCP plan. The
following is a list of some ingredients for which you should implement
such controls:

1.  Any of the 8 foods listed in Section 1.22

2.  Sulfites, in concentrations of 10 parts per million (ppm) or greater

3.  FD&C Yellow No. 5

4.  FD&C Yellow No. 6

5.  Lactose

**1.24 Pesticide Residues**

Pesticides are used widely to treat (e.g., for insect control) fruits,
vegetables, grains, and other foods, and may be present in small amounts
as residues on these foods. Before a pesticide may be sold in the United
States, the Environmental Protection Agency (EPA) evaluates the
pesticide and determines whether or not to grant a registration that
permits its sale and use. For pesticides used on foods, EPA also must
establish a tolerance, which is the amount of residue legally permitted
to remain in or on each treated food commodity, or an exemption from the
requirement of a tolerance for the pesticide residue on the particular
commodity.

Residues from unapproved pesticides, or residues in excess of pesticide
tolerances, are illegal and could pose a potential hazard in juice
warranting control in a HACCP plan if the residues occurred over a
period of time at levels capable of causing health effects from repeated
exposure, or if they occurred for only a brief period of time at levels
capable of causing acute health effects.

**1.25 Lead**

Juice can become contaminated with lead if lead-contaminated fruit is
used to make the juice. Lead contamination of fruit can occur in a
number of ways due to the widespread past and present use of lead in
agricultural and industrial settings. For example, past use of lead
arsenate as a pesticide in what were apple orchards is believed to have
caused persistent lead contamination of the soil causing carrots
presently grown on these sites to contain elevated lead levels. Lead is
especially hazardous to young children.

In 1993, FDA established an emergency action level for lead in juice
packed in lead soldered cans of 80 ppb and above (see the Federal
Register notice of April 1, 1993 (58 FR 17233)). However, based upon a
recent toxicological assessment for lead carried out by the Joint
WHO/FAO Expert Committee on Food Additives, the Codex Alimentarius
Commission, an international food standards organization that
establishes safe levels for the protection of consumers, has recently
established a maximum level of 50 ppb for lead in ready-to-drink fruit
juices, including fruit nectars that are in international trade, to
protect the public health. FDA concurs with this recent assessment that
lead levels in juice above 50 ppb may constitute a health hazard, and
FDA may establish an action level for lead in juice at levels above 50
ppb. If you determine that lead is a hazard that is reasonably likely to
occur in your juice, we recommend that you establish controls to ensure
that lead levels do not exceed 50 ppb.

If produce used to make your juice is to be purchased from a source,
e.g., a country, a geographic region, or a local region, that is known
or suspected to have lead contamination problems with produce, you
should consider identifying lead as a hazard that is reasonably likely
to occur in your hazard analysis. You could control this hazard by
requiring a supplier guarantee specifying that the shipment of fruit
supplied was harvested from sources known not to yield lead contaminated
fruit. (See section V. D on "Control strategies for patulin for apple
juice processors" for examples of how control measures for incoming
fruit based upon a supplier guarantee could be incorporated into your
HACCP plan.) It also would be useful as a periodic verification activity
to test your juice to affirm the efficacy of your controls for lead.

**1.26 Tin**

Tin is used frequently as a coating in un-lacquered metal cans used to
pack light colored juices, such as pineapple juice. Typically, some tin
plating leaches into the juice in small amounts that help retain the
light color of the juice due to the antioxidant activity of tin. These
small amounts generally do not pose any potential harm.

However, some factors that may be encountered in juice processing can
contribute to excessive amounts of tin leaching into juice. The manner
in which these factors affect the leaching of tin into juice is complex.
These factors include the amount of ions such as nitrate and sulfate in
the juice (e.g., as affected by the level of nitrate in the soil in
which a fruit or vegetable is grown and the level of nitrate in water
used to reconstitute juice concentrate), the amount of residual oxygen
in the metal can after the juice is packed, the thickness of the tin
layer of the container, the presence of certain food components in the
juice such as organic acids and pigments, the length of time and the
temperature of storage of the juice, and the pH of the juice including
the presence of any additive that can affect its pH.

Consumption of juice containing excessive levels of tin can lead to
acute gastrointestinal illness. The Codex Alimentarius Commission is
considering establishing a maximum level of 200 ppm for tin in canned
liquid foods for the protection of consumers.

Although it is not common for levels of tin in canned juice to approach
200 ppm, if you pack juice in un-lacquered metal cans, you should know
what levels of tin are present in your juice after the longest
anticipated storage time at the highest anticipated storage temperature
for the juice. If the tin levels in your juice may approach 200 ppm, you
should consider whether excessive levels of tin is a hazard that is
reasonably likely to occur, i.e., if it is necessary for you to
establish control measures to ensure that your juice will not contain
harmful levels of tin due to leaching of tin from the container into the
juice.

**1.3 Physical Hazards**

**1.31 Glass Fragments**

Consideration of potential hazards associated with glass breakage should
be a part of your hazard analysis if you package your juice in glass.
Glass bottle breakage resulting in glass fragments that may result in
serious injury can be caused in a number of ways, including damage of
bottles in transit to the juice processing facility, mechanized handling
(cleaning, filling, and capping) of bottles, and thermal shock to the
glass during hot filling or pasteurization. If you pack your juice in
glass, we anticipate that you will conclude that glass fragments are a
hazard that is reasonably likely to occur in your juice, and that you
will establish controls for glass fragments in your HACCP plan.

Glass fragments originating from sources other than containers, e.g., a
broken light bulb, can be addressed where applicable under your SSOPs
(see 21 CFR 120.6 (a)(5)).

**1.32 Metal Fragments**

Consideration of potential hazards associated with metal fragments
should be a part of your hazard analysis if you conduct operations such
as the grinding of fruit, the extraction of juice from fruit, or the
blending of juice, where metal fatigue, wear of metal parts, or metal to
metal contact can occur in your processing equipment. If your process
includes such operations, we anticipate that you will conclude that
metal fragments are a hazard that is reasonably likely to occur in your
juice, and that you will establish controls for metal fragments in your
HACCP plan.

2.  **Evaluate All Potential Hazards**

**Step 2\--**Evaluate each of the potential hazards (from Step 1) by
assessing the likelihood of occurrence and the severity of health
consequences associated with the potential hazard. For instance:

-   Although potential hazards that may be introduced into food through
    pests in your facility may be of low to moderate severity, they are
    unlikely to occur if your facility carries out an effective pest
    control program as part of its SSOPs.

-   Numerous U.S. government regulatory programs address aspects of
    pesticide usage, e.g., applicator licensure, usage instructions on
    the label, official monitoring of pesticide residues in foods, and
    enforcement actions against violators. Experience in the U.S. has
    demonstrated that domestically grown fruits and vegetables have a
    high level of compliance with U.S. pesticide tolerance regulations
    and that the occurrence of unlawful pesticide residues in food is
    likely to be infrequent and unlikely to have a severe public health
    impact. While pesticide compliance experience for imported fruits
    and vegetables is generally comparable to that for domestic produce,
    you should ensure that government controls in the foreign country
    that supplies your produce result in a high rate of compliance with
    U.S. pesticide tolerance regulations. If you can't achieve this
    assurance you should evaluate carefully whether pesticide residues
    pose a hazard that may warrant control under your HACCP plan.

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-   Exposure over time to high levels of patulin may pose a health
    hazard. Available information indicates that high levels of patulin
    may occur in apple juice if controls are not carried out to prevent
    this occurrence.

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-   Enteric microbial pathogens such as *E. coli* O157:H7, various
    *Salmonella* species, and the protozoan parasite *Cryptosporidium
    parvum* have caused serious foodborne illness outbreaks due to
    consumption of contaminated juice. Any occurrence of these pathogens
    in juice is capable of causing severe adverse health effects
    including death, particularly in the very young, the elderly, and
    immune-compromised persons. The juice HACCP regulation includes a
    5-log pathogen reduction performance standard that requires you to
    establish controls in your HACCP plan for the "pertinent
    microorganism," which is likely to be one of the enteric microbial
    pathogens or *Listeria monocytogenes*. Because a mandatory control
    measure for pathogens is part of the juice HACCP regulation, your
    responsibility in the hazard evaluation step is not to assess the
    severity of the illness or injury that these pathogens could cause
    (to determine whether control is necessary), but to determine which
    pathogen is the "pertinent microorganism" in your juice, that is,
    the most resistant pathogen among those potentially present, which
    is the pathogen that your process controls must be designed to
    eliminate. See section V.C.11 for more information on selecting the
    pertinent microorganism and establishing process controls to meet
    the 5-log pathogen reduction performance standard.

3.  **Determine if Potential Hazards Will Require Controls in Your HACCP
    Plan**

**Step 3\--**Based upon the information gathered in steps 1 and 2,
determine whether each potential hazard will require controls in your
HACCP plan pursuant to 21 CFR 120.8(a).

A hazard that will require control is referred to in the juice HACCP
regulation as a hazard that is "reasonably likely to occur." Section
120.7(a)(2) describes such a hazard as "one for which a prudent
processor would establish controls because experience, illness data,
scientific reports, or other information provide a basis to conclude
that there is a reasonable possibility that, in the absence of those
controls, the food hazard will occur in the particular type of product
being processed."

A hazard that is "reasonably likely to occur" is one that presents an
identifiable and significant food safety risk, that you, acting as a
responsible processor, would act to reduce to an acceptable level,
prevent or eliminate, by establishing and carrying out control measures
for that hazard. Generally, you will carry out your control measures at
CCPs (which are specific points in the process for producing juice)
identified in your HACCP plan.

**3.1 Potential Hazards "Reasonably Likely to Occur"**

If a potential hazard has a severe, acute public health impact (e.g.,
injury caused by ingestion of glass container fragments), that hazard
presents a significant risk, even at an extremely low frequency of
occurrence, and thus, should be identified as a hazard that is
reasonably likely to occur.

Hazards that require exposure over time to cause harm would need to
occur over time at levels of concern in the juice to be classified as a
hazard that is reasonably likely to occur. The mycotoxin, patulin, which
can occur at high levels in apple juice, is an example of a hazard that
could result over time from exposure to a contaminant and thus, may need
to be controlled through your HACCP plan.

**3.2 Potential Hazards "Not Reasonably Likely to Occur"**

Your HACCP team may identify a potential hazard for your juice, that
upon further evaluation is determined not to require control. For
example, processors of carrot juice may identify lead as a potential
hazard because high lead levels have recently occurred in some carrot
products apparently due to the carrots being grown in soils contaminated
with lead from the past application of a no longer permitted
lead-containing pesticide on orchards formerly on the land. However, you
may be able to establish that the land upon which your supplier grows
carrots is not contaminated with lead, or that crops were never grown on
that land that would have had lead-containing pesticides applied to
them. Having established either of these premises, you could conclude
appropriately that elevated levels of lead are not reasonably likely to
occur in the carrots that you use to make juice. However, if you acquire
a new supplier of carrots, you should reassess the potential for
elevated levels of lead to pose a hazard in your juice as part of the
re-validation of your hazard analysis required in 21 CFR 120.11 (b).

> **3.3 Hazards Related to Facility Sanitation**

FDA recognizes that hazards controlled by most types of sanitation
programs may be impractical to manage in a HACCP plan format because it
is often difficult to determine appropriate critical limits and
corrective actions for sanitation controls.

Therefore, when you conduct your hazard analysis, and identify hazards
that derive from any of the eight areas listed in 21 CFR 120.6 (a), with
one exception, you may classify such hazards as "not reasonably likely
to occur," and control those hazards under your SSOP program. However,
as provided in 21 CFR 120.6 (d), you also have the option to control any
of these sanitation- related hazards under your HACCP plan using a
control measure implemented at a CCP. The exception referred to above
concerns hazards that can occur in your juice due to unsanitary food
contact surfaces that can contaminate juice with pathogens or with
residues of food processed on the equipment in prior runs that can cause
allergic reactions in sensitive individuals. Pathogen and food allergen
hazards that arise from unsanitary food contact surfaces have a
relatively high potential to affect the safety of a juice product
because they arise from points within the process and not from general
conditions within the facility. As such, these types of hazards should
be afforded a high level of consideration in your hazard analysis and
should be classified as "reasonably likely to occur" if you determine
that control measure(s) are necessary for the hazard. As provided in 21
CFR 120.6 (d), you may elect to control such a hazard under your SSOP
program or your HACCP plan, however we recommend that you control such
hazards under your HACCP plan in certain instances, as described in the
next section.

**3.4 Controls for Pathogens and Allergens Arising from Food Contact
Surfaces**

As noted in the previous section, hazards that arise in juice processing
from insanitary food contact surfaces that can contaminate juice with
pathogens or with residues of food allergens should be considered to be
"reasonably likely to occur." We recommend that you control such hazards
under your HACCP plan and not under your SSOPs when the hazard is
amenable to control at a CCP because we believe that control at a CCP
will afford a greater level of assurance of public health protection due
to the validation and verification activities that are carried out for
CCP controls and due to inclusion of the written CCP control procedures
in the HACCP plan. To be amenable to control at a CCP, the control
measure must lend itself to validation and to the establishment of
critical limits. We may question the adequacy of a HACCP plan to control
hazards identified in the hazard analysis as "reasonably likely to
occur" when the plan does not include rigorous SSOP controls, or where
applicable (as discussed in the next paragraph), CCP controls for such
hazards.

For example, if you produce juice on equipment that also is used to
process milk, you should identify undeclared milk residues in your juice
as a hazard that is "reasonably likely to occur." If a control measure
for cleaning food contact surfaces to avoid contamination with milk
residues from prior product runs is available to you and it can be
validated, and critical limits can be established, we recommend that you
incorporate such a control measure into your HACCP plan at a CCP rather
than control the hazard under your SSOP program. If it is not possible
to validate control measures for cleaning food contact surfaces, and
critical limits cannot be established, your control activity would not
be amenable to incorporation into a CCP and you would have to control
the hazard through a rigorous SSOP procedure. Examples of a CCP and an
SSOP for cleaning operations are given in Section VII. C.

4.  **Identify Control Measures and CCPs**

**Step 4\--**Identify control measures and critical control points for
hazards determined in step 3 to be reasonably likely to occur, and
review your current process to identify needed modifications to the
process. Control measures are discussed in section V.

> **4.1 NACMCF CCP Decision Tree**

This NACMCF CCP decision tree may assist you in determining critical
control points for controlling the hazards that were identified in your
hazard analysis as reasonably likely to occur.

![](media/image1.png)

**4.2. Location of CCPs**

A CCP may be established at any process step where you can effectively
apply controls. See the Example Hazard Analyses and Example HACCP Plans
in sections VII A and B. For instance, for a pasteurized apple juice
process that includes controls for pathogens and for the mycotoxin
patulin:

-   CCPs for the control of patulin may be established at the receiving
    step at the processing facility at which time the shipment of apples
    can be checked to ensure that it originated from a supplier who has
    provided a guarantee that only apples harvested to exclude fallen
    fruit were supplied in the shipment, and at the culling or trimming
    steps, where bruised, damaged, moldy and rotten apples are removed
    from the product stream.

-   A CCP may be established at the pasteurization step where treatment
    to achieve the 5-log pathogen reduction will be carried out.

Similarly, for a fresh orange juice process, for the control of
pathogens:

-   A CCP may be established at the step where oranges are received at
    the processing facility at which time the shipment can be checked to
    ensure that it originated from a supplier who has provided a
    guarantee that only tree-picked oranges were supplied in the
    shipment.

**V. Control Measures**

**A. HACCP Control Measures**

Under 21 CFR 120.8(a), you are required to implement HACCP control
measures if you determine in your hazard analysis that a food hazard is
reasonably likely to occur in your juice product.

Examples of HACCP control measures used in the processing of juice
include measures carried out at CCPs specified in a HACCP plan such as
the pasteurization of juice for the elimination of microbial pathogens;
the culling or trimming of apples after storage to eliminate moldy,
damaged, bruised or rotten apples to ensure that patulin will not be
present at levels of concern in the finished apple juice; and
periodically monitoring processing lines for evidence of glass breakage.

**B. Activities [Not]{.underline} Considered to be HACCP Control
Measures**

Some activities firms may undertake in processing juice and in related
functions are not HACCP control measures. These include Good
Agricultural Practices (GAPs) and Current Good Manufacturing Practices.

**1.0 GAPs**

The HACCP regulation applies to firms engaged in the processing of
juice. It does not apply to firms that conduct activities such as the
growing, harvesting, and transporting of fruits and vegetables that will
be processed into juice. Growers may voluntarily implement GAPs based
upon FDA's GAPs guidance document. Because growers and transporters of
raw agricultural ingredients of juice are not subject to the
requirements of the HACCP regulation, GAPs measures voluntarily
undertaken by these parties are not HACCP controls. However, if a hazard
originating from the agricultural environment is determined to be
reasonably likely to occur on your incoming fruit, pursuant to 21 CFR
120.8 (a), it must be identified in your hazard analysis and controlled
through your HACCP plan. If control of such a hazard involves actions
that will be carried out by your grower, e.g., supplying you with only
tree-picked fruit or fruit that does not include fallen fruit, your
control measure could be based upon a supplier guarantee to this effect
implemented as part of your HACCP plan.

However, we encourage you to work with your suppliers to evaluate and
modify agricultural practices in accordance with FDA's GAPs guidance
document.

> **2.0 CGMPs**

As noted above, juice processors are still required to comply with the
CGMPs requirements of 21 CFR Part 110. One common misconception about
HACCP is that some hazards that are reasonably likely to occur can be
controlled under a firm's CGMP programs under 21 CFR Part 110. Because
programs to comply with 21 CFR Part 110 are general in nature and are
not designed to control specific hazards, they are not HACCP control
measures. Therefore, you cannot use CGMP programs to control a specific
hazard that you have concluded is reasonably likely to occur in your
hazard analysis. You must use HACCP controls for any such hazard.

**C. Control Measures for Biological Hazards**

**1.0 Minimum Requirement of 5-Log Pathogen Reduction**

The 5-log pathogen reduction requirement in 21 CFR 120.24 describes the
minimum level of pathogen "kill" that your pathogen control measures
must consistently achieve. Processing experts evaluate treatments
intended to destroy or inactivate pathogens in food in terms of "logs"
of kill, where the term "log" is a shorthand expression of the
mathematical term logarithm. A logarithm is \"the exponent of the power
to which a base number must be raised to equal a given number.\" If the
base number is ten, it must be raised to the second power to equal 100,
so the exponent is 2, i.e., 10 X 10 = 100. Again, if the base number is
ten, it must be raised to the third power to equal 1000, so the exponent
is 3, i.e., 10 X 10 X 10 = 1000.

The HACCP regulation requires you to use treatments capable of
consistently achieving at least a 5-log reduction (using ten as the base
number) in the level of the pertinent microorganism in your juice. The
important thing to understand is that each log of kill is capable of
causing a tenfold reduction in the number of organisms of the pathogen
that the treatment is designed to kill, i.e., the "pertinent
microorganism." A 1-log process would be one that is capable of reducing
the level of the pertinent microorganism in the food by 10 fold, e.g.,
from 100 organisms (of the pathogen) per gram of food to 10 organisms
(of the pathogen) per gram of food. A 2-log process further reduces the
level of the target pathogen by another factor of 10, i.e., from 10
organisms (of the pathogen) per gram to 1 organism (of the pathogen) per
gram of food. Thus, the 5-log performance standard means that you must
treat your juice using a process capable of reducing levels of the
pertinent pathogen in the juice by at least 100,000-fold (10 X 10 X 10 X
10 X 10 = 100,000).

This is illustrated in the following table:

+--------------+--------+----------------------+--------+-------------+
| **Initial**  | **Log  | **Decrease in**      | **P    | **Final**   |
|              | reduc  |                      | ercent |             |
| **number     | tion** | **pertinent          | of     | **number    |
| of**         |        | microorganism        | ch     | of**        |
|              |        | bacteria levels**    | ange** |             |
| **pertinent  |        |                      |        | **bacteria  |
| m            |        |                      |        | per gram of |
| icroorganism |        |                      |        | food**      |
| bacteria per |        |                      |        |             |
| gram of      |        |                      |        |             |
| food**       |        |                      |        |             |
+--------------+--------+----------------------+--------+-------------+
| 100,000      | 1      | 10-fold              | 90 %   | 10,000      |
| (10^5^)      |        |                      |        | (10^4^)     |
+--------------+--------+----------------------+--------+-------------+
| 100,000      | 2      | 10x10 = 100 fold     | 99 %   | 1,000       |
| (10^5^)      |        |                      |        | (10^3^)     |
+--------------+--------+----------------------+--------+-------------+
| 100,000      | 3      | 10x10x10=1000 fold   | 99.9 % | 100 (10^2^) |
| (10^5^)      |        |                      |        |             |
+--------------+--------+----------------------+--------+-------------+
| 100,000      | 4      | 10x10x10x10=10,000   | 99.99  | 10 (10^1^)  |
| (10^5^)      |        | fold                 | %      |             |
+--------------+--------+----------------------+--------+-------------+
| 100,000      | 5      | 10                   | 99.999 | 1 (10^0^)   |
| (10^5^)      |        | x10x10x10x10=100,000 | %      |             |
|              |        | fold                 |        |             |
+--------------+--------+----------------------+--------+-------------+

The initial number of pathogens present in your untreated juice is
likely to be far less than 10^5^ organisms per gram, i.e., only 10^1^ or
10^2^ organisms per gram. Applying a 5-log treatment to juice that may
contain such levels of pathogens achieves a tolerable level of risk by
ensuring that the process is adequate to destroy microorganisms of
public health significance or to prevent their growth.

Thus, if you use pasteurization as your pathogen control measure, that
treatment must be carried out to achieve [consistently at least a 5-log
reduction]{.underline} in the "pertinent microorganism." Likewise, if
you use UV radiation as your pathogen control measure, that UV treatment
must be carried out to achieve [consistently at least a 5-log reduction
in the "pertinent microorganism]{.underline}."

If you are a citrus juice processor and rely on a series of surface
sanitization treatments and pinpoint extraction of fruit as your
pathogen control measure as provided for under 21 CFR 120.24 (b), these
treatments must [consistently achieve at least a 5-log reduction in the
"pertinent microorganism]{.underline}."

Multiple processing steps, such as a series of surface sanitization
treatments for citrus fruit, may be used to achieve the 5-log reduction.
However, under 21 CFR 120.24 (b) and (c), all of the processing steps
you perform to meet the 5-log pathogen reduction requirement must be
carried out in a single production facility.

We recommend that all juice processors consult with a process authority
(see "Process Validation" in section V.C.5) to establish their control
measures for achieving the 5-log pathogen reduction required under the
HACCP regulation.

1.  **What Does the "Pertinent Microorganism" Mean?**

The "pertinent microorganism" is the most resistant microorganism of
public health significance that is likely to occur in the juice and is
the pathogen that you must target for the 5-log pathogen reduction
treatment (21 CFR 120.24(a)). By choosing the most resistant pathogen as
your target, you are also treating the product for all other pathogens
that are less resistant to the means of treatment.

One way to identify the pertinent microorganism for your juice is to
consider whether there have been any illness outbreaks associated with
this type of juice, and what microorganisms have caused the outbreaks.
If certain pathogens have been demonstrated, i.e., through outbreaks, to
be potential contaminants in certain juices, then the pertinent
microorganism for your process typically should be one of these
pathogens.

For example, *Salmonella* species have been the cause of several illness
outbreaks related to orange juice and may be considered the "pertinent
microorganism" for orange juice products. *E. coli* O157:H7, a bacterial
pathogen, and *Cryptosporidium parvum,* a protozoan parasite, have both
been the cause of outbreaks in untreated apple juice, and both should be
identified as potential hazards in a hazard analysis for apple juice.
Which of these two pathogens is determined to be the pertinent
microorganism will depend upon which of the two is most resistant to the
means of treatment, e.g., pasteurization, UV radiation, that you will
use to achieve the 5-log reduction of pathogens that is required under
the juice HACCP regulation. The pertinent microorganism for apple juice
is discussed further in section V. C. 5.0.

Although *Listeria monocytogenes* has not been linked specifically to an
illness outbreak from juice, it is ubiquitous in nature. For this
reason, *Listeria monocytogenes* should be considered as a possible
"pertinent microorganism" for juices that have not been associated with
illness outbreaks caused by *Salmonella* species, *E. coli* O157:H7, or
*Cryptosporidium parvum.*

A general thermal process for juice that will achieve a 5-log reduction
for *Salmonella* species*, E. coli* O157:H7, and *Listeria
monocytogenes*, is discussed in section V.C.5.0 under "Process
Validation."

**1.2 Shelf Life and Moderate Temperature Abuse Conditions**

The 5-log pathogen reduction treatment must last through the normal
shelf life of the product when held under moderate temperature abuse
conditions (21 CFR 120.24(a)). Some microorganisms may be injured in
processing, but survive if held under optimal growing conditions. Normal
handling of juice includes the movement of the juice from the plant to
retail (e.g., transportation, warehouse storage) and consumer handling
after purchase (e.g., transport home, setting out on a counter or
table). Moderate abuse may occur when unusual circumstances occur during
customary handling. For example, unloading a truck on a hot day where
the product may sit on a loading dock for a short period of time could
constitute moderate abuse. In addition, moderate abuse could occur if
consumers purchase a product on a warm day, place it in their car, and
run errands before refrigerating the product. Moderate abuse does not
include exposure to warm temperatures for extended periods of time.

Your "process authority" (see "Process Validation" in section V.C.5)
should be able to determine that the process you use, e.g.,
pasteurization, UV irradiation, will ensure that pathogens will not
proliferate in your juice should it undergo moderate temperature abuse.

> **1.3 5-Log Treatment Performed on Juice after Extraction, with One
> Exception**

With one exception, under 21 CFR 120.24(b), you must meet the 5-log
pathogen reduction requirement by treating the juice directly, i.e.,
after it has been extracted from the fruit. However, for citrus juices,
you may meet this requirement by applying pathogen reduction treatments
to the surface of the citrus fruit prior to extracting the juice. Such
treatments usually are carried out through a series of washing,
brushing, and sanitizing steps. Use of special extraction methods such
as pinpoint extraction may also be counted towards the 5-log reduction.
If you use such treatments to meet the 5-log pathogen reduction
requirement, you must also adhere to certain specific requirements in 21
CFR 120.24 (b) that are summarized in subsection 3.0 of this section.

> **2.0 Location of Juice Extraction, Processing, and Packaging**

Pursuant to 21 CFR 120.24(c), you must carry out the 5-log pathogen
reduction, whether it is via a one-step process or a multi-step process,
in a single facility, and that facility must be the same facility in
which the product is packaged in final form for sale. There are two
potential exceptions discussed in the following paragraphs. If you do
treat your juice at a different facility than the one in which the final
packaging is carried out, the treatments applied at the first facility
cannot be counted towards meeting the 5-log pathogen reduction
requirement.

The first exception noted in the previous paragraph applies to producers
and users of high degree Brix juice concentrate. In a letter dated
January 22, 2002 (and a January 25, 2002 letter of correction), FDA
stated that it would consider the exercise of enforcement discretion
with respect to the "single facility" requirement as applied to
producers and users of high degree Brix concentrate[^4] where the
following three conditions are satisfied: (1) the producer and user
establish appropriate prerequisite and SSOPs for the transport of high
Brix juice concentrate; (2) the producer and user designate as a CCP in
their respective HACCP plans the transport of high Brix concentrate from
the production facility to a second facility for formulation and final
packaging of concentrates; and (3) the producer and user establish
control measures to prevent, reduce, or eliminate the risk of
recontamination of the concentrate during transport (The January 22,
2002, letter and a correction to that letter dated January 25, 2002, are
available at the website listed in section I. B.)

The second exception applies to the bulk transport and packaging of
shelf-stable single strength juice that is transported in aseptic
packaging. FDA also stated in the January 22, 2002 letter that it would
consider using its enforcement discretion to not penalize processors for
the bulk transport and packaging of shelf-stable single strength juice
that is transported in aseptic packaging.

FDA also stated in the January 22, 2000, letter that it intended to
develop and issue guidance that will contain FDA's basic recommendations
for appropriate control measures for several transport modalities (modes
of transportations), including tankers, mobile tank farms within cargo
ships, single-use sanitary containers (e.g., bag-in-box containers), and
reusable containers with single-use liners (e.g., 55 gallon drums with
single-use liners). This guidance (initially in draft and subsequently
final) will be posted on the website listed in section I. B above upon
issuance.

You may extract juice from the fruit in one location and ship the
untreated juice to another plant for processing (i.e., to achieve the
5-log pathogen reduction requirement) and packaging. If you do this you
should obtain assurance that the juice will be given the required 5-log
treatment at the other processing location, and you should cite this
assurance in your hazard analysis as the justification for not carrying
out the 5-log reduction in your facility.

**3.0 Requirements for Certain Citrus Juices**

If you produce a citrus juice and you choose to meet the 5-log pathogen
reduction requirement by surface treatment of the fruit, the following
additional requirements apply:

-   The fruit must be tree-picked, cleaned, and culled prior to
    application of treatments to achieve the 5-log pathogen reduction
    (see 21 CFR 120.24(b)).

-   All treatments to achieve the 5-log pathogen reduction, e.g.,
    cumulative treatments, must be performed in a single facility. Final
    product packaging must also be performed in that same facility (see
    21 CFR 120.24 (b)).

-   Certain process verification requirements (testing of finished
    product for generic E. coli) set out in 21 CFR 120.25 are required.
    If E. coli is found in the processed juice, it can be an indication
    of failure of the HACCP system, or that the system may be
    approaching failure. See the discussion in the next section. A rapid
    method for testing the finished product for generic E. coli entitled
    "Comparative evaluation of a rapid method for detecting Escherichia
    coli in artificially contaminated orange juice," by Stephen D.
    Weagant and Peter Feng (FDA Laboratory Information Bulletin 4239,
    Vol. 17, March 2001) is available by mail at the address given in
    section I. C.

> **3.1 Compliance with Requirement to Use Tree-Picked, Culled Fruit**

If you produce a citrus juice using surface treatments to meet the 5-log
pathogen reduction requirement, FDA recommends that you do the following
to meet the requirement that you use tree-picked and culled fruit:

-   You obtain a written guarantee from your supplier for each fruit
    shipment stating that only tree-picked fruit was supplied in the
    shipment, and establish a CCP at the receiving step for the citrus
    fruit citing the existence of the guarantee as a critical limit to
    be met for acceptance of the lot of fruit. An additional critical
    limit at this CCP (the receiving step) should be that a sample of
    fruit from the shipment shows no evidence of inclusion of fallen
    fruit.

-   You establish a CCP at a culling step in the process at which any
    damaged fruit is removed prior to any pathogen reduction treatments
    on the fruit surface.

Under such an approach, for the CCP at the receiving step:

-   The existence of a supplier guarantee for each shipment of incoming
    fruit specifying that only tree-picked fruit is supplied in the
    shipment would be one critical limit. A monitoring procedure would
    be to confirm visually the existence of the guarantee for each
    incoming shipment of fruit.

-   The second critical limit would be that a sample of fruit from the
    shipment shows no evidence of fallen fruit. Monitoring could consist
    of visual inspection of fruit sampled from each incoming shipment to
    ensure that the fruit shows no evidence of inclusion of fallen
    fruit, e.g., flat dirty spots on the fruit.

-   The corrective action procedure would be to reject any shipment of
    fruit from a supplier not accompanied by a guarantee, or any
    shipment that does not meet the inspectional criterion, e.g., shows
    evidence of containing fallen fruit.

-   The verification procedure could consist of periodic auditing of the
    supplier to ensure that the supplier is following the provisions of
    the guarantee. Generally in HACCP, wherever you rely on guarantees
    or certificates from suppliers to control a hazard, there is a need
    to couple these types of controls with a strong verification
    procedure, such as visiting the farm periodically or periodically
    testing the juice.

> **3.2 Positive *E. coli* Test Results for Citrus Juices Made Using
> Surface Treatment of Fruit to Achieve 5-Log Reduction**

If your verification testing yields a single positive for E. coli, §
120.25(d) requires that you review monitoring records for the control
measures used to attain the 5-log pathogen reduction standard and
correct those conditions and practices that are not met. You also must
look at results for the preceding six tests for that product; under 21
CFR 120.25(e), if a second positive result is found within seven
consecutive tests, the control measures used to attain the 5-log
reduction standard are inadequate and you must start immediate
corrective action.

In the juice HACCP final rule, we also suggested that if you get a
single positive test result, you should review your test results over a
larger window of tests (more than just the last 7 tests) to see if these
test results are an early warning that the process may be approaching
failure. We stated that review should be sufficiently extensive to allow
you to spot a trend towards loss of process control. Here, we provide
some guidance on how far back you should review your records.

The 2-out-of-7 criterion, which is established in the final juice HACCP
regulation, was chosen because it offers appropriate consumer protection
while simultaneously having a low rate of "false alarms" (because the
likelihood of 2 positives occurring by chance in 7 consecutive tests
when citrus juice is appropriately treated is about 1 in 1000
(p=0.001)). As the window gets larger (i.e., you review a larger set of
consecutive tests), the chance of finding two positives, even when juice
is appropriately treated, increases. Therefore, looking at results over
a larger window is not required and finding two positive results in the
larger window does not impose any additional regulatory requirements.

However, as noted above, looking at test results over an extended time
period may allow you to spot a trend towards loss of process control and
take appropriate actions before your system fails. How far back you
choose to look may depend on a number of factors, including production
volume, testing frequency, and experience. A good place to start would
be to consider 2 positives in any series of 17 tests (or 3 positives in
any series of 52 tests) as a potential warning. The likelihood of 2
positives occurring by chance in 17 consecutive tests, or 3 times in 52
tests, when citrus juice is appropriately treated is about 7 in 1000
(p=0.007).

Thus, if you find 2 positives in 17 tests, or 3 positives in 52 tests,
this could be an indication that your controls are not functioning as
intended and that they may fail at some point. You would then be able to
investigate the operation of your control measures and take any
necessary action to ensure that they are functioning as intended before
a failure occurs.

As window width increases to 20, 25, and 30 tests, the probabilities of
finding two positives when the system is functioning correctly are 9.4
in 1000 (p=0.0094), 14.6 in 1000 (p=0.0146), and 20.6 in 1000
(p=0.0206), respectively.

**4.0 Heat Treated Shelf Stable Juices and Concentrates, and Other
Non-Heat Treated Juices**

Factors that you should consider when establishing control measures for
heat treated shelf stable juices and concentrates, and other non heat-
treated juices are discussed in 4.1, 4.2, 4.3, and 4.4.

**4.1 Heat Treated Shelf Stable Juices and Concentrates**

If you use a single thermal processing step to produce a shelf stable
juice, or a thermal concentration process that includes all of the
ingredients, you are not required to include control measures in your
HACCP plan for achieving the 5-log pathogen reduction. However, under 21
CFR 120.24(a)(2), you must include a copy of the thermal process or the
concentration process in your written hazard analysis and you must
establish controls in your HACCP plan for any chemical and physical
hazards identified in your hazard analysis.

> **4.2 Example of a Process for a Shelf Stable Juice**

The National Food Processors Association states that a typical hot
fill/hold process used for shelf stable juices might be to treat the
juice at 90 degrees C (194 degrees F) for 2 seconds, followed by filling
at 85 degrees C (185 degrees F) and holding for 1 minute at that
temperature. Based upon research it conducted for *E. coli* O157:H7,
Salmonella species (spp.) and *Listeria monocytogenes* in fruit juices,
NFPA calculated that this typical process used for shelf stable juices
would achieve a 50,000 log reduction for these pathogens without taking
the cumulative lethality during the cool down period into account. (See
reference to publication by Mazzotta in section V. C. 5.0).

**4.3 Juices Subject to the Low-Acid Canned Foods and Acidified Foods
Regulations**

If you produce a juice that is subject to the requirements of 21 CFR
Parts 113 or 114, i.e., the regulations for low acid canned foods and
acidified foods, you do not have to include control measures in your
HACCP plan for the potential hazards that are addressed through
compliance with 21 CFR Parts 113 or 114, e.g., hazards associated with
the formation of Clostridium botulinum toxin. You may identify such
hazards as potential hazards in the hazard identification phase of your
hazard analysis, but in the hazard evaluation phase you may conclude
that such hazards are not reasonably likely to occur because they are
controlled through compliance with the requirements of 21 CFR Parts 113
or 114. However, the hazard analysis and HACCP plan should completely
address any other hazards associated with such juices, i.e., any
chemical and physical hazards such as metal or glass fragments.

**4.4 Other Non-Thermal Treatments for Juice**

If the treatment includes the use of a source of radiation, e.g., UV
irradiation, pulsed light, FDA approval of the means of treatment for
the control of microorganisms is required. Both UV radiation and pulsed
light have been approved by FDA for the control of microorganisms, and
the regulations specifying the conditions under which they may be safely
used are at 21 CFR 179.39 (UV radiation) and 21 CFR 179.41 (Pulsed
light).

If the treatment includes the use of a chemical anti-microbial agent,
such as a sanitizer, to reduce pathogen levels on the surface of citrus
fruit, the chemical agent must be approved by FDA for that use (i.e., to
control or reduce levels of microorganisms) under the agency's food
additive regulations in 21 CFR Parts 170-199, or it must be generally
recognized as safe (GRAS) for such use.

If you use sanitizing agents as surface treatments on fruit used in the
production of citrus juice, you should secure documentation from your
supplier that the sanitizing agent is either GRAS, or is approved by the
FDA for this use.

Treatment technologies that do not involve the use of a source of
radiation or a chemical agent, e.g., high pressure processing, are not
likely to require FDA approval. However you should verify any such
assumption with your process authority (see following section).

Whether you use a form of radiation (UV radiation or pulsed light), a
chemical treatment, or some other type of treatment for pathogen
reduction purposes, the process used for pathogen control must be
validated for this purpose according to the validation requirements in
21 CFR 120.11 of the juice HACCP regulation.

**5.0 Process Validation**

You must ensure that the process you will use has been validated, i.e.,
that at all times it will deliver the required 5-log pathogen reduction
at a minimum (21 CFR 120.24(a)).

**5.1 Role of a "Process Authority"**

In order to ensure the validity of your process, you should employ or
consult with a "process authority." A process authority is an expert in
the processes for controlling pathogenic microorganisms in food, and as
such, is qualified by training and experience to evaluate all of the
aspects of your pathogen control measures, e.g., process time,
temperature, type of equipment, etc., and determine that your control
measures, if properly implemented, will effectively control pathogens
such as *E. coli* O157:H7, *Salmonella*, *Listeria monocytogenes,* and
*Cryptosporidium parvum*.

Many different types of processes may be used to reduce the level of the
organism of concern. For each of these processes, the critical control
points and critical limits must be identified. A process authority
should know what critical limits, such as time and temperature, would be
effective for treating juice. Other processing factors such as flow
rate, turbulence, pressure, concentration, composition, intensity,
penetration depth, and absorbance may also be important to a process.
Your process authority should be able to evaluate such other aspects of
your processing system that could affect its performance.

Although your process authority will be your source for information on
the critical limits for your pathogen reduction process, you will have
to know what those limits are, e.g., the time and temperature parameters
for a pasteurization process, or the amount of UV energy to which the
juice is exposed, and you will have to enter those values in your HACCP
plan as "critical limits." We will need this information to be able to
conduct an official review of your HACCP system.

You may be able to identify a process authority through your national or
regional food processors trade association, or through educational
institutions such as food science and technology departments in state
universities. Some state government agencies, e.g., state departments of
agriculture or public health, may have such experts on their staffs.
Some processing equipment vendors employ or retain (as consultants) such
experts who also have detailed knowledge about the performance
capabilities of the vendor's equipment and can work with you to
establish that the equipment will effectively control pathogens in your
processing operation.

**5.2 Validated Pasteurization Treatments for Juice**

At this time there are some published studies on pasteurization
processes for controlling pathogens in juice. Based upon the available
studies we can cite the following processes to assist you in developing
your HACCP plan.

A study done by the NFPA[^5] has resulted in a recommended general
thermal process of 3 seconds at 71.1 degrees C (160 degrees F), for
achieving a 5-log reduction for *E. coli* O157:H7, *Salmonella,* and
*Listeria monocytogenes* in fruit juices. The efficacy of this process
was measured using single strength apple, orange, and white grape juices
adjusted to a pH of 3.9. The authors noted that a pH in the range of 3.6
to 4.0 has been reported as a non-significant variable in the heat
resistance of *E. coli* O157:H7. The authors also noted that the heat
resistance of these vegetative bacterial pathogens might be considerably
greater at pH values of 4.5 and higher. This process assumes that the
pathogens will have increased thermal resistance due to their being acid
adapted. This process should be adequate to ensure a 5-log reduction of
the three stated vegetative bacterial pathogens, (*E. coli* O157:H7,
*Salmonella* and *Listeria monocytogenes*) (at juice pH values
comparable to those in the study) but we do not at this time recommend
using this process for juices, such as apple juice, where the protozoan
parasite *Cryptosporidium parvum* has been identified as a hazard that
is reasonably likely to occur, because the available scientific
literature suggests that *Cryptosporidium parvum*[^6] may be more
resistant to thermal processing than the three vegetative bacterial
pathogens.

A study done at the University of Wisconsin[^7] has shown that
treatments of 68.1 degrees C (155 degrees F) for 14 seconds (recommended
treatment conditions in Wisconsin) and 71.1 degrees C (160 degrees F)
for 6 seconds (recommended treatment conditions in New York) are capable
of achieving a 5-log reduction of acid adapted *E. coli* O157:H7 in
apple cider (pH values of 3.3 and 4.1). The Wisconsin study also
confirmed the adequacy of the treatment conditions of the NFPA study
(71.1 degrees C (160 degrees F) for 3 seconds) for achieving a 5-log
reduction for *E. coli* O157:H7 in apple cider. Either of these
processes evaluated in the Wisconsin study should be adequate to ensure
a 5-log reduction of the three stated bacterial pathogens, (*E. coli*
O157:H7, *Salmonella* and *Listeria monocytogenes*) (at juice pH values
comparable to those in the study) if any of these pathogens are the
pertinent microorganism in your juice.

However, for juices such as apple juice, *Cryptosporidium parvum* may be
reasonably expected to occur (based upon outbreaks that have occurred).
Thus, based upon the available literature concerning thermal destruction
of *Cryptosporidium parvum* oocysts (see above citation in this
section), we recommend a process of at least 71.1 degrees C (160 degrees
F) for at least 6 seconds (recommended treatment conditions in New
York). The thermal destruction of *Cryptosporidium parvum* has not been
as widely studied in the published literature as it has for the
vegetative bacterial pathogens. Therefore, we have given what we
consider to be a conservative recommendation for a process that should
ensure the destruction of both *E. coli O157:H7* and *Cryptosporidium
parvum*. Also, while it appears that *Cryptosporidium parvum* may be
more resistant to thermal processing than the vegetative bacterial
pathogens noted, in view of the limited data on the thermal destruction
of *Cryptosporidium parvum*, we recommend that processors designate both
*E. coli O157:H7* and *Cryptosporidium parvum* as the pertinent
microorganism in their HACCP plans for apple juice, until more
definitive data becomes available on the relative resistance to thermal
processing of these two pathogens.

The process that is typically carried out for milk pasteurization, 71.7
degrees C (161 degrees F) for 15 seconds should be acceptable for juices
such as apple juice (at juice pH values comparable to those in the NFPA
and Wisconsin studies) where *Cryptosporidium parvum* has been
identified as a hazard that is reasonably likely to occur.

> **5.3 Equipment and System Considerations**

Equipment and Systems that should be considered are discussed in 5.31,
5.32, 5.33, and 5.34.

31. **Pasteurization Equipment**

If you use batch pasteurization equipment, you should continuously
monitor both the time and temperature of the juice treatment as critical
limits to ensure that your process is achieving the 5-log pathogen
reduction.

If you use continuous (high temperature short time (HTST))
pasteurization equipment, you should designate the juice temperature and
juice heating time as critical limits in your HACCP plan. Under your
HACCP plan, you will continuously monitor the juice temperature, but you
may not have to monitor the heating time continuously if the equipment
(the positive displacement timing pump and holding tube length, volume
and slope) is constructed to deliver a controlled flow rate of the juice
through the heat exchanger to ensure that it is heated for the minimum
required time. In this case, as a monitoring procedure for flow rate,
you could periodically visually check the set point of the positive
displacement pump to ensure that it is at the point that has been
documented to deliver the proper flow rate. As a verification procedure,
you could check the actual flow rate semi-annually (or whatever is
needed to keep the system working properly) by performing testing of the
timing pump to ensure that it is effectively controlling the flow rate.

A magnetic flow- based timing system is another type of flow rate timing
system for an HTST pasteurizer. In such a system the flow rate (heating
time), in addition to the juice temperature, should be continuously
monitored.

> **5.32 UV Processing Systems**

UV systems for treating juice have recently begun to be commercialized.
The FDA approval in 2000 of UV radiation to treat juice to reduce human
pathogens in 21 CFR 179.39 requires that the UV radiation be provided by
low pressure mercury lamps emitting 90 percent of the emission at a
wavelength of 253.7 nanometers (2,537 Angstroms), and that during the
treatment, the juice undergo turbulent flow through tubes with a minimum
Reynolds number of 2,200. If you are considering using UV radiation to
process your juice, you should confirm with your process authority that
the system you are considering meets the requirements of 21 CFR 179.39.

We also recommend that you consider the following questions in
consultation with your process authority:

-   Have you identified the appropriate pathogen as the "pertinent
    microorganism" considering that UV radiation is the means of
    treatment for achieving the 5-log pathogen reduction? For instance,
    if you are processing apple juice, you need to know whether *E.
    coli* O157:H7, *Crytopsporidium parvum*, or some other pathogen is
    more resistant to UV radiation to determine which of these is the
    pertinent microorganism. The relative resistance of pathogens to UV
    radiation may not be the same as it is for thermal treatment.

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-   Has the UV system been validated to achieve effectively a 5-log
    pathogen reduction for the "pertinent microorganism" (see previous
    bullet) in the juice that you will be processing? The effectiveness
    of given UV treatment conditions may vary from one juice to another.
    The treatment parameters, e.g., flow rate, UV energy level, needed
    to achieve a 5-log pathogen reduction, may vary from one juice to
    another juice. You should consult with your process authority to
    ensure yourself that the system and processing parameters you will
    use have been validated to achieve a 5-log pathogen reduction in
    your juice.

-   What are the critical limits for the process? Is the flow rate of
    the juice through the UV exposure chamber critical to the
    effectiveness of the process? Is the delivery of a minimum level of
    UV energy critical to the process? If so what are the critical flow
    rate and UV energy parameters? You need to know what the critical
    limits are to be able to enter them into your HACCP plan.

-   What monitoring procedures will you have to carry out to ensure that
    the critical limits are met? Is it necessary to monitor flow rate
    continuously, or does the design of the equipment regulate the flow
    rate to not exceed the critical limit? What monitoring procedure,
    e.g., UV sensors, will indicate that the juice continually receives
    the critical level of UV energy? Is the system designed to shut down
    if a sensor fails or if a sensor indicates that a critical limit is
    not being met?

-   What verification procedures will you have to carry out? These may
    include checking the UV sensors periodically to ensure that they are
    operating properly.

-   What cleaning procedures should be carried out between runs to
    ensure that residues, e.g., particulates, do not accumulate in the
    equipment that would reduce the effectiveness of the treatment?

-   What corrective action procedures will you specify in your HACCP
    plan? Your corrective action procedures should ensure that should
    the system fail, e.g., due to failure of a UV lamp, any juice that
    may not have received the 5-log pathogen reduction is segregated
    and, if necessary, treated again to ensure a 5-log reduction, and
    that the failed lamp is replaced.

> **5.33 High Pressure Processing Systems**

High pressure processing has been shown to be effective in reducing
vegetative pathogens. Both semi-continuous and batch processes have been
developed using high pressure processing. The process time and pressure
will be critical limits for both types of processes. However,
temperature may or may not need to be a critical limit. During high
pressure processing, the temperature of the product does increase. This
increase in temperature is dependent on the composition of the food
product, the initial temperature of the product/vessel, the pressure
transmitting fluid for batch systems, and the time the product is held
at the processing pressure. Many high-pressure systems do not control
the temperature of the product during treatment and the temperature of
the product tends to decrease with time due to heat loss to the
surrounding pressure vessel. For many systems a minimum initial
temperature of the product/vessel may be specified and controlled.
However, the temperature during the process may not be monitored as a
critical limit. For batch systems, changes in the composition of the
pressure transmitting fluid should be controlled and checked
periodically.

> **5.34 Extraction Equipment for Certain Citrus Juice Processes**

If you process citrus juice using surface treatment of fruit to achieve
the 5-log pathogen reduction, it is important that the extraction of the
juice be performed in a manner that avoids any potential for
contamination of the juice by pathogens that may be present on the peel
during the extraction operation. One type of extraction known as
"pinpoint extraction" can accomplish this by ensuring that virtually no
contact of the juice with the peel occurs during the extraction step.
However, if you are considering using an extraction method other than
pinpoint extraction, we recommend that, as part of meeting the
validation requirements of 21 CFR 120.11, you generate data that
establish that contamination of juice by pathogens that may be present
on the peel will not occur during the extraction operation. Such
validation data should be included among the records you make available
for official review under 21 CFR 120.12.

**D. Control Measures for Chemical Hazards**

There are no specific chemical hazards for which HACCP control measures
are required explicitly under the juice HACCP regulation. If you
identify a chemical hazard that is reasonably likely to occur in your
juice, you will need to establish control measures for that hazard in
your HACCP plan. However, because FDA has recently established an action
level for patulin, a mycotoxin, that can occur in apple juice, we have
included information on control strategies for patulin. The information
in this section includes examples of control measures for incoming fruit
based upon a supplier guarantee. These examples may be useful for
devising control measures for other chemical hazards such as lead and
tin, if such control measures also are based upon a supplier guarantee.

We have also included information about appropriate controls to prevent
cross contamination of juice by other foods, e.g., milk, that may cause
allergic reactions in sensitive individuals when these other foods are
produced on the same processing equipment.

**1.0 Control Strategies for Patulin for Apple Juice Processors**

This section discusses factors you may consider in your hazard analysis
to determine whether patulin is a hazard that is reasonably likely to
occur in your juice. It also discusses control measures and CCPs you may
consider for your HACCP plan should you determine that patulin is
reasonably likely to occur in your juice.

The potential for high levels of patulin to occur depends on several
factors. There is no single factor that will, in all cases, determine
whether your apple juice may contain high levels of patulin. The most
significant factors are:

-   Whether the apples used include fallen fruit -- Apple juice made
    from apples that include fallen fruit is more likely to contain high
    levels of patulin than juice made from apples harvested to exclude
    fallen fruit.

-   The condition of apples at the time of harvest -- Juice made from
    apples with visible damage (e.g., from birds or insects, mold, or
    rot), is more likely to contain high levels of patulin than juice
    made from apples without such visible defects. Proper agricultural
    control practices by the grower, e.g., insect control, anti-fungal
    applications when needed, can assist in minimizing mold growth and
    rot on apples.

-   How apples are handled prior to storage -- Patulin production can
    occur during the storage of apples, particularly in apples that are
    bruised in handling prior to and during storage.

-   Storage conditions for apples -- Apples stored without proper
    temperature and atmospheric control of the storage environment are
    more likely to contain high levels of patulin than apples stored
    under controlled conditions.

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-   Monitoring apples during storage for core rot -- Patulin production
    in stored apples can be caused by core rot that is not visible by
    observation of the exterior of the apple. Lots of apples that are
    experiencing core rot may be identified by cutting and
    cross-sectional examination. Eliminating lots of apples with high
    levels of core rot from the juice production stream will reduce
    patulin levels in the juice.

-   Culling or trimming apples prior to juice production -- Growth of
    patulin producing molds is evidenced frequently by the appearance of
    visible mycelia or rot on the apple. Culling or trimming apples just
    prior to juice production to eliminate damaged, bruised, moldy, and
    rotting apples will reduce patulin levels in the juice.

Not all apples are equally affected by these factors. For example, FDA
research to be submitted shortly for publication indicates that
different apple varieties, e.g., Red Rome, Granny Smith, Red Delicious,
may differ in how patulin levels in their juices are affected by factors
such as whether fallen fruit is used or whether apples are culled prior
to juice production.

> **1.1 Hazard Analysis**

You may be able to gather a substantial amount of data pertinent to your
juice and process and perform a comprehensive hazard analysis,
considering all of the factors in the previous section, and determine
that no controls (in rare instances), or relatively limited measures,
are necessary to control patulin for your apple juice process.

For instance, you may determine, based upon data for the type of apples
you use, that the use of apples that include fallen fruit would likely
lead to excessive levels of patulin in your juice. You may opt to
control for patulin via a CCP at the receiving step for apples based
upon a supplier guarantee specifying that no fallen fruit is included
among the apples supplied in the shipment. However, you also may
determine that because you produce juice from apples that are stored
only for very brief periods, during which data indicate that significant
patulin production will not occur in the varieties of apple you use, the
culling or trimming of apples prior to juice production is not necessary
for the control of it, provided that you establish a control to ensure
that apples are stored for a maximum period of time before juice
production.

However, because patulin levels in juice can be affected by many factors
as noted previously, not all processors may be able to acquire data or
other information to perform a comprehensive hazard analysis considering
all of the factors noted in the previous section. In such cases, it may
be prudent for you to assume that patulin is a hazard that is reasonably
likely to occur and to control for patulin by requiring a supplier
guarantee for each shipment specifying that no fallen fruit is included
among the apples supplied, and also by establishing a culling or
trimming step in your process after the storage step, at which rotten,
moldy, bruised and damaged apples are removed from the production
stream.

Thus, your process should have two CCPs for the control of patulin, the
receipt of apples and the culling (or trimming) step prior to juice
production. If you store apples for extended periods of time, it also
may be prudent to have a third control measure, inspecting apples taken
from stored lots by cutting the apples and visually checking for core
rot at various times during the storage period. Lots of apples showing
significant levels of core rot may not be acceptable for juice
production. These checks for core rot would constitute a third CCP. By
establishing the three aforementioned controls, i.e., exclusion of
fallen fruit, culling or trimming of rotten, moldy, bruised and damaged
apples from production stream, and eliminating stored apples with high
levels of core rot, it is likely that you will be able to adequately
control patulin levels in your juice.

We suggest that you test some of your juice to show that your control
measures will effectively control patulin. A commercial laboratory can
do this testing for you. We suggest that an appropriate basis for
determining that your control measures are effective is, if upon
analysis of at least 3 samples of your juice for patulin taken during
one year (each analyzed in duplicate and sampled under conditions where
the occurrence of patulin is most likely, e.g., after apples are stored
for the longest potential storage time), you find that all patulin
levels are below FDA's action level and that the value achieved by
adding 2 standard deviations to the mean is below FDA's action level of
50 parts per billion. This is illustrated in the following examples for
hypothetical juices A, B and C:

+-----------------+-----------------+-----------------+-----------------+
| Juice           | Patulin level,  | Patulin level   | Is patulin      |
|                 |                 | at mean plus 2x | being           |
|                 | Mean (std dev)  | std deviations. | effectively     |
|                 | (derived from 6 |                 | controlled?     |
|                 | data points; 3  |                 |                 |
|                 | analyses during |                 |                 |
|                 | the year, each  |                 |                 |
|                 | in duplicate)   |                 |                 |
+-----------------+-----------------+-----------------+-----------------+
| A               | 40.2 (7.2)      | 54.6            | No              |
+-----------------+-----------------+-----------------+-----------------+
| B               | 0.97 (1.67)     | 4.31            | Yes             |
+-----------------+-----------------+-----------------+-----------------+
|                 |                 |                 |                 |
+-----------------+-----------------+-----------------+-----------------+
| C               | 3.43 (31.9)     | 67.23           | No              |
+-----------------+-----------------+-----------------+-----------------+

Processors in the same geographic region that use common varieties of
apples and common production techniques may wish to consider pooling
resources to test representative samples of their juices to develop
baseline data on patulin for use in their hazard analyses.

If there are significant changes in your process or in factors that may
affect patulin levels, e.g., a change in the variety of apples you use
to make juice, a change in your storage practices, a new supplier, or
abnormal weather conditions, we also recommend that you re-validate your
hazard analysis by testing juice made under the new conditions.

# 1.2 Control Measures 

If the receiving of apples is a CCP:

A supplier guarantee specifying that only apples harvested to exclude
fallen fruit were supplied in the shipment is likely to be an effective
control measure for patulin. Under such an approach:

-   The existence of the supplier guarantee for each shipment of
    incoming fruit specifying that only apples harvested to exclude
    fallen fruit were supplied in the shipment would be the critical
    limit.

-   A monitoring procedure would be to confirm visually the existence of
    the guarantee for each incoming shipment of apples. A small
    processor who harvests apples from his own orchard can essentially
    accomplish this by ensuring that his apple pickers have been
    instructed not to harvest fallen fruit.

-   The corrective action procedure would be to reject any shipment of
    fruit not accompanied by a guarantee from the supplier.

-   The verification procedure could consist of periodic auditing of the
    supplier to ensure that the supplier is following the provisions of
    the guarantee, or the testing of the juice periodically to confirm
    that the juice does not contain high levels of patulin. Generally in
    HACCP, wherever you rely on guarantees or certificates from
    suppliers to control a hazard, there is a need to couple these types
    of controls with a strong verification procedure, such as visiting
    the farm periodically or periodically testing the juice.

If culling or trimming apples after storage is a CCP:

-   The culling or trimming of the fruit during the sorting step after
    storage to eliminate moldy, rotten, bruised and damaged (e.g., from
    birds or insects) fruit is likely to be an effective control
    measure.

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-   The use of only apples or apple portions free of mold, rot,
    bruising, and other damage would be the critical limit.

-   A monitoring procedure would be to inspect apples at the sorting
    step to ensure that the apples are free of rot, mold, bruising, and
    other damage.

-   The corrective action procedure would be to cull or trim any apples
    that show mold, rot, bruising, or other damage. In practice, you
    should establish visual or other criteria for what constitutes a
    damaged apple that should be culled. The criteria should be
    established based upon validation data showing that juice made from
    apples culled using the criteria do not contain unacceptable levels
    of patulin.

-   The verification procedure could consist of periodically testing the
    juice to confirm that the juice does not contain high levels of
    patulin and reviewing records of monitoring, corrective action, and
    verification.

# 1.3 If You Make Apple Juice from Purchased Concentrate

If you make apple juice from purchased concentrate, your concentrate
supplier is responsible under his/her HACCP program for controlling
patulin if it is reasonably likely to occur in the concentrate. In such
a situation, the processor who, for example, purchases concentrate and
processes it into single strength apple juice, can conclude in his
hazard analysis that patulin is not reasonably likely to occur because
it is controlled under the HACCP plan of the concentrate supplier.

> 2.0 Control Measures for Allergens that Can Contaminate Juice from
> Improperly Cleaned Shared Processing Equipment

If you process juice on equipment that also has been used to process a
food that can cause allergic reactions, you should implement CCP or
rigorous SSOP controls that will ensure that the equipment has been
cleaned properly before it is used to process juice. (See discussion
about when FDA recommends use of a CCP vs. an SSOP for contaminants from
food contact surfaces in section IV. C. 3.2.) A list of eight foods that
can cause serious allergic reactions in some individuals and account for
more than 90% of all food allergies is found in section IV C. 1.22.

::: Definition-Term
For example, if you process milk on equipment also used to process
juice, you should clean the equipment to eliminate the milk residues
before using the equipment to process juice.
:::

::: Definition-Term
An appropriate SSOP would be to establish a procedure for cleaning your
equipment with a cleaning solution, e.g., a pre-rinse followed by a
caustic wash followed by a rinse. The procedure could include
maintaining a log of what foods, e.g., milk, eggnog, soy drinks, were
processed on your equipment, the sequence in which the foods were
processed, and how/when the equipment was cleaned. Your operator could
check that log prior to starting any production run for juice. Your
control could provide that the equipment would not be used for juice
until the prescribed cleaning procedure was carried out, recorded in the
log, and the equipment was visually checked for cleanliness (See Example
SSOP in section VII C). A CCP procedure could similarly be based upon a
pre-rinse, caustic wash followed by rinse procedure, but the parameters
of the procedure such as time, temperature and percent caustic, would
initially be validated for the effective removal of milk protein from
the processing equipment and monitoring of the parameters as critical
limits would be carried out (See Example CCP in section VII C).
:::

**E. Control Measures for Physical Hazards**

1.  **Physical Hazards**

There are no specific physical hazards, e.g., glass or metal fragments,
for which control measures are explicitly required under the juice HACCP
regulation. The necessity for control measures for any potential
physical hazard is dependent upon a finding in your hazard analysis that
the specific hazard is reasonably likely to occur in your juice. FDA has
issued a Compliance Policy Guide (CPG Section 555.425) (see section I. C
for availability information) describing when hard or sharp foreign
objects in food, such as glass or metal fragments, could pose a health
hazard. If it is reasonably likely that your juice may become
contaminated with hard or sharp foreign objects that meet the criteria
in this CPG, you should regard the object as a potential hazard in your
juice.

**1.1 Glass Fragments**

There are several ways you could establish control measures for glass
fragments in juice.

One way could involve the use of on-line glass detection equipment such
as x-ray detection. In this method, the product itself is continuously
monitored after the last step at which glass inclusion is reasonably
likely to occur (e.g. after bottling and sealing of the juice). This
could be, for example, at a process step designated for x-ray
examination. The critical limit might be designated as "no glass
fragments in the finished product." The following illustrates the
elements that might be entered into your HACCP plan.

-   Critical limit -- no glass fragments in finished product (Note:
    FDA's Health Hazard Evaluation Board has supported regulatory action
    against product with glass fragments of 0.3" (7 mm) to 1.0" (25 mm)
    in length. See also FDA Compliance Policy Guide 555.425).

-   What will be monitored -- the presence of glass fragments in
    containers passing the CCP

-   How is monitoring done -- use of x-ray equipment or other defect
    rejection system

-   How often -- continuous; each container is subjected to detection.
    For x-ray equipment and other defect rejection systems, you should
    confirm that the device is operating correctly, at least at the
    start of each production day

-   Who will perform the monitoring -- for x-ray detection and other
    defect rejection systems the equipment itself performs monitoring. A
    check should be made at least once per day to ensure that the device
    is operating.

Another way to control glass fragments, applicable in operations where
the containers are manually (not mechanically) handled and sealed, could
involve inspecting glass containers visually before they are filled to
ensure that glass fragments are not present in the containers. An
appropriately trained individual at a container inspection step in the
process may do this. A check should be made at the start of production
to ensure that the appropriate personnel are assigned to the processing
step where the inspection will occur. The critical limit might be
designated as "no glass fragments in empty glass containers at the
container inspection step."

Another way to control glass fragments could involve visual inspection
at steps in the process where glass breakage can result in glass
entering the juice such as the glass container receiving, glass
container storage, mechanical conveying, mechanical filling, and
mechanical capping. The inspection looks for any evidence of glass
breakage in those areas. CCPs might be identified as the glass receiving
and storage steps and the mechanical conveying, filling and capping
steps. The critical limit might be designated as "no broken glass at the
CCPs for glass inclusion." If broken glass is observed, the line is
stopped, the glass is removed and the product that has moved through
that area since the last inspection is placed on hold for further action
as appropriate, e.g. to be run through off-line glass detection
equipment, to be destroyed, to be diverted to non-food use or to be
re-run through a process that includes a glass detection step.

-   What is the critical limit? No broken glass at the CCPs for glass
    inclusion

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-   What will be monitored? The presence of broken glass on or near
    equipment at the CCPs

-   How is monitoring done? Visual check of the glass handling areas for
    broken glass

-   How often? You should check before starting operations each day,
    check at least every four hours during operation, check at the end
    of operations each day, and check whenever there is an equipment or
    other malfunction that could increase the likelihood that glass
    containers could be damaged

-   Who should perform the monitoring? Any person who has a thorough
    understanding of the proper condition of the glass handling
    equipment and surrounding area may perform monitoring. In assigning
    the responsibility for this monitoring function you should consider
    the complexity of the equipment and the level of understanding
    necessary to evaluate its condition.

If broken glass is observed at a CCP, the corrective action procedure
should be to stop the line, remove the broken glass, and then place on
hold any product that has moved through the area where the glass
breakage was observed since the last inspection, for further action as
appropriate, e.g., to be run through off-line glass detection equipment,
to be destroyed, to be diverted to non-food use or to be re-run through
a process that includes a glass detection step.

**1.2 Metal Fragments**

There are several possible ways to establish control measures for metal
fragments in juice.

One way could involve the use of on-line metal detection equipment. With
this method, the equipment continuously monitors the product after the
last step at which metal inclusion is reasonably likely to occur (e.g.
after bottling and sealing of the juice) at a process step designated
for metal detection. The critical limit might be designated as "no metal
fragments in the finished product." The following illustrates some of
the elements that might be entered into your HACCP plan.

-   What is the critical limit? No metal fragments in finished product
    (Note: FDA's Health Hazard Evaluation Board has supported regulatory
    action against product with glass fragments of 0.3" (7 mm) to 1.0"
    (25 mm) in length. See also FDA Compliance Policy Guide 555.425).

-   What will be monitored? The presence of metal fragments in
    containers passing the CCP.

-   How is monitoring done? By the use of metal detection equipment.

-   How often? Continuously. Each container is subjected to detection.
    You should confirm that the device is operating correctly at least
    at the start of each production day.

-   Who should perform the monitoring? -- Monitoring is performed by the
    equipment itself. A check should be made at least once per day to
    ensure that the device is operating correctly.

Another way to control metal fragments could involve the use of a
separation device such as a screen after the last step at which metal
inclusion is reasonably likely to occur, at a process step designated
for screening. For this approach (see example HACCP plans for
Pasteurized Refrigerated Apple Juice and Not-from-concentrate Orange
Juice in section VII):

-   The critical limit might be designated as "screen is operational."

-   Monitoring may be done by a daily visual check for screen integrity.

-   Verification should include periodic calibration testing to ensure
    that the screen retains its separation capability for metal
    particles of a specific size. In establishing this size you should
    bear in mind that FDA's Health Hazard Evaluation Board has supported
    regulatory action against product with glass fragments of 0.3"
    (7 mm) to 1.0" (25 mm) in length. (See also FDA Compliance Policy
    Guide 555.425).

Another way to control metal fragments could involve visually inspecting
equipment for damage or missing parts at process steps such as
extraction and grinding, where such damage or loss of parts could lead
to metal inclusion in your juice. This approach may only be feasible for
relatively simple equipment that can be fully visually inspected in a
reasonable time period. Under this approach, CCPs might be identified as
the fruit grinding and extraction steps in a process. The critical limit
might be designated as "no broken or missing metal parts from equipment
at the CCPs for metal inclusion." If broken or missing metal parts are
observed, the line is stopped, the equipment is repaired and, if
necessary, adjusted or modified and the product that has moved through
that area since the last inspection is placed on hold for further action
as appropriate, e.g., to be run through off-line metal detection
equipment, to be destroyed, to be diverted to non-food use, or to be
re-run through a process that includes a metal detection step. The
following illustrates the elements that might be entered into your HACCP
plan.

-   What is the critical limit? No broken or missing metal parts from
    grinding (or extraction) equipment

```{=html}
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```
-   What will be monitored? The presence of broken or missing metal
    parts on or near the grinder

-   How is monitoring done? By visual check of the grinder and immediate
    vicinity for broken or missing metal parts

-   How often? Check before starting operations each day, check at least
    every four hours during operation, check at the end of operations
    each day, and check whenever there is an equipment or other
    malfunction that could increase the likelihood that metal inclusion
    could occur

-   Who will perform the monitoring? Any person who has a thorough
    understanding of the proper condition of the equipment and
    surrounding area may perform monitoring.

-   If broken or missing metal parts are observed at a CCP, the
    corrective action procedure would be to stop the line, repair,
    adjust, and modify the equipment as necessary; then the product that
    has moved through that area since the last inspection is placed on
    hold for further action as appropriate, e.g., to be run through
    off-line metal detection equipment, to be destroyed, to be diverted
    to non-food use, or to be re-run through a process that includes a
    metal detection step.

**F. Table of Most Likely Hazards/Control Measures for Juice**

####### 

####### The following table lists the hazards that you are most likely to address under your HACCP program, some of the control measures you may use for those hazards, and where to find information in this guidance about those control measures.

**Table 1. Most Likely Hazards/Control Measures for Juice**

+--------+--------------------+------------------+-------------------+
| **     | # Hazard rationale | **Possible       | **For additional  |
| Hazard |                    | control          | controls          |
| Iden   |                    | measures**[^8]   | information see   |
| tity** |                    |                  | section ...**     |
+--------+--------------------+------------------+-------------------+
| Pathog | Unless you produce | 1.               | -   V C 1.1 --    |
| ens[^9 | one of the types   |   Pasteurization |     Pertinent     |
| ]/biol | of juice listed in |                  |     microorganism |
| ogical | footnote #8, one   | 2.  UV radiation |                   |
|        | of the pathogens   |                  | ```{=html}        |
|        | listed in footnote | 3.  Pulsed light | <!-- -->          |
|        | #9 is likely to be |                  | ```               |
|        | the "pertinent     | 4.  High         | -   V C 5.0 --    |
|        | microorganism" for |     pressure     |     Process       |
|        | your required      |     processing   |     validation    |
|        | 5-log pathogen     |                  |                   |
|        | reduction          | 5.  For fresh    | ```{=html}        |
|        | treatment.         |     citrus juice | <!-- -->          |
|        |                    |     only:        | ```               |
|        |                    |     Supplier     | -   V C 5.31 --   |
|        |                    |     guarantee    |                   |
|        |                    |     for each     |    Pasteurization |
|        |                    |     shipment     |     Equipment     |
|        |                    |     (only        |                   |
|        |                    |     tree-picked  | ```{=html}        |
|        |                    |     fruit was    | <!-- -->          |
|        |                    |     supplied),   | ```               |
|        |                    |     culling to   | -   V C 5.32 - UV |
|        |                    |     remove       |     Processing    |
|        |                    |     damaged      |     Systems       |
|        |                    |     fruit,       |                   |
|        |                    |     wa           | ```{=html}        |
|        |                    | shing/sanitizing | <!-- -->          |
|        |                    |     fruit        | ```               |
|        |                    |     surface, and | -   V C 3.1, 3.2  |
|        |                    |     pinpoint     |     and 5.34 --   |
|        |                    |     extraction   |     Fresh citrus  |
|        |                    |                  |     juices, also  |
|        |                    |                  |     Example HACCP |
|        |                    |                  |     plan for      |
|        |                    |                  |     fresh citrus  |
|        |                    |                  |     juice in VII  |
|        |                    |                  |     B 2.0.        |
+--------+--------------------+------------------+-------------------+
| Patu   | Patulin is a       | 1.  Supplier     | V D 1.2 and       |
| lin/ch | mycotoxin that can |     guarantee    | Example HACCP     |
| emical | occur on rotten,   |     for each     | Plan for apple    |
|        | moldy, bruised or  |     shipment;    | juice in VII B    |
|        | damaged apples,    |     only apples  | 1.0.              |
|        | and may occur at   |     harvested to |                   |
|        | hazardous levels   |     exclude      |                   |
|        | if such apples are |     fallen fruit |                   |
|        | used to make juice |     were         |                   |
|        |                    |     supplied     |                   |
|        |                    |                  |                   |
|        |                    | 2.  Cull or trim |                   |
|        |                    |     apples after |                   |
|        |                    |     storage to   |                   |
|        |                    |     remove       |                   |
|        |                    |     rotten,      |                   |
|        |                    |     moldy,       |                   |
|        |                    |     bruised and  |                   |
|        |                    |     damaged      |                   |
|        |                    |     apples       |                   |
+--------+--------------------+------------------+-------------------+

**Most Likely Hazards/Control Measures for Juice\--**Continued

+--------+--------------------+------------------+-------------------+
| **     | # Hazard rationale | **Possible       | **For additional  |
| Hazard |                    | control          | controls          |
| Ide    |                    | measures**       | information see   |
| ntity/ |                    |                  | section ...**     |
| Type** |                    |                  |                   |
+--------+--------------------+------------------+-------------------+
| :      | May occur in juice | CCP or SSOP      | V D 2.0 and       |
| :: Def | processed using    | control for      | Example CCP and   |
| initio | equipment also     | adequate         | SSOP in VII C.    |
| n-Term | used to process    | cleaning of      |                   |
| Milk   | milk               | processing       |                   |
| r      |                    | equipment        |                   |
| esidue |                    | between a milk   |                   |
| (an    |                    | run and a juice  |                   |
| all    |                    | run              |                   |
| ergen) |                    |                  |                   |
| in     |                    |                  |                   |
| ju     |                    |                  |                   |
| ice/ch |                    |                  |                   |
| emical |                    |                  |                   |
| :::    |                    |                  |                   |
+--------+--------------------+------------------+-------------------+
| Fra    | Glass fragments in | Check processing | V E 1.1           |
| gments | juice can pose an  | line for         |                   |
| from   | injury risk if     | evidence of      |                   |
| glass  | ingested           | glass breakage   |                   |
| c      |                    | (if containers   |                   |
| ontain |                    | are mechanically |                   |
| ers/ph |                    | handled)         |                   |
| ysical |                    |                  |                   |
|        |                    | Pass product     |                   |
|        |                    | through x-ray    |                   |
|        |                    | equipment or     |                   |
|        |                    | other defect     |                   |
|        |                    | rejection system |                   |
|        |                    |                  |                   |
|        |                    | Pass product     |                   |
|        |                    | through          |                   |
|        |                    | separation       |                   |
|        |                    | device such as a |                   |
|        |                    | screen           |                   |
|        |                    |                  |                   |
|        |                    | Check containers |                   |
|        |                    | prior to filling |                   |
|        |                    | for glass        |                   |
|        |                    | breakage (if     |                   |
|        |                    | containers are   |                   |
|        |                    | manually         |                   |
|        |                    | handled)         |                   |
+--------+--------------------+------------------+-------------------+
| Metal  | Metal fragments in | Check equipment  | V. E. 1.2         |
| Fra    | juice can pose an  | for evidence of  |                   |
| gments | injury risk if     | broken or        |                   |
|        | ingested           | missing metal    |                   |
|        |                    | parts that may   |                   |
|        |                    | enter the juice  |                   |
|        |                    |                  |                   |
|        |                    | Pass product     |                   |
|        |                    | through metal    |                   |
|        |                    | detection        |                   |
|        |                    | equipment        |                   |
|        |                    |                  |                   |
|        |                    | Pass product     |                   |
|        |                    | through          |                   |
|        |                    | separation       |                   |
|        |                    | device such as a |                   |
|        |                    | screen or magnet |                   |
+--------+--------------------+------------------+-------------------+

####### VI. Preparing for HACCP 

####### 

####### A. Getting people ready

In implementing your HACCP system, you will rely on people to perform a
variety of tasks that will begin well before you produce any juice under
your HACCP system, e.g., the development of your hazard analysis and
HACCP plan.

To carry out these tasks, your employees should familiarize themselves,
as appropriate, with HACCP principles and acquire any necessary HACCP
training. In Part B of this section, we have listed several sources of
information about HACCP resource materials and HACCP training.

You also may wish to retain outside experts to assist your staff in
these tasks. For instance, a process authority can provide specialized
expertise to validate the processing parameters, e.g., time/temperature,
that you will use to meet the 5-log pathogen reduction requirement.

Successful implementation of HACCP requires trained people who cooperate
from the preliminary stages to the implementation and ongoing operation
of the HACCP system. We strongly recommend that you begin with step 1 of
NACMCF's 5 preliminary steps of HACCP, by assembling a HACCP team that
includes plant level and corporate level personnel. (See the HACCP
Principles and Guidelines publication discussed in section IV. B.)

B.  **HACCP Training and HACCP Resource Materials**

```{=html}
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```
1.  **Juice HACCP Alliance Training Curriculum**

The Juice HACCP Alliance is in the process of finalizing a manual for a
training curriculum designed to instill the principles of HACCP as
applied to the processing of juice under the requirements of the juice
HACCP regulation.[^10] FDA anticipates that this manual, the 1^st^
Edition of the Juice HACCP Training Curriculum of the Juice HACCP
Alliance (the standardized curriculum), will be adequate for use in
training individuals to meet the requirements of the juice HACCP
regulation in 21 CFR 120.13 (FDA plans to issue shortly a guidance
document entitled "Standardized Training Curriculum for Application of
HACCP Principles to Juice Processing"). Other curricula that are
equivalent in coverage to that of the standardized curriculum may also
be used to meet this training requirement (see 21 CFR 120.13(b)). The
manual for the standardized curriculum will be available for purchase
from the National Center for Food Safety and Technology at the Illinois
Institute of Technology, and will be available for viewing and
downloading at no cost at
[www.ncfst.iit.edu](http://www.ncfst.iit.edu/).

> **2.0 USDA/FDA HACCP Training Programs and Resources Database**

The USDA and FDA created the HACCP Training Programs and Resources
Database to support the increasing educational information needs of
industry and food service professionals in implementing HACCP programs.
This database provides up-to-date listings of HACCP training programs
and HACCP resource materials. Its intended users are educators,
trainers, field staff in Extension, Food Safety and Inspection Service
(FSIS) personnel, FDA personnel, private sector food processing plants
and organizations, and others interested in identifying HACCP training
resources. The internet address is
http://www.nal.usda.gov/fnic/foodborne/haccp/index.shtml.

**VII. Example Documents**

This section includes example documents showing components of hazard
analyses and HACCP plans for a pasteurized refrigerated apple juice, a
fresh orange juice, and a not-from-concentrate pasteurized orange juice.
Hazard analysis summary tables, and excerpts from HACCP plans for the
three juices, and a hazard identification and evaluation exercise for
apple juice are included. These are provided as examples for you to
consider when you conduct your hazard analysis and write your HACCP
plan. However, you should consider the factors that are specific to your
juice and your process in preparing your hazard analysis and HACCP plan.

**A. Hazard Analysis Examples**

> **1.0 Example Hazard Analysis for Pasteurized Refrigerated Apple
> Juice**

On the following page is an example of a "Hazard Analysis Summary Table"
for a pasteurized refrigerated apple juice packed in plastic bottles. In
the example, the process steps are simplified as compared with what may
be performed in an actual process, but all critical process steps for
this type of juice are included. For this example, we assumed that
patulin was a hazard that was reasonably likely to occur if fallen fruit
was used to make the juice or if the apples were not culled or trimmed
after storage to remove rotten, moldy, damaged or bruised fruit. See the
discussion in section V. C. 5.2 about why two pathogens are identified
as the pertinent microorganism in this hazard analysis.

**Pasteurized Refrigerated Apple Juice**

**Procedures/Steps**

**Incoming Materials**

-   Locally grown fresh apples are received directly from farms.

-   Packaging materials are delivered in clean, well-maintained and
    covered vehicles.

**Processing**

-   Fruit is unloaded and placed into cold storage.

-   Fruit is transferred from cold storage to the processing area, and
    dumped onto a slotted hopper where stems, leaves and other
    extraneous materials are removed.

-   From the slotted hopper, the fruit goes to a flume tank containing
    treated water.

-   Fruit is elevated, dewatered and moved over inspection rollers where
    visually defective apples are culled and fruit is rinsed with
    potable water.

-   Fruit continues on to a wet scrubber where it is brushed and sprayed
    with treated water. Fruit then passes along a rubberized roller
    where it is partially dried.

-   Fruit is elevated, rinsed in potable water, drained, and dropped
    into a hammermill grinder.

-   After grinding, the slurry goes to a continuous belt press where the
    pomace and juice slurry are separated.

-   The juice slurry is screened to separate the juice from the pulp,
    achieve a particle size compatible with the pasteurizer
    manufacturer's recommendations, and to remove metal fragments.

-   The juice is pumped to a holding tank.

-   The juice is pasteurized in a plate heat exchanger which heats the
    juice to a predetermined temperature, holds the juice for a set
    time, and cools the juice as it exits.

-   The juice is pumped into a refrigerated bulk storage tank.

**Packaging and Shipping**

-   Juice is filled into High Density Polyethylene (HDPE) blow-molded
    bottles of various sizes. Bottles are capped, labeled, coded, cased,
    palletized and stored refrigerated until shipping.

Table 2. Hazard Analysis Summary Table (for Pasteurized Refrigerated
Apple Juice)

+-----------+-----------+--------+-----------+----------------+-------+
| **(1)**   | **(2)**   | *      | **(4)**   | **(5)**        | **    |
|           |           | *(3)** |           |                | (6)** |
| **In      | *         |        | **Justify | **What         |       |
| gredient/ | *Identify | **Are  | your      | preventative   | **Is  |
| p         | potential | any    | decision  | measure(s) can | this  |
| rocessing | hazards   | pot    | for       | be applied to  | step  |
| step**    | in        | ential | Column    | prevent the    | a     |
|           | troduced, | food-  | 3**       | significant    | Cri   |
|           | c         | safety |           | hazards?**     | tical |
|           | ontrolled | h      |           |                | Co    |
|           | or        | azards |           |                | ntrol |
|           | enhanced  | si     |           |                | Poi   |
|           | at this   | gnific |           |                | nt?** |
|           | step**    | ant?** |           |                |       |
|           |           |        |           |                | **    |
|           |           | **(Yes |           |                | (Yes/ |
|           |           | /No)** |           |                | No)** |
+-----------+-----------+--------+-----------+----------------+-------+
| **Re      | ## Biol   | Yes    | History   | Pasteurization | No    |
| ceiving** | ogical(B) |        | of        |                |       |
|           |  -- Veget | No     | outbreaks | None required  | #     |
| **(raw    | ative and |        | for apple |                |       |
| apples)** |  protozoa | Yes    | juice.    | Supplier       | No    |
|           | n enteric |        |           | guarantee      |       |
|           |  pathogen |        | #         | (apples        | Yes   |
|           | s (i.e.,  |        |           | harvested to   |       |
|           | *E.coli*  |        | #         | exclude fallen |       |
|           | O157:H7 a |        |           | fruit) and     |       |
|           | nd *Crypt |        | #         | culling or     |       |
|           | osporidiu |        |           | trimming       |       |
|           | m parvum* |        | #         | defective      |       |
|           | ) {#biolo |        |           | (i.e, moldy,   |       |
|           | gicalb-ve |        | #         | rotten,        |       |
|           | getative- |        |           | bruised and    |       |
|           | and-proto |        | # In U.S  | damaged)       |       |
|           | zoan-ente |        | . produce | apples.        |       |
|           | ric-patho |        |  unapprov |                |       |
|           | gens-i.e. |        | ed pestic |                |       |
|           | -e.coli-o |        | ide resid |                |       |
|           | 157h7-and |        | ues occur |                |       |
|           | -cryptosp |        |  infreque |                |       |
|           | oridium-p |        | ntly and  |                |       |
|           | arvum .un |        | public he |                |       |
|           | numbered} |        | alth impa |                |       |
|           |           |        | ct is typ |                |       |
|           | **Chemica |        | ically no |                |       |
|           | l(C)**--- |        | t severe. |                |       |
|           |           |        |           |                |       |
|           | 1\.       |        | :         |                |       |
|           | P         |        | :: Defini |                |       |
|           | esticides |        | tion-Term |                |       |
|           |           |        | Causes    |                |       |
|           | 2\.       |        | illness   |                |       |
|           | Patulin   |        | or injury |                |       |
|           |           |        | :::       |                |       |
|           | **Physica |        |           |                |       |
|           | l(P)**\-- |        |           |                |       |
|           | None      |        |           |                |       |
+-----------+-----------+--------+-----------+----------------+-------+
| **        | **B       |        |           |                |       |
| Receiving | **---None |        |           |                |       |
| (plastic  |           |        |           |                |       |
| bottle    | **C       |        |           |                |       |
| s/caps)** | **---None |        |           |                |       |
|           |           |        |           |                |       |
|           | **P       |        |           |                |       |
|           | ---**None |        |           |                |       |
+-----------+-----------+--------+-----------+----------------+-------+
| **Dry     | **B       |        |           |                |       |
| Storage** | **---None |        |           |                |       |
|           |           |        |           |                |       |
| *         | **C       |        |           |                |       |
| *(plastic | **---None |        |           |                |       |
| bottle    |           |        |           |                |       |
| s/caps)** | **P       |        |           |                |       |
|           | ---**None |        |           |                |       |
+-----------+-----------+--------+-----------+----------------+-------+

+-----------+-----------+--------+-----------+----------------+-------+
| **(1)**   | **(2)**   | *      | **(4)**   | **(5)**        | **    |
|           |           | *(3)** |           |                | (6)** |
| **In      | *         |        | **Justify | **What         |       |
| gredient/ | *Identify | **Are  | your      | preventative   | **Is  |
| p         | potential | any    | decision  | measure(s) can | this  |
| rocessing | hazards   | pot    | for       | be applied to  | step  |
| step**    | in        | ential | Column    | prevent the    | a     |
|           | troduced, | food-  | 3**       | significant    | Cri   |
|           | c         | safety |           | hazards?**     | tical |
|           | ontrolled | h      |           |                | Co    |
|           | or        | azards |           |                | ntrol |
|           | enhanced  | si     |           |                | Poi   |
|           | at this   | gnific |           |                | nt?** |
|           | step**    | ant?** |           |                |       |
|           |           |        |           |                | **    |
|           |           | **(Yes |           |                | (Yes/ |
|           |           | /No)** |           |                | No)** |
+-----------+-----------+--------+-----------+----------------+-------+
| **Cold    | **B       | Yes    | Patulin   | Cull or trim   | No    |
| Storage** | **\--None |        | levels    | defective      |       |
|           |           |        | may       | apples         |       |
|           | **C**-    |        | increase  |                |       |
|           | --Patulin |        | in        |                |       |
|           |           |        | storage.  |                |       |
|           | **P       |        |           |                |       |
|           | ---**None |        |           |                |       |
+-----------+-----------+--------+-----------+----------------+-------+
| **Remove  | **B       |        |           |                |       |
| Debris**  | **---None |        |           |                |       |
|           |           |        |           |                |       |
| *         | **C       |        |           |                |       |
| *(slotted | **---None |        |           |                |       |
| hopper)** |           |        |           |                |       |
|           | **P       |        |           |                |       |
|           | ---**None |        |           |                |       |
+-----------+-----------+--------+-----------+----------------+-------+
| **Wash    | **B       |        |           |                |       |
| (flume    | ---**None |        |           |                |       |
| tank)**   |           |        |           |                |       |
|           | **C       |        |           |                |       |
|           | ---**None |        |           |                |       |
|           |           |        |           |                |       |
|           | #         |        |           |                |       |
|           |  P\--None |        |           |                |       |
+-----------+-----------+--------+-----------+----------------+-------+
| **Cull**  | **B       | Yes    | Patulin   | Cull defective | Yes   |
|           | ---**None |        | levels    | apples.        |       |
|           |           |        | are       |                |       |
|           | **C---    |        | reduced   |                |       |
|           | **Patulin |        | by        |                |       |
|           |           |        | culling   |                |       |
|           | **P       |        | defective |                |       |
|           | **\--None |        | apples.   |                |       |
+-----------+-----------+--------+-----------+----------------+-------+
| **Bru     | **B       |        |           |                |       |
| sh/Wash** | ---**None |        |           |                |       |
|           |           |        |           |                |       |
|           | **C       |        |           |                |       |
|           | ---**None |        |           |                |       |
|           |           |        |           |                |       |
|           | **P       |        |           |                |       |
|           | **\--None |        |           |                |       |
+-----------+-----------+--------+-----------+----------------+-------+

+-----------+-----------+--------+-----------+----------------+-------+
| **(1)**   | **(2)**   | *      | **(4)**   | **(5)**        | **    |
|           |           | *(3)** |           |                | (6)** |
| **In      | *         |        | **Justify | **What         |       |
| gredient/ | *Identify | **Are  | your      | preventative   | **Is  |
| p         | potential | any    | decision  | measure(s) can | this  |
| rocessing | hazards   | pot    | for       | be applied to  | step  |
| step**    | in        | ential | Column    | prevent the    | a     |
|           | troduced, | food-  | 3**       | significant    | Cri   |
|           | c         | safety |           | hazards?**     | tical |
|           | ontrolled | h      |           |                | Co    |
|           | or        | azards |           |                | ntrol |
|           | enhanced  | si     |           |                | Poi   |
|           | at this   | gnific |           |                | nt?** |
|           | step**    | ant?** |           |                |       |
|           |           |        |           |                | **    |
|           |           | **(Yes |           |                | (Yes/ |
|           |           | /No)** |           |                | No)** |
+-----------+-----------+--------+-----------+----------------+-------+
| **        | **B       |        |           |                |       |
| Partially | ---**None |        |           |                |       |
| Dried**   |           |        |           |                |       |
|           | **C       |        |           |                |       |
|           | ---**None |        |           |                |       |
|           |           |        |           |                |       |
|           | **P       |        |           |                |       |
|           | ---**None |        |           |                |       |
+-----------+-----------+--------+-----------+----------------+-------+
| **Grind** | **B       | Yes    | Metal     | Screen         | No    |
|           | ---**None |        | fatigue,  |                |       |
|           |           |        | worn and  |                |       |
|           | **C       |        | damaged   |                |       |
|           | ---**None |        | blades    |                |       |
|           |           |        | can cause |                |       |
|           | **P*      |        | cont      |                |       |
|           | *---Metal |        | amination |                |       |
|           | fragments |        | of        |                |       |
|           |           |        | slurry.   |                |       |
+-----------+-----------+--------+-----------+----------------+-------+
| **Press** | **B       |        |           |                |       |
|           | ---**None |        |           |                |       |
|           |           |        |           |                |       |
|           | **C       |        |           |                |       |
|           | ---**None |        |           |                |       |
|           |           |        |           |                |       |
|           | **P       |        |           |                |       |
|           | ---**None |        |           |                |       |
+-----------+-----------+--------+-----------+----------------+-------+
| *         | **B       | Yes    | Intact    | Screen         | Yes   |
| *Screen** | ---**None |        | screen    |                |       |
|           |           |        | filters   |                |       |
|           | **C       |        | out the   |                |       |
|           | ---**None |        | metal     |                |       |
|           |           |        | fragments |                |       |
|           | **P*      |        |           |                |       |
|           | *---Metal |        |           |                |       |
|           | fragments |        |           |                |       |
+-----------+-----------+--------+-----------+----------------+-------+
| **Holding | **B       |        |           |                |       |
| Tank**    | ---**None |        |           |                |       |
|           |           |        |           |                |       |
|           | **C       |        |           |                |       |
|           | ---**None |        |           |                |       |
|           |           |        |           |                |       |
|           | **P       |        |           |                |       |
|           | **---None |        |           |                |       |
+-----------+-----------+--------+-----------+----------------+-------+

+-----------+-----------+--------+-----------+----------------+-------+
| **(1)**   | **(2)**   | *      | **(4)**   | **(5)**        | **    |
|           |           | *(3)** |           |                | (6)** |
| **In      | *         |        | **Justify | **What         |       |
| gredient/ | *Identify | **Are  | your      | preventative   | **Is  |
| p         | potential | any    | decision  | measure(s) can | this  |
| rocessing | hazards   | pot    | for       | be applied to  | step  |
| step**    | in        | ential | Column    | prevent the    | a     |
|           | troduced, | food-  | 3**       | significant    | Cri   |
|           | c         | safety |           | hazards?**     | tical |
|           | ontrolled | h      |           |                | Co    |
|           | or        | azards |           |                | ntrol |
|           | enhanced  | si     |           |                | Poi   |
|           | at this   | gnific |           |                | nt?** |
|           | step**    | ant?** |           |                |       |
|           |           |        |           |                | **    |
|           |           | **(Yes |           |                | (Yes/ |
|           |           | /No)** |           |                | No)** |
+-----------+-----------+--------+-----------+----------------+-------+
| **Past    | ##        | Yes    | Microbial | Pasteurization | Yes   |
| eurize/** | B---Veget |        | cont      |                |       |
|           | ative and |        | amination |                |       |
| **Cool**  |  protozoa |        | on        |                |       |
|           | n enteric |        | incoming  |                |       |
|           |  pathogen |        | apples.   |                |       |
|           | s (*E. co |        |           |                |       |
|           | li* O157: |        |           |                |       |
|           | H7 and *C |        |           |                |       |
|           | ryptospor |        |           |                |       |
|           | idium par |        |           |                |       |
|           | vum* are  |        |           |                |       |
|           | the perti |        |           |                |       |
|           | nent micr |        |           |                |       |
|           | oorganism |        |           |                |       |
|           | s {#bvege |        |           |                |       |
|           | tative-an |        |           |                |       |
|           | d-protozo |        |           |                |       |
|           | an-enteri |        |           |                |       |
|           | c-pathoge |        |           |                |       |
|           | ns-e.-col |        |           |                |       |
|           | i-o157h7- |        |           |                |       |
|           | and-crypt |        |           |                |       |
|           | osporidiu |        |           |                |       |
|           | m-parvum- |        |           |                |       |
|           | are-the-p |        |           |                |       |
|           | ertinent- |        |           |                |       |
|           | microorga |        |           |                |       |
|           | nisms .un |        |           |                |       |
|           | numbered} |        |           |                |       |
|           |           |        |           |                |       |
|           | **C       |        |           |                |       |
|           | ---**None |        |           |                |       |
|           |           |        |           |                |       |
|           | **P       |        |           |                |       |
|           | ---**None |        |           |                |       |
+-----------+-----------+--------+-----------+----------------+-------+
| **Holding | **B       |        |           |                |       |
| Tank**    | ---**None |        |           |                |       |
|           |           |        |           |                |       |
|           | **C       |        |           |                |       |
|           | ---**None |        |           |                |       |
|           |           |        |           |                |       |
|           | **P       |        |           |                |       |
|           | **---None |        |           |                |       |
+-----------+-----------+--------+-----------+----------------+-------+
| **Fill**  | **B       |        |           |                |       |
|           | ---**None |        |           |                |       |
|           |           |        |           |                |       |
|           | **C       |        |           |                |       |
|           | ---**None |        |           |                |       |
|           |           |        |           |                |       |
|           | **P       |        |           |                |       |
|           | **---None |        |           |                |       |
+-----------+-----------+--------+-----------+----------------+-------+
| **Cap**   | **B       |        |           |                |       |
|           | ---**None |        |           |                |       |
|           |           |        |           |                |       |
|           | **C       |        |           |                |       |
|           | ---**None |        |           |                |       |
|           |           |        |           |                |       |
|           | **P       |        |           |                |       |
|           | **---None |        |           |                |       |
+-----------+-----------+--------+-----------+----------------+-------+
| **Cod     | **B       |        |           |                |       |
| e/Case/** | ---**None |        |           |                |       |
|           |           |        |           |                |       |
| **Pa      | **C       |        |           |                |       |
| lletize** | ---**None |        |           |                |       |
|           |           |        |           |                |       |
|           | **P       |        |           |                |       |
|           | **---None |        |           |                |       |
+-----------+-----------+--------+-----------+----------------+-------+
| **Cold    | **B       |        |           |                |       |
| Storage** | ---**None |        |           |                |       |
|           |           |        |           |                |       |
|           | **C       |        |           |                |       |
|           | ---**None |        |           |                |       |
|           |           |        |           |                |       |
|           | **P       |        |           |                |       |
|           | **---None |        |           |                |       |
+-----------+-----------+--------+-----------+----------------+-------+
| **Ship**  | **B       |        |           |                |       |
|           | ---**None |        |           |                |       |
|           |           |        |           |                |       |
|           | **C       |        |           |                |       |
|           | ---**None |        |           |                |       |
|           |           |        |           |                |       |
|           | **P       |        |           |                |       |
|           | **---None |        |           |                |       |
+-----------+-----------+--------+-----------+----------------+-------+

\* For the purpose of this example hazard analysis, a "significant
hazard" is one that meets the definition of a hazard that is reasonably
likely to occur in §120.7(a)(2) of the juice HACCP regulation, i.e., it
is one for which a prudent processor would establish controls, i.e., at
CCPs in his HACCP plan

**2.0 Hazard Identification and Evaluation Exercise for Apple Juice**

**2.1 Step 1. Hazard identification**

*The team develops a list of potential biological, chemical, and
physical hazards that may be introduced, increased, or controlled at
each step in the production process.*

**Vegetative and Protozoan Enteric Pathogens**

-   Enteric pathogens such as the bacterium *Esherichia coli* O157:H7
    and the protozoan parasite *Cryptosporidium parvum* can be present
    on and in apples and can contaminate apple juice at the time the
    juice is extracted from the fruit.

**Patulin**

-   High levels of patulin can occur in juice made from fallen apples or
    damaged apples that contain mold, rot, or other damage.

-   Patulin present in the extracted juice will carry through to the
    final product because patulin is not destroyed by pasteurization.

**Metal Fragments**

-   Metal fatigue or worn/damaged blades in equipment used for grinding
    apples can introduce metal fragments into juice.

**Pesticides**

-   Residues from unapproved pesticides or residues in excess of
    pesticide tolerances in juice could pose a potential hazard if they
    occurred over an extended period of time at levels capable of
    causing health effects from chronic exposure, or if they occurred
    for only a brief period of time at levels capable of causing acute
    health effects.

**2.2 Step 2. Hazard evaluation**

####  

*The team assesses the severity of the health consequences if a
potential hazard is not properly controlled.*

> **Vegetative and Protozoan Enteric Pathogens**

-   Epidemiological evidence indicates that *E.coli* O157:H7 and
    *Cryptosporidium parvum* can cause severe and life-threatening
    foodborne illness. Unpasteurized apple cider has been linked to
    illness outbreaks from these pathogens.

> **Patulin**

-   Exposure over a period of time to high levels of patulin may pose a
    health hazard.

> **Metal Fragments**

-   If large enough, metal fragments in juice can cause injury when
    ingested.

> **Pesticides**

-   Acute or chronic exposure to unapproved pesticide residues can cause
    a variety of adverse health effects, some of which could be severe.

*The team determines the likelihood of a potential hazard occurring if
not properly controlled.*

> **Vegetative and Protozoan Enteric Pathogens**

-   Since the entire fruit will be extracted, there is a reasonable
    chance for the pathogen to be present in the extracted juice if it
    is present in or on the fruit.

**Patulin**

-   Available data indicates that if dropped apples or damaged apples
    are used to make juice, high levels of patulin may be reasonably
    expected to occur in the juice.

**Metal Fragments**

-   Without controls there is no means in the process by which metal
    fragments from grinding equipment would be removed from the juice.

**Pesticides**

-   Harmful pesticide residues in the juice are not likely because in
    U.S. produce, unapproved pesticide residues occur infrequently and
    the public health impact is typically not severe.

> Using the evaluation, determine if a potential hazard needs to be
> addressed in the HACCP plan.

The HACCP team decides that *E.coli* O157:H7, *Cryptosporidium parvum*,
patulin, and metal fragments are hazards that are reasonably likely to
occur in the apple juice.

> **3.0 Example Hazard Analysis for Fresh Orange Juice**

On the following page is an example of a "Hazard Analysis Summary Table
" for a fresh orange juice packed in plastic bottles for which the 5-log
pathogen reduction process is achieved through surface treatments of the
oranges. In the example, the process steps are simplified as compared
with what may be performed in an actual process, but all critical
process steps for this type of juice are included. A hazard
identification and evaluation exercise is not shown for this juice, but
for enteric pathogens, it would be similar to the one shown above for
apple juice, except that *Salmonella* species would be identified as the
pathogen of concern (the pertinent microorganism) because of the history
of illness outbreaks caused by *Salmonella* in orange juice. For
pesticides, the hazard identification and evaluation exercise would be
identical to the one shown for apple juice. Patulin is not a concern for
citrus juices. Metal fragments could occur in the orange juice, but they
would originate from the extraction equipment in this example, because
no grinding of fruit (as was performed in the apple juice process) is
performed in this process.

**Fresh Orange Juice**

**Procedures/Steps**

***Incoming Materials***

-   Locally grown tree-picked oranges of various varieties are received
    either directly from the field or from local cold storage
    facilities.

-   Packaging materials are delivered in clean, well-maintained and
    covered vehicles.

***Processing***

-   Fruit is visually inspected prior to unloading and placed into cold
    storage.

-   Fruit is washed prior to primary culling.

-   During primary culling, damaged fruit is culled out and disposed
    (primary cull step).

-   Fruit is rinsed with potable water.

-   Fruit is sprayed with sanitizer solution.

-   Fruit passes through a brush washer while being sprayed with a
    detergent/sanitizer.

-   Fruit is graded (secondary cull step).

-   Fruit is sprayed with a sanitizer solution and rinsed with potable
    water.

-   Juice is extracted with a pinpoint extractor.

-   Juice is chilled using a tube-in-shell heat exchanger.

-   Juice is batched in a chilled surge tank.

***Packaging and Shipping***

-   Juice is filled into HDPE blow-molded bottles of various sizes.
    Bottles are capped, passed through a metal detector, labeled, cased
    and stored refrigerated until shipping.

**Table 3. Hazard Analysis Summary Table (for Fresh Orange Juice)**

+----------+----------+------+------------+-------------------+-----+
| **(1)**  | **(2)**  | **(  | **(4)**    | **(5)**           | *   |
|          |          | 3)** |            |                   | *(6 |
| **Ing    | **       |      | **Justify  | **What            | )** |
| redient/ | Identify | *    | your       | preventative      |     |
| pr       | p        | *Are | decision   | measure(s) can be | *   |
| ocessing | otential | any  | for Column | applied to        | *Is |
| step**   | hazards  | p    | 3**        | prevent           | t   |
|          | int      | oten |            | /reduce/eliminate | his |
|          | roduced, | tial |            | the hazard?**     | s   |
|          | co       | foo  |            |                   | tep |
|          | ntrolled | d-sa |            |                   | a   |
|          | or       | fety |            |                   | Cr  |
|          | enhanced | haz  |            |                   | iti |
|          | at this  | ards |            |                   | cal |
|          | step**   | si   |            |                   | C   |
|          |          | gnif |            |                   | ont |
|          |          | ican |            |                   | rol |
|          |          | t?** |            |                   | Po  |
|          |          |      |            |                   | int |
|          |          | **   |            |                   | ?** |
|          |          | (Yes |            |                   |     |
|          |          | /No) |            |                   | **( |
|          |          | \*** |            |                   | Yes |
|          |          |      |            |                   | /No |
|          |          |      |            |                   | )** |
+----------+----------+------+------------+-------------------+-----+
| **1.     | B -      | Yes  | B --       | B -- Supplier     | Yes |
| Rec      | P        |      | History of | agreement         |     |
| eiving** | athogens | No   | outbreaks  | specifying that   | No  |
|          | (Sa      |      |            | only tree-picked  |     |
| **(raw   | lmonella | No   | C -- In    | fruit will be     | No  |
| fruit)** | spp. was |      | U.S.       | supplied.         |     |
|          | de       |      | produce,   |                   |     |
|          | termined |      | unapproved | C -- None         |     |
|          | to be    |      | pesticide  | required          |     |
|          | the      |      | residues   |                   |     |
|          | p        |      | occur      |                   |     |
|          | ertinent |      | in         |                   |     |
|          | microo   |      | frequently |                   |     |
|          | rganism) |      | and public |                   |     |
|          |          |      | health     |                   |     |
|          | C -      |      | impact is  |                   |     |
|          | Pe       |      | typically  |                   |     |
|          | sticides |      | not severe |                   |     |
|          |          |      |            |                   |     |
|          | P - None |      |            |                   |     |
+----------+----------+------+------------+-------------------+-----+
| **2.     | B - None | No   |            |                   | No  |
| Inspect, |          |      |            |                   |     |
| Wash,    | C --     |      |            |                   |     |
| Cold     | None     |      |            |                   |     |
| S        |          |      |            |                   |     |
| torage** | P --     |      |            |                   |     |
|          | None     |      |            |                   |     |
+----------+----------+------+------------+-------------------+-----+
| **3.     | B -      | Yes  | Culling to | Cull visually     | Yes |
| Primary  | P        |      | remove     | damaged fruit     |     |
| cull**   | athogens |      | damaged    |                   |     |
|          |          |      | fruit is   |                   |     |
|          |          |      | required   |                   |     |
|          |          |      | by the     |                   |     |
|          |          |      | HACCP      |                   |     |
|          |          |      | rule.      |                   |     |
+----------+----------+------+------------+-------------------+-----+

**B=Biological; C=Chemical; P=Physical**

\*For the purpose of this example hazard analysis, a "significant
hazard" is one that meets the definition of a hazard that is reasonably
likely to occur in § 120.7(a)(2) of the juice HACCP regulation, i.e., it
is one for which a prudent processor would establish controls, i.e., at
CCPs in his HACCP plan.

**Table 3. Hazard Analysis Summary Table (for Fresh Orange Juice) \--
Continued**

<table style="width:100%;">
<colgroup>
<col style="width: 11%" />
<col style="width: 11%" />
<col style="width: 7%" />
<col style="width: 13%" />
<col style="width: 20%" />
<col style="width: 6%" />
<col style="width: 6%" />
<col style="width: 6%" />
<col style="width: 6%" />
<col style="width: 6%" />
</colgroup>
<tbody>
<tr class="odd">
<td><p><strong>(1)</strong></p>
<p><strong>Ingredient/ processing step</strong></p></td>
<td><p><strong>(2)</strong></p>
<p><strong>Identify potential hazards introduced, controlled or enhanced
at this step</strong></p></td>
<td><p><strong>(3)</strong></p>
<p><strong>Are any potential food-safety hazards
significant?</strong></p>
<p><strong>(Yes/No)</strong></p></td>
<td><p><strong>(4)</strong></p>
<p><strong>Justify your decision for Column 3</strong></p></td>
<td><p><strong>(5)</strong></p>
<p><strong>What preventative measure(s) can be applied to
prevent/reduce/eliminate the hazard?</strong></p></td>
<td><p><strong>(6)</strong></p>
<p><strong>Is this step a Critical Control Point?</strong></p>
<p><strong>(Yes/No)</strong></p></td>
<td colspan="4"></td>
</tr>
<tr class="even">
<td><strong>4. Potable Water Rinse</strong></td>
<td><p>B - None</p>
<p>C – None</p>
<p>P – None</p></td>
<td>No</td>
<td></td>
<td></td>
<td>No</td>
<td colspan="4"></td>
</tr>
<tr class="odd">
<td><strong>5. Sanitize</strong></td>
<td>B - Pathogens</td>
<td>Yes</td>
<td>B – Adequate concentrations of sanitizer and contact time are
required to achieve pathogen reduction at this step</td>
<td><div class="Definition-Term">
<p>Sanitized wash used to achieve portion of cumulative 5-log pathogen
reduction</p>
</div></td>
<td>Yes</td>
<td colspan="4"></td>
</tr>
<tr class="even">
<td><strong>6. Brush Washing with Detergent/Sanitzer</strong></td>
<td>B - Pathogens</td>
<td>Yes</td>
<td>B – Adequate concentrations of sanitizer and contact time are
required to achieve pathogen reduction at this step</td>
<td>Sanitized wash used with brusher used to achieve portion of
cumulative 5-log pathogen reduction</td>
<td>Yes</td>
<td colspan="4"></td>
</tr>
<tr class="odd">
<td><strong>7. Grading (secondary cull)</strong></td>
<td><p>B - None</p>
<p>C – None</p>
<p>P – None</p></td>
<td>No</td>
<td></td>
<td></td>
<td>No</td>
<td colspan="4"></td>
</tr>
<tr class="even">
<td><strong>8. Re-sanitize</strong></td>
<td>B - Pathogens</td>
<td>Yes</td>
<td>B – Adequate concentrations of sanitizer and contact time are
required to achieve pathogen reduction at this step</td>
<td>Sanitized wash used to achieve portion of cumulative 5-log pathogen
reduction</td>
<td>Yes</td>
<td colspan="4"></td>
</tr>
<tr class="odd">
<td><p><strong>(1)</strong></p>
<p><strong>Ingredient/ processing step</strong></p></td>
<td><p><strong>(2)</strong></p>
<p><strong>Identify potential hazards introduced, controlled or enhanced
at this step</strong></p></td>
<td><p><strong>(3)</strong></p>
<p><strong>Are any potential food-safety hazards
significant?</strong></p>
<p><strong>(Yes/No)</strong></p></td>
<td><p><strong>(4)</strong></p>
<p><strong>Justify your decision for Column 3</strong></p></td>
<td><p><strong>(5)</strong></p>
<p><strong>What preventative measure(s) can be applied to
prevent/reduce/eliminate the hazard?</strong></p></td>
<td><p><strong>(6)</strong></p>
<p><strong>Is this step a Critical Control Point?</strong></p>
<p><strong>(Yes/No)</strong></p></td>
<td></td>
<td></td>
<td></td>
<td>No</td>
</tr>
<tr class="even">
<td><ol start="9" type="1">
<li><p><strong>Extract</strong></p></li>
</ol></td>
<td><p>B – Pathogens</p>
<p>P – Metal fragments</p></td>
<td><p>B – Yes</p>
<p>P - Yes</p></td>
<td><p>B – Use of pinpoint type extractor enables 5-log reduction by
ensuring that contamination of juice during extraction will not occur
from contact with peel.</p>
<p>P - Metal fragments from extraction equipment due to wear, metal
fatigue, and breakage may cause injury if ingested</p></td>
<td><div class="Definition-Term">
<p>P – Metal detector</p>
</div></td>
<td><p>No **</p>
<p>P - No – Controlled at metal detection step</p></td>
<td colspan="4"></td>
</tr>
<tr class="odd">
<td><ol start="10" type="1">
<li><p><strong>Chill</strong></p></li>
</ol></td>
<td><p>B - None</p>
<p>C – None</p>
<p>P – None</p></td>
<td>No</td>
<td></td>
<td></td>
<td>No</td>
<td colspan="4"></td>
</tr>
</tbody>
</table>

\*\* In this example hazard analysis, the extraction step was not
determined to be a CCP because the pinpoint extractor, which enables the
5-log pathogen reduction to be achieved, is the only extractor in the
facility. Should a different extractor be used in the facility, the
processor would have to re-validate the HACCP plan under § 120.11 (b).

**Table 3. Hazard Analysis Summary Table (for Fresh Orange Juice) \--
Continued**

+----------+----------+------+------------+-------------------+-----+
| **(1)**  | **(2)**  | **(  | **(4)**    | **(5)**           | *   |
|          |          | 3)** |            |                   | *(6 |
| **Ing    | **       |      | **Justify  | **What            | )** |
| redient/ | Identify | *    | your       | preventative      |     |
| pr       | p        | *Are | decision   | measure(s) can be | *   |
| ocessing | otential | any  | for Column | applied to        | *Is |
| step**   | hazards  | p    | 3**        | prevent           | t   |
|          | int      | oten |            | /reduce/eliminate | his |
|          | roduced, | tial |            | the hazard?**     | s   |
|          | co       | foo  |            |                   | tep |
|          | ntrolled | d-sa |            |                   | a   |
|          | or       | fety |            |                   | Cr  |
|          | enhanced | haz  |            |                   | iti |
|          | at this  | ards |            |                   | cal |
|          | step**   | si   |            |                   | C   |
|          |          | gnif |            |                   | ont |
|          |          | ican |            |                   | rol |
|          |          | t?** |            |                   | Po  |
|          |          |      |            |                   | int |
|          |          | **(Y |            |                   | ?** |
|          |          | es/N |            |                   |     |
|          |          | o)** |            |                   | **( |
|          |          |      |            |                   | Yes |
|          |          |      |            |                   | /No |
|          |          |      |            |                   | )** |
+----------+----------+------+------------+-------------------+-----+
| 11.      | B - None | No   |            |                   | No  |
|  **Batch |          |      |            |                   |     |
|     in   | C --     |      |            |                   |     |
|          | None     |      |            |                   |     |
|  chilled |          |      |            |                   |     |
|          | P --     |      |            |                   |     |
|    surge | None     |      |            |                   |     |
|          |          |      |            |                   |     |
|   tank** |          |      |            |                   |     |
+----------+----------+------+------------+-------------------+-----+
| **12.    | B - None | No   |            |                   | No  |
| Package, |          |      |            |                   |     |
| cap**    | C --     |      |            |                   |     |
|          | None     |      |            |                   |     |
|          |          |      |            |                   |     |
|          | P --     |      |            |                   |     |
|          | None     |      |            |                   |     |
+----------+----------+------+------------+-------------------+-----+
| **13.    | P --     | Yes  | Eliminates | Metal detector    | Yes |
| Metal    | Metal    |      | metal      |                   |     |
| De       | f        |      | fragments  |                   |     |
| tector** | ragments |      | introduced |                   |     |
|          |          |      | at         |                   |     |
|          |          |      | extraction |                   |     |
|          |          |      | step       |                   |     |
+----------+----------+------+------------+-------------------+-----+
| **14.    | B - None | No   |            |                   | No  |
| Label,   |          |      |            |                   |     |
| case,    | C --     |      |            |                   |     |
| pal      | None     |      |            |                   |     |
| letize** |          |      |            |                   |     |
|          | P --     |      |            |                   |     |
|          | None     |      |            |                   |     |
+----------+----------+------+------------+-------------------+-----+
| **15.    | B - None | No   |            |                   | No  |
| Store,   |          |      |            |                   |     |
| ship**   | C --     |      |            |                   |     |
|          | None     |      |            |                   |     |
|          |          |      |            |                   |     |
|          | P --     |      |            |                   |     |
|          | None     |      |            |                   |     |
+----------+----------+------+------------+-------------------+-----+

# 4.0 Example Hazard Analysis for Not-from-Concentrate Pasteurized Orange Juice

On the following page is an example of a "Hazard Analysis Summary Table
" for a not-from-concentrate pasteurized orange juice packed in cartons.
The orange juice is derived from oranges that are extracted at the
facility, and from un-pasteurized juice received in tankers. FDA permits
un-pasteurized juice to be shipped in bulk if the processor receives
assurance that another processor will treat the juice to achieve the
5-log pathogen reduction in the facility where final packaging is to be
performed (see "The Juice HACCP Regulation Questions and Answers," at
the web address given in section I. B above).

In the example, the process steps are simplified as compared with what
may be performed in an actual process, but all critical process steps
for this type of juice are included.

A hazard identification and evaluation exercise is not shown for this
juice, but for enteric pathogens, it would be similar to the one shown
above for apple juice, except that *Salmonella* species would be
identified as the pathogen of concern (the pertinent microorganism)
because of the history of illness outbreaks caused by *Salmonella* in
orange juice. For pesticides, the hazard identification and evaluation
exercise would be identical to the one shown for apple juice. Patulin is
not a concern for citrus juices.

Metal fragments could occur in the orange juice, but they would
originate from the extraction equipment in this example, because no
grinding of fruit (as was performed in the apple juice process) is
performed in this process. Metal fragments in the un-pasteurized juice
received in tankers would be handled under the HACCP Plan of the
processor of that juice (see section V. D. 1.3).

**Not-from-Concentrate Pasteurized Orange Juice**

# 

# Procedures/Steps

# *Incoming materials*

-   Locally grown fresh oranges of various varieties are received
    directly from the field. Un-pasteurized juice is also received in
    tankers.

-   Packaging materials are delivered in clean, well-maintained and
    covered vehicles.

######### Processing

-   At fruit receiving/bin staging, fruit is unloaded, de-stemmed.

-   Fruit is rinsed with potable water.

-   Fruit is graded (initial culling)

-   Graded fruit is stored in bins.

-   Upon removal from bins, fruit is rinsed and then brush washed with
    detergent/sanitizer.

-   Fruit is rinsed with potable water.

-   Fruit is graded (final culling).

-   Fruit is sized and the juice is extracted.

-   Pulp is removed from the extracted juice by finishers and pumped to
    a jacketed surge tank.

-   Incoming juice (un-pasteurized) from tankers is pumped to a jacketed
    storage tank.

-   Juices are then blended in a surge tank for pasteurization.

-   Juice is pasteurized using a tube-in-shell heat exchanger.

-   Pasteurized juice is chilled and pumped to a jacketed surge tank.

######### Packaging and Shipping

-   Chilled pasteurized juice is screened and filled into cartons

-   Cartons are sealed, coded, cased, palletized, and put into
    refrigerated storage.

-   Products are shipped in clean, well-maintained refrigerated
    tractor-trailers.

# 

**Table 4. Hazard Analysis Summary Table (for Not-from-concentrate
Pasteurized Orange Juice)**

+----------+----------+------+------------+-------------------+-----+
| **(1)**  | **(2)**  | **(  | **(4)**    | **(5)**           | *   |
|          |          | 3)** |            |                   | *(6 |
| **Ing    | **       |      | **Justify  | **What            | )** |
| redient/ | Identify | *    | your       | preventative      |     |
| pr       | p        | *Are | decision   | measure(s) can be | *   |
| ocessing | otential | any  | for Column | applied to        | *Is |
| step**   | hazards  | p    | 3**        | prevent           | t   |
|          | int      | oten |            | /reduce/eliminate | his |
|          | roduced, | tial |            | the hazard?**     | s   |
|          | co       | foo  |            |                   | tep |
|          | ntrolled | d-sa |            |                   | a   |
|          | or       | fety |            |                   | Cr  |
|          | enhanced | haz  |            |                   | iti |
|          | at this  | ards |            |                   | cal |
|          | step**   | si   |            |                   | C   |
|          |          | gnif |            |                   | ont |
|          |          | ican |            |                   | rol |
|          |          | t?** |            |                   | Po  |
|          |          |      |            |                   | int |
|          |          | **   |            |                   | ?** |
|          |          | (Yes |            |                   |     |
|          |          | /No) |            |                   | **( |
|          |          | \*** |            |                   | Yes |
|          |          |      |            |                   | /No |
|          |          |      |            |                   | )** |
+----------+----------+------+------------+-------------------+-----+
| **1.     | B -      | Yes  | B --       | B -- Controlled   | No  |
| Rec      | P        |      | History of | at the            |     |
| eiving/S | athogens | No   | outbreaks  | pasteurization    | No  |
| taging** | (Sa      |      |            | step.             |     |
|          | lmonella |      | C -- In    |                   |     |
| **(raw   | spp.     |      | U.S.       |                   |     |
| fruit)** | were     |      | produce,   |                   |     |
|          | de       |      | unapproved |                   |     |
|          | termined |      | pesticide  |                   |     |
|          | to be    |      | residues   |                   |     |
|          | the      |      | occur      |                   |     |
|          | p        |      | in         |                   |     |
|          | ertinent |      | frequently |                   |     |
|          | microo   |      | and public |                   |     |
|          | rganism) |      | health     |                   |     |
|          |          |      | impact is  |                   |     |
|          | C -      |      | typically  |                   |     |
|          | Pe       |      | not severe |                   |     |
|          | sticides |      |            |                   |     |
|          |          |      |            |                   |     |
|          | P - None |      |            |                   |     |
+----------+----------+------+------------+-------------------+-----+
| **2.     | B - None | No   |            |                   | No  |
| Dest     |          |      |            |                   |     |
| emming** | C --     |      |            |                   |     |
|          | None     |      |            |                   |     |
|          |          |      |            |                   |     |
|          | P --     |      |            |                   |     |
|          | None     |      |            |                   |     |
+----------+----------+------+------------+-------------------+-----+
| **3.     | B - None | No   |            |                   | No  |
| Rinse**  |          |      |            |                   |     |
|          | C --     |      |            |                   |     |
|          | None     |      |            |                   |     |
|          |          |      |            |                   |     |
|          | P --     |      |            |                   |     |
|          | None     |      |            |                   |     |
+----------+----------+------+------------+-------------------+-----+

**Table 4. Hazard Analysis Summary Table (for Not-from-concentrate
Pasteurized Orange Juice) \-- Continued**

+----------+----------+------+------------+-------------------+-----+
| **(1)**  | **(2)**  | **(  | **(4)**    | **(5)**           | *   |
|          |          | 3)** |            |                   | *(6 |
| **Ing    | **       |      | **Justify  | **What            | )** |
| redient/ | Identify | *    | your       | preventative      |     |
| pr       | p        | *Are | decision   | measure(s) can be | *   |
| ocessing | otential | any  | for Column | applied to        | *Is |
| step**   | hazards  | p    | 3**        | prevent           | t   |
|          | int      | oten |            | /reduce/eliminate | his |
|          | roduced, | tial |            | the hazard?**     | s   |
|          | co       | foo  |            |                   | tep |
|          | ntrolled | d-sa |            |                   | a   |
|          | or       | fety |            |                   | Cr  |
|          | enhanced | haz  |            |                   | iti |
|          | at this  | ards |            |                   | cal |
|          | step**   | si   |            |                   | C   |
|          |          | gnif |            |                   | ont |
|          |          | ican |            |                   | rol |
|          |          | t?** |            |                   | Po  |
|          |          |      |            |                   | int |
|          |          | **(Y |            |                   | ?** |
|          |          | es/N |            |                   |     |
|          |          | o)** |            |                   | **( |
|          |          |      |            |                   | Yes |
|          |          |      |            |                   | /No |
|          |          |      |            |                   | )** |
+----------+----------+------+------------+-------------------+-----+
| **4.     | B - None | No   |            |                   | No  |
| Primary  |          |      |            |                   |     |
| C        | C --     |      |            |                   |     |
| ulling** | None     |      |            |                   |     |
|          |          |      |            |                   |     |
|          | P --     |      |            |                   |     |
|          | None     |      |            |                   |     |
+----------+----------+------+------------+-------------------+-----+
| **5. Bin | B - None | No   |            |                   | No  |
| S        |          |      |            |                   |     |
| torage** | C --     |      |            |                   |     |
|          | None     |      |            |                   |     |
|          |          |      |            |                   |     |
|          | P --     |      |            |                   |     |
|          | None     |      |            |                   |     |
+----------+----------+------+------------+-------------------+-----+
| **6.     | B - None | No   |            |                   | No  |
| Rinse    |          |      |            |                   |     |
| and      | C --     |      |            |                   |     |
| Brush    | None     |      |            |                   |     |
| Wash     |          |      |            |                   |     |
| w/D      | P --     |      |            |                   |     |
| etergent | None     |      |            |                   |     |
| Sa       |          |      |            |                   |     |
| nitzer** |          |      |            |                   |     |
+----------+----------+------+------------+-------------------+-----+
| **7.     | B - None | No   |            |                   | No  |
| Potable  |          |      |            |                   |     |
| Water    | C --     |      |            |                   |     |
| Rinse**  | None     |      |            |                   |     |
|          |          |      |            |                   |     |
|          | P --     |      |            |                   |     |
|          | None     |      |            |                   |     |
+----------+----------+------+------------+-------------------+-----+
| **8.     | B - None | No   |            |                   | No  |
| Final    |          |      |            |                   |     |
| C        | C --     |      |            |                   |     |
| ulling** | None     |      |            |                   |     |
|          |          |      |            |                   |     |
|          | P --     |      |            |                   |     |
|          | None     |      |            |                   |     |
+----------+----------+------+------------+-------------------+-----+
| **9.     | B - None | No   |            |                   | No  |
| Sizing** |          |      |            |                   |     |
|          | C --     |      |            |                   |     |
|          | None     |      |            |                   |     |
|          |          |      |            |                   |     |
|          | P --     |      |            |                   |     |
|          | None     |      |            |                   |     |
+----------+----------+------+------------+-------------------+-----+

+----------+----------+------+------------+-------------------+-----+
| **(1)**  | **(2)**  | **(  | **(4)**    | **(5)**           | *   |
|          |          | 3)** |            |                   | *(6 |
| **Ing    | **       |      | **Justify  | **What            | )** |
| redient/ | Identify | *    | your       | preventative      |     |
| pr       | p        | *Are | decision   | measure(s) can be | *   |
| ocessing | otential | any  | for Column | applied to        | *Is |
| step**   | hazards  | p    | 3**        | prevent           | t   |
|          | int      | oten |            | /reduce/eliminate | his |
|          | roduced, | tial |            | the hazard?**     | s   |
|          | co       | foo  |            |                   | tep |
|          | ntrolled | d-sa |            |                   | a   |
|          | or       | fety |            |                   | Cr  |
|          | enhanced | haz  |            |                   | iti |
|          | at this  | ards |            |                   | cal |
|          | step**   | si   |            |                   | C   |
|          |          | gnif |            |                   | ont |
|          |          | ican |            |                   | rol |
|          |          | t?** |            |                   | Po  |
|          |          |      |            |                   | int |
|          |          | **(Y |            |                   | ?** |
|          |          | es/N |            |                   |     |
|          |          | o)** |            |                   | **( |
|          |          |      |            |                   | Yes |
|          |          |      |            |                   | /No |
|          |          |      |            |                   | )** |
+----------+----------+------+------------+-------------------+-----+
| **10.    | B - None | Yes  | Metal      | P -- Controlled   | No  |
| Extr     |          |      | fragments  | at screen step    | --  |
| action** | C --     |      | from       |                   | c   |
|          | None     |      | extraction |                   | ont |
|          |          |      | equipment  |                   | rol |
|          | P --     |      | due to     |                   | led |
|          | Metal    |      | wear,      |                   | at  |
|          | f        |      | metal      |                   | scr |
|          | ragments |      | fatigue,   |                   | een |
|          |          |      | and        |                   | s   |
|          |          |      | breakage   |                   | tep |
|          |          |      | may cause  |                   |     |
|          |          |      | injury if  |                   |     |
|          |          |      | ingested   |                   |     |
+----------+----------+------+------------+-------------------+-----+
| **11.    | B -      | Yes  | History of | B -- Controlled   | No  |
| Receipt  | Pa       |      | outbreaks  | at the            |     |
| of       | thogens, |      |            | pasteurization    |     |
| un-pas   | Sa       |      |            | step              |     |
| teurized | lmonella |      |            |                   |     |
| juice in | spp.     |      |            |                   |     |
| t        |          |      |            |                   |     |
| ankers** | C --     |      |            |                   |     |
|          | None     |      |            |                   |     |
|          |          |      |            |                   |     |
|          | P --     |      |            |                   |     |
|          | None --  |      |            |                   |     |
|          | (metal   |      |            |                   |     |
|          | f        |      |            |                   |     |
|          | ragments |      |            |                   |     |
|          | are      |      |            |                   |     |
|          | handled  |      |            |                   |     |
|          | under    |      |            |                   |     |
|          | s        |      |            |                   |     |
|          | hipper's |      |            |                   |     |
|          | HACCP    |      |            |                   |     |
|          | plan)    |      |            |                   |     |
+----------+----------+------+------------+-------------------+-----+
| 12. *    | B - None | No   |            |                   | No  |
| *Blend** |          |      |            |                   |     |
|          | C --     |      |            |                   |     |
|          | None     |      |            |                   |     |
|          |          |      |            |                   |     |
|          | P --     |      |            |                   |     |
|          | None     |      |            |                   |     |
+----------+----------+------+------------+-------------------+-----+
| 12       | B - None | No   |            |                   | No  |
| . **Past |          |      |            |                   |     |
| eurize** | C --     |      |            |                   |     |
|          | None     |      |            |                   |     |
|          |          |      |            |                   |     |
|          | P --     |      |            |                   |     |
|          | None     |      |            |                   |     |
+----------+----------+------+------------+-------------------+-----+

**Table 4. Hazard Analysis Summary Table (for Not-from-concentrate
Pasteurized Orange Juice) \-- Continued**

+----------+----------+------+------------+-------------------+-----+
| **(1)**  | **(2)**  | **(  | **(4)**    | **(5)**           | *   |
|          |          | 3)** |            |                   | *(6 |
| **Ing    | **       |      | **Justify  | **What            | )** |
| redient/ | Identify | *    | your       | preventative      |     |
| pr       | p        | *Are | decision   | measure(s) can be | *   |
| ocessing | otential | any  | for Column | applied to        | *Is |
| step**   | hazards  | p    | 3**        | prevent           | t   |
|          | int      | oten |            | /reduce/eliminate | his |
|          | roduced, | tial |            | the hazard?**     | s   |
|          | co       | foo  |            |                   | tep |
|          | ntrolled | d-sa |            |                   | a   |
|          | or       | fety |            |                   | Cr  |
|          | enhanced | haz  |            |                   | iti |
|          | at this  | ards |            |                   | cal |
|          | step**   | si   |            |                   | C   |
|          |          | gnif |            |                   | ont |
|          |          | ican |            |                   | rol |
|          |          | t?** |            |                   | Po  |
|          |          |      |            |                   | int |
|          |          | **(Y |            |                   | ?** |
|          |          | es/N |            |                   |     |
|          |          | o)** |            |                   | **( |
|          |          |      |            |                   | Yes |
|          |          |      |            |                   | /No |
|          |          |      |            |                   | )** |
+----------+----------+------+------------+-------------------+-----+
| **14.    | B - None | No   |            |                   | No  |
| Chill**  |          |      |            |                   |     |
|          | C --     |      |            |                   |     |
|          | None     |      |            |                   |     |
|          |          |      |            |                   |     |
|          | P --     |      |            |                   |     |
|          | None     |      |            |                   |     |
+----------+----------+------+------------+-------------------+-----+
| **15.    | B - None | No   |            |                   | No  |
| Surge    |          |      |            |                   |     |
| Tank**   | C --     |      |            |                   |     |
|          | None     |      |            |                   |     |
|          |          |      |            |                   |     |
|          | P --     |      |            |                   |     |
|          | None     |      |            |                   |     |
+----------+----------+------+------------+-------------------+-----+
| **16.    | B - None | Yes  | Eliminates | Screen            | Yes |
| Screen** |          |      | metal      |                   |     |
|          | C --     |      | fragments  |                   |     |
|          | None     |      | introduced |                   |     |
|          |          |      | at         |                   |     |
|          | P --     |      | extraction |                   |     |
|          | Metal    |      | step       |                   |     |
|          | f        |      |            |                   |     |
|          | ragments |      |            |                   |     |
+----------+----------+------+------------+-------------------+-----+
| **17.    | B - None | No   |            |                   | No  |
| Fill in  |          |      |            |                   |     |
| C        | C --     |      |            |                   |     |
| artons** | None     |      |            |                   |     |
|          |          |      |            |                   |     |
|          | P --     |      |            |                   |     |
|          | None     |      |            |                   |     |
+----------+----------+------+------------+-------------------+-----+
| **18.    | B - None | No   |            |                   | No  |
| Seal     |          |      |            |                   |     |
| C        | C --     |      |            |                   |     |
| artons** | None     |      |            |                   |     |
|          |          |      |            |                   |     |
|          | P --     |      |            |                   |     |
|          | None     |      |            |                   |     |
+----------+----------+------+------------+-------------------+-----+

+----------+----------+------+------------+-------------------+-----+
| **(1)**  | **(2)**  | **(  | **(4)**    | **(5)**           | *   |
|          |          | 3)** |            |                   | *(6 |
| **Ing    | **       |      | **Justify  | **What            | )** |
| redient/ | Identify | *    | your       | preventative      |     |
| pr       | p        | *Are | decision   | measure(s) can be | *   |
| ocessing | otential | any  | for Column | applied to        | *Is |
| step**   | hazards  | p    | 3**        | prevent           | t   |
|          | int      | oten |            | /reduce/eliminate | his |
|          | roduced, | tial |            | the hazard?**     | s   |
|          | co       | foo  |            |                   | tep |
|          | ntrolled | d-sa |            |                   | a   |
|          | or       | fety |            |                   | Cr  |
|          | enhanced | haz  |            |                   | iti |
|          | at this  | ards |            |                   | cal |
|          | step**   | si   |            |                   | C   |
|          |          | gnif |            |                   | ont |
|          |          | ican |            |                   | rol |
|          |          | t?** |            |                   | Po  |
|          |          |      |            |                   | int |
|          |          | **(Y |            |                   | ?** |
|          |          | es/N |            |                   |     |
|          |          | o)** |            |                   | **( |
|          |          |      |            |                   | Yes |
|          |          |      |            |                   | /No |
|          |          |      |            |                   | )** |
+----------+----------+------+------------+-------------------+-----+
| **19.    | B - None | No   |            |                   | No  |
| Code,    |          |      |            |                   |     |
| case,    | C --     |      |            |                   |     |
| pal      | None     |      |            |                   |     |
| letize** |          |      |            |                   |     |
|          | P --     |      |            |                   |     |
|          | None     |      |            |                   |     |
+----------+----------+------+------------+-------------------+-----+
| **20.    | B - None | No   |            |                   | No  |
| Store**  |          |      |            |                   |     |
|          | C --     |      |            |                   |     |
|          | None     |      |            |                   |     |
|          |          |      |            |                   |     |
|          | P --     |      |            |                   |     |
|          | None     |      |            |                   |     |
+----------+----------+------+------------+-------------------+-----+
| **21.    | B - None | No   |            |                   | No  |
| Ship**   |          |      |            |                   |     |
|          | C --     |      |            |                   |     |
|          | None     |      |            |                   |     |
|          |          |      |            |                   |     |
|          | P --     |      |            |                   |     |
|          | None     |      |            |                   |     |
+----------+----------+------+------------+-------------------+-----+

# B. HACCP Plan Examples 

Included in this section are three examples of how to write components
of a HACCP plan. The first example is for a pasteurized refrigerated
apple juice, the second example is for a fresh orange juice and the
third is for a not-from-concentrate pasteurized orange juice.

**1.0 Example HACCP Plan for Pasteurized Refrigerated Apple Juice**

The following table represents excerpts from a Summary HACCP Plan for a
pasteurized refrigerated apple juice packed in plastic bottles. For this
example, it is assumed that the pasteurization process is performed
using a continuous (non-batch) system with a positive displacement
(constant flow) timing pump. (See Discussion of Pasteurization Equipment
in section V.C.5.11.) The excerpts included in this example are for the
control of enteric pathogens, patulin and metal fragments. An actual
HACCP plan for such a product might be more detailed, but the summary
table format lists all of the elements that would be included in the
plan.

**Table 5. Excerpts from Summary HACCP Plan (For Pasteurized
Refrigerated Apple Juice)**

<table>
<colgroup>
<col style="width: 7%" />
<col style="width: 7%" />
<col style="width: 9%" />
<col style="width: 7%" />
<col style="width: 7%" />
<col style="width: 9%" />
<col style="width: 7%" />
<col style="width: 16%" />
<col style="width: 18%" />
<col style="width: 9%" />
</colgroup>
<tbody>
<tr class="odd">
<td rowspan="2"><p><strong>Critical Control</strong></p>
<p><strong>Point</strong></p>
<p><strong>(CCP)</strong></p></td>
<td rowspan="2"><strong>Hazard(s)</strong></td>
<td rowspan="2"><strong>Critical Limits</strong></td>
<td colspan="4"><strong>Monitoring</strong></td>
<td rowspan="2"><strong>Corrective Action</strong></td>
<td rowspan="2"><strong>Verification</strong></td>
<td rowspan="2"><strong>Record keeping</strong></td>
</tr>
<tr class="even">
<td><h2 id="section-15"></h2>
<h2 id="what" class="unnumbered">What</h2></td>
<td><h2 id="section-16"></h2>
<h2 id="how" class="unnumbered">How</h2></td>
<td><h2 id="section-17"></h2>
<h2 id="frequency" class="unnumbered">Frequency</h2></td>
<td><h2 id="section-18"></h2>
<h1 id="who">Who</h1></td>
</tr>
<tr class="odd">
<td><p>CCP1</p>
<p>Receiving</p></td>
<td>Patulin</td>
<td>A supplier guarantee specifying that the shipment includes only
apples harvested to exclude fallen fruit.</td>
<td>Ensure supplier guarantee exists for each incoming shipment of
fruit.</td>
<td>Supplier guarantee is visually confirmed.</td>
<td>Each incoming fruit shipment</td>
<td>Receiving manager</td>
<td><div class="Definition-Term">
<p>Reject fruit if not accompanied by supplier guarantee.</p>
</div></td>
<td><p>Review monitoring corrective action and verification records
within one week of preparation</p>
<p>Audit the supplier periodically for adherence to guarantee</p>
<p>Periodically test juice for patulin levels</p></td>
<td><p>Supplier guarantee</p>
<p>Receiving log</p>
<p>Supplier audit report</p>
<p>Patulin test results</p></td>
</tr>
<tr class="even">
<td><p>CCP 2</p>
<p>Culling</p></td>
<td>Patulin</td>
<td>Undamaged apples<a href="#fn1" class="footnote-ref" id="fnref1"
role="doc-noteref"><sup>1</sup></a></td>
<td>Moldy, rotten, bruised or otherwise damaged apples</td>
<td>Visual inspection</td>
<td>Continuous</td>
<td>Culling inspector</td>
<td><p>Stop belt and remove damaged fruit</p>
<p>AND</p>
<p>Adjust belt speed if necessary</p></td>
<td><p>Review monitoring, corrective action, and verification records
within one week of preparation</p>
<p>Periodically test juice for patulin levels</p></td>
<td><p>Culling log</p>
<p>Patulin test results</p></td>
</tr>
<tr class="odd">
<td><p>CCP 3</p>
<p>Screen</p></td>
<td>Metal inclusion</td>
<td>Screen is operational.</td>
<td>Integrity of screen</td>
<td>Visual</td>
<td>Daily</td>
<td><p>Production</p>
<p>Employee</p></td>
<td><p>Segregate product and rework to eliminate metal pieces, or run
product through metal detector, or</p>
<p>divert to nonfood use, or destroy</p>
<p>AND</p>
<p>Replace screen.</p></td>
<td><p>Calibrate screen to ensure metal pieces 7 mm or greater do not
pass screen, semi-annually.</p>
<p>Review monitoring corrective action and verification records within
one week of preparation</p></td>
<td><p>Screen integrity log</p>
<p>Screen calibration log</p></td>
</tr>
<tr class="even">
<td><p>CCP 4</p>
<p>Pasteurize</p></td>
<td><em>E. coli</em> O157:H7 and <em>Cryptosporidium parvum</em></td>
<td><p>Minimum</p>
<p>160°F and 6 seconds (provides a 5-log reduction)</p></td>
<td><p>1.Tempera-</p>
<p>ture of juice</p>
<p>2. Flow rate</p></td>
<td><p>1.Tempera-ture recorder</p>
<p>2. Visual check of positive displacement pump setting</p></td>
<td><p>Continuous monitoring with visual check hourly</p>
<p>Daily</p></td>
<td><p>Pasteurizer</p>
<p>operator</p>
<p>Pasteurizer operator</p></td>
<td><p>Segregate and hold affected product for evaluation or destroy or
divert to nonfood use</p>
<p>AND</p>
<p>Adjust pasteurizer to achieve the critical limit.</p></td>
<td><p>Documentation of process establishment;</p>
<p>Check the accuracy of the temperature recording device (TRD) against
a mercury and glass thermometer daily;</p>
<p>Calibrate the mercury and glass (MIG) thermometer annually;</p>
<p>Flow rate test and resealing of pump speed monthly;</p>
<p>Review monitoring, corrective action, and verification records within
one week of preparation.</p></td>
<td><p>Operator’s log</p>
<p>Recorder</p>
<p>Thermometer Chart</p>
<p>TRD, MIG and pump check and calibration records</p></td>
</tr>
</tbody>
</table>
<aside id="footnotes" class="footnotes footnotes-end-of-document"
role="doc-endnotes">
<hr />
<ol>
<li id="fn1"><p>In practice, this processor should establish visual
criteria for what constitutes a damaged apple that should be culled. The
criteria should be established based upon validation data showing that
juice made from apples culled using the criteria do not contain
unacceptable levels of patulin.<a href="#fnref1" class="footnote-back"
role="doc-backlink">↩︎</a></p></li>
</ol>
</aside>

**2.0 Example HACCP Plan for Fresh Orange Juice**

The following table represents excerpts from a HACCP plan for fresh
orange juice. Under the juice HACCP regulation, surface treatment of the
peel can be used to achieve all or part of the 5-log pathogen reduction
for citrus juices. Table 6 shows six critical control points (steps 1,
3, 5, 6, 8 and 13 in the summary table shown in the Hazard Analysis
example for this juice) for ensuring that the incoming fruit is properly
culled, that the orange peel is effectively sanitized to achieve a
cumulative 5-log pathogen reduction before extracting the juice, and
that any juice packages with metal fragments are rejected by the metal
detector.

Processing steps other than those cited as critical control points are
also important to ensuring a safe juice. For example, the effectiveness
of the pathogen reduction process depends upon ensuring that juice is
not contaminated by any pathogens that may be present on the peel during
the extraction operation. For this hypothetical process, it was assumed
that the juice was extracted using the pinpoint extraction process,
which allows for virtually no contact of the juice with the peel during
the extraction operation.

2.  **Example HACCP Plan for Fresh Orange Juice**

# Table 6. Excerpts from Summary HACCP Plan 

<table>
<colgroup>
<col style="width: 10%" />
<col style="width: 10%" />
<col style="width: 10%" />
<col style="width: 8%" />
<col style="width: 8%" />
<col style="width: 12%" />
<col style="width: 9%" />
<col style="width: 10%" />
<col style="width: 11%" />
<col style="width: 9%" />
</colgroup>
<tbody>
<tr class="odd">
<td rowspan="2"><strong>Critical Control Point (CCP)</strong></td>
<td rowspan="2"><strong>Hazard(s)</strong></td>
<td rowspan="2"><strong>Critical Limits</strong></td>
<td colspan="4"><strong>Monitoring</strong></td>
<td rowspan="2"><strong>Corrective Action</strong></td>
<td rowspan="2"><strong>Verification</strong></td>
<td rowspan="2"><strong>Record keeping</strong></td>
</tr>
<tr class="even">
<td><h2 id="what-1" class="unnumbered">What</h2></td>
<td><h2 id="how-1" class="unnumbered">How</h2></td>
<td><h2 id="frequency-1" class="unnumbered">Frequency</h2></td>
<td><h2 id="who-1" class="unnumbered">Who</h2></td>
</tr>
<tr class="odd">
<td><p>CCP 1</p>
<p>(biological)</p>
<p>Receiving</p></td>
<td><p>Pathogens--</p>
<p><em>Salmonella</em></p></td>
<td>A supplier guarantee specifying that the shipment includes only
tree-picked oranges.</td>
<td>Ensure supplier guarantee exists for each incoming shipment of
fruit.</td>
<td>Supplier guarantee is visually confirmed.</td>
<td><div class="Definition-Term">
<p>Each incoming fruit shipment</p>
</div></td>
<td>Receiving manager</td>
<td><div class="Definition-Term">
<p>Reject fruit if not accompanied by supplier guarantee.</p>
</div></td>
<td><p>Review monitoring corrective action and verification records
within one week of preparation.</p>
<p>Audit the supplier annually for adherence to guarantee.</p></td>
<td><p>Supplier guarantee</p>
<p>Receiving log</p>
<p>Supplier audit report</p></td>
</tr>
<tr class="even">
<td><p>CCP 2</p>
<p>(biological)</p>
<p>Primary cull</p></td>
<td>Pathogens- <em>Salmonella</em></td>
<td><div class="Definition-Term">
<p>Undamaged fruit</p>
</div></td>
<td>Damaged peel, e.g., punctures, cuts, splitting, rot, mold</td>
<td>Visual inspection</td>
<td>Continuous</td>
<td>Culling inspector</td>
<td><p>Stop belt and remove damaged fruit.</p>
<p>AND</p>
<p>Adjust belt speed if necessary.</p></td>
<td>Review monitoring, corrective action, and verification records
within one week of preparation.</td>
<td>Culling log.</td>
</tr>
</tbody>
</table>

<table>
<colgroup>
<col style="width: 10%" />
<col style="width: 10%" />
<col style="width: 10%" />
<col style="width: 8%" />
<col style="width: 8%" />
<col style="width: 12%" />
<col style="width: 9%" />
<col style="width: 10%" />
<col style="width: 11%" />
<col style="width: 9%" />
</colgroup>
<tbody>
<tr class="odd">
<td><p>CCP 3</p>
<p>(biological)</p>
<p>Sanitize</p></td>
<td><p>Pathogens--</p>
<p><em>Salmonella</em></p></td>
<td><p>1. Minimum of 200ppm of available chlorine</p>
<p>2. 30 sec contact time</p></td>
<td><p>1. Free available chlorine</p>
<p>2. Belt speed (RPM)</p></td>
<td><p>1. Low concentration alarm</p>
<p>2. Measure belt marking speed with stopwatch</p></td>
<td><p>1. Continuous</p>
<p>2. Daily</p></td>
<td><p>1. Operator</p>
<p>2. Operator</p></td>
<td><p>1. Stop line, adjust sanitizer strength to achieve critical
limit, AND segregate and hold affected product for evaluation or destroy
or divert to nonfood use</p>
<p>Stop line, adjust belt speed to achieve critical limit, AND segregate
and hold affected product for evaluation or destroy or divert to nonfood
use</p></td>
<td><p>Test alarm daily</p>
<p>Review monitoring corrective action and verification records within
one week of preparation.</p>
<p>Review of required testing for biotype 1 E. coli.</p></td>
<td><p>Log of alarm test, belt speed test</p>
<p><em>E. coli</em> test results</p></td>
</tr>
</tbody>
</table>

<table>
<colgroup>
<col style="width: 10%" />
<col style="width: 10%" />
<col style="width: 10%" />
<col style="width: 8%" />
<col style="width: 8%" />
<col style="width: 12%" />
<col style="width: 9%" />
<col style="width: 10%" />
<col style="width: 11%" />
<col style="width: 9%" />
</colgroup>
<tbody>
<tr class="odd">
<td><p>CCP 4</p>
<p>(biological) Brush wash with Detergent/Sanitizer</p></td>
<td><p>Pathogens--</p>
<p><em>Salmonella</em></p></td>
<td><p>Minimum of 200ppm of available chlorine</p>
<p>Contact time ___ seconds (processor should include appropriate entry
in HACCP plan)</p></td>
<td><p>Strength of sanitizer</p>
<p>Belt speed ___ RPM</p>
<p>(processor should include appropriate entry in HACCP plan)</p></td>
<td>Chlorine test kit or equivalent</td>
<td>At the beginning of the operation and hourly thereafter</td>
<td>Operator</td>
<td>Stop line, adjust sanitizer strength to achieve critical limit, AND
segregate and hold affected product for evaluation or destroy or divert
to nonfood use.</td>
<td><p>Review monitoring, corrective action, and verification records
within one week of preparation.</p>
<p>Review of required testing for biotype 1 E. coli.</p></td>
<td><p>Operator test log</p>
<p><em>E. coli</em> test results</p></td>
</tr>
<tr class="even">
<td><p>CCP 5</p>
<p>(biological)</p>
<p>Re-sanitize</p></td>
<td><p>Pathogens--</p>
<p><em>Salmonella</em></p></td>
<td><p>Minimum of 200ppm of available chlorine</p>
<p>Contact time ___ seconds (processor should include appropriate entry
in HACCP plan)</p></td>
<td><p>Strength of sanitizer</p>
<p>Belt speed ___ RPM</p>
<p>(processor should include appropriate entry in HACCP plan)</p></td>
<td>Chlorine test kit or equivalent</td>
<td>At the beginning of the operation and hourly thereafter.</td>
<td>Operator</td>
<td>Same as CCP 4</td>
<td>Same as CCP 4</td>
<td>Same as CCP 4</td>
</tr>
</tbody>
</table>

<table>
<colgroup>
<col style="width: 10%" />
<col style="width: 10%" />
<col style="width: 10%" />
<col style="width: 8%" />
<col style="width: 8%" />
<col style="width: 12%" />
<col style="width: 9%" />
<col style="width: 10%" />
<col style="width: 11%" />
<col style="width: 9%" />
</colgroup>
<tbody>
<tr class="odd">
<td><p>CCP 6</p>
<p>(physical)</p>
<p>Metal Detector</p></td>
<td>Metal Inclusion</td>
<td>No detectable metal fragments in finished product</td>
<td>Presence of detectable metal fragments in finished product.</td>
<td>Metal detector</td>
<td>Every finished package, with operational check at start up.</td>
<td>Operator</td>
<td><p>Destroy any product rejected by metal detector</p>
<p>Identify source of metal found in product and fix damaged
equipment.</p>
<p>If product is processed without metal detection, hold product for
metal detection.</p></td>
<td><p>Test metal detector with three test units before production each
day, and recalibrate if needed.</p>
<p>Review monitoring, corrective action, and verification records within
one week of preparation.</p></td>
<td>Metal detector operation log</td>
</tr>
</tbody>
</table>

**3.0 Example HACCP Plan for Not-from-concentrate Pasteurized Orange
Juice**

#  {#section-19}

The following table represents excerpts from a Summary HACCP Plan for a
not from concentrate pasteurized orange juice packed in cartons. For
this example, it is assumed that the pasteurization process is performed
using a continuous (non-batch) system with monitoring of the flow rate
of the juice through the heat exchanger. (See Discussion of
Pasteurization Equipment in section V.C 5.31) The excerpts included in
this example are for the control of enteric pathogens and metal
fragments. An actual HACCP plan for such a product might be more
detailed, but the summary table format lists all of the elements that
would be included in the plan.

# Table 7. Excerpts from Summary HACCP Plan 

<table>
<colgroup>
<col style="width: 8%" />
<col style="width: 10%" />
<col style="width: 10%" />
<col style="width: 8%" />
<col style="width: 8%" />
<col style="width: 0%" />
<col style="width: 9%" />
<col style="width: 12%" />
<col style="width: 10%" />
<col style="width: 11%" />
<col style="width: 9%" />
</colgroup>
<tbody>
<tr class="odd">
<td rowspan="2"><strong>Critical Control Point (CCP)</strong></td>
<td rowspan="2"><strong>Hazard(s)</strong></td>
<td rowspan="2"><strong>Critical Limits</strong></td>
<td colspan="5"><strong>Monitoring</strong></td>
<td rowspan="2"><strong>Corrective Action</strong></td>
<td rowspan="2"><strong>Verification</strong></td>
<td rowspan="2"><strong>Record keeping</strong></td>
</tr>
<tr class="even">
<td><h2 id="what-2" class="unnumbered">What</h2></td>
<td colspan="2"><h2 id="how-2" class="unnumbered">How</h2></td>
<td><h2 id="frequency-2" class="unnumbered">Frequency</h2></td>
<td><h2 id="who-2" class="unnumbered">Who</h2></td>
</tr>
<tr class="odd">
<td><p>CCP 1</p>
<p>Pasteurization</p></td>
<td><p>Pathogens--</p>
<p><em>Salmonella</em></p></td>
<td><p>160 deg. F</p>
<p>AND</p>
<p>Min. 3 sec. Hold loop</p></td>
<td><p>Temperature</p>
<p>Flow rate</p></td>
<td><p>Chart recorder</p>
<p>Flow meters</p></td>
<td colspan="2"><p>Continuous with hourly visual check.</p>
<p>Continuous with daily visual check.</p></td>
<td><p>Operator</p>
<p>Operator</p></td>
<td>Divert and isolate affected product. Adjust pasteurizer to achieve
critical limit.</td>
<td><p>Documentation of process establishment.</p>
<p>Check accuracy of temperature recording device against mercury in
glass thermometer</p>
<p>daily.</p>
<p>Calibrate MIG thermometer annually.</p>
<p>Weekly fill test for flow rate.</p>
<p>Review monitoring, corrective action, and verification records w/in
one week of preparation.</p></td>
<td><p>Operator inspection log</p>
<p>Calibration records</p>
<p>Fill test log</p></td>
</tr>
<tr class="even">
<td><p>CCP 2</p>
<p>Screen</p></td>
<td>Metal fragments</td>
<td>Screen is operational.</td>
<td>Integrity of screen</td>
<td colspan="2">Visual</td>
<td>Daily</td>
<td><p>Production</p>
<p>employee</p></td>
<td><p>Segregate product and rework to eliminate metal pieces, or run
product through metal detector, or</p>
<p>divert to nonfood use, or destroy</p>
<p>AND</p>
<p>Replace screen.</p></td>
<td><p>Calibrate screen to ensure metal pieces 7 mm or greater do not
pass screen, semi-annually.</p>
<p>Review monitoring, corrective action, and verification records within
one week of preparation.</p></td>
<td><p>Screen integrity log.</p>
<p>Calibration log.</p></td>
</tr>
</tbody>
</table>

##  {#section-20 .unnumbered}

## C. Example CCP and SSOP for prevention of occurrence of undeclared milk residues in juice {#c.-example-ccp-and-ssop-for-prevention-of-occurrence-of-undeclared-milk-residues-in-juice .unnumbered}

#  {#section-21}

**Example SSOP Item**

This example SSOP illustrates how contamination of juice with milk
residues due to cross contact from the use of processing equipment also
used to process milk may be prevented. Such an SSOP would be applicable
in a facility that processes both dairy beverages, e.g., milk, and
juice.

# Goal: All surfaces of equipment that contact juice during processing are pre-rinsed, then cleaned with caustic cleaning solution and rinsed, prior to processing juice on any equipment that has been used to process milk during the previous production run. 

**Procedure:** An equipment log is to be maintained for each piece of
processing equipment, e.g., pasteurizer, filler, that may contact milk
or juice that indicates what foods were processed on the equipment and
the time of the process. The log also will record all cleanings of the
equipment, and will denote the cleaning procedure, e.g., pre-rinse, then
caustic followed by rinse, and the time of the cleaning. The log will
also denote that a visual check of the equipment for cleanliness was
conducted after the equipment was cleaned. An alternate way of checking
the efficacy of the cleaning procedure would be to test the final CIP
rinse water for milk protein (casein) to verify cleanliness of the
equipment before product changeover.

The production supervisor will review the equipment log prior to every
juice production run to determine whether milk was processed during the
previous production run on the equipment to be used for the juice run.
If milk was processed in the previous run, the supervisor will verify
that the equipment has been cleaned using the prescribed procedure, and
that a visual check of the equipment for cleanliness was conducted after
the cleaning.

Weekly Equipment Log

  -------------- --------------- ------------- ------------- -------------
  Equipment      Food Processed  Cleaning      Date/time of  Allergen Test
                 (date/time)     procedure     visual        Result of CIP
                                 followed      inspection    rinse water
                                 (date/time)   for           if conducted
                                               cleanliness   

  Pasteurizer #1                                             

                                                             

                                                             

                                                             

                                                             

  Pasteurizer #2                                             

                                                             

                                                             

                                                             

                                                             

  Filler #1                                                  

                                                             

                                                             

                                                             

                                                             

  Filler #2                                                  

                                                             

                                                             

                                                             

                                                             

  Holding Tank                                               
  #1                                                         

                                                             

                                                             

                                                             

                                                             

                                                             

  Holding Tank                                               
  #2                                                         

                                                             

                                                             

                                                             

                                                             

                                                             
  -------------- --------------- ------------- ------------- -------------

**Example CCP Item**

This example CCP illustrates how contamination of juice with milk
residues due to cross contact from the use of processing equipment also
used to process milk may be prevented. Such a CCP would be applicable in
a facility that processes both dairy beverages, e.g., milk, and juice.

<table>
<colgroup>
<col style="width: 8%" />
<col style="width: 10%" />
<col style="width: 10%" />
<col style="width: 8%" />
<col style="width: 8%" />
<col style="width: 0%" />
<col style="width: 9%" />
<col style="width: 12%" />
<col style="width: 10%" />
<col style="width: 11%" />
<col style="width: 9%" />
</colgroup>
<tbody>
<tr class="odd">
<td rowspan="2"><strong>Critical Control Point (CCP)</strong></td>
<td rowspan="2"><strong>Hazard(s)</strong></td>
<td rowspan="2"><strong>Critical Limits</strong></td>
<td colspan="5"><strong>Monitoring</strong></td>
<td rowspan="2"><strong>Corrective Action</strong></td>
<td rowspan="2"><strong>Verification</strong></td>
<td rowspan="2"><strong>Record keeping</strong></td>
</tr>
<tr class="even">
<td><h2 id="what-3" class="unnumbered">What</h2></td>
<td colspan="2"><h2 id="how-3" class="unnumbered">How</h2></td>
<td><h2 id="frequency-3" class="unnumbered">Frequency</h2></td>
<td><h2 id="who-3" class="unnumbered">Who</h2></td>
</tr>
<tr class="odd">
<td><p>Product changeover from product containing a known food allergen
to product that does not contain that allergenic material.</p>
<p>Equipment cleaning <u>after</u> producing the allergen-containing
product, prior to producing the non-allergen (or different allergen)
containing product.</p></td>
<td><p>Chemical –undeclared food allergen</p>
<p>Product changeover presents an unintentional opportunity for product
that contains an allergen(s) to cross-contact product that doesn’t
contain that particular allergen, thus resulting in an undeclared
allergen.</p></td>
<td>Validated cleaning process parameters: e.g., values for pre-rinse
time &amp; temperature; alkali cleaner %, time and temperature; and/or
rinse time and temperature – whatever values for control measures that
are critical for allergen control</td>
<td>Critical cleaning parameters</td>
<td>Monitoring devices used to measure cleaning parameters</td>
<td colspan="2">After cleaning and prior to product changeover</td>
<td><div class="Definition-Term">
<p>Operator</p>
</div></td>
<td><p><strong><u>During production</u>:</strong> If monitoring
indicates non-compliance with the critical limits, use alternate
methodology to clean the equipment surfaces to remove the residue prior
to running the non-allergen (or different allergen) containing product,
and document on the equipment inspection log.</p>
<p><strong><u>After production</u></strong> If records review indicates
that critical limits may not have been met, place the entire production
of product on hold and assess for allergen hazard.</p></td>
<td><p>Review monitoring, corrective action and verification records
w/in one week of preparation.</p>
<p>Calibration of all monitoring, corrective action and verification
instruments.</p>
<p>Periodic check to verify the CCP is effective and under control
(e.g., testing of CIP solution, final product, or certain equipment
swabs for allergenic protein).</p></td>
<td>Monitoring, corrective action and CCP verification records</td>
</tr>
</tbody>
</table>

[^1]: Except for high Brix juice concentrates and certain shelf-stable
    juices as discussed in section V. C. 2.0.

[^2]: An action level is a guideline that FDA uses in considering
    whether the level of a contaminant in a food may constitute a health
    hazard sufficient to warrant regulatory action by FDA against the
    product.

[^3]: Food allergens (see CPG chapter 555.250) are naturally occurring
    proteins in certain foods that cause abnormal responses of the
    immune system involving the production of allergen specific IgE
    antibodies in some individuals.

[^4]: In the January 22, and January 25, 2002 letters, FDA described
    high degree Brix juice concentrate as a concentrate that is diluted
    and repackaged as either frozen juice concentrate for consumer use
    or as institutional concentrate, and also stated that high degree
    Brix juice concentrates that are diluted to single strength and
    repackaged are not covered under the FDA policy stated therein.

[^5]: Mazzotta, Alejandro S., Thermal Inactivation of Stationary-Phase
    and Acid-Adapted *Escherichia coli* O157:H7, *Salmonella,* and
    *Listeria monocytogenes* in Fruit Juices, Journal of Food
    Protection, Vol. 64, No. 3, 2001, pp. 315-320.

[^6]: See Deng, Ming Qi, and Cliver, Dean O., Inactivation of
    *Cryptosporidium parvum* Oocysts in Cider by Flash Pasteurization,
    Journal of Food Protection, Vol. 64, No. 4, 2001, pp. 523-527, and
    Harp, James A., Fayer, Ronald, Pesch, Bruce A., and Jackson, George
    J., Effect of Pasteurization on Infectivity of *Cryptosporidium
    parvum* Oocysts in Water and Milk, Applied and Environmental
    Microbiology, Vol. 62, No. 8, 1996, pp. 2866-2868.

[^7]: Mak, Peggy P., Ingham, Barbara H., and Ingham, Steven C.,
    Validation of Apple Cider Pasteurization Treatments against
    *Escherichia coli* O157:H7, *Salmonella,* and *Listeria
    monocytogenes,* Journal of Food Protection: Vol. 64, No. 11, 2001
    pp. 1679--1689.

[^8]: The juice HACCP regulation requires control measures that will
    achieve a 5-log reduction in the "pertinent microorganism" for all
    juices except shelf stable juices, juice concentrates, and juices
    subject to the low acid canned foods or acidified foods regulations.

[^9]: Pathogens include enteric pathogens such as *E. coli* O157:H7,
    *Cryptosporidium parvum,* *Salmonella spp*., and *Listeria
    monocytogenes*, which is ubiquitous in nature.

[^10]: The Juice HACCP Alliance was formed through the voluntary
    participation of industry, government and academic members
    interested in guiding the juice industry to the higher level of food
    safety assurance provided by HACCP. The Alliance was coordinated
    through the efforts of the National Center for Food Safety and
    Technology at the Illinois Institute of Technology. Staff from the
    FDA participated as technical advisors in the development of the
    curriculum.