FSIS Compliance Guideline

HACCP Systems Validation

April 2015

This guidance document is designed to

help very small meat and poultry
establishments meet the initial
validation requirements in 9 CFR 417.4.
In particular, the guidance covers:

• The difference between initial

validation and ongoing
verification;

• How to identify scientific

support relevant to their
process;

• What are critical operational

parameters and how to identify
them in the scientific or
technical support;

• How to demonstrate that the

critical operational parameters
are being met during initial
validation (i.e., through the
collection of in-plant validation
data); and

• How an existing establishment

can incorporate this guidance
into their HACCP system.

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This Compliance Guideline follows the procedures for guidance documents in the Office
of Management and Budget’s (OMB) “Final Bulletin for Agency Good Guidance
Practices” (GGP). More information can be found on the Food Safety and Inspection
Service (FSIS) Web page.

This guidance has been revised in response to public comment. A summary of the
comments received and responses to those comments can be found at
http://www.fsis.usda.gov/wps/wcm/connect/3ba826ec-6e79-4f17-85fc-
29200f4e8d05/2009-0019-2015.pdf?MOD=AJPERES. It is important to note that this
Guideline represents FSIS’s current thinking on this topic and should be considered
usable as of this issuance.

Purpose
The purpose of this guidance document is to aid small and very small establishments in
meeting the initial validation requirements in 9 CFR 417.4. This document provides
guidance to assist establishments in meeting FSIS regulations. Guidance represents
best practice recommendations by FSIS, based on the best scientific and practical
considerations, and does not represent requirements that must be met. Establishments
may choose to adopt different procedures than those outlined in the guideline, but they
would need to support why those procedures are effective.

Is this version of the guideline final?

Yes, this version of the guideline, dated April, 2015 is final. FSIS will update this
guideline as necessary should new information become available, although comments
will no longer be accepted through regulations.gov on this guideline.

What if I still have questions after I read this guideline?

If the desired information cannot be found within the Compliance Guideline, FSIS
recommends that users search the publicly posted Questions & Answers (Q&As) in the
AskFSIS database or submit questions through AskFSIS. Documenting these questions
helps FSIS improve and refine present and future versions of the Compliance Guideline
and associated issuances.

When submitting a question, use the Submit a Question tab, and enter the following
information in the fields provided:

Subject Field: Enter HACCP Systems Validation Guideline

Question Field: Enter question with as much detail as possible.
Product Field: Select General Inspection Policy from the drop-down menu.
Category Field: Select Sampling from the drop-down menu.
Policy Arena: Select Domestic (U.S.) Only from the drop-down menu.

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When all fields are complete, press Continue.

Table of Contents
Purpose ............................................................................................................................ii
Is this version of the guideline final? ................................................................................ii
What if I still have questions after I read this guideline? ...................................................ii
Who is this guidance designed for?................................................................................. 1
Why did FSIS develop this guidance document? ............................................................ 1
What concepts and skills will small and very small establishments learn from this
guidance?........................................................................................................................ 2
What is the history of validation in the context of the HACCP regulations?..................... 2
What is HACCP System Validation? ............................................................................... 4
What is the definition of a HACCP System, and do prerequisite programs have to be
validated? ........................................................................................................................ 5
What is the first element of HACCP Systems Validation? ............................................... 6
What is the second element of HACCP Systems Validation? ....................................... 20
How long does an establishment have to complete initial validation (Elements 1 and 2)?
...................................................................................................................................... 26
What types of records are validation documents, and how long should an establishment
keep them? ................................................................................................................... 28
...................................................................................................................................... 28
What is the difference between initial validation and on-going verification, and what
happens after the initial validation period is over? ......................................................... 29
References .................................................................................................................... 35
Web links....................................................................................................................... 35
Appendix 1: Examples of Food Safety Problems Linked to Inadequate Validation ...... 36
Appendix 2: Example Decision-making Document ....................................................... 39
Appendix 3: Guidance to Identify Critical Operational Parameters from Scientific or
Technical Support ......................................................................................................... 40
Appendix 4: Validation Worksheet Examples ............................................................... 43
Appendix 5: Guidance for Establishments that No Longer Have the In-Plant Validation
Data............................................................................................................................... 64

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Who is this guidance designed for?
This guideline is focused on small and very small establishments in support of the Small
Business Administration’s initiative to provide small and very small establishments with
compliance assistance under the Small Business Regulatory Flexibility Act (SBRFA).
However, all FSIS regulated meat and poultry establishments may be able to apply the
recommendations in this guideline. It is important that small and very small
establishments have access to a full range of scientific and technical support, and the
assistance needed to establish safe and effective HACCP systems. Although large
establishments can benefit from the guidance that FSIS provides, focusing the guidance
on the needs of small and very small establishments provides them with information that
may be otherwise unavailable to them.

Why did FSIS develop this guidance document?

FSIS has determined from its HACCP verification activities that many establishments
have not properly validated their systems. In particular, establishments have not
conducted adequate activities during the initial validation period to translate all the
required critical operating parameters from the scientific or technical support into their
processes and gather in-plant validation data demonstrating the HACCP plan is
functioning as intended. In addition, Agency enforcement actions have identified
instances in which inadequate validation has led to the
production of adulterated product and in some cases even
illnesses. Specific examples of when inadequate validation Agency enforcement actions
has led to the production of adulterated product and in some have identified instances in
cases illnesses are provided in Appendix 1. which inadequate validation
has led to the production of
Based on the findings from FSIS data analyses and adulterated product and in
outbreak investigations summarized in Appendix 1, FSIS some cases even illnesses
recommends that establishments use this guidance
document to ensure that their HACCP systems are properly
validated. While most establishments have assembled the
scientific or technical support for the judgments made in designing their HACCP
systems, which is the first element of initial validation, many establishments have not
gathered the necessary in-plant validation data demonstrating that the HACCP system
is functioning as intended. FSIS has also found establishments have not:

HACCP System Design Issues

• Identified scientific support that properly relates to the establishments’
current processes; or
• Identified the critical operating parameters in the scientific support
necessary for the intervention to function as intended.

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 HACCP System Execution Issues
• Translated those critical operating parameters into their HACCP systems;
or
• Documented that they have validated their HACCP systems under actual
in-plant conditions.

By ensuring that the HACCP system is designed

and executed properly, an establishment can
reduce the likelihood for product contamination
and illnesses in the future. Initial validation of any FSIS stated in the HACCP Final Rule
HACCP system must include scientific or that validation data for any HACCP
technical support related to the establishment’s system must include practical data or
process supporting the design of the HACCP information reflecting an
system along with some practical in-plant establishment’s actual experience in
validation data reflecting an establishment’s implementing the HACCP system
actual early experience in executing the HACCP
system. Validation must demonstrate not only
that the HACCP system is theoretically sound (design), but also that the establishment
can implement it and make it work (execution).

What concepts and skills will small and very small

establishments learn from this guidance?
Small and very small establishments that utilize this guidance will learn:

• The difference between initial validation and ongoing verification;

• How to identify scientific or technical support relevant to their processes;
• What are critical operational parameters and how to identify them in the
scientific and technical support; and
• How to demonstrate that the critical operational parameters are being met
during initial validation (i.e., through in-plant validation data).

Establishments that understand these topics should have the tools needed to
successfully validate their HACCP systems.

What is the history of validation in the context of the HACCP

regulations?
On July 25, 1996, FSIS published a final rule on Pathogen Reduction; Hazard Analysis
and Critical Control Point (HACCP) Systems (PR/HACCP) (61 FR 38806). The
PR/HACCP rule requires that meat and poultry establishments under Federal inspection
take responsibility for, among other things, reducing the contamination of meat and
poultry products with disease-causing (pathogenic) bacteria by implementing a system,
known as HACCP, of preventative controls designed to improve the safety of their

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 Key Requirement

products. An establishment must have an 9 CFR 417.4(a)(1) requires “upon

effective HACCP system to comply with completion of the hazard analysis and
regulatory requirements and prevent adulteration development of the HACCP plan, the
of product. establishment shall conduct activities
designed to determine that the HACCP
The HACCP requirements that establishments plan is functioning as intended. During
must meet are set out in 9 CFR Part 417. These this HACCP plan validation period, the
requirements are based on the seven HACCP establishment shall repeatedly test the
principles recommended by the National adequacy of the CCP’s, critical limits,
Advisory Committee on Microbiological Criteria monitoring and recordkeeping procedures,
for Food (NACMCF) in 1992. One of the and corrective actions set forth in the
principles identified by the NACMCF was HACCP plan. Validation also
“Verification” describing that HACCP systems encompasses reviews of the records
should be systematically verified. In the themselves, routinely generated by the
NACMCF explanation of the verification principle, HACCP system, in the context of other
which FSIS follows, an establishment is validation activities.”
responsible for the following three processes
encompassing the verification principle:

• Validation,
• Verification, and
• Reassessment

NOTE: This guidance document speaks only to the initial

validation component of the verification HACCP principle.

The recommendations in the verification principle form the Key definition

basis for the requirements in 9 CFR 417.4. This section
requires that every establishment validate the HACCP HACCP is a scientific
plan’s adequacy in controlling the food safety hazards system for process control
identified in the hazard analysis, verify that the plan is being that has long been used in
effectively implemented on an ongoing basis, and reassess food production to prevent
the plan at least annually, or when an unforeseen hazard or problems by applying
change occurs, or whenever any changes occur that could controls at points in a food
affect the hazard analysis or alter the HACCP plan. production process where
hazards could be controlled,
Although the HACCP regulations were implemented over reduced, or eliminated.
15 years ago, FSIS has found through Food Safety
Assessments (FSAs) that establishments have not The HACCP system is
complied with the initial validation requirement. In defined as the HACCP plan
particular, establishments have not collected the necessary in operation, including the
in-plant validation data demonstrating that the HACCP HACCP plan itself. The
system is functioning as intended. Therefore, FSIS HACCP plan in operation
determined that additional validation guidance for HACCP includes the hazard analysis,
systems is needed. any supporting
documentation including
prerequisite programs
supporting decisions in the
hazard analysis, and all 3
HACCP records.
What is HACCP System Validation?
Validation is the process of demonstrating that the HACCP system as designed can
adequately control potential hazards to produce a safe, unadulterated product.
Validation encompasses activities designed to determine whether the entire HACCP
system is functioning as intended. Validation of a HACCP system involves two
separate elements 1) design and 2) execution. Under 9 CFR 417.4(a)(1)
establishments are required to assemble two types of supporting documentation
to demonstrate these elements are met:

1. The scientific or technical support for the HACCP system design (design) - that is
the theoretical principles, expert advice from processing authorities, scientific or
technical data, peer-reviewed journal articles, pathogen modeling programs, or
other information demonstrating that particular process control measures can
adequately prevent, reduce, or eliminate specific hazards; and

2. The in-plant validation data (execution) - that is the in-plant observations,

measurements, microbiological test results, or other information demonstrating
the control measures in the HACCP system can perform as expected within a
particular establishment to achieve the intended food safety objective.

Under 9 CFR 417.5(a)(1) and 9 CFR 417.5(a)(2), these supporting documents must be
kept for the life of the plan. The two elements will be discussed in detail throughout this
document. In summary, to validate the HACCP system, establishments should:
•Gather scientific or technical support (e.g., published processing
guidelines, journal articles, challenge studies, etc.) for its HACCP
system that:

•Closely matches the actual process; and

Element 1:
•Shows that the establishment's process prevents, reduces, or
Scientific or eliminates the hazard identified in the hazard analysis; and
Technical
Support •Identifies the critical operational parameters from the scientific
support relevant to the establishment's process
(Design)
•Implements critical operational parameters in the actual production
process consistent with the parameters in the scientific or technical
support;

•Identifies at least one product from each HACCP category to gather

in-plant validation data;

Element 2: In- •Collects in-plant data demonstrating the effectiveness of the

plant Validation implementation of the critical operational parameters for at least one
product from each HACCP category; and
Data
•Analyzes the data to determine whether the critical operational
(Execution) parameters are being implemented effectively.
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What is the definition of a HACCP System, and do
prerequisite programs have to be validated?
Validation of the HACCP system involves validation of the critical control points in the
HACCP plan, as well as of any interventions or processes used to support decisions in
the hazard analysis. The regulations provide that "[v]alidation … encompasses reviews
of the records themselves, routinely generated by the HACCP system, in the context of
other validation activities" (9 CFR 417.4(a)(1)). Because the results obtained under
prerequisite programs could affect decisions made in the hazard analysis, an
establishment is required to maintain records associated with these programs as
supporting documentation for its hazard analysis (9 CFR 417.5(a)). Said differently,
when an establishment determines that a potential hazard is not reasonably likely to
occur because the implementation of a prerequisite program (e.g., Sanitation SOP,
written sanitary dressing procedures incorporated into prerequisite programs, purchase
specifications, antimicrobial interventions) prevents conditions that make the potential
hazard likely, that prerequisite program then becomes part of the HACCP system and
as a result, must be validated. This means that establishments must maintain scientific
or technical support for the design of those prerequisite programs used to support
decisions in the hazard analysis (Element 1 of validation) and must collect in-plant
validation data to support that the programs are implemented as designed (Element 2).

For this reason, the HACCP system rather than the HACCP plan only is discussed
throughout the rest of this document.

KEY QUESTION

Question: Are establishments required to collect in-plant microbiological data to

comply with the initial validation requirements?

Answer: FSIS encourages establishments to gather in-plant microbiological data as

part of in-plant validation data but does not require that they do so, provided that the
establishment has adequate scientific or technical support (the first element of
validation), is following the parameters in the scientific or technical support, and can
demonstrate that it can meet the critical parameters during operation through in-plant
validation data (the second element of validation). A discussion of scientific and
technical support can be found beginning on page 6 and a discussion of in-plant data
can be found beginning on page 20.

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What is the first element of HACCP Systems Validation?
The first element of HACCP systems validation is the scientific or technical
support that demonstrates that the HACCP system is theoretically sound. To meet the
first element of validation, establishments should:

• Gather scientific or technical support (e.g., published processing guidelines,

journal articles, challenge studies, etc.) for it’s HACCP system that:
o Closely matches the actual process; and
o Shows that the establishment’s process prevents, reduces, or eliminates
the hazard identified in the hazard analysis; and
• Identify the critical operational parameters from the scientific or technical support
relevant to the establishment’s process.

The scientific or technical support should reflect current thinking and not be outdated.
In order to identify scientific or technical support that closely matches the actual
process, establishments should understand the major types of scientific and technical
support documents.

What are the major types of scientific and technical support

documents used to satisfy the design element of HACCP Systems
Validation?
There are several types of documents that can be used as scientific and technical
support. These include:

1. Published processing guidelines that achieve a stated reduction of a pathogen are

examples of scientific support. The time-temperature guidelines in Appendix A of the
final rule “Performance Standards for the Production of Certain Meat and Poultry
Products” (64 FR 746-748) is an example of a guideline that addresses process
lethality. The guidelines in Appendix B, Compliance Guidelines for Cooling Heat-
Treated Meat and Poultry Products (Stabilization), address product stabilization to
meet the requirements of 9 CFR 318.17(a)(2), 9 CFR 318.23(c)(1), and 9 CFR
381.150(a)(2). Published processing guidelines are not limited to those published by
FSIS. Published guidelines from other agencies, trade organizations, or universities
can also be used as scientific support. Extension publications may also be cited as
scientific support; however, extension publications often reference the original
journal articles that were used to develop the support. In those cases,
establishments should have the original journal articles on-file referenced in the
extension publication because the extension publications often do not include all of
the critical operational parameters that establishments would need to implement.
Establishments need information on all the critical operational parameters in order to
determine whether the process in the publication matches their actual process.

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2. Peer-reviewed scientific or technical data or information that describe a process, and
the results of the process can provide adequate
scientific or technical support. This type of support
could include journal articles, graduate student theses,
or information found in a textbook. All of these types of
scientific data go through a process of evaluation
involving qualified individuals within the relevant field.
In addition to describing the microbiological results of Key definitions
the process, the data may also describe the role
intrinsic and extrinsic product factors play on the growth Intrinsic factors are those
of microorganisms. For example, a textbook may inherent parameters of a food
contain data on the growth limits of certain pathogens that affect the growth of
based on a food product’s water activity and pH. For microorganisms. Examples
journal articles, the study should relate closely to the of intrinsic factors include,
establishment’s process with regards to species, among other things, pH,
product characteristics, and equipment (to the extent moisture content, water
that the use of different equipment would result in an activity, and nutrient content.
inability to achieve the critical parameters of the study).
The establishment should use the critical operational Extrinsic factors are those
parameters cited in the journal article that achieve the parameters that are external
required or expected lethality or stabilization if the to the food that affect the
establishment does not intend to perform additional growth of microorganisms.
research to validate its process. In addition, for Examples of extrinsic factors
biological hazards, the scientific article should contain include, among other things,
microbiological data specifying the level of pathogen temperature of storage, time
reduction achieved by the intervention strategy for the of storage, and relative
target pathogen identified in the hazard analysis. A lack humidity.
of microbial data in the scientific support could raise
questions concerning whether the process design has been adequately validated.

NOTE: Most scholarly journals use a process of peer review before publishing an
article. As part of the review, scholars with expertise in the topic addressed by the
draft article critically assess the article. Peer-reviewed journals only publish articles
that have passed through a review process. The review process helps ensure that
published articles contain solid research work. If an establishment uses scientific or
technical data that is not peer-reviewed, the establishment may be subject to
additional scrutiny by Agency personnel performing verification activities.

3. Expert advice from processing authorities may also be used as scientific or technical
support. Such expert advice may include reference to established scientific
principles as well as reference to peer-reviewed scientific data. Expert advice from
processing authorities should not rely on expert opinion alone. The scientific
principles and data should relate to the establishment’s product and process as well
as the hazard identified in the hazard analysis. One example of how expert advice
may be used is a processing authority’s justification for why a different level of a
critical operational parameter from the one studied in the scientific support should

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 not impact the effectiveness of an intervention. As part of the justification, in addition
to their own expert opinion, the processing authority should cite one or more peer-
reviewed scientific data sets or documents that provide a science-based rationale for
why the different level of the critical operational parameter should be at least equally
as effective from the one in the scientific support. Another example of how expert
advice from a processing authority may be used is as support for a scheduled
process to produce a commercially sterile product. Prior to the processing of
canned product for distribution in commerce, an establishment must have a process
schedule for each canned meat or poultry product to be packed by the
establishment. The process schedule used by an establishment is developed or
determined by a processing authority. Any changes that may adversely affect the
adequacy of the process must also be evaluated by a processing authority and that
process schedule amended accordingly. When developing the process schedule,
the processing authority should take into account established scientific principles as
well as peer-reviewed scientific data in order to establish a thermal process that will
specify the amount of time at a specific temperature necessary to ensure the
destruction of Clostridium botulinum and spoilage organisms that may be present.

4. A challenge or inoculated pack study that is designed to determine the lethality or

stabilization of a process also is an example of scientific support. These studies are
performed in a laboratory or pilot plant by a processing authority or expert and
sometimes can be accessed through the internet. The documentation on file should
specify the level of pathogen reduction, elimination, or growth control (e.g., for
stabilization); describe the process, including all critical parameters affecting the
reduction or elimination; and give the source of the documentation. Such studies
are often not published in peer-reviewed journal articles but should contain the same
level of detail as is provided for peer-reviewed studies.

Challenge studies should be based on a sound statistical design (i.e., a statistical

design that ensures confidence in the data) and should also employ positive and
negative controls. The statistical design should include the number of samples
collected at each time interval and the number of study replicates needed to ensure
the validity of the study. There are quantitative methods for assessing the statistical
quality of a study (e.g., power analysis). As recommended by the National Advisory
Committee on Microbiological Criteria of Foods (NACMCF), the number of samples
to be analyzed initially and at each time interval during processing or storage should
be at least two; however, NACMCF recommends analysis of three or more samples.
According to NACMCF, replicates should also be conducted. Replicates should be
independent trials using different lots of product and inoculum to account for
variations in product, inoculum, and other factors. When the number of samples
analyzed at each time interval is only two, it is better for the study to be repeated
(replicated) more than two times. In studies with three or more samples tested at
each time interval, two replicates are usually adequate.

NOTE: For more information on conducting challenge studies, please review the
article, “Parameters for Determining Inoculated Pack/Challenge Study Protocols,”

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 published by the National Advisory Committee on Microbiological Criteria for Foods
in the Journal of Food Protection in 2010. For more information on the use of
positive and negative controls in challenge studies as well as general guidance on
how to select a microbiological testing laboratory please review FSIS’ Establishment
Guidance for the Selection of a Commercial or Private Microbiological Testing
Laboratory.

5. Pathogen modeling programs are computer-based software that, based on such

factors as growth, lethality, and survival in culture broth and food products, estimate
the growth or decline of foodborne microbes in food samples in production.
Examples of uses of pathogen modeling programs include those to support the
development of custom cooling schedules; to support product safety following
heating, cooling, and storage deviations; and to support the use level of antimicrobial
agents. Establishments may use the results of modeling programs as scientific
support provided that the establishment inputs accurate values into the modeling
program, and that the modeling program has been validated for the product in
question. Validation data for the model is often provided along with the modeling
program or can be obtained by contacting the model developer. The modeling
program chosen should also be specific for the pathogen identified in the hazard
analysis. If the modeling program has not been validated for the product in question,
the establishment should provide additional scientific support for its use. Such
additional support could include in-plant data showing routine levels of pathogens in
the product, or documentation addressing the production of the raw materials and
the product’s intended use. Establishments should have the modeling results on-file
for review and should have documentation supporting the values entered into the
model (e.g., time-temperature profile data, pH, salt concentration).

6. Data gathered by the establishment in-plant can also be used to validate a process
as part of a research study or other study. This data gathering can be done if the
establishment could not implement the process as documented in the literature
within its processing environment. Examples of this approach could be if an
establishment is introducing a new technology not established in the literature or
applying a standard technology in an unusual way (e.g., modifying critical
operational parameters from the literature). In these cases the establishment should
gather scientific support and in-plant validation data for its HACCP system under
commercial operating conditions. For example, microbiological data may show that a
steam vacuum process is achieving a certain level of reduction for the specified
microorganism. If the establishment is modifying the critical operational parameters
of the steam vacuum process then the documentation gathered in-plant used to
show that the HACCP system is valid as designed should contain information from
all the tests performed, such as temperature of steam, time of exposure, and
microbiological results of swab tests, and information that makes clear whether the
testing was performed on a routine or specified schedule. When collecting data in-
plant, the establishment should develop a sampling plan in advance of data
collection to ensure that the data collected are adequate to make statistical
determinations about effectiveness.

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 In-plant data could also be collected as technical support for an establishment’s
HACCP system design. For example, an establishment may identify foreign material
as a hazard in ground product because of the wooden pallets it uses, and how the
product is loaded to be dumped into a hopper. The establishment could determine
that the foreign material hazard is not reasonably likely to occur because of a
prerequisite program that includes steps the establishment takes to ensure that
pieces of the pallet do not break off and fall into the grinder to contaminate the
product. The establishment could collect in-plant data to demonstrate the
effectiveness of these technical procedures for preventing the hazard from occurring
in its process.
NOTE: FSIS does not advocate the introduction of pathogens in the plant
environment.

Large corporations with multiple establishments often conduct studies in one

establishment to gain scientific information to validate an intervention’s design and
then extend the use of the intervention to other establishments within the corporate
umbrella. For the establishment at which the data were gathered, FSIS would
consider the data to be data gathered in-house, and thus the data would meet both
parts of validation (design and execution). However, for the establishments to which
use of the intervention was extended, the data would meet only the first element of
validation. To meet the second element of validation, the corporation would still
need to demonstrate that the intervention will function as intended in each of those
establishments by gathering data on the critical operating parameters’ execution in
those additional establishments. So, for biological hazards, microbial data collected
at one establishment could be used to support effectiveness of the intervention or
process (i.e., the first element of validation) at other establishments within the
corporation that use the same procedures.

7. Regulatory performance standards, as defined in the Code of Federal Regulations,

that outline specific prescribed procedures such as time/temperature combinations,
product storage conditions, or product reconditioning procedures. The poultry
chilling requirements defined in 9 CFR 381.66 or the trichinae requirements in 9
CFR 318.10 would be examples of instances where the regulations clearly define
the performance standard for a processing step and can be used to support the
HACCP system design.

8. Best practice guidelines are another example of scientific or technical support.

These guidelines generally contain a list of procedures or a set of principles that
have been identified by experts as having a scientific or technical basis for
preventing a hazard from occurring when implemented. For example, the Beef
Industry Food Safety Council (BIFSCO) has developed a document that contains
Best Practices for Beef Slaughter. This document may be used as scientific support
that an establishment’s sanitary dressing program prevents contamination with

10
 microbiological hazards such as STEC and ensures that the interventions the
establishment has in place achieve their intended effect.

What are some examples of incomplete scientific or technical

support?
The following are examples of incomplete scientific or technical support for validation:

• Documentation that specifies the log reduction achieved by the process but that
does not include information about critical parameters, such as pH, critical to
achieving that reduction. That information should be included in order for the
process to be considered validated.

• Having a validated process on file but not following the process described.

• Validating a process for a specific log reduction of a pathogen in a product other

than meat and poultry. This validation data alone would not be sufficient
scientific support. For example, a process that achieves a 5-log reduction of E.
coli O157:H7 in apple cider would not be sufficient scientific support for the
reduction of E. coli O157:H7 in a beef product process.

• Implementing an intervention based on scientific or technical support that did not

contain data supporting the process’s effectiveness. For example, implementing
a lactic acid intervention in a prerequisite program to support E. coli O157:H7 as
a hazard not reasonably likely to occur but maintaining scientific support with
microbiological data for Salmonella.

NOTE: Ensuring that the scientific support contains microbiological data for the
hazard listed in the hazard analysis is particularly important for slaughter
processes where interventions have different efficacy depending on the species
of product and the pathogen. In other cases, such as for lethality processes,
Salmonella may be used as an indicator of lethality for other pathogens.

• Documentation in the form of a No Objection Letter or FSIS Directive 7120.1

without additional scientific or technical support that provides information on the
levels of all of the critical operational parameters used, and without support that
demonstrates the effectiveness of the new ingredient or technology against the
specific hazards identified in the hazard analysis. Examples of such necessary
scientific and technical support are included on pages 6 through 11 of this
document. This additional support is needed because the No Objection Letter
and FSIS Directive 7120.1 Safe and Suitable Ingredients Used in the Production
of Meat and Poultry Products do not contain efficacy data or data on all of the
critical operational parameters.

• Expert opinion from a processing authority stating the growth limit of a pathogen
without any reference to established scientific principles or peer-reviewed data.

11
How can an establishment identify whether the scientific or technical
support closely matches the process, product, and hazard analysis?
In all cases, the scientific or technical support should identify:

• The product studied (including formulation and intrinsic factors)

• The hazard (biological, physical, or chemical),
• The expected level of hazard reduction or prevention to be achieved,
• All critical operational parameters or conditions necessary,
• The processing steps that will achieve the specified reduction or prevention, and
• How these processing steps can be monitored.

The establishment should evaluate this information to determine whether it’s scientific or
technical support is sufficiently related to the process, product, and hazard identified in
the hazard analysis. The scientific or technical support should be complete and
available for FSIS review, so that FSIS personnel can also determine whether the
support is sufficiently related to the actual process. Failure to take these steps would
raise questions about whether the HACCP system has been adequately designed and
validated.

How can an establishment identify scientific support that adequately

addresses the expected level of hazard reduction or prevention to be
achieved for biological hazards?
The type of scientific support (e.g., published processing guideline, peer-reviewed data
or information, pathogen modeling program results) and the type of data or information
contained in the support will differ depending on the product, biological hazards
identified in the hazard analysis, and the intervention strategy the establishment designs
to reduce, eliminate, or prevent the hazards. Some of these considerations for
identifying scientific support for intervention strategies used to address hazards in RTE
and raw products are outlined below.

Scientific Support for RTE Products

Establishments producing meat or poultry products that are RTE must support that
potential hazards have been addressed in the product according to 9 CFR 417.2(a)(1).
The Listeria Rule (9 CFR 430.1) defines RTE products as meat or poultry products that
are edible without additional preparation to achieve food safety. To support that
products are RTE, among other steps, establishments need to achieve lethality of
pathogens in the product. To support decisions in the hazard analysis related to
lethality of pathogens RTE products, establishments must provide scientific support that
specifies the expected level of pathogen reduction achieved by the intervention strategy
for the product being produced. For example, establishments producing RTE semi-dry
fermented products must provide scientific support that the fermentation and drying
steps achieve a specific level of pathogen reduction. In the Salmonella Compliance

12
Guidelines for Small and Very Small Meat and Poultry Establishments that Produce
Ready-to-Eat (RTE) Products, FSIS recommends that these processes achieve at least
a 5.0-log10 reduction on of Salmonella spp. Without data demonstrating a specific log
reduction is achieved, it would be difficult for an establishment to support that a product
is RTE.

KEY QUESTION

Question: Can an establishment use Appendix A, which was designed to

address Salmonella, to support other pathogens such as E. coli O157:H7 or
Listeria monocytogenes are controlled?

Answer: Yes, an establishment can cite Appendix A as support that E. coli

O157:H7 and Listeria monocytogenes are controlled as a result of a thermal
process. Although Appendix A was developed based on experiments
measuring the efficacy of thermal processes on Salmonella, Salmonella can
be used as an indicator of lethality for other pathogens such as E. coli
O157:H7 and Listeria monocytogenes.

The scientific support for RTE products should be sufficiently related to the process,
product, and hazard identified in the hazard analysis. For thermal lethality treatments
(i.e., cooking), establishments can use scientific support that demonstrates reduction in
one pathogen to support that another pathogen would also be reduced. For example,
although establishments may identify several biological hazards (i.e., Salmonella,
Listeria monocytogenes (Lm), and E. coli O157:H7) that are addressed by a lethality
treatment, Salmonella is generally considered the reference organism for lethality for
most RTE meat and poultry products because: (1) It is prevalent in raw poultry, beef,
and pork; (2) it causes a high incidence of foodborne illness; and (3) foodborne illness
associated with Salmonella is severe (66 FR 12593). In addition, FSIS recommends
that establishments use Salmonella as an indicator of lethality because it tends to be
more heat resistant than other pathogens. Therefore, if an establishment’s scientific
support demonstrates that its lethality treatment achieves sufficient reduction in
Salmonella, it does not need to provide additional support that adequate reduction in
other pathogens such as Lm or E. coli O157:H7 is achieved. For these reasons,
establishments should not use pathogens other than Salmonella as indicators of
lethality unless they can provide support that the pathogen studied displays similar
resistance to the process that destroys the bacteria (e.g., heat, acid, or drying). For
example, establishments should not use scientific support demonstrating reductions in
Lm from a lethality treatment to support that similar reductions in Salmonella would be
achieved without support that Lm is at least equally as resistant as Salmonella under
the conditions being studied. Non-pathogenic indicator organisms may be used and will
be discussed in a later section.

13
Scientific Support for Raw Products

Under 9 CFR 417.2(a)(1), establishments producing raw meat or poultry products must
support that potential hazards have been addressed in the product. For the production
of raw products, the scientific support should contain microbiological data specifying the
expected level of pathogen control or prevention achieved by the intervention strategy
so that the establishment can determine whether the intervention is adequate for its
product and process. Using documentation that does not contain microbiological data
on the specific level of reduction achieved could represent a vulnerability in an
establishment’s HACCP system design. For example, an establishment that identifies
Salmonella as a hazard reasonably likely to occur in its poultry slaughter process
because it has historically occurred would have a vulnerability in its process if it relies
on scientific support that contains the number of samples that test positive for
Salmonella before and after the application of an intervention. Using this type of data
would represent a vulnerability because it would not provide information on the specific
log reduction achieved. Without this information, the establishment would be unable to
determine whether the intervention would reduce Salmonella in its process to
acceptable levels.

The scientific support for raw meat and poultry products should also be sufficiently
related to the process, product, and hazard identified in the hazard analysis. It is
particularly important that the scientific support for intervention strategies used in the
production of raw products include microbiological data that specifies the expected level
of pathogen reduction for the same hazard identified in the hazard analysis. For
example, in slaughter establishments, interventions such as lactic acid and peroxyacetic
acid (PAA) have been found to perform differently for different pathogens (e.g.,
Salmonella and E. coli O157:H7) and different species (e.g., poultry vs. beef).
Therefore, it would be important for a beef slaughter establishment that references a
lactic acid intervention applied to beef carcasses as a control for E. coli O157:H7 in its
hazard analysis during slaughter and dressing to provide support that a specific log
reduction in E. coli O157:H7 is achieved when the lactic acid is applied to beef
carcasses. One exception when the scientific support may not need to address the
specific pathogen listed in the hazard analysis for raw products is for intervention
strategies designed to control or prevent non-O157 shiga-toxin producing Escherichia
coli (STEC). At this time, FSIS is not aware of any controls specific to non-O157
STEC. Interventions validated to control E. coli O157:H7 should be effective in
controlling non-O157 STEC when properly implemented as described in the
establishment’s scientific support.

Can establishments use scientific support containing microbiological

data from indicator or surrogate organisms?
In general, establishments should not rely on scientific support containing data only
from indicator or surrogate organisms unless there is sufficient data to establish a
relationship between the presence or level of a pathogen or toxin and the indicator
organism. When selecting the appropriate surrogate organism, the establishment

14
should consider the process that destroys the bacteria (e.g, heat, acid, drying). For
example, a surrogate organism that is at least as heat resistant as the pathogen of
concern should be used if the process primarily relies on thermal destruction (i.e., heat).
If the primary pathogen reduction mechanism is fermentation, then a surrogate should
be at least as acid resistant as the pathogen of concern. The surrogate chosen in each
of these situations may not be the same.

Data demonstrating a relationship between the presence or level of a pathogen or toxin

and the indicator organism can be collected from studies using indicator organisms that
parallel the data in a challenge study performed with the inoculated pathogen. This
data could be collected by performing the study with the indicator and pathogen as part
of a single study or separately in two studies performed under similar conditions. If
similar and consistent reduction or control can be established, then control of the
indicator organisms can be reliably used to indicate expected pathogen control in actual
application.

An example of when similar and consistent reduction in an indicator or surrogate

organism and a pathogen have been found is research that was done by the University
of Wisconsin with ground-and-formed jerky that found that two Pediococcus strains
(Saga 200 and Biosource) have similar heat-resistance to Salmonella and can be used
in validation studies (Borowski et al., 2009) for jerky lethality processes. In addition,
FSIS has identified four surrogate organisms that have been shown to respond similarly
to E. coli O157:H7 during cooking (see the following askFSIS Q&A 1 for more
information) for use in validation studies designed to demonstrate a reduction in E. coli
O157:H7. At this time, however, FSIS is not aware of supporting documentation
demonstrating a strong correlation to support the use of generic E. coli testing in lieu of
testing for E. coli O157:H7 or non-O157 STEC.

How can an establishment identify scientific or technical support that

adequately addresses the expected level of hazard reduction or
prevention to be achieved for physical and chemical hazards?
For physical and chemical hazards, establishments will often use technical support to
demonstrate that particular process control measures can adequately address specific
hazards. As with biological hazards, the scientific or technical support should closely
match the product, process, and hazard. For example, if the establishment uses
detection equipment to identify foreign material such as metal in a particular product, it
should have technical support on-file that demonstrates that the equipment can in fact
detect the targeted materials (e.g., metal of a defined size and type) in the product. The
same is true for chemical hazards. For example, an establishment that uses a lactic
acid intervention during a beef slaughter process may identify a chemical hazard from

http://askfsis.custhelp.com/app/answers/detail/a_id/1392/kw/surrogate/session/L3RpbWUvMTMyNzUyMT
Y0Ni9zaWQvVFR6c3cyUGs%3D

15
excessive levels of lactic acid. The establishment may support that the hazard is not
reasonably likely to occur based on instructions from the manufacturer on mixing the
lactic acid with water to achieve a concentration that is safe and suitable in accordance
with FSIS Directive 7120.1. In this case, the manufacturer’s instructions or conditions of
use are often provided as technical support that demonstrates the use of the chemical is
controlled.

How can an establishment identify scientific support for prerequisite

programs?
As previously discussed on page 5, when an establishment determines that a hazard is
not reasonably likely to occur because the implementation of a prerequisite program
prevents the hazard from occurring, that prerequisite program becomes part of the
HACCP system. Therefore, prerequisite programs designed to support decisions in the
hazard analysis (e.g. Sanitation Standard Operating Procedures [Sanitation SOPs],
written sanitary dressing procedures incorporated into prerequisite programs, purchase
specifications, antimicrobial interventions) must be validated to ensure that the overall
system can operate effectively.

Although prerequisite programs within HACCP systems are often designed as multiple
hurdles of control, establishments should be able to provide scientific or technical
support that each hurdle or combination of hurdles provides the necessary level of
prevention for the identified hazards. For some prerequisite programs that are
implemented at a discrete point or step in the process, such as those for antimicrobial
interventions, the guidance provided on the previous pages for identifying scientific
support for the expected level of reduction necessary to prevent the hazard can be
applied. When using an antimicrobial intervention as a prerequisite program,
establishments should identify scientific support that matches the product, process, and
hazard and that contains microbiological data specifying the expected level of pathogen
reduction necessary to prevent the hazard from occurring. For other prerequisite
programs that are implemented across multiple points or steps in the process, such as
those for allergen control or programs that incorporate written sanitary dressing
procedures, establishments may rely on scientific or technical support that contain best
practices regarding the implementation of such programs. For example, the Beef
Industry Food Safety Council (BIFSCO) has developed a document that contains Best
Practices for Beef Slaughter. FSIS has identified, through both scientific literature
review and best practice guidance created by industry, the points in the slaughter
process where carcasses are most vulnerable to contamination and has included these
steps in FSIS Directive 6410.1 Verifying Sanitary Dressing and Process Control
Procedures by Off-line Inspection Program Personnel (IPP) in Slaughter Operations of
Cattle of Any Age. These documents may be used as scientific support that an
establishment’s sanitary dressing program prevents contamination with microbiological
hazards such as STEC and ensures that the interventions the establishment has in
place achieve their intended effect.

16
See Appendix 4 page 55 for an example of scientific support and in-plant data that
could be collected to validate Sanitation SOP’s, page 56 for an example of scientific
support and in-plant data that could be collected to validate a temperature control
prerequisite program, and page 57 for an example of scientific support and in-plant data
that could be collected to validate a sanitary dressing program.

What are the critical operational parameters of a process, and how

does an establishment identify them in its scientific support?
Critical operational parameters are the specific conditions that the intervention must
operate under in order for it to be effective. For an establishment to validate an
intervention, it should first identify the critical operational parameters within its process
that it needs to implement and monitor. These critical operational parameters are
identified in documents gathered as part of Element 1 of validation and often include but
are not limited to:

• Time • pH
• Temperature • Contact Time
• Concentration • Product Coverage
• Humidity • Spatial Configuration
• Dwell Time • Pressure
• Water Activity • Equipment Settings or calibration

To be effective, the process procedures should be consistent with the critical

operational parameters in the scientific support. For example, if the scientific support
listed a particular critical operational parameter such as the concentration of an
antimicrobial, that same concentration should be used in the process. In some cases,
establishments may be able to support using different levels of a critical operational
parameter than that used in the support. For example, an establishment may be able to
provide a justification for why using a higher lethality temperature than that used in the
scientific support would result in the same level of pathogen reduction. When different
levels of a critical operational parameter than those in the support document are used,
establishments should consider developing a decision-making document that explains
the scientific rationale for why the different level would not affect the efficacy of the
intervention or process. See Appendix 2 for an example. This scientific rationale could
be provided by a processing authority or other expert provided there is reference to
established scientific principles or peer-reviewed scientific data and does not rely on
expert opinion alone.

Developing a decision-making document and explaining the rationale for use of a critical
operational parameter different from the one in the scientific support is important
because changing a critical operational parameter can impact the intended result in
unexpected ways. For example, antimicrobials have been determined to be safe and
suitable up to specific concentrations at specific pH levels as listed in FSIS Directive
7120.1 and 9 CFR 424.21(c)). Although the Directive and regulation provide maximum
allowable concentrations for antimicrobials, the establishment needs to determine the
17
optimum concentration for its process based on the critical operational parameters in its
scientific support (e.g., journal articles, challenge studies). The concentration chosen
by an establishment is often the concentration at which maximum efficacy is observed.
A synergistic or an additive effect may be observed when combinations of antimicrobials
are used. Above the optimum concentration, although still within the allowable range,
the chemical or antimicrobial efficacy decreases because the cells/membrane of the
microorganism are saturated with the compound, and further inactivation of the bacteria
is not observed. In other words, more of an antimicrobial is not always better. An
establishment may be able support using a higher concentration of an antimicrobial in
its process than that used in the scientific support but within the allowable range,
provided that it evaluates whether changes to the concentration would affect the
efficacy of the intervention or process, and that there is scientific support for its
decisions.

To identify the critical operational parameters when evaluating the scientific support,
there are several questions one can ask. For example:

• What parameters were measured in the research?

• Where in the process or on the product were the measurements taken?
o Is the establishment taking measurements in these locations?
• What parameters, if any, were held constant across experimental conditions?
• What parameters, if any, were varied or changed in the research?
o When these parameters were changed, did the effectiveness of the
intervention change as well?
o If so, are these parameters that you have considered in your process?
• Did the authors provide some guidelines as to the limitations of the research
or any cautions against applying the findings outside of the scope of the
study?
o For example, were there some parameters that were controlled in the
laboratory that differ in-plant that you should be aware of?
o If so, have you considered if those apply to your process?

If the scientific support does not document the measurement of a critical operational
parameter, the establishment should evaluate whether this parameter really needs to be
met or measured, or whether additional support is needed for the level of that parameter
in the actual process. For example, humidity is a critical operational parameter in the
cooking or heating of many ready-to-eat meat and poultry products. For the production
of some of these products, however, humidity does not need to be met or measured.
For example, as addressed in the Appendix A Guidance on Relative Humidity and
Time/Temperature for Cooking/Heating and Applicability to Production of Other Ready-
to-eat Meat and Poultry Products, humidity does not need to be met or measured when
a product is cooked in a sealed, moisture impermeable bag. Establishments producing
such cook-in-bag products may develop a decision-making document and cite the
Appendix A Guidance on relative humidity as support for why humidity does not need to
met or measured in the process. What is important in this case is that the
establishment considers the parameters that are relevant for their product and process

18
and does not assume that just because the parameter was not measured in the
scientific support it is not important.

For prerequisite programs that are implemented across multiple points or steps in the
process, such as those for allergen control or programs that incorporate written sanitary
dressing procedures, establishments may rely on scientific or technical support that
contains best practices regarding the implementation of such programs. When relying
on these types of scientific or technical support, establishments may consider the
recommended procedures that should be incorporated into the written prerequisite
program as critical operational parameters. These procedures would be considered
critical operational parameters because these steps need to be implemented and
monitored in order to ensure that the program is effectively preventing a hazard from
occurring.

See Appendix 3 for additional guidance as to how to identify critical operational

parameters from the scientific support. Appendix 4 contains examples of critical
operational parameters that have been identified for different types of processes and
scientific support. Examples of the types of in-plant documentation expected are also
provided.

Key Point: An establishment that gathers scientific support for its processes (and
properly identifies the critical operational parameters in the support) as described above
would meet the threshold indicated in the HACCP Systems Final Rule (61 FR 38806)
for the first element of initial validation in designing a valid HACCP system. The
establishment’s processes would be considered by FSIS to be based on or supported
with documented scientific evidence. These processes would not need any additional
scientific support as part of the initial validation process. However, as stated in the
HACCP Systems Final Rule (61 FR 38826), an establishment introducing a new
technology not established in the literature or applying a standard technology in an
unusual way (e.g., modifying critical operational parameters from the literature) should
gather scientific support and in-plant validation data for its new or modified HACCP
system under commercial operating conditions. The effort to develop such information
may require that the establishment conduct, or have conducted for it, scientific studies
either in a laboratory setting, pilot plant, or in-plant. An establishment that lacks
experience with a technology should also gather scientific support and in-plant
validation data with the exception of when the effectiveness of the new technology has
already been studied, but the establishment lacks experience implementing the
technology. In this case, the effort to develop such information may focus more on the
collection on in-plant validation data (discussed further in the next section).

19
KEY QUESTION

Question: Can an establishment’s process use a different level of a critical operational parameter
(for example, a higher concentration of an antimicrobial or a higher processing temperature) than
what was used in the scientific or technical support?

Answer: Generally, establishments should use the same critical operational parameters as those
in the scientific or technical support. However, some minor differences are acceptable. For
example, Table 1 of the Tompkin paper can be used to support a storage temperature CCP for
raw meat of 45oF even though it cites 44.6oF as minimum growth temperature for Salmonella.
This rounding is suitable because the growth rate of Salmonella at 45oF is not significantly
different from its growth rate at 44.6oF. Furthermore, when temperatures are converted from
Celsius to Fahrenheit, as in Table 1 of the Tompkin paper, numbers are often converted as
fractions, which establishments may round to whole numbers because of practical measurement
limitations of equipment in establishments. On the other hand, rounding may not be suitable for
other critical operational parameters such as water activity and pH because minor changes in the
values can have a significant impact on pathogen growth.

In some circumstances, establishments may be able to support using critical operational

parameters (e.g., higher concentrations of antimicrobials or higher thermal processing
temperatures) that are different from those in the scientific or technical support. In these cases,
establishments should provide justification supporting that the levels chosen are at least as
effective as those in the scientific or technical support. This justification is needed because higher
levels of a critical operational parameter may not always be equally effective. For example,
antimicrobial agents may only be effective within a range of concentration after which point
efficacy may decrease. Similarly, higher processing temperatures may result in the surface of the
product drying out before adequate lethality is achieved. In addition to ensuring that the levels
chosen are at least equally as effective, establishments should ensure the levels are also safe
and suitable (FSIS Directive 7120.1 Safe and Suitable Ingredients Used in the Production of Meat
and Poultry Products and 9 CFR 424.21(c)).

What is the second element of HACCP Systems Validation?

The second element of HACCP systems validation is initial in-plant validation
which may include in-plant observations, measurements, microbiological test results, or
other information demonstrating that the control measures, as written into a HACCP
system, can be executed within a particular establishment to achieve the process’s
intended result (61 FR 38806, 38826 (July 25, 1996)).

FSIS stated in the HACCP Final Rule that validation data for any HACCP system must
include practical data or information reflecting an establishment’s actual experience in
implementing the HACCP system. The validation must demonstrate not only that the
HACCP system is theoretically sound in its design (Element 1), but also that the
20
establishment can execute it as designed to reach the desired effect (Element 2). To
meet the second element of validation, establishments should:

• Implement the critical operational parameters in the actual production process

consistent with the parameters in the scientific support;
• Identify at least one product from each HACCP category for which to gather in-
plant validation data;
• Collect in-plant data demonstrating the effectiveness of the implementation of the
critical operational parameters for at least one product from each HACCP
category; and
• Analyze the data to determine whether the critical operational parameters are
being implemented effectively.

Once the critical operational parameters are identified, how should

they be implemented in the actual process?

Once the critical operational parameters are identified, an establishment should

implement the critical operational parameters in the actual process consistent with the
scientific support.

If an establishment is using the scientific support as support for the development

of a CCP and its critical limits (9 CFR 417.5(a)(2)) to prevent, reduce, or eliminate
a hazard identified as RLTO, the establishment should incorporate all of the
critical operational parameters into the critical limits of the CCP. An establishment
may determine, however, based on its decision making, that some of the parameters
can be monitored on an ongoing basis as part of a prerequisite program. An
establishment may also determine that it only needs to ensure some of the critical
operational parameters are implemented consistent with the support during the initial
validation period (e.g., spatial configuration, equipment type to the extent that it affects
other parameters, or ingredient formulation provided it does not change). These
parameters should be included in a decision-making document, but they do not need to
be monitored after the 90 days of initial validation unless there is a change.

If an establishment is using the scientific support as support for a decision that a

hazard is not reasonably likely to occur (9 CFR 417.5(a)(1) because the
implementation of a prerequisite program prevents conditions that make the
potential hazard likely, then all of the critical operational parameters should be
incorporated into the prerequisite program. An establishment may also determine
that it only needs to ensure some of the critical operational parameters are implemented
consistent with the support during the initial validation period (e.g., spatial configuration,
equipment type to the extent that it affects other parameters, or ingredient formulation
provided it does not change).

21
What types of data should establishments collect during the initial in-
plant validation period?
Often establishments incorporate interventions into their processes to reduce the level
of certain pathogens and use published scientific articles as scientific support for the
design of the interventions (see above discussion of the first part of validation).
Establishments may implement those interventions consistent with the scientific
support or make modifications to the critical operating parameters that could affect the
efficacy of the intervention. To implement an intervention consistent with the scientific
support means that changes among the critical operational parameters used in the
scientific support and those used in the actual process will not affect the efficacy of the
intervention or treatment. Depending on how an establishment implements the critical
operational parameters for an intervention and the type of support used, different data
should be collected during the initial in-plant validation period. These two scenarios are
described below:

Scenario 1 – In cases where the establishment’s process is implemented consistent

with the critical operational parameters described in the scientific support, and when
the scientific support used contains microbiological data specifying the level of
pathogen reduction achieved by the intervention strategy for the target pathogen
identified in the hazard analysis, to meet the second element of validation, the
establishment should:

 Identify the critical operating parameters in the scientific support,

AND
 Implement those critical operational parameters in the
establishment's production process consistent with the scientific
support, AND
 Collect in-plant data that demonstrates that the critical operating
parameters are being met (e.g., data on quantifiable characteristics
of the critical operational parameters such as pressure,
temperature, and concentration).

Thus, if an establishment implements the actual process consistent with the critical
operational parameters in the scientific support, the establishment should collect in-
plant data demonstrating that the critical operational parameters can all be met, and no
in-plant microbiological data would be needed. For example, if the scientific support for
a carcass wash intervention includes critical parameters of water pressure at the nozzle,
water temperature at the point of contact with the carcass, whole carcass coverage, and
a water/carcass contact time, then the establishment should measure and gather data
on whether those parameters are being achieved. The water temperature measured in
a holding tank or at the nozzle may not be the actual water temperature at point of
contact with a carcass, so it is crucial to design measurement procedures appropriately.

Scenario 2 - In cases where the establishment’s process is not implemented in a

manner that is consistent with the critical operational parameters described in the

22
scientific support without justification, or when the scientific support used does not
contain microbiological data specifying the level of pathogen reduction achieved by
the intervention strategy for the target pathogen identified in the hazard analysis, to
meet the second element of validation the establishment should:

 Identify the critical operating parameters in the actual process

(either because they were modified from the scientific support
without justification, or the scientific support does not contain
microbiological data), AND
 Collect in-plant microbiological data that demonstrates the
intervention’s effectiveness under actual in-plant conditions or
identify scientific support with microbiological data demonstrating
the effectiveness of those critical operational parameters,
 AND
 Collect in-plant data that demonstrates that the modified critical
operating parameters are being met.

Thus, if an establishment implements different critical operational parameters in the

process from the scientific support, or if the scientific support does not contain
microbiological data, then the establishment should collect in-plant data demonstrating
the critical operational parameters that it has implemented can all be met AND collect
in-plant microbiological validation data or identify scientific support with microbiological
data for the effectiveness of those implemented critical operational parameters.

The establishment should develop the appropriate in-plant data during the initial 90
days of implementing a new HACCP system, or whenever a new or modified food
safety hazard control is introduced into an existing HACCP system (e.g., as
implemented after a HACCP plan reassessment). During these 90 calendar days, as
described in the HACCP Final Rule, an establishment gathers the necessary in-plant
data to demonstrate that the critical operating parameters are being achieved. In
essence, the establishment would repeatedly test the adequacy of the process steps in
the HACCP system to establish that the HACCP system meets the designed
parameters and achieves the intended results. These in-plant data become part of the
validation scientific support along with the scientific support used to design the HACCP
system. See the section below on records for more information. Failure to take these
steps would raise questions as to whether the HACCP system has been adequately
validated.

In addition to collecting the in-plant data described, it is critical that the establishment
analyze the data to whether the critical operational parameters are being
implemented effectively. This analysis should include a review of the records
generated by the HACCP system during the initial validation period. Establishments
may need to work with a statistician to conduct more in-depth statistical analyses of the
in-plant data collected. For example, an establishment may need to work with a
statistician to determine whether the in-plant validation data supports that it is
implementing the critical operational parameters consistent with the scientific support.

23
An establishment may also need to conduct more in-depth analysis if it implements
critical operational parameters that are different from the process in the scientific
support, and, as a result, it would need to collect in-plant microbiological data.

For what types of processes and products should establishments

collect in-plant validation data?
Establishments should maintain scientific support for all processes and products;
however, establishments should collect in-plant data for at least one product from each
HACCP process category at that establishment. Depending on the HACCP category
and products, establishments should consider collecting in-plant data for more than one
product within each category. The object is to collect in-plant data for a wide variety of
different products and worst case scenarios. Establishments should collect in-plant
data for all CCPs and prerequisite programs used to support decisions in the hazard
analysis for at least one product from each HACCP category at that establishment.
Establishments should use food science principles in their decision making when
deciding which product types within a HACCP category should be used to gather in-
plant data. In addition, establishments should use decision-making documents to
describe how the HACCP team decided on the product or product types that would be
used during initial validation. Similarities and differences in species, process, intrinsic
factors, product public health risk, and food safety hazards should be considered.
Some examples of food science principles that could be used to decide which product
within a HACCP category should be used to gather in-plant data include:

• Fat content: Fat level in meat has been documented to influence bacterial heat
resistance (Juneja et al., 2001). As the fat level increases, bacterial heat
resistance increases. Therefore, higher fat content meat or poultry products
require greater time or temperatures to achieve equal lethality compared with
lower fat content products.
o How this criterion could be used: If an establishment produces several
fully cooked poultry products, the establishment should gather data for the
product with the highest fat content. Similarly, if an establishment
produces several ground poultry products, and some of the products are
made from skin-on thigh meat while others are made with boneless,
skinless thigh meat, the establishment should collect in-plant validation
data for the ground product made from the skin-on thigh meat because of
the additional fat from the skin.

• Size and shape of the food: The size and shape of food affects heat
penetration, heating rate, and heating uniformity. Irregularly shaped products, for
example, are subjected to non-uniform heating because of differences in product
thickness. In addition, in thicker products, more time will be needed for the heat
to penetrate to the center of the product.
o How this criterion could be used: If an establishment produces several
fully cooked deli meat products of various thicknesses, the establishment

24
 should gather data on the thickest product because heat penetration is
critical.

• Number and type of processing steps or ingredients: Certain processing

steps, such as slicing of ready-to-eat product, are known to be potential sources
of cross-contamination. In addition, some ingredients such as spices are known
to introduce contamination (biological, chemical, or physical). Therefore,
establishments should consider whether some products within a HACCP
category undergo additional processing steps or contain additional ingredients
that may introduce contamination and should collect in-plant validation data for
that product.
o How this criterion could be used: If an establishment fabricates beef
manufacturing trimmings and uses the trimmings to produce ground beef
and patties, the establishment should collect in-plant validation data for
the patty process because the patty forming process introduces an
additional step that could provide an opportunity for contamination.

• Product species: Studies have shown that there is a difference in bacterial

resistance in products from different types of species. Therefore, establishments
should consider collecting data separately for each species slaughtered or
processed within a HACCP category.
o How this criterion could be used: If an establishment slaughters hogs and
cattle under one HACCP category, in-plant data should be gathered for
both species because the slaughter process and the hazards associated
with each are substantially different.

• Public health risk: Establishments should take past outbreaks into account
when selecting a product to collect in-plant data for within a HACCP category.
o How this criterion could be used: If an establishment produces several
types of fully cooked ready-to-eat products, and one of the products is
Lebanon bologna, data should be gathered for the Lebanon bologna
because it was associated with an illness outbreak.

In some cases, an establishment may produce products that are all of equal risk. In
those cases, FSIS recommends that establishments select the product with the highest
production volume because that product would have the greatest public exposure.
o How this criterion could be used: If an establishment makes several types
of fully cooked sausages and the only difference among these products
are ingredients such as pimentos or pickles that are used as flavorings
and that do not affect food safety, an establishment should gather data on
the product produced in the highest volume.

Finally, in other cases establishments may consider selecting more than one product
from a HACCP category.
• For example: If an establishment processes both hot dogs and RTE whole
turkey breast that is sliced, both products should be validated because their

25
 processes are substantially different, and both have been found to represent an
increased risk of listeriosis illness to the consumer.

How long does an establishment have to complete initial

validation (Elements 1 and 2)?

During the process of conducting a hazard analysis and developing a HACCP plan,
establishments gather supporting documentation in the form of scientific or technical
support for the HACCP system design (Element 1). New establishments must conduct
a hazard analysis (9 CFR 417.2) and develop and validate a HACCP plan (9 CFR
417.4) before being granted Federal inspection as required by 9 CFR 304.3(b) and
381.22(b). Additionally, establishments must conduct a hazard analysis and develop a
HACCP plan (9 CFR 417.2) before producing a new product for distribution in
commerce as required by 9 CFR 304.3(c) and 381.22(c). Consistent with these
requirements, establishments should gather scientific or technical support for a modified
HACCP plan before implementation, if the results of a reassessment indicate new or
additional support is needed (e.g., if significant changes to an intervention are made or
a new intervention is added). Establishments can begin gathering their support by
conducting reviews of the available scientific literature, published processing guidelines,
and regulatory performance standards to determine whether scientific documentation
already exists matching their actual product and process.

After the hazard analysis has been conducted, and the HACCP plan has been
developed, establishments gather in-plant validation data proving that the HACCP
system can perform as expected (Element 2). New establishments are issued a
conditional grant of inspection for a period up to 90 days during which they must
complete the initial validation as required in 9 CFR 304.3(b) and 381.22(b) (Element 2).
Additionally, 9 CFR 304.3(c) and 381.22(c) require establishments producing a new
product to complete the initial validation of the new HACCP plan during a period not to
exceed 90 days after the date the new product is produced for distribution in commerce.
Consistent with these requirements, initial validation should encompass the first 90
calendar days of an establishment’s processing experience with a modified HACCP
plan, if the results of a reassessment indicate in-plant validation data should be
collected (e.g., if significant changes to an intervention are made or a new intervention
is added).

For large establishments, 90 calendar days equates to approximately 60 production

days. FSIS recognizes that many small and very small establishments do not operate
daily. Therefore, FSIS recommends a minimum level of records from 13 production
days within those initial 90 calendar days should be used to initially validate a small or
very small establishment’s HACCP system. FSIS also recognizes that there are some
establishments that produce products so infrequently that they would not be able to
gather records from 13 production days within those 90 initial calendar days. If the
establishment infrequently produces several products that are each part of a separate
HACCP category, there is inherent risk with the processes if the establishment does not
have experience in producing them. Therefore, to determine whether the system is
26
properly designed and executed, even though the regulations provide 90 days for initial
validation, an establishment needing more than 90 days can ask the District Office, in
writing, for additional time to collect at least 13 production days of records when it first
starts operating, or when it begins producing new product, or for a modified HACCP
plan if the results of a reassessment indicate additional support is needed. In the
request, an establishment should indicate why more than 90 days are needed to collect
the in-plant validation data, and how it plans to gather at least 13 production days worth
of in-plant validation data within the next 30 calendar days. The request will then be
evaluated on a case by case basis. The establishment should consider focusing
validation activities on the product produced most frequently within each HACCP
category. In addition, the establishment may consider evaluating data collected for
products across multiple HACCP categories to determine whether the data together can
support its ability to meet critical operational parameters.

As previously discussed, if an establishment implements a process consistent with the

process specifications described in the scientific support, and the scientific support
contains microbiological data specifying the level of pathogen reduction achieved by
the intervention strategy for the target pathogen identified in the hazard analysis, the in-
plant validation data collected during the 90 day initial validation period will consist of
data on quantifiable characteristics of the critical operational parameters, such as
pressure, temperature, and concentration. However, if an establishment implements
different critical operational parameters in the process from the scientific support, or
the scientific support identified does not contain microbiological data, then the
establishment should collect in-plant data demonstrating the critical operational
parameters that it has implemented can all be met AND should collect in-plant
microbiological validation data or identify scientific support with microbiological data that
demonstrates the effectiveness of those implemented critical operational parameters.

Establishments can continue producing and shipping product into commerce during the
90 day initial validation period with the exception of establishments that are gathering in-
plant microbiological data to support that a product is RTE. For example, if an
establishment producing a RTE product is implementing a lethality process using
different critical operational parameters (e.g., time, temperature, or relative humidity)
from its scientific support, the establishment could commission a challenge study to
demonstrate the effectiveness of the alternate parameters during the 90 day initial
validation period. During this time, the establishment could not ship the RTE product
into commerce because it does not have the necessary scientific support to
demonstrate that all potential hazards have been addressed and that the product would
meet the definition of RTE in 9 CFR 430.1 (that it is in a form that is edible without
additional preparation to achieve food safety).

If an establishment has questions as to whether complete scientific support is needed

for its products before the products can be shipped into commerce, then it can submit a
question through askFSIS at http://askfsis.custhelp.com/ following the guidance on page
ii of this document.

27
What types of records are validation documents, and how
long should an establishment keep them?
The scientific support (design) and in-plant (execution) Key Requirement
validation data support the decisions made in the hazard
analysis and the adequacy of the process to control those The scientific or
hazards. Therefore, these supporting documents must be kept technical support for the
for the life of the plan to meet the requirements of 9 CFR design and initial in-plant
417.5(a)(1) & (2). execution validation
documents must be kept
NOTE: Establishments using existing HACCP systems on file as part of 9 CFR
developed before the issuance of this document that do not 417.5(a)(1) & (2)
have the documents from their initial validation on file will need supporting
to gather the necessary data. Appendix 5 contains further documentation records.
guidance for establishments that no longer have the in-plant
validation data.

KEY QUESTION

Question: If an establishment has not utilized a process for a year or more,

is the process still validated?

Answer: Most likely, no. An establishment would need to perform a

reassessment in order to determine whether changes have occurred that
could affect the hazard analysis or alter the HACCP plan. If the
reassessment led to modifications in the HACCP system, then the
establishment would need to gather additional in-plant validation data.
Meat and poultry establishments must document each reassessment and
the reasons for any changes to the HACCP plan based on the
reassessment, or the reasons for not changing the HACCP plan based on
the reassessment (9 CFR 417.4(a)(3)). For annual reassessments, if the
establishment determines that no changes are needed to its HACCP plan, it
is not required to document the basis for this determination.

28
KEY QUESTION

Question: If an establishment moves physical locations, will it have to repeat the in-plant
documentation element of its initial validation?

Answer: Most likely yes, as a result of the establishment’s reassessment. Much like with large
corporations with multiple establishments, the establishment will be able to transfer the scientific
support from one location to another (meeting the first element of validation - design) but will most
likely need to gather in-plant data to support the second element of validation (execution). There
are often differences from location to location that may affect whether the critical operational
parameters in the scientific or technical support can be implemented properly in the new
establishment. For example, the same type of spray cabinet made by different manufacturers
may have different flow rates for the intervention spray delivery that would require changes to
other critical operational parameters in order to achieve equivalent application. The same may be
true for the effect of employees or the size or shape of the physical location on the critical
operational parameters.

What is the difference between initial validation and on-going

verification, and what happens after the initial validation
period is over?
Many agree that validation should be a distinct function from verification (see, e.g., Scott
and Stevenson, 2006). During the 90 calendar days of initial validation following
completion of the hazard analysis and development of the HACCP system,
establishments check the validity or adequacy of the HACCP system. Establishments
are to conduct validation activities during their initial experience with a new HACCP
system. Establishments are required to complete the initial validation of the new
HACCP plan in accordance with 9 CFR 417.4 during a period not to exceed 90 calendar
days after the date the new process is used to produce product for distribution in
commerce. During these 90 calendar days, an establishment gathers data from its
monitoring and on-going verification activities at an increased frequency compared to
the frequency listed in the HACCP plan and gathers additional data to demonstrate that
the process is being executed effectively. During this period an establishment should
be reviewing these data and making modifications to its system as necessary.

NOTE: Establishments may determine that modifications are needed to an intervention

during the initial validation period either because the design did not result in the
intended effect or because the establishment could not execute the intervention as
designed. Such modifications are part of the initial validation process. However,
establishments that make major modifications multiple times throughout the initial
validation period and as a result do not generate sufficient records that support the

29
design and execution of the intervention used in the hazard analysis may not be able to
support that the HACCP system is adequate.

Following the 90 calendar day period of initial validation, an establishment uses its
findings during the initial validation period to fully implement its system and solidify its
monitoring and on-going verification procedures and frequencies. The establishment
then continues on a daily basis to perform monitoring and verification activities to
ensure that the HACCP system continues to be implemented properly. Establishments
are required to support both the monitoring and verification procedures selected and the
frequency of those procedures as part of 9 CFR 417.5(a)(2). Data gathered during
initial validation, during which critical operational parameters are monitored at an
intense frequency, is one source of information that can be used to support monitoring
and verification procedures and frequencies (see examples in Appendix 4).

Importantly, not all critical operational parameters that are measured during initial
validation are monitored on an ongoing basis after the initial validation period is
over. For example, some parameters, such as spatial configuration or ingredient
formulation, may not change over time and therefore do not need to be monitored. In
addition, ongoing verification may include activities that were not performed as part of
initial validation because the purposes of these two processes differ.

The purpose of validation is to demonstrate that the HACCP system as designed

can adequately control identified hazards to produce a safe, unadulterated
product, while the purpose of ongoing verification is to support that the HACCP
system is functioning as intended on an ongoing basis. Although it may be
adequate to measure the critical operational parameters during initial validation to
ensure that the HACCP system as designed can be executed, doing so does not negate
the need for ongoing verification activities, such as testing for appropriate pathogens or
other microorganisms, to support that the HACCP system is working as intended on an
ongoing basis.

In addition to continuing ongoing verification following the completion of the initial

validation period, it is also important to recognize the role of reassessment in the
process. At every reassessment, establishments should reassess the hazard analysis
taking into account information on any foodborne illnesses associated with the products
to determine whether all relevant hazards have been considered. In addition,
establishments should ask:

“Is my HACCP system adequate to control the identified food safety hazards?”
Annually and whenever changes occur that affect the hazard analysis, the
establishment should review records generated over the course of the previous year, or
during the period the change occurred, that reflect how the HACCP system is
performing as a whole, and analyze them to determine whether food safety goals are
being met. This review should include records of the monitoring of critical limits and
parameters of prerequisite programs to ensure that the critical operational parameters in
the scientific support continue to be met and any records from ongoing verification

30
activities, such as microbiological testing, to ensure identified food safety hazards are
being controlled.

If the establishment determines at the end of the reassessment that the HACCP system
is effective and functioning as intended, the establishment can continue on with the
same system and the same monitoring and verification procedures and frequencies. If
the establishment determines at the end of the
reassessment that either its HACCP system was not set
up correctly, is not being implemented consistently, or is If the establishment
no longer effective, the establishment should make determines at the end of the
changes to its HACCP system (e.g., add another reassessment that the
intervention) and then would, in most cases, be required to HACCP system is effective
validate any changes to its HACCP system. and functioning as intended,
the establishment can
In some cases, however, changes that result from consider continuing on with
reassessment would not require validation. For example, the same system and the
an establishment that reassesses its HACCP system same monitoring and
following a change in supplier of a raw material may find verification procedures and
that the change does not require validation because the frequencies.
composition of the raw material and its microbiological
profile are not significantly different from the material
provided by the previous supplier. In other cases,
changes that result from the reassessment would not require additional scientific
support but would require additional in-plant validation data. For example, an
establishment may find through reassessment that the design of an intervention was
adequate, but that the employees were not implementing it correctly. In that case, the
establishment would only need to collect in-plant validation data demonstrating the
intervention could be implemented appropriately. Finally, depending on the change, the
establishment will likely only need to validate that the change is functioning as intended
and not assess the entire HACCP system. For example, an establishment may change
the thickness of a raw patty product and determine that it only needs to validate that the
cooking instructions still achieve the desired endpoint temperature and does not need to
validate the entire HACCP system.

NOTE: Official establishments are to make a record of each reassessment required by

9 CFR 417.4(a)(3)(i). The regulations require establishments to document the reasons
for any changes to the HACCP plan based on the reassessment or the reasons for not
changing the HACCP plan based on the reassessment. For annual reassessments,
according to the regulation, if an official establishment determines that it does not need
to make changes to its HACCP plan, it is not required to document the reasons for not
changing the HACCP plan.

While the establishment is validating any changes it made to its HACCP system, the
establishment continues to implement other parts of its HACCP system, such as any
on-going verification activities, including testing that is done as part of its existing
system. In other words, when an establishment makes changes to its existing HACCP

31
system and is validating those changes, this validation does not occur in a vacuum.
While microbiological testing is not required specifically as part of initial validation, other
HACCP principles, such as on-going verification activities, continue to apply, including
verification testing that is done to support that the HACCP system addresses identified
hazards on an on-going basis. The following chart illustrates some of the key
differences between initial validation and ongoing verification and shows the sequence
of these key steps.

Initial Ongoing Reassessment

Validation Verification

•Frequency: •Frequency •Frequency

•Once over a •Ongoing •Annually and
period of the following whenever
first 90 days of completion of changes occur
new or revised initial that affect the
HACCP system validation (i.e., hazard analysis
day 91) and or HACCP plan
onward
•Purpose:
•Purpose:
•To ensure the
•Purpose: •To determine
HACCP system
•To ensure the whether the
as designed HACCP system
functions as HACCP system
is functioning as designed and
intended executed is still
as intended on
adequate
an ongoing
•Process: basis
•Repeatedly •Process:
test all critical •Review of
operational •Process:
records
parameters to •Conducting generated from
show the ongoing ongoing
establishment verification verification to
can implement activities ensure that the
them, and that including HACCP system
they are calibration, as designed and
effective at direct executed is still
controlling the observation, adequate (i.e.,
identified and review of through test
hazards records as well results and
as other monitoring of
independent critical
checks such as operational
testing parameters)

If reassessment results in no changes

If reassessment results in changes to the HACCP system

32
An example of the dynamic process illustrated earlier for a ground beef establishment is
shown below. In this example, the establishment has decided to add an antimicrobial
intervention to trimmings prior to grinding. Please note that the example only shows
one part of the entire HACCP system.

Initial Ongoing Reassessment

Verification
Validation
•During the first 90 •On day 91 and • At the yearly
days the onward the reassessment the
establishment: establishment establishment
•Identified the chose to monitor evaluated the
scientific or the critical records
technical support. operational
parameters as part generated during
•Carpenter et al. ongoing
2011. Meat Sci: of a CCP.
•The establishment verification for
88.
conducted ongoing the past year.
•Identified the Since there were
critical operational verification
parameters of the activities related to no positives and
intervention the parameters the critical
•Concentration: 2%
being monitored operational
including parameters of
lactic acid
calibration, direct the intervention
•Dwell time: 20s observation, and
•Pressure: 20 psi were consistently
review of records.
met, the
•Temperature: In addition the
55°C establishment, establishment
•Equipment: CHAD taking into account determined that
cabinet volume, chose to the HACCP
•Complete conduct ongoing system is working
coverage verification testing as intended and
of E. coli O157:H7 will continue with
•Demonstrated the
in trim on a conducting
critical operational
quarterly basis. ongoing
parameters were
The establishment verification at the
met
collected samples
•Trim Spray of trim after
current
Cabinet allowing the frequency.
Worksheet was antimicrobial
used to record appropriate drip
critical operational time and increased
parameters the the frequency
of testing during
the high prevalence
months.

Reassessment resulted in no changes

33
HACCP Initial Validation Self-Assessment

Does my HACCP system:

1. Contain supporting documents for each CCP or prerequisite program that is used to
support decisions in my hazard analysis?
2. Contain supporting documents that relate sufficiently to my product/process?
3. Identify the critical operating parameters based on the supporting documents used as
scientific or technical support?
4. Contain critical operating parameters that are aligned with the referenced supporting
document?
5. Contain critical operating parameters that support rather than contradict the selected
critical operating parameter if multiple supporting references are used?
6. Contain in-plant validation data from 90 calendar days (see pages 26-27 for
expectations regarding the equivalent number of production days) documenting the
critical operating parameters are implemented for at least one product within each
HACCP category?
7. Contain HACCP system in-plant validation data for at least one product within each
HACCP category that was reviewed and found acceptable by the HACCP team to
support that the process is validated by the HACCP team or other group responsible for
food safety?
8. Contain additional research data demonstrating the effectiveness of the process in
instances where the critical operational parameters from the support were not followed?

For each HACCP category, identify at least one product from the category for which collect in-
plant demonstration data and complete a validation worksheet for such product containing the
following information. Examples can be found in Appendix 4.

Product: Name the HACCP plan type or product category.

Hazard: Name the hazard of concern. This should be the same content that is in the hazard
analysis.

Process: Name the processing step or prerequisite program that addresses the hazard.

Critical Operating Parameters: Refers to the critical limits or other parameters cited in the
scientific or technical support necessary for effective execution of the process step or program.

Validation:
Scientific or Technical Support - State the scientific or technical support document references
and page numbers where the critical operating parameters are described.

In-plant Validation Data - State the name of the monitoring documents or other records where
observations were collected including the time frame.

34
References
FSIS. 1996. Pathogen Reduction; Hazard Analysis Critical Control Point (HACCP)
Systems: Final Rule. 9 CFR Part 304 et al., Federal Register 61(144), 38805-38989.

Juneja, V.K., Eblen, B.S., Marks, H.M. 2001. Modeling non-linear survival curves to
calculate thermal inactivation of Salmonella in poultry of different fat levels.
International Journal of Food Microbiology. 70: 37-51.

NACMCF. 1998. Hazard Analysis and critical control point principles and application
guidelines. J. Food Prot. 61:762-775.

Scott, V.N., Stevenson, K.E., and Gombas, D.E. 2006. Verification procedures. Pp.
91-98. In Scott, V.N., and Stevenson, K.E. (ed.), HACCP - A Systematic Approach to
Food Safety, 4th ed. The Food Products Association, Washington, D.C.

Web links
Food Safety Inspection Service (FSIS) –

HACCP Validation Webpage:

http://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/haccp/resources-
and-information/haccp-validation

Compliance Assistance:
http://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance

State HACCP Contacts & Coordinators:

http://www.fsis.usda.gov/wps/portal/informational/contactus/state-haccp-contacts-and-
coordinators

Ohio State University, Meat Science Extension – http://meatsci.osu.edu/home

University of Wisconsin, Center for Meat Process Validation – www.meathaccp.wisc.edu

Penn State University, Food Science – http://foodsafety.psu.edu/extension-people.html

HACCP Alliance - http://www.haccpalliance.org/sub/index.html

35
Appendix 1: Examples of Food Safety Problems Linked to
Inadequate Validation
Below are some specific examples where FSIS has found that inadequate validation
has led to adulterated product and in some cases illness outbreaks.

2012 – Veal E. coli O157:H7 and adulterant non-O157 STEC Positives from FSIS
Testing

FSIS test results show that the percent positive for E. coli O157:H7 and adulterant non-
O157 STEC from ground beef and raw ground beef components produced from veal
appear to be higher than ground beef and raw ground beef components produced from
other cattle slaughter classes.

Following up on these results, FSIS conducted a review of Food Safety Assessments

(FSAs) and onsite visits to veal slaughter establishments to identify concerns unique to
veal slaughter. FSIS found that veal slaughter establishments, in applying their
antimicrobial interventions, failed to achieve carcass coverage because of the practice
of suspending carcasses from the rail system with both hind limbs on a single hook.
Because of this practice, antimicrobial or hot water interventions, such as sprays, did
not reach all parts of the carcasses. Carcass coverage –ensuring that the entire
carcass surface is treated -- is a critical operational parameter that is necessary for the
intervention to operate effectively and as intended. As a result of the incomplete
carcass coverage, interventions were likely less effective than intended, and this
ineffectiveness may have contributed to the production of products contaminated
with E. coli O157:H7.

In addition, during on-site visits to beef fabrication establishments, FSIS found that beef
fabrication establishments, in applying their antimicrobial intervention, had also failed to
achieve product coverage because establishments stacked products and folded longer
pieces, particularly loins. These actions prevented antimicrobial sprays from reaching
all product surfaces. Additionally, establishment personnel did not adjust the conveyor
belt timing, properly design spray applications, or ensure that product was single-
stacked and lying flat so that all product surfaces received the antimicrobial spray.
Validation Take-away: Had establishments translated this critical operational parameter
– product coverage – into their HACCP system (either through a pre-requisite program,
CCP, or during the initial set-up of their system) the contamination of raw beef products
with E. coli O157:H7 and other STEC may have been prevented.

2011 – Lebanon Bologna E. coli O157:H7 Illness Outbreak

In March 2011, there was a foodborne illness outbreak of E. coli O157:H7 associated
with Lebanon bologna. The establishment that produced the product recalled it. An
FSIS investigation into the processing of the product revealed that the establishment
relied on scientific support that did not match the actual commercial process used. In
the scientific support, to represent a commercial process for Lebanon bologna, raw
36
Lebanon bologna mix was compacted in 27 millimeter diameter impermeable sealed
glass tubes that were immersed in a well-controlled water bath. However, in the actual
process at the establishment, raw Lebanon bologna mix was compacted in 52 to 119
mm diameter permeable casings that were placed in a large smokehouse fitted with a
single source of heat and humidity that was not well-controlled.

The difference in the diameter and type of casing material likely led to a lower
reduction in foodborne pathogens of concern in the actual process than what was
demonstrated in the support. If the diameter of the establishment’s product is larger
than that of the product used in the support, it is possible that the product core will
take longer to reach the desired temperature and pH. Taking a longer time than
expected to reach the desired temperature and pH may lead to a lower level of
pathogen reduction. Critical operational parameters such as the product diameter and
type of casing material can also affect the amount of moisture exchange between the
product and the environment and can play a role in the effectiveness of the
fermentation. For these reasons, it is important that the support used by the
establishment is representative of the establishment’s actual process so that the results
can be repeatable.

Validation Take-away: Had the establishment ensured that its actual process matched
its scientific support during the initial design of its system, the establishment could have
addressed actual relative humidity and the time it took the actual product to reach the
desired temperature and pH compared to that in the support, preventing product
contamination and illnesses.

2007 – Chicken Pot Pie Salmonella Illness Outbreak and 2011 – Turkey Burger
Salmonella Illness Outbreak

In October 2007, a number of varieties of frozen pot pies were linked to an outbreak of
salmonellosis. The establishment that produced the product recalled it. The pot pies
contained pre-cooked poultry products but raw vegetables and dough. Testing of two of
the pies taken from case patient homes found that the filling of the pot pies tested
positive for Salmonella. An investigation revealed that the likely cause of illnesses was
that consumers were not cooking the products in the microwave to a lethality
temperature. Specifically, the investigation revealed that the instructions may have
been confusing because different parts of the package recommended different
preparation times. In addition, microwave time varied by wattage; however, most case
patients interviewed did not know the wattage of their microwave. Other patients
reported not following the microwave directions, including not following the rest time and
microwaving more than one pie at a time. Therefore, one of the primary conclusions of
the investigation was that the cooking instructions for such products should be
validated to account for variability in microwave wattage and common misconceptions
among consumers regarding the nature of not-ready-to-eat foods
(http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5747a3.htm).

37
Between late December of 2010 and March of 2011, an outbreak of Salmonella Hadar
linked to turkey burgers sickened 12 people, three of whom were hospitalized.
Investigators were not able to determine consumption of turkey burgers for all case-
patients. However, FSIS determined that at least three of the case-patients in three
states specifically reported eating turkey burgers produced at the same establishment
the week before their illness began. Samples of ground turkey burgers were collected
by public health agencies from the homes of two case-patients who tested positive for
the outbreak strain of Salmonella Hadar. Both turkey burger samples were positive for
the outbreak strain. As a result of these findings, the establishment that produced the
product recalled 54,960 pounds of potentially contaminated product
(http://www.cdc.gov/salmonella/hadar0411/040411/index.html?s_cid=ccu041111_016).

In a post-outbreak investigation, FSIS found that the cooking instructions for the turkey
burger were not sufficient to guarantee that a safe end-point temperature would be
reached so that pathogens would be killed in the cooking process.

Validation Take-away: Had the establishments validated the cooking instructions on the
pot pies and turkey burgers to ensure they would achieve the desired end-point
temperature under actual consumer cooking conditions; these illnesses may have been
prevented.

38
Appendix 2: Example Decision-making Document
The following is an example of a decision-making document that could be used by a
beef jerky processing establishment to justify using modified levels of critical operational
parameters. In this case, the establishment has identified scientific support for its
process; however, it has modified the critical operational parameters (length of cooking
time and dry-bulb temperature during drying) in the actual process from those used in
the scientific support. A rationale is provided for why the modified critical operational
parameters should also be considered validated.

XYZ Meat Company - October 5, 2012

Beef Jerky Decision-Making Documentation

Process Step: Cooking and Drying

Process Step Overview: This process step includes the cooking and drying of beef
jerky using a modified Type 1A process from Buege et al (2006).

Scientific Support:
• Critical limit summary for shelf stability of beef jerky and related
products:http://www.meathaccp.wisc.edu/validation/assets/CLSummary_WMJerk
yJune2013.pdf.
• Buege, D.R., Searls, G., and Ingham, S.C. 2006. Lethality of commercial whole-
muscle beef jerky manufacturing processes against Salmonella Serovars and
Escherichia coli O157:H7. J. Food Prot: 69(9): 2091-2099.

Cooking and Drying Critical Operational Parameters:

Stage 1 –
170°F for 30 minutes.

Stage 2 –
Dry-bulb at 170°F and wet-bulb at 125°F for at least 90* minutes

Stage 3 - Dry at 175°F* dry-bulb to doneness

*Rationale for Modified Critical Operational Parameters (those with an *): The
length of Stage 2 and the dry bulb temperature during Stage 3 were increased from
what was studied in Buege et al. In Buege et al. the length of Stage 2 with a wet bulb of
125°F was 60 minutes, while the dry bulb temperature during Stage 3 was 170°F. As
stated in the critical limit summary that goes along with the article: Type 1-A processes
with a higher wet-bulb temperature or longer time in Stage 2, or a higher dry-bulb
temperature in Stage 3, can also be considered validated as long as other parts of the
process are not changed. So, these changes can also be considered validated.

39
Appendix 3: Guidance to Identify Critical Operational
Parameters from Scientific or Technical Support
If a journal article from the scientific literature is used as the scientific support, it is
important to understand how to read it and to identify the critical operational parameters
used in the study. Researchers may measure a number of parameters during the
scientific study; however, not all of these parameters are critical to the efficacy of the
intervention studied. The establishment should document and explain any differences
in its production process relative to any of the studies it used as scientific support.
Critical operational parameters are those parameters of an intervention that must be
met in order for the intervention to operate effectively and as intended. Typically critical
parameters, identified in scientific documents gathered as part of Element 1 of
validation, may include but are not limited to:
• Time • pH
• Temperature • Contact Time
• Concentration • Product Coverage
• Humidity • Spatial Configuration
• Dwell Time • Pressure
• Water Activity • Equipment Settings or
Calibration

The following discussion provides an overview of the sections of a journal article along
with questions one can ask while reading each section to help identify the critical
operating parameters in the scientific support.

Organization of Journal Articles

In most scientific journals, scientific papers follow a standard format. Papers are
divided into several sections, and each section serves a specific purpose. Common
sections include the:

• Abstract • Results
• Introduction • Discussion
• Materials & Methods • Conclusion

Abstract

The paper begins with a short summary or abstract. Generally, the abstract gives a
brief background to the topic, describes concisely the major findings of the paper, and
relates these findings to the field of study.

40
 When reading the abstract, first consider and review what you know
about the topic. Discuss the study within the HACCP Team and gain
an understanding of how you can apply the study in your HACCP
decision making.

Introduction

This section presents the background necessary for the reader to understand why the
findings of the paper are an advance on the knowledge in the field of study. Typically,
the introduction:
• First, describes the accepted state of knowledge in a specialized field.
• Then, focuses more specifically on a particular aspect, usually describing a
finding or a set of findings that led to the work described in the paper (i.e.
objective or rationale).

Materials & Methods

In some journals, this section is the last one but not in most food science-related
journals. Its purpose is to describe the materials used in the experiments and the
methods by which the experiments were carried out.

Questions to ask when reading the Materials & Methods

• What food products did the researchers study?

• How similar are the products to the ones you are processing?
• If a product’s characteristics were provided (i.e., % salt, fat, moisture, etc.), how
similar are they to your product’s characteristics?
• What hazards did the researchers study? Are they the same hazards you have
identified in your hazard analysis? Or did they study surrogates or indicator
organisms only?
• Can you identify which operational parameters were measured? For example:
o pH of the product;
o Temperature of the product or carcass;
o Temperature of the laboratory and/or processing facility;
o Pressure or temperature at which that wash or antimicrobial was applied;
o Length of time intervention was applied for.
• Where in the process or on the product were the measurements taken?
o Is your establishment taking measurements in these locations?
• What parameters, if any, were held constant across experimental conditions?
• What parameters, if any, were varied or changed in the research?

Although some parameters may or may not have been experimentally manipulated, they are
all important and their impact on the effectiveness on the intervention should be considered.
Note that some measured parameters in a study are not related to the efficacy of interventions
and are not, therefore, critical operational parameters.

41
 Results

• This section describes the experiments and documents the experiment

outcomes.
• Generally, the logic of this section follows directly from that of the introduction.
• Usually contains the bulk of the data in the form of tables and graphs.

Discussion

In some journals the Results & Discussion section may be combined. When the
discussion section is a stand-alone section it usually serves several purposes:

• Analyzing and interpreting the data in the results section.

• Explaining how the findings relate to other findings in the field of study.
• Explaining how the findings contribute to knowledge or correct errors of
previous work.
• Sometimes provides guidance on appropriate applications of the
research.

Questions to ask when reading the Discussion:

• Did the authors provide some guidelines as to the limitations of the research or any
cautions against applying the findings outside of the scope of the study?
o For example, were there some parameters that were controlled in the laboratory
that differ in-plant that you should be aware of?
o If so, have you considered if those apply to your process?

Conclusion

• This section summarizes key findings.

• Often includes implications of research for broader field.
• May highlight limitations of the study.

Figures & Tables

• Contain the data described in the paper.

• Give details of a particular experiment or experiments conducted.
• The “meat” of the article.

42
For Illustration Purposes Only

Appendix 4: Validation Worksheet Examples

The following pages include validation worksheet examples that can be used to help an establishment understand the
types of scientific support and in-plant documentation that are needed to comply with the validation requirements. Please
note that these are only examples. Each establishment will have to identify scientific support that closely matches its
process and identify and implement the critical operational parameters in the support. Depending on the support chosen,
different critical operational parameters may be identified. In addition, mention of trademarks or commercial names does
not constitute endorsement by USDA.

43
For Illustration Purposes Only

Critical Validation
Product Hazard Process Operational In-Plant Validation
Parameters 2 Scientific or Technical Support
Data
Poultry Biological - Final Dilution of 15% Bauermeister, L.J., J.W.J. Bowers, J.C. In plant monitoring
Carcass Salmonella Chiller peracetic Townsend, and S.R. McKee. 2008. records for 90 day
acid/10% Validating the Efficacy of Peracetic Acid period recorded on
hydrogen Mixture as an Antimicrobial in Poultry Final Chiller
peroxide mixture Chillers. J. Food Prot. 71(6): 1119- Monitoring Check
(PAHP) to a final 1122. Sheet (including
concentration of PAHP concentration,
85 ppm Food and Drug Administration estimation of
peracetic acid in Environmental Decision Memo for Food exposure time, pH,
chiller; exposure Contact Notification No. 000323: April and carcass
in chiller for 20 10, 2003 coverage); Trial report
minutes; pH = showing consistent
4.5; complete FSIS Directive 7120.1 Safe and operational
carcass Suitable Ingredients used in the parameters and
coverage Production of Meat, Poultry, and Egg microbial analysis, if
Products possible, for 90 days.

2
Refers to the critical limit or other parameter cited in the scientific support necessary for effective execution of the
intervention.
44
For Illustration Purposes Only

Product Hazard Process Critical Validation

Operational
Parameters
In-Plant Validation
Scientific or Technical Support
Data
Poultry Biological - Spraying 25-230 ppm of Challenge study from “XYZ” laboratory In plant monitoring
Carcass Salmonella of peracetic acid demonstrating a 1 log reduction records for 90 day
carcasses (PAA). Salmonella on poultry carcasses after period confirm that
with spraying with PAA using critical antimicrobial solution
peroxy- Pressure or flow operational parameters specified. was applied
acetic acid rate, pH, contact consistent with the
prior to time, and Food and Drug Administration critical operational
chiller complete Environmental Decision Memo for Food parameters (pressure,
carcass Contact Notification No. 000323: April pH, contact time, and
coverage 10, 2003. carcass coverage)in
specified in the study.
challenge study. FSIS No Objection Letter for Use of
PAA spray, June 12, 2007 on file with
company “ABC”.

FSIS Directive 7120.1

45
For Illustration Purposes Only

Critical Validation
Product Hazard Process Operational Scientific or Technical
Parameters In-Plant Validation Data
Support
Poultry parts Biological - Acidified 1200 ppm Chemical In plant monitoring records
intended for Salmonella sodium acidified manufacturer’s for 90 day period that
grinding and chlorite sodium chlorite pamphlet indicate the antimicrobial
ground applied to in combination demonstrating a 1-log10 was applied to the poultry
poultry poultry with any GRAS reduction Salmonella parts prior to grinding and
(including parts as a acid at a level on poultry parts the mechanically
mechanically dip prior to sufficient to following acidified separated poultry prior to
separated grinding achieve a pH of sodium chlorite dip mixing according to the
poultry) and 2.5 in using critical appropriate concentration
applied to accordance operational parameters and pH and that indicate
ground with 21 CFR specified. contact time and complete
poultry. 173.325 and coverage were achieved
scientific 21 CFR 173.325 for according to scientific
support poultry parts and support.
(Note: The pH acceptability
depends on the determination for
application, see ground poultry.
21 CFR
173.325) FSIS Directive 7120.1

Contact time of
dip and
complete
coverage.

46
For Illustration Purposes Only

Critical Validation
Product Hazard Process Operational
Parameters Scientific or Technical Support In-Plant Validation Data
Ground Biological - Validated Time and Food Safety Inspection In plant monitoring
Poultry Salmonella cooking temperature Service. 1999. Appendix A records for 90 day
Patties instructions combinations of the Compliance period that
for specific to Guidelines for meeting demonstrate
consumers various cooking Lethality Performance establishment
methods (skillet Standards for Certain Meat produces products that
on electric stove, and Poultry Products. are of the thickness,
skillet on gas Available at: diameter, fat level, and
stove, gas grill, http://www.fsis.usda.gov/wp state for which the
charcoal grill), s/wcm/connect/212e40b3- instructions are
diameter and b59d-43aa-882e- validated.
thickness of e5431ea7035f/95033F-
patties produced, a.pdf?MOD=AJPERES.
formulation of
patties produced Cooking trials on-file
(80% lean supporting the time-
patties vs. 95% temperature combination
lean patties), selected from Appendix A
and state of can be achieved using
patties during various cooking instructions
cooking (frozen provided on the label.
and thawed). Cooking trials should be for
the thickest and largest
diameter patties produced
as these will need the
greatest time to achieve the
desired endpoint
temperature.

47
 For Illustration Purposes Only

Critical Validation
Product Hazard Process Operational
Parameters Scientific or Technical Support In-Plant Validation Data
Hog Biological - Hot Lactic A least a 2% Van Netten. P., D.A.A. Mossel, and In plant monitoring records
Carcass Salmonella Acid Spray Lactic acid J. Huis In’t Veld. 1995 Lactic acid for 90 day period recorded
Cabinet solution at decontamination of fresh pork on Spray Cabinet
131°F carcasses: a pilot plant study. Int. J. Monitoring Check Sheet
(55°C) for Food Micro. 5: 1-9. (including parameters for
more than water temperature, and
60 seconds Dormedy, E.S., M.M. Brashears, water pressure), records of
and 13-23 C.N. Cutter, and D.E. Burson. 2000 lactic acid concentration
psi. Validation of acid washes as critical and Trial Reports run under
control points in hazard analysis and specified critical parameters
Complete critical control point systems. J. demonstrating complete
carcass Food Prot. 63:1676-1680. coverage of carcass with
coverage. spray and temperature of
FSIS Directive 7120.1 the spray at the carcass.
Hog Biological - Scalding Scalding in Gill, C.O. and J. Bryant. 1993. The In plant monitoring records
Carcass Salmonella water at presence of Escherichia coli, for 90 day period recorded
145°F Salmonella, and Campylobacter in on Scalding Tank
(62°C) for 5 pig carcass dehairing equipment. Monitoring Check Sheet
minutes. Food Microbiol. 10: 337-344. (including reading for
temperature of water and
Complete Bolton, D.J., R.A. Pearce, J.J. transit time).
carcass Sheridan, D.A. McDowell, and I.S.
coverage. Blair. 2003. Decontamination of pork
carcasses during scalding and the
prevention of Salmonella cross-
contamination. J Appl Microbiol. 94:
1036-1042.

48
 For Illustration Purposes Only

Critical Validation
Product Hazard Process Operational In-Plant Validation
Parameters Scientific or Technical Support
Data
Beef Biological - Hot Carcass Hot Carcass K.R. Davey, M.G. Smith. 1989 A In plant monitoring
Carcass E. coli Wash or Wash: Water laboratory evaluation of a novel hot records for 90 day
O157:H7, Carcass Temp over water cabinet for the decontamination of period documenting
non-O157 Thermal 180°F, sides of beef. Int J Food Sci Tech. 24: critical parameters
STEC Treatment Pressure over 305-316. and trial Reports run
13 psi. under specified
Dorsa, W.J., C.N. Cutter, G.R. Sirgusa, critical parameters
Complete M. Koohmaraie. 1996. Microbial demonstrating
carcass Decontamination of Beef and Sheep complete coverage
coverage. carcasses by Steam, Hot water Spray of carcass with
Washes, and a Steam-vacuum spray and
Contact time: Sanitizer. J. Food Prot. 59: 127-135. temperature of the
10 or more spray at the carcass.
seconds. AMI Lethality model, demonstrating
lethality at 160°F at carcass surface. In plant monitoring
Carcass records for 90 day
Thermal Nutsch, A.L., R.K. Phebus, M.J. period of plant
Treatment: Riemann, J.S. Kotrola, R.C. Wilson, temperature
Ambient steam J.E. Boyer, and T.L. Brown. 1998. mapping.
temp sufficient Steam pasteurization of commercially
to achieve slaughtered beef carcasses: evaluation
160°F at the of bacterial populations at five
surface in five anatomical locations. J. Food Prot.
key anatomical 61:571-577.
locations.
Nutsch, A.L., R.K. Phebus, M.J.
Riemann, D.E. Schafer, J.E. Boyer,
R.C. Wilson, J.D. Leising, C.L. Kastner.
1997. Evaluation of a Steam
Pasteurization Process in a Commercial
Beef Facility. J. Food Prot. 60:485-492.

49
For Illustration Purposes Only

Product Hazard Process Critical Operational Parameters Validation

Scientific or
In-Plant Validation Data
Technical Support
Beef Biological – Lactic 2% lactic acid applied within 12 Antimicrobial In plant monitoring records for 90
carcass E. coli Acid inches of carcass surface and Spray Treatments day period recorded on Hot Water
O157:H7, Spray entire carcass covered using a for Red Meat and Drip Time Monitoring Check
Salmonella stainless steel spray tank fitted Carcasses Sheet (including parameters for
Typhimurium with a pressure gauge and air Processed in the time the carcass is sprayed
compressor. Very Small Meat with hot water, carcass coverage,
Establishments. method application (from top to
Each side of beef should be Pennsylvania bottom and spray nozzle within 12
sprayed for at least 1 minute State University. inches of carcass), and drip time.
and sprayed from top to bottom 2005.
and sufficient lactic acid is http://www.meatha Records of lactic acid
applied such that some of it ccp.wisc.edu/valid concentration. Trial Reports run
drips off. ation/assets/acid_ under specified lactic acid critical
spray_intervention parameters demonstrating
Note: The entire carcass is _booklet_from_Pe complete carcass coverage,
sprayed with lactic acid nn_State_2005.pd sufficient amount (lactic acid drips
following washing each side of f. off carcass), contact time, method
beef from top to bottom for at of application (spray nozzle within
least 2 minutes with hot water FSIS Directive 12 inches of carcass and from top
and allowing a 5 minute drip 7120.1 to bottom).
time after the hot water wash.

50
 For Illustration Purposes Only

Product Hazard Process Critical Validation

Operational
In-Plant Validation
Parameters Scientific or Technical Support
Data
Beef Biological Lactic Lactic Acid >2%; Gastillo, A, L.M. Lucia, K.J. In plant monitoring
carcass -E. coli Acid Pressure 40 psi Goodson, J.W. Savell, G.R. records for 90 day
O157:H7 Spray (CHAD spray Acuff. 1998. Comparison of period recorded on
cabinet), Water Washing, Trimming, and Pre-evisceration
Dwell time: combined Hot Water and Lactic cabinet worksheet
minimum of 10 Acid Treatment for Reducing that monitored lactic
seconds Bacteria of Fecal Origin on acid percent, dwell
Lactic Acid Beef Carcasses. J. Food Prot. time of the carcass
Temperature: 61: 823-828. in the cabinet,
104°F at point of pressure, carcass
delivery. Hardin, M.D., Acuff, G.R., coverage and lactic
Lucia, L.M., Oman, J.S., Savell, acid temperature at
Complete carcass J.W. 1995. Comparison of point of delivery.
coverage. Methods for Decontamination
from Beef Carcass Surfaces.
Design of the J. Food Prot. 58: 368-374.
spray cabinet
includes an Delmore, R.J., J.N. Sofos, G.R.
oscillating (90 rpm) Schmidt, K.E. Belk, W.R. Lloyd,
nozzle-header G.C. Smith. 2000. Interventions
arrangement to Reduce Microbiological
composed of four Contamination of Beef Variety
spray nozzles. Meats. J. Food Prot. 63: 44-50.

FSIS Directive 7120.1

51
 For Illustration Purposes Only

Critical Validation
Product Hazard Process Operational
Parameters Scientific or Technical Support In-Plant Validation Data
Raw Biological Prerequisite Supplier Documentation from the In plant records for 90
Ground -E. coli Program: program to supplier assuring that the day period that show
Beef or O157:H7 Supplier demonstrate a supplier employs validated plant employees obtain
Beef Trim Programs pathogen interventions addressing E. and review purchase
for use in intervention coli O157:H7, certificates of specifications for
Raw strategy, analysis or web based adequacy at receiving
Ground including a information that conveys same for each lot and any
Beef testing protocol information, records of additional verification
and notification ongoing communication with testing results or web
of test results. supplier and verification data based information on
to support the achievement of incoming product lots.
the first two conditions.

Beef Industry Food Safety

Council. 2009. Best Practices
for Raw Ground Beef
Products.

52
 For Illustration Purposes Only

Critical Validation
Product Hazard Process Operational
Parameters Scientific or Technical Support In-Plant Validation Data
Raw Biological – Trimmings Acetic acid Carpenter, C.E., Smith, J.V., In plant monitoring
Ground E. coli prior to (2%); OR and Broadbent, J.R. 2011. records for 90 day
Beef or O157:H7 Grinding Lactic acid Efficacy of washing meat period recorded on
Beef Trim (2%) sprayed surfaces with 2% levulinic, Trim Spray Cabinet
for use in on trim for acetic, or lactic acid for Worksheet
Raw 20s at 20psi pathogen decontamination demonstrating that the
Ground and 55°C and residual growth inhibition. antimicrobial is applied
Beef using a Meat Sci. 88:256-260. per concentration,
custom- pressure, dwell time,
made FSIS Directive 7120.1 and temperature in the
stainless article during 90 day
steel washing period. Records
apparatus demonstrating that
(CHAD spray complete coverage of
cabinet). trimmings is
consistently achieved.
Complete
coverage of
trimmings.

53
 For Illustration Purposes Only
Critical Validation
Product Hazard Process Operational Scientific or Technical
In-Plant Validation Data
Parameters Support
Beef Biological – Cooking (For the Type 1-A Process) Critical limit summary In plant monitoring
Jerky E. coli and Stage 1* – for shelf stability of records for 90 day period
O157:H7, Drying 170°F (oven must reach beef jerky and related demonstrating Time and
Salmonella, 145°F within 10 minutes and products: dry-bulb and wet bulb
Listeria http://www.meathaccp. temperature data.
170°F within 25 minutes.
monocytogenes wisc.edu/validation/ass
ets/CLSummary_WMJ Use of dry and wet bulb
Stage 2 – erkyJune2013.pdf. thermometers to
Choose either: calculate the relative
Dry-bulb at 170°F and wet- Buege, D.R., Searls, humidity or use of a
bulb at 125F for at least 60 G., and Ingham, S.C. humidity sensor to
minutes; OR Dry-bulb at 2006. Lethality of measure relative
commercial whole- humidity during wet-bulb
170°F and wet-bulb at 130°F
muscle beef jerky temperature spike and
for at least 60 minutes; manufacturing compare test results with
OR Dry-bulb at 170°F and processes against relative humidity results
wet-bulb at 135°F for at least Salmonella Serovars in Table 2 of article.
30 minutes; and Escherichia coli
OR Dry-bulb at 170°F and O157:H7. J. Food Test beef jerky product
wet-bulb at 140°F for at least Prot: 69(9): 2091-2099. for water activity at the
end of wet-bulb
10 minutes.
temperature spike and
compare test results with
Stage 3- Dry at 170°F dry- water activity results in
bulb to doneness Table 2 of article.

Relative humidity during wet-bulb

temperature spike at Stage 2,
water activity of the product at the
end of wet-bulb temperature spike,
and total drying time.
*This example is for the Type 1-A process. Note that Type 1-A processes with a higher dry-bulb temperature in Stage 1, a higher wet-bulb
temperature or longer time in Stage 2, or a higher dry-bulb temperature in Stage 3, as long as the oven reaches the minimum temperature as
outlined in Stage 1.

54
 For Illustration Purposes Only

Validation
Critical
Product Hazard Process Operational
Parameters Scientific or Technical Support In-Plant Validation Data

Post- Biological - Prerequisite Listeria Joint Industry Task Force on Control of In plant records for 90
lethality Listeria program – control Microbial Pathogens in Ready-to-Eat Meat and day period mapping food
exposed monocytogenes SSOPs program for Poultry Products. 1999. Interim Guidelines: contact surface swab
ready-to- food contact Microbial Control During Production of Ready- results for Listeria spp.
eat surfaces. to-Eat Meat and Poultry Products, Controlling collected on different
meats the Incident of Microbial Pathogens. processing dates and at
Sanitary different times and
design of Sanitary Design Assessment Fact Sheet locations a 90-day period
equipment http://www.sanitarydesign.org/pdf/Sanitary%20D to potentially find hard-to-
and sanitary esign%20Fact%20Sheet.pdf. control areas in the plant
zone and to support ongoing
concept. Tompkin, R.B. 2004. Environmental Sampling verification testing
– A tool to verify the effectiveness of frequency after the initial
Frequency preventative hygiene measures. Mitt Lebens validation period*.
for Hyg. 95:45-51.
collecting Assessment of sanitary
samples Tompkin, R.B. 2002. Control of Listeria design of equipment in
and number monocytogenes in the food processing the post-lethality
of samples environment. J Food Prot. 65: 709-725. environment using the
that should AMI Sanitary Equipment
be collected FSIS. 2012. Compliance Guidelines to Control Design worksheet and
per line. Listeria monocytogenes in Post-lethality changes to Listeria
Exposed Ready-to-eat Meat and Poultry control program based
Products. on assessment.
http://www.fsis.usda.gov/wps/wcm/connect/
d3373299-50e6-47d6-a577- Identification of all
e74a1e549fde/Controlling_LM_RTE_guidel possible food contact
ine_0912.pdf?MOD=AJPERES. surfaces.

*NOTE: Establishments may also collect environmental swab samples on different processing dates and at different times during the 90-day initial
validation period to potentially find hard-to-control areas and niches within the establishment.

55
 For Illustration Purposes Only

Validation
Critical
Product Hazard Process Operational
Parameters Scientific or Technical Support In-Plant Validation Data

Post- Biological - Storage - Storage Tompkin Paper. Table 2. In plant records for 90 day
lethality Listeria Time and temperature http://www.meathaccp.wisc.edu/Model_ period demonstrating
exposed monocytogenes Temperature ≤ 50°F. Haccp_Plans/assets/raw_ground/Tomp ambient air temperature
ready-to- GMP’s kinPaper.pdf. does not exceed 50°F and
eat Product that product is not held
meats remains in during storage at that
storage ≤ 24 temperature for more than
hours. 24 hours.

56
 For Illustration Purposes Only

Validation
Critical
Product Hazard Process Operational
Parameters Scientific or Technical Support In-Plant Validation Data

Raw beef Biological Sanitary Employee BIFSCO. 2009. Best Practices In plant records for 90
products (e.g., -STEC dressing procedures for Slaughter. day period demonstrating
beef procedures associated http://www.bifsco.org/CMDocs/B employees consistently
carcasses, prerequisite with each IFSCO/Best%20Practices/BestP perform the sanitary
beef program station as racslaught%20Sept%2009.pdf dressing procedures as
manufacturing (same defined in the written.
trimmings) question as written sanitary FSIS. 2002. Guidance for
above) dressing Minimizing the Risk of Review of additional
program ( e.g., Escherichia coli O157:H7 and records generated during
specific steps Salmonella in Beef Slaughter the 90 day period as part
employees Operations. of the HACCP system
take at each that support that the
station to FSIS. 2012. Compliance procedures are effective
prevent Guideline for Establishments (e.g., carcass audits,
contamination Sampling Beef Trimmings for generic E. coli test
during hide Shiga Toxin-Producing results, and any other
removal, Escherichia coli (STEC) microbial test results).
evisceration, Organisms or Virulence
etc.) Markers.
http://www.fsis.usda.gov/wps/wc
m/connect/e0f06d97-9026-
4e1e-a0c2-
1ac60b836fa6/Compliance_Gui
de_Est_Sampling_STEC_0512.
pdf?MOD=AJPERES

57
 For Illustration Purposes Only

Validation
Critical
Product Hazard Process Operational
Parameters Scientific or Technical
In-Plant Validation Data
Support
Post- Biological -Listeria Hot water Hot water Muriana, P.M., In plant monitoring records
lethality monocytogenes Pasteurization temperature at Quimby, W., for 90 day period
exposed 195°F; product Davidson, C.A., demonstrating time and
ready-to- submersed for at Grooms, J. 2002. temperature can be
eat least 6 minutes. Postpackage consistently achieved.
smoked pasteurization of
turkey deli ready-to-eat deli In plant monitoring records
meat with meats by submersion for 90 day period in which
skin on* heating for reduction temperature of water is
of Listeria mapped and measured at
monocytogenes. J. increased frequencies to
Food Prot. 65(6): support monitoring
963-969. procedures and
frequencies.

*NOTE: Reduction of Lm was found to be less for smoked turkey deli meat with skin-on using these time/temperature
parameters than smoked turkey deli meat without skin, although the log reduction was > 1 log. For products subject to 9
CFR 430, the post-lethality treatment should be designed to achieve at least a 1-log lethality of Lm before the product
leaves the establishment.

58
 For Illustration Purposes Only

Validation
Critical
Product Hazard Process Operational
Parameters Scientific or Technical
In-Plant Validation Data
Support
Semi-dry Biological - Fermentation Ferment American Meat Institute. In plant monitoring records
sausage Staphylococcus product to a 1995. Interim Good for 90 day period
aureus pH<5.3 within Manufacturing Practices demonstrating Degree
fewer than for Fermented Dry and Hour Calculation per GMP
1000 degree- Semi-Dry Products. conducted and
hours*. demonstrating Degree-
Degree Hour Calculation hours are < 1000. For
Shrink to an - Degree-hours to reach a example on 10/24/99:
MPR of 3.1:1 pH of 5.3 or less for a Establishment process =
or less (which process when the highest (95°F-60°F) multiplied by
equates to chamber temperature is 12 = 420 degree hours to a
<11% product between 90 and 100°F = pH of 4.9, well within the
shrink) and 1000 degree-hours or guidelines for control of
achieve a pH of less. Staphylococcus aureus.
5.0 or less to
be considered FSIS Food Standards In plant monitoring records
a shelf stable and Labeling Policy Book for 90 day period indicating
dry or semi-dry and Ingham et al. 2005. pH is ≤ 5.3 for the Degree
fermented Fate of Staphylococcus Hours Calculation and ≤5.0
sausage. aureus on Vacuum- and a MPR of 3.1:1 or less
Packaged Ready-to-Eat for shelf stability.
Meat Products Stored at
21°C. Journal of Food
Protection. 68:1911-
1915.

*NOTE: The limit for degree-hours will depend on the highest chamber temperature.

59
 For Illustration Purposes Only

Validation
Critical Operational
Product Hazard Process
Parameters Scientific or Technical In-Plant Validation
Support Data
Roast Beef Biological -C. Stabilization Chilling should begin within Appendix B: Compliance In plant monitoring
(uncured) perfringens 90 minutes after the cooking Guidelines for Cooling Heat- records for 90 day
and C. cycle is completed. All Treated Meat and Poultry period showing
botulinum product should be chilled Products (Stabilization) each batch of
from 120°F to 55°F in no available at: product cooled
more than 6 hours. Chilling http://www.fsis.usda.gov/wps/ from 120°F to 55°F
should then continue until wcm/connect/a3165415-09ef- in no more than 6
the product reaches 40°F. 4b7f-8123-93bea41a7688/95- hours, and that all
033F_Appendix_B.pdf?MOD batches reached
Chilling between 120°F to =AJPERES 40°F.
80°F should take no more
than 1 ½ hours. Results (including screen In plant monitoring
shots of the predicted growth) records for 90 day
pH = 6.2, salt concentration from the ComBase period
= 3% Perfringens Predictor model demonstrating
demonstrating no more than product chilling for
1 log growth C. perfringens is each batch
achieved using the produced was
establishment’s custom between 120°F to
stabilization schedule and 80°F in less than 1
intrinsic factors. ½ hours.

Perfringens Predictor User Product testing

Manual results for pH at 6.2
(http://modelling.combase.cc/H and salt
elpPerPredictor/Perfringens_P concentration at 3
redictor_Manual.pdf) %.
supporting that the model has
been validated for cured and
uncured meat and poultry
products.

60
 For Illustration Purposes Only

Validation
Critical
Product Hazard Process Scientific or Technical
Operational Parameters In-Plant Validation Data
Support
Semi-dry Biological - Fermentation Diameter:115 mm ± 23 mm Getty, K.J.K, Phebus, In plant monitoring records for
Sausage Salmonella, and Starter culture: Pediococcus, R.K, Marsden, J.L., 90 day period recording time
(Lebanon E. coli intermediate Lactobacillus, and Schwenke, J.R., and and dry-bulb and wet bulb
Bologna) O157:H7 heating step Micrococcus spp. Kastner, C.L. 1999. temperature data.
Casing: Cellulose Control of Escherichia coli
O157:H7 in Large (115 Use of dry and wet bulb
Smokehouse Schedule: mm) and Intermediate (90 thermometers to calculate the
Stage 1: mm) Diameter Lebanon- relative humidity or use of a
Come-up to 80°F – 5 hours style Bologna. J of Food humidity sensor to measure
Hold at 80°F – 8 hours Sci. 64(6): 1100-1107. relative humidity during wet-
Relative humidity – 88 ± 2% bulb temperature spike and
compare test results with
Stage 2: relative humidity results in
Come-up to 100°F – 4 hours article.
Hold at 100°F – 25 hours
Relative humidity – 80 ± 2% Cold-spot determination in
smokehouse to support
Stage 3: monitoring procedures and
Come-up to 110°F – 2 hours frequencies.
Hold at 110°F – 24 hours
Relative humidity – 80 ± 2% Records assessing variability in
sausage diameter.
During the last 2 hours at
110°F hickory smoke applied Records supporting product
composition data.
Product Composition:
pH = 4.39 Decision-making document
aw = 0.94 showing that starter culture and
% salt = 4.77 casing used in actual process
% fat = 10.43 are the same as those used in
support documents.

61
 For Illustration Purposes Only

Critical Validation
Product Hazard Process Operational Scientific or Technical
Parameters In-Plant Validation Data
Support
Fully Biological - Impingement D62°C/145°F -values for American Meat Institute In plant monitoring records
Cooked Salmonella Oven chicken with between 2 Process Lethality generated during 90 day period
Not Shelf Cooking and 6.3% fat (D62°C/145°F Spreadsheet. Available at demonstrating that process can
Stable = 1.14 min). Cook to http://www.amif.org/proce achieve time and temperature.
Poultry internal temp of ss-lethality/.
Fillets ≥145°F, hold for ≥ 8 Records documenting that
minutes. Juneja, V.J., B.S. Eblen, variability in thickness of the
and H.M. Marks. 2001. fillets; arrangement of fillets on
Product formulation: Modeling non-linear survival the conveyor belt; conveyor belt
salt and phosphate curves to calculate thermal speed; and the air flow rate used
concentration (%) and inactivation of Salmonella in in the process will consistently
in-going sodium nitrite poultry of different fat levels, meet time and temperature
level (ppm); pH of the Int J Food Microbiol. 70: parameters.
product. 37-51.
Records supporting that the %
Thickness of the fillets; Documentation supporting fat of product is consistently
arrangement of fillets that the D- and z-values of between 2 and 6.3%.
on the belt; conveyor the product are comparable
belt speed; and air flow to the values used in the Records generated during 90
rate. AMI spreadsheet. Factors days demonstrating the dry-bulb
that can impact D- and z- and wet-bulb temperatures meet
Wet-bulb and dry-bulb values include the salt and those in the scientific support.
temperature. phosphate concentration
(%), the in-going sodium
nitrite level (ppm), the pH of
the product, and the fat
level.

62
 For Illustration Purposes Only

Validation
Critical
Product Hazard Process Operational
Parameters Scientific or Technical
In-Plant Validation Data
Support

Fully Biological - Product Internal temperature Food Safety Inspection In plant monitoring records
Cooked Salmonella, Cooking of 130°F for a Service. 1999. Appendix for 90 day period indicating a
Roast E. coli minimum of 112 A of the Compliance minimum internal
Beef O157:H7 minutes. Guidelines for meeting temperature of 130° F for
Lethality Performance 112 minutes is achieved.
Relative humidity Standards for Certain
>90% for at least Meat and Poultry In plant monitoring records
25% of the cooking Products. Available at: for 90 day period
time and in no case http://www.fsis.usda.gov/ demonstrating use of dry
less than one hour. wps/wcm/connect/212e4 and wet bulb thermometers
0b3-b59d-43aa-882e- to calculate the relative
e5431ea7035f/95033F- humidity or use of a humidity
a.pdf?MOD=AJPERES. sensor to measure relative
humidity during cooking.
Doyle, M.P., and J.L. Records should indicate that
Schoeni. 1984. Survival humidity can be maintained
and growth >90% for at least 25% of the
characteristics of cooking time and in no case
Escherichia coli less than one hour by use of
associated with steam injection for 90 days.
hemorrhagic colitis.
Appl. Environ. Microbiol.
48:855-856.

63
Appendix 5: Guidance for Establishments that No Longer
Have the In-Plant Validation Data
FSIS realizes that some establishments may not have kept their initial in-plant validation
data from when HACCP was originally implemented. These documents for example
would generally include 90 days of production records and any additional data gathered
to demonstrate the establishment is able to effectively execute the critical operating
parameters of their system as described below. Those establishments that have not
kept the records will be allowed the time to assemble their in-plant validation data.

For large establishments, FSIS will wait until January 4, 2016 before including
verification that establishments have complied with the second element of validation (in-
plant validation data) as part of its inspection activities. Thus, large establishments will
have six months to gather all necessary in-plant validation documents.

Small and very small establishments will have until April 4, 2016 gather all necessary in-
plant validation data before FSIS will verify and enforce the second element of
validation (in-plant validation data).

Such documents may include HACCP records that are already generated as part of the
monitoring of critical limits or parameters of prerequisite programs. Examples of
documents that can be used by existing establishments that no longer have in-plant
validation data include:

• HACCP records collected during 90 days when the current HACCP system is in
operation.
• Decision-making documents related to CCPs and critical operational parameters
data gathering methods.
• Records associated with initial equipment set up or calibration that contain data
on additional critical operational parameters that did not become CCPs to
support that the parameters were met during the initial set-up.
• Any establishment sampling results for the product and process of interest.

Establishments should review such in-plant validation data already being collected to
ensure that they continue to support that the critical operational parameters identified in
the scientific documentation are being met. If these documents do not address all of the
critical operational parameters identified in the scientific or technical support, then
additional data may need to be generated to demonstrate that those parameters can be
properly implemented. Establishments may also wish to use the HACCP Initial
Validation Self-assessment provided on Page 34 as a check to ensure that the HACCP
system was designed correctly the first time.

64
http://askfsis.custhelp.com/

FSIS/USDA
www.fsis.usda.gov
2015

65