United States
Department of
Agriculture
Food Safety
and Inspection
Service
May 1999
HACCP-8
Generic HACCP
Model for
Irradiated,Raw
Meat and
Poultry
Products
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
Irradiated,Raw Model
Table of Contents
Introduction………………………………………….……………………………………,3
Using This Generic Model………………………….…………………………………….,5
Process Flow Diagram and Product Description….………………………………………,7
Hazard Analysis…………………………………………………………………………… 8
Developing Your HACCP Plan………..………………………………………………….,10
Identifying CCPs…………………………………….……………………………………,12
Appendix A
References for all HACCP Model Teams………………………………………… 19
References for Irradiated,Raw Meat and Poultry Products..…………………….,21
Appendix B
Process Flow Diagram (Figure 1)…………………………………………………,25
Product Description Form (Figure 2)……………………………………………… 26
Hazard Analysis Form (Figure 3)…………………………………………………,27
HACCP Plan Form (Figure 4)..…………………………………………………… 32
Form letter requesting Salmonella data (1)……………………………………….,37
Form letter requesting Salmonella data (2)……………………….……………….,38
Generic Establishment X,Product Temperature Log …………………………….,39
Generic Establishment X,Room Temperature Log…………..…………………… 40
Thermometer Calibration Log………………………………………………..……,41
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Generic Establishment X,Irradiation/Dose Mapping Log ……………………….,42
Corrective Actions Log……………………………………………………………,43
Pre-Shipment Review Log………………………………………………………… 44
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GENERIC HACCP MODEL
FOR
IRRADIATED,RAW MEAT AND POULTRY PRODUCTS
Introduction
The Hazard Analysis Critical Control Point (HACCP) system is a scientific approach to process
control,It is designed to prevent the occurrence of problems by assuring that controls are
applied at any point in a food production system where hazardous or critical situations could
occur,Hazards include biological,chemical,or physical contamination of food products,
The Food Safety and Inspection Service (FSIS) published a final rule in July 1996 mandating
that HACCP be implemented as the system of process control in all inspected meat and poultry
plants,As part of its efforts to assist establishments in the preparation of plant-specific HACCP
plans,FSIS determined that a generic model for each process defined in the regulation would be
made available for use on a voluntary basis by inspected establishments,
The generic models have been revised since their initial publication and distribution as
DRAFTS,The most important change in the revised versions is to make certain that these
models are fully consistent with the features of the final regulation,Also,other technical and
editorial improvements have been made,
Throughout this generic model,FSIS discusses a HACCP team,with members from different
departments,In many very small establishments,there will not be separate departments with
different employees,But there will be employees who perform these different functions – often
several of them,For purposes of explaining concepts,it is easier to speak as if these were
different people,even though in many cases,they may be the same person carrying out more
than one responsibility,
Each generic model can be used as a starting point for the development of plant-specific plan(s)
reflecting actual plant environments and the processes conducted,The generic model is not
intended to be used,as is” for plant specific HACCP plans,
The generic models are designed for use in conjunction with the list of process categories found
in the HACCP regulations in section 417.2(b)(1),
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(b) The HACCP plan,(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,
This generic model is designed for use with the process subcategory,Irradiated,raw product,
The purpose of the process category listing in 417.2 is to set out the circumstances under which a
HACCP team may develop a single HACCP plan for multiple products,This may be done when
products are in the same process category,and food safety hazards,critical control points,and
other features are essentially the same,There is a generic model for each process category,plus
two for subcategories that present special issues,irradiated products and mechanically separated
products,
In order to select the model or models that will be most useful for the activities performed in any
specific plant,the following steps should be taken,
1) For slaughtering operations,select the model for the appropriate species,
2) For processed products,make a list of all products produced in the plant,
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Irradiated,Raw Model
3) Examine the list and group like products,considering common processing steps and
equipment used,
4) Compare the grouped products with the list of processes in the regulations; this step should
reveal how many and which of the generic models might be useful,
Deciding on a generic model and which products can be covered by a single plan is an important
achievement,If the team does it well,it can save a lot of unnecessary effort and paperwork,
Selecting an inappropriate generic model reduces its potential benefits,However,often the
HACCP team will discover they have made this error when they develop their process flow
diagram or during their hazard analysis,These are early stages in the process when it is
relatively easy to make changes,
In any case,establishments must meet all regulatory requirements for their products,
Using This Generic Model
This generic model is designed to be used by establishments that produce irradiated,raw
product(s),The model can be used for all irradiated,raw meat and poultry products,
The model will be most useful to a HACCP team that includes access to one trained individual,
as specified in 417.7(b),
(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,
Since this generic model entails the use of ionizing radiation,at least one team member must be
trained in quality control,food technology,irradiation processing,and radiation health and
safety,This team member must have a working knowledge of FSIS regulations on irradiation
(e.g,9 CFR 381.135,381.147,and 381.149 for poultry),and other requirements set forth by the
FDA,National Regulatory Commission,and the Office of Safety and Health Administration,
It would be beneficial for other team members to have reviewed any of the various guidance
materials available on how to develop a HACCP plan for your company,including several useful
videos,handbooks,or computer programs,Once the HACCP team has prepared itself as
thoroughly as possible in general HACCP principles and how to use them,this model should be
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helpful,
Note,This generic model includes a number of forms that can be used to record various types of
required information,The forms themselves are samples; a company HACCP team can develop
whatever forms it finds most useful,All the forms mentioned in this document are included in
Appendix B; they appear in the order in which they are discussed in the text,
All FSIS generic models are designed to assist establishments in applying the seven HACCP
principles to their meat and poultry processing operations AND to meet the regulatory
requirements of Part 417,Therefore,the definitions used in this and all other FSIS generic
models are those found in 417.1,
§ 417.1 Definitions,
For purposes of this part,the following definitions shall apply,
Corrective action,Procedures to be followed when a deviation occurs,
Critical control point,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,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,Any biological,chemical,or physical property that may cause a
food to be unsafe for human consumption,
HACCP System,The HACCP plan in operation,including the HACCP plan itself,
Hazard,SEE Food Safety Hazard,
Preventive measure,Physical,chemical,or other means that can be used to control an
identified food safety hazard,
Process-monitoring instrument,An instrument or device used to indicate conditions
during processing at a critical control point,
Responsible establishment official,The individual with overall authority on-site or a
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higher level official of the establishment,
Process Flow Diagram and Product Description
To begin using this model,the company's HACCP team should first describe the product(s),
which are part of this process category and covered by this HACCP plan,The product(s) should
be described in two ways,
(1) by a simple diagram which shows the steps the company uses when it produces the product,
and
(2) in a brief written description which provides key facts about the product and its use,
In this generic model,there is an example for irradiated,raw product - fresh poultry,FSIS has
developed certain forms as part of the examples in the generic models; company HACCP teams
are not required to use these forms,
Figure 1 is an example of a PROCESS FLOW DIAGRAM for the production of irradiated
fresh poultry in generic establishment X,Figure 2 is an example of a PRODUCT
DESCRIPTION for the production of irradiated fresh poultry produced by generic
establishment X,
Once the company HACCP team in your establishment has prepared your Process Flow
Diagram,they should verify it by walking through the establishment following the flow of
product and making sure that all the steps of the process are included in the flow diagram,The
team should also review the information provided on the Product Description to make sure all
the key facts are included,such as identifying consumers,especially those with particular health
problems or known to be at risk,
Note,In this generic model,it is assumed that packaged poultry will be transported to another
facility for the irradiation process,If in your process,irradiation is to be done in the same
establishment that the poultry is received and packaged,then the transporting step may be
omitted,That is generally,how you use these generic model examples--just omit the features
which do not apply to your operation,or if your operation includes features not included in this
example,they should be added,
By completing a Process Flow Diagram and a Product Description,you have met the
requirements of 417.2(a)(2),You can use the Process Flow Diagram in particular to help you
complete the rest of the hazard analysis,Use the flow diagram to systematically review each
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step in the process and ask the question,"Is there a food safety hazard which is reasonably likely
to occur which may be introduced at this step?" In answering the question,your HACCP team
needs to consider biological (including microbiological),chemical,and physical hazards,
Hazard Analysis
Once your product(s) are accurately described through the flow diagram and product description,
the HACCP team should begin work on the HAZARD ANALYSIS,The hazard analysis is
fundamental to developing a good HACCP plan and one that meets regulatory requirements,
The regulatory requirements for a hazard analysis are found at 417.2(a),
§ 417.2 Hazard Analysis and HACCP Plan,
(a) Hazard analysis,(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,
Generic establishment X,which we are using for our example,is capturing these regulatory
requirements on a 6-column Hazard Analysis Form (See Figure 3),A good way to use a form
like this is to create the first column by using the Process Flow Diagram and the second by
answering the question,Once the HACCP team has considered all the steps in the flow diagram
and determined if a food safety hazard could be introduced,it needs to consider whether the
hazard is "reasonably likely to occur",using the meaning of this phrase included in 417.2(a),On
the 6-column form used by generic establishment X,the third and fourth columns address this
issue,If the establishment's HACCP team has decided that the hazard is not reasonably likely to
occur,they enter "No" in column three,explain the basis for their determination in column four,
and do not need to further consider activity at this point in the process,
If,however,the team has determined there is a "food safety hazard reasonably likely to occur"
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introduced at a certain point in the process,column five is used to describe a measure which
could be applied to "prevent,eliminate,or reduce to acceptable levels" the food safety hazard
identified in column three,
Look at the entries for,Receiving-Raw Poultry” on the first page of the six column form; the
HACCP team has determined that Salmonella may be present at high levels in incoming raw
product,so it has put a,Yes” in the third column,Column four explains the basis for the team’s
determination,In the fifth column,the HACCP team has described the preventive measures it
will use to make sure that each hazard has been prevented,eliminated,or reduced to an
acceptable level,For the Salmonella hazard,the HACCP team decided to tell its suppliers that
product could not be accepted unless it was accompanied by the most recent Salmonella
performance standard sampling results which demonstrated that the supplier had not failed two
consecutive Salmonella performance standard sets,FSIS does not consider safe handling
instructions on labels alone to be an adequate CCP for any pathogenic microorganisms such as
bacteria and viruses,
You will notice that in our generic hazard analysis for irradiated fresh poultry,there are five
safety hazards in which the HACCP team has identified a point in the process at which a food
safety hazard is reasonably likely to occur,For each one of these they have identified a measure
which can be used to control the hazard,
When your HACCP team has completed their hazard analysis (whether they use this format or
not),it is a good idea to review the flow diagram,the product description and the hazard analysis
itself to make sure they are complete,Part 417.2(a)(3) includes a list of sources from which food
safety hazards might be expected to arise,Reviewing that list could help the HACCP team
check for completeness,
Note,If you are using this generic model to produce a different raw irradiated product or if you
use a different process flow,you may have different hazards which are reasonably likely to
occur,For these different hazards,there may be different measures that could be used for
control purposes,
This,and all other FSIS generic models,contains a list of references which can help your
HACCP team in making sure the hazard analysis is complete,The references for raw,irradiated
product are found in Appendix A,A member of your HACCP team might want to review at
least some of the references to make sure hazards have not been omitted from the hazard
analysis,
Completing the hazard analysis is a very significant and important element in developing your
HACCP system,Your HACCP team should feel a real sense of accomplishment when they get
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this far; this is like completing the foundation of a house,
Developing Your HACCP Plan
The company HACCP team can now take the materials it developed while doing the hazard
analysis and use them to build the HACCP Plan,Remember that one of the important
objectives of the FSIS generic models is to provide examples that illustrate how to meet the
regulatory requirements of Part 417,as well as to correctly apply the principles of HACCP,
Part 417.2 (c) and (d) are the regulatory requirements,
(c) The contents of the HACCP plan,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
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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,(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,
Generic establishment X has prepared its HACCP plan for irradiated fresh poultry on a six
column form (See Figure 4),You do not need to use this form,although some kind of a form is
probably the easiest way to present your HACCP plan,
Identifying CCPs
The first column on this particular form is used to enter information developed and contained on
the hazard analysis form,Part 417.2(c)(1) and (2) require that the food safety hazards identified
in the hazard analysis be listed on the HACCP plan and that there be a CCP for each identified
hazard,You will notice that there are five points on the hazard analysis form where food safety
hazards reasonably likely to occur were identified,Salmonella on raw poultry at receiving,
pathogen proliferation at packaging and labeling,pathogen proliferation at storage
(cold)/transporting,pathogen survival and/or proliferation after irradiation,and pathogen
proliferation at finished product storage(cold),
The establishment HACCP team has chosen to have five CCPs to address these five hazards,
Salmonella certification,use of approved packaging material for irradiation and clear product
label features to indicate the product is irradiated,raw,and must be fully cooked,proper
temperature maintenance during transport and storage,compliance with FSIS/FDA requirements
for the process of irradiation,and proper temperature maintenance at finished product storage
(cold),
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After identifying its CCPs,the HACCP team proceeded to consider critical limits,monitoring
procedures and their frequencies,and verification procedures and their frequencies,and HACCP
records,
In deciding what would be the critical limits,the HACCP team first considered whether there
were any regulatory requirements which had to be met and would function as critical limits,
The team was aware of regulatory requirements for the packaging material and labeling of
irradiated products as stated in 9 CFR 381.135 and 21 CFR 179.45,For their critical limit,the
HACCP team decided that air permeable packaging material,and a label with features to indicate
a raw,irradiated product has the irradiation logo,the radura,along with the statement,Treated
with radiation” or,Treated by Irradiation”,handling statement,clear cooking instructions,and
safe handling instructions,
,
The team set the critical limits for the minimum and maximum absorbed dose for irradiation of
poultry as found in 9 CFR 381.147,For developing a HACCP plan for irradiation of pork,the
required absorbed dose will be different,
Once they had decided on their critical limits,they needed to identify how the monitoring
procedures would be carried out and at what frequency,
The HACCP team decided that receiving personnel check the packaging and labeling materials
for irradiated products at Receiving-packaging materials,At this location,receiving personnel
also routinely check all letters of guarantee and incoming packaging materials to make sure they
met specifications,Since labels are manufactured in large lots by a single company,the
receiving clerks would randomly sample each arriving lot,Some packaging materials do not
have their labels and safe handling instructions printed on them and therefore these need to be
applied to the packaging material later in the process,Monitoring at the packaging and labeling
step ensures that the necessary pressure sensitive sticker labels are applied to the package,
For the CCP on the irradiation process,the HACCP team decided that the production supervisor
would be in the best position to assure that the irradiation unit was functioning properly by
checking the data log printout from the irradiation control board or,process monitoring
instrument” as the product goes through the irradiation process,The irradiation control board
shows all function movement which take place within the irradiation chamber during the
irradiation process,It will indicate whether the unit is functioning properly,and will alert the
operator for any abnormal movements,
These decisions by the HACCP team regarding critical limits,plus monitoring procedures and
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their frequencies are written up in columns two and three of the HACCP Plan,
The team then went on to consider appropriate verification procedures; the team knew that there
were different types of verification and that Part 417.4(a)(2) included specific regulatory
requirements for each,The regulatory requirements for ongoing verification are,
(2) Ongoing verification activities,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,
The HACCP team decided that they could verify the raw poultry irradiation step through the
following procedures and frequency,
1,QA will verify the irradiation data log printout,
2,QA will verify the letter of guarantee for calibration of the dosimeter every 12 months,
3. QA will verify that absorbed doses received by product are within the minimum and
maximum limits from results of dose mapping,
The HACCP team described the verification procedures and their frequencies in the fifth column
of their HACCP plan,
The HACCP team for generic establishment X knew that their HACCP Plan needed to provide
for a recordkeeping system,They wanted their records to be easy to create and understand,
They wanted to be sure their records met regulatory requirements,so they reviewed part 417.5(a)
and (b),
§ 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
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supporting documentation;
(2) The written HACCP plan,including decision making documents associated with the
selection and development of CCPs 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 CCPs 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,
The HACCP team decided that their records would be kept on some simple forms,some of
which the team itself devised,The HACCP team decided that three records were necessary,
Irradiation Data Log,Irradiation/Dose Mapping Log,and Letter of guarantee for dosimeter
calibration,
The forms(logs) were designed to provide spaces for all entries necessary for the monitoring and
verification activities at the raw poultry irradiation step,
On its HACCP Plan,generic establishment X has listed the names of the forms it will be using
for monitoring and verification records,
There is one other form included in column four,where the establishment has described its
recordkeeping system,That is the Corrective Actions Log; it is used to create the records of any
corrective actions taken because of deviations from critical limits at CCPs,Column six
references the planned corrective actions for each CCP,The HACCP team carefully reviewed
the regulatory requirements for planned corrective actions,found at 417.3(a),
§ 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
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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,
The HACCP team has developed a specific corrective action plan which will be followed
whenever there is a deviation from a critical limit at a CCP; each of the planned corrective
actions meets the four regulatory requirements of 417.3(a),
Planned Corrective Actions for CCP 4,
1,QA supervisor takes control of and segregates all products processed when the irradiation unit
was not functioning properly,
2,QA condemns affected products and dispose according to standard operating procedures,
3,Certified irradiation maintenance personnel identify problem with the irradiation unit and
repair it so that the integrity of the unit is restored and the same problem does not recur,
4,QA implements preventive maintenance checks,
The HACCP team also develops planned corrective actions for each of the other CCPs and
attaches them to the HACCP plan,Whenever a deviation from a critical limit occurs,company
employees follow the corrective action plan and use the Corrective Action Log to create a record
of their actions,The Corrective Action Log forms are available at CCPs,so they can be used
immediately when an employee performing a monitoring check discovers and records a
deviation,All Corrective Action Logs,which have been used during the day,are turned in to the
HACCP coordinator,
There is one final verification/recordkeeping requirement which the company must perform; it is
found at 417.5(c),
(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
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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,
In generic establishment X,product is shipped out,often in small lots,throughout the day,This
means that pre-shipment verification checks must be as complete as possible when finished
product is in storage,so that a shipment can be made up quickly and moved into distribution
channels,
The establishment uses a half day lotting system and a midshift cleanup,While the midshift
cleanup is being performed,QA personnel or the HACCP coordinator review results of
monitoring and verification checks applied to that lot; if there were deviations from critical
limits,they review the Corrective Action Logs to make sure all appropriate planned responses
were carried out,If everything is in order and there are complete records showing that the
establishment has controlled production of this product through its HACCP system,the HACCP
coordinator will sign the pre-shipment review form which the HACCP team devised for this
purpose,
Note,It is not a regulatory requirement that a separate form be used for pre-shipment review; in
addition,FSIS has indicated that it will be very flexible in accepting a variety of arrangements
for accomplishing pre-shipment review to reflect the variety of commercial practices which it
has encountered in the industry,It is,however,important to remember that pre-shipment review
is a regulatory requirement that must be met,as it indicates that the establishment is taking full
responsibility for the product having been produced under a well-functioning HACCP system,
The HACCP team believes it has now completed preparation of the documents which are
necessary to meet regulatory requirements for a Hazard Analysis and a HACCP Plan for their
irradiated,raw production process,They have secured a copy of FSIS Directive 5000.1,
Enforcement of Regulatory Requirements in Establishments Subject to HACCP System
Requirements,the HACCP Basic Compliance Checklist which will be used by inspection
program personnel,The HACCP team has modified the inspection form to make the statements
into positives,and now has a checklist for its own use to make sure they have not omitted
anything in their plan development and preparation,When they are confident that they have done
what is necessary,they will turn their Hazard Analysis and HACCP Plan over to the
establishment owner for decisions about implementation,
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APPENDIX A
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References for all HACCP Model 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 (beef slaughter,roaster beef,ham,chicken
slaughter,etc.)
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 R.F,Steir,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,
18
Irradiated,Raw Model
10,International Commission on Microbiological Specifications 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 (NACMCF),March
20,1992 – Hazard Analysis and Critical Control Point System,Int,J,Food Micr,16,1-23,
1993,
13,National Advisory Committee on Microbiological Criteria for Foods (NACMCF),June
1993-Report on Generic HACCP for Raw Beef,Food Microbiol,10,449-488,1994,
14,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
15, Notermans,S.,et al,The HACCP concept,Identification of potentially hazardous
microorganisms,Food Microbiol,11:203-214,1994,
16,Pearson,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
17,Pierson,M.D,and Corlett,D.A.,Jr,Editors,HACCP/Principles and Applications,Van
19
Irradiated,Raw Model
Nostrand Reinhold,1992,
18,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 section in particular is,
Chapter 11 – forms for hazard analysis,CCP,limits,HACCP master sheet,
example HACCP for breaded chicken
19,Tompkin,R.B,The Use of HACCP in the Production of Meat and Poultry Products,J,of
Food Protect,53(9),795-803,1990,
20,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 (HACCP) in Meat,Poultry and Seafoods,Chapman & Hall,1995,
References for Irradiated,Raw Meat and Poultry Products
1. American Meat Institute,Palatability,Color,and Shelf life of Low-Dose Irradiated Beef,
AMI,Washington,DC,1995,
2. American Society for Tests and Measures,Standard Guide for Selection and Application
of Dosimetry Systems for Radiation Processing of Food,In Annual Book of ASTM
Standards,ASTM,Washington,DC,12.02,785-788,1989,
3. Clavero,M,Rocelle S,Inactivation of Escherichia coli 0157:H7,Salmonellae,and
Campylobacter jejuni in Raw Ground Beef by Gamma Irradiation,App,Environ,
Microbiol,June 1994,2069-2075,1994,
4. Codex,Codex General Standard for Irradiated Foods (Annex 2)(and other sections
regarding irradiation),In Codex Alimentarius,Vol,XV,1984,
5. FDA,Irradiation in the Production,Processing and Handling of Food (Part 179),In
Code of Federal Regulations,National Archives and Records Administration,
Washington,DC 21:179.2,411-415,1977,
6,FDA,Irradiation in the Production,Processing and Handling of Food,In Federal
20
Irradiated,Raw Model
Register/Rules and Regulations,Food and Drug Administration,Washington,DC,
55:18538-18533,1990,
7. FSIS,USDA,Irradiation of Pork for Control of Trichinella spiralis (Part 318),In
Federal Register/Rules Regulations,U.S,Department of Agriculture,Washington,DC,
51:1769-1771,318.7 p,257,1999,
8. Hashim,I,B.,et al,Consumer Attitudes Toward Irradiated Poultry,Food Technol,
March 1996,77-80,1996,
9. Monk,J,David.,et al,Irradiation Inactivation of Listeria monocytogenes and
Staphylococcus aureus in Low-and High-fat,Frozen and Refrigerated Ground Beef,J,
Food Protect,57:969-974,1994,
10. Murano,Elsa A,Irradiation of Fresh Meats,Food Technol,December 1995,52-54,
1995,
11. Murano,E,A.,Editor,Irradiation Processing (Chapter 1),In Food Irradiation A
Sourcebook,Iowa State University Press,Ames,IA,1995,
12. Patterson,Margaret,Sensitivity of Bacteria to Irradiation of Poultry Meat Under Various
Atmospheres,Letters in Appl,Microbiol,7,55-58,1988,
13. Radomyski,Tomasz.,et al,Elimination of Pathogens of Significance in Food by Low-
dose Irradiation,A Review,J,Food Protect,57,73-86,1994,
14. Renwick,Stephen P.,et al,The RF Linear Accelerator in In-Lear E-Beam Processing of
Beef and Poultry,Dairy Food Environ,Sanit,16,214-221,1996,
15. Robeck,Mark R,Product Liability Issues Related to Food Irradiation,Food Technol,
February 1996,78-82,1996,
16. Rodriguez,H,Ricardo,et al,Low-dose Gamma Irradiation and Refrigeration to Extend
Shelf Life of Aerobically Packed Fresh Beef Round,J,Food Protect,56,505-509,1993,
17. Tarte,R,R.,et al,Survival and Injury of Listeria monocytogenes,Listeria innocua and
Listeria ivanovii in Ground Pork Following Electron Beam Irradiation,J,Food Protect,
59,596-600,1996,
18,Thayer,D,W,Use of Irradiation to Kill Pathogens on Meat and Poultry,J,Food
21
Irradiated,Raw Model
Science,15,181-192,1995,
19. Thayer,D,W.,et al,Extending Shelf Life of Poultry and Red Meat by Irradiation
Processing,J,Food Protect,56,831-833,1993,
20. Thayer,D,W.,et al,Elimination of Escherichia coli 0157:H7 in Meats by Gamma
Irradiation,Appl,Environ,Microbiol,April 1993,1030-1034,1993,
21. USDA,Irradiation of Poultry Products (Part 381),In Federal Register/Rules and
Regulation,U.S,Department of Agriculture,Washington,DC 57:43588-43600,1992,
22
Irradiated,Raw Model
APPENDIX B
23
Irradiated,Raw Model
PROCESS FLOW DIAGRAM Figure 1
PROCESS CATEGORY,IRRADIATED,RAW PRODUCT
PRODUCT,FRESH POULTRY
RECEIVING
PACKAGING
MATERIALS
STORING
PACKAGING
MATERIALS
RECEIVING
RAW
POULTRY
STORAGE
(COLD)RAW
POULTRY
PACKAGING/
LABELING
**Processes separated by dotted line may
actually occur in separate storage facilities,This
model considers receiving of fresh raw product
to distribution; however,product may enter at
this process step for contract irradiators,
SHIPPING
RAW POULTRY
IRRADIATION
STORAGE
(COLD)/
TRANSPORTING
FINISHED
PRODUCT
STORAGE
(COLD)
24
Irradiated,Raw Model
PRODUCT DESCRIPTION Figure 2
PROCESS CATEGORY,IRRADIATED,RAW PRODUCT
PRODUCT,FRESH POULTRY
1,COMMON NAME? FRESH POULTRY
2,HOW IS IT TO BE USED? COOKED AND CONSUMED
3,TYPE OF PACKAGE? BULK-PACK/RESEALABLE
POUCH OR RETAIL PACKAGE(with
air permeable and approved packaging
material for irradiation)
4,LENGTH OF SHELF LIFE,APPROX,1-3 WEEKS AT 27-40° F
AT WHAT TEMPERATURE?
5,WHERE WILL IT BE SOLD? RETAIL AND HRI,WHOLESALE
CONSUMERS? GENERAL PUBLIC
INTENDED USE?
6,LABELING INSTRUCTIONS? RADURA SIGN,“TREATED WITH
RADIATION” OR,TREATED BY
IRRADIATION”; KEEP
REFRIGERATED ; COOKING
INSTRUCTIONS; SAFE HANDLING
INSTRUCTIONS,
7,IS SPECIAL DISTRIBUTION KEEP REFRIGERATED
CONTROL NEEDED?
25
Irradiated,Raw Model
HAZARD ANALYSIS – IRRADIATED,RAW PRODUCT
Process Step Food Safety
Hazard
Reasonably
Likely to
Occur?
Basis If Yes in Column 3,
What Measures Could
be Applied to Prevent,
Eliminate,or Reduce
the Hazard to an
Acceptable Level?
Critical Control
Point
Receiving – Raw
Poultry
Biological,Pathogens -
microbial (Salmonella)
Yes Salmonella may be
present on incoming raw
product,
Certification from suppliers
that product has been
sampled for Salmonella and
passed standards,
1B
Chemical – None
Physical – Foreign
materials
No Plant records show that
there has been no
incidence of foreign
materials in products
received into the plant,
Figure 3
27
Irradiated,Raw Model
HAZARD ANALYSIS – IRRADIATED,RAW PRODUCT
Process Step Food Safety
Hazard
Reasonably
Likely to
Occur?
Basis If Yes in Column 3,
What Measures Could
be Applied to Prevent,
Eliminate,or Reduce
the Hazard to an
Acceptable Level?
Critical Control
Point
Receiving – Packaging
Materials
Biological – None
Chemical – Not
acceptable for
intended use
No Letters of guarantee for
air permeable direct
food contact packaging
material and labels with
required features
approved for
irradiation,
Physical – Foreign
materials (insects,dirt,
etc.)
No Plant records
demonstrate that foreign
material contamination
has not occurred during
the past several years,
Figure 3
28
Irradiated,Raw Model
HAZARD ANALYSIS – IRRADIATED,RAW PRODUCT
Process Step Food Safety
Hazard
Reasonably
Likely to
Occur?
Basis If Yes in Column 3,
What Measures Could
be Applied to Prevent,
Eliminate,or Reduce
the Hazard to an
Acceptable Level?
Critical Control
Point
Storage (Cold)- Raw
Poultry
Biological - Pathogens No Temperature of
product and storage
area will be maintained
below a level to prevent
pathogen growth,
Chemical – None
Physical – None
Storage –Packaging
Materials
Biological – None
Chemical – None
Physical - None
Packaging/Labeling Biological - Pathogens Yes Improper packaging
materials and labeling
may allow pathogen
growth including
anaerobes,
Plant will use approved
packaging materials for
irradiation,Labels with
radura,and required
features will clearly indicate
an irradiated,raw product,
2B
Chemical - None
Physical - None
Figure 3
29
Irradiated,Raw Model
HAZARD ANALYSIS – IRRADIATED,RAW PRODUCT
Process Step Food Safety
Hazard
Reasonably
Likely to
Occur?
Basis If Yes in Column 3,
What Measures Could
be Applied to Prevent,
Eliminate,or Reduce
the Hazard to an
Acceptable Level?
Critical Control
Point
Storage (Cold)/
Transporting
Biological - Pathogens Yes Pathogens are
reasonably likely to
grow in this product if
temperature is not
maintained at or below
a level sufficient to
prevent growth,
Maintain product
temperature at or below a
level sufficient to prevent
pathogen growth,
3B
Chemical – None
Physical – None
Raw Poultry
Irradiation
Biological – Pathogens Yes Improper use of
irradiation may not
reduce/kill pathogens
as intended,
Correct dose range as per
FSIS regulation (according
to approved treatment
protocol in 9 CFR 381.147,
381.149) will be used,
4B
Chemical- None
Physical – None
Figure 3
30
Irradiated,Raw Model
HAZARD ANALYSIS – IRRADIATED,RAW PRODUCT
Process Step Food Safety
Hazard
Reasonably
Likely to
Occur?
Basis If Yes in Column 3,
What Measures Could
be Applied to Prevent,
Eliminate,or Reduce
the Hazard to an
Acceptable Level?
Critical Control
Point
Finished Product
Storage (Cold)
Biological – Pathogens Yes Pathogens are
reasonably likely to
grow in this product if
temperature is not
maintained at or below
a level to maintain
process integrity,
Maintain product
temperature at or below a
level sufficient to prevent
pathogen growth,
5B
Chemical – None
Physical – None
Shipping Biological – None
Chemical – None
Physical - None
Figure 3
31
Irradiated,Raw Model
HACCP PLAN
PROCESS CATEGORY,IRRADIATED,RAW PRODUCT
PRODUCT EXAMPLE,FRESH POULTRY
CCP # and
Location
Critical
Limits
Monitoring
Procedures and
Frequency
HACCP
Records
Verification Procedures and
Frequency
Corrective Actions
1B
Receiving –
Raw Poultry
Supplier
certification
that product
has been
sampled for
Salmonella
must
accompany
shipment,
Receiving personnel
will check each
shipment for
Salmonella
certification,
Receiving Log
Corrective
Actions Log
Every two months QA will request
Salmonella testing results from FSIS
for at least 2 suppliers,
Will not receive product
unaccompanied by Salmonella
certification,
Signature, _______________________________ Date:___________________________ Figure 4
32
Irradiated,Raw Model
HACCP PLAN
PROCESS CATEGORY,IRRADIATED,RAW PRODUCT
PRODUCT EXAMPLE,FRESH POULTRY
CCP # and
Location
Critical
Limits
Monitoring
Procedures and
Frequency
HACCP
Records
Verification Procedures and
Frequency
Corrective Actions
2B
Packaging/
Labeling
Approved
packaging
material listed
in 21 CFR
179.45 and 9
CFR 381.149,
Label with
radura,
“Treated with
radiation”,or
“Treated by
irradiation”
Handling
Statement,
Cooking
Instructions,
Safe
Handling
Instructions,
Packaging line
supervisor will
randomly sample
packages of product
once per shift and
ensure packaging
material and labeling
requirements are met,
Packaging/
Labeling Log
Corrective
Actions Log
QA will observe packaging line
supervisor perform monitoring activity
once per shift,
QA will sample labels intended for use
from label storage area twice weekly to
ensure label accuracy,
QA will check labels once a day on
packaged product to ensure label
accuracy on packaged product,
QA will segregate and hold incorrectly
packaged and/or labeled product,
Follow SOPs for product disposition,
QA will identify the cause of the
deviation and prevent reoccurrence,
Signature, _______________________________ Date:___________________________ Figure 4
33
Irradiated,Raw Model
HACCP PLAN
PROCESS CATEGORY,IRRADIATED,RAW PRODUCT
PRODUCT EXAMPLE,FRESH POULTRY
CCP # and
Location
Critical
Limits
Monitoring
Procedures and
Frequency
HACCP
Records
Verification Procedures and
Frequency
Corrective Actions
3B
Storage
(Cold)/Trans
porting
Temperature
of product,
storage and
transport at
27-38° F,
QA personnel will
check raw product
temperature every
two hours,
Maintenance
personnel will check
storage area
temperature every
two hours,
Product
Temperature Log
Room
Temperature Log
Thermometer
Calibration Log
Corrective
Actions Log
QA supervisor will check Product
Temperature Log and Room
Temperature Log twice per shift,
Maintenance supervisor will verify
accuracy of the Room Temperature Log
once per shift,
QA will check all thermometers used
for monitoring and verification for
accuracy daily and calibrate to within
1° F accuracy as necessary,
QA will reject or hold product until
temperature is achieved,dependent on
time and temperature deviation,Follow
standard operating procedures for
product disposition,
QA and maintenance personnel will
identify the cause of the deviation and
prevent reoccurrence,
Signature, ________________________________ Date:___________________________ Figure 4
34
Irradiated,Raw Model
HACCP PLAN
PROCESS CATEGORY,IRRADIATED,RAW PRODUCT
PRODUCT EXAMPLE,FRESH POULTRY
CCP # and
Location
Critical
Limits
Monitoring
Procedures and
Frequency
HACCP
Records
Verification Procedures and
Frequency
Corrective Actions
4B
Raw Poultry
Irradiation
Minimum
absorbed
dose,1.5
kilogray (150
kilorads)
Maximum
absorbed
dose,3.0
kilogray (300
kilorads) as
found in 9
CFR 381.147
and 381.149
Production supervisor
will monitor the data
log printout from the
irradiation control
board for each
irradiated batch,
Production supervisor
will take dosimeter
readings for each
irradiated batch
Irradiation Data
Log printout
Irradiation/Dose
Mapping Log
Letter of
guarantee for
dosimeter
calibration
Corrective
Actions Log
QA will verify irradiation data log
printout,
QA will verify letter of guarantee for
calibration of the dosimeter every 12
months,
QA will verify that absorbed doses
received by product are within the
minimum and maximum limits from
results of dose mapping,
QA supervisor will segregate and hold
affected products,
QA will condemn affected products,
Follow standard operating procedures
for disposition of irradiated products,
Certified irradiation maintenance
personnel will identify and correct the
problem with the irradiation unit and
ensure no reocurrence of the problem,
QA will implement a preventive
maintenance program,
Signature, ________________________________ Date:___________________________ Figure 4
35
Irradiated,Raw Model
HACCP PLAN
PROCESS CATEGORY,IRRADIATED,RAW PRODUCT
PRODUCT EXAMPLE,FRESH POULTRY
CCP #
and
Location
Critical
Limits
Monitoring
Procedures and
Frequency
HACCP
Records
Verification Procedures and
Frequency
Corrective Actions
5B
Finished
Product
Storage
(Cold)
Finished
product and
storage area
shall be
maintained at
27-38° F,
QA personnel will
check raw product
temperature every
two hours,
Maintenance
personnel will check
storage area
temperature every
two hours,
Product
Temperature Log
Room
Temperature Log
Thermometer
Calibration Log
Corrective
Actions Log
QA supervisor will check Product
Temperature Log and Room
Temperature Log twice per shift,
Maintenance supervisor will verify
accuracy of the Room Temperature Log
once per shift,
QA will check all thermometers used
for monitoring and verification for
accuracy daily and calibrate to within
1° F accuracy as necessary,
QA will reject or hold product until
temperature is achieved,dependent on
time and temperature deviation,Follow
standard operating procedures for
product disposition,
QA and maintenance personnel will
identify the cause of the deviation and
prevent reoccurrence,
Signature, ________________________________ Date:___________________________ Figure 4
36
Irradiated,Raw Model
FORM LETTER requesting Salmonella Data
Date
To: FSIS
FOIA Coordinator
USDA
This is to request results of any Salmonella performance standard sample sets completed during the past two months from
establishments listed below,
Thank you,
File Copy Date Results
Received
Two Consecutive
Failed Sets?
If Yes,Remarks
Est,YYY
Est,ZZZ
Est,AAA
37
Irradiated,Raw Model
FORM LETTER requesting Salmonella Data
To: FSIS
FOIA Coordinator
USDA
This is to request results of any Salmonella performance standard sample sets completed during the past two months from
establishments listed below,
Thank you,
Est,YYY
Est,ZZZ
Est,AAA
38
Irradiated,Raw Model
GENERIC ESTABLISHMENT X,
PRODUCT:______________________________
TIME TEMP Deviation from
CL? if
yes)
If Yes,
Corrective Action?
Monitored by,Verified by,
6:36 AM 34°F PS
8:30 AM 33°F PS
10:32 AM 34°F PS
CB
12:30 PM 36°F
Notify maint,supv.,CB & QA PS
PRODUCT TEMPERATURE LOG
DATE:_________
(Check
TIME/TEMPERATURE CRITICAL LIMIT,
39
Irradiated,Raw Model
GENERIC ESTABLISHMENT X,
STORAGE ROOM:_________________________
TIME TEMP Deviation from
CL? if
yes)
If Yes,
Corrective Action?
Monitored by,Verified by,
6:36 AM 34°F PS
8:30 AM 33°F PS
10:32 AM 34°F PS
CB
12:30 PM 36°F
Notify maint,supv.,CB & QA PS
ROOM TEMPERATURE LOG
DATE:_________
(Check
TIME/TEMPERATURE CRITICAL LIMIT,
40
Irradiated,Raw Model
THERMOMETER CALIBRATION LOG
Criteria Within 1? °F of Control Thermometer
Date Time Department or
Area
Thermometer ID# Control
Thermometer
Reading
Personal
Thermometer
Reading
Adjustment
Required (Yes
or No)
Initials Comments
6/15 1:00 PM Chiller 2A 32°F 32°F No HK
* If a thermometer is broken or taken out of service,document this in the comment column,
Verified by,_______________________
Date/Time,_______________________
41
Irradiated,Raw Model
GENERIC ESTABLISHMENT X,IRRADIATION/ DOSE MAPPING LOG
DATE,_________________
Lot or
Irradiation ID
Dosimeter
Positions
Absorption Dose (KGY) Verified By,
42
Irradiated,Raw Model
CORRECTIVE ACTIONS LOG
Product,___________________________________________
CCP Deviation/
Problem
Disposition of
Product
Corrective Action
Procedures/Explain
Measures to
Prevent
Recurrence
Responsible
Person
Time
SIGNATURE,__________________________ DATE,______________________
43
Irradiated,Raw Model
Pre-Shipment Review Log Date:______________
LOT ID TIME RECORDS
REVIEWED
BY
WHOM
LOT RELEASED FOR SHIPMENT?
SIGNATURE
11:10 a.m,
11:10 p.m,
44
Department of
Agriculture
Food Safety
and Inspection
Service
May 1999
HACCP-8
Generic HACCP
Model for
Irradiated,Raw
Meat and
Poultry
Products
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
Irradiated,Raw Model
Table of Contents
Introduction………………………………………….……………………………………,3
Using This Generic Model………………………….…………………………………….,5
Process Flow Diagram and Product Description….………………………………………,7
Hazard Analysis…………………………………………………………………………… 8
Developing Your HACCP Plan………..………………………………………………….,10
Identifying CCPs…………………………………….……………………………………,12
Appendix A
References for all HACCP Model Teams………………………………………… 19
References for Irradiated,Raw Meat and Poultry Products..…………………….,21
Appendix B
Process Flow Diagram (Figure 1)…………………………………………………,25
Product Description Form (Figure 2)……………………………………………… 26
Hazard Analysis Form (Figure 3)…………………………………………………,27
HACCP Plan Form (Figure 4)..…………………………………………………… 32
Form letter requesting Salmonella data (1)……………………………………….,37
Form letter requesting Salmonella data (2)……………………….……………….,38
Generic Establishment X,Product Temperature Log …………………………….,39
Generic Establishment X,Room Temperature Log…………..…………………… 40
Thermometer Calibration Log………………………………………………..……,41
1
Irradiated,Raw Model
Generic Establishment X,Irradiation/Dose Mapping Log ……………………….,42
Corrective Actions Log……………………………………………………………,43
Pre-Shipment Review Log………………………………………………………… 44
2
Irradiated,Raw Model
GENERIC HACCP MODEL
FOR
IRRADIATED,RAW MEAT AND POULTRY PRODUCTS
Introduction
The Hazard Analysis Critical Control Point (HACCP) system is a scientific approach to process
control,It is designed to prevent the occurrence of problems by assuring that controls are
applied at any point in a food production system where hazardous or critical situations could
occur,Hazards include biological,chemical,or physical contamination of food products,
The Food Safety and Inspection Service (FSIS) published a final rule in July 1996 mandating
that HACCP be implemented as the system of process control in all inspected meat and poultry
plants,As part of its efforts to assist establishments in the preparation of plant-specific HACCP
plans,FSIS determined that a generic model for each process defined in the regulation would be
made available for use on a voluntary basis by inspected establishments,
The generic models have been revised since their initial publication and distribution as
DRAFTS,The most important change in the revised versions is to make certain that these
models are fully consistent with the features of the final regulation,Also,other technical and
editorial improvements have been made,
Throughout this generic model,FSIS discusses a HACCP team,with members from different
departments,In many very small establishments,there will not be separate departments with
different employees,But there will be employees who perform these different functions – often
several of them,For purposes of explaining concepts,it is easier to speak as if these were
different people,even though in many cases,they may be the same person carrying out more
than one responsibility,
Each generic model can be used as a starting point for the development of plant-specific plan(s)
reflecting actual plant environments and the processes conducted,The generic model is not
intended to be used,as is” for plant specific HACCP plans,
The generic models are designed for use in conjunction with the list of process categories found
in the HACCP regulations in section 417.2(b)(1),
3
Irradiated,Raw Model
(b) The HACCP plan,(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,
This generic model is designed for use with the process subcategory,Irradiated,raw product,
The purpose of the process category listing in 417.2 is to set out the circumstances under which a
HACCP team may develop a single HACCP plan for multiple products,This may be done when
products are in the same process category,and food safety hazards,critical control points,and
other features are essentially the same,There is a generic model for each process category,plus
two for subcategories that present special issues,irradiated products and mechanically separated
products,
In order to select the model or models that will be most useful for the activities performed in any
specific plant,the following steps should be taken,
1) For slaughtering operations,select the model for the appropriate species,
2) For processed products,make a list of all products produced in the plant,
4
Irradiated,Raw Model
3) Examine the list and group like products,considering common processing steps and
equipment used,
4) Compare the grouped products with the list of processes in the regulations; this step should
reveal how many and which of the generic models might be useful,
Deciding on a generic model and which products can be covered by a single plan is an important
achievement,If the team does it well,it can save a lot of unnecessary effort and paperwork,
Selecting an inappropriate generic model reduces its potential benefits,However,often the
HACCP team will discover they have made this error when they develop their process flow
diagram or during their hazard analysis,These are early stages in the process when it is
relatively easy to make changes,
In any case,establishments must meet all regulatory requirements for their products,
Using This Generic Model
This generic model is designed to be used by establishments that produce irradiated,raw
product(s),The model can be used for all irradiated,raw meat and poultry products,
The model will be most useful to a HACCP team that includes access to one trained individual,
as specified in 417.7(b),
(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,
Since this generic model entails the use of ionizing radiation,at least one team member must be
trained in quality control,food technology,irradiation processing,and radiation health and
safety,This team member must have a working knowledge of FSIS regulations on irradiation
(e.g,9 CFR 381.135,381.147,and 381.149 for poultry),and other requirements set forth by the
FDA,National Regulatory Commission,and the Office of Safety and Health Administration,
It would be beneficial for other team members to have reviewed any of the various guidance
materials available on how to develop a HACCP plan for your company,including several useful
videos,handbooks,or computer programs,Once the HACCP team has prepared itself as
thoroughly as possible in general HACCP principles and how to use them,this model should be
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Irradiated,Raw Model
helpful,
Note,This generic model includes a number of forms that can be used to record various types of
required information,The forms themselves are samples; a company HACCP team can develop
whatever forms it finds most useful,All the forms mentioned in this document are included in
Appendix B; they appear in the order in which they are discussed in the text,
All FSIS generic models are designed to assist establishments in applying the seven HACCP
principles to their meat and poultry processing operations AND to meet the regulatory
requirements of Part 417,Therefore,the definitions used in this and all other FSIS generic
models are those found in 417.1,
§ 417.1 Definitions,
For purposes of this part,the following definitions shall apply,
Corrective action,Procedures to be followed when a deviation occurs,
Critical control point,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,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,Any biological,chemical,or physical property that may cause a
food to be unsafe for human consumption,
HACCP System,The HACCP plan in operation,including the HACCP plan itself,
Hazard,SEE Food Safety Hazard,
Preventive measure,Physical,chemical,or other means that can be used to control an
identified food safety hazard,
Process-monitoring instrument,An instrument or device used to indicate conditions
during processing at a critical control point,
Responsible establishment official,The individual with overall authority on-site or a
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higher level official of the establishment,
Process Flow Diagram and Product Description
To begin using this model,the company's HACCP team should first describe the product(s),
which are part of this process category and covered by this HACCP plan,The product(s) should
be described in two ways,
(1) by a simple diagram which shows the steps the company uses when it produces the product,
and
(2) in a brief written description which provides key facts about the product and its use,
In this generic model,there is an example for irradiated,raw product - fresh poultry,FSIS has
developed certain forms as part of the examples in the generic models; company HACCP teams
are not required to use these forms,
Figure 1 is an example of a PROCESS FLOW DIAGRAM for the production of irradiated
fresh poultry in generic establishment X,Figure 2 is an example of a PRODUCT
DESCRIPTION for the production of irradiated fresh poultry produced by generic
establishment X,
Once the company HACCP team in your establishment has prepared your Process Flow
Diagram,they should verify it by walking through the establishment following the flow of
product and making sure that all the steps of the process are included in the flow diagram,The
team should also review the information provided on the Product Description to make sure all
the key facts are included,such as identifying consumers,especially those with particular health
problems or known to be at risk,
Note,In this generic model,it is assumed that packaged poultry will be transported to another
facility for the irradiation process,If in your process,irradiation is to be done in the same
establishment that the poultry is received and packaged,then the transporting step may be
omitted,That is generally,how you use these generic model examples--just omit the features
which do not apply to your operation,or if your operation includes features not included in this
example,they should be added,
By completing a Process Flow Diagram and a Product Description,you have met the
requirements of 417.2(a)(2),You can use the Process Flow Diagram in particular to help you
complete the rest of the hazard analysis,Use the flow diagram to systematically review each
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Irradiated,Raw Model
step in the process and ask the question,"Is there a food safety hazard which is reasonably likely
to occur which may be introduced at this step?" In answering the question,your HACCP team
needs to consider biological (including microbiological),chemical,and physical hazards,
Hazard Analysis
Once your product(s) are accurately described through the flow diagram and product description,
the HACCP team should begin work on the HAZARD ANALYSIS,The hazard analysis is
fundamental to developing a good HACCP plan and one that meets regulatory requirements,
The regulatory requirements for a hazard analysis are found at 417.2(a),
§ 417.2 Hazard Analysis and HACCP Plan,
(a) Hazard analysis,(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,
Generic establishment X,which we are using for our example,is capturing these regulatory
requirements on a 6-column Hazard Analysis Form (See Figure 3),A good way to use a form
like this is to create the first column by using the Process Flow Diagram and the second by
answering the question,Once the HACCP team has considered all the steps in the flow diagram
and determined if a food safety hazard could be introduced,it needs to consider whether the
hazard is "reasonably likely to occur",using the meaning of this phrase included in 417.2(a),On
the 6-column form used by generic establishment X,the third and fourth columns address this
issue,If the establishment's HACCP team has decided that the hazard is not reasonably likely to
occur,they enter "No" in column three,explain the basis for their determination in column four,
and do not need to further consider activity at this point in the process,
If,however,the team has determined there is a "food safety hazard reasonably likely to occur"
8
Irradiated,Raw Model
introduced at a certain point in the process,column five is used to describe a measure which
could be applied to "prevent,eliminate,or reduce to acceptable levels" the food safety hazard
identified in column three,
Look at the entries for,Receiving-Raw Poultry” on the first page of the six column form; the
HACCP team has determined that Salmonella may be present at high levels in incoming raw
product,so it has put a,Yes” in the third column,Column four explains the basis for the team’s
determination,In the fifth column,the HACCP team has described the preventive measures it
will use to make sure that each hazard has been prevented,eliminated,or reduced to an
acceptable level,For the Salmonella hazard,the HACCP team decided to tell its suppliers that
product could not be accepted unless it was accompanied by the most recent Salmonella
performance standard sampling results which demonstrated that the supplier had not failed two
consecutive Salmonella performance standard sets,FSIS does not consider safe handling
instructions on labels alone to be an adequate CCP for any pathogenic microorganisms such as
bacteria and viruses,
You will notice that in our generic hazard analysis for irradiated fresh poultry,there are five
safety hazards in which the HACCP team has identified a point in the process at which a food
safety hazard is reasonably likely to occur,For each one of these they have identified a measure
which can be used to control the hazard,
When your HACCP team has completed their hazard analysis (whether they use this format or
not),it is a good idea to review the flow diagram,the product description and the hazard analysis
itself to make sure they are complete,Part 417.2(a)(3) includes a list of sources from which food
safety hazards might be expected to arise,Reviewing that list could help the HACCP team
check for completeness,
Note,If you are using this generic model to produce a different raw irradiated product or if you
use a different process flow,you may have different hazards which are reasonably likely to
occur,For these different hazards,there may be different measures that could be used for
control purposes,
This,and all other FSIS generic models,contains a list of references which can help your
HACCP team in making sure the hazard analysis is complete,The references for raw,irradiated
product are found in Appendix A,A member of your HACCP team might want to review at
least some of the references to make sure hazards have not been omitted from the hazard
analysis,
Completing the hazard analysis is a very significant and important element in developing your
HACCP system,Your HACCP team should feel a real sense of accomplishment when they get
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Irradiated,Raw Model
this far; this is like completing the foundation of a house,
Developing Your HACCP Plan
The company HACCP team can now take the materials it developed while doing the hazard
analysis and use them to build the HACCP Plan,Remember that one of the important
objectives of the FSIS generic models is to provide examples that illustrate how to meet the
regulatory requirements of Part 417,as well as to correctly apply the principles of HACCP,
Part 417.2 (c) and (d) are the regulatory requirements,
(c) The contents of the HACCP plan,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
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Irradiated,Raw Model
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,(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,
Generic establishment X has prepared its HACCP plan for irradiated fresh poultry on a six
column form (See Figure 4),You do not need to use this form,although some kind of a form is
probably the easiest way to present your HACCP plan,
Identifying CCPs
The first column on this particular form is used to enter information developed and contained on
the hazard analysis form,Part 417.2(c)(1) and (2) require that the food safety hazards identified
in the hazard analysis be listed on the HACCP plan and that there be a CCP for each identified
hazard,You will notice that there are five points on the hazard analysis form where food safety
hazards reasonably likely to occur were identified,Salmonella on raw poultry at receiving,
pathogen proliferation at packaging and labeling,pathogen proliferation at storage
(cold)/transporting,pathogen survival and/or proliferation after irradiation,and pathogen
proliferation at finished product storage(cold),
The establishment HACCP team has chosen to have five CCPs to address these five hazards,
Salmonella certification,use of approved packaging material for irradiation and clear product
label features to indicate the product is irradiated,raw,and must be fully cooked,proper
temperature maintenance during transport and storage,compliance with FSIS/FDA requirements
for the process of irradiation,and proper temperature maintenance at finished product storage
(cold),
11
Irradiated,Raw Model
After identifying its CCPs,the HACCP team proceeded to consider critical limits,monitoring
procedures and their frequencies,and verification procedures and their frequencies,and HACCP
records,
In deciding what would be the critical limits,the HACCP team first considered whether there
were any regulatory requirements which had to be met and would function as critical limits,
The team was aware of regulatory requirements for the packaging material and labeling of
irradiated products as stated in 9 CFR 381.135 and 21 CFR 179.45,For their critical limit,the
HACCP team decided that air permeable packaging material,and a label with features to indicate
a raw,irradiated product has the irradiation logo,the radura,along with the statement,Treated
with radiation” or,Treated by Irradiation”,handling statement,clear cooking instructions,and
safe handling instructions,
,
The team set the critical limits for the minimum and maximum absorbed dose for irradiation of
poultry as found in 9 CFR 381.147,For developing a HACCP plan for irradiation of pork,the
required absorbed dose will be different,
Once they had decided on their critical limits,they needed to identify how the monitoring
procedures would be carried out and at what frequency,
The HACCP team decided that receiving personnel check the packaging and labeling materials
for irradiated products at Receiving-packaging materials,At this location,receiving personnel
also routinely check all letters of guarantee and incoming packaging materials to make sure they
met specifications,Since labels are manufactured in large lots by a single company,the
receiving clerks would randomly sample each arriving lot,Some packaging materials do not
have their labels and safe handling instructions printed on them and therefore these need to be
applied to the packaging material later in the process,Monitoring at the packaging and labeling
step ensures that the necessary pressure sensitive sticker labels are applied to the package,
For the CCP on the irradiation process,the HACCP team decided that the production supervisor
would be in the best position to assure that the irradiation unit was functioning properly by
checking the data log printout from the irradiation control board or,process monitoring
instrument” as the product goes through the irradiation process,The irradiation control board
shows all function movement which take place within the irradiation chamber during the
irradiation process,It will indicate whether the unit is functioning properly,and will alert the
operator for any abnormal movements,
These decisions by the HACCP team regarding critical limits,plus monitoring procedures and
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Irradiated,Raw Model
their frequencies are written up in columns two and three of the HACCP Plan,
The team then went on to consider appropriate verification procedures; the team knew that there
were different types of verification and that Part 417.4(a)(2) included specific regulatory
requirements for each,The regulatory requirements for ongoing verification are,
(2) Ongoing verification activities,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,
The HACCP team decided that they could verify the raw poultry irradiation step through the
following procedures and frequency,
1,QA will verify the irradiation data log printout,
2,QA will verify the letter of guarantee for calibration of the dosimeter every 12 months,
3. QA will verify that absorbed doses received by product are within the minimum and
maximum limits from results of dose mapping,
The HACCP team described the verification procedures and their frequencies in the fifth column
of their HACCP plan,
The HACCP team for generic establishment X knew that their HACCP Plan needed to provide
for a recordkeeping system,They wanted their records to be easy to create and understand,
They wanted to be sure their records met regulatory requirements,so they reviewed part 417.5(a)
and (b),
§ 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
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Irradiated,Raw Model
supporting documentation;
(2) The written HACCP plan,including decision making documents associated with the
selection and development of CCPs 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 CCPs 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,
The HACCP team decided that their records would be kept on some simple forms,some of
which the team itself devised,The HACCP team decided that three records were necessary,
Irradiation Data Log,Irradiation/Dose Mapping Log,and Letter of guarantee for dosimeter
calibration,
The forms(logs) were designed to provide spaces for all entries necessary for the monitoring and
verification activities at the raw poultry irradiation step,
On its HACCP Plan,generic establishment X has listed the names of the forms it will be using
for monitoring and verification records,
There is one other form included in column four,where the establishment has described its
recordkeeping system,That is the Corrective Actions Log; it is used to create the records of any
corrective actions taken because of deviations from critical limits at CCPs,Column six
references the planned corrective actions for each CCP,The HACCP team carefully reviewed
the regulatory requirements for planned corrective actions,found at 417.3(a),
§ 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
14
Irradiated,Raw Model
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,
The HACCP team has developed a specific corrective action plan which will be followed
whenever there is a deviation from a critical limit at a CCP; each of the planned corrective
actions meets the four regulatory requirements of 417.3(a),
Planned Corrective Actions for CCP 4,
1,QA supervisor takes control of and segregates all products processed when the irradiation unit
was not functioning properly,
2,QA condemns affected products and dispose according to standard operating procedures,
3,Certified irradiation maintenance personnel identify problem with the irradiation unit and
repair it so that the integrity of the unit is restored and the same problem does not recur,
4,QA implements preventive maintenance checks,
The HACCP team also develops planned corrective actions for each of the other CCPs and
attaches them to the HACCP plan,Whenever a deviation from a critical limit occurs,company
employees follow the corrective action plan and use the Corrective Action Log to create a record
of their actions,The Corrective Action Log forms are available at CCPs,so they can be used
immediately when an employee performing a monitoring check discovers and records a
deviation,All Corrective Action Logs,which have been used during the day,are turned in to the
HACCP coordinator,
There is one final verification/recordkeeping requirement which the company must perform; it is
found at 417.5(c),
(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
15
Irradiated,Raw Model
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,
In generic establishment X,product is shipped out,often in small lots,throughout the day,This
means that pre-shipment verification checks must be as complete as possible when finished
product is in storage,so that a shipment can be made up quickly and moved into distribution
channels,
The establishment uses a half day lotting system and a midshift cleanup,While the midshift
cleanup is being performed,QA personnel or the HACCP coordinator review results of
monitoring and verification checks applied to that lot; if there were deviations from critical
limits,they review the Corrective Action Logs to make sure all appropriate planned responses
were carried out,If everything is in order and there are complete records showing that the
establishment has controlled production of this product through its HACCP system,the HACCP
coordinator will sign the pre-shipment review form which the HACCP team devised for this
purpose,
Note,It is not a regulatory requirement that a separate form be used for pre-shipment review; in
addition,FSIS has indicated that it will be very flexible in accepting a variety of arrangements
for accomplishing pre-shipment review to reflect the variety of commercial practices which it
has encountered in the industry,It is,however,important to remember that pre-shipment review
is a regulatory requirement that must be met,as it indicates that the establishment is taking full
responsibility for the product having been produced under a well-functioning HACCP system,
The HACCP team believes it has now completed preparation of the documents which are
necessary to meet regulatory requirements for a Hazard Analysis and a HACCP Plan for their
irradiated,raw production process,They have secured a copy of FSIS Directive 5000.1,
Enforcement of Regulatory Requirements in Establishments Subject to HACCP System
Requirements,the HACCP Basic Compliance Checklist which will be used by inspection
program personnel,The HACCP team has modified the inspection form to make the statements
into positives,and now has a checklist for its own use to make sure they have not omitted
anything in their plan development and preparation,When they are confident that they have done
what is necessary,they will turn their Hazard Analysis and HACCP Plan over to the
establishment owner for decisions about implementation,
16
Irradiated,Raw Model
APPENDIX A
17
Irradiated,Raw Model
References for all HACCP Model 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 (beef slaughter,roaster beef,ham,chicken
slaughter,etc.)
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 R.F,Steir,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,
18
Irradiated,Raw Model
10,International Commission on Microbiological Specifications 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 (NACMCF),March
20,1992 – Hazard Analysis and Critical Control Point System,Int,J,Food Micr,16,1-23,
1993,
13,National Advisory Committee on Microbiological Criteria for Foods (NACMCF),June
1993-Report on Generic HACCP for Raw Beef,Food Microbiol,10,449-488,1994,
14,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
15, Notermans,S.,et al,The HACCP concept,Identification of potentially hazardous
microorganisms,Food Microbiol,11:203-214,1994,
16,Pearson,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
17,Pierson,M.D,and Corlett,D.A.,Jr,Editors,HACCP/Principles and Applications,Van
19
Irradiated,Raw Model
Nostrand Reinhold,1992,
18,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 section in particular is,
Chapter 11 – forms for hazard analysis,CCP,limits,HACCP master sheet,
example HACCP for breaded chicken
19,Tompkin,R.B,The Use of HACCP in the Production of Meat and Poultry Products,J,of
Food Protect,53(9),795-803,1990,
20,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 (HACCP) in Meat,Poultry and Seafoods,Chapman & Hall,1995,
References for Irradiated,Raw Meat and Poultry Products
1. American Meat Institute,Palatability,Color,and Shelf life of Low-Dose Irradiated Beef,
AMI,Washington,DC,1995,
2. American Society for Tests and Measures,Standard Guide for Selection and Application
of Dosimetry Systems for Radiation Processing of Food,In Annual Book of ASTM
Standards,ASTM,Washington,DC,12.02,785-788,1989,
3. Clavero,M,Rocelle S,Inactivation of Escherichia coli 0157:H7,Salmonellae,and
Campylobacter jejuni in Raw Ground Beef by Gamma Irradiation,App,Environ,
Microbiol,June 1994,2069-2075,1994,
4. Codex,Codex General Standard for Irradiated Foods (Annex 2)(and other sections
regarding irradiation),In Codex Alimentarius,Vol,XV,1984,
5. FDA,Irradiation in the Production,Processing and Handling of Food (Part 179),In
Code of Federal Regulations,National Archives and Records Administration,
Washington,DC 21:179.2,411-415,1977,
6,FDA,Irradiation in the Production,Processing and Handling of Food,In Federal
20
Irradiated,Raw Model
Register/Rules and Regulations,Food and Drug Administration,Washington,DC,
55:18538-18533,1990,
7. FSIS,USDA,Irradiation of Pork for Control of Trichinella spiralis (Part 318),In
Federal Register/Rules Regulations,U.S,Department of Agriculture,Washington,DC,
51:1769-1771,318.7 p,257,1999,
8. Hashim,I,B.,et al,Consumer Attitudes Toward Irradiated Poultry,Food Technol,
March 1996,77-80,1996,
9. Monk,J,David.,et al,Irradiation Inactivation of Listeria monocytogenes and
Staphylococcus aureus in Low-and High-fat,Frozen and Refrigerated Ground Beef,J,
Food Protect,57:969-974,1994,
10. Murano,Elsa A,Irradiation of Fresh Meats,Food Technol,December 1995,52-54,
1995,
11. Murano,E,A.,Editor,Irradiation Processing (Chapter 1),In Food Irradiation A
Sourcebook,Iowa State University Press,Ames,IA,1995,
12. Patterson,Margaret,Sensitivity of Bacteria to Irradiation of Poultry Meat Under Various
Atmospheres,Letters in Appl,Microbiol,7,55-58,1988,
13. Radomyski,Tomasz.,et al,Elimination of Pathogens of Significance in Food by Low-
dose Irradiation,A Review,J,Food Protect,57,73-86,1994,
14. Renwick,Stephen P.,et al,The RF Linear Accelerator in In-Lear E-Beam Processing of
Beef and Poultry,Dairy Food Environ,Sanit,16,214-221,1996,
15. Robeck,Mark R,Product Liability Issues Related to Food Irradiation,Food Technol,
February 1996,78-82,1996,
16. Rodriguez,H,Ricardo,et al,Low-dose Gamma Irradiation and Refrigeration to Extend
Shelf Life of Aerobically Packed Fresh Beef Round,J,Food Protect,56,505-509,1993,
17. Tarte,R,R.,et al,Survival and Injury of Listeria monocytogenes,Listeria innocua and
Listeria ivanovii in Ground Pork Following Electron Beam Irradiation,J,Food Protect,
59,596-600,1996,
18,Thayer,D,W,Use of Irradiation to Kill Pathogens on Meat and Poultry,J,Food
21
Irradiated,Raw Model
Science,15,181-192,1995,
19. Thayer,D,W.,et al,Extending Shelf Life of Poultry and Red Meat by Irradiation
Processing,J,Food Protect,56,831-833,1993,
20. Thayer,D,W.,et al,Elimination of Escherichia coli 0157:H7 in Meats by Gamma
Irradiation,Appl,Environ,Microbiol,April 1993,1030-1034,1993,
21. USDA,Irradiation of Poultry Products (Part 381),In Federal Register/Rules and
Regulation,U.S,Department of Agriculture,Washington,DC 57:43588-43600,1992,
22
Irradiated,Raw Model
APPENDIX B
23
Irradiated,Raw Model
PROCESS FLOW DIAGRAM Figure 1
PROCESS CATEGORY,IRRADIATED,RAW PRODUCT
PRODUCT,FRESH POULTRY
RECEIVING
PACKAGING
MATERIALS
STORING
PACKAGING
MATERIALS
RECEIVING
RAW
POULTRY
STORAGE
(COLD)RAW
POULTRY
PACKAGING/
LABELING
**Processes separated by dotted line may
actually occur in separate storage facilities,This
model considers receiving of fresh raw product
to distribution; however,product may enter at
this process step for contract irradiators,
SHIPPING
RAW POULTRY
IRRADIATION
STORAGE
(COLD)/
TRANSPORTING
FINISHED
PRODUCT
STORAGE
(COLD)
24
Irradiated,Raw Model
PRODUCT DESCRIPTION Figure 2
PROCESS CATEGORY,IRRADIATED,RAW PRODUCT
PRODUCT,FRESH POULTRY
1,COMMON NAME? FRESH POULTRY
2,HOW IS IT TO BE USED? COOKED AND CONSUMED
3,TYPE OF PACKAGE? BULK-PACK/RESEALABLE
POUCH OR RETAIL PACKAGE(with
air permeable and approved packaging
material for irradiation)
4,LENGTH OF SHELF LIFE,APPROX,1-3 WEEKS AT 27-40° F
AT WHAT TEMPERATURE?
5,WHERE WILL IT BE SOLD? RETAIL AND HRI,WHOLESALE
CONSUMERS? GENERAL PUBLIC
INTENDED USE?
6,LABELING INSTRUCTIONS? RADURA SIGN,“TREATED WITH
RADIATION” OR,TREATED BY
IRRADIATION”; KEEP
REFRIGERATED ; COOKING
INSTRUCTIONS; SAFE HANDLING
INSTRUCTIONS,
7,IS SPECIAL DISTRIBUTION KEEP REFRIGERATED
CONTROL NEEDED?
25
Irradiated,Raw Model
HAZARD ANALYSIS – IRRADIATED,RAW PRODUCT
Process Step Food Safety
Hazard
Reasonably
Likely to
Occur?
Basis If Yes in Column 3,
What Measures Could
be Applied to Prevent,
Eliminate,or Reduce
the Hazard to an
Acceptable Level?
Critical Control
Point
Receiving – Raw
Poultry
Biological,Pathogens -
microbial (Salmonella)
Yes Salmonella may be
present on incoming raw
product,
Certification from suppliers
that product has been
sampled for Salmonella and
passed standards,
1B
Chemical – None
Physical – Foreign
materials
No Plant records show that
there has been no
incidence of foreign
materials in products
received into the plant,
Figure 3
27
Irradiated,Raw Model
HAZARD ANALYSIS – IRRADIATED,RAW PRODUCT
Process Step Food Safety
Hazard
Reasonably
Likely to
Occur?
Basis If Yes in Column 3,
What Measures Could
be Applied to Prevent,
Eliminate,or Reduce
the Hazard to an
Acceptable Level?
Critical Control
Point
Receiving – Packaging
Materials
Biological – None
Chemical – Not
acceptable for
intended use
No Letters of guarantee for
air permeable direct
food contact packaging
material and labels with
required features
approved for
irradiation,
Physical – Foreign
materials (insects,dirt,
etc.)
No Plant records
demonstrate that foreign
material contamination
has not occurred during
the past several years,
Figure 3
28
Irradiated,Raw Model
HAZARD ANALYSIS – IRRADIATED,RAW PRODUCT
Process Step Food Safety
Hazard
Reasonably
Likely to
Occur?
Basis If Yes in Column 3,
What Measures Could
be Applied to Prevent,
Eliminate,or Reduce
the Hazard to an
Acceptable Level?
Critical Control
Point
Storage (Cold)- Raw
Poultry
Biological - Pathogens No Temperature of
product and storage
area will be maintained
below a level to prevent
pathogen growth,
Chemical – None
Physical – None
Storage –Packaging
Materials
Biological – None
Chemical – None
Physical - None
Packaging/Labeling Biological - Pathogens Yes Improper packaging
materials and labeling
may allow pathogen
growth including
anaerobes,
Plant will use approved
packaging materials for
irradiation,Labels with
radura,and required
features will clearly indicate
an irradiated,raw product,
2B
Chemical - None
Physical - None
Figure 3
29
Irradiated,Raw Model
HAZARD ANALYSIS – IRRADIATED,RAW PRODUCT
Process Step Food Safety
Hazard
Reasonably
Likely to
Occur?
Basis If Yes in Column 3,
What Measures Could
be Applied to Prevent,
Eliminate,or Reduce
the Hazard to an
Acceptable Level?
Critical Control
Point
Storage (Cold)/
Transporting
Biological - Pathogens Yes Pathogens are
reasonably likely to
grow in this product if
temperature is not
maintained at or below
a level sufficient to
prevent growth,
Maintain product
temperature at or below a
level sufficient to prevent
pathogen growth,
3B
Chemical – None
Physical – None
Raw Poultry
Irradiation
Biological – Pathogens Yes Improper use of
irradiation may not
reduce/kill pathogens
as intended,
Correct dose range as per
FSIS regulation (according
to approved treatment
protocol in 9 CFR 381.147,
381.149) will be used,
4B
Chemical- None
Physical – None
Figure 3
30
Irradiated,Raw Model
HAZARD ANALYSIS – IRRADIATED,RAW PRODUCT
Process Step Food Safety
Hazard
Reasonably
Likely to
Occur?
Basis If Yes in Column 3,
What Measures Could
be Applied to Prevent,
Eliminate,or Reduce
the Hazard to an
Acceptable Level?
Critical Control
Point
Finished Product
Storage (Cold)
Biological – Pathogens Yes Pathogens are
reasonably likely to
grow in this product if
temperature is not
maintained at or below
a level to maintain
process integrity,
Maintain product
temperature at or below a
level sufficient to prevent
pathogen growth,
5B
Chemical – None
Physical – None
Shipping Biological – None
Chemical – None
Physical - None
Figure 3
31
Irradiated,Raw Model
HACCP PLAN
PROCESS CATEGORY,IRRADIATED,RAW PRODUCT
PRODUCT EXAMPLE,FRESH POULTRY
CCP # and
Location
Critical
Limits
Monitoring
Procedures and
Frequency
HACCP
Records
Verification Procedures and
Frequency
Corrective Actions
1B
Receiving –
Raw Poultry
Supplier
certification
that product
has been
sampled for
Salmonella
must
accompany
shipment,
Receiving personnel
will check each
shipment for
Salmonella
certification,
Receiving Log
Corrective
Actions Log
Every two months QA will request
Salmonella testing results from FSIS
for at least 2 suppliers,
Will not receive product
unaccompanied by Salmonella
certification,
Signature, _______________________________ Date:___________________________ Figure 4
32
Irradiated,Raw Model
HACCP PLAN
PROCESS CATEGORY,IRRADIATED,RAW PRODUCT
PRODUCT EXAMPLE,FRESH POULTRY
CCP # and
Location
Critical
Limits
Monitoring
Procedures and
Frequency
HACCP
Records
Verification Procedures and
Frequency
Corrective Actions
2B
Packaging/
Labeling
Approved
packaging
material listed
in 21 CFR
179.45 and 9
CFR 381.149,
Label with
radura,
“Treated with
radiation”,or
“Treated by
irradiation”
Handling
Statement,
Cooking
Instructions,
Safe
Handling
Instructions,
Packaging line
supervisor will
randomly sample
packages of product
once per shift and
ensure packaging
material and labeling
requirements are met,
Packaging/
Labeling Log
Corrective
Actions Log
QA will observe packaging line
supervisor perform monitoring activity
once per shift,
QA will sample labels intended for use
from label storage area twice weekly to
ensure label accuracy,
QA will check labels once a day on
packaged product to ensure label
accuracy on packaged product,
QA will segregate and hold incorrectly
packaged and/or labeled product,
Follow SOPs for product disposition,
QA will identify the cause of the
deviation and prevent reoccurrence,
Signature, _______________________________ Date:___________________________ Figure 4
33
Irradiated,Raw Model
HACCP PLAN
PROCESS CATEGORY,IRRADIATED,RAW PRODUCT
PRODUCT EXAMPLE,FRESH POULTRY
CCP # and
Location
Critical
Limits
Monitoring
Procedures and
Frequency
HACCP
Records
Verification Procedures and
Frequency
Corrective Actions
3B
Storage
(Cold)/Trans
porting
Temperature
of product,
storage and
transport at
27-38° F,
QA personnel will
check raw product
temperature every
two hours,
Maintenance
personnel will check
storage area
temperature every
two hours,
Product
Temperature Log
Room
Temperature Log
Thermometer
Calibration Log
Corrective
Actions Log
QA supervisor will check Product
Temperature Log and Room
Temperature Log twice per shift,
Maintenance supervisor will verify
accuracy of the Room Temperature Log
once per shift,
QA will check all thermometers used
for monitoring and verification for
accuracy daily and calibrate to within
1° F accuracy as necessary,
QA will reject or hold product until
temperature is achieved,dependent on
time and temperature deviation,Follow
standard operating procedures for
product disposition,
QA and maintenance personnel will
identify the cause of the deviation and
prevent reoccurrence,
Signature, ________________________________ Date:___________________________ Figure 4
34
Irradiated,Raw Model
HACCP PLAN
PROCESS CATEGORY,IRRADIATED,RAW PRODUCT
PRODUCT EXAMPLE,FRESH POULTRY
CCP # and
Location
Critical
Limits
Monitoring
Procedures and
Frequency
HACCP
Records
Verification Procedures and
Frequency
Corrective Actions
4B
Raw Poultry
Irradiation
Minimum
absorbed
dose,1.5
kilogray (150
kilorads)
Maximum
absorbed
dose,3.0
kilogray (300
kilorads) as
found in 9
CFR 381.147
and 381.149
Production supervisor
will monitor the data
log printout from the
irradiation control
board for each
irradiated batch,
Production supervisor
will take dosimeter
readings for each
irradiated batch
Irradiation Data
Log printout
Irradiation/Dose
Mapping Log
Letter of
guarantee for
dosimeter
calibration
Corrective
Actions Log
QA will verify irradiation data log
printout,
QA will verify letter of guarantee for
calibration of the dosimeter every 12
months,
QA will verify that absorbed doses
received by product are within the
minimum and maximum limits from
results of dose mapping,
QA supervisor will segregate and hold
affected products,
QA will condemn affected products,
Follow standard operating procedures
for disposition of irradiated products,
Certified irradiation maintenance
personnel will identify and correct the
problem with the irradiation unit and
ensure no reocurrence of the problem,
QA will implement a preventive
maintenance program,
Signature, ________________________________ Date:___________________________ Figure 4
35
Irradiated,Raw Model
HACCP PLAN
PROCESS CATEGORY,IRRADIATED,RAW PRODUCT
PRODUCT EXAMPLE,FRESH POULTRY
CCP #
and
Location
Critical
Limits
Monitoring
Procedures and
Frequency
HACCP
Records
Verification Procedures and
Frequency
Corrective Actions
5B
Finished
Product
Storage
(Cold)
Finished
product and
storage area
shall be
maintained at
27-38° F,
QA personnel will
check raw product
temperature every
two hours,
Maintenance
personnel will check
storage area
temperature every
two hours,
Product
Temperature Log
Room
Temperature Log
Thermometer
Calibration Log
Corrective
Actions Log
QA supervisor will check Product
Temperature Log and Room
Temperature Log twice per shift,
Maintenance supervisor will verify
accuracy of the Room Temperature Log
once per shift,
QA will check all thermometers used
for monitoring and verification for
accuracy daily and calibrate to within
1° F accuracy as necessary,
QA will reject or hold product until
temperature is achieved,dependent on
time and temperature deviation,Follow
standard operating procedures for
product disposition,
QA and maintenance personnel will
identify the cause of the deviation and
prevent reoccurrence,
Signature, ________________________________ Date:___________________________ Figure 4
36
Irradiated,Raw Model
FORM LETTER requesting Salmonella Data
Date
To: FSIS
FOIA Coordinator
USDA
This is to request results of any Salmonella performance standard sample sets completed during the past two months from
establishments listed below,
Thank you,
File Copy Date Results
Received
Two Consecutive
Failed Sets?
If Yes,Remarks
Est,YYY
Est,ZZZ
Est,AAA
37
Irradiated,Raw Model
FORM LETTER requesting Salmonella Data
To: FSIS
FOIA Coordinator
USDA
This is to request results of any Salmonella performance standard sample sets completed during the past two months from
establishments listed below,
Thank you,
Est,YYY
Est,ZZZ
Est,AAA
38
Irradiated,Raw Model
GENERIC ESTABLISHMENT X,
PRODUCT:______________________________
TIME TEMP Deviation from
CL? if
yes)
If Yes,
Corrective Action?
Monitored by,Verified by,
6:36 AM 34°F PS
8:30 AM 33°F PS
10:32 AM 34°F PS
CB
12:30 PM 36°F
Notify maint,supv.,CB & QA PS
PRODUCT TEMPERATURE LOG
DATE:_________
(Check
TIME/TEMPERATURE CRITICAL LIMIT,
39
Irradiated,Raw Model
GENERIC ESTABLISHMENT X,
STORAGE ROOM:_________________________
TIME TEMP Deviation from
CL? if
yes)
If Yes,
Corrective Action?
Monitored by,Verified by,
6:36 AM 34°F PS
8:30 AM 33°F PS
10:32 AM 34°F PS
CB
12:30 PM 36°F
Notify maint,supv.,CB & QA PS
ROOM TEMPERATURE LOG
DATE:_________
(Check
TIME/TEMPERATURE CRITICAL LIMIT,
40
Irradiated,Raw Model
THERMOMETER CALIBRATION LOG
Criteria Within 1? °F of Control Thermometer
Date Time Department or
Area
Thermometer ID# Control
Thermometer
Reading
Personal
Thermometer
Reading
Adjustment
Required (Yes
or No)
Initials Comments
6/15 1:00 PM Chiller 2A 32°F 32°F No HK
* If a thermometer is broken or taken out of service,document this in the comment column,
Verified by,_______________________
Date/Time,_______________________
41
Irradiated,Raw Model
GENERIC ESTABLISHMENT X,IRRADIATION/ DOSE MAPPING LOG
DATE,_________________
Lot or
Irradiation ID
Dosimeter
Positions
Absorption Dose (KGY) Verified By,
42
Irradiated,Raw Model
CORRECTIVE ACTIONS LOG
Product,___________________________________________
CCP Deviation/
Problem
Disposition of
Product
Corrective Action
Procedures/Explain
Measures to
Prevent
Recurrence
Responsible
Person
Time
SIGNATURE,__________________________ DATE,______________________
43
Irradiated,Raw Model
Pre-Shipment Review Log Date:______________
LOT ID TIME RECORDS
REVIEWED
BY
WHOM
LOT RELEASED FOR SHIPMENT?
SIGNATURE
11:10 a.m,
11:10 p.m,
44
