Guidance for Industry

Juice HACCP

Hazards and Controls Guidance

First Edition

Final Guidance

Comments and suggestions regarding this document may be submitted at any
time. Submit comments to Dockets Management Branch (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
All comments should be identified with the Docket Number 02D-0333.

For questions regarding this document, contact Michael E. Kashtock at
the Center for Food Safety and Applied Nutrition (CFSAN) at (Tel)
301-436-2022, (Fax) 301-436-2651, or e-mail mkashtoc@cfsan.fda.gov.

*Additional copies are available from:*

*Office of Plant and Dairy Foods*

*Center for Food Safety and Applied Nutrition*

*Food and Drug Administration; 5100 Paint Branch Parkway*

*College Park, MD 20740*

*http://www.cfsan.fda.gov/dms/guidance.html*

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

**Food and Drug Administration**

**Center for Food Safety and Applied Nutrition (CFSAN)**

**February 2004**

##   {#section .TOC-2}

**Guidance for Industry**[^1]

Juice HACCP

Hazards and Controls Guidance

First Edition

This guidance represents the Food and Drug Administration\'s (FDA\'s)
current thinking on this topic. It does not create or confer any rights
for or on any person and does not operate to bind FDA or the public. You
can use an alternative approach if the approach satisfies the
requirements of the applicable statutes and regulations. If you want to
discuss an alternative approach, contact the FDA staff responsible for
implementing this guidance. If you cannot identify the appropriate FDA
staff, call the appropriate number listed on the title page of this
guidance.

# 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 preempt 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,[^2] 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 and juice subject to the acidified foods
    regulation 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, or the acidified foods regulation, as appropriate, and
    all of the other requirements of the juice HACCP regulation.

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-   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 FDA's food labeling regulation in 21 CFR 101.17(g) that
    requires a warning statement on packaged fruit and vegetable juice
    products that have not been processed to prevent, reduce, or
    eliminate pathogenic microorganisms that may be present, and with
    any applicable state regulations.

### **Table of Contents** {#table-of-contents .unnumbered}

##### 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 Principles 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 Pathogens that may Occur in Acidic Juices (pH 4.6 or less)

12. Pathogens that may Occur in Low-acid Juices (pH greater than 4.6)

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 Whether 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 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

2.  Example of a Process for a Shelf Stable Juice

3.  Thermal Concentration Processes

> 4.4 Juices Subject to the Low-Acid Canned Foods and Acidified Foods
> Regulations
>
> 4.5 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

33. High Pressure Processing Systems

34. Dense Phase CO~2~ Processing Systems

> 5.35 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 Hazard Identification and Evaluation Exercise for Apple Juice
>
> 1.1 Step 1 -- Hazard Identification
>
> 1.2 Step 2 -- Hazard Evaluation
>
> 2.0 Example Hazard Analysis for Pasteurized Refrigerated Apple Juice
>
> 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 the first edition of the Food and Drug Administration's (FDA)
\"Juice HACCP Hazards and Controls Guidance.\" FDA recommends that this
guidance 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 it's
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 21 CFR 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>.

On our website, you can also find background information on fruit and
vegetable juice safety, and in particular, foodborne illness outbreaks
involving juice that in part, led to the establishment of the juice
HACCP regulation. This information can be viewed at
<http://www.foodsafety.gov/~dms/fs-toc2.html#juice>.

**C. Scope and Limitations**

The controls and practices provided in this guidance are recommendations
and guidance from FDA primarily 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. We recommend
that this information 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
or shelf stable acidified foods. Mandatory controls for this hazard are
contained in the Low Acid Canned Foods 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.

FDA\'s guidance documents, including this guidance, do not establish
legally enforceable responsibilities. Instead, guidance documents
describe the Agency\'s current thinking on a topic and should be viewed
only as recommendations, unless specific regulatory or statutory
requirements are cited. The use of the word *should* in Agency guidance
documents means that something is suggested or recommended, but not
required.

**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 prevent, reduce to an acceptable level, or eliminate an identified food hazard. {#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-prevent-reduce-to-an-acceptable-level-or-eliminate-an-identified-food-hazard. .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. Under this guidance, for processors of citrus juices
using treatments to fruit surfaces to comply with 21 CFR 120.24, FDA
will consider tree-picked, undamaged citrus fruit to be "culled" for
purposes of compliance with the juice HACCP regulation. *(Note: The
definition of the term "culled" in 21 CFR 120.3(f) includes the
requirement that the fruit is of U.S. Department of Agriculture (USDA)
choice or higher quality, however, there is no current USDA standard for
choice or higher quality.)*

**[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, or 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}

**[Hazard Analysis and Critical Control Points (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.  {#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. .unnumbered}

##  {#section-1 .unnumbered}

## *Additional helpful information*: All juice processors subject to the juice HACCP regulation are required to prepare a written hazard analysis. 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-all-juice-processors-subject-to-the-juice-haccp-regulation-are-required-to-prepare-a-written-hazard-analysis.-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]{.underline}** means the aqueous liquid expressed or extracted
from one or more fruits or vegetables, purees of the edible portions of
one or more fruits or vegetables, or any concentrates of such liquid or
puree.

*Additional helpful information:* The juice HACCP regulation requires
that processors apply HACCP principles if they make juice or juice
concentrates for subsequent beverage use. Any processor making a product
that could be labeled as 100 percent juice under 21 CFR 101.30, or a
concentrate of that juice for subsequent beverage use must apply HACCP
principles. For beverages containing less than 100 percent juice, only
the juice ingredient must be made applying HACCP principles.

**[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 vegetative cells of 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

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-   acidic juices such as canned orange juice and "juice box" style
    grape juice, which are made shelf stable using a single thermal
    processing step

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```
-   juice concentrates like orange juice concentrate or apple 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 or experience must validate your hazard
analysis. In addition, your hazard analysis must be reassessed (e.g.,
revalidated) by a person with appropriate training or experience
whenever there is any change 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, which 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 or qualified individual (as set forth in
Section 120.13) 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 is subject to the requirements of the
juice HACCP regulation, with the exception of juice produced at a retail
establishment (i.e., for sale directly to consumers only; see definition
of "Retail Establishment"), (However, see subpart D 1.0 of this section
for information about labeling requirements for certain juices produced
at a retail establishment).

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)) which are 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)) which are 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 (At this time, no such MOU has been
    established with any country concerning juice. Should an MOU be
    established with any country concerning juice, FDA will publish a
    notice to this effect in the Federal Register and make the MOU
    available on its website.)

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 any product that
may be labeled as 100 percent juice under 21 CFR 101.30 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
that any container of juice that has not been treated to achieve a 5-log
reduction in the most resistant pathogen 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, 2003, very small
businesses may still use label-warning statements for an additional
year. 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, we recommend that the systems used to generate the
electronic records comply with the electronic records and electronic
signature provisions of 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 today's 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 the vegetative cells of 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. However, packaged juice produced at
a retail establishment is subject to FDA's food labeling regulation in
21 CFR 101.17(g), which requires a warning statement on fruit and
vegetable juice products that have not been processed to prevent,
reduce, or eliminate pathogenic microorganisms.

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 selling 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 you
are not providing all of the juice 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 help 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**

##  {#section-3 .unnumbered}

## 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-4 .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 may 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-may-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
for which you could reach this conclusion may be controlled under your
SSOPs as discussed in section IV.[^3] C. 3.2. If you produce a shelf
stable juice or a thermally concentrated juice as described in 21 CFR
120.24, and you determine that no hazards are "reasonably likely to
occur" in your juice, 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 recommended steps 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---** We recommend that 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 at a
minimum, we recommend be considered in your hazard analysis.

In this section*,* we have included some specific biological, chemical,
and physical hazards that we recommend you 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 Pathogens that may Occur in Acidic Juices (pH 4.6 or less) {#pathogens-that-may-occur-in-acidic-juices-ph-4.6-or-less .unnumbered}

Acidic juices (pH 4.6 or less) containing enteric bacterial pathogens
such as *E. coli* O157:H7, various Salmonella species, and the protozoan
parasite *Cryptosporidium parvum* have caused serious foodborne illness
outbreaks. Some of the illnesses associated with juices have been very
severe (e.g., cases of long-term reactive arthritis and severe chronic
illness). In one case, consumption of contaminated juice resulted in the
death of a child and in another case, consumption of contaminated juice
contributed to the death of an elderly man. These microorganisms inhabit
the intestinal tracts of animals; when animals and their manure or feces
share proximity in an environment, produce can become contaminated,
either directly or indirectly through such means as contaminated
irrigation water or runoff. 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. Illness-causing organisms that
are ubiquitous in nature, such as *Listeria monocytogenes*, have also
been identified as possible contaminants in juice. Guidance on selecting
the pertinent microorganism for acidic juices for purposes of meeting
the 5-log pathogen reduction requirement is provided in Section V. C.
1.1.

######### **1.12 Pathogens that may Occur in Low-acid Juices (pH greater than 4.6)**

While enteric pathogens present in acidic fruit juices have been the
cause of most food-borne illness outbreaks associated with juice, these
are not the only types of harmful microorganisms that could occur in
juice. We recommend that a processor of low acid juices, such as carrot
juice, that are distributed under refrigeration and that are not subject
to the Low Acid Canned Foods regulation (in 21 CFR Part 113) give
consideration to toxins produced by non-proteolytic and proteolytic
strains of *Clostridium botulinum* as potential hazards to be controlled
under its HACCP plan. Guidance on control measures and on selecting the
pertinent microorganism for low-acid juices for purposes of meeting the
5-log pathogen reduction requirement is provided in Section V. C. 1.1.

**1.13 Pathogen Hazard Identification/Evaluation for Acidic Shelf Stable
Juices**

If you produce acidic shelf stable juice, under 21 CFR 120.24 (a)(2),
you are exempt from the requirement to include control measures in your
HACCP plan for the control of microbial pathogens. We recommend that you
identify the relevant pertinent microorganism for your juice, e.g.,
salmonella, as a potential hazard 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
the product is processed to achieve shelf stability. A partial hazard
analysis summary table (illustrating only the receipt of raw fruit and
pasteurization steps) for such an analysis could be as follows:

+-----------+-------------+--------+-----------+--------------+-------+
| **(1)**   | **(2)**     | *      | **(4)**   | **(5)**      | **    |
|           |             | *(3)** |           |              | (6)** |
| **Ingr    | **Identify  |        | **Justify | **What       |       |
| edient/Pr | potential   | **Are  | your      | preventative | **Is  |
| o-cessing | hazards     | any    | decision  | measure(s)   | this  |
| Step**    | introduced, | pot    | for       | can be       | step  |
|           | controlled  | ential | Column    | applied to   | a     |
|           | or enhanced | food-  | 3**       | p            | cri   |
|           | at this     | safety |           | revent/reduc | tical |
|           | step.**     | h      |           | e/elimin-ate | co    |
|           |             | azards |           | the          | ntrol |
|           |             | si     |           | hazard?**    | p     |
|           |             | gnific |           |              | oint? |
|           |             | ant?** |           |              | (     |
|           |             |        |           |              | Yes// |
|           |             | **(Yes |           |              | No)** |
|           |             | /No)** |           |              |       |
+-----------+-------------+--------+-----------+--------------+-------+
| Receipt   | B-          | ##     | Product   |              |       |
| of raw    | pathogens   | ### No | is shelf  |              |       |
| fruit     | such as     |  {#no  | stable    |              |       |
|           | *           | .unnum | per       |              |       |
| Paste     | Salmonella* | bered} | attached  |              |       |
| urization |             |        | process.  |              |       |
|           | B --        | #      | 21 CFR    |              |       |
|           | pathogens   | ####   | 120.24    |              |       |
|           | such as     | {#sect | (a) (2)   |              |       |
|           | *           | ion-5  | provides  |              |       |
|           | Salmonella* | .unnum | exemption |              |       |
|           |             | bered} | for 5-log |              |       |
|           |             |        | reduction |              |       |
|           |             | #      | re        |              |       |
|           |             | ####   | quirement |              |       |
|           |             | {#sect | for juice |              |       |
|           |             | ion-6  | p         |              |       |
|           |             | .unnum | rocessors |              |       |
|           |             | bered} | producing |              |       |
|           |             |        | shelf     |              |       |
|           |             | #      | stable    |              |       |
|           |             | ####   | product   |              |       |
|           |             | {#sect |           |              |       |
|           |             | ion-7  | Product   |              |       |
|           |             | .unnum | is shelf  |              |       |
|           |             | bered} | stable    |              |       |
|           |             |        | per       |              |       |
|           |             | #      | attached  |              |       |
|           |             | ####   | process.  |              |       |
|           |             | {#sect | 21 CFR    |              |       |
|           |             | ion-8  | 120.24    |              |       |
|           |             | .unnum | (a) (2)   |              |       |
|           |             | bered} | provides  |              |       |
|           |             |        | exemption |              |       |
|           |             | #      | for 5-log |              |       |
|           |             | ####   | reduction |              |       |
|           |             | {#sect | re        |              |       |
|           |             | ion-9  | quirement |              |       |
|           |             | .unnum | for juice |              |       |
|           |             | bered} | p         |              |       |
|           |             |        | rocessors |              |       |
|           |             | ##     | producing |              |       |
|           |             | ###  { | shelf     |              |       |
|           |             | #secti | stable    |              |       |
|           |             | on-10  | product   |              |       |
|           |             | .unnum |           |              |       |
|           |             | bered} |           |              |       |
|           |             |        |           |              |       |
|           |             | ##     |           |              |       |
|           |             | ###  { |           |              |       |
|           |             | #secti |           |              |       |
|           |             | on-11  |           |              |       |
|           |             | .unnum |           |              |       |
|           |             | bered} |           |              |       |
|           |             |        |           |              |       |
|           |             | ##     |           |              |       |
|           |             | ###  { |           |              |       |
|           |             | #secti |           |              |       |
|           |             | on-12  |           |              |       |
|           |             | .unnum |           |              |       |
|           |             | bered} |           |              |       |
|           |             |        |           |              |       |
|           |             | ##     |           |              |       |
|           |             | ###  { |           |              |       |
|           |             | #secti |           |              |       |
|           |             | on-13  |           |              |       |
|           |             | .unnum |           |              |       |
|           |             | bered} |           |              |       |
|           |             |        |           |              |       |
|           |             | ##     |           |              |       |
|           |             | ###  { |           |              |       |
|           |             | #secti |           |              |       |
|           |             | on-14  |           |              |       |
|           |             | .unnum |           |              |       |
|           |             | bered} |           |              |       |
|           |             |        |           |              |       |
|           |             | ####   |           |              |       |
|           |             | # No { |           |              |       |
|           |             | #no-1  |           |              |       |
|           |             | .unnum |           |              |       |
|           |             | bered} |           |              |       |
+-----------+-------------+--------+-----------+--------------+-------+

# 1.14 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, under its SSOPs, employee health and hygiene conditions that
could result in the microbiological contamination of food, food
packaging materials, and food contact surfaces.

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 (see Section V. B. 1.0 below for availability information)
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[^4] 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;
section I. C provides 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[^5] 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 into 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 and unexpected
health risk upon consuming the juice containing the milk protein.

Under 21 CFR 120.6 of the juice HACCP regulation, you may address these
types of potential hazards by establishing effective equipment cleaning
procedures at a CCP in your process, or as part of your SSOPs. (Section
IV. C. 3.4, discusses this issue.)

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**

The juice HACCP regulation applies to any juice, juice concentrate, or
puree product that could be labeled as 100 percent juice in accord with
the requirements of 21 CFR 101.30, "Percentage juice declaration for
foods purporting to be beverages that contain fruit or vegetable juice."
Some products that may be labeled as 100 percent juice under 21 CFR
101.30 also may contain added ingredients such as soy protein or a
preservative such as sulfites, which can cause allergic or allergic-type
(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 allergic-type (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 proper labels are used should
be part of your HACCP plan. The following is a list of some ingredients
for which we recommend that you 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

**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. See additional information on
pesticides in section IV. C. 2.0.

**1.25 Lead**

Juice can become contaminated with lead if lead-contaminated produce is
used to make the juice. Lead contamination of produce can occur as a
result of past use of lead in agricultural 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. Produce could also become contaminated with airborne lead if it
is handled at sites where vehicles or equipment are operated that use
leaded fuel, if the equipment is operated in a manner that exposes the
produce to excessive emissions from the equipment.

Lead is especially hazardous to young children. In 1993, FDA established
an emergency action level of 80 ppb and above for lead in juice packed
in lead soldered cans. (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 in the future 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 in your hazard analysis whether lead is a hazard that is
reasonably likely to occur. If you determine that lead is a hazard that
is reasonably likely to occur, 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 unlacquered 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 unlacquered metal cans, we recommend that
you 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 tin levels due to leaching of tin from the container into the
juice.

**1.3 Physical Hazards**

**1.31 Glass Fragments**

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

Glass fragments originating from facility related sources and not from
glass containers, e.g., from a broken light bulb, may be addressed where
applicable under your SSOPs (See 21 CFR 120.6 (a)(5)).

**1.32 Metal Fragments**

We recommend that consideration of potential hazards associated with
metal fragments be a part of your hazard analysis if you conduct
operations such as the grinding of fruit, or cutting operations, where
metal fatigue or metal to metal contact can occur in your processing
equipment. If your process includes such operations, we recommend that
you classify metal fragments as a hazard that is reasonably likely to
occur in the absence of data or experience about your operation that
shows that your process does result in the presence of metal fragments
in juice when there are no controls in place. For instance, if you have
used a metal detector in your process for a year, and have had no
occurrences of metal fragments in your juice, you could conclude that
metal fragments are not a hazard that is reasonably likely to occur in
your process. If you conclude in your hazard analysis that metal
fragments are a hazard that is reasonably likely to occur in your juice,
you must establish controls for metal fragments in your HACCP plan.

2.  **Evaluate All Potential Hazards**

**Step 2---** The second step of a hazard analysis is to 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:

-   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, which resulted in hospitalizations and deaths.
    Any occurrence of pathogens such as these 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." 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 a pathogen 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.1.1 for more information on selecting the
    pertinent microorganism and establishing process controls to meet
    the 5-log pathogen reduction performance standard.

-   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.

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

**Step 3---** The third step of the written hazard analysis is to
determine, based upon the information gathered in steps 1 and 2, 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.,
cuts in the mouth 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 to 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), you
may usually classify such hazards as "not reasonably likely to occur,"
and control those hazards under your SSOP program. 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.

Examples of potential hazards that may be controlled under your SSOP
program include substances used on juice processing equipment, such as
lubricants and sanitizing chemicals, or substances applied to juice
packaging materials under the provisions of a food additive regulation,
such as hydrogen peroxide that is used to sterilize packaging materials
on aseptic packaging lines for juice. If you have SSOPs designed to
ensure that the substance will be used in accord CGMPs or with the
provisions of the applicable food additive regulation, you may, in your
hazard analysis, cite the SSOP as a justification for determining that
the hazard is not reasonably likely to occur. Examples of this approach
are included in the Example Hazard Analyses in section VII A for
pasteurized refrigerated apple juice (the sanitizer used for cleaning
the holding tank) and for not-from-concentrate pasteurized orange juice
(the lubricant used on the extraction equipment). In addition, the
following partial hazard analysis summary table for an aseptic juice
packaging operation (illustrating only the aseptic filling and packaging
step) where hydrogen peroxide is used as a sterilant illustrates the
same approach.

+-----------+-------------+--------+-----------+--------------+-------+
| **(1)**   | **(2)**     | *      | **(4)**   | **(5)**      | **    |
|           |             | *(3)** |           |              | (6)** |
| **Ing     | **Identify  |        | **Justify | **What       |       |
| redient/P | potential   | **Are  | your      | preventative | **Is  |
| rocessing | hazards     | any    | decision  | measure(s)   | this  |
| Step**    | introduced, | pot    | for       | can be       | step  |
|           | controlled  | ential | Column    | applied to   | a     |
|           | or enhanced | food-  | 3**       | prevent/redu | cri   |
|           | at this     | safety |           | ce/eliminate | tical |
|           | step.**     | h      |           | the          | co    |
|           |             | azards |           | hazard?**    | ntrol |
|           |             | si     |           |              | p     |
|           |             | gnific |           |              | oint? |
|           |             | ant?** |           |              | (     |
|           |             |        |           |              | Yes// |
|           |             | **(Yes |           |              | No)** |
|           |             | /No)** |           |              |       |
+-----------+-------------+--------+-----------+--------------+-------+
| Aseptic   | Hydrogen    | ####   | Not       |              |       |
| filling   | peroxide    | # No { | r         |              |       |
| and       |             | #no-2  | easonably |              |       |
| packaging |             | .unnum | likely to |              |       |
|           |             | bered} | occur due |              |       |
|           |             |        | to SSOP   |              |       |
|           |             | ##     | to ensure |              |       |
|           |             | ###  { | c         |              |       |
|           |             | #secti | ompliance |              |       |
|           |             | on-15  | with the  |              |       |
|           |             | .unnum | maximum   |              |       |
|           |             | bered} | level of  |              |       |
|           |             |        | hydrogen  |              |       |
|           |             | ##     | peroxide  |              |       |
|           |             | ###  { | residual  |              |       |
|           |             | #secti | allowed   |              |       |
|           |             | on-16  | by        |              |       |
|           |             | .unnum | r         |              |       |
|           |             | bered} | egulation |              |       |
|           |             |        | (21 CFR   |              |       |
|           |             | ##     | 178.1005; |              |       |
|           |             | ###  { | of 0.5    |              |       |
|           |             | #secti | ppm in    |              |       |
|           |             | on-17  | water     |              |       |
|           |             | .unnum | filled    |              |       |
|           |             | bered} | and       |              |       |
|           |             |        | packaged  |              |       |
|           |             | ##     | in the    |              |       |
|           |             | ###  { | system.)  |              |       |
|           |             | #secti |           |              |       |
|           |             | on-18  |           |              |       |
|           |             | .unnum |           |              |       |
|           |             | bered} |           |              |       |
+-----------+-------------+--------+-----------+--------------+-------+

However, a special concern exists with respect to unsanitary food
contact surfaces that can contaminate juice with residues of food
processed on the equipment in prior runs that contain allergens. If the
allergen containing food is not declared on the ingredient label,
consumption of the juice and that can cause allergic reactions in
sensitive individuals. Undeclared food allergens that arise from
unsanitary food contact surfaces could pose a severe food safety hazard,
if they occur in juice. As such, we recommend that these types of
hazards should be classified as "reasonably likely to occur" and
controlled in your HACCP plan if you determine that control measure(s)
are necessary for the hazard. However, as provided in 21 CFR 120.6 (d),
you may elect to control such a hazard under your SSOP program.

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

As noted in the previous section, hazards that arise in juice processing
from unsanitary food contact surfaces that can contaminate juice 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 that may arise from
unsanitary food contact surfaces 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, we recommend that you 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---** The fourth step in a written hazard analysis is to
identify control measures and critical control points for hazards
determined in step 3 to be reasonably likely to occur, and to 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 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 which is available at
<http://www.foodsafety.gov/~dms/prodguid.html>, and by mail from the
address given in section I. C above. 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, e.g., patulin on
incoming apples, or pathogens on incoming raw fruit, pursuant to 21 CFR
120.8 (a), that hazard 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 may 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, based upon your hazard analysis, you have concluded is
reasonably likely to occur in your juice. 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**  | *      | **Decrease in**      | **P    | **Final**   |
|              | *Log** |                      | ercent |             |
| **number     | *      | **pertinent          | of     | **number    |
| of**         | *reduc | microorganism        | ch     | of**        |
|              | tion** | 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, as your pathogen
control measure, a series of surface sanitization treatments and an
extraction process that limits juice/peel contact 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, we recommend that *Listeria monocytogenes* 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.* Alternatively, for juices
other than apple juice, you may generically designate "vegetative
bacterial pathogens" as your pertinent microorganism if your juice is an
acidic juice, i.e., pH of 4.6 or less, no illness outbreaks believed to
have been caused by non-bacterial pathogens have been attributed to that
juice type, and you are processing your juice using a process that has
been validated to achieve a 5-log reduction for *Salmonella* species*,
E. coli* O157:H7, and *Listeria monocytogenes*, such as the general
process which is discussed in section V.C.5.0 under "Process
Validation."

Low-acid juices, such as carrot juice, that are distributed under
refrigeration, and are not subject to the Low Acid Canned Foods
regulation (21 CFR Part 113) may pose hazards associated with spore
forming pathogens, specifically, toxins of non-proteolytic and
proteolytic strains of *Clostridium botulinum*. Control measures for
such juices are likely to involve multiple measures, e.g., a combination
of a process step to destroy the non-proteolytic spores and measures to
ensure that "Keep Refrigerated" labeling is used for the juice if the
juice does not receive a treatment sufficient to destroy the proteolytic
spores (Destruction of spores of the proteolytic strains requires a more
severe heat treatment but germination and growth of these spores may be
prevented by keeping the product under refrigeration during its
lifecycle. Destruction of spores of the non-proteolytic strains requires
a less severe heat treatment, but these spores can germinate and produce
toxin even under refrigerated storage conditions).

**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)). This requirement is intended to ensure
the effectiveness of the treatment if any microorganisms that may be
injured in processing, might be capable of surviving 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**

You must meet the 5-log pathogen reduction requirement by treating the
juice directly, i.e., after it has been extracted from the fruit, with
one exception provided by 21 CFR 120.24(b). 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 extraction methods that limit
juice/peel contact 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[^6] where the
following three conditions are satisfied: (1) the producer and user
establish appropriate prerequisite programs 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 with respect to processors
that transport in bulk and package shelf-stable single strength juice
that is transported in aseptic packaging.

FDA also stated in the January 22, 2002, 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 entitled "Guidance on Bulk Transport
of Juice Concentrates and Certain Shelf Stable Juices," is available on
the website listed in section I. B above.

You may extract juice from the fruit in one location and ship the
untreated juice to a second location for processing (i.e., to achieve
the 5-log pathogen reduction requirement) and packaging. If you do this,
we recommend that you obtain assurance, e.g., a letter from the juice
processor receiving the untreated juice, that the juice will be given
the required 5-log treatment at the second 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. We also recommend
that the label of the untreated juice, or if transported in bulk, the
invoice or other shipping documents, state that the juice has not
received a treatment sufficient to yield a 5 log pathogen reduction.

**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 may 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 the shipment contains only tree-picked fruit,
    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. The culling step is important because damage
    to the peel of citrus fruit (e.g., punctures, cuts, splitting, rot,
    or mold) may allow pathogens to contaminate the edible portion of
    the fruit from which the juice is made.

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 the shipment contains only tree-picked fruit
    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, we recommend
    that you 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. We recommend
that you conduct these activities as quickly as possible. 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
how far back we recommend you 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 action 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. We recommend that you start
by considering 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, a finding of 2 positives in 17 tests, or 3 positives in 52 tests,
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**

Our recommendations for factors to 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, 4.4 and
4.5.

**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 of a juice, 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
into account the cumulative lethality during the cool down period. (See
reference to publication by Mazzotta in section V. C. 5.0).

2.  **Thermal Concentration Processes**

To obtain the exemption from the requirement to include controls in your
HACCP plan to achieve the 5-log pathogen reduction, the juice HACCP
regulation requires a copy of the process used to produce the thermally
processed juice concentrate to be included in your hazard analysis. The
thermal process must be applied to the concentrate and all of its
ingredients.

We recommend that the copy of the thermal process used to achieve
concentration describe the steps in the process, such as the
pre-evaporation heat treatment and the evaporation steps. We also
recommend that it describe the type of equipment used in each process
step such as a "continuous flow tubular heat exchanger" for the
pre-evaporation step and a "X effect high temperature short time
evaporator" (X-representing the number of effects) for the evaporation
steps. In addition, we recommend that it describe the product
temperature and exposure time for the pre-treatment step, the product
temperature for each of the evaporation effects, and the process time
and temperature for the thermal process for any ingredient of the
concentrate that is processed separately and then added to the
concentrate.

To ensure the safety of a "thermally processed concentrate" we recommend
all of the juice receive a pretreatment consisting of a thermal
treatment of at least 80 degrees Centigrade for thirty seconds. Such a
process delivers a degree of thermal inactivation of pathogens that is
extraordinarily beyond the required 5-log reduction (see Reference #68
in the juice HACCP final rule). FDA is not likely to question whether a
product processed in such a manner is a "thermal concentrate" and thus,
qualifies for the exemption from a process control to achieve the 5-log
performance standard for pathogen reduction.

However concentrates produced using unconventional processes that
involve low temperatures might not receive enough heat to ensure a
comparable level of inactivation of potentially harmful microorganisms
that might be present in the juice. If we encounter a concentrate that
is processed in such an unconventional manner, we may ask for additional
data demonstrating that the process delivers a level of thermal
inactivation of microorganisms that is comparable to that delivered by a
conventional thermal concentration process. Absent providing such data,
we may advise you of our view that the exemption from a process control
to achieve the 5-log performance standard for pathogen reduction is not
available for the product and that you should include control(s)
(CCP(s)) in your HACCP plan for achieving the 5-log reduction.

**4.4 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.

**4.5 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, at a minimum, the required 5-log
pathogen reduction (21 CFR 120.24(a)).

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

In order to ensure the validity of your process, FDA recommends that you
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 aspects of your pathogen control measures, e.g., process time,
temperature, type of equipment, etc., and to 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 likely 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; these values serve as the critical
limits in your HACCP plan. We will need this information to be able to
conduct an official review of your HACCP system.

You may employ a process authority as a member of your staff, or
alternatively, 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 that we can comment on to
assist you in developing your HACCP plan.

Study #1 Summary: A study done by the NFPA[^7] 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 4.0 and higher. This
process assumes that the pathogens will have increased thermal
resistance due to their being acid-adapted.

Study #2 Summary: A study done at the University of Wisconsin[^8] 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.

FDA Comments/Recommendations: We believe that the process recommended in
the NFPA study is 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. However, other validation studies may be needed for juices
that have pH values greater than 4.0. We also believe that either of the
processes evaluated in the University of Wisconsin study is 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.

Neither of these two studies evaluated thermal processes for achieving a
5-log reduction for oocysts of the protozoan parasite *Cryptosporidium
parvum* that has been a cause of illness outbreaks associated with the
consumption of apple juice. In fact, the thermal destruction of
*Cryptosporidium parvum* oocysts has not been as widely studied in the
published literature as it has for the vegetative bacterial pathogens;
however, the available scientific literature suggests that
*Cryptosporidium parvum*[^9] oocysts may be more resistant to thermal
processing than the three vegetative bacterial pathogens. Therefore, we
recommend that you consider *Cryptosporidium parvum* to be the pertinent
microorganism when you are establishing a HACCP plan for apple juice.

For apple juice at pH values of 4.0 or less, we are recommending the
following thermal processes to achieve a 5-log reduction for oocysts of
*Cryptosporidium parvum* (in addition to the three aforementioned
vegetative bacterial pathogens) based upon a conservative evaluation of
the available scientific data;

-   160 degrees F for 6 seconds (recommended treatment conditions in New
    York),

-   165 degrees F for 2.8 seconds,

-   170 degrees F for 1.3 seconds,

-   175 degrees F for 0.6 seconds, or

-   180 degrees F for 0.3 seconds

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*, processors may designate both *E. coli
O157:H7* and *Cryptosporidium parvum* as the pertinent microorganism in
their HACCP plans for apple juice, and use one of the recommended
thermal processes given above for the a 5-log reduction of
*Cryptosporidium parvum* oocysts, until more definitive data become
available on the relative resistance to thermal processing of these two
pathogens.

We also believe that the process that is typically carried out for milk
pasteurization, 71.7 degrees C (161 degrees F) for 15 seconds, is
adequate to achieve a 5-log reduction of oocysts of *Cryptosporidium
parvum* and the aforementioned three vegetative bacterial pathogens when
this process is used for apple juice (at juice pH values of 4.0 or
less).

> **5.3 Equipment and System Considerations**

Equipment and Systems that should be considered are discussed in 5.31,
5.32, 5.33, 5.34 and 5.35.

31. **Pasteurization Equipment**

If you use batch pasteurization equipment, we recommend that you
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, we recommend that you designate the juice
temperature and juice heating time as critical limits in your HACCP
plan. Under your HACCP plan, we recommend that you continuously monitor
the juice temperature; we do not recommend continuous monitoring of the
heating time 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, we recommend that you periodically
perform a visual check of 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, we recommend
that you 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, we recommend that the
flow rate (heating time), in addition to the juice temperature, be
continuously monitored.

> **5.32 UV Processing Systems**

UV systems for treating juice have recently begun to be commercialized.
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?[^10] The
    effectiveness of given UV treatment conditions can vary from one
    juice to another due to factors such as the opacity of the juice.
    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. We recommend that you 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 if the
    system fails, 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, a technology in which pressure (in excess of
30,000 to 45,000 psig) is the principal anti-microbial agent, has been
shown to be effective in reducing vegetative pathogens. Both
semi-continuous and batch processes have been developed using high
pressure processing. We recommend that the process time and pressure 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, we recommend that changes in the composition of the pressure
transmitting fluid should be controlled and checked periodically.

34. **Dense Phase CO~2~ Processing Systems**

Dense phase carbon dioxide processing, a technology in which carbon
dioxide under moderate pressure (1200-1500 psig) is the principal
anti-microbial agent, has been shown to be effective in reducing
vegetative pathogens. In the gas industry, supercritical and liquid
carbon dioxide (CO~2~) are known collectively as dense phase CO~2~.
Continuous processes have been developed using this technology. Pathogen
challenge tests showed that microbial inactivation increases as CO2
concentration increases. It appears that pressure and residence time may
be used to optimize the bactericidal effects of CO~2~. For these
processes, CO~2~ concentration is critical to the process. The process
is performed under ambient conditions, and temperature is not monitored
as a critical factor.

> **5.35 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. Juice extractors are available that
have been designed to limit juice/peel contact during the extraction
process for this purpose. We recommend that, as part of meeting the
validation requirements of 21 CFR 120.11, you ensure that studies have
been done to establish that contamination of juice by pathogens that may
be present on the peel will not occur during the extraction operation.
We recommend that such studies 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, which 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 wish to 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 wish to 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,
recently published research[^11] indicates that different apple
varieties, e.g., Red Rome, Granny Smith, and 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, you might elect to 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, we
recommend 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. For a small processor who harvests apples from his own
    orchard, we recommend, in lieu of a supplier guarantee, that the
    processor's apple pickers be instructed not to harvest fallen fruit
    and the processor confirm that the workers are adhering to the
    instructions.

-   A monitoring procedure would be to confirm visually the existence of
    the guarantee for each incoming shipment of apples.

-   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 testing the juice periodically to confirm that it
    does not contain high levels of patulin. We recommend that
    processor's who rely on guarantees or certificates from suppliers to
    control a hazard 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, we
    recommend that you establish visual or other criteria for what
    constitutes a damaged apple that should be culled. We further
    recommend that criteria 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, it is reasonable for the processor who, for example,
purchases concentrate and processes it into single strength apple juice,
to 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, we recommend that you 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. 3.3.) 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, we recommend that you clean the equipment to eliminate the milk
residues before using the equipment to process juice.
:::

::: Definition-Term
An appropriate SSOP might 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, and recorded in
the log (See Example SSOP in section VII C). We recommend that you
initially validate the effectiveness of the cleaning procedure by
conducting tests for milk protein residue on the equipment after running
the cleaning. We also recommend that you establish a procedure to
monitor the efficacy of the cleaning process, e.g., swabbing the
equipment surfaces and testing the swabs for milk protein residue.
:::

::: Definition-Term
A CCP procedure could similarly be based upon a pre-rinse, caustic wash,
followed by rinse procedure. We do recommend that the parameters of the
procedure such as time, temperature, and percent caustic, initially be
validated for the effective removal of milk protein from the processing
equipment and monitoring of the parameters as critical limits be carried
out (See Example CCP in section VII C).
:::

Whether an SSOP or a CCP is used, you should consider whether the
equipment's design makes cleaning difficult absent disassembly of the
equipment. If necessary to achieve effective cleaning, we recommend that
you disassemble the equipment as part of the cleaning process.

**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, we recommend that you regard the object as a potential
hazard in your juice.

**1.1 Glass Fragments**

We can recommend several ways to establish control measures for glass
fragments in juice.

One way is 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.

-   What is the 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, we recommend
    that you 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.
    We recommend that you check 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,
involves 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. We recommend that there be a check 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."

A third way to control glass fragments is 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? We recommend that you 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, we recommend that
    you consider the complexity of the equipment and the level of
    understanding necessary to evaluate its condition.

If broken glass is observed at a CCP, we recommend that the corrective
action procedure 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**

We can recommend several possible ways to establish control measures for
metal fragments in juice.

One way involves 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.
    We recommend that you 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. We recommend that a check be made at least once
    per day to ensure that the device is operating correctly.

A second way to control metal fragments involves 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 functional."

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

-   We recommend that verification include periodic calibration testing
    to ensure that the screen retains its separation capability for
    metal particles of a specific size. In establishing this size, we
    recommend that you consider 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).

A third way to control metal fragments involves 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 fragments in your juice. This approach may only be feasible for
relatively simple equipment that can be fully inspected visually 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

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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; 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**[^12]  | information see   |
| tity** |                    |                  | section ...**     |
+--------+--------------------+------------------+-------------------+
| Pa     | Unless you produce | 1.               | -   V. C. 1.1 --  |
| thogen | one of the types   |   Pasteurization |     Pertinent     |
| s[^13] | of juice listed in |                  |     microorganism |
|        | footnote #12, or a | 2.  UV radiation |                   |
| /biol  | low acid juice not |                  | ```{=html}        |
| ogical | subject to the Low | 3.  Pulsed light | <!-- -->          |
|        | Acid Canned Foods  |                  | ```               |
|        | regulations (21    | 4.  High         | -   V. C. 5.0 --  |
|        | CFR Part 113) one  |     pressure     |     Process       |
|        | of the pathogens   |     processing   |     validation    |
|        | listed in footnote |                  |                   |
|        | #13 is likely to   | 5.  Dense phase  | ```{=html}        |
|        | be the "pertinent  |     CO~2~        | <!-- -->          |
|        | microorganism" for |     processing   | ```               |
|        | your required      |                  | -   V. C. 5.31 -- |
|        | 5-log pathogen     | 6.  For fresh    |                   |
|        | reduction          |     citrus juice |    Pasteurization |
|        | treatment.         |     only:        |     Equipment     |
|        |                    |     Supplier     |                   |
|        |                    |     guarantee    | ```{=html}        |
|        |                    |     for each     | <!-- -->          |
|        |                    |     shipment     | ```               |
|        |                    |     (only        | -   V. C. 5.32 -  |
|        |                    |     tree-picked  |     UV Processing |
|        |                    |     fruit was    |     Systems       |
|        |                    |     supplied),   |                   |
|        |                    |     culling to   | -   V. C. 5.33    |
|        |                    |     remove       |     High Pressure |
|        |                    |     damaged      |     Processing    |
|        |                    |     fruit that   |     Systems       |
|        |                    |     may have     |                   |
|        |                    |     pathogens in | -   V. C. 5.34 -- |
|        |                    |     edible       |     Dense Phase   |
|        |                    |     portion,     |     CO~2~         |
|        |                    |     wa           |     Processing    |
|        |                    | shing/sanitizing |     Systems       |
|        |                    |     fruit        |                   |
|        |                    |     surface,     | ```{=html}        |
|        |                    |     extraction   | <!-- -->          |
|        |                    |     process that | ```               |
|        |                    |     minimizes    | -   V. C. 3.1 and |
|        |                    |     juice/peel   |     3.2 -- For    |
|        |                    |     contact      |     fresh citrus  |
|        |                    |                  |     juices; also  |
|        |                    |                  |     Example HACCP |
|        |                    |                  |     plan for      |
|        |                    |                  |     fresh citrus  |
|        |                    |                  |     juice         |
|        |                    |                  |     in VII. B.    |
|        |                    |                  |     2.0.          |
+--------+--------------------+------------------+-------------------+
| Pa     | Patulin is a       | 1.  Supplier     | V. D. 1.2 and     |
| tulin/ | mycotoxin that can |     guarantee    | Example HACCP     |
|        | occur on rotten,   |     for each     | Plan for apple    |
| ch     | moldy, bruised or  |     shipment;    | juice in VII. B.  |
| emical | damaged apples,    |     only apples  | 1.0.              |
|        | and may occur at   |     harvested to |                   |
|        | hazardous levels   |     exclude      |                   |
|        | if such apples are |     fallen fruit |                   |
|        | used to make       |     were         |                   |
|        | juice.             |     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 or dairy      | processing       |                   |
| r      | products           | equipment        |                   |
| esidue |                    | between a milk   |                   |
| (an    |                    | run and a juice  |                   |
| unde   |                    | run              |                   |
| clared |                    |                  |                   |
| all    |                    |                  |                   |
| ergen) |                    |                  |                   |
| in     |                    |                  |                   |
| ju     |                    |                  |                   |
| ice/ch |                    |                  |                   |
| emical |                    |                  |                   |
| :::    |                    |                  |                   |
+--------+--------------------+------------------+-------------------+
| Fra    | Glass fragments in | Check processing | V. E. 1.1         |
| gments | juice can pose a   | line for         |                   |
| from   | risk of injury if  | evidence of      |                   |
| glass  | ingested           | glass breakage   |                   |
| conta  |                    | (if containers   |                   |
| iners/ |                    | are mechanically |                   |
|        |                    | handled)         |                   |
| ph     |                    |                  |                   |
| 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 a   | for evidence of  |                   |
| gments | risk of injury 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 |                   |
|        |                    | (if the metal is |                   |
|        |                    | ferrous, e.g., a |                   |
|        |                    | steel grinder    |                   |
|        |                    | blade)           |                   |
+--------+--------------------+------------------+-------------------+

####### 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}
<!-- -->
```
1.  **Juice HACCP Alliance Training Curriculum**

The Juice HACCP Alliance has produced 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.[^14] In a
guidance document entitled "Standardized Training Curriculum for
Application of HACCP Principles to Juice Processing" (see section I. C.
for availability information) FDA has advised that this manual, the
1^st^ Edition of the Juice HACCP Training Curriculum of the Juice HACCP
Alliance (the standardized curriculum), is adequate for use in training
individuals to meet the requirements of the juice HACCP regulation in 21
CFR 120.13 issued. FDA also stated that 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 is available for purchase from
the National Center for Food Safety and Technology at the Illinois
Institute of Technology, and is 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, we recommend that as you develop your hazard analysis and
HACCP plan, you consider whether other control measures, monitoring
activities, and verification activities, etc., are appropriate for your
particular process. Most importantly, in your hazard analysis, we
recommend that you should consider the factors that are specific to your
juice and your process, and any unique conditions in your facility, to
identify appropriate control measures for your HACCP plan.

**A. Hazard Analysis Examples**

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

**1.1 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* may 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.

**1.2 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**

-   Because 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 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.

*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.*

> **2.0 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
    sanitizer 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 control |       |
| gredient/ | *Identify | **Are  | your      | measure(s) can | **Is  |
| p         | potential | any    | decision  | be applied to  | this  |
| rocessing | hazards   | pot    | for       | prevent the    | step  |
| step**    | in        | ential | Column    | significant    | a     |
|           | troduced, | food-  | 3**       | hazards?**     | Cri   |
|           | co        | safety |           |                | tical |
|           | ntrolled, | h      |           |                | Co    |
|           | or        | azards |           |                | ntrol |
|           | enhanced  | si     |           |                | Poi   |
|           | at this   | gnific |           |                | nt?** |
|           | step**    | ant?** |           |                |       |
|           |           |        |           |                | **    |
|           |           | **     |           |                | (Yes/ |
|           |           | (Yes/N |           |                | No)** |
|           |           | o)\*** |           |                |       |
+-----------+-----------+--------+-----------+----------------+-------+
| **Re      | ## Biol   | Yes    | History   | Pasteurization | No    |
| ceiving** | ogical(B) |        | of        |                |       |
|           |  -- Veget | No     | outbreaks | Supplier       | #     |
| **(raw    | ative and |        | for apple | guarantee      |       |
| apples)** |  protozoa | Yes    | juice.    | (apples        | No    |
|           | n enteric |        |           | harvested to   |       |
|           |  pathogen |        | #         | exclude fallen | Yes   |
|           | s (i.e.,  |        |           | fruit) and     |       |
|           | *E.coli*  |        | #         | culling or     |       |
|           | O157:H7 a |        |           | trimming       |       |
|           | nd *Crypt |        | #         | defective      |       |
|           | osporidiu |        |           | (i.e., moldy,  |       |
|           | m parvum* |        | #         | rotten,        |       |
|           | ) {#biolo |        |           | bruised and    |       |
|           | gicalb-ve |        | #         | damaged)       |       |
|           | getative- |        |           | apples.        |       |
|           | and-proto |        | # In U    |                |       |
|           | zoan-ente |        | .S. grown |                |       |
|           | ric-patho |        |  produce, |                |       |
|           | gens-i.e. |        |  unapprov |                |       |
|           | -e.coli-o |        | ed pestic |                |       |
|           | 157h7-and |        | ide resid |                |       |
|           | -cryptosp |        | ues occur |                |       |
|           | oridium-p |        |  infreque |                |       |
|           | arvum .un |        | ntly and  |                |       |
|           | numbered} |        | public he |                |       |
|           |           |        | alth impa |                |       |
|           | **Chemica |        | ct is typ |                |       |
|           | l(C)**--- |        | ically no |                |       |
|           |           |        | t severe. |                |       |
|           | 1\.       |        |           |                |       |
|           | P         |        | :         |                |       |
|           | esticides |        | :: Defini |                |       |
|           |           |        | tion-Term |                |       |
|           | 2\.       |        | May have  |                |       |
|           | Patulin   |        | adverse   |                |       |
|           |           |        | effects   |                |       |
|           | **Phys    |        | :::       |                |       |
|           | ical(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 control |       |
| gredient/ | *Identify | **Are  | your      | measure(s) can | **Is  |
| p         | potential | any    | decision  | be applied to  | this  |
| rocessing | hazards   | pot    | for       | prevent the    | step  |
| step**    | in        | ential | Column    | significant    | a     |
|           | troduced, | food-  | 3**       | hazards?**     | Cri   |
|           | c         | safety |           |                | tical |
|           | ontrolled | h      |           |                | Co    |
|           | or        | azards |           |                | ntrol |
|           | enhanced  | si     |           |                | Poi   |
|           | at this   | gnific |           |                | nt?** |
|           | step**    | ant?** |           |                |       |
|           |           |        |           |                | **    |
|           |           | **     |           |                | (Yes/ |
|           |           | (Yes/N |           |                | No)** |
|           |           | o)\*** |           |                |       |
+-----------+-----------+--------+-----------+----------------+-------+
| **Cold    | **B**     | No     | Growth    | Cull or trim   | No    |
| Storage** | ---Growth |        | not       | defective      |       |
|           | of        | Yes    | likely    | apples         |       |
|           | pathogens |        | due to    |                |       |
|           | such as   |        | the pH of |                |       |
|           | s         |        | apples.   |                |       |
|           | almonella |        |           |                |       |
|           | and *E.   |        | Patulin   |                |       |
|           | coli*     |        | levels    |                |       |
|           | O157:H7   |        | may       |                |       |
|           | due to    |        | increase  |                |       |
|           | te        |        | in        |                |       |
|           | mperature |        | storage.  |                |       |
|           | abuse     |        |           |                |       |
|           |           |        |           |                |       |
|           | **C**-    |        |           |                |       |
|           | --Patulin |        |           |                |       |
|           |           |        |           |                |       |
|           | **P       |        |           |                |       |
|           | ---**None |        |           |                |       |
+-----------+-----------+--------+-----------+----------------+-------+
| **Remove  | **B       |        |           |                |       |
| Debris**  | **---None |        |           |                |       |
|           |           |        |           |                |       |
| *         | **C       |        |           |                |       |
| *(slotted | **---None |        |           |                |       |
| hopper)** |           |        |           |                |       |
|           | **P       |        |           |                |       |
|           | ---**None |        |           |                |       |
+-----------+-----------+--------+-----------+----------------+-------+
| **Wash    | **B       | No     | Not       |                |       |
| (flume    | ---**Cont |        | likely to |                |       |
| tank)**   | amination |        | occur due |                |       |
|           | with      |        | to SSOP   |                |       |
|           | pathogens |        | for water |                |       |
|           | such as   |        | quality   |                |       |
|           | s         |        |           |                |       |
|           | almonella |        |           |                |       |
|           | from      |        |           |                |       |
|           | water     |        |           |                |       |
|           |           |        |           |                |       |
|           | **C       |        |           |                |       |
|           | ---**None |        |           |                |       |
|           |           |        |           |                |       |
|           | #         |        |           |                |       |
|           |  P---None |        |           |                |       |
+-----------+-----------+--------+-----------+----------------+-------+
| **Cull**  | **B       | Yes    | Patulin   | Cull or trim   | Yes   |
|           | ---**None |        | levels    | defective      |       |
|           |           |        | are       | apples.        |       |
|           | **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 control |       |
| gredient/ | *Identify | **Are  | your      | measure(s) can | **Is  |
| p         | potential | any    | decision  | be applied to  | this  |
| rocessing | hazards   | pot    | for       | prevent the    | step  |
| step**    | in        | ential | Column    | significant    | a     |
|           | troduced, | food-  | 3**       | hazards?**     | Cri   |
|           | c         | safety |           |                | tical |
|           | ontrolled | h      |           |                | Co    |
|           | or        | azards |           |                | ntrol |
|           | enhanced  | si     |           |                | Poi   |
|           | at this   | gnific |           |                | nt?** |
|           | step**    | ant?** |           |                |       |
|           |           |        |           |                | **    |
|           |           | **     |           |                | (Yes/ |
|           |           | (Yes/N |           |                | No)** |
|           |           | o)\*** |           |                |       |
+-----------+-----------+--------+-----------+----------------+-------+
| **        | **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       | No     | :         |                |       |
| Tank**    | ---**None |        | :: Defini |                |       |
|           |           |        | tion-Term |                |       |
|           | **C---**S |        | Not       |                |       |
|           | anitizing |        | likely to |                |       |
|           | chemicals |        | occur     |                |       |
|           |           |        | because   |                |       |
|           | **P       |        | of SSOP   |                |       |
|           | **---None |        | for       |                |       |
|           |           |        | cleaning  |                |       |
|           |           |        | and       |                |       |
|           |           |        | sa        |                |       |
|           |           |        | nitizing; |                |       |
|           |           |        | residue   |                |       |
|           |           |        | levels    |                |       |
|           |           |        | not       |                |       |
|           |           |        | r         |                |       |
|           |           |        | easonably |                |       |
|           |           |        | likely to |                |       |
|           |           |        | cause     |                |       |
|           |           |        | illness.  |                |       |
|           |           |        | :::       |                |       |
+-----------+-----------+--------+-----------+----------------+-------+

+-----------+-----------+--------+-----------+----------------+-------+
| **(1)**   | **(2)**   | *      | **(4)**   | **(5)**        | **    |
|           |           | *(3)** |           |                | (6)** |
| **In      | *         |        | **Justify | **What control |       |
| gredient/ | *Identify | **Are  | your      | measure(s) can | **Is  |
| p         | potential | any    | decision  | be applied to  | this  |
| rocessing | hazards   | pot    | for       | prevent the    | step  |
| step**    | in        | ential | Column    | significant    | a     |
|           | troduced, | food-  | 3**       | hazards?**     | Cri   |
|           | c         | safety |           |                | tical |
|           | ontrolled | h      |           |                | Co    |
|           | or        | azards |           |                | ntrol |
|           | enhanced  | si     |           |                | Poi   |
|           | at this   | gnific |           |                | nt?** |
|           | step**    | ant?** |           |                |       |
|           |           |        |           |                | **    |
|           |           | **     |           |                | (Yes/ |
|           |           | (Yes/N |           |                | No)** |
|           |           | o)\*** |           |                |       |
+-----------+-----------+--------+-----------+----------------+-------+
| **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       | No     | :         |                |       |
| Tank**    | ---**None |        | :: Defini |                |       |
|           |           |        | tion-Term |                |       |
|           | **C---**S |        | Not       |                |       |
|           | anitizing |        | likely to |                |       |
|           | chemicals |        | occur     |                |       |
|           |           |        | because   |                |       |
|           | **P       |        | of SSOP   |                |       |
|           | **---None |        | for       |                |       |
|           |           |        | cleaning  |                |       |
|           |           |        | and       |                |       |
|           |           |        | sa        |                |       |
|           |           |        | nitizing; |                |       |
|           |           |        | residue   |                |       |
|           |           |        | levels    |                |       |
|           |           |        | not       |                |       |
|           |           |        | r         |                |       |
|           |           |        | easonably |                |       |
|           |           |        | likely to |                |       |
|           |           |        | cause     |                |       |
|           |           |        | illness.  |                |       |
|           |           |        | :::       |                |       |
+-----------+-----------+--------+-----------+----------------+-------+
| **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

**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 treatment 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. For this example, we assume that the processor has data
of the type discussed in section IV. C. 1.32, indicating that there were
no occurrences of metal fragments in the juice, and thus was able to
conclude that the potential hazard of metal fragments from the
extraction equipment was not reasonably likely to occur.

**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 of
    (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 using a process that limits juice/peel contact.

-   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 control    | )** |
| redient/ | Identify | *    | your       | measure(s) can be |     |
| pr       | p        | *Are | decision   | applied to        | *   |
| ocessing | otential | any  | for Column | prevent           | *Is |
| step**   | hazards  | p    | 3**        | /reduce/eliminate | t   |
|          | int      | oten |            | the hazard?**     | his |
|          | roduced, | tial |            |                   | 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 |      | Pathogens  | agreement         |     |
| eiving** | athogens | No   | in raw     | specifying that   | No  |
|          | (Sa      |      | fruit have | only tree-picked  |     |
| **(raw   | lmonella | No   | been known | fruit will be     | No  |
| fruit)** | spp. was |      | to cause   | supplied, culling |     |
|          | de       |      | illness    | to remove damaged |     |
|          | termined |      |            | fruit that may    |     |
|          | to be    |      | C -- In    | contain pathogens |     |
|          | the      |      | U.S.       | in edible         |     |
|          | p        |      | produce,   | portion, brush    |     |
|          | ertinent |      | unapproved | washing and       |     |
|          | microo   |      | pesticide  | sanitizing fruit. |     |
|          | rganism) |      | residues   |                   |     |
|          |          |      | occur      |                   |     |
|          | C*       |      | in         |                   |     |
|          | *---**Pe |      | frequently |                   |     |
|          | sticides |      | and public |                   |     |
|          |          |      | health     |                   |     |
|          | P**-     |      | impact is  |                   |     |
|          | --**None |      | typically  |                   |     |
|          |          |      | not severe |                   |     |
+----------+----------+------+------------+-------------------+-----+
| **2.     | B**-     | No   |            |                   | No  |
| Inspect, | --**None |      |            |                   |     |
| Wash,    |          |      |            |                   |     |
| Cold     | C**-     |      |            |                   |     |
| S        | --**None |      |            |                   |     |
| torage** |          |      |            |                   |     |
|          | P**-     |      |            |                   |     |
|          | --**None |      |            |                   |     |
+----------+----------+------+------------+-------------------+-----+
| **3.     | B        | Yes  | Pathogens  | Cull visually     | Yes |
| Primary  | **---**P |      | in raw     | damaged fruit,    |     |
| cull**   | athogens |      | fruit have | e.g., punctures,  |     |
|          |          |      | been known | splitting, cuts,  |     |
|          |          |      | to cause   | rot, mold in peel |     |
|          |          |      | illness    |                   |     |
+----------+----------+------+------------+-------------------+-----+

**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**

+----------+----------+------+------------+-------------------+-----+
| **(1)**  | **(2)**  | **(  | **(4)**    | **(5)**           | *   |
|          |          | 3)** |            |                   | *(6 |
| **Ing    | **       |      | **Justify  | **What control    | )** |
| redient/ | Identify | *    | your       | measure(s) can be |     |
| pr       | p        | *Are | decision   | applied to        | *   |
| ocessing | otential | any  | for Column | prevent           | *Is |
| step**   | hazards  | p    | 3**        | /reduce/eliminate | t   |
|          | int      | oten |            | the hazard?**     | his |
|          | roduced, | tial |            |                   | 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 |
|          |          |      |            |                   | )** |
+----------+----------+------+------------+-------------------+-----+
| **4.     | B        | No   | Not likely |                   |     |
| Potable  | **---**P |      | to occur   |                   |     |
| Water    | athogens |      | due to     |                   |     |
| Rinse**  | from     |      | SSOP for   |                   |     |
|          | water    |      | water      |                   |     |
|          |          |      | quality.   |                   |     |
|          | C**-     |      |            |                   |     |
|          | --**None |      |            |                   |     |
|          |          |      |            |                   |     |
|          | P**-     |      |            |                   |     |
|          | --**None |      |            |                   |     |
+----------+----------+------+------------+-------------------+-----+
| **5.     | B        | Yes  | B --       | ::                | Yes |
| Sa       | **---**P |      | Pathogens  | : Definition-Term |     |
| nitize** | athogens |      | in raw     | Sanitized wash    |     |
|          |          |      | fruit have | used to achieve   |     |
|          |          |      | been known | portion of        |     |
|          |          |      | to cause   | cumulative 5-log  |     |
|          |          |      | illness    | pathogen          |     |
|          |          |      |            | reduction         |     |
|          |          |      |            | :::               |     |
+----------+----------+------+------------+-------------------+-----+
| **6.     | B        | Yes  | B --       | Sanitized wash    | Yes |
| Brush    | **---**P |      | Pathogens  | used with brusher |     |
| Washing  | athogens |      | in raw     | used to achieve   |     |
| with     |          |      | fruit have | portion of        |     |
| Deter    |          |      | been known | cumulative 5-log  |     |
| gent/San |          |      | to cause   | pathogen          |     |
| itizer** |          |      | illness    | reduction         |     |
+----------+----------+------+------------+-------------------+-----+
| **7.     | B**-     | No   |            |                   | No  |
| Grading  | --**None |      |            |                   |     |
| (s       |          |      |            |                   |     |
| econdary | C**-     |      |            |                   |     |
| cull)**  | --**None |      |            |                   |     |
|          |          |      |            |                   |     |
|          | P**-     |      |            |                   |     |
|          | --**None |      |            |                   |     |
+----------+----------+------+------------+-------------------+-----+
| **8.     | B        | Yes  | B **---**  | Sanitized wash    | Yes |
| Re-sa    | **---**P |      | Pathogens  | used to achieve   |     |
| nitize** | athogens |      | in raw     | portion of        |     |
|          |          |      | fruit have | cumulative 5-log  |     |
|          |          |      | been known | pathogen          |     |
|          |          |      | to cause   | reduction         |     |
|          |          |      | illness    |                   |     |
+----------+----------+------+------------+-------------------+-----+

<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 control 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<strong>—</strong>None</p>
<p>P<strong>—</strong>Metal fragments</p></td>
<td>P<strong>—</strong>No</td>
<td>P – Processor has metal detector data for more than one year showing
that no metal fragments capable of causing injury have occurred in juice
from the extraction equipment</td>
<td></td>
<td>No **</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<strong>—</strong>None</p>
<p>C<strong>—</strong>None</p>
<p>P<strong>—</strong>None</p></td>
<td></td>
<td></td>
<td></td>
<td>No</td>
<td colspan="4"></td>
</tr>
<tr class="even">
<td><ol start="11" type="1">
<li><p><strong>Batch in chilled surge tank</strong></p></li>
</ol></td>
<td><p>B<strong>—</strong>None</p>
<p>C<strong>—</strong>None</p>
<p>P<strong>—</strong>None</p></td>
<td>No</td>
<td></td>
<td></td>
<td>No</td>
<td colspan="4"></td>
</tr>
<tr class="odd">
<td><strong>12. Package, cap</strong></td>
<td><p>B<strong>—</strong>None</p>
<p>C<strong>—</strong>None</p>
<p>P<strong>—</strong>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 extractor is of a design that
facilitates the 5-log pathogen reduction by limiting juice/peel contact
during extraction, and 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 control    | )** |
| redient/ | Identify | *    | your       | measure(s) can be |     |
| pr       | p        | *Are | decision   | applied to        | *   |
| ocessing | otential | any  | for Column | prevent           | *Is |
| step**   | hazards  | p    | 3**        | /reduce/eliminate | t   |
|          | int      | oten |            | the hazard?**     | his |
|          | roduced, | tial |            |                   | 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 |
|          |          |      |            |                   | )** |
+----------+----------+------+------------+-------------------+-----+
| **13.    | B**-     | No   |            |                   | No  |
| Label,   | --**None |      |            |                   |     |
| case,    |          |      |            |                   |     |
| pal      | C**-     |      |            |                   |     |
| letize** | --**None |      |            |                   |     |
|          |          |      |            |                   |     |
|          | P**-     |      |            |                   |     |
|          | --**None |      |            |                   |     |
+----------+----------+------+------------+-------------------+-----+
| **14.    | B**-     | No   |            |                   | No  |
| Store,   | --**None |      |            |                   |     |
| ship**   |          |      |            |                   |     |
|          | 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

# 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 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
unpasteurized 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 unpasteurized 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 the juice
    is pumped to a jacketed surge tank.

-   Incoming juice (unpasteurized) 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                 | No  |
| Rec      | **---**P |      | **Possible | **---**Controlled |     |
| eiving/S | athogens | No   | presence   | at the            | No  |
| taging** | (Sa      |      | of         | pasteurization    |     |
|          | lmonella |      | pathogens  | step.             |     |
| **(raw   | spp.     |      | on         |                   |     |
| fruit)** | were     |      | incoming   |                   |     |
|          | de       |      | fruit      |                   |     |
|          | termined |      |            |                   |     |
|          | to be    |      | C**---**In |                   |     |
|          | the      |      | U.S.       |                   |     |
|          | p        |      | produce,   |                   |     |
|          | ertinent |      | unapproved |                   |     |
|          | microo   |      | pesticide  |                   |     |
|          | rganism) |      | residues   |                   |     |
|          |          |      | occur      |                   |     |
|          | C*       |      | in         |                   |     |
|          | *---**Pe |      | frequently |                   |     |
|          | sticides |      | and public |                   |     |
|          |          |      | health     |                   |     |
|          | P**-     |      | impact is  |                   |     |
|          | --**None |      | typically  |                   |     |
|          |          |      | not severe |                   |     |
+----------+----------+------+------------+-------------------+-----+
| **2.     | B**-     | No   |            |                   | No  |
| Dest     | --**None |      |            |                   |     |
| emming** |          |      |            |                   |     |
|          | C**-     |      |            |                   |     |
|          | --**None |      |            |                   |     |
|          |          |      |            |                   |     |
|          | P**-     |      |            |                   |     |
|          | --**None |      |            |                   |     |
+----------+----------+------+------------+-------------------+-----+
| **3.     | B**-     | No   |            |                   | No  |
| Rinse**  | --**None |      |            |                   |     |
|          |          |      |            |                   |     |
|          | 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 |
|          |          | **   |            |                   | ?** |
|          |          | (Yes |            |                   |     |
|          |          | /No) |            |                   | **( |
|          |          | \*** |            |                   | Yes |
|          |          |      |            |                   | /No |
|          |          |      |            |                   | )** |
+----------+----------+------+------------+-------------------+-----+
| **4.     | B**-     | No   |            |                   | No  |
| Primary  | --**None |      |            |                   |     |
| C        |          |      |            |                   |     |
| ulling** | C**-     |      |            |                   |     |
|          | --**None |      |            |                   |     |
|          |          |      |            |                   |     |
|          | P**-     |      |            |                   |     |
|          | --**None |      |            |                   |     |
+----------+----------+------+------------+-------------------+-----+
| **5. Bin | B**-     | No   |            |                   | No  |
| S        | --**None |      |            |                   |     |
| torage** |          |      |            |                   |     |
|          | C**-     |      |            |                   |     |
|          | --**None |      |            |                   |     |
|          |          |      |            |                   |     |
|          | P**-     |      |            |                   |     |
|          | --**None |      |            |                   |     |
+----------+----------+------+------------+-------------------+-----+
| **6.     | B**-     | No   |            |                   | No  |
| Rinse    | --**None |      |            |                   |     |
| and      |          |      |            |                   |     |
| Brush    | C**-     |      |            |                   |     |
| Wash     | --**None |      |            |                   |     |
| w/Det    |          |      |            |                   |     |
| ergent** | P**-     |      |            |                   |     |
| **San    | --**None |      |            |                   |     |
| itizer** |          |      |            |                   |     |
+----------+----------+------+------------+-------------------+-----+
| **7.     | B**-     | No   |            |                   | No  |
| Potable  | --**None |      |            |                   |     |
| Water    |          |      |            |                   |     |
| Rinse**  | C**-     |      |            |                   |     |
|          | --**None |      |            |                   |     |
|          |          |      |            |                   |     |
|          | P**-     |      |            |                   |     |
|          | --**None |      |            |                   |     |
+----------+----------+------+------------+-------------------+-----+
| **8.     | B**-     | No   |            |                   | No  |
| Final    | --**None |      |            |                   |     |
| C        |          |      |            |                   |     |
| ulling** | C**-     |      |            |                   |     |
|          | --**None |      |            |                   |     |
|          |          |      |            |                   |     |
|          | P**-     |      |            |                   |     |
|          | --**None |      |            |                   |     |
+----------+----------+------+------------+-------------------+-----+
| **9.     | B**-     | No   |            |                   | No  |
| Sizing** | --**None |      |            |                   |     |
|          |          |      |            |                   |     |
|          | 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 |
|          |          | **   |            |                   | ?** |
|          |          | (Yes |            |                   |     |
|          |          | /No) |            |                   | **( |
|          |          | \*** |            |                   | Yes |
|          |          |      |            |                   | /No |
|          |          |      |            |                   | )** |
+----------+----------+------+------------+-------------------+-----+
| **10.    | B**-     | No   | Not likely | P -- Controlled   | No  |
| Extr     | --**None |      | to occur   | at screen step    | --  |
| action** |          | Yes  | due to     |                   | c   |
|          | C*       |      | pr         |                   | ont |
|          | *---**Lu |      | eventative |                   | rol |
|          | bricants |      | m          |                   | led |
|          |          |      | aintenance |                   | at  |
|          | P**--    |      | SSOP and   |                   | scr |
|          | -**Metal |      | use of     |                   | een |
|          | f        |      | food grade |                   | s   |
|          | ragments |      | l          |                   | tep |
|          |          |      | ubricants. |                   |     |
|          |          |      |            |                   |     |
|          |          |      | Metal      |                   |     |
|          |          |      | fragments  |                   |     |
|          |          |      | from       |                   |     |
|          |          |      | extraction |                   |     |
|          |          |      | equipment  |                   |     |
|          |          |      | due to     |                   |     |
|          |          |      | wear,      |                   |     |
|          |          |      | metal      |                   |     |
|          |          |      | fatigue,   |                   |     |
|          |          |      | and        |                   |     |
|          |          |      | breakage   |                   |     |
|          |          |      | may cause  |                   |     |
|          |          |      | injury if  |                   |     |
|          |          |      | ingested   |                   |     |
+----------+----------+------+------------+-------------------+-----+
| **11.    | B*       | Yes  | Possible   | B -- Controlled   | No  |
| Receipt  | *---**Pa |      | presence   | at the            |     |
| of       | thogens, |      | of         | pasteurization    |     |
| un-pas   | Sa       |      | pathogens  | step              |     |
| teurized | lmonella |      | in         |                   |     |
| juice in | spp.     |      | unp        |                   |     |
| t        |          |      | asteurized |                   |     |
| ankers** | C**-     |      | juice      |                   |     |
|          | --**None |      |            |                   |     |
|          |          |      |            |                   |     |
|          | P**-     |      |            |                   |     |
|          | --**None |      |            |                   |     |
|          | --       |      |            |                   |     |
|          | (metal   |      |            |                   |     |
|          | f        |      |            |                   |     |
|          | ragments |      |            |                   |     |
|          | are      |      |            |                   |     |
|          | handled  |      |            |                   |     |
|          | under    |      |            |                   |     |
|          | s        |      |            |                   |     |
|          | hipper's |      |            |                   |     |
|          | HACCP    |      |            |                   |     |
|          | plan)    |      |            |                   |     |
+----------+----------+------+------------+-------------------+-----+
| 12. *    | B**-     | No   |            |                   | No  |
| *Blend** | --**None |      |            |                   |     |
|          |          |      |            |                   |     |
|          | C**-     |      |            |                   |     |
|          | --**None |      |            |                   |     |
|          |          |      |            |                   |     |
|          | P**-     |      |            |                   |     |
|          | --**None |      |            |                   |     |
+----------+----------+------+------------+-------------------+-----+
| 12       | B*       | Yes  | Possible   | Pasteurization    | Yes |
| . **Past | *---**Pa |      | presence   |                   |     |
| eurize** | thogens, |      | of         |                   |     |
|          | Sa       |      | pathogens  |                   |     |
|          | lmonella |      | on         |                   |     |
|          | spp.     |      | incoming   |                   |     |
|          |          |      | fruit and  |                   |     |
|          | C**-     |      | in         |                   |     |
|          | --**None |      | unp        |                   |     |
|          |          |      | asteurized |                   |     |
|          | P**-     |      | juice      |                   |     |
|          | --**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 |
|          |          | **   |            |                   | ?** |
|          |          | (Yes |            |                   |     |
|          |          | /No) |            |                   | **( |
|          |          | \*** |            |                   | Yes |
|          |          |      |            |                   | /No |
|          |          |      |            |                   | )** |
+----------+----------+------+------------+-------------------+-----+
| **14.    | B**-     | No   |            |                   | No  |
| Chill**  | --**None |      |            |                   |     |
|          |          |      |            |                   |     |
|          | C**-     |      |            |                   |     |
|          | --**None |      |            |                   |     |
|          |          |      |            |                   |     |
|          | P**-     |      |            |                   |     |
|          | --**None |      |            |                   |     |
+----------+----------+------+------------+-------------------+-----+
| **15.    | B**-     | No   |            |                   | No  |
| Surge    | --**None |      |            |                   |     |
| Tank**   |          |      |            |                   |     |
|          | C**-     |      |            |                   |     |
|          | --**None |      |            |                   |     |
|          |          |      |            |                   |     |
|          | P**-     |      |            |                   |     |
|          | --**None |      |            |                   |     |
+----------+----------+------+------------+-------------------+-----+
| **16.    | B**-     | Yes  | Eliminates | Screen            | Yes |
| Screen** | --**None |      | metal      |                   |     |
|          |          |      | fragments  |                   |     |
|          | C**-     |      | introduced |                   |     |
|          | --**None |      | at         |                   |     |
|          |          |      | extraction |                   |     |
|          | P**--    |      | step       |                   |     |
|          | -**Metal |      |            |                   |     |
|          | f        |      |            |                   |     |
|          | ragments |      |            |                   |     |
+----------+----------+------+------------+-------------------+-----+
| **17.    | B**-     | No   |            |                   | No  |
| Fill in  | --**None |      |            |                   |     |
| C        |          |      |            |                   |     |
| artons** | C**-     |      |            |                   |     |
|          | --**None |      |            |                   |     |
|          |          |      |            |                   |     |
|          | P**-     |      |            |                   |     |
|          | --**None |      |            |                   |     |
+----------+----------+------+------------+-------------------+-----+
| **18.    | B**-     | No   |            |                   | No  |
| Seal     | --**None |      |            |                   |     |
| C        |          |      |            |                   |     |
| artons** | 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 |
|          |          | **   |            |                   | ?** |
|          |          | (Yes |            |                   |     |
|          |          | /No) |            |                   | **( |
|          |          | \*** |            |                   | Yes |
|          |          |      |            |                   | /No |
|          |          |      |            |                   | )** |
+----------+----------+------+------------+-------------------+-----+
| **19.    | B**-     | No   |            |                   | No  |
| Code,    | --**None |      |            |                   |     |
| case,    |          |      |            |                   |     |
| pal      | C**-     |      |            |                   |     |
| letize** | --**None |      |            |                   |     |
|          |          |      |            |                   |     |
|          | P**-     |      |            |                   |     |
|          | --**None |      |            |                   |     |
+----------+----------+------+------------+-------------------+-----+
| **20.    | B**-     | No   |            |                   | No  |
| Store**  | --**None |      |            |                   |     |
|          |          |      |            |                   |     |
|          | C**-     |      |            |                   |     |
|          | --**None |      |            |                   |     |
|          |          |      |            |                   |     |
|          | P**-     |      |            |                   |     |
|          | --**None |      |            |                   |     |
+----------+----------+------+------------+-------------------+-----+
| **21.    | B**-     | No   |            |                   | No  |
| Ship**   | --**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

# 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 example 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 we recommend be included in
the plan.

<table>
<colgroup>
<col style="width: 8%" />
<col style="width: 5%" />
<col style="width: 8%" />
<col style="width: 7%" />
<col style="width: 8%" />
<col style="width: 7%" />
<col style="width: 7%" />
<col style="width: 7%" />
<col style="width: 9%" />
<col style="width: 28%" />
</colgroup>
<tbody>
<tr class="odd">
<td rowspan="2"></td>
<td rowspan="2"></td>
<td rowspan="2"></td>
<td colspan="4"></td>
<td rowspan="2"></td>
<td rowspan="2"></td>
<td rowspan="2"></td>
</tr>
<tr class="even">
<td><h2 id="section-30"></h2>
<h2 id="section-31" class="unnumbered"></h2></td>
<td><h2 id="section-32"></h2>
<h2 id="section-33" class="unnumbered"></h2></td>
<td><h2 id="section-34"></h2>
<h2 id="section-35" class="unnumbered"></h2></td>
<td><h2 id="section-36"></h2>
<h2 id="section-37"></h2></td>
</tr>
<tr class="odd">
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
</tbody>
</table>

**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-38"></h2>
<h2 id="what" class="unnumbered">What</h2></td>
<td><h2 id="section-39"></h2>
<h2 id="how" class="unnumbered">How</h2></td>
<td><h2 id="section-40"></h2>
<h2 id="frequency" class="unnumbered">Frequency</h2></td>
<td><h2 id="section-41"></h2>
<h1 id="who">Who</h1></td>
</tr>
<tr class="odd">
<td><p>CCP1</p>
<p>Receiv-ing</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 guaran-tee exists for each income-ing ship-ment of
fruit.</td>
<td>Supplier guaran-tee is visually confirmed.</td>
<td>Each incoming fruit shipment</td>
<td>Receiv-ing 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>Undam-aged apples<a href="#fn1" class="footnote-ref" id="fnref1"
role="doc-noteref"><sup>1</sup></a></td>
<td>Moldy, rotten, bruised or other-wise dam-aged apples</td>
<td>Visual inspect-tion</td>
<td>Continu-ous</td>
<td>Culling inspect-tor</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 inclu-sion</td>
<td>Screen is intact and in place</td>
<td>Integrity of screen</td>
<td>Visual</td>
<td>Daily</td>
<td><p>Produc-tion</p>
<p>Employee</p></td>
<td><p>Segregate product and rework to eliminate metal pieces, run
product through metal detector, 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>Pasteur-ize</p></td>
<td><em>E. coli</em> O157:H7 and <em>Crypto-sporidi-um parvum</em></td>
<td><p>Minimum</p>
<p>160°F and 6 seconds (provides a 5-log reduction)</p></td>
<td><p>1.Temp-erature of juice</p>
<p>2. Flow rate</p></td>
<td><p>1.Temp-erature recorder</p>
<p>2. Visual check of positive displace-ment pump setting</p></td>
<td><p>Continuous monitor-ing with visual check hourly</p>
<p>Daily</p></td>
<td><p>Pasteur-izer</p>
<p>operator</p>
<p>Pasteur-izer operator</p></td>
<td><p>Segregate and hold affected product for evaluation, destroy, or
divert to nonfood use</p>
<p>AND</p>
<p>Adjust pasteurizer (temperature or flow rate) to achieve the critical
limit.</p>
<p>AND</p>
<p>Reprocess any product that did not undergo 5-log pathogen
reduction</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>Thermo-3meter 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 packed in plastic bottles. For this example, surface
treatment of the orange peel is performed to achieve the 5-log pathogen
reduction. The excerpts in this example show five critical control
points (steps 1, 3, 5, 6, and 8 in the summary table shown in the Hazard
Analysis example for this juice) for ensuring that the incoming fruit is
properly culled to remove damaged fruit that may contain pathogens in
the edible portion of the fruit, that the orange peel is effectively
sanitized to achieve a cumulative 5-log pathogen reduction before
extracting the juice.

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 an extraction process, which limits
juice/peel contact during the extraction operation.

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

# Table 6. Excerpts from Summary HACCP Plan 

<table>
<colgroup>
<col style="width: 9%" />
<col style="width: 9%" />
<col style="width: 9%" />
<col style="width: 8%" />
<col style="width: 8%" />
<col style="width: 8%" />
<col style="width: 8%" />
<col style="width: 9%" />
<col style="width: 11%" />
<col style="width: 13%" />
</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 accompan-ied 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 concen-tration 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, 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, 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 style="width:100%;">
<colgroup>
<col style="width: 9%" />
<col style="width: 9%" />
<col style="width: 9%" />
<col style="width: 7%" />
<col style="width: 9%" />
<col style="width: 11%" />
<col style="width: 7%" />
<col style="width: 10%" />
<col style="width: 10%" />
<col style="width: 14%" />
</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 appropri-ate 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 or belt speed to achieve
critical limit, AND segregate and hold affected product for evaluation,
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>(process-sor should include appropri-ate 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>

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

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

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

#  {#section-42}

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 we
recommend 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>Pasteuriza-tion</p></td>
<td><p>Pathogens--</p>
<p><em>Salmonella</em></p></td>
<td><p>Minimum 160 deg. F</p>
<p>AND</p>
<p>Min. 3 sec. Hold loop</p></td>
<td><p>Tempera-ture</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><p>Isolate affected product.</p>
<p>Reprocess, destroy, or divert (to non-food use) the affected
product</p>
<p>Adjust pasteurizer to achieve critical limit.</p></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 intact and in place</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, run
product through metal detector, 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>Calibra-tion log.</p></td>
</tr>
</tbody>
</table>

##  {#section-43 .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-44}

**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 or dairy products 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,
dairy products, or juice that indicates what foods were processed using
the equipment and the time of the processing. 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 efficacy of the cleaning procedure will be monitored by
swabbing the surfaces of the equipment and testing the swabs for milk
protein residue.

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.

Weekly Equipment Log

  ----------------------- ------------------------ ----------------------
  Equipment               Food Processed           Swab Test Result
                          (date/time)              

  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 change-over from product contain-ing a known food
allergen to product that does not contain that allergenic material.</p>
<p>Equip-ment cleaning <u>after</u> produc-ing the allergen-contain-ing
product, prior to produc-ing the non-allergen (or different allergen)
contain-ing product.</p></td>
<td><p>Chemical –undeclared food allergen</p>
<p>Product changeover presents an unintention-al 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 parame-ters</td>
<td>Moni-toring devices used to measure cleaning parame-ters</td>
<td colspan="2">Every time the cleaning process is performed</td>
<td><div class="Definition-Term">
<p>Operator</p>
</div></td>
<td><p><strong><u>During cleaning</u>:</strong> If monitoring indicates
non-compliance with the critical limits, use alternate methodolo-gy to
clean the equipment surfaces to remove the residue prior to running the
non-allergen (or different allergen) containing product, and document
the cleaning 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 verifica-tion records</td>
</tr>
</tbody>
</table>

[^1]: This guidance has been prepared by the Division of Plant Product
    Safety in the Center for Food Safety and Applied Nutrition (CFSAN)
    at the U.S. Food and Drug Administration.

[^2]: Except for high Brix juice concentrates and certain shelf-stable
    juices as discussed in section V. C. 2.0.

[^3]: Comments on the draft of this guidance requested clarification on
    how to classify probable hazards, i.e., "reasonably likely to
    occur," or "not reasonably likely to occur," that fall under the
    realm of facility sanitation related hazards that may be addressed
    under SSOPs or under the HACCP plan (at the processor's option). We
    believe that it is only necessary to classify this type of hazard as
    "reasonably likely to occur" when you have opted to control the
    hazard through your HACCP plan at a CCP, as we have recommended in
    Section IV. C. 3.3 for undeclared allergens in juice arising from
    inadequately cleaned processing equipment previously used to process
    milk. If you have opted to control a facility sanitation related
    hazard through your SSOPs, it is not necessary to classify it as
    reasonably likely to occur.

[^4]: 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.

[^5]: 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.

[^6]: 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.

[^7]: 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.

[^8]: 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.

[^9]: 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.

[^10]: See Hanes, D.E., Orlandi, P.A., Burr, D.H., Miliotis, M.D., Robl,
    M.G., Bier, J.W., Arrowood, M.J., Churey, J.J., Jackson, G.J., and
    Worobo, R.W., Inactivation of *Crytposporidium parvum* Oocysts in
    Fresh Apple Cider by UV Irradiation, Applied and Environmental
    Microbiology, Vol. 68 No. 8, 2002, pp. 4168-4172.

[^11]: Jackson, Lauren S., Beacham-Bowden, Tina, Keller, Susanne E.,
    Adhikari, Chaitali, Taylor, Kirk T., Chirtel, Stewart J., and
    Merker, Robert I., Apple Quality, Storage, and Washing Treatments
    Affect Patulin Levels in Apple Cider, Journal of Food Protection:
    Vol. 66, No. 4, 2003, pp. 618-624

[^12]: 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.

[^13]: Pathogens include enteric pathogens (e.g., *E. coli* O157:H7,
    *Cryptosporidium parvum,* *Salmonella spp*.) and *Listeria
    monocytogenes*, which is ubiquitous in nature.

[^14]: 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.