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height="0.8138888888888889in"}

## 

## United States

## Department of

**Agriculture**

### Food Safety

and Inspection

Service

September 1999

### HACCP-1

## Guidebook for the Preparation of HACCP Plans

> Additional copies of the Guidebook for the Preparation of HACCP Plans
> and the Generic HACCP Models are available from:
>
> U.S. Department of Agriculture
>
> Food Safety and Inspection Service (FSIS)
>
> Office of Policy, Program Development,
>
> and Evaluation (OPPDE)
>
> Inspection Systems Development Division
>
> Room 202, Cotton Annex Building
>
> 300 12^th^ Street SW
>
> Washington, D.C. 20250-3700
>
> Phone: (202) 720-3219
>
> Fax: (202) 690-0824
>
> This material is also available on the FSIS Homepage:
> <http://www.fsis.usda.gov/index.htm>

![](media/image2.png){width="0.4979166666666667in"
height="0.48819444444444443in"} United States Food Safety Washington,
D.C.

Department of and Inspection 20250

Agriculture Service

> September 8, 1999

**[TO THE USERS OF THESE VOLUMES]{.underline}**

As some of you may know, the Food Safety and Inspection Service (FSIS)
received a substantial package of comments on its Guidebook for Hazard
Analysis and Critical Control Point (HACCP) Plan Development and the 13
Generic HACCP models, from a coalition of industry and trade
associations. This package represents a large and thoughtful effort on
the part of these organizations. FSIS intends to give it the careful
attention and response that it deserves.

The comments included many technical suggestions for improvements in the
FSIS documents. It also included reiteration of longstanding differing
policy viewpoints that have been frequently discussed by the Agency and
the regulated industry. For the first time, the comments revealed
substantially differing expectations on the part of these organizations
and FSIS with respect to the purpose of the FSIS documents and their
intended use. We want to address some aspects of this latter point.

When the Pathogen Reduction/Hazard Analysis and Critical Control Point
systems (PR/HACCP) final regulation was published on July 25, 1996, the
DRAFT Guidebook was included as an appendix. The Generic Models,
developed for FSIS under contract, were available shortly thereafter in
April 1997. It was probably inevitable that there were significant
differences between the final regulatory language of CFR Part 417 and
the DRAFT Generic Models as they were developed independently. It would
have been inappropriate for FSIS to discuss its final regulatory
language with any outside group. The contractor was appropriately
proceeding from what it knew best, the National Advisory Committee on
Microbiological Criteria for Foods (NACMCF) documents on the subject of
HACCP. Therefore, FSIS accepted that work product with full knowledge
that significant revisions would be necessary.

As time passed, FSIS managers became increasingly uncomfortable with the
situation in which its major technical assistance documents did not
appropriately and completely inform the regulated industry of Agency
expectations regarding regulatory compliance. Because the intended
audience for these technical assistance materials was primarily the very
small establishments, which the Agency believed to have the least
HACCP‑experience, the Agency began the systematic revision of the
documents to overcome this problem. We targeted the summer of 1999 as
the completion date for this effort.

FSIS now believes that others had very different ideas about the purpose
and use of the documents than it did. As is consistently reiterated in
the documents themselves, they are not designed to be used \"as is.\"
That is, they cannot be copied and used by an establishment to meet all
the regulatory requirements of 9 CFR Part 417. Nor were they designed to
be the ultimate teaching and training materials, as some would suggest.
The development of ideal generic models is left to others who may have
an interest in doing so. The generic models are not

> 2

designed to extend or further interpret existing regulations; rather,
they are designed to send the user back to the regulations so he/she can
become familiar with the requirements as well as the flexibility they
permit. The generic models are not designed to present new or
alternative methods of producing and processing meat and poultry
products. That is also left to others with an interest in doing so.

FSIS envisioned that the generic models might be used in the following
way: Suppose a HACCP team leader of a three‑person HACCP team in a very
small establishment attended a training course, but the others on
his/her team were not able to do so. Suppose the HACCP training course
met all the requirements of 417.7 but did not provide participants with
much in the way of \"take away materials\" like workbooks, practical
questions and answers, access to follow‑up resources, etc., which the
Research Triangle Institute (RTI) needs assessment indicated were so
important to these establishments. The trained HACCP team leader returns
to the establishment and begins the process of attempting to develop
HACCP plans for the company\'s products and processes. He/she is quite
confident that he/she has grasped the material presented in the training
course and begins to work with this team immediately, while the concepts
are fresh in his/her mind.

First, he/she has the rest of the team review the Canadian video and the
Guidebook from FSIS so that all members of his team have a basic level
of information.

The team members begin their work, and as they proceed, some questions
arise as to whether what they have developed is appropriate. This is the
point when FSIS expects the team to pick up the appropriate generic
model and get a sense of whether they are on the right track. They
should be able to determine whether the forms that they have developed,
while different from the various ones in the generic models and not the
same as what other companies use, are acceptable because they include
the required information. They will also be able to discover what are
some typical food safety hazards that are reasonably likely to occur, as
explicitly defined in 417.2, and how to think through the problems that
these hazards represent for their own products. They can see how
critical limits might arise from existing regulatory requirements like
the ones for rapid chilling of poultry products. They can also see that
in the absence of settled regulatory requirements, there may be several
sources of scientific expertise, and they can choose to make a
conservative decision to provide a good margin of safety. They can find
out the essential differences between monitoring and verification and
have a basis for making their choices about verification activities and
their frequencies. FSIS believes that these are useful, beneficial and
worthwhile functions for which its generic models can be used.

FSIS is publishing these updated revisions of the generic models,
beginning with the Guidebook and the Generic Model for Raw, Ground
Product, because a large backlog of requests exists for these two
documents. FSIS intends to publish revisions of all the generic models
no later than September 30, 1999. Moreover, as a result of public
consultation, it may publish an additional revision of some of these
models, but given the backlog and the impending HACCP implementation
date, we considered it important to get a version of these documents out
now.

We hope that these documents are helpful.

# Table of Contents

Introduction...........................................................................................
3

Developing a HACCP
Plan..........................................................................
3

Policy
Notices.........................................................................................
4

Preliminary
Steps......................................................................................
5

1\. Assemble the HACCP team, including one person who is
HACCP-trained...... 5

2\. Describe the food and its method of production and
distribution................... 6

3\. Develop and verify process flow
diagram(s)........................................... 6

4\. Decide whether products can be grouped using the process
categories............ 7

PRINCIPLE I: CONDUCT A HAZARD
ANALYSIS........................................... 8

Biological
Hazards...........................................................................
8

Chemical
Hazards............................................................................
8

Physical
Hazards...........................................................................\...
9

PRINCIPLE II: IDENTIFY THE CRITICAL CONTROL
POINTS........................... 10

PRINCIPLE III: ESTABLISH CRITICAL LIMITS FOR EACH CRITICAL

CONTROL
POINT.............................................................\...
11

PRINCIPLE IV: ESTABLISH MONITORING
PROCEDURES...........................\.... 12

PRINCIPLE V: ESTABLISH CORRECTIVE
ACTIONS...................................... 13

PRINCIPLE VI: ESTABLISH RECORDKEEPING
PROCEDURES......................... 14

PRINCIPLE VII: ESTABLISH VERIFICATION
PROCEDURES............................ 15

Validation......................................................................................
15

Ongoing
verification..........................................................................
15

Reassessment..................................................................................
15

ATTACHMENTS

Attachment 1 -- PRODUCT
DESCRIPTION............................................. 17

Attachment 2 -- PROCESS FLOW DIAGRAM (Raw
product-ground)...............18

Attachment 3 -- PROCESS FLOW DIAGRAM (Beef
Slaughter).......................19

Attachment 4 -- Checklist of Questions (Hazard Analysis
Process).................... 20

Attachment 5 -- HAZARD IDENTIFICATION/ PREVENTIVE MEASURES...... 24

Attachment 6 -- HAZARD ANALYSIS -- RAW PRODUCT, GROUND............ 25

Attachment 7 -- HACCP PLAN DEVELOPMENT FORM: MONITORING

PROCEDURES AND FREQUENCY.................................. 30

Attachment 8 -- HACCP PLAN DEVELOPMENT FORM: CORRECTIVE

ACTIONS...................................................................
31

Attachment 9 -- HACCP
PLAN............................................................. 32

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

in
Operation..............................................................
33

## APPENDIX A

PART 417 -- HAZARD ANALYSIS AND CRITICAL CONTROL

POINT (HACCP) SYSTEMS............................................... 36

APPENDIX B

References for HACCP
Teams.............................................................. 45

APPENDIX C

Livestock Carcasses and Poultry Carcasses Contaminated with Visible
Fecal

Material........................................................................................
49

Contents of HACCP Plans: Critical Control
Points...................................... 53

Contents of HACCP
Plans...................................................................
56

Establishment Review of Product Production
Records.................................. 59

HACCP Plan Requirements and Meat and Poultry Product Processing

Categories; Policy
Clarification.............................................................
62

Listeria Monocytogenes Contamination of Ready-to-Eat
Products.................... 65

GUIDEBOOK FOR THE PREPARATION OF HACCP PLANS

Introduction

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

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

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

**Large** plants -- those with 500 or more employees -- on January 26,
1998;

**Smaller** plants -- those with fewer than 500 but at least 10
employees on January 25, 1999; and

**Very small** plants -- those with fewer than 10 employees or annual
sales less than \$2.5 million -- on January 25, 2000.

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

# Developing a HACCP Plan

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

# Policy Notices

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

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

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

**Contents of HACCP Plans** (January 30, 1998)

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

> **HACCP Plan Requirements and Meat and Poultry Product Processing
> Categories; Policy Clarification** (April 1, 1998)
>
> **Listeria Monocytogenes Contamination of Ready-to-Eat Products** (May
> 26, 1999)

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

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

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

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

# Preliminary Steps

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

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

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

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

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

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

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

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

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

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

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

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

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

1.  What is the common name of the product?

2.  How is the product to be used?

3.  What type of packaging encloses the product?

4.  What is the length of shelf life of the product, at what
    temperature?

5.  Where will the product be sold? **\***Who is the intended consumer
    and what is the intended use?

6.  What labeling instructions are needed?

7.  Is special distribution control needed?

**\*** Regulatory requirement

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

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

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

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

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

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

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

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

*(ii) Raw product---ground: ground beef, ground pork, ground turkey*

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

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

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

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

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

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

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

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

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

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

# PRINCIPLE I: CONDUCT A HAZARD ANALYSIS

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

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

# 1 Biological Hazards

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

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

For details, refer to NACMCF document reference 14 listed in Appendix B.

# 

# 2. Chemical Hazards

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

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

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

# 

# 3. Physical Hazards

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

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

\--Contaminated raw materials;

\--Poorly designed or poorly maintained facilities and equipment;

\--Contaminated packaging materials; and,

\--Inattention to details by employees with key responsibilities.

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

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

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

We cannot overemphasize how important it is to do a good job on your
hazard analysis. This is often a difficult and time-consuming step, and
one that requires all the various technical and

scientific resources you can obtain. You can refer to the NACMCF DRAFT
document - *"FSIS Microbiological Hazard Identification Guide for Meat
and Poultry Components of Products Produced by Very Small Plants",*
August 1999 (Appendix B, Reference 14)" We know that doing a good job
and taking your time here is worth the effort. You cannot expect to
develop a good HACCP system if you have not been careful and thorough in
your hazard analysis.

# 

# PRINCIPLE II: IDENTIFY THE CRITICAL CONTROL POINTS

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

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

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

\--Chilling to temperatures that minimize microbial growth;

> \--Cooking to specific temperatures for exact times in order to
> destroy microbial
>
> pathogens;

\--Product formulations, such as the addition of cultures or adjustment
of pH or water

activity;

\--Processing procedures such as filling and sealing cans; and,

\--Slaughter procedures such as evisceration or antimicrobial
interventions.

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

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

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

PRINCIPLE III: ESTABLISH CRITICAL LIMITS FOR EACH CRITICAL CONTROL POINT

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

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

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

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

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

# PRINCIPLE IV: ESTABLISH MONITORING PROCEDURES

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

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

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

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

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

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

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

# PRINCIPLE V: ESTABLISH CORRECTIVE ACTIONS

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

1\. Has the cause of the deviation been identified and eliminated?;

2\. Will the CCP be under control after the corrective action has been
taken?;

3\. Have measures to prevent recurrence of the deviation been
established?; and,

> 4\. Do the corrective action procedures make sure that no product,
> which is injurious to
>
> health or otherwise adulterated because of the deviation enters
> commerce?

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

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

> How will people be informed when the deviation occurs? If a person is
> performing the monitoring procedure, who will that person contact?
>
> Who will be responsible for controlling the product that may have been
> affected by the deviation? How should that person decide how much
> product needs to be controlled?
>
> Who will be involved in deciding what to do about the product which
> might have been affected by the deviation?
>
> How will we decide what was the cause of the deviation? If we need
> technical experts outside the company, how do we get them?
>
> Once we have figured out what was the cause of the deviation, who will
> be involved in deciding how to get the process back in control and
> prevent recurrence of the deviation?
>
> If our HACCP trained individual is not available in the plant
> immediately, how can we get HACCP expertise to help decide if our plan
> needs to be modified?

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

> Who will be responsible for keeping the records of everything we do in
> response to a deviation from a critical limit at this CCP?
>
> If any person who has a responsibility in our corrective action plan
> is not available, who will be the back-up?

Is this set of corrective actions feasible at all times?

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

# PRINCIPLE VI: ESTABLISH RECORDKEEPING PROCEDURES

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

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

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

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

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

# PRINCIPLE VII: ESTABLISH VERIFICATION PROCEDURES

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

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

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

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

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

ATTACHMENTS

#### PRODUCT DESCRIPTION Attachment 1

+-----------------------------------------------------------------------+
| #######                                                               |
|                                                                       |
| ####### PROCESS CATEGORY: SLAUGHTER                                   |
|                                                                       |
| ####### PRODUCT: BEEF                                                 |
+-----------------------------------------------------------------------+
| 1\. COMMON NAME? BEEF; BEEF VARIETY MEATS                             |
|                                                                       |
| 2\. HOW IS IT TO BE USED? CARCASSES; VARIETY MEATS                    |
|                                                                       |
| 3\. TYPE OF PACKAGE? CARCASSES -- NONE; VARIETY                       |
|                                                                       |
| MEATS -- 50 POUND BOXES                                               |
|                                                                       |
| 4\. LENGTH OF SHELF LIFE,                                             |
|                                                                       |
| AT WHAT TEMPERATURE? 7 DAYS AT 40° F                                  |
|                                                                       |
| 5\. WHERE WILL IT BE SOLD? WHOLESALE TO DISTRIBUTORS                  |
|                                                                       |
| CONSUMERS? ONLY                                                       |
|                                                                       |
| INTENDED USE?                                                         |
|                                                                       |
| 6\. LABELING INSTRUCTIONS? KEEP REFRIGERATED                          |
|                                                                       |
| 7\. IS SPECIAL DISTRIBUTION KEEP REFRIGERATED                         |
|                                                                       |
| CONTROL NEEDED?                                                       |
+-----------------------------------------------------------------------+

> **PROCESS FLOW DIAGRAM** **Attachment 2**

**PROCESS CATEGORY: RAW PRODUCT, GROUND**

#### PRODUCT: FRESH PORK SAUSAGE

> **PROCESS FLOW DIAGRAM Attachment 3**

## PROCESS CATEGORY: SLAUGHTER

#### PRODUCT: BEEF

####  

#  Checklist of Questions Attachment 4 

# (Hazard Analysis Process)

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

> **1. Ingredients**
>
> Does the food contain any sensitive ingredients that are likely to
> present microbiological hazards (e.g. *Salmonella. Staphylococcus
> aureus*), chemical hazards (e.g., aflatoxin, antibiotic, or pesticide
> residues) or physical hazards (stones, glass, bone, metal)?
>
> **2. Intrinsic factors of food**
>
> Physical characteristics and composition (e.g., pH, type of acids,
> fermentable carbohydrates, water activity, preservatives) of the food
> during and after preparation which can cause or prevent a hazard.
>
> Which intrinsic factors of the food must be controlled in order to
> ensure food safety?
>
> Does the food permit survival or multiplication of pathogens and/or
> toxin formation before or during preparation?
>
> Will the food permit survival or multiplication of pathogens and/or
> toxin formation during subsequent steps of preparation, storage, or
> consumer possession?
>
> Are there other similar products in the market place? What has been
> the safety record for these products?
>
> **3. Procedures used for preparation/processing**
>
> Does the preparation procedure or process include a controllable step
> that destroys pathogens or their toxins? Consider both vegetative
> cells and spores.
>
> Is the product subject to recontamination between the preparation step
> (e.g., cooking) and packaging?
>
> **4. Microbial content of the food**
>
> Is the food commercially sterile (i.e., low acid canned food)?
>
> Is it likely that the food will contain viable sporeforming or
> nonsporeforming pathogens?
>
> What is the normal microbial content of the food stored under proper
> conditions?
>
> Does the microbial population change during the time the food is
> stored before consumption?
>
> Does that change in microbial population alter the safety of the food?
>
> **5. Facility design**
>
> Does the layout of the facility provide an adequate separation of raw
> materials from ready-to-eat foods?
>
> Is positive air pressure maintained in product packaging areas? Is
> this essential for product safety?
>
> Is the traffic pattern for people and moving equipment a potential
> source of contamination?

### 6. Equipment design

> Will the equipment provide the time/temperature control that is
> necessary to meet critical limits?
>
> Is the equipment properly sized for the volume of food that will be
> prepared?
>
> Can the equipment be controlled so that the variation in performance
> will be within the tolerances required to produce a safe food?
>
> Is the equipment reliable or is it prone to frequent breakdowns?
>
> Is the equipment designed so that it can be cleaned and sanitized?
>
> Is product contamination with hazardous substances, e.g., glass,
> likely to occur?
>
> What product safety devices such as time/temperature integrators are
> used to enhance consumer safety?

### 7. Packaging

> Does the method of packaging affect the multiplication of microbial
> pathogens and/or the formation of toxins?
>
> Is the packaging material resistant to damage, thereby preventing the
> entrance of microbial contamination?
>
> Is the package clearly labeled "Keep Refrigerated" if this is required
> for safety?
>
> Does the package include instructions for the safe handling and
> preparation of the food by the consumer?
>
> Are tamper-evident packaging features used?
>
> Is each package legibly and accurately coded to indicate production
> lot?
>
> Does each package contain the proper label?

### 8. Sanitation

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

> Can the facility be cleaned and sanitized to permit the safe handling
> of foods?
>
> Is it possible to provide sanitary conditions consistently and
> adequately to ensure safe foods?

### 9. Employee health, hygiene, and education

> Can employee health or personal hygiene practices impact the safety of
> the food being prepared?
>
> Do the employees understand the food preparation process and the
> factors they must control to ensure safe foods?
>
> Will the employees inform management of a problem which could impact
> food safety?

### 10. Conditions of storage between packaging and the consumer

> What is the likelihood that the food will be improperly stored at the
> wrong temperature?
>
> Would storage at improper temperature lead to a microbiologically
> unsafe food?

### 11. Intended use

> Will the food be heated by the consumer?
>
> Will there likely be leftovers?

### 12. Intended consumer

> Is the food intended for the general public, i.e., a population that
> does not have an increased risk of becoming ill?
>
> Is the food intended for consumption by a population with increased
> susceptibility to illness (e.g., infants, the elderly, the infirm, and
> immunocompromised individuals)?

#### Attachment 5

+-----------------------+-----------------------+-----------------------+
| ####                  |                       |                       |
|                       |                       |                       |
| ########              |                       |                       |
|  HAZARD IDENTIFICATIO |                       |                       |
| N/PREVENTIVE MEASURES |                       |                       |
|                       |                       |                       |
| PROCESS CATEGORY:     |                       |                       |
|                       |                       |                       |
| PRODUCT:              |                       |                       |
|                       |                       |                       |
| ####                  |                       |                       |
+-----------------------+-----------------------+-----------------------+
| #                     | ####                  | ####                  |
| ######## PROCESS STEP |                       |                       |
|                       | ##                    | ####                  |
|                       | ## FOOD SAFETY HAZARD | PREVENTIVE MEASURE(S) |
+-----------------------+-----------------------+-----------------------+
| ####                  | ####                  | ####                  |
+-----------------------+-----------------------+-----------------------+

#### 

#### APPROVED BY:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Date:\_\_\_\_\_\_\_\_\_\_\_

#### HAZARD ANALYSIS -- RAW PRODUCT, GROUND -- Fresh Pork Sausage

Attachment 6

+-----------+-----------+--------+-----------+-------------+----------+
| Process   | **Food    | **Reas | ######    | **If Yes in | **       |
| Step      | Safety    | onably | ### Basis | Column 3,   | Critical |
|           | Hazard**  | Likely |           | What        | Control  |
|           |           | to     |           | Measures    | Point**  |
|           |           | Oc     |           | Could be    |          |
|           |           | cur?** |           | Applied to  |          |
|           |           |        |           | Prevent,    |          |
|           |           |        |           | Eliminate,  |          |
|           |           |        |           | or Reduce   |          |
|           |           |        |           | the Hazard  |          |
|           |           |        |           | to an       |          |
|           |           |        |           | Acceptable  |          |
|           |           |        |           | Level?**    |          |
+-----------+-----------+--------+-----------+-------------+----------+
| **Re      | **Bi      | *      | **Either  | **Letters   | **1B**   |
| ceiving - | ological: | *Yes** | pathogen  | of guaranty |          |
| Meat**    | Pathogens |        | may be    | that        |          |
|           | -mi       |        | present   | supplier    |          |
|           | crobial** |        | on        | meets base  |          |
|           | (*Sal     |        | incoming  | line        |          |
|           | monella*, |        | raw       | criteria or |          |
|           |           |        | p         | in process  |          |
|           | *Es       |        | roduct.** | control of  |          |
|           | cherichia |        |           | room        |          |
|           | coli      |        |           | temperature |          |
|           | 0157:H7)* |        |           | or storage  |          |
|           |           |        |           | temperature |          |
|           |           |        |           | to prevent  |          |
|           |           |        |           | growth**    |          |
+-----------+-----------+--------+-----------+-------------+----------+
|           | *         |        |           |             |          |
|           | *Chemical |        |           |             |          |
|           | -- None** |        |           |             |          |
+-----------+-----------+--------+-----------+-------------+----------+
|           | *         | **No** | **Plant   |             |          |
|           | *Physical |        | records   |             |          |
|           | --        |        | show that |             |          |
|           | Foreign   |        | there has |             |          |
|           | ma        |        | been no   |             |          |
|           | terials** |        | incidence |             |          |
|           |           |        | of        |             |          |
|           |           |        | foreign   |             |          |
|           |           |        | materials |             |          |
|           |           |        | in        |             |          |
|           |           |        | products  |             |          |
|           |           |        | received  |             |          |
|           |           |        | into the  |             |          |
|           |           |        | plant.**  |             |          |
+-----------+-----------+--------+-----------+-------------+----------+
| **        | **B       |        |           |             |          |
| Receiving | iological |        |           |             |          |
| --        | -- None** |        |           |             |          |
| Nonmeat   |           |        |           |             |          |
| Ing       |           |        |           |             |          |
| redients/ |           |        |           |             |          |
| Packaging |           |        |           |             |          |
| Ma        |           |        |           |             |          |
| terials** |           |        |           |             |          |
+-----------+-----------+--------+-----------+-------------+----------+
|           | *         | **No** | **Letters |             |          |
|           | *Chemical |        | of        |             |          |
|           | -- Not    |        | guaranty  |             |          |
|           | a         |        | are       |             |          |
|           | cceptable |        | received  |             |          |
|           | for       |        | from all  |             |          |
|           | intended  |        | suppliers |             |          |
|           | use**     |        | of        |             |          |
|           |           |        | nonmeat   |             |          |
|           |           |        | in        |             |          |
|           |           |        | gredients |             |          |
|           |           |        | and       |             |          |
|           |           |        | packaging |             |          |
|           |           |        | mat       |             |          |
|           |           |        | erials.** |             |          |
+-----------+-----------+--------+-----------+-------------+----------+
|           | *         | **No** | **Plant   |             |          |
|           | *Physical |        | records   |             |          |
|           | --        |        | de        |             |          |
|           | Foreign   |        | monstrate |             |          |
|           | ma        |        | that      |             |          |
|           | terials** |        | foreign   |             |          |
|           |           |        | material  |             |          |
|           |           |        | cont      |             |          |
|           |           |        | amination |             |          |
|           |           |        | has not   |             |          |
|           |           |        | occurred  |             |          |
|           |           |        | during    |             |          |
|           |           |        | the past  |             |          |
|           |           |        | several   |             |          |
|           |           |        | years.**  |             |          |
+-----------+-----------+--------+-----------+-------------+----------+

########  

HAZARD ANALYSIS -- RAW PRODUCT, GROUND

**Attachment 6**

+-----------+-----------+--------+-----------+-------------+-----------+
| **Process | **Food    | **Reas | **Basis** | **If Yes in | *         |
| Step**    | Safety    | onably |           | Column 3,   | *Critical |
|           | Hazard**  | Likely |           | What        | Control   |
|           |           | to     |           | Measures    | Point**   |
|           |           | Oc     |           | Could be    |           |
|           |           | cur?** |           | Applied to  |           |
|           |           |        |           | Prevent,    |           |
|           |           |        |           | Eliminate,  |           |
|           |           |        |           | or Reduce   |           |
|           |           |        |           | the Hazard  |           |
|           |           |        |           | to an       |           |
|           |           |        |           | Acceptable  |           |
|           |           |        |           | Level?**    |           |
+-----------+-----------+--------+-----------+-------------+-----------+
| **Storage | **B       | *      | **        | **Maintain  | **2B**    |
| (Cold) -  | iological | *Yes** | Pathogens | product     |           |
| Meat**    | --        |        | are       | temperature |           |
|           | Pa        |        | r         | at or below |           |
|           | thogens** |        | easonably | a level     |           |
|           |           |        | likely to | sufficient  |           |
|           | **(List   |        | grow in   | to preclude |           |
|           | those     |        | this      | pathogen    |           |
|           | specific  |        | product   | growth.**   |           |
|           | to the    |        | if        |             |           |
|           | p         |        | te        |             |           |
|           | roduct)** |        | mperature |             |           |
|           |           |        | is not    |             |           |
|           |           |        | m         |             |           |
|           |           |        | aintained |             |           |
|           |           |        | at or     |             |           |
|           |           |        | below a   |             |           |
|           |           |        | level     |             |           |
|           |           |        | s         |             |           |
|           |           |        | ufficient |             |           |
|           |           |        | to        |             |           |
|           |           |        | preclude  |             |           |
|           |           |        | the       |             |           |
|           |           |        | growth.** |             |           |
+-----------+-----------+--------+-----------+-------------+-----------+
|           | *         |        |           |             |           |
|           | *Chemical |        |           |             |           |
|           | -- None** |        |           |             |           |
+-----------+-----------+--------+-----------+-------------+-----------+
|           | *         |        |           |             |           |
|           | *Physical |        |           |             |           |
|           | -- None** |        |           |             |           |
+-----------+-----------+--------+-----------+-------------+-----------+
| **Storage | **B       |        |           |             |           |
| --        | iological |        |           |             |           |
| Nonmeat   | -- None** |        |           |             |           |
| Ing       |           |        |           |             |           |
| redients/ |           |        |           |             |           |
| Packaging |           |        |           |             |           |
| Ma        |           |        |           |             |           |
| terials** |           |        |           |             |           |
+-----------+-----------+--------+-----------+-------------+-----------+
|           | *         |        |           |             |           |
|           | *Chemical |        |           |             |           |
|           | -- None** |        |           |             |           |
+-----------+-----------+--------+-----------+-------------+-----------+
|           | *         |        |           |             |           |
|           | *Physical |        |           |             |           |
|           | -- None** |        |           |             |           |
+-----------+-----------+--------+-----------+-------------+-----------+
| **        | **B       |        |           |             |           |
| Assemble/ | iological |        |           |             |           |
| Pre-weigh | -- None** |        |           |             |           |
| Nonmeat   |           |        |           |             |           |
| Ingr      |           |        |           |             |           |
| edients** |           |        |           |             |           |
+-----------+-----------+--------+-----------+-------------+-----------+
|           | **        |        |           |             |           |
|           | Chemical- |        |           |             |           |
|           | None**    |        |           |             |           |
+-----------+-----------+--------+-----------+-------------+-----------+
|           | *         |        |           |             |           |
|           | *Physical |        |           |             |           |
|           | -- None** |        |           |             |           |
+-----------+-----------+--------+-----------+-------------+-----------+
| **Assem   | **B       |        |           |             |           |
| ble/Weigh | iological |        |           |             |           |
| Meat**    | -- None** |        |           |             |           |
+-----------+-----------+--------+-----------+-------------+-----------+
|           | *         |        |           |             |           |
|           | *Chemical |        |           |             |           |
|           | -- None** |        |           |             |           |
+-----------+-----------+--------+-----------+-------------+-----------+
|           | *         |        |           |             |           |
|           | *Physical |        |           |             |           |
|           | -- None** |        |           |             |           |
+-----------+-----------+--------+-----------+-------------+-----------+

HAZARD ANALYSIS -- RAW PRODUCT, GROUND

**Attachment 6**

  ----------------- ----------------- -------------- --------------- --------------- ------------
  **Process Step**  **Food Safety     **Reasonably   **Basis**       **If Yes in     **Critical
                    Hazard**          Likely to                      Column 3, What  Control
                                      Occur?**                       Measures Could  Point**
                                                                     be Applied to   
                                                                     Prevent,        
                                                                     Eliminate, or   
                                                                     Reduce the      
                                                                     Hazard to an    
                                                                     Acceptable      
                                                                     Level?**        

  **Grind/Blend**   **Biological -                                                   
                    None**                                                           

                    **Chemical --                                                    
                    None**                                                           

                    **Physical --     **Yes**        **Plant records **In-line       **3P**
                    Metal                            show that       magnets are     
                    contamination**                  during the      installed on    
                                                     grinding        the stuffing    
                                                     process metal   lines.**        
                                                     contamination                   
                                                     is likely to                    
                                                     occur.**                        

  **Sausage         **Biological --                                                  
  Stuffer**         None**                                                           

                    **Chemical --                                                    
                    None**                                                           

                    **Physical --                                                    
                    None**                                                           

  **Rework**        **Biological --   **Yes**        **Rework can be **Rework is     **4B**
                    Pathogens**                      a source of     condemned or    
                                                     continuing      used in a       
                                                     inoculation     cooked product  
                                                     with            at the plant.   
                                                     pathogens.**    If it will not  
                                                                     be used that    
                                                                     day or is coded 
                                                                     and not mixed   
                                                                     so that the     
                                                                     identity and    
                                                                     total time in   
                                                                     plant or        
                                                                     process can be  
                                                                     determined.**   

                    **Chemical-                                                      
                    None**                                                           

                    **Physical --                                                    
                    None**                                                           
  ----------------- ----------------- -------------- --------------- --------------- ------------

HAZARD ANALYSIS -- RAW PRODUCT, GROUND

**Attachment 6**

  ------------------------ ----------------- -------------- --------------- -------------------- ------------
  **Process Step**         **Food Safety     **Reasonably   **Basis**       **If Yes in Column   **Critical
                           Hazard**          Likely to                      3, What Measures     Control
                                             Occur?**                       Could be Applied to  Point**
                                                                            Prevent, Eliminate,  
                                                                            or Reduce the Hazard 
                                                                            to an Acceptable     
                                                                            Level?**             

  **Packaging/Labeling**   **Biological:     **Yes**        ***Trichina*    **Labels that        **5B**
                           Pathogens --                     has             clearly indicate     
                           parasitic                        historically    this is a raw        
                           (*Trichina*)**                   occurred in raw product, along with  
                                                            pork            cooking              
                                                            products.**     instructions, and    
                                                                            the safe food        
                                                                            handling             
                                                                            statement.**         

                           **Chemical --                                                         
                           None**                                                                

                           **Physical --     **Yes**        **Metal         **Functional metal   **6P**
                           Metal                            contamination   detector is on-line  
                           contamination**                  that may have   in the               
                                                            come into the   packaging/labeling   
                                                            establishment   area to remove metal 
                                                            or is           contamination.**     
                                                            contaminated                         
                                                            during the                           
                                                            grinding                             
                                                            process must be                      
                                                            removed.**                           

  **Finished Product       **Biological --   **Yes**        **Pathogens are **Maintain product   **7B**
  Storage (Cold)**         Pathogens**                      reasonably      temperature at or    
                                                            likely to grow  below a level        
                                                            in this product sufficient to        
                                                            if temperature  preclude pathogen    
                                                            is not          growth.**            
                                                            maintained at                        
                                                            or below a                           
                                                            level                                
                                                            sufficient to                        
                                                            preclude their                       
                                                            growth.**                            

                           **Chemical --                                                         
                           None**                                                                

                           **Physical -                                                          
                           None**                                                                
  ------------------------ ----------------- -------------- --------------- -------------------- ------------

HAZARD ANALYSIS -- RAW PRODUCT, GROUND

**Attachment 6**

+-----------+-----------+--------+-----------+-------------+-----------+
| **Process | **Food    | **Reas | ######    | **If Yes in | *         |
| Step**    | Safety    | onably | ### Basis | Column 3,   | *Critical |
|           | Hazard**  | Likely |           | What        | Control   |
|           |           | to     |           | Measures    | Point**   |
|           |           | Oc     |           | Could be    |           |
|           |           | cur?** |           | Applied to  |           |
|           |           |        |           | Prevent,    |           |
|           |           |        |           | Eliminate,  |           |
|           |           |        |           | or Reduce   |           |
|           |           |        |           | the Hazard  |           |
|           |           |        |           | to an       |           |
|           |           |        |           | Acceptable  |           |
|           |           |        |           | Level?**    |           |
+-----------+-----------+--------+-----------+-------------+-----------+
| **S       | **B       |        |           |             |           |
| hipping** | iological |        |           |             |           |
|           | -- None** |        |           |             |           |
+-----------+-----------+--------+-----------+-------------+-----------+
|           | **        |        |           |             |           |
|           | Chemical- |        |           |             |           |
|           | None**    |        |           |             |           |
+-----------+-----------+--------+-----------+-------------+-----------+
|           | *         |        |           |             |           |
|           | *Physical |        |           |             |           |
|           | -- None** |        |           |             |           |
+-----------+-----------+--------+-----------+-------------+-----------+

####  Attachment 7 

+--------------+----------------------+--------------------------------+
| ####         |                      |                                |
|              |                      |                                |
| **HACCP PLAN |                      |                                |
| DEVELOPMENT  |                      |                                |
| FORM:        |                      |                                |
| MONITORING   |                      |                                |
| PROCEDURES   |                      |                                |
| AND          |                      |                                |
| FREQUENCY**  |                      |                                |
|              |                      |                                |
| PROCESS      |                      |                                |
| CATEGORY:    |                      |                                |
|              |                      |                                |
| #            |                      |                                |
| ### PRODUCT: |                      |                                |
+--------------+----------------------+--------------------------------+
| #### PROC    | #### CRITICAL LIMITS | #### MONITORING PR             |
| ESS STEP/CCP |                      | OCEDURES \*(WHO/WHAT/WHEN/HOW) |
+--------------+----------------------+--------------------------------+
| ####         | ####                 | ####                           |
+--------------+----------------------+--------------------------------+
| ####         | ####                 | ####                           |
+--------------+----------------------+--------------------------------+
| ####         | ####                 | ####                           |
+--------------+----------------------+--------------------------------+
| ####         | ####                 | ####                           |
+--------------+----------------------+--------------------------------+
| ####         | ####                 | ####                           |
+--------------+----------------------+--------------------------------+
| ####         | ####                 | ####                           |
+--------------+----------------------+--------------------------------+
| ####         | ####                 | ####                           |
+--------------+----------------------+--------------------------------+
| ####         | ####                 | ####                           |
+--------------+----------------------+--------------------------------+
| ####         | ####                 | ####                           |
+--------------+----------------------+--------------------------------+

#### 

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

####  Attachment 8 

+-------+--------------+----------------------+----------------------+
| ####  |              |                      |                      |
|       |              |                      |                      |
| **    |              |                      |                      |
| HACCP |              |                      |                      |
| PLAN  |              |                      |                      |
| D     |              |                      |                      |
| EVELO |              |                      |                      |
| PMENT |              |                      |                      |
| FORM: |              |                      |                      |
| CORRE |              |                      |                      |
| CTIVE |              |                      |                      |
| ACTI  |              |                      |                      |
| ONS** |              |                      |                      |
|       |              |                      |                      |
| PR    |              |                      |                      |
| OCESS |              |                      |                      |
| CATE  |              |                      |                      |
| GORY: |              |                      |                      |
|       |              |                      |                      |
| ###   |              |                      |                      |
| # PRO |              |                      |                      |
| DUCT: |              |                      |                      |
+-------+--------------+----------------------+----------------------+
| #     | #### CRI     | #### M               | ####                 |
| ### P | TICAL LIMITS | ONITORING PROCEDURES | \*CORRECTIVE ACTIONS |
| ROCES |              |  (WHO/WHAT/WHEN/HOW) |                      |
| S STE |              |                      |                      |
| P/CCP |              |                      |                      |
+-------+--------------+----------------------+----------------------+
| ####  | ####         | ####                 | ####                 |
+-------+--------------+----------------------+----------------------+
| ####  | ####         | ####                 | ####                 |
+-------+--------------+----------------------+----------------------+
| ####  | ####         | ####                 | ####                 |
+-------+--------------+----------------------+----------------------+
| ####  | ####         | ####                 | ####                 |
+-------+--------------+----------------------+----------------------+
| ####  | ####         | ####                 | ####                 |
+-------+--------------+----------------------+----------------------+
| ####  | ####         | ####                 | ####                 |
+-------+--------------+----------------------+----------------------+
| ####  | ####         | ####                 | ####                 |
+-------+--------------+----------------------+----------------------+
| ####  | ####         | ####                 | ####                 |
+-------+--------------+----------------------+----------------------+

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

> Attachment 9

+-----+------+--------+---------+----------------+-------------------+
| *   |      |        |         |                |                   |
| *HA |      |        |         |                |                   |
| CCP |      |        |         |                |                   |
| PLA |      |        |         |                |                   |
| N** |      |        |         |                |                   |
|     |      |        |         |                |                   |
| **P |      |        |         |                |                   |
| ROC |      |        |         |                |                   |
| ESS |      |        |         |                |                   |
| CAT |      |        |         |                |                   |
| EGO |      |        |         |                |                   |
| RY: |      |        |         |                |                   |
| \_\ |      |        |         |                |                   |
| _\_ |      |        |         |                |                   |
| \_\ |      |        |         |                |                   |
| _\_ |      |        |         |                |                   |
| \_\ |      |        |         |                |                   |
| _\_ |      |        |         |                |                   |
| \_\ |      |        |         |                |                   |
| _\_ |      |        |         |                |                   |
| \_\ |      |        |         |                |                   |
| _\_ |      |        |         |                |                   |
| \_\ |      |        |         |                |                   |
| _\_ |      |        |         |                |                   |
| \_\ |      |        |         |                |                   |
| _\_ |      |        |         |                |                   |
| \_\ |      |        |         |                |                   |
| _\_ |      |        |         |                |                   |
| \_\ |      |        |         |                |                   |
| _\_ |      |        |         |                |                   |
| \_\ |      |        |         |                |                   |
| _\_ |      |        |         |                |                   |
| \_\ |      |        |         |                |                   |
| _** |      |        |         |                |                   |
|     |      |        |         |                |                   |
| **P |      |        |         |                |                   |
| ROD |      |        |         |                |                   |
| UCT |      |        |         |                |                   |
| EX  |      |        |         |                |                   |
| AMP |      |        |         |                |                   |
| LE: |      |        |         |                |                   |
| \_  |      |        |         |                |                   |
| \_\ |      |        |         |                |                   |
| _\_ |      |        |         |                |                   |
| \_\ |      |        |         |                |                   |
| _\_ |      |        |         |                |                   |
| \_\ |      |        |         |                |                   |
| _\_ |      |        |         |                |                   |
| \_\ |      |        |         |                |                   |
| _\_ |      |        |         |                |                   |
| \_\ |      |        |         |                |                   |
| _\_ |      |        |         |                |                   |
| \_\ |      |        |         |                |                   |
| _\_ |      |        |         |                |                   |
| \_\ |      |        |         |                |                   |
| _\_ |      |        |         |                |                   |
| \_\ |      |        |         |                |                   |
| _\_ |      |        |         |                |                   |
| \_\ |      |        |         |                |                   |
| _\_ |      |        |         |                |                   |
| \_\ |      |        |         |                |                   |
| _\_ |      |        |         |                |                   |
| \_\ |      |        |         |                |                   |
| _\_ |      |        |         |                |                   |
| \_\ |      |        |         |                |                   |
| _\_ |      |        |         |                |                   |
| \_\ |      |        |         |                |                   |
| _\_ |      |        |         |                |                   |
| \_\ |      |        |         |                |                   |
| _\_ |      |        |         |                |                   |
| \_\ |      |        |         |                |                   |
| _** |      |        |         |                |                   |
+-----+------+--------+---------+----------------+-------------------+
| #   | #### | **Moni | ####    | **Verification | ######### C       |
| ### |  Cri | toring |  HACCP  | Procedures and | orrective Actions |
|  CC | tica | Proc   | Records | Frequency**    |                   |
| P#  | l Li | edures |         |                |                   |
| and | mits | and    |         |                |                   |
|  Lo |      | Frequ  |         |                |                   |
| cat |      | ency** |         |                |                   |
| ion |      |        |         |                |                   |
+-----+------+--------+---------+----------------+-------------------+
|     |      |        |         |                |                   |
+-----+------+--------+---------+----------------+-------------------+

## Signature: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Date: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ 

#  Attachment 10

# List of Some Typical Records of a HACCP System in Operation

1.  **Ingredients**

-   Records from all monitored CCPs.

```{=html}
<!-- -->
```
-   Supplier certification documenting compliance with establishment's
    specifications.

```{=html}
<!-- -->
```
-   Establishment's audit records verifying supplier compliance.

```{=html}
<!-- -->
```
-   Storage temperature record for temperature-sensitive ingredients.

```{=html}
<!-- -->
```
-   Storage time records of limited shelf-life ingredients.

2.  **Preparation**

-   Records from all monitored CCPs.

```{=html}
<!-- -->
```
-   Records verifying the continued adequacy of the food preparation
    procedures.

3.  **Packaging**

-   Records indicating compliance with specifications for packaging
    materials.

```{=html}
<!-- -->
```
-   Records indicating compliance with sealing specifications.

4.  **Finished product**

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

```{=html}
<!-- -->
```
-   Sufficient data and records to establish the safe shelf-life of the
    product if age of product can affect safety.

```{=html}
<!-- -->
```
-   Documentation of the adequacy of the HACCP procedures from an
    authority knowledgeable of the hazards involved and necessary
    controls.

5.  **Storage and distribution**

-   Temperature records.

```{=html}
<!-- -->
```
-   Records showing no product shipped after shelf-life date on
    temperature-sensitive products.

6.  **Deviation and corrective action**

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

```{=html}
<!-- -->
```
-   Reassessment records and modifications to the HACCP plan indicating
    approved revisions and changes in ingredients, formulations,
    preparation, packaging, and distribution control, as needed.

7.  **Employee training**

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

##  

#### 

#### 

#### 

#### 

#### 

#### 

#### 

#### 

#### 

#### 

#### 

#### 

#### 

#### 

#### 

#### 

#### 

#### 

#### 

#### 

#### APPENDIX A 

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

§ 417.1 Definitions.

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

[Corrective action]{.underline}. Procedures to be followed when a
deviation occurs.

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

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

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

[HACCP System]{.underline}. The HACCP plan in operation, including the
HACCP plan itself.

[Hazard]{.underline}. SEE Food Safety Hazard.

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

[Process‑monitoring instrument]{.underline}. An instrument or device
used to indicate conditions during processing at a critical control
point.

[Responsible establishment official]{.underline}. The individual with
overall authority on‑site or a higher level official of the
establishment.

**§ 417.2 Hazard Analysis and HACCP Plan.**

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

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

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

\(i\) Natural toxins;

\(ii\) Microbiological contamination;

\(iii\) Chemical contamination;

\(iv\) Pesticides;

\(v\) Drug residues;

\(vi\) Zoonotic diseases;

\(vii\) Decomposition;

\(viii\) Parasites;

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

\(x\) Physical hazards.

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

\(i\) Slaughter‑‑all species.

\(ii\) Raw product‑‑ground.

\(iii\) Raw product‑‑not ground.

\(iv\) Thermally processed‑‑commercially sterile.

\(v\) Not heat treated‑‑shelf stable.

\(vi\) Heat treated‑‑shelf stable.

\(vii\) Fully cooked‑‑not shelf stable.

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

\(ix\) Product with secondary inhibitors‑‑not shelf stable.

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

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

\(c\) [The contents of the HACCP plan]{.underline}. The HACCP plan
shall, at a minimum:

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

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

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

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

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

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

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

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

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

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

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

\(i\) Upon initial acceptance;

\(ii\) Upon any modification; and

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

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

**§ 417.3 Corrective actions.**

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

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

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

\(3\) Measures to prevent recurrence are established; and

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

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

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

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

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

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

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

**§ 417.4 Validation, Verification, Reassessment.**

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

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

\(2\) [Ongoing verification activities]{.underline}. Ongoing
verification activities include, but are not limited to:

\(i\) The calibration of process‑monitoring instruments;

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

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

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

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

**§ 417.5 Records.**

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

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

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

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

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

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

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

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

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

\(f\) [Official review]{.underline}. All records required by this part
and all plans and procedures required by this part shall be available
for official review and copying.

**§ 417.6 Inadequate HACCP Systems.**

A HACCP system may be found to be inadequate if:

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

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

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

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

\(e\) Adulterated product is produced or shipped.

**§ 417.7 Training.**

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

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

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

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

**§ 417.8 Agency verification.**

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

\(a\) Reviewing the HACCP plan;

\(b\) Reviewing the CCP records;

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

\(d\) Reviewing the critical limits;

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

\(f\) Direct observation or measurement at a CCP;

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

\(h\) On‑site observations and record review.

**APPENDIX B**

# References for HACCP Teams

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Useful sections in particular are:

###  **Chapter 4 -- microbiological hazards, pp. 72-103**

##  Chapter 9 -- raw meat, pp. 193-199

##  Chapter 9 -- processed meats, pp. 199-216

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

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

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

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

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

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

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

22. Tompkin, R.B. *The Use of HACCP in the Production of Meat and
    Poultry Products.*

J. Food Protect. 53(9): 795-803, 1990.

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

**APPENDIX C**

**Livestock Carcasses and Poultry Carcasses Contaminated With Visible
Fecal Material**

\[Federal Register: November 28, 1997 (Volume 62, Number 229)\]

\[Rules and Regulations\]

\[Page 63254-63255\]

From the Federal Register Online via GPO Access \[wais.access.gpo.gov\]

\[DOCID:fr28no97-2\]

=======================================================================

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

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

\[Docket No. 97-067N\]

Livestock Carcasses and Poultry Carcasses Contaminated With

Visible Fecal Material

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Notice on complying with food safety standards under the
**HACCP**

system regulations.

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

SUMMARY: The Food Safety and Inspection Service is publishing this

notice to assure that the owners and operators of federally inspected

slaughter establishments are aware that the Agency views its "zero

tolerance" for visible fecal material as a food safety standard. Fecal

material is a vehicle for microbial pathogens, and microbiological

contamination is a food safety hazard that is reasonably likely to

occur in the slaughter production process. In controlling

microbiological contamination, a hazard analysis and critical control

point plan for slaughter must be designed, among other things, to

ensure that, by the point of post-mortem inspection of livestock

carcasses or when poultry carcasses enter the chilling tank, no visible

fecal material is present.

FOR FURTHER INFORMATION CONTACT: Patricia F. Stolfa, Assistant Deputy

Administrator, Regulations and Inspection Methods, Food Safety and

Inspection Service, Washington, DC 20250-3700; (202) 205-0699.

SUPPLEMENTARY INFORMATION: The Food Safety and Inspection Service

(FSIS) administers a regulatory program under the Federal Meat

Inspection Act (FMIA) (21 U.S.C. 601 et seq.) and the Poultry Products

Inspection Act (PPIA) (21 U.S.C. 451 et seq.) to protect the health and

welfare of consumers by preventing the distribution of livestock

products and poultry products that are unwholesome, adulterated, or

misbranded. A livestock product or poultry product is adulterated under

any of a number of circumstances, including the following: if it bears

or contains any poisonous or deleterious substance which may render it

injurious to health, unless when the substance is not an added

substance, the quantity in or on the article does not ordinarily render

it injurious to health; if it consists in whole or in part of any

filthy, putrid, or decomposed substance or is for any other reason

unsound, unhealthful, unwholesome, or otherwise

\[\[Page 63255\]\]

unfit for human food; or if it has been prepared, packed, or held under

unsanitary conditions whereby it may have become contaminated with

filth or whereby it may have been rendered injurious to health (21

U.S.C. 453(g)(1), (g)(3), and (g)(4) and 601(m)(1), (m)(3), and

(m)(4)). Both the FMIA and the PPIA include requirements for government

inspection and prohibit transactions in products required to be

inspected unless they have been \`\`inspected and passed\'\' or if they
are

adulterated (21 U.S.C. 458(a)(2) and 610(c)).

FSIS enforces a \`\`zero tolerance\'\' standard for visible fecal

material on carcasses and carcass parts at inspected establishments

that slaughter livestock or poultry. This standard is reflected in the

Agency\'s regulations under the FMIA and the PPIA (9 CFR chapter III,

subchapter A and subchapter C, respectively), which require (among

other things) that establishments handle livestock carcasses and

carcass parts to prevent contamination with fecal material and promptly

remove contamination if it occurs (Sec. 310.18) and that establishments

prevent poultry carcasses contaminated with visible fecal material from

entering the chilling tank (Sec. 381.65(e)). When inspection program

personnel observe fecal material at post-mortem livestock inspection or

thereafter (i.e., at or after the final rail) under the FMIA or when

poultry carcasses are about to enter the chilling tank or thereafter

(i.e., at any point after the final pre-chiller wash) under the PPIA,

they condemn affected carcasses and carcass parts unless the

contamination is removed in accordance with regulatory requirements.

The Agency is publishing this notice to assure that the owners and

operators of federally inspected slaughter establishments are aware

that FSIS regards its zero tolerance for visible fecal material as a

food safety standard under both the FMIA and the PPIA. Reiterating the

Agency\'s position is particularly appropriate now, as federally

inspected establishments prepare to comply with the hazard analysis and

critical control point (**HACCP**) system regulations (part 417).
\<SUP\>1\</SUP\>

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

\\1\\ Part 417 requirements, as well as pathogen reduction

performance standards for Salmonella in establishments that

slaughter cattle, swine, chickens, or turkeys, prepare ground beef

or fresh pork sausage, or process ground chicken or turkey

(Secs. 310.25(b) and 381.94(b)) will apply as of January 26, 1998,

in establishments with 500 or more employees; January 25, 1999, in

establishments with 10 or more but fewer than 500 employees (unless

the establishment has annual sales of less than \$2.5 million); and

January 25, 2000, in establishments with fewer than 10 employees or

annual sales of less than \$2.5 million.

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

The essence of FSIS\'s position is that fecal material is a vehicle

for microbial pathogens, and microbiological contamination is a food

safety hazard that is reasonably likely to occur in the slaughter

production process (Sec. 417.2(a) and (b)). Consequently, **HACCP**
plans

must control for microbiological contamination at slaughter, and to

meet the zero tolerance standard, an establishment\'s controls must

(among other things) include limits that ensure that no visible fecal

material is present by the point of post-mortem inspection of livestock

carcasses or before poultry carcasses enter the chilling tank

(Sec. 417.2(c)).

In the Pathogen Reduction-**HACCP** Systems final rule (61 FR 38806,

July 25, 1996), FSIS explained the reasoning underlying its position on

fecal contamination, and at the beginning of this year, FSIS addressed

the role of its zero tolerance for visible fecal material on poultry

carcasses in the final rule that codified the standard under the PPIA

(62 FR 5139, February 4, 1997). Preparation for implementation of the

**HACCP** system regulations has not changed the Agency\'s conclusions
about

the appropriateness of this standard, under the FMIA as well as the

PPIA.

As the Agency stated in the Pathogen Reduction-**HACCP** Systems final

rule (61 FR 38837):

In slaughter establishments, fecal contamination of carcasses is

the primary avenue for contamination by pathogens. Pathogens may

reside in fecal material and ingesta, both within the

gastrointestinal tract and on the exterior surfaces of animals going

to slaughter. Therefore, without care being taken in handling and

dressing procedures during slaughter and processing, the edible

portions of the carcass can become contaminated with bacteria

capable of causing illness in humans. Additionally, once introduced

into the establishment environment, the organisms may be spread from

carcass to carcass.

Because the microbial pathogens associated with fecal

contamination are the single most likely source of potential food

safety hazard in slaughter establishments, preventing and removing

fecal contamination and associated bacteria are vital

responsibilities of slaughter establishments. Further, because such

contamination is largely preventable, controls to address it will be

a critical part of any slaughter establishment\'s **HACCP** plan. Most

slaughter establishments already have in place procedures designed

to prevent and remove visible fecal contamination.

As noted in the zero tolerance final rule and confirmed today with

respect to livestock as well as poultry, establishments that process

animals must adopt controls that they can demonstrate are effective in

reducing the occurrence of microbial pathogens, including controls that

prevent the fecal contamination of carcasses (62 FR 5140). Under the

**HACCP** system regulations, critical control points to eliminate

contamination with visible fecal material are predictable and essential

components of all slaughter establishments\' **HACCP** plans. Initial

validation of a **HACCP** plan for slaughter and monitoring thereunder,
as

verified and documented in establishment records, must demonstrate the

effective operation of the plan\'s controls on a continuing basis

(Secs. 417.3(a), 417.4, and 417.5).

FSIS personnel will continue to verify compliance with the zero

tolerance standard in slaughter establishments that are subject to part

417 requirements. The Agency will use visual observations and other

findings by FSIS personnel in evaluating the effectiveness of an

establishment\'s preventive controls and corrective actions for fecal

contamination (Secs. 417.6 and 417.8). The presence of visible fecal

contamination on livestock carcasses presented for post-mortem

inspection or poultry carcasses entering the chilling tank will mean

that establishment controls have failed; repeated failures will

evidence that establishment corrective actions have failed to prevent

recurrence and, thus, possible system inadequacy.

In addition to enforcing the zero tolerance for visible fecal

material, FSIS will use the results of establishment testing for

generic E. coli (Escherichia coli Biotype I, as already required by

Sec. 310.25(a) or Sec. 381.94(a)) in assessing how well an

establishment is controlling its slaughter and dressing processes to

prevent fecal contamination. The pathogen reduction performance

standards for Salmonella (Secs. 310.25(b) and 381.94(b)), which FSIS

will enforce through its own testing program, will complement the zero

tolerance standard and E. coli testing.

Done at Washington, D.C., on November 18, 1997.

Thomas J. Billy,

Administrator.

\[FR Doc. 97-31176 Filed 11-26-97; 8:45 am\]

BILLING CODE 3410-DM-P

**Contents of HACCP Plans: Critical Control Points**

\[Federal Register: January 30, 1998 (Volume 63, Number 20)\]

\[Rules and Regulations\]

\[Page 4560-4562\]

From the Federal Register Online via GPO Access \[wais.access.gpo.gov\]

\[DOCID:fr30ja98-2\]

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Part 417

\[Docket No. 97-082N\]

Contents of HACCP Plans; Critical Control Points

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Compliance with the HACCP system regulations.

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

SUMMARY: The Food Safety and Inspection Service (**FSIS**) is publishing

this document to ensure that the owners and operators of federally

inspected establishments are aware that the identification of

appropriate critical

\[\[Page 4561\]\]

control points is crucial to complying with the Agency\'s regulations on

hazard analysis and critical control point (HACCP) systems. The HACCP

system regulations require that a HACCP plan list critical control

points for each food safety hazard identified as reasonably likely to

occur in the production process. The number of critical control points

will depend upon the production process and the hazard, but a HACCP

plan must specify as critical control points the points, steps, or

procedures at which control can be applied and, as measured by critical

limits, occurrence of the hazard can be prevented, eliminated, or

reduced to an acceptable level, and at a minimum, the critical limits

must be designed to ensure that applicable targets or performance

standards established by **FSIS**, and any other requirement in the

Agency\'s regulations pertaining to the specific process or product, are

met. These requirements implement **FSIS**\'s judgment that whenever a
food

safety hazard is reasonably likely to occur in the production process,

by applying control measures, the establishment can at least reduce the

hazard to an acceptable level, even if it cannot entirely prevent or

eliminate its occurrence.

FOR FURTHER INFORMATION CONTACT: Patricia F. Stolfa, Assistant Deputy

Administrator, Regulations and Inspection Methods, Food Safety and

Inspection Service, Washington, DC 20250-3700; (202) 205-0699.

SUPPLEMENTARY INFORMATION: The Food Safety and Inspection Service

(**FSIS**) administers a regulatory program under the Federal Meat

Inspection Act (FMIA) (21 U.S.C. 601 et seq.) and the Poultry Products

Inspection Act (PPIA) (21 U.S.C. 451 et seq.) to protect the health and

welfare of consumers by preventing the distribution of livestock

products and poultry products that are unwholesome, adulterated, or

misbranded. To further the goal of reducing the risk of foodborne

illness from meat and poultry products to the maximum extent possible,

**FSIS** issued the Pathogen Reduction-Hazard Analysis and Critical
Control

Point (HACCP) Systems final rule (61 FR 38806, July 25, 1996).

The HACCP system regulations, part 417,\<SUP\>1\</SUP\> require that

every federally inspected establishment conduct, or have conducted for

it, a hazard analysis to determine the food safety hazards reasonably

likely to occur in the production process and identify the preventive

measures the establishment can apply to control those hazards

(Sec. 417.2(a)). Whenever a hazard analysis reveals one or more food

safety hazards that are reasonably likely to occur, the establishment

must develop and implement a HACCP plan, or plans, to control those

hazards (Sec. 417.2(b)). Although it is possible that a hazard analysis

conducted in accordance with the regulations will reveal no food safety

hazard that is reasonably likely to occur, as the Agency stated when it

issued the regulations, **FSIS** is not aware of any meat or poultry

production process that can be deemed, categorically, to pose no likely

hazards (61 FR 38824).\<SUP\>2\</SUP\>

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

\\1\\ Part 417 requirements will apply as of January 26, 1998, in

establishments with 500 or more employees; January 25, 1999, in

establishments with 10 or more but fewer than 500 employees (unless

the establishment has annual sales of less than \$2.5 million); and

January 25, 2000, in establishments with fewer than 10 employees or

annual sales of less than \$2.5 million.

\\2\\ Food safety hazards include any biological, chemical, or

physical property that may cause a food to be unsafe for human

consumption (Sec. 417.1).

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

For purposes of part 417, a critical control point (CCP) is a

point, step, or procedure in a food process at which control can be

applied and, as a result, a food safety hazard can be prevented,

eliminated, or reduced to acceptable levels (Sec. 417.1).) Every HACCP

plan must \`\`list the critical control points for each of the
identified

food safety hazards, including, as appropriate:\'\'

\(i\) Critical control points designed to control food safety

hazards that could be introduced in the establishment, and

\(ii\) Critical control points designed to control food safety

hazards introduced outside the establishment, including food safety

hazards that occur before, during, and after entry into the

establishment \* \* \*

(Sec. 417.2(c)(2)). The plan also must comply with the related

requirements to specify the critical limits (maximum and minimum

values) to be met at CCP\'s, the corrective actions to be followed in

response to deviations from critical limits at CCP\'s, and the

monitoring and verification procedures to ensure appropriate corrective

actions if and when those deviations occur (Secs. 417.1, 417.2(c),

417.3(a), and 417.4(a)). At a minimum, critical limits must be designed

to ensure that applicable targets or performance standards established

by **FSIS**, and any other requirement in **FSIS**\'s regulations (9 CFR
chapter

III\) pertaining to the specific process or product, are met

(Sec. 417.2(c)(3)).

It has come to **FSIS**\'s attention that in developing HACCP plans,

some persons are viewing CCP\'s so narrowly that they risk noncompliance

with regulatory requirements. **FSIS** is concerned that some

establishments may be relying solely on HACCP concepts and theory,

without evaluating CCP\'s in accordance with regulatory requirements.

The Agency is publishing this notice to ensure that the owners and

operators of federally inspected establishments are aware that the

identification of appropriate critical control points is crucial.

The number of critical control points will depend upon the

production process and the hazard. **FSIS** will treat failure to
specify

at least one CCP for each food safety hazard identified in accordance

with the regulations as reasonably likely to occur as a failure to

develop and implement a HACCP plan that complies with Sec. 417.2

(Sec. 417.2(e)). The only exception, as specified in Sec. 417.2(b)(3),

is for food safety hazards associated with microbiological

contamination: HACCP plans that cover thermally processed/commercially

sterile products produced in accordance with the current canning

regulations (part 318, subpart G, or part 381, subpart X) need not, at

this time, address microbial hazards.\<SUP\>3\</SUP\>

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

\\3\\ **FSIS** intends to convert the canning regulations to

performance standards, which are more consistent with HACCP (61 FR

38824).

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

**FSIS** anticipates that to operate in accordance with part 417, many

establishments will find that for each identified hazard, they need

more than one CCP, particularly if they are producing raw products. The

Agency believes that depending upon a single CCP increases

establishment exposure to production-disrupting corrective actions that

affect large amounts of product. While **FSIS** is not prepared to say
that

compliance cannot be achieved with a single CCP when, for example, a

product is treated sufficiently to be shelf stable, even though it is

not commercially sterile, the Agency is concerned that establishments

may be viewing CCP\'s too restrictively to ensure compliance with the

regulations.

The part 417 requirements addressed in this notice implement the

Agency\'s conclusion that whenever a food safety hazard is reasonably

likely to occur in the production process, even if an establishment

cannot entirely prevent or eliminate occurrence of the hazard, by

applying control measures, the establishment can at least reduce it to

an acceptable level. Part 417 requires all federally inspected

establishments to take the prudent, preventive approach and develop

systematic measures for controlling such hazards.

\[\[Page 4562\]\]

Done at Washington, D.C., on: January 26, 1998.

Thomas J. Billy,

Administrator.

\[FR Doc. 98-2297 Filed 1-29-98; 8:45 am\]

BILLING CODE 3410-DM-P

**Contents of HACCP Plans**

\[Federal Register: January 30, 1998 (Volume 63, Number 20)\]

\[Rules and Regulations\]

\[Page 4562\]

From the Federal Register Online via GPO Access \[wais.access.gpo.gov\]

\[DOCID:fr30ja98-3\]

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Part 417

\[Docket No. 97-074N\]

Contents of HACCP Plans

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Compliance with the HACCP system regulations.

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

SUMMARY: The Food Safety and Inspection Service is publishing this

document to ensure that the owners and operators of federally inspected

establishments are aware that its hazard analysis and critical control

point (HACCP) system regulations require that an HACCP plan be a self-

contained document. In particular, the Agency does not view references

to good manufacturing practices, or establishment actions in accordance

with good manufacturing practices, as satisfying the requirements for

the contents of an HACCP plan. Among other things, an HACCP plan must

list the critical control points for each food safety hazard reasonably

likely to occur in the production process, the critical limits that

must be met at each of the critical control points, and the procedures,

and frequency with which they will be performed, that will be used to

monitor each critical control point to ensure compliance with critical

limits and to verify that the plan is being effectively implemented. An

HACCP plan also must identify the corrective actions to be followed in

response to deviations from critical limits at critical control points.

FOR FURTHER INFORMATION CONTACT: Patricia F. Stolfa, Assistant Deputy

Administrator, Regulations and Inspection Methods, Food Safety and

Inspection Service, Washington, DC 20250-3700; (202) 205-0699.

SUPPLEMENTARY INFORMATION: The Food Safety and Inspection Service

(FSIS) administers a regulatory program under the Federal Meat

Inspection Act (FMIA) (21 U.S.C. 601 et seq.) and the Poultry Products

Inspection Act (PPIA) (21 U.S.C. 451 et seq.) to protect the health and

welfare of consumers by preventing the distribution of livestock

products and poultry products that are unwholesome, adulterated, or

misbranded. To further the goal of reducing the risk of foodborne

illness from meat and poultry products to the maximum extent possible,

FSIS issued the Pathogen Reduction-Hazard Analysis and Critical Control

Point (HACCP) Systems final rule (61 FR 38806, July 25, 1996). As

amended by that rule, FSIS\'s regulations require federally inspected

establishments to take preventive and corrective measures at each stage

of the food production process where food safety hazards occur.

The regulations on HACCP systems, part 417,\* require a hazard

analysis to determine the food safety hazards reasonably likely to

occur in the production process and identify the preventive measures an

establishment can apply to control them (Sec. 417.2(a)(1)) and,

whenever this analysis reveals one or more such hazards, development

and implementation of a written HACCP plan (Sec. 417.2(b)(1)). In

Sec. 417.2(c), the regulations specify minimum requirements for the

contents of each HACCP plan, including requirements to list the food

safety hazards for each process; list the critical control points for

each of the identified hazards; list the critical limits that must be

met at each of the critical control points; list the procedures, and

frequency with which they will be performed, that will be used to

monitor each of the critical control points to ensure compliance with

the critical limits; and list the verification procedures, and the

frequency with which they will be performed, that the establishment

will use in accordance with Sec. 417.4 (i.e., to verify that the plan

is being effectively implemented) (paragraphs (c)(1), (c)(2), (c)(3),

(c)(4), and (c)(7) of Sec. 417.2). In addition, a HACCP plan must

include all corrective actions that have been developed in accordance

with Sec. 417.3(a), which requires the identification of the corrective

action to be followed in response to a deviation from a critical limit

(Sec. 417.2(c)(5)).

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

\* Part 417 requirements will apply as of January 26, 1998, in

establishments with 500 or more employees; January 25, 1999, in

establishments with 10 or more but fewer than 500 employees (unless

the establishment has annual sales of less than \$2.5 million); and

January 25, 2000, in establishments with fewer than 10 employees or

annual sales of less than \$2.5 million.

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

Given the explicit requirements to list critical control points,

critical limits, and monitoring and verification procedures and to

develop and identify corrective actions, and the Agency\'s statement, in

issuing part 417, that it was clarifying requirements for the

identification of critical control points within a HACCP plan (61 FR

38825), FSIS is concerned that some industry members and consultants to

industry think that they can comply with Sec. 417.2(c) by referring to

good manufacturing practices, or establishment actions in accordance

with good manufacturing practices. While FSIS has considered good

manufacturing practices in developing some requirements that protect

the public against livestock products and poultry products that are

misbranded or economically adulterated (21 U.S.C. 453 and 601), the

Agency has not adopted specific good manufacturing practices as part of

its regulations.

The Agency is publishing this notice to ensure that the owners and

operators of federally inspected establishments are aware that

references to good manufacturing practices, or establishment actions in

accordance with good manufacturing practices, rather than stating the

critical control points, critical limits, monitoring and verification

procedures, and corrective actions themselves is insufficient to

satisfy the requirements of Sec. 417.5(c). Part 417 requires that a

HACCP plan be a self-contained document.

Moreover, the function of critical control points and critical

limits is to prevent, eliminate, or reduce to an acceptable level one

or more food safety hazards. By definition, critical limits are maximum

and minimum values (Sec. 417.1), and by regulation, critical limits

must be designed, at a minimum, to ensure that applicable targets or

performance standards established by FSIS, and any other requirement in

FSIS\'s regulations (9 CFR chapter III) pertaining to the specific

process or product, are met (Sec. 417.2(c)(3)). To determine whether

critical limits are met and, if not, prevent the distribution of

adulterated food and future deviations, the regulations require plan-

specific monitoring, verification, and corrective action procedures.

Done at Washington, D.C., on: January 26, 1998.

Thomas J. Billy,

Administrator.

\[FR Doc. 98-2296 Filed 1-29-98; 8:45 am\]

BILLING CODE 3410-DM-P

**Establishment Review of Product Production Records**

\[Federal Register: March 6, 1998 (Volume 63, Number 44)\]

\[Rules and Regulations\]

\[Page 11104-11105\]

From the Federal Register Online via GPO Access \[wais.access.gpo.gov\]

\[DOCID:fr06mr98-3\]

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Part 417

\[Docket No. 98-003N\]

Establishment Review of Product Production Records

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Notice on complying with the HACCP system regulations.

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

SUMMARY: The Food Safety and Inspection Service is publishing this

document to provide information to owners and operators of federally

inspected establishments about what actions they must take to comply

with the requirement, in the hazard analysis and critical control point

system regulations, to review the records associated with production of

a product prior to its shipment for distribution. The regulations do

not prescribe how establishments meet this requirement and, thus, are

sufficiently flexible to accommodate various records\' review schemes.

However, establishments must determine that all critical limits were

met and, when appropriate, that corrective actions were taken.

Establishments must also ensure the completeness of their records

before shipping the product for distribution.

FOR FURTHER INFORMATION CONTACT: Patricia F. Stolfa, Assistant Deputy

Administrator, Regulations and

\[\[Page 11105\]\]

Inspection Methods, Food Safety and Inspection Service, Washington, DC

20250-3700; (202) 205-0699.

SUPPLEMENTARY INFORMATION: The Food Safety and Inspection Service

(FSIS) administers a regulatory program under the Federal Meat

Inspection Act (FMIA) (21 U.S.C. 601 et seq.) and the Poultry Products

Inspection Act (PPIA) (21 U.S.C. 451 et seq.) to protect the health and

welfare of consumers by preventing the distribution of livestock

products and poultry products that are unwholesome, adulterated, or

misbranded. To further the goal of reducing the risk of foodborne

illness from meat and poultry products to the maximum extent possible,

FSIS issued part 417 of the regulations, Hazard Analysis and Critical

Control Point (HACCP) Systems.\*

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

\* Part 417 requirements will apply as of January 26, 1998, in

establishments with 500 or more employees; January 25, 1999, in

establishments with 10 or more but fewer than 500 employees (unless

the establishment has annual sales of less than \$2.5 million); and

January 25, 2000, in establishments with fewer than 10 employees or

annual sales of less than \$2.5 million.

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

Part 417 requires federally inspected establishments to determine

the food safety hazards reasonably likely to occur in the production

process and to develop and implement a HACCP plan, or plans, to control

these hazards (Sec. 417.2(a), (b), and (c)). Under part 417,

establishments control food safety hazards through monitoring

procedures that apply critical limits at critical control points and,

when deviations occur, by taking corrective actions that restore

establishment control and keep adulterated food out of commerce, as

documented in records that are subject to establishment verification

(Secs. 417.2(c), 417.3, and 417.5).

To ensure that HACCP plans are implemented effectively and function

as intended to control food safety hazards and prevent the distribution

of adulterated livestock products and poultry products, part 417 also

requires that establishments conduct validation and verification

activities (Sec. 417.4(a)). Verification includes review of the records

that the establishment must keep to document a HACCP plan in operation

(Sec. 417.5(a)(3)). For a particular product, verification does not end

until, in accordance with Sec. 417.5(c), the establishment has reviewed

the records associated with its production.

Paragraph (c) of Sec. 417.5 provides that:

Prior to shipping product, the establishment shall review the

records associated with the production of that product, documented

in accordance with this section, to ensure completeness, including

the determination that all critical limits were met and, if

appropriate, corrective actions were taken, including the proper

disposition of product. Where practicable, this review shall be

conducted, dated, and signed by an individual who did not produce

the record(s), preferably by someone trained in accordance with

Sec. 417.7 of this part, or the responsible establishment official.

As federally inspected establishments prepare to implement HACCP plans

under part 417, the Agency has received inquiries about what actions

establishments must take to comply with this paragraph of the

regulations. In particular, people have asked whether an establishment

can satisfy the requirement for a final, records-based verification by

using any procedure other than one in which a single reviewer looks at

all the records for the product as it is assembled on the shipping dock

and loaded for transportation from the establishment.

FSIS is publishing this notice to provide information to owners and

operators of federally inspected establishments on the types of

procedures that the Agency anticipates will satisfy this requirement.

The essence of Sec. 417.5(c) is to require that establishments take

responsibility not only for developing and implementing HACCP plans,

but also for maintaining control of products until they ensure that

establishment personnel have applied those plans appropriately and

effectively. FSIS has not prescribed how establishments comply, and it

views the regulations as sufficiently flexible to accommodate records\'

review schemes in addition to the procedure described in the previous

paragraph.

Establishment personnel can review production records at any point

after processing and before shipment of the product, including, for

example, at the end of the day of production before a product goes into

on-site storage, while a product is in on-site storage, or during

preparation of shipping documents before assembling product for

transportation from the establishment. Consistent with the regulations,

an establishment also can initiate checks for records\' completeness

earlier and accomplish the review in stages. For example, an

establishment that slaughters and bones cattle carcasses one day and

prepares ground beef the next could make one reviewer responsible for

performing slaughter and boning records\' review on the first day and

carry the review forward to the second day, when another reviewer

assumes responsibility for the remaining tasks necessary to ensure that

there has been an establishment determination that all critical limits

were met and, if appropriate, corrective actions were taken and that

production records are otherwise complete and then signs and dates the

review. In addition, establishments that maintain records on computers

in accordance with Sec. 417.5(d) may be able to accomplish much of the

record checking electronically.

The crucial concern is that there be verification that

establishment controls have ensured proper product disposition, so that

adulterated product is not distributed. FSIS has not, at this point,

ruled out the possibility that a company might operate in compliance

with this regulation despite the fact that the records-based

verification is being conducted when the company transfers a product

from the preparation establishment to another, storage location and

holds the product there, maintaining control of the product, until the

company completes the review and releases the product for shipment to

retail outlets. Industry members interested in instituting a records\'

review scheme that includes this type of feature may wish to consult

with the Agency about the types of safeguards needed to ensure that

product is not shipped for distribution until the required verification

is performed. (In Secs. 318.309(d)(1)(viii) and 381.309(d)(1)(viii),

the canning and canned products\' regulations address a similar

situation as an exception, for which an establishment must obtain area

supervisor approval, to the prohibition against shipping product from

the establishments before the end of the required incubation period.)

FSIS also notes that establishment compliance with part 417

requirements does not affect the applicability of section 10 of the

FMIA or section 9(a) of the PPIA (21 U.S.C. 610 and 458(a)); in

particular, transporting, or offering for transportation,adulterated

livestock products or poultry products is prohibited.

Done at Washington, D.C., on: February 27, 1998.

Thomas J. Billy,

Administrator.

\[FR Doc. 98-5770 Filed 3-5-98; 8:45 am\]

BILLING CODE 3410-DM-P

**HACCP Plan Requirements and Meat and Poultry Product Processing
Categories; Policy Clarification**

\[Federal Register: April 1, 1998 (Volume 63, Number 62)\]

\[Rules and Regulations\]

\[Page 15739-15740\]

From the Federal Register Online via GPO Access \[wais.access.gpo.gov\]

\[DOCID:fr01ap98-1\]

=======================================================================

Rules and Regulations

Federal Register

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

This section of the FEDERAL REGISTER contains regulatory documents

having general applicability and legal effect, most of which are keyed

to and codified in the Code of Federal Regulations, which is published

under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of
Documents.

Prices of new books are listed in the first FEDERAL REGISTER issue of
each

week.

=======================================================================

\[\[Page 15739\]\]

=======================================================================

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Part 417

\[Docket No. 98-006N\]

HACCP Plan Requirements and Meat and Poultry Product Processing

Categories; Policy Clarification

AGENCY: Food Safety and Inspection Service.

ACTION: Policy clarification.

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

SUMMARY: The Food Safety and Inspection Service (FSIS) is publishing

this document to clarify its policy in regard to HACCP (Hazard Analysis

and Critical Control Points) requirements for meat and poultry

establishments producing either multiple products that fall within a

single processing category or single products that pass through

multiple processing categories.

DATES: Comments must be received on or before June 1, 1998.

ADDRESSES: Submit one original and two copies of written comments to

FSIS Docket Clerk, Docket #98-006N, U.S. Department of Agriculture,

Food Safety and Inspection Service, Room 102, Cotton Annex, 300 12 St.,

SW, Washington, DC 20250-3700. All comments submitted in response to

this document will be available for public inspection in the Docket

Clerk\'s Office between 8:30 a.m. and 4:30 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT:

Patricia F. Stolfa, Assistant Deputy Administrator, Regulations and

Inspection Methods, Food Safety and Inspection Service, U.S. Department

of Agriculture (202) 205-0699.

SUPPLEMENTARY INFORMATION:

Background

On July 25, 1996, FSIS published a final rule establishing new

requirements intended to improve the safety of meat and poultry

products and facilitate the modernization of USDA\'s meat and poultry

inspection system ("Pathogen Reduction; Hazard Analysis and Critical

Control Point (HACCP) Systems"; 61 FR 38806). The final rule requires

all official meat and poultry establishments to implement HACCP, a

science-based process control system. Under the new regulations, all

official establishments are responsible for developing and implementing

HACCP plans incorporating the controls necessary and appropriate to

ensure that their meat or poultry products are safe.

HACCP is a flexible system that enables establishments to develop

and implement control systems customized to the nature and volume of

their production. Accordingly, FSIS has promulgated regulatory

requirements meant to provide meat and poultry establishments with the

maximum flexibility for developing and implementing HACCP plans. FSIS

is publishing this notice to clarify the regulatory requirements for

establishments that wish to develop and implement a single HACCP plan

for multiple, similar products or for a single product that passes

through multiple processing categories.

Under Sec. 417.2, paragraph (a) of the HACCP requirements, FSIS

requires meat and poultry establishments to conduct a hazard analysis

to determine what food safety hazards are reasonably likely to occur in

the production process and identify the preventive measures it can

apply to control those hazards. Whenever a hazard analysis reveals that

one or more food safety hazards are reasonably likely to occur, FSIS

requires that each establishment develop and implement a written HACCP

plan covering each product produced by that establishment. Further,

FSIS specifically requires that establishments develop HACCP plans for

products that fall into the following processing categories:

\(i\) Slaughter\--all species.

\(ii\) Raw product\--ground.

\(iii\) Raw product\--not ground.

\(iv\) Thermally processed\--commercially sterile.

\(v\) Not heat treated\--shelf stable.

\(vi\) Heat treated\--shelf stable.

\(vii\) Fully cooked\--not shelf stable.

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

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

Section 417.2(b)(2) states "A single HACCP plan may encompass

multiple products within a single processing category identified in

this paragraph, if the food safety hazards, critical control points

(CCP\'s), critical limits, and procedures required to be identified and

performed \* \* \* are essentially the same, provided that any required

features of the plan that are unique to a specific product are clearly

delineated in the plan and are observed in practice." Many meat and

poultry establishments, especially processing establishments,

manufacture numerous products that have most of their processing steps

in common. Allowing a single HACCP plan for such products was intended

to simplify and improve both compliance and inspection.

For example, an establishment producing both ready-to-eat corned

beef and ready-to-eat roast beef could develop and implement a single

HACCP plan for both products. The HACCP plan would identify the common

CCP\'s and critical limits (cooking and cooling product in accordance

with time/temperature combinations predetermined by the establishment),

as well as any processing differences (the corned beef would undergo a

curing step). In this example, compliance with HACCP requirements is

simplified, and it is probably more efficient and cost-effective to

develop and implement a single HACCP plan for the two products than to

produce two separate plans. Inspection is also improved and simplified

because FSIS inspection personnel can more efficiently and effectively

review a single, unified HACCP plan.

In this document, FSIS also is clarifying that meat and poultry

establishments may develop a single HACCP plan for a single product

that passes through multiple processing categories. It is likely that

such HACCP plans would be developed and implemented, for the most part,

by establishments that both slaughter (category (i)) and process

(categories (ii) through (ix)) meat or poultry. For example, there are

numerous establishments that slaughter, grind, and package meat for

retail sale. There also are numerous establishments that slaughter, cut

up, and package poultry for retail sale. Many of these and similar

establishments probably will choose to develop and implement a single

HACCP

\[\[Page 15740\]\]

plan covering both slaughter and processing. Developing and

implementing a single HACCP plan for a single product often would be

more efficient and cost effective than producing two plans (one for

slaughter and one for processing). In many cases, FSIS inspection

personnel will be able to more efficiently and effectively review a

single HACCP plan that covers all of the processing (including

slaughter) within a meat or poultry establishment.

Done in Washington, DC: March 18, 1998.

Thomas J. Billy,

Administrator, Food Safety Inspection Service.

\[FR Doc. 98-8432 Filed 3-31-98; 8:45 am\]

BILLING CODE 3410-DM-P

**Listeria Monocytogenes Contamination of Ready-to-Eat Products**

\[Federal Register: May 26, 1999 (Volume 64, Number 101)\]

\[Rules and Regulations\]

\[Page 28351-28353\]

From the Federal Register Online via GPO Access \[wais.access.gpo.gov\]

\[DOCID:fr26my99-2\]

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 416 and 417

\[Docket No. 99-025N\]

Listeria Monocytogenes Contamination of Ready-to-Eat Products

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Compliance with the HACCP system regulations and request for

comment.

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

SUMMARY: The Food Safety and Inspection Service (FSIS) is publishing

this document to inform manufacturers of ready-to-eat livestock and

poultry products of the Agency\'s views about the application of the

hazard analysis and critical control point (HACCP) system regulations

to contamination with Listeria monocytogenes.

FSIS believes that the findings from testing a range of ready-to-

eat products and information from investigations of outbreaks of

listeriosis constitute changes that could affect an establishment\'s

hazard analysis or alter the HACCP plan for affected products.

Therefore, establishments must reassess their HACCP plans for ready-to-

eat livestock and poultry products. If reassessment results in a

determination that Listeria monocytogenes contamination is a food

safety hazard reasonably likely to occur in the establishment\'s

production process, then it is a type of microbiological contamination

that must be addressed in a HACCP plan.

In this document, FSIS is setting out several factors that it

believes an establishment should consider when performing its

reassessment. Also, FSIS is making guidance material available that

establishments may find helpful. (See ADDRESSES). FSIS invites comments

on the factors addressed in this document and on its guidance material.

DATES: Comments may be submitted by July 26, 1999.

ADDRESSES: Submit one original and two copies of written comments to

FSIS Docket Clerk, Docket No. 99-025N, U.S. Department of Agriculture,

Food Safety and Inspection Service, Room 102, Cotton Annex, 300 12th

Street, SW, Washington, DC 20250-3700. All comments submitted in

response to this document will be available for public inspection in

the Docket Clerk\'s office between 8:30 a.m. and 4:30 p.m., Monday

through Friday.

Guidance material is available from the Inspection Systems

Development Division, FSIS, USDA, Room 202, Cotton Annex Building, 300

12th Street SW, Washington, DC 20250-3700, phone (202) 720-3219, Fax

\(202\) 690-0824. The material is also available on the FSIS Homepage:

http://www.fsis.usda.gov/index.htm

FOR FURTHER INFORMATION CONTACT: Daniel L. Engeljohn, Ph.D., Director,

Regulations Development and Analysis Division, Food Safety and

Inspection Service, Washington, DC 20250-3700; (202) 720-5627.

SUPPLEMENTARY INFORMATION:

Regulatory Context

The Food Safety and Inspection Service (FSIS) administers the

regulatory program under the Federal Meat Inspection Act (FMIA) (21

U.S.C. 601 et seq.) and the Poultry Products Inspection Act (PPIA) (21

U.S.C. 451 et seq.) to protect the health and welfare of consumers by

preventing the distribution of livestock and poultry products that are

unwholesome, adulterated, or misbranded. To further the goal of

reducing the risk of foodborne illness from livestock and poultry

products to the maximum extent possible, FSIS issued the Pathogen

Reduction-Hazard Analysis and Critical Control Point (HACCP) Systems

final rule on July 25, 1996 (61 FR 38806). These regulations require

federally inspected establishments to take preventive and corrective

measures at each stage of the food production process where food safety

hazards occur.

Part 416, the regulations on Sanitation Standard Operating

Procedures (SOP\'s), requires establishments to develop, implement, and

maintain written SOP\'s for sanitation that describe daily procedures

that are sufficient to prevent direct contamination or adulteration of

products (Sec. 416.11 and 416.12(a)). Part 417, the regulations on

HACCP systems, requires a hazard analysis to determine the food safety

hazards reasonably likely to occur in the production process and

identify the preventive measures an establishment can apply to control

those hazards in the production of particular products (Sec. 417.2(a)).

Whenever a hazard analysis reveals one or more such hazards, the

regulations require the establishment to develop and implement a

written HACCP plan, for each product, that includes specified controls

for each hazard so identified (Sec. 417.2(b)(1) and (c)).

When FSIS issued the Pathogen Reduction-HACCP Systems final rule,

it responded to questions about the link between Sanitation SOP\'s and

HACCP plans by noting the importance of Sanitation SOP\'s as tools for

meeting existing sanitation responsibilities and preventing direct

product contamination and adulteration and their appropriateness as

near-term procedures\--that is, for implementation prior to HACCP

implementation and, in a sense, as a prerequisite to HACCP. In response

to concerns about redundancy, the Agency noted that a sanitation

procedure incorporated into a validated HACCP plan need not be

duplicated in the establishment\'s Sanitation SOP\'s. FSIS also

anticipated that some Sanitation SOP procedures, such as those

addressing pre-operational cleaning of facilities, equipment, and

utensils were likely to remain in an establishment\'s Sanitation SOP\'s.

(61 FR 38834.)

The HACCP system regulations require an official establishment to

develop and implement a written HACCP plan whenever a hazard analysis

reveals one or more food safety hazards that are reasonably likely to

occur in the production process ((Sec. 417.2(a), (b)(1), and (c)).

Paragraph (a)(1) of Sec. 417.2 specifies the purpose of a hazard

analysis: \`\`to determine the food safety hazards reasonably likely to

occur in the production process and identify the preventive measures

the establishment can apply to control those hazards.\'\' Ten potential

hazard areas, including microbiological contamination, are listed to

guide establishments in this analysis (Sec. 417.2(a)(3)).

Section 417.2(a)(1) also provides that a food safety hazard is

reasonably likely to occur if a prudent establishment would establish

controls because the hazard historically has occurred, or because there

is a reasonable possibility that it will occur in the particular type

of product being processed, in the absence of those controls.

The likelihood that a potential food safety hazard will occur in

the production process for a particular

\[\[Page 28352\]\]

product at a given location, and the identification and adequacy of

preventive measures to control a likely hazard, must be determined by

each establishment. Obviously, conditions may well change over time.

For this reason, the HACCP system regulations require every

establishment to reassess HACCP plan adequacy at least annually and

whenever any changes occur that could affect the underlying hazard

analysis or alter the HACCP plan (Sec. 417.4(a)(3)). When reassessment

reveals that a plan no longer meets the requirements for the contents

of a HACCP plan, the establishment must modify the plan immediately

(Sec. 417.4(a)(3)).

Listeria Monocytogenes

Listeria monocytogenes is a type of pathogenic bacteria often found

in the intestines of healthy animals (including humans) and in the

environments in which food producing animals are raised and processed

(e.g., in soil, water, and vegetation and on the surfaces of equipment,

floors, and walls). Therefore, food may be contaminated with this

microorganism and, after cooking or other treatment to destroy the

pathogen, may be recontaminated.

Listeria monocytogenes can cause listeriosis, a serious and

sometimes fatal illness, for which pregnant women, newborns, the

elderly, and people with weakened immune systems are at risk. The most

common manifestation of listeriosis is meningitis. It also can cause

miscarriages and stillbirths. Advances in molecular subtyping methods

have improved scientists\' ability to associate Listeria monocytogenes

with particular products and to detect outbreaks of listeriosis.

Since the late 1980\'s, FSIS and the Food and Drug Administration

(FDA) have worked with food manufacturers to improve procedures for

ensuring that ready-to-eat foods (i.e., products that may be consumed

without any further cooking or other preparation) are free of Listeria

monocytogenes. In addition, for the past decade, FSIS has conducted a

microbiological testing program in which the Agency samples ready-to-

eat livestock and poultry products, including cooked and fermented

sausages, cooked corned beef, sliced ham and luncheon meats, beef

jerky, cooked uncured poultry, and salads and spreads, in federally

inspected establishments. (For the Agency\'s current testing program

instructions, see FSIS Directive 10,240.2, Microbial Sampling of Ready-

to-Eat Products Produced by Establishments Operating Under a HACCP

System.) FSIS treats ready-to-eat products in which Listeria

monocytogenes is found as adulterated under the FMIA or the PPIA (21

U.S.C. 453(g) or 601(m)).

Between 1989 and 1993, the rate of illness from Listeria

monocytogenes declined. Over the next several years, there did not

appear to be any further decline, however, and since last fall, there

has been an increase in the number of cases caused by a specific

subtype\--a previously rare \`\`E\'\' pattern\--of Listeria
monocytogenes.

The Centers for Disease Control, U.S. Public Health Service, Department

of Health and Human Services (DHHS), have reported 101 illnesses, 15

adult deaths and 6 stillbirths or miscarriages associated with this

\`\`E\'\' pattern. Using methodological advances that provide more
specific

information about pathogens isolated from foods and humans, public

health agencies have obtained information associating the \`\`E\'\'
pattern

subtype of Listeria monocytogenes with livestock and poultry products.

FSIS currently is evaluating a range of measures, both short- and

long-term, to improve public health protection against this pathogen.

In aid of this evaluation, FSIS held a public meeting on February 10,

1999, at which research, regulation, and education activities along

with industry and government procedures, were discussed.

Controlling Listeria Monocytogenes Contamination

FSIS is publishing this document to advise federally inspected

establishments of the Agency\'s current position on one aspect of the

public health strategy to deal with Listeria monocytogenes

contamination and to provide an opportunity to comment on that position

as FSIS continues to develop a comprehensive strategy. FSIS is

concerned because some establishments have not reassessed their HACCP

plans after recent outbreaks of listeriosis caused by contaminated

ready-to-eat livestock and poultry products, and after some

establishments have produced ready-to-eat products adulterated with

Listeria monocytogenes. If Listeria monocytogenes contamination is a

food safety hazard reasonably likely to occur in an establishment\'s

production process, then it must be addressed in a HACCP plan. It would

not be sufficient to claim that the hazard is adequately dealt with in

the establishment\'s Sanitation SOP. HACCP plan reassessment is

necessary to determine whether the plan appropriately addresses this

hazard.

FSIS views investigations of recent outbreaks of listeriosis and

findings of Listeria monocytogenes contamination, along with other

information now available on the prevalence and persistence of this

foodborne pathogen, as sufficient evidence that some establishments\'

present approach to the food safety hazard presented by ready-to-eat

livestock food and poultry products adulterated with Listeria

monocytogenes does not comply with part 417 requirements. Therefore,

FSIS believes that Sec. 417.4(a)(3) requires that establishments

reassess the HACCP plans that cover ready-to-eat livestock and poultry

products.

Put another way, the Agency does not see how\--given the current

record of contamination incidents and information now available on the

prevalence and persistence of the microorganism, its ability to survive

under adverse conditions, and the apparent susceptibility of some

products to contamination\--an establishment that produces a ready-to-

eat product (other than one that is thermally processed-commercially

sterile, in accordance with part 318, subpart G, or part 381, subpart

X, of the regulations) could have confidence that, in operation, the

HACCP plan for the product meets part 417 requirements.

FSIS\' conclusion addresses only the need for HACCP plan

reassessment. FSIS cannot predict the likelihood that an establishment

producing ready-to-eat products would be required under the regulations

to incorporate, or alter, controls to prevent Listeria monocytogenes

contamination in one or more HACCP plans as a result of plan

reassessment. FSIS does believe, however, that given current knowledge,

Listeria monocytogenes contamination should be considered to be

reasonably likely to occur in the production of ready-to-eat livestock

and poultry products, especially if an establishment has produced

products adulterated with Listeria monocytogenes, or if the

establishment is producing one or more ready-to-eat products that are

susceptible to Listeria monocytogenes contamination in an environment

that is not known to be free of this pathogen.

FSIS urges establishments that produce ready-to-eat livestock and

poultry products to perform the reassessment of their HACCP plans

within 30 days of the publication of this document. FSIS will instruct

its inspection personnel to verify that reassessments were conducted.

If an establishment does not reassess its HACCP plan in accord with

this document, FSIS will evaluate the establishment\'s compliance with

Part 417.

\[\[Page 28353\]\]

Set out below are factors that FSIS believes are relevant in

determining whether Listeria monocytogenes contamination is a food

safety hazard reasonably likely to occur in the production process and

in identifying preventive measures that establishments can apply to

control the hazard. Reassessments of HACCP plans should take these

factors into account. FSIS is providing technical information and other

Agency guidance material. (See ADDRESSES to obtain copies.) The Agency

invites comments on this guidance material and the factors set out

below.

\(1\) Pathogen Levels in Starting Materials FSIS believes that it is

crucial that each establishment know the characteristics of its

starting materials and, in particular, keep itself informed about

evidence of Listeria monocytogenes contamination of the raw materials

or source of raw materials that the establishments use.

\(2\) Validation of Lethality Treatment FSIS believes industry

members must comply rigorously with the HACCP plan validation

requirements of Sec. 417.4(a)(1), especially in ensuring that the

establishment can successfully apply a scientifically appropriate

lethality treatment under its commercial operating conditions (see 61

FR 38826-38827). Until the establishment demonstrates that it achieves

the anticipated lethality effect under actual in-plant conditions,

effectiveness is theoretical, and the plan is not validated.

\(3\) Exposure to Contamination After Lethality Treatment The

available evidence on the presence of Listeria monocytogenes in food

processing environments appears to indicate an increased potential for

the contamination of product after a food is processed to destroy

pathogenic microorganisms. Therefore, an establishment\'s reassessment

of its HACCP plans needs to address such potential contamination.

Establishments should account for finished product characteristics such

as water activity, pH, and the presence or absence of one or more

barriers that inhibit pathogen growth. The HACCP plan must incorporate

any hazards identified by the reassessment.

\(4\) Evidence of Product Contamination FSIS believes that any

finding of Listeria monocytogenes in an establishment\'s ready-to-eat

product, whether in government or industry test results, is

substantial, and perhaps conclusive, evidence that Listeria

monocytogenes contamination is a food safety hazard that is reasonably

likely to occur in its production process for that product. Therefore,

in the event of such a finding, FSIS\' position is as follows. If the

establishment\'s HACCP plan does not already provide for the control of

Listeria monocytogenes, and absent substantial, scientifically

supportable reasons, that HACCP plan must be modified to address the

Listeria monocytogenes hazard and incorporate appropriate controls. If

the establishment\'s HACCP plan does address and control for Listeria

monocytogenes, the establishment must take the appropriate corrective

actions in accord with the requirements of 9 CFR 417.3. FSIS inspection

personnel will verify that the establishment has taken the necessary

corrective actions.

Done at Washington, D.C., on May 19, 1999.

Thomas J. Billy,

Administrator.

\[FR Doc. 99-13223 Filed 5-25-99; 8:45 am\]

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